@article {721426,
	title = {Data-driven coaching to improve statewide outcomes in CABG: before and after interventional study},
	journal = {Int J Surg},
	year = {2024},
	month = {2024 Feb 13},
	abstract = {BACKGROUND: The impact of quality improvement initiatives Program (QIP) on coronary artery bypass grafting surgery (CABG) remains scarce, despite improved outcomes in other surgical areas. This study aims to evaluate the impact of a package of QIP on mortality rates among patients undergoing CABG.

MATERIALS AND METHODS: This prospective cohort study utilized data from the multicenter database Registro Paulista de Cirurgia Cardiovascular II (REPLICCAR II), spanning from July 2017 to June 2019. Data from 4,018 isolated CABG adult patients were collected and analyzed in three phases: before-implementation, implementation, and after-implementation of the intervention (which comprised QIP training for the hospital team). Propensity Score Matching was used to balance the groups of 2,170 patients each for a comparative analysis of the following outcomes: reoperation, deep sternal wound infection/mediastinitis <= 30 days, cerebrovascular accident, acute kidney injury, ventilation time\&gt;24 hours, length of stay\&lt;6 days, length of stay\&gt;14 days, morbidity and mortality, and operative mortality. A multiple regression model was constructed to predict mortality outcomes.

RESULTS: Following implementation, there was a significant reduction of operative mortality (61.7\%, P=0.046), as well as deep sternal wound infection/mediastinitis (P\&lt;0.001), sepsis (P=0.002), ventilation time in hours (P\&lt;0.001), prolonged ventilation time (P=0.009), postoperative peak blood glucose (P\&lt;0.001), total length of hospital stay (P\&lt;0.001). Additionally, there was a greater use of arterial grafts, including internal thoracic (P\&lt;0.001) and radial (P=0.038), along with a higher rate of skeletonized dissection of the internal thoracic artery.

CONCLUSIONS: QIP was associated with a 61.7\% reduction in operative mortality following CABG. Although not all complications exhibited a decline, the reduction in mortality suggests a possible decrease in failure to rescue during the after-implementation period.},
	issn = {1743-9159},
	doi = {10.1097/JS9.0000000000001153},
	author = {Mejia, Omar A V and Borgomoni, Gabrielle B and de Freitas, Fabiane Let{\'\i}cia and Furl{\'a}n, Lucas S and Orlandi, Bianca Maria M and Tiveron, Marcos G and Silva, Pedro Gabriel M de B E and Nakazone, Marcelo A and Oliveira, Marco Antonio P de and Campagnucci, Valqu{\'\i}ria P and Normand, Sharon-Lise and Dias, Roger D and Jatene, F{\'a}bio B}
}
@article {721421,
	title = {How Treatment Effect Heterogeneity Works},
	journal = {NEJM Evid},
	volume = {3},
	number = {3},
	year = {2024},
	month = {2024 Mar},
	pages = {EVIDstat2400019},
	abstract = {How Treatment Effect Heterogeneity WorksThis Stats, STAT! animated video explores the concept of treatment effect heterogeneity. Differences in the effectiveness of treatments across participants in a clinical trial is important to understand when deciding how to apply clinical trial results to clinical practice.},
	keywords = {Humans, Treatment effect heterogeneity},
	issn = {2766-5526},
	doi = {10.1056/EVIDstat2400019},
	author = {Hardin, C Corey and Fralick, Michael and Muller, Daniel and Knoper, Kimberly and Burke, Alison and Stern, Kathy and Li, Suellen and Normand, Sharon-Lise and Sacks, Chana A}
}
@article {721451,
	title = {Quality Measure Adherence and Oral Health Outcomes in Children},
	journal = {JAMA Netw Open},
	volume = {7},
	number = {1},
	year = {2024},
	month = {2024 Jan 02},
	pages = {e2353861},
	abstract = {IMPORTANCE: Process-based quality measures are generally intended to promote evidence-based practices that have been proven to improve outcomes. However, due to lack of standardized implementation of diagnostic codes in dentistry, assessing the association between process and oral health outcomes has been challenging.

OBJECTIVE: To estimate the association of adhering to dental quality measures with patient oral health outcomes.

DESIGN, SETTING, AND PARTICIPANTS: Using a target trial emulation, a causal inference framework, this retrospective cohort study estimated the difference in the risk of developing tooth decay between US children who adhered to process-based dental quality measures (receiving topical fluoride and sealant [treated groups]) and those who did not (control groups). Electronic health records of US children and adolescents aged 0 to 18 years from January 1, 2014, to December 31, 2020, were used. To emulate random treatment assignment based on baseline confounders, coarsened exact matching was used to produce covariate balance between the treated and control groups. A time-to-event regression model produced effect estimates, adjusting for time-varying covariates. Near-far matching was used to account for unmeasured confounders as a sensitivity analysis. Data were analyzed from May 1 to August 7, 2023.

EXPOSURES: Adherence to dental quality measures.

MAIN OUTCOMES AND MEASURES: Incidence of tooth decay.

RESULTS: Among 69 212 US children aged between 0 and 18 years (mean [SD] age, 10.2 [5.0] years; 49.5\% male, 50.4\% female, and 0.1\% unknown or transgender), 1930 (2.8\%) were Asian, 2038 (2.9\%) were Black, 8667 (12.5\%) were Hispanic, 33 632 (48.6\%) were White, and 22 945 (33.2\%) were multiracial, other, or missing racial and ethnic group identification. Relative to control individuals, treated individuals were more likely to be at elevated risk of caries (fluoride measure: 16 453 [76.5\%] vs 15 236 [39.8\%]; sealant measure: 2264 [54.6\%] vs 997 [44.0\%]) and have regular dental visits (fluoride measure: 21 498 [100\%] vs 13 741 [35.9\%]; sealant measure: 1623 [39.2\%] vs 871 [38.4\%]). Adherence to quality measures was associated with reduced risk of tooth decay with adjusted hazard ratios of 0.82 (95\% CI, 0.78- 0.86) for fluoride and 0.86 (95\% CI, 0.76-0.97) for sealant in the matched cohort. Benefits of adhering to quality measures were greater among children at elevated vs low risk and with public vs commercial insurance for both measures.

CONCLUSIONS: In this cohort study, adhering to dental quality measures was associated with reduced risk of tooth decay, and benefits were greater among children at elevated risk and with public insurance. These findings provide insights in facilitating targeted application of quality measures or developing more tailored quality improvement initiatives.},
	keywords = {Adolescent, Child, Child, Preschool, Cohort Studies, Female, Fluorides, Humans, Infant, Infant, Newborn, Male, Outcome Assessment, Health Care, Quality Indicators, Health Care, Retrospective Studies},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2023.53861},
	author = {Choi, Sung Eun and Ankur Pandya and White, Joel and Mertz, Elizabeth and Normand, Sharon-Lise}
}
@article {721416,
	title = {Questioning a Sensible Result},
	journal = {NEJM Evid},
	volume = {3},
	number = {3},
	year = {2024},
	month = {2024 Mar},
	pages = {EVIDe2300324},
	abstract = {Contemporary data collection strategies, storage capabilities, and modern statistical methodology have made retrospective analyses of observational databases commonplace. Such databases afford opportunities to learn about the effectiveness and risks of interventions or health behaviors that generally cannot be randomized. In this issue of NEJM Evidence, Cho et~al.1 assemble survey data and cohort data from four countries to quantify the association between age-sex-specific smoking cessation and mortality. The authors conclude that smoking cessation at any age is associated with lower excess overall mortality risk and lower death from diseases made more common by smoking. It is difficult to argue with this conclusion - to question the magnitude of the associations is not.},
	keywords = {Data Collection, Databases, Factual, Female, Health Behavior, Humans, Learning, Male, Observational Studies as Topic, Retrospective Studies},
	issn = {2766-5526},
	doi = {10.1056/EVIDe2300324},
	author = {Normand, Sharon-Lise T.}
}
@article {722001,
	title = {Racial and Ethnic Differences in Telemedicine Use},
	journal = {JAMA Health Forum},
	volume = {5},
	number = {3},
	year = {2024},
	month = {2024 Mar 01},
	pages = {e240131},
	abstract = {IMPORTANCE: Individuals of racial and ethnic minority groups may be less likely to use telemedicine in part due to lack of access to technology (ie, digital divide). To date, some studies have found less telemedicine use by individuals of racial and ethnic minority groups compared with White individuals, and others have found the opposite. What explains these different findings is unclear.

OBJECTIVE: To quantify racial and ethnic differences in the receipt of telemedicine and total visits with and without accounting for demographic and clinical characteristics and geography.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included individuals who were continuously enrolled in traditional Medicare from March 2020 to February 2022 or until death.

EXPOSURE: Race and ethnicity, which was categorized as Black non-Hispanic, Hispanic, White non-Hispanic, other (defined as American Indian/Pacific Islander, Alaska Native, and Asian), and unknown/missing.

MAIN OUTCOMES AND MEASURES: Total telemedicine visits (audio-video or audio); total visits (telemedicine or in-person) per individual during the study period. Multivariable models were used that sequentially adjusted for demographic and clinical characteristics and geographic area to examine their association with differences in telemedicine and total visit utilization by documented race and ethnicity.

RESULTS: In this national sample of 14 305 819 individuals, 7.4\% reported that they were Black, 5.6\% Hispanic, and 4.2\% other race. In unadjusted results, compared with White individuals, Black individuals, Hispanic individuals, and individuals of other racial groups had 16.7 (95\% CI, 16.1-17.3), 32.9 (95\% CI, 32.3-33.6), and 20.9 (95\% CI, 20.2-21.7) more telemedicine visits per 100 beneficiaries, respectively. After adjustment for clinical and demographic characteristics and geography, compared with White individuals, Black individuals, Hispanic individuals, and individuals of other racial groups had 7.9 (95\% CI, -8.5 to -7.3), 13.2 (95\% CI, -13.9 to -12.6), and 9.2 (95\% CI, -10.0 to -8.5) fewer telemedicine visits per 100 beneficiaries, respectively. In unadjusted and fully adjusted models, and in 2019 and the second year of the COVID-19 pandemic, Black individuals, Hispanic individuals, and individuals of other racial groups continued to have fewer total visits than White individuals.

CONCLUSIONS AND RELEVANCE: The results of this cross-sectional study of US Medicare enrollees suggest that although nationally, Black individuals, Hispanic individuals, and individuals of other racial groups received more telemedicine visits during the pandemic and disproportionately lived in geographic regions with higher telemedicine use, after controlling for geographic region, Black individuals, Hispanic individuals, and individuals of other racial groups received fewer telemedicine visits than White individuals.},
	keywords = {Aged, Cross-Sectional Studies, ethnicity, Humans, Medicare, Minority Groups, Pandemics, United States},
	issn = {2689-0186},
	doi = {10.1001/jamahealthforum.2024.0131},
	author = {Marcondes, Felippe O and Normand, Sharon-Lise T. and Le Cook, Benjamin and Huskamp, Haiden A. and Rodriguez, Jorge A and Michael L. Barnett and Uscher-Pines, Lori and Alisa B. Busch and Ateev Mehrotra}
}
@article {721446,
	title = {Targeted learning in observational studies with multi-valued treatments: An evaluation of antipsychotic drug treatment safety},
	journal = {Stat Med},
	volume = {43},
	number = {8},
	year = {2024},
	month = {2024 Apr 15},
	pages = {1489-1508},
	abstract = {We investigate estimation of causal effects of multiple competing (multi-valued) treatments in the absence of randomization. Our work is motivated by an intention-to-treat study of the relative cardiometabolic risk of assignment to one of six commonly prescribed antipsychotic drugs in a cohort of nearly 39~000 adults with serious mental illnesses. Doubly-robust estimators, such as targeted minimum loss-based estimation (TMLE), require correct specification of either the treatment model or outcome model to ensure consistent estimation; however, common TMLE implementations estimate treatment probabilities using multiple binomial regressions rather than multinomial regression. We implement a TMLE estimator that uses multinomial treatment assignment and ensemble machine learning to estimate average treatment effects. Our multinomial implementation improves coverage, but does not necessarily reduce bias, relative to the binomial implementation in simulation experiments with varying treatment propensity overlap and event rates. Evaluating the causal effects of the antipsychotics on 3-year diabetes risk or death, we find a safety benefit of moving from a second-generation drug considered among the safest of the second-generation drugs to an infrequently prescribed first-generation drug known for having low cardiometabolic risk.},
	keywords = {Antipsychotic Agents, Cardiovascular Diseases, Computer Simulation, Humans, Likelihood Functions, Models, Statistical},
	issn = {1097-0258},
	doi = {10.1002/sim.10003},
	author = {Poulos, Jason and Horvitz-Lennon, Marcela and Zelevinsky, Katya and Cristea-Platon, Tudor and Huijskens, Thomas and Tyagi, Pooja and Yan, Jiaju and Diaz, Jordi and Normand, Sharon-Lise}
}
@article {715916,
	title = {Analysis of Race and Ethnicity, Socioeconomic Factors, and Tooth Decay Among US Children},
	journal = {JAMA Netw Open},
	volume = {6},
	number = {6},
	year = {2023},
	month = {2023 Jun 01},
	pages = {e2318425},
	abstract = {IMPORTANCE: While large oral health disparities remain by race and ethnicity among children, the associations of race, ethnicity, and mediating factors with oral health outcomes are poorly characterized. Identifying the pathways that explain these disparities would be critical to inform policies to effectively reduce them.

OBJECTIVE: To measure racial and ethnic disparities in the risk of developing tooth decay and quantify relative contributions of factors mediating the observed disparities among US children.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used electronic health records of US children from 2014 to 2020 to measure racial and ethnic disparities in the risk of tooth decay. Elastic net regularization was used to select variables to be included in the model among medical conditions, dental procedure types, and individual- and community-level socioeconomic factors. Data were analyzed from January 9 to April 28, 2023.

EXPOSURES: Race and ethnicity of children.

MAIN OUTCOMES AND MEASURES: The main outcome was diagnosis of tooth decay in either deciduous or permanent teeth, defined as at least 1 decayed, filled, or missing tooth due to caries. An Anderson-Gill model, a time-to-event model for recurrent tooth decay events with time-varying covariates, stratified by age groups (0-5, 6-10, and 11-18 years) was estimated. A nonlinear multiple additive regression tree-based mediation analysis quantified the relative contributions of factors underlying the observed racial and ethnic disparities.

RESULTS: Among 61 083 children and adolescents aged 0 to 18 years at baseline (mean [SD] age, 9.9 [4.6] years; 30 773 [50.4\%] female), 2654 Black individuals (4.3\%), 11 213 Hispanic individuals (18.4\%), 42 815 White individuals (70.1\%), and 4401 individuals who identified as another race (eg, American Indian, Asian, and Hawaiian and Pacific Islander) (7.2\%) were identified. Larger racial and ethnic disparities were observed among children aged 0 to 5 years compared with other age groups (Hispanic children: adjusted hazard ratio [aHR], 1.47; 95\% CI, 1.40-1.54; Black children: aHR, 1.30; 95\% CI, 1.19-1.42; other race children: aHR, 1.39; 95\% CI, 1.29-1.49), compared with White children. For children aged 6 to 10 years, higher risk of tooth decay was observed for Black children (aHR, 1.09; 95\% CI, 1.01-1.19) and Hispanic children (aHR, 1.12; 95\% CI, 1.07-1.18) compared with White children. For adolescents aged 11 to 18 years, a higher risk of tooth decay was observed only in Black adolescents (aHR, 1.17; 95\% CI, 1.06-1.30). A mediation analysis revealed that the association of race and ethnicity with time to first tooth decay became negligible, except for Hispanic and children of other race aged 0 to 5 years, suggesting that mediators explained most of the observed disparities. Insurance type explained the largest proportion of the disparity, ranging from 23.4\% (95\% CI, 19.8\%-30.2\%) to 78.9\% (95\% CI, 59.0\%-114.1\%), followed by dental procedures (receipt of topical fluoride and restorative procedures) and community-level factors (education attainment and Area Deprivation Index).

CONCLUSIONS: In this retrospective cohort study, large proportions of disparities in time to first tooth decay associated with race and ethnicity were explained by insurance type and dental procedure types among children and adolescents. These findings can be applied to develop targeted strategies to reduce oral health disparities.},
	keywords = {Adolescent, Asian American Native Hawaiian and Pacific Islander, Black or African American, Child, Dental Caries, ethnicity, Hispanic or Latino, Humans, Retrospective Studies, Socioeconomic Factors, White},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2023.18425},
	author = {Choi, Sung Eun and White, Joel and Mertz, Elizabeth and Normand, Sharon-Lise}
}
@article {715876,
	title = {Antipsychotics and the risk of diabetes and death among adults with serious mental illnesses},
	journal = {Psychol Med},
	volume = {53},
	number = {16},
	year = {2023},
	month = {2023 Dec},
	pages = {7677-7684},
	abstract = {BACKGROUND: Individuals with schizophrenia exposed to second-generation antipsychotics (SGA) have an increased risk for diabetes, with aripiprazole purportedly a safer drug. Less is known about the drugs{\textquoteright} mortality risk or whether serious mental illness (SMI) diagnosis or race/ethnicity modify these effects.

METHODS: Authors created a retrospective cohort of non-elderly adults with SMI initiating monotherapy with an SGA (olanzapine, quetiapine, risperidone, and ziprasidone, aripiprazole) or haloperidol during 2008-2013. Three-year diabetes incidence or all-cause death risk differences were estimated between each drug and aripiprazole, the comparator, as well as effects within SMI diagnosis and race/ethnicity. Sensitivity analyses evaluated potential confounding by indication.

RESULTS: 38 762 adults, 65\% White and 55\% with schizophrenia, initiated monotherapy, with haloperidol least (6\%) and quetiapine most (26{\textperiodcentered}5\%) frequent. Three-year mortality was 5\% and diabetes incidence 9.3\%. Compared with aripiprazole, haloperidol and olanzapine reduced diabetes risk by 1.9 (95\% CI 1.2-2.6) percentage points, or a 18.6 percentage point reduction relative to aripiprazole users{\textquoteright} unadjusted risk (10.2\%), with risperidone having a smaller advantage. Relative to aripiprazole users{\textquoteright} unadjusted risk (3.4\%), all antipsychotics increased mortality risk by 1.1-2.2 percentage points, representing 32.4-64.7 percentage point increases. Findings within diagnosis and race/ethnicity were generally consistent with overall findings. Only quetiapine{\textquoteright}s higher mortality risk held in sensitivity analyses.

CONCLUSIONS: Haloperidol{\textquoteright}s, olanzapine{\textquoteright}s, and risperidone{\textquoteright}s lower diabetes risks relative to aripiprazole were not robust in sensitivity analyses but quetiapine{\textquoteright}s higher mortality risk proved robust. Findings expand the evidence on antipsychotics{\textquoteright} risks, suggesting a need for caution in the use of quetiapine among individuals with SMI.},
	keywords = {Adult, Antipsychotic Agents, Aripiprazole, Benzodiazepines, Diabetes Mellitus, Haloperidol, Humans, Middle Aged, Olanzapine, Quetiapine Fumarate, Retrospective Studies, Risperidone, Schizophrenia},
	issn = {1469-8978},
	doi = {10.1017/S0033291723001502},
	author = {Poulos, Jason and Normand, Sharon-Lise T. and Zelevinsky, Katya and Newcomer, John W and Denis Agniel and Abing, Haley K and Horvitz-Lennon, Marcela}
}
@article {715896,
	title = {Association of a calcium channel blocker and diuretic prescribing cascade with adverse events: A population-based cohort study},
	journal = {J Am Geriatr Soc},
	year = {2023},
	month = {2023 Nov 27},
	abstract = {BACKGROUND: Prescribing cascades occur when a drug adverse event is misinterpreted as a new medical condition and a second, potentially unnecessary drug, is prescribed to treat the adverse event. The population-level consequences of prescribing cascades remain unknown.

METHODS: This population-based cohort study used linked health administrative databases in Ontario, Canada. The study included community-dwelling adults, 66 years of age or older with hypertension and no history of heart failure (HF) or diuretic use in the prior year, newly dispensed a calcium channel blocker (CCB). Individuals subsequently dispensed a diuretic within 90 days of incident CCB dispensing were classified as the prescribing cascade group, and compared to those not dispensed a diuretic, classified as the non-prescribing cascade group. Those with and without a prescribing cascade were matched one-to-one on the propensity score and sex. The primary outcome was a serious adverse event (SAE), which was the composite of emergency room visits and hospitalizations in the 90-day follow-up period. We estimated hazard ratios (HRs) with 95\% confidence intervals (CI) for SAE using an Andersen-Gill recurrent events regression model.

RESULTS: Among 39,347 older adults with hypertension and no history of HF who were newly dispensed a CCB, 1881 (4.8\%) had a new diuretic dispensed within 90 days after CCB initiation. Compared to the non-prescribing cascade group, those in the prescribing cascade group had higher rates of SAEs (HR: 1.21, 95\% CI: 1.02-1.43).

CONCLUSIONS: The CCB-diuretic prescribing cascade was associated with an increased rate of SAEs, suggesting harm beyond prescribing a second drug therapy. Our study raises awareness of the downstream impact of the CCB-diuretic prescribing cascade at a population level and provides an opportunity for clinicians who identify this prescribing cascade to review their patients{\textquoteright} medications to determine if they can be optimized.},
	issn = {1532-5415},
	doi = {10.1111/jgs.18683},
	author = {Rochon, Paula A and Austin, Peter C and Normand, Sharon-Lise and Savage, Rachel D and Read, Stephanie H and McCarthy, Lisa M and Giannakeas, Vasily and Wu, Wei and Strauss, Rachel and Wang, Xuesong and Chen, Simon and Gurwitz, Jerry H}
}
@article {721441,
	title = {Bayesian Way},
	journal = {NEJM Evid},
	volume = {2},
	number = {5},
	year = {2023},
	month = {2023 May},
	pages = {EVIDstat2300090},
	abstract = {Bayesian WayThis animated video explores two possible approaches to analyzing data in a randomized controlled trial: "Frequentist" versus "Bayesian."},
	keywords = {Bayes Theorem, Randomized Controlled Trials as Topic},
	issn = {2766-5526},
	doi = {10.1056/EVIDstat2300090},
	author = {Hardin, C Corey and Halabi, Susan and Muller, Daniel and Koscal, Natalie and Vining, Tim and Normand, Sharon-Lise and Sacks, Chana A}
}
@article {721411,
	title = {Data sources and applied methods for paclitaxel safety signal discernment},
	journal = {Front Cardiovasc Med},
	volume = {10},
	year = {2023},
	month = {2023},
	pages = {1331142},
	abstract = {BACKGROUND: Following the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB) and drug-eluting stent (DES). The objective of this review is to (1) identify and summarize the existing clinical and cohort studies assessing paclitaxel-coated DCBs and DESs, (2) describe and determine the quality of the available data sources for the evaluation of these devices, and (3) present methodologies that can be leveraged for proper signal discernment within available data sources.

METHODS: Studies and data sources were identified through comprehensive searches. original research studies, clinical trials, comparative studies, multicenter studies, and observational cohort studies written in the English language and published from January 2007 to November 2021, with a follow-up longer than 36 months, were included in the review. Data quality of available data sources identified was assessed in three groupings. Moreover, accepted data-driven methodologies that may help circumvent the limitations of the extracted studies and data sources were extracted and described.

RESULTS: There were 39 studies and data sources identified. This included 19 randomized clinical trials, nine single-arm studies, eight registries, three administrative claims, and electronic health records. Methodologies focusing on the use of existing premarket clinical data, the incorporation of all contributed patient time, the use of aggregated data, approaches for individual-level data, machine learning and artificial intelligence approaches, Bayesian approaches, and the combination of various datasets were summarized.

CONCLUSION: Despite the multitude of available studies over the course of eleven years following the first clinical trial, the FDA-convened advisory panel found them insufficient for comprehensively assessing the late-mortality signal. High-quality data sources with the capabilities of employing advanced statistical methodologies are needed to detect potential safety signals in a timely manner and allow regulatory bodies to act quickly when a safety signal is detected.},
	issn = {2297-055X},
	doi = {10.3389/fcvm.2023.1331142},
	author = {Gressler, Laura Elisabeth and Avila-Tang, Erika and Mao, Jialin and Avalos-Pacheco, Alejandra and Shaya, Fadia T and Torosyan, Yelizaveta and Liebeskind, Alexander and Kinard, Madris and Mack, Christina D and Normand, Sharon-Lise and Ritchey, Mary E and Marinac-Dabic, Danica}
}
@article {715886,
	title = {Healthcare Access for a Diverse Population with Schizophrenia Following the Onset of the COVID-19 Pandemic},
	journal = {Community Ment Health J},
	year = {2023},
	month = {2023 May 18},
	pages = {1-9},
	abstract = {COVID-19 has had a disproportionate impact on the most disadvantaged members of society, including minorities and those with disabling chronic illnesses such as schizophrenia. We examined the pandemic{\textquoteright}s impacts among New York State{\textquoteright}s Medicaid beneficiaries with schizophrenia in the immediate post-pandemic surge period, with a focus on equity of access to critical healthcare. We compared changes in utilization of key behavioral health outpatient services and inpatient services for life-threatening conditions between the pre-pandemic and surge periods for White and non-White beneficiaries. We found racial and ethnic differences across all outcomes, with most differences stable over time. The exception was pneumonia admissions-while no differences existed in the pre-pandemic period, Black and Latinx beneficiaries were less likely than Whites to be hospitalized in the surge period despite minorities{\textquoteright} heavier COVID-19 disease burden. The emergence of racial and ethnic differences in access to scarce life-preserving healthcare may hold lessons for future crises.},
	issn = {1573-2789},
	doi = {10.1007/s10597-023-01105-1},
	author = {Horvitz-Lennon, Marcela and Leckman-Westin, Emily and Finnerty, Molly and Jeong, Junghye and Tsuei, Jeannette and Zelevinsky, Katya and Chen, Qingxian and Normand, Sharon-Lise T.}
}
@article {721436,
	title = {How Censoring Works},
	journal = {NEJM Evid},
	volume = {2},
	number = {10},
	year = {2023},
	month = {2023 Oct},
	pages = {EVIDstat2300205},
	abstract = {How Censoring WorksA common challenge in clinical research is determining the time to occurrence of a given event. This animated video explores the concept of censoring in survival analysis and how investigators deal with ambiguity in the time of an event{\textquoteright}s occurrence.},
	issn = {2766-5526},
	doi = {10.1056/EVIDstat2300205},
	author = {Hardin, C Corey and Muller, Daniel and Li, Suellen and Fralick, Michael and Vining, Tim and Normand, Sharon-Lise and Sacks, Chana A}
}
@article {721431,
	title = {How Statistical Power Works},
	journal = {NEJM Evid},
	volume = {2},
	number = {12},
	year = {2023},
	month = {2023 Dec},
	pages = {EVIDstat2300283},
	abstract = {How Statistical Power WorksThis Stats, STAT! animated video explores the concept of statistical power and explains how clinical investigators determine how many participants to enroll in a randomized trial.},
	issn = {2766-5526},
	doi = {10.1056/EVIDstat2300283},
	author = {Li, Suellen and Hardin, C Corey and Muller, Daniel and Ling, Emily and Vining, Tim and Normand, Sharon-Lise and Sacks, Chana A}
}
@article {715906,
	title = {Medical and Psychiatric Care Preceding the First Psychotic Disorder Diagnosis},
	journal = {Schizophr Bull},
	year = {2023},
	month = {2023 Aug 22},
	abstract = {BACKGROUND: Individuals with psychotic symptoms experience substantial morbidity and have shortened life expectancies; early treatment may mitigate the worst effects. Understanding care preceding a first psychotic disorder diagnosis is critical to inform early detection and intervention.

STUDY DESIGN: In this observational cohort study using comprehensive information from the Massachusetts All-Payer Claims Database, we identified the first psychotic disorder diagnosis in 2016, excluding those with historical psychotic disorder diagnoses in the prior 48 months among those continuous enrollment data. We reviewed visits, medications, and hospitalizations 2012-2016. We used logistic regression to examine characteristics associated with pre-diagnosis antipsychotic use.

STUDY RESULTS: There were 2505 individuals aged 15-35 years (146 per 100 000 similarly aged individuals in the database) with a new psychotic disorder diagnosis in 2016. Most (97\%) had at least one outpatient visit in the preceding 48 months; 89\% had a prior mental health diagnosis unrelated to psychosis (eg, anxiety [60\%], depression [60\%]). Many received psychotropic medications (77\%), including antipsychotic medications (46\%), and 68\% had a visit for injury or trauma during the preceding 48 months. Characteristics associated with filling an antipsychotic medication before the psychotic disorder diagnosis included male sex and Medicaid insurance at psychosis diagnosis.

CONCLUSIONS: In this insured population of Massachusetts residents with a new psychotic disorder diagnosis, nearly all had some healthcare utilization, visits for injury or trauma were common, and nearly half filled an antipsychotic medication in the preceding 48 months. These patterns of care could represent either pre-disease signals, delays, or both in receiving a formal diagnosis.},
	issn = {1745-1701},
	doi = {10.1093/schbul/sbad125},
	author = {Benson, Nicole M and Yang, Zhiyou and Fung, Vicki and Normand, Sharon-Lise and Keshavan, Matcheri S and {\"O}ng{\"u}r, Dost and Hsu, John}
}
@article {715901,
	title = {Medical and Psychiatric Care Preceding the First Psychotic Disorder Diagnosis},
	journal = {Schizophr Bull},
	year = {2023},
	month = {2023 Aug 22},
	abstract = {BACKGROUND: Individuals with psychotic symptoms experience substantial morbidity and have shortened life expectancies; early treatment may mitigate the worst effects. Understanding care preceding a first psychotic disorder diagnosis is critical to inform early detection and intervention.

STUDY DESIGN: In this observational cohort study using comprehensive information from the Massachusetts All-Payer Claims Database, we identified the first psychotic disorder diagnosis in 2016, excluding those with historical psychotic disorder diagnoses in the prior 48 months among those continuous enrollment data. We reviewed visits, medications, and hospitalizations 2012-2016. We used logistic regression to examine characteristics associated with pre-diagnosis antipsychotic use.

STUDY RESULTS: There were 2505 individuals aged 15-35 years (146 per 100 000 similarly aged individuals in the database) with a new psychotic disorder diagnosis in 2016. Most (97\%) had at least one outpatient visit in the preceding 48 months; 89\% had a prior mental health diagnosis unrelated to psychosis (eg, anxiety [60\%], depression [60\%]). Many received psychotropic medications (77\%), including antipsychotic medications (46\%), and 68\% had a visit for injury or trauma during the preceding 48 months. Characteristics associated with filling an antipsychotic medication before the psychotic disorder diagnosis included male sex and Medicaid insurance at psychosis diagnosis.

CONCLUSIONS: In this insured population of Massachusetts residents with a new psychotic disorder diagnosis, nearly all had some healthcare utilization, visits for injury or trauma were common, and nearly half filled an antipsychotic medication in the preceding 48 months. These patterns of care could represent either pre-disease signals, delays, or both in receiving a formal diagnosis.},
	issn = {1745-1701},
	doi = {10.1093/schbul/sbad125},
	author = {Benson, Nicole M and Yang, Zhiyou and Fung, Vicki and Normand, Sharon-Lise and Keshavan, Matcheri S and {\"O}ng{\"u}r, Dost and Hsu, John}
}
@article {715926,
	title = {Nursing home infection control strategies during the COVID-19 pandemic},
	journal = {J Am Geriatr Soc},
	volume = {71},
	number = {8},
	year = {2023},
	month = {2023 Aug},
	pages = {2593-2600},
	abstract = {BACKGROUND: The American Rescue Plan Act of 2021 awarded $500 million toward scaling "strike teams" to mitigate the impact of Coronavirus Disease 2019 (COVID-19) within nursing homes. The Massachusetts Nursing Facility Accountability and Support Package (NFASP) piloted one such model during the first weeks of the pandemic, providing nursing homes financial, administrative, and educational support. For a subset of nursing homes deemed high-risk, the state offered supplemental, in-person technical infection control support.

METHODS: Using state death certificate data and federal nursing home occupancy data, we examined longitudinal all-cause mortality per 100,000 residents and changes in occupancy across NFASP participants and subgroups that varied in their receipt of the supplemental intervention.

RESULTS: Nursing home mortality peaked in the weeks preceding the NFASP, with a steeper increase among those receiving the supplemental intervention. There were contemporaneous declines in weekly occupancy. The potential for temporal confounding and differential selection across NFASP subgroups precluded estimation of causal effects of the intervention on mortality.

CONCLUSIONS: We offer policy and design suggestions for future strike team iterations that could inform the allocation of state and federal funding. We recommend expanded data collection infrastructure and, ideally, randomized assignment to intervention subgroups to support causal inference as strike team models are scaled under the direction of state and federal agencies.},
	keywords = {Covid-19, Humans, Infection Control, Nursing Homes, Pandemics, Skilled Nursing Facilities},
	issn = {1532-5415},
	doi = {10.1111/jgs.18402},
	author = {Festa, Natalia and Katz-Christy, Nina and Weiss, Max and Lisk, Rebecca and Normand, Sharon-Lise and Grabowski, David C and Joseph P. Newhouse and Hsu, John}
}
@article {715881,
	title = {Relationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {16},
	number = {7},
	year = {2023},
	month = {2023 Jul},
	pages = {e009573},
	abstract = {BACKGROUND: Hospitals with high mortality and readmission rates for patients with heart failure (HF) might also perform poorly in other quality concepts. We sought to evaluate the association between hospital performance on mortality and readmission with hospital performance rates of safety adverse events.

METHODS: This cross-sectional study linked the 2009 to 2019 patient-level adverse events data from the Medicare Patient Safety Monitoring System, a randomly selected medical records-abstracted patient safety database, to the 2005 to 2016 hospital-level HF-specific 30-day all-cause mortality and readmissions data from the United States Centers for Medicare \&amp; Medicaid Services. Hospitals were classified to one of 3 performance categories based on their risk-standardized 30-day all-cause mortality and readmission rates: better (both in \&lt;25th percentile), worse (both \&gt;75th percentile), and average (otherwise). Our main outcome was the occurrence (yes/no) of one or more adverse events during hospitalization. A mixed-effect model was fit to assess the relationship between a patient{\textquoteright}s risk of having adverse events and hospital performance categories, adjusted for patient and hospital characteristics.

RESULTS: The study included 39 597 patients with HF from 3108 hospitals, of which 252 hospitals (8.1\%) and 215 (6.9\%) were in the better and worse categories, respectively. The rate of patients with one or more adverse events during a hospitalization was 12.5\% (95\% CI, 12.1-12.8). Compared with patients admitted to better hospitals, patients admitted to worse hospitals had a higher risk of one or more hospital-acquired adverse events (adjusted risk ratio, 1.24 [95\% CI, 1.06-1.44]).

CONCLUSIONS: Patients admitted with HF to hospitals with high 30-day all-cause mortality and readmission rates had a higher risk of in-hospital adverse events. There may be common quality issues among these 3 measure concepts in these hospitals that produce poor performance for patients with HF.},
	keywords = {Aged, Cross-Sectional Studies, Heart Failure, Hospital Mortality, Hospitals, Humans, Medicare, Patient Readmission, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.122.009573},
	author = {Wang, Yun and Eldridge, Noel and Metersky, Mark L and Rodrick, David and Eckenrode, Sheila and Mathew, Jasie and Galusha, Deron H and Peterson, Andrea A and Hunt, David and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {715871,
	title = {Use of Telemedicine and Quality of Care Among Medicare Enrollees With Serious Mental Illness},
	journal = {JAMA Health Forum},
	volume = {4},
	number = {10},
	year = {2023},
	month = {2023 Oct 06},
	pages = {e233648},
	abstract = {IMPORTANCE: During the COVID-19 pandemic, a large fraction of mental health care was provided via telemedicine. The implications of this shift in care for use of mental health service and quality of care have not been characterized.

OBJECTIVE: To compare changes in care patterns and quality during the first year of the pandemic among Medicare beneficiaries with serious mental illness (schizophrenia or bipolar I disorder) cared for at practices with higher vs lower telemedicine use.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, Medicare fee-for-service beneficiaries with schizophrenia or bipolar I disorder were attributed to specialty mental health practices that delivered the majority of their mental health care in 2019. Practices were categorized into 3 groups based on the proportion of telemental health visits provided during the first year of the pandemic (March 2020-February 2021): lowest use (0\%-49\%), middle use (50\%-89\%), or highest use (90\%-100\%). Across the 3 groups of practices, differential changes in patient outcomes were calculated from the year before the pandemic started to the year after. These changes were also compared with differential changes from a 2-year prepandemic period. Analyses were conducted in November 2022.

EXPOSURE: Practice-level use of telemedicine during the first year of the COVID-19 pandemic.

MAIN OUTCOMES AND MEASURES: The primary outcome was the total number of mental health visits (telemedicine plus in-person) per person. Secondary outcomes included the number of acute hospital and emergency department encounters, all-cause mortality, and quality outcomes, including adherence to antipsychotic and mood-stabilizing medications (as measured by the number of months of medication fills) and 7- and 30-day outpatient follow-up rates after discharge for a mental health hospitalization.

RESULTS: The pandemic cohort included 120 050 Medicare beneficiaries (mean [SD] age, 56.5 [14.5] years; 66 638 females [55.5\%]) with serious mental illness. Compared with prepandemic changes and relative to patients receiving care at practices with the lowest telemedicine use: patients receiving care at practices in the middle and highest telemedicine use groups had 1.11 (95\% CI, 0.45-1.76) and 1.94 (95\% CI, 1.28-2.59) more mental health visits per patient per year (or 7.5\% [95\% CI, 3.0\%-11.9\%] and 13.0\% [95\% CI, 8.6\%-17.4\%] more mental health visits per year, respectively). Among patients of practices with middle and highest telemedicine use, changes in adherence to antipsychotic and mood-stabilizing medications were -0.4\% (95\% CI, -1.3\% to 0.5\%) and -0.1\% (95\% CI, -1.0\% to 0.8\%), and hospital and emergency department use for any reason changed by 2.4\% (95\% CI, -1.5\% to 6.2\%) and 2.8\% (95\% CI, -1.2\% to 6.8\%), respectively. There were no significant differential changes in postdischarge follow-up or mortality rates according to the level of telemedicine use.

CONCLUSIONS AND RELEVANCE: In this cohort study of Medicare beneficiaries with serious mental illness, patients receiving care from practices that had a higher level of telemedicine use during the COVID-19 pandemic had more mental health visits per year compared with prepandemic levels, with no differential changes in other observed quality metrics over the same period.},
	keywords = {Aftercare, Aged, Antipsychotic Agents, Cohort Studies, Covid-19, Female, Humans, Medicare, Mental Disorders, Middle Aged, Pandemics, Patient Discharge, Telemedicine, United States},
	issn = {2689-0186},
	doi = {10.1001/jamahealthforum.2023.3648},
	author = {Wilcock, Andrew D and Huskamp, Haiden A. and Alisa B. Busch and Normand, Sharon-Lise T. and Uscher-Pines, Lori and Raja, Pushpa V and Zubizarreta, Jose R and Michael L. Barnett and Ateev Mehrotra}
}
@article {696330,
	title = {Analysis of Hospital-Level Readmission Rates and Variation in Adverse Events Among Patients With Pneumonia in the United States},
	journal = {JAMA Netw Open},
	volume = {5},
	number = {5},
	year = {2022},
	month = {2022 May 02},
	pages = {e2214586},
	abstract = {IMPORTANCE: It is known that hospitalized patients who experience adverse events are at greater risk of readmission; however, it is unknown whether patients admitted to hospitals with higher risk-standardized readmission rates had a higher risk of in-hospital adverse events.

OBJECTIVE: To evaluate whether patients with pneumonia admitted to hospitals with higher risk-standardized readmission rates had a higher risk of adverse events.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study linked patient-level adverse events data from the Medicare Patient Safety Monitoring System (MPSMS), a randomly selected medical record abstracted database, to the hospital-level pneumonia-specific all-cause readmissions data from the Centers for Medicare \&amp; Medicaid Services. Patients with pneumonia discharged from July 1, 2010, through December 31, 2019, in the MPSMS data were included. Hospital performance on readmissions was determined by the risk-standardized 30-day all-cause readmission rate. Mixed-effects models were used to examine the association between adverse events and hospital performance on readmissions, adjusted for patient and hospital characteristics. Analysis was completed from October 2019 through July 2020 for data from 2010 to 2017 and from March through April 2022 for data from 2018 to 2019.

EXPOSURES: Patients hospitalized for pneumonia.

MAIN OUTCOMES AND MEASURES: Adverse events were measured by the rate of occurrence of hospital-acquired events and the number of events per 1000 discharges.

RESULTS: The sample included 46 047 patients with pneumonia, with a median (IQR) age of 71 (58-82) years, with 23 943 (52.0\%) women, 5305 (11.5\%) Black individuals, 37 763 (82.0\%) White individuals, and 2979 (6.5\%) individuals identifying as another race, across 2590 hospitals. The median hospital-specific risk-standardized readmission rate was 17.0\% (95\% CI, 16.3\%-17.7\%), the occurrence rate of adverse events was 2.6\% (95\% CI, 2.54\%-2.65\%), and the number of adverse events per 1000 discharges was 157.3 (95\% CI, 152.3-162.5). An increase by 1 IQR in the readmission rate was associated with a relative 13\% higher patient risk of adverse events (adjusted odds ratio, 1.13; 95\% CI, 1.08-1.17) and 5.0 (95\% CI, 2.8-7.2) more adverse events per 1000 discharges at the patient and hospital levels, respectively.

CONCLUSIONS AND RELEVANCE: Patients with pneumonia admitted to hospitals with high all-cause readmission rates were more likely to develop adverse events during the index hospitalization. This finding strengthens the evidence that readmission rates reflect the quality of hospital care for pneumonia.},
	keywords = {Aged, Aged, 80 and over, Cross-Sectional Studies, Female, Hospitals, Humans, Male, Medicare, Patient Readmission, Pneumonia, United States},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2022.14586},
	author = {Wang, Yun and Eldridge, Noel and Metersky, Mark L and Rodrick, David and Faniel, Constance and Eckenrode, Sheila and Mathew, Jasie and Galusha, Deron H and Tasimi, Anila and Ho, Shih-Yieh and Jaser, Lisa and Peterson, Andrea and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {696329,
	title = {Author Correction: Performance of a novel risk model for deep sternal wound infection after coronary artery bypass grafting},
	journal = {Sci Rep},
	volume = {12},
	number = {1},
	year = {2022},
	month = {2022 Nov 18},
	pages = {19850},
	issn = {2045-2322},
	doi = {10.1038/s41598-022-23963-7},
	author = {Orlandi, Bianca Maria Maglia and Mejia, Omar Asdr{\'u}bal Vilca and Sorio, Jennifer Lor{\'\i}a and de Barros E Silva, Pedro and Oliveira, Marco Antonio Pra{\c c}a and Nakazone, Marcelo Arruda and Tiveron, Marcos Gradim and Campagnucci, Valqu{\'\i}ria Pelliser and Lisboa, Luiz Augusto Ferreira and Zubelli, Jorge and Normand, Sharon-Lise and Jatene, Fabio Biscegli}
}
@article {696324,
	title = {Evaluating The Accuracy Of Medicare Risk Adjustment For Alzheimer{\textquoteright}s Disease And Related Dementias},
	journal = {Health Aff (Millwood)},
	volume = {41},
	number = {9},
	year = {2022},
	month = {2022 Sep},
	pages = {1324-1332},
	abstract = {In 2020 Medicare reintroduced Alzheimer{\textquoteright}s disease and related dementias (ADRD) Hierarchical Condition Categories (HCCs) to risk-adjust Medicare Advantage and accountable care organization (ACO) payments. The potential for Medicare spending increases from this policy change are not well understood because the baseline accuracy of ADRD HCCs is uncertain. Using linked 2016-18 claims and electronic health record data from a large ACO, we evaluated the accuracy of claims-based ADRD HCCs against a reference standard of clinician-adjudicated disease. An estimated 7.5~percent of beneficiaries had clinician-adjudicated ADRD. Among those with ADRD HCCs, 34~percent did not have clinician-adjudicated disease. The false-negative and false-positive rates were 22.7~percent and 3.2~percent, respectively. Medicare spending for those with false-negative ADRD HCCs exceeded that of true positives by $14,619 per beneficiary. If, after the reintroduction of risk adjustment for ADRD, all false negatives were coded as having ADRD, expenditure benchmarks for beneficiaries with ADRD would increase by 9~percent. Monitoring ADRD coding could become challenging in the setting of concurrent incentives to decrease false-negative rates and increase false-positive rates.},
	keywords = {Accountable Care Organizations, Aged, Alzheimer Disease, Health Expenditures, Humans, Medicare Part C, Risk Adjustment, United States},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.2022.00185},
	author = {Festa, Natalia and Price, Mary and Weiss, Max and Moura, Lidia M V R and Benson, Nicole M and Sahar Zafar and Blacker, Deborah and Normand, Sharon-Lise T. and Joseph P. Newhouse and Hsu, John}
}
@article {696323,
	title = {Evaluation of Claims-Based Ascertainment of Alzheimer Disease and Related Dementias Across Health Care Settings},
	journal = {JAMA Health Forum},
	volume = {3},
	number = {4},
	year = {2022},
	month = {2022 Apr},
	pages = {e220653},
	abstract = {This cohort study evaluates the ascertainment of Alzheimer disease and related dementia using diagnostic codes in various health care settings.},
	keywords = {Alzheimer Disease, Cohort Studies, Delivery of Health Care, Dementia, Humans},
	issn = {2689-0186},
	doi = {10.1001/jamahealthforum.2022.0653},
	author = {Festa, Natalia and Price, Mary and Moura, Lidia M V R and Blacker, Deborah and Normand, Sharon-Lise and Joseph P. Newhouse and Hsu, John}
}
@article {696328,
	title = {An Evidence-Based Educational Intervention for Reducing Coercive Measures in Psychiatric Hospitals: A Randomized Clinical Trial},
	journal = {JAMA Netw Open},
	volume = {5},
	number = {8},
	year = {2022},
	month = {2022 Aug 01},
	pages = {e2229076},
	abstract = {IMPORTANCE: Investing in health care staffs{\textquoteright} education can change the scope of action and improve care. The effectiveness of staff education remains inconclusive.

OBJECTIVE: To examine whether an evidence-based educational intervention for nurses decreases the use of seclusion rooms in psychiatric hospitals compared with usual practice.

DESIGN, SETTING, AND PARTICIPANTS: In this pragmatic, 2-arm parallel, stratified cluster randomized clinical trial, 28 wards in 15 psychiatric hospitals in Finland were screened for eligibility and randomly allocated (1:1). Nurses joined on either intervention (n = 13) or usual practice (n = 15) wards. The intervention was performed from May 1, 2016, to October 31, 2017. The follow-up data for January 1 to December 31, 2017, were collected from hospital registers in 2018. Data analysis was performed October 27, 2021.

INTERVENTIONS: Evidence-based education delivered during 18 months, including 8 months of active education, followed by a 10-month maintenance period.

MAIN OUTCOMES AND MEASURES: The primary outcome was the occurrence of patient seclusion (events per total number of patients).

RESULTS: Of 28 psychiatric hospital wards screened (437 beds and 648 nurses), 27 wards completed the study. A total of 8349 patients were receiving care in the study wards, with 53\% male patients and a mean (SD) age of 40.6 (5.7) years. The overall number of seclusions was 1209 (14.5\%) in 2015 and 1349 (16.5\%) in 2017. In the intervention group, the occurrence rate of seclusion at the ward level decreased by 5.3\% from 629 seclusions among 4163 patients (15.1\%) to 585 seclusions among 4089 patients (14.3\%) compared with a 34.7\% increase from 580 seclusions among 4186 patients (13.9\%) to 764 seclusions among 4092 patients (18.7\%) in the usual practice group. The adjusted rate ratio was 0.86 (95\% CI, 0.40-1.82) in 2015 and 0.66 (95\% CI, 0.31-1.41) in 2017 (P = .003). However, the number of forced injections increased in the intervention group from 317 events among 4163 patients (7.6\%) in 2015 to 486 events among 4089 patients (11.9\%) in 2017 compared with an increase in the usual practice group from 414 events among 4186 patients (9.9\%) in 2015 to 481 events among 4092 patients (11.8\%) in 2017. Seven adverse events were reported.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the educational intervention had a limited effect on the change of occurrence rate of patient seclusion, whereas the use of forced injections increased. More studies are needed to better understand the reasons for these findings.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02724748.},
	keywords = {Adult, Coercion, Female, Finland, Hospitals, Psychiatric, Humans, Male},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2022.29076},
	author = {V{\"a}lim{\"a}ki, Maritta and Lantta, Tella and Anttila, Minna and Vahlberg, Tero and Normand, Sharon-Lise and Yang, Min}
}
@article {696319,
	title = {Identifying Medicare Beneficiaries With Delirium},
	journal = {Med Care},
	volume = {60},
	number = {11},
	year = {2022},
	month = {2022 Nov 01},
	pages = {852-859},
	abstract = {BACKGROUND: Each year, thousands of older adults develop delirium, a serious, preventable condition. At present, there is no well-validated method to identify patients with delirium when using Medicare claims data or other large datasets. We developed and assessed the performance of classification algorithms based on longitudinal Medicare administrative data that included International Classification of Diseases, 10th Edition diagnostic codes.

METHODS: Using a linked electronic health record (EHR)-Medicare claims dataset, 2 neurologists and 2 psychiatrists performed a standardized review of EHR records between 2016 and 2018 for a stratified random sample of 1002 patients among 40,690 eligible subjects. Reviewers adjudicated delirium status (reference standard) during this 3-year window using a structured protocol. We calculated the probability that each patient had delirium as a function of classification algorithms based on longitudinal Medicare claims data. We compared the performance of various algorithms against the reference standard, computing calibration-in-the-large, calibration slope, and the area-under-receiver-operating-curve using 10-fold cross-validation (CV).

RESULTS: Beneficiaries had a mean age of 75 years, were predominately female (59\%), and non-Hispanic Whites (93\%); a review of the EHR indicated that 6\% of patients had delirium during the 3 years. Although several classification algorithms performed well, a relatively simple model containing counts of delirium-related diagnoses combined with patient age, dementia status, and receipt of antipsychotic medications had the best overall performance [CV- calibration-in-the-large \&amp;lt;0.001, CV-slope 0.94, and CV-area under the receiver operating characteristic curve (0.88 95\% confidence interval: 0.84-0.91)].

CONCLUSIONS: A delirium classification model using Medicare administrative data and International Classification of Diseases, 10th Edition diagnosis codes can identify beneficiaries with delirium in large datasets.},
	keywords = {Aged, Antipsychotic Agents, Delirium, Electronic Health Records, Female, Humans, International Classification of Diseases, Medicare, United States},
	issn = {1537-1948},
	doi = {10.1097/MLR.0000000000001767},
	author = {Moura, Lidia M V R and Sahar Zafar and Benson, Nicole M and Festa, Natalia and Price, Mary and Donahue, Maria A and Normand, Sharon-Lise and Joseph P. Newhouse and Blacker, Deborah and Hsu, John}
}
@article {696322,
	title = {MEASURING PERFORMANCE FOR END-OF-LIFE CARE},
	journal = {Ann Appl Stat},
	volume = {16},
	number = {3},
	year = {2022},
	month = {2022 Sep},
	pages = {1586-1607},
	abstract = {Although not without controversy, readmission is entrenched as a hospital quality metric with statistical analyses generally based on fitting a logistic-Normal generalized linear mixed model. Such analyses, however, ignore death as a competing risk, although doing so for clinical conditions with high mortality can have profound effects; a hospital{\textquoteright}s seemingly good performance for readmission may be an artifact of it having poor performance for mortality. in this paper we propose novel multivariate hospital-level performance measures for readmission and mortality that derive from framing the analysis as one of cluster-correlated semi-competing risks data. We also consider a number of profiling-related goals, including the identification of extreme performers and a bivariate classification of whether the hospital has higher-/lower-than-expected readmission and mortality rates via a Bayesian decision-theoretic approach that characterizes hospitals on the basis of minimizing the posterior expected loss for an appropriate loss function. in some settings, particularly if the number of hospitals is large, the computational burden may be prohibitive. To resolve this, we propose a series of analysis strategies that will be useful in practice. Throughout, the methods are illustrated with data from CMS on N = 17,685 patients diagnosed with pancreatic cancer between 2000-2012 at one of J = 264 hospitals in California.},
	issn = {1932-6157},
	doi = {10.1214/21-aoas1558},
	author = {Sebastien Haneuse and Schrag, Deborah and Francesca Dominici and Normand, Sharon-Lise and Lee, Kyu Ha}
}
@article {696327,
	title = {Mortality Prediction After Cardiac Surgery in Children: An STS Congenital Heart Surgery Database Analysis},
	journal = {Ann Thorac Surg},
	volume = {114},
	number = {3},
	year = {2022},
	month = {2022 Sep},
	pages = {785-798},
	abstract = {BACKGROUND: The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database (CHSD) provides risk-adjusted operative mortality rates to approximately 120 North American congenital heart centers. Optimal case-mix adjustment methods for operative mortality risk prediction in this population remain unclear.

METHODS: A panel created diagnosis-procedure combinations of encounters in the CHSD. Models for operative mortality using the new diagnosis-procedure categories, procedure-specific risk factors, and syndromes or abnormalities included in the CHSD were estimated using Bayesian additive regression trees and least absolute shrinkage and selector operator (lasso) models. Performance of the new models was compared with the current STS CHSD risk model.

RESULTS: Of 98 825 operative encounters (69 063 training; 29 762 testing), 2818 (2.85\%) STS-defined operative mortalities were observed. Differences in sensitivity, specificity, and true and false positive predicted values were negligible across models. Calibration for mortality predictions at the higher end of risk from the lasso and Bayesian additive regression trees models was better than predictions from the STS CHSD model, likely because of the new models{\textquoteright} inclusion of diagnosis-palliative procedure variables affecting \&lt;1\% of patients overall but accounting for 27\% of mortalities. Model discrimination varied across models for high-risk procedures, hospital volume, and hospitals.

CONCLUSIONS: Overall performance of the new models did not differ meaningfully from the STS CHSD risk model. Adding procedure-specific risk factors and allowing diagnosis to modify predicted risk for palliative operations may augment model performance for very high-risk surgical procedures. Given the importance of risk adjustment in estimating hospital quality, a comparative assessment of surgical program quality evaluations using the different models is warranted.},
	keywords = {Bayes Theorem, Cardiac Surgical Procedures, Child, Databases, Factual, Heart Defects, Congenital, Humans, Risk Assessment, Societies, Medical, Thoracic Surgery},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2021.11.077},
	author = {Normand, Sharon-Lise T. and Zelevinsky, Katya and Nathan, Meena and Abing, Haley K and Dearani, Joseph A and Galantowicz, Mark and Gaynor, J William and Habib, Robert H and Hanley, Frank L and Jacobs, Jeffrey P and Kumar, S Ram and McDonald, Donna E and Pasquali, Sara K and Shahian, David M and Tweddell, James S and Vener, David F and Mayer, John E}
}
@article {696317,
	title = { - A New Journal in the NEJM Group Family},
	journal = {N Engl J Med},
	volume = {386},
	number = {2},
	year = {2022},
	month = {2022 Jan 13},
	pages = {182-183},
	keywords = {Biomedical Research, Periodicals as Topic, Research Design},
	issn = {1533-4406},
	doi = {10.1056/NEJMe2118588},
	author = {Sacks, Chana A and Hardin, C Corey and Normand, Sharon-Lise and Kadire, Siri and Takvorian, Kate and Galloway, Neil and Linga, Rebekah and Hannon, Patrick and Drazen, Jeffrey and Rubin, Eric}
}
@article {696326,
	title = {Performance of a novel risk model~for deep sternal wound infection after coronary artery bypass grafting},
	journal = {Sci Rep},
	volume = {12},
	number = {1},
	year = {2022},
	month = {2022 Sep 07},
	pages = {15177},
	abstract = {Clinical prediction models for deep sternal wound infections (DSWI) after coronary artery bypass graft (CABG) surgery exist, although they have a poor impact in external validation studies. We developed and validated a new predictive model for 30-day DSWI after CABG (REPINF) and compared it with the Society of Thoracic Surgeons model (STS). The REPINF model was created through a multicenter cohort of adults undergoing CABG surgery (REPLICCAR II Study) database, using least absolute shrinkage and selection operator (LASSO) logistic regression, internally and externally validated comparing discrimination, calibration in-the-large (CL), net reclassification improvement (NRI) and integrated discrimination improvement (IDI), trained between the new model and the STS PredDeep, a validated model for DSWI after cardiac surgery. In the validation data, c-index = 0.83 (95\% CI 0.72-0.95). Compared to the STS PredDeep, predictions improved by 6.5\% (IDI). However, both STS and REPINF had limited calibration. Different populations require independent scoring systems to achieve the best predictive effect. The external validation of REPINF across multiple centers is an important quality improvement tool to generalize the model and to guide healthcare professionals in the prevention of DSWI after CABG surgery.},
	keywords = {Adult, Cardiac Surgical Procedures, Coronary Artery Bypass, Humans, Risk Factors, Sternum, Surgical Wound Infection},
	issn = {2045-2322},
	doi = {10.1038/s41598-022-19473-1},
	author = {Orlandi, Bianca Maria Maglia and Mejia, Omar Asdr{\'u}bal Vilca and Sorio, Jennifer Lor{\'\i}a and de Barros E Silva, Pedro and Oliveira, Marco Antonio Pra{\c c}a and Nakazone, Marcelo Arruda and Tiveron, Marcos Gradim and Campagnucci, Valqu{\'\i}ria Pelliser and Lisboa, Luiz Augusto Ferreira and Zubelli, Jorge and Normand, Sharon-Lise and Jatene, Fabio Biscegli}
}
@article {696318,
	title = {Predicting Risk or Adjusting for Risk?},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {15},
	number = {8},
	year = {2022},
	month = {2022 Aug},
	pages = {e009082},
	keywords = {Acute Kidney Injury, Benchmarking, Humans},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.122.009082},
	author = {Normand, Sharon-Lise T.}
}
@article {696325,
	title = {Premium tax credits in the American Rescue Plan and off-marketplace enrollees},
	journal = {Am J Manag Care},
	volume = {28},
	number = {8},
	year = {2022},
	month = {2022 Aug},
	pages = {404-408},
	abstract = {OBJECTIVES: The 2021 American Rescue Plan Act (ARPA) increased the availability and magnitude of premium tax credits (PTCs) for consumers purchasing individual marketplace plans in 2021-2022. Millions currently purchase PTC-ineligible plans off of the marketplace. We estimate the proportion of off-marketplace enrollees who would be eligible for the expanded PTCs under ARPA, calculate PTC amounts for eligible enrollees, and examine factors influencing plan choice that could inform outreach efforts.

STUDY DESIGN: We analyzed data from a survey of a random sample of off-marketplace enrollees in California in 2017 (n = 829).

METHODS: Using survey data including self-reported income, household size, and employment status combined with 2021 benchmark premium data from Covered California, we estimate eligibility for PTCs and potential PTC amounts under ARPA among off-marketplace enrollees. We adjust for both survey design weights and poststratification weights.

RESULTS: Among off-marketplace enrollees, we estimate that approximately 12\% are potentially ineligible for PTCs because they reported incomes less than 100\% of the poverty level or because they had access to employer-sponsored coverage for their family through themselves or their partner. The median annual PTC in 2021 for eligible off-marketplace enrollees was $311 but varied greatly by age, family or individual plan, and household income (5\%-95\% range, $0-$14,836). In 2017, 69\% of off-marketplace enrollees were unaware that they had to enroll in marketplace plans to receive PTCs, and 51\% received enrollment assistance from insurance brokers.

CONCLUSIONS: These findings suggest the need for targeted outreach to encourage off-marketplace enrollees to switch to marketplace plans.},
	keywords = {Consumer Behavior, Eligibility Determination, Health Insurance Exchanges, Humans, Insurance Coverage, Insurance, Health, Patient Protection and Affordable Care Act, Taxes, United States},
	issn = {1936-2692},
	doi = {10.37765/ajmc.2022.89199},
	author = {Fung, Vicki and Tevis, Delaney and Weiss, Max and Normand, Sharon-Lise and Bertko, John and Joseph P. Newhouse and Hsu, John}
}
@article {696321,
	title = {Reevaluating Congenital Heart Surgery Center Performance Using Operative Mortality},
	journal = {Ann Thorac Surg},
	volume = {114},
	number = {3},
	year = {2022},
	month = {2022 Sep},
	pages = {776-784},
	abstract = {BACKGROUND: The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) provides observed-to-expected (O/E) operative mortality ratios to more than 100 congenital heart centers in North America. We compared the current approach for estimating O/E ratios to approaches incorporating information on diagnosis as moderators of procedures, other unused risk factors, and additional variation in confidence interval construction to characterize center performance.

METHODS: Bayesian additive regression trees (BART) and lasso models linked operative mortality to diagnosis-procedure categories, procedure-specific risk factors, and syndromes/abnormalities. Bootstrapping accounted for variation in the STS-CHSD (STS bootstrap) and lasso CIs. We compared O/E estimates, interquartile range of CI widths, and concordance of center performance categorizations (worse-than-, as-, or better-than-expected mortality) of the new approaches to the STS-CHSD.

RESULTS: In 110 surgical centers including 98,822 surgical operative encounters, there were 2818 (2.85\%) operative mortalities (center range, 0.37\%-10\%). Compared with the STS-CHSD, BART- and lasso-estimated O/E ratios varied more and had narrower confidence intervals (interquartile range of confidence interval: STS-CHSD~= 1.11, STS bootstrap~= 0.98; lasso~= 0.80; BART~= 0.96). Concordance of performance categorization with the STS-CHSD ranged from 84\% (lasso) to 91\% (STS Bootstrap); more than 70\% of discordant centers improved categories. Discordant centers had smaller volumes, fewer operative mortalities, and treated more patients with congenital lung abnormalities.

CONCLUSIONS: Relative to the STS-CHSD, up to 16\% of hospitals changed performance categories, most improving performance. Given the significance of quality reports for congenital heart centers, inclusion of additional risk factors and unaddressed variation should be considered.},
	keywords = {Bayes Theorem, Cardiac Surgical Procedures, Databases, Factual, Heart Defects, Congenital, Humans, Outcome Assessment, Health Care, Societies, Medical, Thoracic Surgery},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2021.11.076},
	author = {Normand, Sharon-Lise T. and Zelevinsky, Katya and Nathan, Meena and Abing, Haley K and Dearani, Joseph A and Galantowicz, Mark and Gaynor, J William and Habib, Robert H and Hanley, Frank L and Jacobs, Jeffrey P and Kumar, S Ram and McDonald, Donna E and Pasquali, Sara K and Shahian, David M and Tweddell, James S and Vener, David F and Mayer, John E}
}
@article {677240,
	title = {Significance and Factors Associated with Antipsychotic Polypharmacy Utilization Among Publicly Insured US Adults},
	journal = {Adm Policy Ment Health},
	volume = {49},
	number = {1},
	year = {2022},
	month = {2022 Jan},
	pages = {59-70},
	abstract = {Antipsychotic polypharmacy (APP) lacks evidence of effectiveness in the care of schizophrenia or other disorders for which antipsychotic drugs are indicated, also exposing patients to more risks. Authors assessed APP prevalence and APP association with beneficiary race/ethnicity and payer among publicly-insured adults regardless of diagnosis. Retrospective repeated panel study of fee-for-service (FFS) Medicare, Medicaid, and dually-eligible white, black, and Latino adults residing in California, Georgia, Iowa, Mississippi, Oklahoma, South Dakota, or West Virginia, filling antipsychotic prescriptions between July 2008 and June 2013. Primary outcome was any monthly APP utilization. Across states and payers, 11\% to 21\% of 397,533 antipsychotic users and 12\% to 19\% of 9,396,741 person-months had some APP utilization. Less than 50\% of person-months had a schizophrenia diagnosis and up to 19\% had no diagnosed mental illness. Payer modified race/ethnicity effects on APP utilization only in CA; however, the odds of APP utilization remained lower for minorities than for whites. Elsewhere, the odds varied by race/ethnicity only in OK, with Latinos having lower odds than whites (odds ratio 0.76; 95\% confidence interval 0.60-0.96). The odds of APP utilization varied by payer in several study states, with odds generally higher for Dual eligibles, although the differences were generally small; the odds also varied by year (lower at study end). APP was frequently utilized but mostly declined over time. APP utilization patterns varied across states, with no consistent association with race/ethnicity and small payer effects. Greater use of APP-reducing strategies are needed, particularly among non-schizophrenia populations.},
	keywords = {Adult, Aged, Antipsychotic Agents, Humans, Medicaid, Medicare, polypharmacy, Retrospective Studies, United States},
	issn = {1573-3289},
	doi = {10.1007/s10488-021-01141-7},
	author = {Horvitz-Lennon, Marcela and Volya, Rita and Zelevinsky, Katya and Shen, Mimi and Donohue, Julie M and Mulcahy, Andrew and Normand, Sharon-Lise T.}
}
@article {696320,
	title = {Statistical Approaches for Quantifying the Quality of Neurosurgical Care},
	journal = {World Neurosurg},
	volume = {161},
	year = {2022},
	month = {2022 May},
	pages = {331-342.e1},
	abstract = {BACKGROUND: Quantifying quality of health care can provide valuable information to patients, providers, and policy makers. However, the observational nature of measuring quality complicates assessments.

METHODS: We describe a conceptual model for defining quality and its implications about the data collected, how to make inferences about quality, and the assumptions required to provide statistically valid estimates. Twenty-one binary or polytomous quality measures collected from 101,051 adult Medicaid beneficiaries aged 18-64 years with schizophrenia from 5 U.S. states show methodology. A categorical principal components analysis establishes dimensionality of quality, and item response theory models characterize the relationship between each quality measure and a unidimensional quality construct. Latent regression models estimate racial/ethnic and geographic quality disparities.

RESULTS: More than 90\% of beneficiaries filled at least 1 antipsychotic prescription and 19\% were hospitalized for schizophrenia during a 12-month observational period in our multistate cohort with approximately 2/3 nonwhite beneficiaries. Four quality constructs emerged: inpatient, emergency room, pharmacologic/ambulatory, and ambulatory only. Using a 2-parameter logistic model, pharmacologic/ambulatory care quality varied from -2.35 to 1.26 (higher~= better quality). Black and Latinx beneficiaries had lower pharmacologic/ambulatory quality compared with whites. Race/ethnicity modified the association of state and pharmacologic/ambulatory care quality in latent regression modeling. Average quality ranged from -0.28 (95\% confidence interval, -2.15 to 1.04) for blacks in New Jersey to 0.46 [95\% confidence interval, -0.89 to 1.40] for whites in Michigan.

CONCLUSIONS: By combining multiple quality measures using item response theory models, a composite measure can be estimated that has more statistical power to detect differences among subjects than the observed mean per subject.},
	keywords = {Adult, Antipsychotic Agents, Black or African American, ethnicity, Humans, Medicaid, United States, White People},
	issn = {1878-8769},
	doi = {10.1016/j.wneu.2022.01.047},
	author = {Normand, Sharon-Lise T. and Zelevinsky, Katya and Abing, Haley K and Horvitz-Lennon, Marcela}
}
@article {682664,
	title = {All-Cause Mortality and Progression to End-Stage Kidney Disease Following Percutaneous Revascularization or Surgical Coronary Revascularization in Patients with CKD},
	journal = {Kidney Int Rep},
	volume = {6},
	number = {6},
	year = {2021},
	month = {2021 Jun},
	pages = {1580-1591},
	abstract = {Introduction: Relative impacts of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) on mortality and end-stage kidney disease (ESKD) in chronic kidney disease (CKD) are uncertain.

Methods: Data from Massachusetts residents with CKD undergoing CABG or PCI from 2003 to 2012 were linked to the United States Renal Data System. Associations with death, ESKD, and combined death and ESKD were analyzed in propensity score-matched multivariable survival models.

Results: We identified 6805 CABG and 17,494 PCI patients. Among 3775 matched-pairs, multi-vessel disease was present in 97\%, and stage 4 CKD was present in 11.9\% of CABG and 12.2\% of PCI patients. One-year mortality (CABG 7.7\%, PCI 11.0\%) was more frequent than ESKD (CABG 1.4\%, PCI 1.7\%). Overall survival was improved and ESKD risk decreased with CABG compared to PCI, but effects differed in the presence of left main disease and prior myocardial infarction (MI). Survival was worse following PCI than following CABG among patients with left main disease and without MI (hazard ratio~= 3.7, 95\% confidence interval~= 1.3-10.5). ESKD risk was higher with PCI for individuals with left main disease and prior infarction (hazard ratio~= 8.1, 95\% confidence interval~= 1.7-39.2).

Conclusion: Risks following CABG and PCI were modified by left main disease and prior MI. In individuals with CKD, survival was greater after CABG than after PCI in patients with left main disease but without MI, whereas ESKD risk was lower with CABG in those with left main and MI. Absolute risks of ESKD were markedly lower than for mortality, suggesting prioritizing mortality over ESKD in clinical decision making.},
	issn = {2468-0249},
	doi = {10.1016/j.ekir.2021.03.882},
	author = {Charytan, David M and Zelevinsky, Katya and Robert Wolf and Normand, Sharon-Lise T.}
}
@article {661400,
	title = {A Bayesian hierarchical model for characterizing the diffusion of new antipsychotic drugs},
	journal = {Biometrics},
	volume = {77},
	number = {2},
	year = {2021},
	month = {2021 Jun},
	pages = {649-660},
	abstract = {New prescription medications are a primary driver of spending growth in the United States. For patients with severe mental illnesses, second-generation antipsychotic (SGA) medications feature prominently. However, many SGAs are costly, particularly before generic entry, and some may increase the risk of diabetes. Because physicians play a prominent role in new prescription adoption, understanding their prescribing behaviors is policy-relevant. Several features of prescription data, such as different antipsychotic choice sets over time, variable physician prescription volumes, and correlation among drug choices within physicians, complicate inferences. We propose a multivariate Bayesian hierarchical model with piecewise random effects to characterize the diffusion of new antipsychotic drugs. This model captures the complex prescriber-specific relationships among the different diffusion processes and takes advantage of the Bayesian paradigm to quantify uncertainty for all parameters straightforwardly. To evaluate the prescribing patterns for each physician, we propose various indices to identify early new SGA adopters. A sample of nearly 17,000 US physicians whose antipsychotic drug prescribing information was collected between January 1, 1997 and December 31, 2007 illustrates the methods. Determinants of high prescription rates and adoption speeds of new SGAs included physician sex, age, hospital affiliation, physician specialty, and office location. Large within- and between-provider variations in prescribing patterns of new SGAs were identified. Early adopters for one drug were not early adopters for another~drug.},
	keywords = {Antipsychotic Agents, Bayes Theorem, Drug Prescriptions, Humans, Mental Disorders, Practice Patterns, Physicians{\textquoteright}, United States},
	issn = {1541-0420},
	doi = {10.1111/biom.13324},
	author = {Gu, Chenyang and Huskamp, Haiden and Donohue, Julie and Normand, Sharon-Lise}
}
@article {677369,
	title = {Evidence of a gabapentinoid and diuretic prescribing cascade among older adults with lower back pain},
	journal = {J Am Geriatr Soc},
	year = {2021},
	month = {2021 Jun 12},
	abstract = {BACKGROUND/OBJECTIVES: Gabapentinoids are commonly prescribed to relieve pain. The development of edema, an established adverse effect of gabapentinoids, may lead to a potentially harmful prescribing cascade whereby individuals are subsequently prescribed diuretics and exposed to diuretic-induced adverse events. The frequency of this prescribing cascade is unknown. Our objective was to measure the association between new dispensing of a gabapentinoid and the subsequent dispensing of a diuretic in older adults with new low back pain.

DESIGN: Population-based cohort study.

SETTING: Ontario, Canada.

PARTICIPANTS: A total of 260,344 community-dwelling adults aged 66 years or older, newly diagnosed with low back pain between April 1, 2011, and March 31, 2019.

MEASUREMENTS: Exposure status was assigned using dispensed medications in the 1 week after low back pain diagnosis. Older adults newly dispensed a gabapentinoid (N~=~7867) were compared with older adults who were not newly dispensed a gabapentinoid (N~=~252,477). Hazard ratios (HRs) with 95\% confidence intervals (CIs) for dispensing of a diuretic within 90 days of follow-up among older adults prescribed gabapentin relative to those who were not.

RESULTS: Older adults newly dispensed a gabapentinoid had a higher risk of being subsequently dispensed a diuretic within 90 days compared with older adults who were not prescribed a gabapentinoid (2.0\% vs. 1.3\%). After covariate adjustment, new gabapentinoid users had a higher rate of being dispensed a diuretic compared with those not prescribed a gabapentinoid (HR: 1.44, 95\% CI: 1.23, 1.70). The rate of diuretic prescription among new gabapentinoid users increased with increasing gabapentinoid dosages.

CONCLUSIONS: We have demonstrated the presence of a potentially inappropriate and harmful prescribing cascade. Given the widespread use of gabapentinoids, the population-based scale of this problem may be substantial. Increased awareness of this prescribing cascade is required to reduce the unnecessary use of diuretics and the exposure of patients to additional adverse drug events.},
	issn = {1532-5415},
	doi = {10.1111/jgs.17312},
	author = {Read, Stephanie H and Giannakeas, Vasily and Pop, Paula and Bronskill, Susan E and Herrmann, Nathan and Chen, Simon and Luke, Miles J and Wu, Wei and McCarthy, Lisa M and Austin, Peter C and Normand, Sharon-Lise and Gurwitz, Jerry H and Stall, Nathan M and Savage, Rachel D and Rochon, Paula}
}
@article {677239,
	title = {Factors Associated With Off-Label Utilization of Second-Generation Antipsychotics Among Publicly Insured Adults},
	journal = {Psychiatr Serv},
	year = {2021},
	month = {2021 Jun 02},
	pages = {appips202000381},
	abstract = {OBJECTIVE: Off-label utilization of second-generation antipsychotic medications may expose patients to significant risks. The authors examined the prevalence, temporal trends, and factors associated with off-label utilization of second-generation antipsychotics among publicly insured adults.

METHODS: A retrospective repeated panel was used to examine monthly off-label utilization of second-generation antipsychotics among fee-for-service Medicare, Medicaid, and dually eligible White, Black, and Latino adult beneficiaries filling prescriptions for second-generation antipsychotics in California, Georgia, Mississippi, and Oklahoma from July 2008 through June 2013.

RESULTS: Among 301,367 users of second-generation antipsychotics, between 36.5\% and 41.9\% had utilization that was always off-label. Payer did not modify effects of race-ethnicity on off-label utilization. Compared with Whites, Blacks had lower monthly odds of off-label utilization in all four states, and Latinos had lower odds of utilization in California and Georgia. Payer was associated with off-label utilization in California, Mississippi, and Oklahoma. California Medicaid beneficiaries were 1.12 (95\% confidence interval=1.10-1.13) times as likely as dually eligible beneficiaries to have off-label utilization. Off-label utilization increased relative to the baseline year in all states, but a downward trend followed in three states.

CONCLUSIONS: Off-label utilization of second-generation antipsychotics was prevalent despite the drugs{\textquoteright} cardiometabolic risks and little evidence of their effectiveness. The lower likelihood of off-label utilization among patients from racial-ethnic minority groups might stem from prescribers{\textquoteright} efforts to minimize risks, given a higher baseline risk for these groups, or from disparities-associated factors. Variation among payers suggests that payer policies can affect off-label utilization.},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.202000381},
	author = {Horvitz-Lennon, Marcela and Volya, Rita and Hollands, Simon and Zelevinsky, Katya and Mulcahy, Andrew and Donohue, Julie M and Normand, Sharon-Lise T.}
}
@article {677241,
	title = {Identifying Medicare beneficiaries with dementia},
	journal = {J Am Geriatr Soc},
	year = {2021},
	month = {2021 Apr 26},
	abstract = {BACKGROUND/OBJECTIVES: No data exist regarding the validity of International Classification of Disease (ICD)-10 dementia diagnoses against a clinician-adjudicated reference standard within Medicare claims data. We examined the accuracy of claims-based diagnoses with respect to expert clinician adjudication using a novel database with individual-level linkages between electronic health record (EHR) and claims.

DESIGN: In this retrospective observational study, two neurologists and two psychiatrists performed a standardized review of patients{\textquoteright} medical records from January 2016 to December 2018 and adjudicated dementia status. We measured the accuracy of three claims-based definitions of dementia against the reference standard.

SETTING: Mass-General-Brigham Healthcare (MGB), Massachusetts, USA.

PARTICIPANTS: From an eligible population of 40,690 fee-for-service (FFS) Medicare beneficiaries, aged 65 years and older, within the MGB Accountable Care Organization (ACO), we generated a random sample of 1002 patients, stratified by the pretest likelihood of dementia using administrative surrogates.

INTERVENTION: None.

MEASUREMENTS: We evaluated the accuracy (area under receiver operating curve [AUROC]) and calibration (calibration-in-the-large [CITL] and calibration slope) of three ICD-10 claims-based definitions of dementia against clinician-adjudicated standards. We applied inverse probability weighting to reconstruct the eligible population and reported the mean and 95\% confidence interval (95\% CI) for all performance characteristics, using 10-fold cross-validation (CV).

RESULTS: Beneficiaries had an average age of 75.3 years and were predominately female (59\%) and non-Hispanic whites (93\%). The adjudicated prevalence of dementia in the eligible population was 7\%. The best-performing definition demonstrated excellent accuracy (CV-AUC 0.94; 95\% CI 0.92-0.96) and was well-calibrated to the reference standard of clinician-adjudicated dementia (CV-CITL \&lt;0.001, CV-slope 0.97).

CONCLUSION: This study is the first to validate ICD-10 diagnostic codes against a robust and replicable approach to dementia ascertainment, using a real-world clinical reference standard. The best performing definition includes diagnostic codes with strong face validity and outperforms an updated version of a previously validated ICD-9 definition of dementia.},
	issn = {1532-5415},
	doi = {10.1111/jgs.17183},
	author = {Moura, Lidia M V R and Festa, Natalia and Price, Mary and Volya, Margarita and Benson, Nicole M and Sahar Zafar and Weiss, Max and Blacker, Deborah and Normand, Sharon-Lise and Joseph P. Newhouse and Hsu, John}
}
@article {682663,
	title = {Measuring the quality of dental care among privately insured children in the United States},
	journal = {Health Serv Res},
	year = {2021},
	month = {2021 Jul 29},
	abstract = {OBJECTIVE: To examine whether quality of dental care varies by age and over time and whether community-level characteristics explain these patterns.

DATA SOURCE: Deidentified medical and dental claims from a commercial insurer from January 2015 to December 2019.

STUDY DESIGN: A retrospective cohort study. The primary outcome was a composite quality score, derived from seven dental quality measures (DQMs), with higher values corresponding to better quality. Hierarchical regression models identified person- and zip code-level factors associated with the quality.

DATA COLLECTION/EXTRACTION METHODS: Continuously enrolled US dental insurance beneficiaries younger than 21 years of age.

PRINCIPAL FINDINGS: Quality was assessed for 4.88 million person-years covering 1.31 million persons. Overall quality slightly improved over time, mostly driven by substantial improvements among children aged 0-5 years by 0.153 points/year (95\% confidence interval [CI]:0.151, 0.156). Quality was poorest and declined over time among adolescents with only 20.5\% of DQMs met as compared to 42.6\% among aged 0-5 years in 2019. Dental professional shortage, median household income, percentages of African Americans, unemployed, and less-educated populations at the zip code level were associated with the composite score.

CONCLUSION: Quality of dental care among adolescents remains low, and place of residence influenced the quality. Increasing the supply of dentists and oral health promotion strategies targeting adolescents and low-performing localities should be explored.},
	issn = {1475-6773},
	doi = {10.1111/1475-6773.13713},
	author = {Choi, Sung Eun and Elsbeth Kalenderian and Normand, Sharon-Lise}
}
@article {682661,
	title = {Performance Metrics for the Comparative Analysis of Clinical Risk Prediction Models Employing Machine Learning},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {14},
	number = {10},
	year = {2021},
	month = {2021 Oct},
	pages = {e007526},
	abstract = {BACKGROUND: New methods such as machine learning techniques have been increasingly used to enhance the performance of risk predictions for clinical decision-making. However, commonly reported performance metrics may not be sufficient to capture the advantages of these newly proposed models for their adoption by health care professionals to improve care. Machine learning models often improve risk estimation for certain subpopulations that may be missed by these metrics.

METHODS AND RESULTS: This article addresses the limitations of commonly reported metrics for performance comparison and proposes additional metrics. Our discussions cover metrics related to overall performance, discrimination, calibration, resolution, reclassification, and model implementation. Models for predicting acute kidney injury after percutaneous coronary intervention are used to illustrate the use of these metrics.

CONCLUSIONS: We demonstrate that commonly reported metrics may not have sufficient sensitivity to identify improvement of machine learning models and propose the use of a comprehensive list of performance metrics for reporting and comparing clinical risk prediction models.},
	keywords = {Benchmarking, Clinical Decision-Making, Humans, machine learning, Percutaneous Coronary Intervention, Risk Assessment},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.120.007526},
	author = {Huang, Chenxi and Li, Shu-Xia and Caraballo, C{\'e}sar and Masoudi, Frederick A and Rumsfeld, John S and Spertus, John A and Normand, Sharon-Lise T. and Mortazavi, Bobak J and Krumholz,Harlan M.}
}
@article {661401,
	title = {The RECOVERY Platform},
	journal = {N Engl J Med},
	volume = {384},
	number = {8},
	year = {2021},
	month = {2021 Feb 25},
	pages = {757-758},
	keywords = {COVID-19 Drug Treatment, Dexamethasone, Humans, SARS-CoV-2},
	issn = {1533-4406},
	doi = {10.1056/NEJMe2025674},
	author = {Normand, Sharon-Lise T.}
}
@article {682662,
	title = {Revisiting performance metrics for prediction with rare outcomes},
	journal = {Stat Methods Med Res},
	volume = {30},
	number = {10},
	year = {2021},
	month = {2021 Oct},
	pages = {2352-2366},
	abstract = {Machine learning algorithms are increasingly used in the clinical literature, claiming advantages over logistic regression. However, they are generally designed to maximize the area under the receiver operating characteristic curve. While area under the receiver operating characteristic curve and other measures of accuracy are commonly reported for evaluating binary prediction problems, these metrics can be misleading. We aim to give clinical and machine learning researchers a realistic medical example of the dangers of relying on a single measure of discriminatory performance to evaluate binary prediction questions. Prediction of medical complications after surgery is a frequent but challenging task because many post-surgery outcomes are rare. We predicted post-surgery mortality among patients in a clinical registry who received at least one aortic valve replacement. Estimation incorporated multiple evaluation metrics and algorithms typically regarded as performing well with rare outcomes, as well as an ensemble and a new extension of the lasso for multiple unordered treatments. Results demonstrated high accuracy for all algorithms with moderate measures of cross-validated area under the receiver operating characteristic curve. False positive rates were \&lt;1\%, however, true positive rates were \&lt;7\%, even when paired with a 100\% positive predictive value, and graphical representations of calibration were poor. Similar results were seen in simulations, with the addition of high area under the receiver operating characteristic curve (\&gt;90\%) accompanying low true positive rates. Clinical studies should not primarily report only area under the receiver operating characteristic curve or accuracy.},
	issn = {1477-0334},
	doi = {10.1177/09622802211038754},
	author = {Adhikari, Samrachana and Normand, Sharon-Lise and Bloom, Jordan and Shahian, David and Rose, Sherri}
}
@article {677242,
	title = {Use of Machine Learning Models to Predict Death After Acute Myocardial Infarction},
	journal = {JAMA Cardiol},
	year = {2021},
	month = {2021 Mar 10},
	abstract = {Importance: Accurate prediction of adverse outcomes after acute myocardial infarction (AMI) can guide the triage of care services and shared decision-making, and novel methods hold promise for using existing data to generate additional insights.

Objective: To evaluate whether contemporary machine learning methods can facilitate risk prediction by including a larger number of variables and identifying complex relationships between predictors and outcomes.

Design, Setting, and Participants: This cohort study used the American College of Cardiology Chest Pain-MI Registry to identify all AMI hospitalizations between January 1, 2011, and December 31, 2016. Data analysis was performed from February 1, 2018, to October 22, 2020.

Main Outcomes and Measures: Three machine learning models were developed and validated to predict in-hospital mortality based on patient comorbidities, medical history, presentation characteristics, and initial laboratory values. Models were developed based on extreme gradient descent boosting (XGBoost, an interpretable model), a neural network, and a meta-classifier model. Their accuracy was compared against the current standard developed using a logistic regression model in a validation sample.

Results: A total of 755 402 patients (mean [SD] age, 65 [13] years; 495 202 [65.5\%] male) were identified during the study period. In independent validation, 2 machine learning models, gradient descent boosting and meta-classifier (combination including inputs from gradient descent boosting and a neural network), marginally improved discrimination compared with logistic regression (C statistic, 0.90 for best performing machine learning model vs 0.89 for logistic regression). Nearly perfect calibration in independent validation data was found in the XGBoost (slope of predicted to observed events, 1.01; 95\% CI, 0.99-1.04) and the meta-classifier model (slope of predicted-to-observed events, 1.01; 95\% CI, 0.99-1.02), with more precise classification across the risk spectrum. The XGBoost model reclassified 32 393 of 121 839 individuals (27\%) and the meta-classifier model reclassified 30 836 of 121 839 individuals (25\%) deemed at moderate to high risk for death in logistic regression as low risk, which were more consistent with the observed event rates.

Conclusions and Relevance: In this cohort study using a large national registry, none of the tested machine learning models were associated with substantive improvement in the discrimination of in-hospital mortality after AMI, limiting their clinical utility. However, compared with logistic regression, XGBoost and meta-classifier models, but not the neural network, offered improved resolution of risk for high-risk individuals.},
	issn = {2380-6591},
	doi = {10.1001/jamacardio.2021.0122},
	author = {Khera, Rohan and Haimovich, Julian and Hurley, Nathan C and McNamara, Robert and Spertus, John A and Desai, Nihar and Rumsfeld, John S and Masoudi, Frederick A and Huang, Chenxi and Normand, Sharon-Lise and Mortazavi, Bobak J and Krumholz,Harlan M.}
}
@article {661405,
	title = {Assessment of Second-Generation Diabetes Medication Initiation Among Medicare Enrollees From 2007 to 2015},
	journal = {JAMA Netw Open},
	volume = {3},
	number = {5},
	year = {2020},
	month = {2020 May 01},
	pages = {e205411},
	abstract = {Importance: Little is known about how new and expensive drugs diffuse into practice affects health care costs.

Objective: To describe the variation in second-generation diabetes drug use among Medicare enrollees between 2007 and 2015.

Design, Setting, and Participants: This population-based, cross-sectional study included data from 100\% of Medicare Parts A, B, and D enrollees who first received diabetes drug therapy from January 1, 2007, to December 31, 2015. Patients with type 1 diabetes were excluded. Data were analyzed beginning in the spring of 2018, and revisions were completed in 2019.

Exposures: For each patient, the initial diabetes drug choice was determined; drugs were classified as first generation (ie, approved before 2000) or second generation (ie, approved after 2000, including dipeptidyl peptidase 4 [DPP-4] inhibitors, glucagon-like peptide-1 [GLP-1] receptor agonists, and sodium-glucose cotransporter-2 [SGLT-2] inhibitors).

Main Outcomes and Measures: The primary outcome was the between-practice variation in use of second-generation diabetes drugs between 2007 and 2015. Practices with use rates of second-generation diabetes drugs more than 1 SD above the mean were considered high prescribing, while those with use rates more than 1 SD below the mean were considered low prescribing.

Results: Among 1 182 233 patients who initiated diabetes drug therapy at 42 977 practices between 2007 and 2015, 1 104 718 (93.4\%) were prescribed a first-generation drug (mean [SD] age, 75.4 [6.7] years; 627 134 [56.8\%] women) and 77 515 (6.6\%) were prescribed a second-generation drug (mean [SD] age, 76.5 [7.2] years; 44 697 [57.7\%] women). By December 2015, 22 457 practices (52.2\%) had used DPP-4 inhibitors once, compared with 3593 practices (8.4\%) that had used a GLP-1 receptor agonist once. Furthermore, 17 452 practices (40.6\%) were using DPP-4 inhibitors in 10\% of eligible patients, while 1286 practices (3.0\%) were using GLP-1 receptor agonists in 10\% of eligible patients, and SGLT-2 inhibitors, available after March 2013, were used at least once by 1716 practices (4.0\%) and used in 10\% of eligible patients by 872 practices (2.0\%) by December 2015. According to Poisson random-effect regression models, beneficiaries in high-prescribing practices were more than 3-fold more likely to receive DPP-4 inhibitors (relative risk, 3.55 [95\% CI, 3.42-3.68]), 24-fold more likely to receive GLP-1 receptor agonists (relative risk, 24.06 [95\% CI, 14.14-40.94]) and 60-fold more likely to receive SGLT-2 inhibitors (relative risk, 60.41 [95\% CI, 15.99-228.22]) compared with beneficiaries in low-prescribing practices.

Conclusions and Relevance: These findings suggest that there was substantial between-practice variation in the use of second-generation diabetes drugs between 2007 and 2015, with a concentration of use among a few prescribers and practices responsible for much of the early diffusion.},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2020.5411},
	author = {Gilstrap, Lauren G and Blair, Rachel A and Huskamp, Haiden A. and Zelevinsky, Katya and Normand, Sharon-Lise}
}
@article {651186,
	title = {Association Between Medicare Expenditures and Adverse Events for Patients With Acute Myocardial Infarction, Heart Failure, or Pneumonia in the United States},
	journal = {JAMA Netw Open},
	volume = {3},
	number = {4},
	year = {2020},
	month = {2020 Apr 01},
	pages = {e202142},
	abstract = {Importance: Studies have shown that adverse events are associated with increasing inpatient care expenditures, but contemporary data on the association between expenditures and adverse events beyond inpatient care are limited.

Objective: To evaluate whether hospital-specific adverse event rates are associated with hospital-specific risk-standardized 30-day episode-of-care Medicare expenditures for fee-for-service patients discharged with acute myocardial infarction (AMI), heart failure (HF), or pneumonia.

Design, Setting, and Participants: This cross-sectional study used the 2011 to 2016 hospital-specific risk-standardized 30-day episode-of-care expenditure data from the Centers for Medicare \& Medicaid Services and medical record-abstracted in-hospital adverse event data from the Medicare Patient Safety Monitoring System. The setting was acute care hospitals treating at least 25 Medicare fee-for-service patients for AMI, HF, or pneumonia in the United States. Participants were Medicare fee-for-service patients 65 years or older hospitalized for AMI, HF, or pneumonia included in the Medicare Patient Safety Monitoring System in 2011 to 2016. The dates of analysis were July 16, 2017, to May 21, 2018.

Main Outcomes and Measures: Hospitals{\textquoteright} risk-standardized 30-day episode-of-care expenditures and the rate of occurrence of adverse events for which patients were at risk.

Results: The final study sample from 2194 unique hospitals included 44 807 patients (26.1\% AMI, 35.6\% HF, and 38.3\% pneumonia) with a mean (SD) age of 79.4 (8.6) years, and 52.0\% were women. The patients represented 84 766 exposures for AMI, 96 917 exposures for HF, and 109 641 exposures for pneumonia. Patient characteristics varied by condition but not by expenditure category. The mean (SD) risk-standardized expenditures were $22 985 ($1579) for AMI, $16 020 ($1416) for HF, and $16 355 ($1995) for pneumonia per hospitalization. The mean risk-standardized rates of occurrence of adverse events for which patients were at risk were 3.5\% (95\% CI, 3.4\%-3.6\%) for AMI, 2.5\% (95\% CI, 2.5\%-2.5\%) for HF, and 3.0\% (95\% CI, 2.9\%-3.0\%) for pneumonia. An increase by 1 percentage point in the rate of occurrence of adverse events was associated with an increase in risk-standardized expenditures of $103 (95\% CI, $57-$150) for AMI, $100 (95\% CI, $29-$172) for HF, and $152 (95\% CI, $73-$232) for pneumonia per discharge.

Conclusions and Relevance: Hospitals with high adverse event rates were more likely to have high 30-day episode-of-care Medicare expenditures for patients discharged with AMI, HF, or pneumonia.},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2020.2142},
	author = {Wang, Yun and Eldridge, Noel and Metersky, Mark L and Sonnenfeld, Nancy and Rodrick, David and Fine, Jonathan M. and Eckenrode, Sheila and Galusha, Deron H and Tasimi, Anila and Hunt, David R and Bernheim, Susannah M and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {661407,
	title = {Association Between Subsequent Hospitalizations and Recurrent Acute Myocardial Infarction Within 1 Year After Acute Myocardial Infarction},
	journal = {J Am Heart Assoc},
	volume = {9},
	number = {6},
	year = {2020},
	month = {2020 Mar 17},
	pages = {e014907},
	abstract = {Background Patients who survive acute myocardial infarction (AMI) are at high risk for recurrence. We determined whether rehospitalizations after AMI further increased risk of recurrent AMI. Methods and Results The study included Medicare fee-for-service patients aged >=65~years discharged alive after AMI from acute-care hospitals in fiscal years 2009-2014. The outcome was recurrent AMI within 1~year of the index AMI. The Clinical Classifications Software (CCS) was used to classify rehospitalizations into disease categories. A Cox regression model was fit accounting for CCS-specific hospitalizations as time-varying variables and patient characteristics at discharge for the index AMI, adjusting for the competing risk of death. The rate of 1-year recurrent AMI was 5.3\% (95\% CI, 5.27\%-5.41\%), and median (interquartile range) time from discharge to recurrent AMI was 115 (34-230) days. Eleven disease categories (diabetes mellitus, anemia, hypertension, coronary atherosclerosis, chest pain, heart failure, pneumonia, chronic obstructive pulmonary disease, gastrointestinal hemorrhage, renal failure, complication of implant or graft) were associated with increased risk of recurrent AMI. Septicemia was associated with lower recurrence risk. Hazard ratios ranged from 1.6 (95\% CI, 1.55-1.70, heart failure) to 1.1 (95\% CI, 1.04-1.25, pneumonia) to 0.6 (95\% CI, 0.58-0.71, septicemia). Conclusions Patient risk of recurrent AMI changed based on the occurrence of hospitalizations after the index AMI. Improving post-acute care to prevent unplanned rehospitalizations, especially rehospitalizations for chronic diseases, and extending the focus of outcomes measures to condition-specific rehospitalizations within 30~days and beyond is important for the secondary prevention of AMI.},
	issn = {2047-9980},
	doi = {10.1161/JAHA.119.014907},
	author = {Wang, Yun and Leifheit, Erica and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {661410,
	title = {The association of hospital teaching intensity with 30-day postdischarge heart failure readmission and mortality rates},
	journal = {Health Serv Res},
	volume = {55},
	number = {2},
	year = {2020},
	month = {2020 Apr},
	pages = {259-272},
	abstract = {OBJECTIVE: To investigate risk-adjusted, 30-day postdischarge heart failure mortality and readmission rates stratified by hospital teaching intensity.

DATA SOURCES AND STUDY SETTING: A total of 709~221 Medicare fee-for-service beneficiaries discharged from 3135 US hospitals between 1/1/2013 and 11/30/2014 with a principal diagnosis of heart failure.

STUDY DESIGN: Hospitals were classified as Council of Teaching Hospitals and Health Systems (COTH) major teaching hospitals, non-COTH teaching hospitals, and nonteaching hospitals. Hospital teaching status was linked with MedPAR patient data and FY2016 Hospital Readmission Reduction Program penalties. Index hospitalization survival probabilities were estimated with hierarchical logistic regression and used to stratify index hospitalization survivors into severity deciles. Decile-specific models were estimated for 30-day postdischarge readmission and mortality. Thirty-day postdischarge outcomes were estimated by teaching intensity and penalty categories.

PRINCIPAL FINDINGS: Averaged across deciles, adjusted 30-day COTH hospital readmission rates were, on a relative scale ([COTH minus nonteaching]~{\textdiv}~nonteaching), 1.63 percent higher (95\% CI: 0.89 percent, 2.25 percent) than at nonteaching hospitals, but their average adjusted 30-day postdischarge mortality rates were 11.55 percent lower (95\% CI: -13.78 percent, -9.37 percent). Penalized COTH hospitals had the highest readmission rates of all categories (23.99 percent [95\% CI: 23.50 percent, 24.49 percent]) but the lowest 30-day postdischarge mortality (8.30 percent [95\% CI: 7.99 percent, 8.57 percent] vs 9.84 percent [95\% CI: 9.69 percent, 9.99 percent] for nonpenalized, nonteaching hospitals).

CONCLUSIONS: Heart failure readmission penalties disproportionately impact major teaching hospitals and inadequately credit their better postdischarge survival.},
	issn = {1475-6773},
	doi = {10.1111/1475-6773.13248},
	author = {Shahian, David M and Liu, Xiu and Mort, Elizabeth A and Normand, Sharon-Lise T.}
}
@article {661408,
	title = {Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data},
	journal = {J Am Heart Assoc},
	volume = {9},
	number = {4},
	year = {2020},
	month = {2020 Feb 18},
	pages = {e013606},
	abstract = {Background More than 600~000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real-world surveillance system exists to monitor their long-term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee-for-service claims for patients aged >=65~years who underwent PCI with drug-eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1~year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415~306 DES placements in 368~194 patients, 33~174 repeat PCIs were identified in Medicare claims within 1~year. Of these, 28~632 (86.3\%) could be linked back to the NCDR CathPCI Registry; 16~942 (51.1\% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4\%) were within a previously placed DES: 7652 for in-stent restenosis and 1341 for stent thrombosis. Of 16~176 patients with a claim for acute myocardial infarction in the follow-up period, 4446 (27.5\%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24~288 patients whose death was identified in claims data, 278 (1.1\%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real-world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in-depth examination to accurately assess stent safety.},
	issn = {2047-9980},
	doi = {10.1161/JAHA.119.013606},
	author = {Dhruva, Sanket S and Parzynski, Craig S and Gamble, Ginger M and Curtis, Jeptha P and Desai, Nihar R. and Yeh, Robert W and Masoudi, Frederick A and Kuntz, Richard and Shaw, Richard E and Marinac-Dabic, Danica and Sedrakyan, Art and Normand, Sharon-Lise T. and Krumholz,Harlan M. and Ross, Joseph S}
}
@article {661399,
	title = {Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting},
	journal = {Ther Innov Regul Sci},
	year = {2020},
	month = {2020 Jun 08},
	abstract = {In late 2018, the Food and Drug Administration (FDA) outlined a framework for evaluating the possible use of real-world evidence (RWE) to support regulatory decision-making. This framework was created to facilitate studies that would generate high-quality RWE, including pragmatic clinical trials (PCTs), which are randomized trials designed to inform clinical or policy decisions by assessing the real-world effectiveness of an intervention. There is general agreement among experts that the use of existing healthcare and patient-generated data holds promise for making randomized trials more efficient, less costly, and more generalizable. Yet the benefits of relying on real-world data sources must be weighed against difficulties with ensuring data integrity and completeness. Additionally, appropriately monitoring patient safety in randomized trials of new drugs using healthcare system data that might not be available in real time can be quite difficult. Recognizing that these and other concerns are critical to the development and acceptability of PCTs, a group of stakeholders from academia, industry, professional organizations, regulatory bodies, government agencies, and patient advocates discussed a path forward for PCT growth and sustainability at a think tank meeting entitled "Monitoring and Analyzing Data from Pragmatic Streamlined Randomized Clinical Trials," which took place in January 2019 (Washington, DC). The goals of this meeting were to: (1) evaluate study design and methodological options specific to PCTs that have the potential to yield high-quality evidence; (2) discuss best practices to ensure data quality in PCTs; and (3) identify appropriate methods for study monitoring. Proceedings from the think tank meeting are summarized in this manuscript.},
	issn = {2168-4804},
	doi = {10.1007/s43441-020-00175-7},
	author = {Lentz, Trevor A and Curtis, Lesley H and Rockhold, Frank W and David Martin and Andersson, Tomas L G and Arias, Carolyn and Berlin, Jesse A and Binns, Cherie and Cook, Andrea and Cziraky, Mark and Dent, Ricardo and Desai, Manisha and Emmett, Andrew and Esserman, Denise and George, Jyothis and Hantel, Stefan and Heagerty, Patrick and Hernandez, Adrian F and Hucko, Thomas and Khan, Naeem and Lee, Shun Fu and LoCasale, Robert and Mardekian, Jack and McCall, Debbe and Monda, Keri and Normand, Sharon-Lise and Riesmeyer, Jeffrey and Roe, Matthew and Roessig, Lothar and Scott, Rob and Siedentop, Harald and Waldstreicher, Joanne and WANG, Lin and Weerakkody, Govinda and Wolf, Myles and Ellenberg, Susan S}
}
@article {661409,
	title = {Hospital Performance Assessment in Congenital Heart Surgery: Where Do We Go From Here?},
	journal = {Ann Thorac Surg},
	volume = {109},
	number = {3},
	year = {2020},
	month = {2020 03},
	pages = {621-626},
	keywords = {Cardiac Surgical Procedures, Heart Defects, Congenital, Hospitals, Humans, Outcome and Process Assessment, Health Care, Quality Indicators, Health Care, Quality of Health Care, Risk Adjustment, United States},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2020.01.002},
	author = {Pasquali, Sara K and Banerjee, Mousumi and Romano, Jennifer C and Normand, Sharon-Lise T.}
}
@article {661402,
	title = {Medication Utilization for Alcohol Use Disorder in a Commercially Insured Population},
	journal = {J Gen Intern Med},
	year = {2020},
	month = {2020 Aug 04},
	abstract = {OBJECTIVE: Examine patterns of alcohol use disorder (AUD) medication use and identify factors associated with prescription fill among commercially insured individuals with an index AUD visit.

DESIGN: Using 2008-2018 claims data from a large national insurer, estimate days to first AUD medication using cause-specific hazards approach to account for competing risk of benefits loss.

PARTICIPANTS: Aged 17-64 with >= 1 AUD visit.

MAIN MEASURE: Days to AUD medication fill.

KEY RESULTS: A total of 13.3\% of the 151,128 with an index visit filled an AUD prescription after that visit, while 69.8\% lost benefits before filling and 17.0\% remained enrolled but did not fill (median days observed = 305). Almost half (46.3\%) of those who filled a prescription received substance use disorder (SUD) inpatient care within 7~days before the fill, and 63.4\% received SUD outpatient care. Likelihood of medication use was higher for those aged 26-35, 36-45, and 46-55~years relative to 56-64~years (e.g., 26-35: hazard ratio = 1.29 [95\% confidence interval 1.23-1.36]); those diagnosed with moderate/severe AUD (2.05 [1.98-2.12]), co-occurring opioid use disorder (OUD) (1.33 [1.26-1.39]), or severe mental illness (1.31 [1.27-1.35]); those with a chronic alcohol-related diagnosis (1.08 [1.04-1.12]); and those whose index visit was in an inpatient/emergency department (1.27 [1.23-1.31]) or intermediate care setting (1.13 [1.07-1.20]) relative to outpatient. Likelihood of use was higher in later years relative to 2008 (e.g., 2018:2.02 [1.89-2.15]) and higher for those who received the majority of AUD care in a practice with a psychiatrist/addiction medicine specialist (1.13 [1.10-1.16]). Likelihood of use was lower for those diagnosed with a SUD other than AUD or OUD (0.88 [0.85-0.92]), those with an acute alcohol-related condition (0.79 [0.75-0.84]), and males (0.71 [0.69-0.73]).

CONCLUSIONS: While AUD medication use increased and was more common among individuals with greater severity, few patients who could benefit from medications are using them. More efforts are needed to identify and treat individuals in non-acute care settings earlier in their course of AUD.},
	issn = {1525-1497},
	doi = {10.1007/s11606-020-06073-w},
	author = {Huskamp, Haiden A. and Reif, Sharon and Greenfield, Shelly F and Normand, Sharon-Lise T. and Alisa B. Busch}
}
@article {677243,
	title = {Nonparametric Bayesian Instrumental Variable Analysis: Evaluating Heterogeneous Effects of Coronary Arterial Access Site Strategies},
	journal = {J Am Stat Assoc},
	volume = {115},
	number = {532},
	year = {2020},
	month = {2020},
	pages = {1635-1644},
	abstract = {Percutaneous coronary interventions (PCIs) are nonsurgical procedures to open blocked blood vessels to the heart, frequently using a catheter to place a stent. The catheter can be inserted into the blood vessels using an artery in the groin or an artery in the wrist. Because clinical trials have indicated that access via the wrist may result in fewer post procedure complications, shortening the length of stay, and ultimately cost less than groin access, adoption of access via the wrist has been encouraged. However, patients treated in usual care are likely to differ from those participating in clinical trials, and there is reason to believe that the effectiveness of wrist access may differ between males and females. Moreover, the choice of artery access strategy is likely to be influenced by patient or physician unmeasured factors. To study the effectiveness of the two artery access site strategies on hospitalization charges, we use data from a state-mandated clinical registry including 7,963 patients undergoing PCI. A hierarchical Bayesian likelihood-based instrumental variable analysis under a latent index modeling framework is introduced to jointly model outcomes and treatment status. Our approach accounts for unobserved heterogeneity via a latent factor structure, and permits nonparametric error distributions with Dirichlet process mixture models. Our results demonstrate that artery access in the wrist reduces hospitalization charges compared to access in the groin, with a higher mean reduction for male patients.},
	issn = {0162-1459},
	doi = {10.1080/01621459.2019.1688663},
	author = {Adhikari, Samrachana and Rose, Sherri and Normand, Sharon-Lise}
}
@article {661398,
	title = {Outpatient care for opioid use disorder among the commercially insured: Use of medication and psychosocial treatment},
	journal = {J Subst Abuse Treat},
	volume = {115},
	year = {2020},
	month = {2020 Aug},
	pages = {108040},
	abstract = {BACKGROUND: Evidence-based outpatient treatment for opioid use disorder (OUD) consists of medications that treat OUD (MOUD) and psychosocial treatments (e.g., psychotherapy or counseling, case management). Prior studies have not examined the use of these components of care in a commercially insured population.

METHODS: We analyzed claims data from a large national commercial insurer of enrollees age 17-64 identified with OUD (2008-2016, N~=~87,877 persons and 122,708 person-years). Multinomial logistic regression models identified factors associated with receiving in a given year: 1) both MOUD and psychosocial visits, 2) MOUD without psychosocial visits, 3) psychosocial visits without MOUD, or 4) neither. We estimated predicted probabilities for key variables of interest.

RESULTS: Identification of OUD nearly tripled during the observation period (0.17\% in 2008, 0.45\% in 2016). Among person-years identified as having OUD, 36.3\% included MOUD (8.1\% both MOUD and psychosocial visits and 28.2\% MOUD without psychosocial visits). In adjusted analyses, women had a lower probability of receiving either treatment alone or in combination (e.g.,MOUD plus psychosocial visits: women~=~6.7\% [6.5\%-6.9\%] vs. men~=~9.2\% [9.0\%-9.4\%]). Moderate/severe vs. mild OUD was associated with a higher probability of receiving MOUD (e.g., MOUD plus psychosocial visits: 8.7\% [8.6\%-8.9\%] vs. 0.9\% [0.7\%-1.0\%]). In contrast, an OUD overdose was associated with a greater probability of receiving neither treatment (78.2\% [77.4\%-79.0\%] vs. 55.5\% [55.2\%-55.8\%]). Over time, the probability of receiving each MOUD and psychosocial treatment category increased relative to 2008, but reached a peak and then plateaued or declined, by the end of the study period.

CONCLUSIONS: A significant treatment gap exists among individuals identified with OUD in this commercially insured population, with greater risks of receiving no treatment for women and for individuals with mild versus moderate or severe OUD. Overdose is associated with receiving neither MOUD nor psychosocial treatment. While treated prevalence initially increased relative to 2008, rates of treatment subsequently plateaued. Additional study and monitoring to elucidate barriers to OUD treatment in commercially insured populations are warranted.},
	issn = {1873-6483},
	doi = {10.1016/j.jsat.2020.108040},
	author = {Alisa B. Busch and Greenfield, Shelly F and Reif, Sharon and Normand, Sharon-Lise T. and Huskamp, Haiden A.}
}
@article {661404,
	title = {Quality of primary health care in China: challenges and recommendations},
	journal = {Lancet},
	volume = {395},
	number = {10239},
	year = {2020},
	month = {2020 06 06},
	pages = {1802-1812},
	abstract = {China has substantially increased financial investment and introduced favourable policies for strengthening its primary health care system with core responsibilities in preventing and managing chronic diseases such as hypertension and emerging infectious diseases such as coronavirus disease 2019 (COVID-19). However, widespread gaps in the quality of primary health care still exist. In this Review, we aim to identify the causes for this poor quality, and provide policy recommendations. System challenges include: the suboptimal education and training of primary health-care practitioners, a fee-for-service payment system that incentivises testing and treatments over prevention, fragmentation of clinical care and public health service, and insufficient continuity of care throughout the entire health-care system. The following recommendations merit consideration: (1) enhancement of the quality of training for primary health-care physicians, (2) establishment of performance accountability to incentivise high-quality and high-value care; (3) integration of clinical care with the basic public health services, and (4) strengthening of the coordination between primary health-care institutions and hospitals. Additionally, China should consider modernising its primary health-care system through the establishment of a learning health system built on digital data and innovative technologies.},
	keywords = {China, Continuity of Patient Care, Coronavirus Infections, Fee-for-Service Plans, Humans, Pandemics, Physicians, Primary Care, Pneumonia, Viral, Primary Health Care, Quality of Health Care},
	issn = {1474-547X},
	doi = {10.1016/S0140-6736(20)30122-7},
	author = {Li, Xi and Krumholz,Harlan M. and Yip, Winnie and Cheng, Kar Keung and De Maeseneer, Jan and Meng, Qingyue and Mossialos, Elias and Li, Chuang and Jiapeng Lu and Su, Meng and Zhang, Qiuli and Xu, Dong Roman and Li, Liming and Normand, Sharon-Lise T. and Peto, Richard and Jing Li and Wang, Zengwu and Yan, Hongbing and Gao, Runlin and Chunharas, Somsak and Gao, Xin and Guerra, Raniero and Ji, Huijie and Ke, Yang and Pan, Zhigang and Wu, Xianping and Xiao, Shuiyuan and Xie, Xinying and Zhang, Yujuan and Zhu, Jun and Zhu, Shanzhu and Hu, Shengshou}
}
@article {661406,
	title = {Surgeons: Buyer beware-does "universal" risk prediction model apply to patients universally?},
	journal = {J Thorac Cardiovasc Surg},
	volume = {160},
	number = {1},
	year = {2020},
	month = {2020 Jul},
	pages = {176-179.e2},
	keywords = {Cohort Studies, Humans, Models, Statistical, Quality Improvement, Risk Assessment, Surgeons},
	issn = {1097-685X},
	doi = {10.1016/j.jtcvs.2019.11.144},
	author = {Mori, Makoto and Shahian, David M and Huang, Chenxi and Li, Shu-Xia and Normand, Sharon-Lise T. and Geirsson, Arnar and Krumholz,Harlan M.}
}
@article {661403,
	title = {Understanding the large heterogeneity in hospital readmissions and mortality for acute myocardial infarction},
	journal = {Health Policy},
	volume = {124},
	number = {7},
	year = {2020},
	month = {2020 Jul},
	pages = {684-694},
	abstract = {This study aims to investigate the variation in two acute myocardial infarction (AMI) outcomes across public hospitals in Portugal. In-hospital mortality and 30-day unplanned readmissions were studied using two distinct AMI cohorts of adults discharged from all acute care public hospital centers in Portugal from 2012-2015. Hierarchical generalized linear models were used to assess the association between patient and hospital characteristics and hospital variability in the two outcomes. Our findings indicate that hospitals are not performing homogeneously-the risk of adverse events tends to be consistently larger in some hospitals and consistently lower in other hospitals. While patient characteristics accounted for a larger share of the explained between-hospital variance, hospital characteristics explain an additional 8\% and 10\% of hospital heterogeneity in the mortality and the readmission cohorts respectively. Admissions to hospitals with low AMI caseloads or located in Alentejo/Algarve and Lisbon had a higher risk of mortality. Discharges from larger-sized hospitals were associated with increased risk of readmissions. Future health policies should incorporate these findings in order to incentivize more consistent health care outcomes across hospitals. Further investigation addressing geographical disparities, hospital caseload and practices is needed to direct actions of improvement to specific hospitals.},
	issn = {1872-6054},
	doi = {10.1016/j.healthpol.2020.04.004},
	author = {Lobo, Mariana F and Azzone, Vanessa and Lopes, Fernando and Freitas, Alberto and Costa-Pereira, Altamiro and Normand, Sharon-Lise and Teixeira-Pinto, Armando}
}
@article {637840,
	title = {Approaches to treatment effect heterogeneity in the presence of confounding},
	journal = {Stat Med},
	volume = {38},
	number = {15},
	year = {2019},
	month = {2019 Jul 10},
	pages = {2797-2815},
	abstract = {The literature on causal effect estimation tends to focus on the population mean estimand, which is less informative as medical treatments are becoming more personalized and there is increasing awareness that subpopulations of individuals may experience a group-specific effect that differs from the population average. In fact, it is possible that there is underlying systematic effect heterogeneity that is obscured by focusing on the population mean estimand. In this context, understanding which covariates contribute to this treatment effect heterogeneity (TEH) and how these covariates determine the differential treatment effect (TE) is an important consideration. Towards such an understanding, this paper briefly reviews three approaches used in making causal inferences and conducts a simulation study to compare these approaches according to their performance in an exploratory evaluation of TEH when the heterogeneous subgroups are not known a priori. Performance metrics include the detection of any heterogeneity, the identification and characterization of heterogeneous subgroups, and unconfounded estimation of the TE within subgroups. The methods are then deployed in a comparative effectiveness evaluation of drug-eluting versus bare-metal stents among 54 099 Medicare beneficiaries in the continental United States admitted to a hospital with acute myocardial infarction in 2008.},
	issn = {1097-0258},
	doi = {10.1002/sim.8143},
	author = {Anoke, Sarah C and Normand, Sharon-Lise and Zigler, Corwin M}
}
@article {637845,
	title = {Association Between Medication Adherence and 1-Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China},
	journal = {J Am Heart Assoc},
	volume = {8},
	number = {9},
	year = {2019},
	month = {2019 05 07},
	pages = {e011793},
	abstract = {Background Secondary prevention after acute myocardial infarction ( AMI ) requires long-term guideline-directed medical therapy. However, the level of medication adherence, factors associated with poor adherence, and extent to which good adherence can reduce adverse events after AMI in China remain uncertain. Methods and Results In 2013 to 2014, 4001 AMI patients aged >=18~years were discharged alive from 53 hospitals across China (mean age 60.5{\textpm}11.7~years; 22.7\% female). Good adherence was defined as taking medications (aspirin, β-blockers, statins, clopidogrel, or angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers) >=90\% of the time as prescribed. Cox models assessed the association between good adherence (a time-varying covariate) and 1-year cardiovascular events after AMI . The most common medications were aspirin (82.2\%) and statins (80.5\%). There were 243 patients who were not prescribed any medications during follow-up; 1-year event rates were higher for these patients (25.1\%, 95\% CI 19.7-30.6\%) versus those taking >=1 medications (6.6\%, 95\% CI 5.76-7.34\%). The overall rate of good adherence was 52.9\%. Good adherence was associated with lower risk of 1-year events (adjusted hazard ratio 0.61, 95\% CI 0.49-0.77). The most common reason for poor adherence was belief that one{\textquoteright}s condition had improved/no longer required medication. More comorbidities and lower education level were associated with poor adherence. Conclusions Good adherence reduced 1-year cardiovascular event risk after AMI . About half of our cohort did not have good adherence. National efforts to improve AMI outcomes in China should focus on medication adherence and educating patients on the importance of cardiovascular medications for reducing risk of recurrent events. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT01624909.},
	keywords = {Aged, Cardiovascular Agents, China, Female, Humans, Longitudinal Studies, Male, Medication Adherence, Middle Aged, Myocardial Infarction, Patient Reported Outcome Measures, Prospective Studies, Protective Factors, Recurrence, Risk Assessment, Risk Factors, Secondary Prevention, Time Factors, Treatment Outcome},
	issn = {2047-9980},
	doi = {10.1161/JAHA.118.011793},
	author = {Shang, Pu and Liu, Gordon G and Zheng, Xin and Ho, P Michael and Hu, Shuang and Jing Li and Zihan Jiang and Li, Xi and Xueke Bai and Gao, Yan and Chao Xing and Wang, Yun and Normand, Sharon-Lise and Krumholz,Harlan M.}
}
@article {661411,
	title = {Association of Hospital Payment Profiles With Variation in 30-Day Medicare Cost for Inpatients With Heart Failure or Pneumonia},
	journal = {JAMA Netw Open},
	volume = {2},
	number = {11},
	year = {2019},
	month = {2019 11 01},
	pages = {e1915604},
	abstract = {Importance: Some uncertainty exists about whether hospital variations in cost are largely associated with differences in case mix.

Objective: To establish whether the same patients admitted with the same diagnosis (heart failure or pneumonia) at 2 different hospitals incur different costs associated with the hospital{\textquoteright}s Medicare payment profile.

Design, Setting, and Participants: This observational cohort study used Centers for Medicare \& Medicaid Services (CMS) discharge data of patients with a principal diagnosis of heart failure (n = 1615) or pneumonia (n = 708) occurring between July 1, 2013, and June 30, 2016. Patients were individuals aged 65 years or older who were enrolled in Medicare fee-for-service Part A and Part B and were discharged from nonfederal, short-term, acute care or critical access hospitals in the United States. Data were analyzed from March 16, 2018, to September 25, 2019.

Main Outcomes and Measures: The CMS heart failure and pneumonia payment measure cohorts were divided into 2 random samples. In the first sample, hospitals were classified into payment quartiles for heart failure and pneumonia. In the second sample, patients with 2 admissions for heart failure or pneumonia, one in a lowest-quartile hospital and one in a highest-quartile hospital more than 1 month apart, were identified. Standardized Medicare payments for these patients were compared for the lowest- and the highest-quartile payment hospitals.

Results: The study sample included 1615 patients with heart failure (mean [SD] age, 78.7 [8.0] years; 819 [50.7\%] male) and 708 with pneumonia (mean [SD] age, 78.3 [8.0] years; 401 [56.6\%] male). The observed 30-day mortality rates for patients among lowest- compared with highest-payment hospitals were not significantly different. The median (interquartile range) hospital 30-day risk-standardized mortality rates were 8.1\% (7.7\%-8.5\%) for heart failure and 11.3\% (10.7\%-12.1\%) for pneumonia. The 30-day episode payment for hospitalization for the same patients at the lowest-payment hospitals was $2118 (95\% CI, $1168-$3068; P ,
	keywords = {Aged, Aged, 80 and over, Cohort Studies, Female, Heart Failure, Hospital Costs, Hospitalization, Humans, Male, Medicare, Pneumonia, Reimbursement mechanisms, Time Factors, United States},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2019.15604},
	author = {Krumholz,Harlan M. and Wang, Yongfei and Wang, Kun and Lin, Zhenqiu and Bernheim, Susannah M and Xu, Xiao and Desai, Nihar R. and Normand, Sharon-Lise T.}
}
@article {661415,
	title = {Bayesian Meta-analysis of Multiple Continuous Treatments with Individual Participant-Level Data: An Application to Antipsychotic Drugs},
	journal = {Med Decis Making},
	volume = {39},
	number = {5},
	year = {2019},
	month = {2019 07},
	pages = {583-592},
	abstract = {Modeling dose-response relationships of drugs is essential to understanding their safety effects on patients under realistic circumstances. While intention-to-treat analyses of clinical trials provide the effect of assignment to a particular drug and dose, they do not capture observed exposure after factoring in nonadherence and dropout. We develop a Bayesian method to flexibly model the dose-response relationships of binary outcomes with continuous treatment, permitting multiple evidence sources, treatment effect heterogeneity, and nonlinear dose-response curves. In an application, we examine the risk of excessive weight gain for patients with schizophrenia treated with the second-generation antipsychotics paliperidone, risperidone, or olanzapine in 14 clinical trials. We define exposure as total cumulative dose (daily dose {\texttimes} duration) and convert to units equivalent to 100 mg of olanzapine (OLZ doses). Averaging over the sample population of 5891 subjects, the median dose ranged from 0 (placebo randomized participants) to 6.4 OLZ doses (paliperidone randomized participants). We found paliperidone to be least likely to cause excessive weight gain across a range of doses. Compared with 0 OLZ doses, at 5.0 OLZ doses, olanzapine subjects had a 15.6\% (95\% credible interval: 6.7, 27.1) excess risk of weight gain; corresponding estimates for paliperidone and risperidone were 3.2\% (1.5, 5.2) and 14.9\% (0.0, 38.7), respectively. Moreover, compared with nonblack participants, black participants had a 6.8\% (1.0, 12.4) greater risk of excessive weight gain at 10.0 OLZ doses of paliperidone. Nevertheless, our findings suggest that paliperidone is safer in terms of weight gain risk than risperidone or olanzapine for all participants at low to moderate cumulative OLZ doses.},
	keywords = {Adult, Antipsychotic Agents, Bayes Theorem, Dose-Response Relationship, Drug, Female, Humans, Male, Markov Chains, Medication Adherence, Middle Aged, Olanzapine, Paliperidone Palmitate, Risperidone, Schizophrenia, Weight Gain},
	issn = {1552-681X},
	doi = {10.1177/0272989X19856884},
	author = {Spertus, Jacob and Horvitz-Lennon, Marcela and Normand, Sharon-Lise T.}
}
@article {649742,
	title = {Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials},
	journal = {Am Heart J},
	volume = {218},
	year = {2019},
	month = {2019 12},
	pages = {110-122},
	abstract = {BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes.

METHODS: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection.

RESULTS: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2\% vs 5.2\%; adjusted κ 0.99), MI (2.2\% vs 2.3\%; adjusted κ 0.96), stroke (0.7\% vs 0.7\%; adjusted κ 0.99), and any revascularization (7.4\% vs 7.9\%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39\% of MIs and 18\% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest.

CONCLUSIONS: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.},
	issn = {1097-6744},
	doi = {10.1016/j.ahj.2019.09.002},
	author = {Brennan, J Matthew and Wruck, Lisa and Pencina, Michael J and Clare, Robert M and Lopes, Renato D and Alexander, John H and O{\textquoteright}Brien, Sean and Krucoff, Mitchell and Rao, Sunil V and Wang, Tracy Y and Curtis, Lesley H and Newby, L Kristin and Granger, Christopher B and Patel, Manesh and Mahaffey, Kenneth and Ross, Joseph S and Normand, Sharon-Lise and Eloff, Benjamin C and Ca{\~n}os, Daniel A and Lokhnygina, Yuliya V and Roe, Matthew T and Califf, Robert M and Marinac-Dabic, Danica and Peterson, Eric D}
}
@article {661417,
	title = {Comparative Effectiveness of New Approaches to Improve Mortality Risk Models From Medicare Claims Data},
	journal = {JAMA Netw Open},
	volume = {2},
	number = {7},
	year = {2019},
	month = {2019 07 03},
	pages = {e197314},
	abstract = {Importance: Risk adjustment models using claims-based data are central in evaluating health care performance. Although US Centers for Medicare \& Medicaid Services (CMS) models apply well-vetted statistical approaches, recent changes in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) coding system and advances in computational capabilities may provide an opportunity for enhancement.

Objective: To examine whether changes using already available data would enhance risk models and yield greater discrimination in hospital-level performance measures.

Design, Setting, and Participants: This comparative effectiveness study used ICD-9-CM codes from all Medicare fee-for-service beneficiary claims for hospitalizations for acute myocardial infarction (AMI), heart failure (HF), or pneumonia among patients 65 years and older from July 1, 2013, through September 30, 2015. Changes to current CMS mortality risk models were applied incrementally to patient-level models, and the best model was tested on hospital performance measures to model 30-day mortality. Analyses were conducted from April 19, 2018, to September 19, 2018.

Main Outcomes and Measures: The main outcome was all-cause death within 30 days of hospitalization for AMI, HF, or pneumonia, examined using 3 changes to current CMS mortality risk models: (1) incorporating present on admission coding to better exclude potential complications of care, (2) separating index admission diagnoses from those of the 12-month history, and (3) using ungrouped ICD-9-CM codes.

Results: There were 361 175 hospital admissions (mean [SD] age, 78.6 [8.4] years; 189 225 [52.4\%] men) for AMI, 716 790 hospital admissions (mean [SD] age, 81.1 [8.4] years; 326 825 [45.6\%] men) for HF, and 988 225 hospital admissions (mean [SD] age, 80.7 [8.6] years; 460 761 [46.6\%] men) for pneumonia during the study; mean 30-day mortality rates were 13.8\% for AMI, 12.1\% for HF, and 16.1\% for pneumonia. Each change to the models was associated with incremental gains in C statistics. The best model, incorporating all changes, was associated with significantly improved patient-level C statistics, from 0.720 to 0.826 for AMI, 0.685 to 0.776 for HF, and 0.715 to 0.804 for pneumonia. Compared with current CMS models, the best model produced wider predicted probabilities with better calibration and Brier scores. Hospital risk-standardized mortality rates had wider distributions, with more hospitals identified as good or bad performance outliers.

Conclusions and Relevance: Incorporating present on admission coding and using ungrouped index and historical ICD-9-CM codes were associated with improved patient-level and hospital-level risk models for mortality compared with the current CMS models for all 3 conditions.},
	keywords = {Aged, Aged, 80 and over, Comparative Effectiveness Research, Fee-for-Service Plans, Female, Heart Failure, Hospital Mortality, Hospitalization, Humans, Male, Medicare, Myocardial Infarction, Pneumonia, Risk Adjustment, United States},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2019.7314},
	author = {Krumholz,Harlan M. and Coppi, Andreas C and Warner, Frederick and Triche, Elizabeth W. and Li, Shu-Xia and Mahajan, Shiwani and Li, Yixin and Bernheim, Susannah M and Grady, Jacqueline and Dorsey, Karen and Lin, Zhenqiu and Normand, Sharon-Lise T.}
}
@article {637841,
	title = {Comparative Safety of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance of the NCDR CathPCI Registry},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {12},
	number = {2},
	year = {2019},
	month = {2019 Feb},
	pages = {e004666},
	abstract = {Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry. We sought to assess the ability of our surveillance strategy to avoid false safety alerts by conducting an active safety surveillance study of aspiration thrombectomy catheters using data within the National Cardiovascular Data Registry CathPCI registry, where no difference in safety outcomes were anticipated for the primary in-hospital safety outcome of death and major adverse cardiovascular events (MACE). We performed a propensity-matched analysis of 5 aspiration thrombectomy catheter devices used during percutaneous coronary intervention among 95 925 patients presenting with ST-segment-elevation myocardial infarction between January 1, 2011 and September 30, 2013. After 33 months of surveillance, no safety alerts were triggered for the primary safety endpoints of death or MACE, with no between-catheter differences observed. The absolute risk of death during acute hospitalization ranged from 5.11\% to 5.32\% among the most commonly used aspiration thrombectomy catheter devices, with relative risks for death ranging from 0.96 to 1.03. The absolute risk of MACE ranged from 9.78\% to 10.18\%, with relative risks for MACE ranging from 0.99 to 1.02. There were no statistically significant differences in the rates of death or MACE between any of the aspiration thrombectomy catheter devices analyzed. Conclusions The CathPCI DELTA study demonstrates that prospective, active safety surveillance of national clinical registries is feasible to provide near-real-time safety assessments of new medical devices.},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.118.004666},
	author = {Majithia, Arjun and Matheny, Michael E and Paulus, Jessica K and Marinac-Dabic, Danica and Robbins, Susan and Ssemaganda, Henry and Hewitt, Kathleen and Ponirakis, Angelo and Loyo-Berrios, Nilsa and Moussa, Issam and Drozda, Joseph and Normand, Sharon-Lise and Resnic, Frederic S}
}
@article {661412,
	title = {Development and Testing of Improved Models to Predict Payment Using Centers for Medicare \& Medicaid Services Claims Data},
	journal = {JAMA Netw Open},
	volume = {2},
	number = {8},
	year = {2019},
	month = {2019 08 02},
	pages = {e198406},
	abstract = {Importance: Predicting payments for particular conditions or populations is essential for research, benchmarking, public reporting, and calculations for population-based programs. Centers for Medicare \& Medicaid Services (CMS) models often group codes into disease categories, but using single, rather than grouped, diagnostic codes and leveraging present on admission (POA) codes may enhance these models.

Objective: To determine whether changes to the candidate variables in CMS models would improve risk models predicting patient total payment within 30 days of hospitalization for acute myocardial infarction (AMI), heart failure (HF), and pneumonia.

Design, Setting, and Participants: This comparative effectiveness research study used data from Medicare fee-for-service hospitalizations for AMI, HF, and pneumonia at acute care hospitals from July 1, 2013, through September 30, 2015. Payments across multiple care settings, services, and supplies were included and adjusted for geographic and policy variations, corrected for inflation, and winsorized. The same data source was used but varied for the candidate variables and their selection, and the method used by CMS for public reporting that used grouped codes was compared with variations that used POA codes and single diagnostic codes. Combinations of use of POA codes, separation of index admission diagnoses from those in the previous 12 months, and use of individual International Classification of Diseases, Ninth Revision, Clinical Modification codes instead of grouped diagnostic categories were tested. Data analysis was performed from December 4, 2017, to June 10, 2019.

Main Outcomes and Measures: The models{\textquoteright} goodness of fit was compared using root mean square error (RMSE) and the McFadden pseudo R2.

Results: Among the 1 943 049 total hospitalizations of the study participants, 343 116 admissions were for AMI (52.5\% male; 37.4\% aged <=74 years), 677 044 for HF (45.5\% male; 25.9\% aged <=74 years), and 922 889 for pneumonia (46.4\% male; 28.2\% aged <=74 years). The mean (SD) 30-day payment was $23 103 ($18 221) for AMI, $16 365 ($12 527) for HF, and $17 097 ($12 087) for pneumonia. Each incremental model change improved the pseudo R2 and RMSE. Incorporating all 3 changes improved the pseudo R2 of the patient-level models from 0.077 to 0.129 for AMI, from 0.042 to 0.129 for HF, and from 0.114 to 0.237 for pneumonia. Parallel improvements in RMSE were found for all 3 conditions.

Conclusions and Relevance: Leveraging POA codes, separating index from previous diagnoses, and using single diagnostic codes improved payment models. Better models can potentially improve research, benchmarking, public reporting, and calculations for population-based programs.},
	keywords = {Adult, Aged, Aged, 80 and over, Centers for Medicare and Medicaid Services, U.S., Female, Forecasting, Heart Failure, Humans, Male, Medicaid, Medicare, Middle Aged, Models, Theoretical, Myocardial Infarction, Patient Readmission, Pneumonia, United States},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2019.8406},
	author = {Krumholz,Harlan M. and Warner, Frederick and Coppi, Andreas and Triche, Elizabeth W. and Li, Shu-Xia and Mahajan, Shiwani and Li, Yixin and Bernheim, Susannah M and Grady, Jacqueline and Dorsey, Karen and Desai, Nihar R. and Lin, Zhenqiu and Normand, Sharon-Lise T.}
}
@article {649743,
	title = {Identification of ESRD in Cardiovascular Procedural Databases},
	journal = {Kidney Int Rep},
	volume = {4},
	number = {10},
	year = {2019},
	month = {2019 Oct},
	pages = {1477-1482},
	issn = {2468-0249},
	doi = {10.1016/j.ekir.2019.06.014},
	author = {Charytan, David M and Zelevinksy, Katya and Robert Wolf and Normand, Sharon-Lise}
}
@article {637844,
	title = {Mandatory public reporting of cardiac surgery outcomes: The 2003 to 2014 Massachusetts experience},
	journal = {J Thorac Cardiovasc Surg},
	volume = {158},
	number = {1},
	year = {2019},
	month = {2019 Jul},
	pages = {110-124.e9},
	abstract = {OBJECTIVES: Beginning in 2002, all 14 Massachusetts nonfederal cardiac surgery programs submitted Society of Thoracic Surgeons (STS) National Database data to the Massachusetts Data Analysis Center for mandatory state-based analysis and reporting, and to STS for nationally benchmarked analyses. We sought to determine whether longitudinal prevalences and trends in risk factors and observed and expected mortality differed between Massachusetts and the nation.

METHODS: We analyzed 2003 to 2014 expected (STS predicted risk of operative [in-hospital~+~30-day] mortality), observed, and risk-standardized isolated coronary artery bypass graft mortality using Massachusetts STS data (N~=~39,400 cases) and national STS data (N~=~1,815,234 cases). Analyses included percentage shares of total Massachusetts coronary artery bypass graft volume and expected mortality rates of 2 hospitals before and after outlier designation.

RESULTS: Massachusetts patients had significantly higher odds of diabetes, peripheral vascular disease, low ejection fraction, and age >=75~years relative to national data and lower odds of shock (odds ratio, 0.66; 99\% confidence interval, 0.53-0.83), emergency (odds ratio, 0.57, 99\% confidence interval, 0.52-0.61), reoperation, chronic lung disease, dialysis, obesity, and female sex. STS predicted risk of operative [in-hospital~+~30-day] mortality for Massachusetts patients was higher than national rates during 2003 to 2007 (P~,
	issn = {1097-685X},
	doi = {10.1016/j.jtcvs.2018.12.072},
	author = {Shahian, David M and Torchiana, David F and Engelman, Daniel T and Sundt, Thoralf M and D{\textquoteright}Agostino, Richard S and Lovett, Ann F and Cioffi, Matthew J and Rawn, James D and Birjiniuk, Vladimir and Habib, Robert H and Normand, Sharon-Lise T.}
}
@article {661416,
	title = {New Guidelines for Statistical Reporting in the },
	journal = {N Engl J Med},
	volume = {381},
	number = {3},
	year = {2019},
	month = {2019 07 18},
	pages = {285-286},
	keywords = {Cardiovascular Diseases, Humans, Neoplasms, Nutrition Therapy, Research Design, Vitamin D},
	issn = {1533-4406},
	doi = {10.1056/NEJMe1906559},
	author = {Harrington, David and D{\textquoteright}Agostino, Ralph B and Gatsonis, Constantine and Hogan, Joseph W and Hunter, David J and Normand, Sharon-Lise T. and Drazen, Jeffrey M and Mary Beth Hamel}
}
@article {637842,
	title = {The relation of telomere length at midlife to subsequent 20-year depression trajectories among women},
	journal = {Depress Anxiety},
	volume = {36},
	number = {6},
	year = {2019},
	month = {2019 Jun},
	pages = {565-575},
	abstract = {BACKGROUND: Telomeres cap and protect DNA but shorten with each somatic cell division. Aging and environmental and lifestyle factors contribute to the speed of telomere attrition. Current evidence suggests a link between relative telomere length (RTL) and depression but the directionality of the relationship remains unclear. We prospectively examined associations between RTL and subsequent depressive symptom trajectories.

METHODS: Among 8,801 women of the Nurses{\textquoteright} Health Study, depressive symptoms were measured every 4 years from 1992 to 2012; group-based trajectories of symptoms were identified using latent class growth-curve analysis. Multinomial logistic models were used to relate midlife RTLs to the probabilities of assignment to subsequent depressive symptom trajectory groups.

RESULTS: We identified four depressive symptom trajectory groups: minimal depressive symptoms (62\%), worsening depressive symptoms (14\%), improving depressive symptoms (19\%), and persistent-severe depressive symptoms (5\%). Longer midlife RTLs were related to significantly lower odds of being in the worsening symptoms trajectory versus minimal trajectory but not to other trajectories. In comparison with being in the minimal symptoms group, the multivariable-adjusted odds ratio of being in the worsening depressive symptoms group was 0.78 (95\% confidence interval, 0.62-0.97; p = 0.02), for every standard deviation increase in baseline RTL.

CONCLUSIONS: In this large prospective study of generally healthy women, longer telomeres at midlife were associated with significantly lower risk of a subsequent trajectory of worsening mood symptoms over 20 years. The results raise the possibility of telomere shortening as a novel contributing factor to late-life depression.},
	issn = {1520-6394},
	doi = {10.1002/da.22892},
	author = {Gillis, Jennifer Cai and Chang, Shun-Chiao and Wang, Wei and Simon, Naomi M. and Normand, Sharon-Lise and Rosner, Bernard A and Blacker, Deborah and de Vivo, Immaculata and Okereke, Olivia I}
}
@article {638864,
	title = {Trends in the use of coercive measures in Finnish psychiatric hospitals: a register analysis of the past two decades},
	journal = {BMC Psychiatry},
	volume = {19},
	number = {1},
	year = {2019},
	month = {2019 Jul 26},
	pages = {230},
	abstract = {BACKGROUND: Coercive measures is a topic that has long been discussed in the field of psychiatry. Despite global reports of reductions in the use of restraint episodes due to new regulations, it is still questionable if practices have really changed over time. For this study, we examined the rates of coercive measures in the inpatient population of psychiatric care providers across Finland to identify changing trends as well as variations in such trends by region.

METHODS: In this nationwide registry analysis, we extracted patient data from the national database (The Finnish National Care Register for Health Care) over a 20-year period. We included adult patients admitted to psychiatric units (care providers) and focused on patients who had faced coercive measures (seclusion, limb restraints, forced injection and physical restraints) during their hospital stay. Multilevel logistical models (a polynomial model of quadratic form) were used to examine trends in prevalence of any coercive measures as well as the other four specified coercive measures over time, and to investigate variation in such trends among care providers and regions.

RESULTS: Between 1995 and 2014, the dataset contained 226,948 inpatients who had been admitted during the 20-year time frame (505,169 treatment periods). The overall prevalence of coercive treatment on inpatients was 9.8\%, with a small decrease during 2011-2014. The overall prevalence of seclusion, limb restraints, forced injection and physical restraints on inpatients was 6.9, 3.8, 2.6 and 0.8\%, respectively. Only the use of limb restraints showed a downward trend over time. Geographic and care provider variations in specific coercive measures used were also observed.

CONCLUSIONS: Despite the decreasing national level of coercive measures used in Finnish psychiatric hospitals, the overall reduction has been small during the last two decades. These results have implications on the future development of structured guidelines and interventions for preventing and more effectively managing challenging situations. Clinical guidelines and staff education related to the use of coercive measures should be critically assessed to ensure that the staff members working with vulnerable patient populations in psychiatric hospitals are ethically competent.},
	issn = {1471-244X},
	doi = {10.1186/s12888-019-2200-x},
	author = {V{\"a}lim{\"a}ki, Maritta and Yang, Min and Vahlberg, Tero and Lantta, Tella and Pekurinen, Virve and Anttila, Minna and Normand, Sharon-Lise}
}
@article {637843,
	title = {Twenty-Year Trends in Outcomes for Older Adults With Acute Myocardial Infarction in the United States},
	journal = {JAMA Netw Open},
	volume = {2},
	number = {3},
	year = {2019},
	month = {2019 Mar 01},
	pages = {e191938},
	abstract = {Importance: Medicare and other organizations have focused on improving quality of care for patients with acute myocardial infarction (AMI) over the last 2 decades. However, there is no comprehensive perspective on the evolution of outcomes for AMI during that period, and it is unknown whether temporal changes varied by patient subgroup, hospital, or county.

Objective: To provide a comprehensive evaluation of national trends in inpatient outcomes and costs of AMI during this period.

Design, Setting, and Participants: This cohort study included analysis of data from a sample of 4 367 485 Medicare fee-for-service beneficiaries aged 65 years or older from January 1, 1995, through December 31, 2014, across 5680 hospitals in the United States. Analyses were conducted from January 15 to June 5, 2018.

Main Outcomes and Measures: Thirty-day all-cause mortality at the patient, hospital, and county levels. Additional outcomes included 30-day all-cause readmissions; 1-year recurrent AMI; in-hospital mortality; length of hospital stay; 2014 Consumer Price Index-adjusted median Medicare inpatient payment per AMI discharge; and rates of catheterization, percutaneous coronary intervention, and coronary artery bypass graft surgery.

Results: The cohort included 4 367 485 Medicare fee-for-service patients aged 65 years or older hospitalized for AMI during the study period. Between 1995 and 2014, the mean (SD) age of patients increased from 76.9 (7.2) to 78.2 (8.7) years, the percentage of female patients declined from 49.5\% to 46.1\%, the percentage of white patients declined from 91.0\% to 86.2\%, and the percentage of black patients increased from 5.9\% to 8.0\%. There were declines in AMI hospitalizations (914 to 566 per 100 000 beneficiary-years); 30-day mortality (20.0\% to 12.4\%; difference, 7.6 percentage points; 95\% CI, 7.3-7.8 percentage points); 30-day all-cause readmissions (21.0\% to 15.3\%; difference, 5.7 percentage points; 95\% CI, 5.4-6.0 percentage points); and 1-year recurrent AMI (7.1\% to 5.1\%; difference, 2.0 percentage points; 95\% CI, 1.8-2.2 percentage points). There were increases in the 2014 Consumer Price Index-adjusted median (interquartile range) Medicare inpatient payment per AMI discharge ($9282 [$6969-$12 173] to $11 031 [$8099-$16 861]); 30-day inpatient catheterization (44.2\% to 59.9\%; difference, 15.7 percentage points; 95\% CI, 15.4-16.0 percentage points); and inpatient percutaneous coronary intervention (18.8\% to 43.3\%; difference, 24.5 percentage points; 95\% CI, 24.2-24.7 percentage points). Coronary artery bypass graft surgery rates decreased from 14.4\% to 10.2\% (difference, 4.2 percentage points; 95\% CI, 3.9-4.3 percentage points). There was heterogeneity by hospital and county in the mortality changes over time.

Conclusions and Relevance: This study shows marked improvements in short-term mortality and readmissions, with an increase in in-hospital procedures and payments, for the increasingly smaller number of Medicare beneficiaries with AMI.},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2019.1938},
	author = {Krumholz,Harlan M. and Normand, Sharon-Lise T. and Wang, Yun}
}
@article {625386,
	title = {Comparison of prescribing practices for older adults treated by female versus male physicians: A retrospective cohort study},
	journal = {PLoS ONE},
	volume = {13},
	number = {10},
	year = {2018},
	url = {https:// doi.org/10.1371/journal.pone.0205524},
	author = {Rochon, Paula A and Gruneir, Andrea and Bell, Chaim M and Savage, Rachel and Gill, Sudeep S and Wu, Wei and Giannakeas, Vasily and Stall, Nathan M and Seitz, Dallas P and Normand, Sharon-Lise T. and Zhu, Lynn and Herrmann, Nathan and McCarthy, Lisa and Faulkner, Colin and Gurwitz, Jerry H and Austin, Peter C and Bronskill, Susan E}
}
@article {620379,
	title = {Risk Factors Associated With Major Cardiovascular Events 1 Year After Acute Myocardial Infarction},
	journal = {JAMA Network Open},
	volume = {1},
	number = {4},
	year = {2018},
	pages = {e181079},
	url = {https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2696505},
	author = {Wang, Yun and Jing Li and Zheng, Xin and Zihan Jiang and Hu, Shuang and Rishi K. Wadhera and Xueke Bai and Jiapeng Lu and Qianying Wang and Yetong Li and Chaoqun Wu and Chao Xing and Normand, Sharon-Lise T. and Krumholz,Harlan M. and Jiang, Lixin}
}
@article {630040,
	title = {Assessment of Between-Hospital Variation in Readmission and Mortality After Cancer Surgical Procedures},
	journal = {JAMA Netw Open},
	volume = {1},
	number = {6},
	year = {2018},
	month = {2018 Oct 05},
	pages = {e183038},
	abstract = {Importance: Although current federal quality improvement programs do not include cancer surgery, the Centers for Medicare \& Medicaid Services and other payers are considering extending readmission reduction initiatives to include these and other common high-cost episodes.

Objectives: To quantify between-hospital variation in quality-related outcomes and identify hospital characteristics associated with high and low performance.

Design, Setting, and Participants: This retrospective cohort study obtained data through linkage of the California Cancer Registry to hospital discharge claims databases maintained by the California Office of Statewide Health Planning and Development. All 351 acute care hospitals in California at which 1 or more adults underwent curative intent surgery between January 1, 2007, and December 31, 2011, with analyses finalized July 15, 2018, were included. A total of 138 799 adults undergoing surgery for colorectal, breast, lung, prostate, bladder, thyroid, kidney, endometrial, pancreatic, liver, or esophageal cancer within 6 months of diagnosis, with an American Joint Committee on Cancer stage of I to III at diagnosis, were included.

Main Outcomes and Measures: Measures included adjusted odds ratios and variance components from hierarchical mixed-effects logistic regression analyses of in-hospital mortality, 90-day readmission, and 90-day mortality, as well as hospital-specific risk-adjusted rates and risk-adjusted standardized rate ratios for hospitals with a mean annual surgical volume of 10 or more.

Results: Across 138 799 patients at the 351 included hospitals, 8.9\% were aged 18 to 44 years and 45.9\% were aged 65 years or older, 57.4\% were women, and 18.2\% were nonwhite. Among these, 1240 patients (0.9\%) died during the index admission. Among 137 559 patients discharged alive, 19 670 (14.3\%) were readmitted and 1754 (1.3\%) died within 90 days. After adjusting for patient case-mix differences, evidence of statistically significant variation in risk across hospitals was identified, as characterized by the variance of the random effects in the mixed model, for all 3 metrics (P ,
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2018.3038},
	author = {Sebastien Haneuse and Francesca Dominici and Normand, Sharon-Lise and Schrag, Deborah}
}
@article {630042,
	title = {Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia: An Analysis of Within- and Between-Hospital Variation},
	journal = {JAMA Netw Open},
	volume = {1},
	number = {5},
	year = {2018},
	month = {2018 Sep 07},
	pages = {e182044},
	abstract = {Importance: Although studies have described differences in hospital outcomes by patient race and socioeconomic status, it is not clear whether such disparities are driven by hospitals themselves or by broader systemic effects.

Objective: To determine patterns of racial and socioeconomic disparities in outcomes within and between hospitals for patients with acute myocardial infarction, heart failure, and pneumonia.

Design, Setting, and Participants: Retrospective cohort study initiated before February 2013, with additional analyses conducted during the peer-review process. Hospitals in the United States treating at least 25 Medicare fee-for-service beneficiaries aged 65 years or older in each race (ie, black and white) and neighborhood income level (ie, higher income and lower income) for acute myocardial infarction, heart failure, and pneumonia between 2009 and 2011 were included.

Main Outcomes and Measures: For within-hospital analyses, risk-standardized mortality rates and risk-standardized readmission rates for race and neighborhood income subgroups were calculated at each hospital. The corresponding ratios using intraclass correlation coefficients were then compared. For between-hospital analyses, risk-standardized rates were assessed according to hospitals{\textquoteright} proportion of patients in each subgroup. These analyses were performed for each of the 12 analysis cohorts reflecting the unique combinations of outcomes (mortality and readmission), demographics (race and neighborhood income), and conditions (acute myocardial infarction, heart failure, and pneumonia).

Results: Between 74\% (3545 of 4810) and 91\% (4136 of 4554) of US hospitals lacked sufficient racial and socioeconomic diversity to be included in this analysis, with the number of hospitals eligible for analysis varying among cohorts. The 12 analysis cohorts ranged in size from 418 to 1265 hospitals and from 144 417 to 703 324 patients. Within included hospitals, risk-standardized mortality rates tended to be lower among black patients (mean [SD] difference between risk-standardized mortality rates in black patients compared with white patients for acute myocardial infarction, -0.57 [1.1] [P = .47]; for heart failure, -4.7 [1.3] [P ,
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2018.2044},
	author = {Downing, Nicholas S and Wang, Changqin and Gupta, Aakriti and Wang, Yongfei and Nuti, Sudhakar V and Ross, Joseph S and Bernheim, Susannah M and Lin, Zhenqiu and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {661413,
	title = {Association of the Hospital Readmissions Reduction Program With Mortality During and After Hospitalization for Acute Myocardial Infarction, Heart Failure, and Pneumonia},
	journal = {JAMA Netw Open},
	volume = {1},
	number = {5},
	year = {2018},
	month = {2018 09 07},
	pages = {e182777},
	abstract = {Importance: The US Hospital Readmissions Reduction Program (HRRP) was associated with reduced readmissions among Medicare beneficiaries hospitalized for acute myocardial infarction (AMI), heart failure (HF), and pneumonia. It is important to assess whether there has been a signal for concomitant harm with an increase in mortality.

Objective: To evaluate whether the announcement or the implementation of HRRP was associated with an increase in either in-hospital or 30-day postdischarge mortality following hospitalization for AMI, HF, or pneumonia.

Design, Setting, and Participants: In this cohort study, using Medicare data, all hospitalizations for AMI, HF, and pneumonia were identified among fee-for-service Medicare beneficiaries aged 65 years and older from January 1, 2006, to December 31, 2014. These were assessed for changes in trends for risk-adjusted rates of in-hospital and 30-day postdischarge mortality after announcement and implementation of the HRRP using an interrupted time series framework. Analyses were done in November 2017 and December 2017.

Exposures: Announcement of the HRRP in March 2010, and implementation of its penalties in October 2012.

Main Outcomes and Measures: Monthly risk-adjusted rates of in-hospital and 30-day postdischarge mortality.

Results: The sample included 1.7 million AMI, 4 million HF, and 3.5 million pneumonia hospitalizations. Between 2006 and 2014, in-hospital mortality decreased for the 3 conditions (AMI, from 10.4\% to 9.7\%; HF, from 4.3\% to 3.5\%; pneumonia, from 5.3\% to 4.0\%) while 30-day postdischarge mortality decreased from 7.4\% to 7.0\% for AMI (P for trend ,
	keywords = {Aged, Aged, 80 and over, Cohort Studies, Female, Heart Failure, Hospitalization, Humans, Male, Medicare, Middle Aged, Myocardial Infarction, Patient Discharge, Patient Readmission, Pneumonia, Risk Factors, United States},
	issn = {2574-3805},
	doi = {10.1001/jamanetworkopen.2018.2777},
	author = {Khera, Rohan and Dharmarajan, Kumar and Wang, Yongfei and Lin, Zhenqiu and Bernheim, Susannah M and Wang, Yun and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {608931,
	title = {Bayesian propensity scores for high-dimensional causal inference: A comparison of drug-eluting to bare-metal coronary stents},
	journal = {Biom J},
	year = {2018},
	month = {2018 Apr 23},
	abstract = {High-dimensional data provide many potential confounders that may bolster the plausibility of the ignorability assumption in causal inference problems. Propensity score methods are powerful causal inference tools, which are popular in health care research and are particularly useful for high-dimensional data. Recent interest has surrounded a Bayesian treatment of propensity scores in order to flexibly model the treatment assignment mechanism and summarize posterior quantities while incorporating variance from the treatment model. We discuss methods for Bayesian propensity score analysis of binary treatments, focusing on modern methods for high-dimensional Bayesian regression and the propagation of uncertainty. We introduce a novel and simple estimator for the average treatment effect that capitalizes on conjugacy of the beta and binomial distributions. Through simulations, we show the utility of horseshoe priors and Bayesian additive regression trees paired with our new estimator, while demonstrating the importance of including variance from the treatment regression model. An application to cardiac stent data with almost 500 confounders and 9000 patients illustrates approaches and facilitates comparison with existing alternatives. As measured by a falsifiability endpoint, we improved confounder adjustment compared with past observational research of the same problem.},
	issn = {1521-4036},
	doi = {10.1002/bimj.201700305},
	author = {Spertus, Jacob V and Normand, Sharon-Lise T.}
}
@article {604141,
	title = {Diffusion of Bevacizumab Across Oncology Practices: An Observational Study},
	journal = {Med Care},
	volume = {56},
	number = {1},
	year = {2018},
	month = {2018 Jan},
	pages = {69-77},
	abstract = {BACKGROUND: Technological advances can improve care and outcomes but are a primary driver of health care spending growth. Understanding diffusion and use of new oncology therapies is important, given substantial increases in prices and spending on such treatments.

OBJECTIVES: Examine diffusion of bevacizumab, a novel (in 2004) and high-priced biologic cancer therapy, among US oncology practices during 2005-2012 and assess variation in use across practices.

RESEARCH DESIGN: Population-based observational study.

SETTING: A total of 2329 US practices providing cancer chemotherapy.

PARTICIPANTS: Random 20\% sample of 236,304 Medicare fee-for-service beneficiaries aged above 65 years in 2004-2012 undergoing infused chemotherapy for cancer.

MEASURES: Diffusion of bevacizumab (cumulative time to first use and 10\% use) in practices, variation in use across practices overall and by higher versus lower-value use. We used hierarchical models with practice random effects to estimate the between-practice variation in the probability of receiving bevacizumab and to identify factors associated with use.

RESULTS: We observed relatively rapid diffusion of bevacizumab, particularly in independent practices and larger versus smaller practices. We observed substantial variation in use; the adjusted odds ratio (95\% confidence interval) of bevacizumab use was 2.90 higher (2.73-3.08) for practices 1 SD above versus one standard deviation below the mean. Variation was less for higher-value [odds ratio=2.72 (2.56-2.89)] than lower-value uses [odds ratio=3.61 (3.21-4.06)].

CONCLUSIONS: Use of bevacizumab varied widely across oncology practices, particularly for lower-value indications. These findings suggest that interventions targeted to practices have potential for decreasing low-value use of high-cost cancer therapies.},
	keywords = {Aged, Antineoplastic Agents, Immunological, Bevacizumab, Fee-for-Service Plans, Female, Humans, Male, Medical Oncology, Medicare, Neoplasms, Odds Ratio, Practice Patterns, Physicians{\textquoteright}, United States},
	issn = {1537-1948},
	doi = {10.1097/MLR.0000000000000840},
	author = {Nancy L. Keating and Huskamp, Haiden A. and Schrag, Deborah and McWilliams, John M and McNeil, Barbara J and Landon, Bruce E and Michael E. Chernew and Normand, Sharon-Lise T.}
}
@article {612974,
	title = {Discussion on "Time-dynamic profiling with application to hospital readmission among patients on dialysis," by Jason P. Estes, Danh V. Nguyen, Yanjun Chen, Lorien S. Dalrymple, Connie M. Rhee, Kamyar Kalantar-Zadeh, and Damla Senturk},
	journal = {Biometrics},
	year = {2018},
	month = {2018 Jun 05},
	issn = {1541-0420},
	doi = {10.1111/biom.12909},
	author = {Sebastien Haneuse and Zubizarreta, Jos{\'e} and Normand, Sharon-Lise T.}
}
@article {614551,
	title = {Double robust estimation for multiple unordered treatments and clustered observations: Evaluating drug-eluting coronary artery stents},
	journal = {Biometrics},
	year = {2018},
	month = {2018 Jul 13},
	abstract = {Postmarket comparative effectiveness and safety analyses of therapeutic treatments typically involve large observational cohorts. We propose double robust machine learning estimation techniques for implantable medical device evaluations where there are more than two unordered treatments and patients are clustered in hospitals. This flexible approach also accommodates high-dimensional covariates drawn from clinical databases. The Massachusetts Data Analysis Center percutaneous coronary intervention cohort is used to assess the composite outcome of 10 drug-eluting stents among adults implanted with at least one drug-eluting stent in Massachusetts. We find remarkable discrimination between stents. A simulation study designed to mimic this coronary intervention cohort is also presented and produced similar results.},
	issn = {1541-0420},
	doi = {10.1111/biom.12927},
	author = {Rose, Sherri and Normand, Sharon-Lise}
}
@article {609753,
	title = {Evaluating Readmission-Need for More Clarity on Methods},
	journal = {JAMA Cardiol},
	volume = {3},
	number = {3},
	year = {2018},
	month = {2018 Mar 01},
	pages = {265},
	issn = {2380-6591},
	doi = {10.1001/jamacardio.2017.5321},
	author = {Krumholz,Harlan M. and Dharmarajan, Kumar and Normand, Sharon-Lise T.}
}
@article {661414,
	title = {Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {11},
	number = {12},
	year = {2018},
	month = {2018 12},
	pages = {e004763},
	abstract = {BACKGROUND: Little is known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-P) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices.

METHODS AND RESULTS: Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31\% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6{\texttimes} higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant.

CONCLUSIONS: CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.},
	keywords = {Administrative Claims, Healthcare, Aged, Aged, 80 and over, Cardiac Resynchronization Therapy, Cardiac Resynchronization Therapy Devices, Clinical Decision-Making, Databases, Factual, Defibrillators, Implantable, Electric Countershock, Female, Healthcare Disparities, Heart Failure, Humans, Male, Medicare, Outcome and Process Assessment, Health Care, Patient Selection, Practice Patterns, Physicians{\textquoteright}, Risk Factors, Time Factors, Treatment Outcome, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.118.004763},
	author = {Kramer, Daniel B and Normand, Sharon-Lise T. and Volya, Rita and Hatfield, Laura A}
}
@article {604140,
	title = {Geographical Health Priority Areas For Older Americans},
	journal = {Health Aff (Millwood)},
	volume = {37},
	number = {1},
	year = {2018},
	month = {2018 Jan},
	pages = {104-110},
	abstract = {There are wide disparities in health across the US population. The identification of geographic health priority areas for Medicare could inform efforts to eliminate health disparities and improve health care. In a sample of 3,282 counties with more than 73~million unique Medicare beneficiaries in the period 1999-2014, we identified geographical areas-"hot spots"-with persistently higher adjusted mortality rates for older adults compared with the rest of the country. During the study period, the risk-standardized mortality rates decreased from 5.52~percent to 4.61~percent (a 0.91-percentage-point change) for the priority areas and from 5.16~percent to 4.11~percent (a 1.05-percentage-point change) for other areas. Faced with decisions surrounding allocation of scarce resources and marked geographic disparities, the identification and prioritization of hot spots may be one way to eliminate disparities and improve health care.},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.2017.0744},
	author = {Krumholz,Harlan M. and Normand, Sharon-Lise T. and Wang, Yun}
}
@article {620376,
	title = {Initial Cholinesterase Inhibitor Therapy Dose and Serious Events in Older Women and Men},
	journal = {J Am Geriatr Soc},
	year = {2018},
	month = {2018 Jul 18},
	abstract = {OBJECTIVES: To examine dose-related prescribing and short-term serious events associated with initiation of cholinesterase inhibitor (ChEI) therapy.

DESIGN: Retrospective, population-based cohort study.

SETTING: Ontario, Canada.

PARTICIPANTS: Women (n=47,829) and men (n=32,503) aged 66 and older who initiated a ChEI between April 1, 2010, and June 30, 2016.

MEASUREMENTS: All-cause serious events (emergency department (ED) visits, inpatient hospitalizations, death) within 30 days of ChEI initiation. Multivariable Cox proportional hazards models were used to estimate adjusted rates of serious events.

RESULTS: Overall, 4.8\% of older adults were dispensed a lower-than-recommended ChEI starting dose, 87.9\% a recommended dose, and 7.3\% a higher-than-recommended starting dose. Eight thousand six hundred seventy-one (10.8\%) individuals experienced a serious event within 30 days of initiating therapy, primarily ED visits (8,540, 10.6\%). Relative to those initiated on a recommended starting dose, those initiated on a higher dose had a significantly increased rate of serious events (women adjusted hazard ratio (aHR) 1.50, 95\% confidence interval (CI) =1.38-1.63; men aHR 1.31, 95\% CI=1.19-1.45). Similar patterns were found for ED visits and inpatient hospitalizations but not death. The relative effect of higher-than-recommended starting dose dispensed vs. recommended starting dose dispensed was greater in women than it was in men: the number needed to harm was 22 (95\% confidence interval (CI)=18-29) for women and 36 (95\% CI= 26-61) for men.

CONCLUSION: Serious events immediately after initiation of ChEIs were associated with starting ChEI dose. This association was stronger in women.},
	issn = {1532-5415},
	doi = {10.1111/jgs.15442},
	author = {Rochon, Paula A and Gruneir, Andrea and Gill, Sudeep S and Wu, Wei and Zhu, Lynn and Herrmann, Nathan and Bell, Chaim M and Austin, Peter C and Stall, Nathan M and McCarthy, Lisa and Giannakeas, Vasily and Alberga, Amanda and Seitz, Dallas P and Normand, Sharon-Lise and Gurwitz, Jerry H and Bronskill, Susan E}
}
@article {620380,
	title = {A maximum likelihood approach to power calculations for stepped wedge designs of binary outcomes},
	journal = {Biostatistics},
	year = {2018},
	month = {2018 Aug 01},
	abstract = {In stepped wedge designs (SWD), clusters are randomized to the time period during which new patients will receive the intervention under study in a sequential rollout over time. By the study{\textquoteright}s end, patients at all clusters receive the intervention, eliminating ethical concerns related to withholding potentially efficacious treatments. This is a practical option in many large-scale public health implementation settings. Little statistical theory for these designs exists for binary outcomes. To address this, we utilized a maximum likelihood approach and developed numerical methods to determine the asymptotic power of the SWD for binary outcomes. We studied how the power of a SWD for detecting risk differences varies as a function of the number of clusters, cluster size, the baseline risk, the intervention effect, the intra-cluster correlation coefficient, and the time effect. We studied the robustness of power to the assumed form of the distribution of the cluster random effects, as well as how power is affected by variable cluster size. \% SWD power is sensitive to neither, in contrast to the parallel cluster randomized design which is highly sensitive to variable cluster size. We also found that the approximate weighted least square approach of Hussey and Hughes (2007, Design and analysis of stepped wedge cluster randomized trials. Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others. The new method was applied to the design of a large-scale intervention program on post-partum intra-uterine device insertion services for preventing unintended pregnancy in the first 1.5 years following childbirth in Tanzania, where it was found that the previously available method under-estimated the power.},
	issn = {1468-4357},
	doi = {10.1093/biostatistics/kxy031},
	author = {Zhou, Xin and Liao, Xiaomei and Kunz, Lauren M and Normand, Sharon-Lise T. and Molin Wang and Spiegelman, Donna}
}
@article {630041,
	title = {The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data},
	journal = {NPJ Schizophr},
	volume = {4},
	number = {1},
	year = {2018},
	month = {2018 Jun 27},
	pages = {14},
	abstract = {Clinical trial data are the gold standard for evaluating pharmaceutical safety and efficacy. There is an ethical and scientific imperative for transparency and data sharing to confirm published results and generate new knowledge. The Open Translational Science in Schizophrenia (OPTICS) Project was an open-science initiative aggregating Janssen clinical trial and NIH/NIMH data from real-world studies and trials in schizophrenia. The project aims were to show the value of using shared data to examine: therapeutic safety and efficacy; disease etiologies and course; and methods development. The success of project investigators was due to collaboration from project applications through analyses, with support from the Harvard Catalyst. Project work was independent of Janssen; all intellectual property was dedicated to the public. Efforts such as this are necessary to gain deeper insights into the biology of disease, foster collaboration, and to achieve the goal of developing better treatments, reducing the overall public health burden of devastating brain diseases.},
	issn = {2334-265X},
	doi = {10.1038/s41537-018-0055-7},
	author = {Wilcox, Marsha A and Savitz, Adam J and Addington, Anjen{\'e} M and Gray, Gary S and Guinan, Eva C and Jackson, John W and Lehner, Thomas and Normand, Sharon-Lise and Ranu, Hardeep and Senthil, Geetha and Spertus, Jake and Valeri, Linda and Ross, Joseph S}
}
@article {614553,
	title = {Risk of weight gain for specific antipsychotic drugs: a meta-analysis},
	journal = {NPJ Schizophr},
	volume = {4},
	number = {1},
	year = {2018},
	month = {2018 Jun 27},
	pages = {12},
	abstract = {People with schizophrenia are at considerably higher risk of cardiometabolic morbidity than the general population. Second-generation antipsychotic drugs contribute to that risk partly through their weight gain effects, exacerbating an already high burden of disease. While standard {\textquoteright}as-randomized{\textquoteright} analyses of clinical trials provide valuable information, they ignore adherence patterns across treatment arms, confounding estimates of realized treatment exposure on outcome. We assess the effect of specific second-generation antipsychotics on weight gain, defined as at least a 7\% increase in weight from randomization, using a Bayesian hierarchical model network meta-analysis with individual patient level data. Our data consisted of 14 randomized clinical trials contributing 5923 subjects (mean age = 39 [SD = 12]) assessing various combinations of olanzapine (n = 533), paliperidone (n = 3482), risperidone (n = 540), and placebo (n = 1368). The median time from randomization to dropout or trial completion was 6 weeks (range: 0-60 weeks). The unadjusted probability of weight gain in the placebo group was 4.8\% across trials. For each 10 g chlorpromazine equivalent dose increase in olanzapine, the odds of weight gain increased by 5 (95\% credible interval: 1.4, 5.3); the effect of risperidone (odds ratio = 1.6 [0.25, 9.1]) was estimated with considerable uncertainty but no different from paliperidone (odds ratio = 1.3 [1.2, 1.5]).},
	issn = {2334-265X},
	doi = {10.1038/s41537-018-0053-9},
	author = {Spertus, Jacob and Horvitz-Lennon, Marcela and Abing, Haley and Normand, Sharon-Lise}
}
@article {515951,
	title = {Prescribing of Clozapine and Antipsychotic Polypharmacy for Schizophrenia in a Large Medicaid Program},
	journal = {Psychiatr Serv},
	volume = {68},
	number = {6},
	year = {2017},
	month = {2017 Jun 01},
	pages = {579-586},
	abstract = {OBJECTIVE: Underuse of clozapine and overuse of antipsychotic polypharmacy are both indicators of poor quality of care. This study examined variation in prescribing clozapine and antipsychotic polypharmacy across providers, as well as factors associated with these practices.

METHODS: Using 2010-2012 Pennsylvania Medicaid data, prescribers were identified if they wrote antipsychotic prescriptions for ten or more nonelderly adult patients with schizophrenia annually. Generalized linear mixed models with a binomial distribution and a logit link were used to examine prescriber-level annual percentages of patients with clozapine use and with long-term (>=90 days) antipsychotic polypharmacy and associated characteristics of prescribers{\textquoteright} patient caseloads, prescriber characteristics, and Medicaid payer (fee-for-service versus managed care plans).

RESULTS: The study cohort included 645 prescribers in 2010, 632 in 2011, and 650 in 2012. In 2012, the mean prescriber-level annual percentage of patients with any clozapine use was 7\% (range 0\%-89\%), and the mean percentage of patients with any long-term antipsychotic polypharmacy was 7\% (range 0\%-45\%) (similar rates were found during 2010-2012). Prescribers with high prescription volume, a smaller percentage of patients from racial or ethnic minority groups, and a larger percentage of patients eligible for Supplemental Security Income were more likely to use both clozapine and antipsychotic polypharmacy for treating schizophrenia. Prescriber specialty and Medicaid payer were also associated with prescribers{\textquoteright} practices.

CONCLUSIONS: Considerable variation was found in clozapine and antipsychotic polypharmacy practices across prescribers in their treatment of schizophrenia. Targeting efforts to selected prescribers holds promise as an approach to promote evidence-based antipsychotic prescribing.},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.201600041},
	author = {Tang, Yan and Horvitz-Lennon, Marcela and Gellad, Walid F and Lave, Judith R and Chang, Chung-Chou H and Normand, Sharon-Lise and Donohue, Julie M}
}
@article {515946,
	title = {Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence},
	journal = {JAMA Surg},
	volume = {152},
	number = {3},
	year = {2017},
	month = {2017 Mar 01},
	pages = {257-263},
	abstract = {Importance: Mesh, a synthetic graft, has been used in pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) to augment and strengthen weakened tissue. Polypropylene mesh has come under scrutiny by the US Food and Drug Administration.

Objective: To examine the rates of mesh complications and invasive reintervention after the placement of vaginal mesh for POP repair or SUI surgery.

Design, Setting, and Participants: This investigation was an observational cohort study at inpatient and ambulatory surgery settings in New York State. Participants were women who underwent transvaginal repair for POP or SUI with mesh between January 1, 2008, and December 31, 2012, and were followed up through December 31, 2013. They were divided into the following 4 groups based on the amount of mesh exposure: transvaginal POP repair surgery with mesh and concurrent sling use (vaginal mesh plus sling group), transvaginal POP repair with mesh and no concurrent sling use (vaginal mesh group), transvaginal POP repair without mesh but concurrent sling use for SUI (POP sling group), and sling for SUI alone (SUI sling group).

Main Outcomes and Measures: The primary outcome was the occurrence of mesh complications and repeated invasive intervention within 1 year after the initial mesh implantation. A time-to-event analysis was performed to examine the occurrence of mesh erosions and subsequent reintervention. Secondary analyses of an age association (,
	issn = {2168-6262},
	doi = {10.1001/jamasurg.2016.4200},
	author = {Chughtai, Bilal and Barber, Matthew D and Mao, Jialin and Forde, James C and Normand, Sharon-Lise T. and Sedrakyan, Art}
}
@article {572931,
	title = {The Atlantic divide in coronary heart disease: Epidemiology and patient care in the US and Portugal},
	journal = {Rev Port Cardiol},
	volume = {36},
	number = {9},
	year = {2017},
	month = {2017 Sep},
	pages = {583-593},
	abstract = {INTRODUCTION AND OBJECTIVES: We aimed to compare access to new health technologies to treat coronary heart disease (CHD) in the health systems of Portugal and the US, characterizing the needs of the populations and the resources available.

METHODS: We reviewed data for 2000 and 2010 on epidemiologic profiles of CHD and on health care available to patients. Thirty health technologies (16 medical devices and 14 drugs) introduced during the period 1980-2015 were identified by interventional cardiologists. Approval and marketing dates were compared between countries.

RESULTS: Relative to the US, Portugal has lower risk profiles and less than half the hospitalizations per capita, but fewer centers per capita provide catheterization and cardiothoracic surgery services. More than 70\% of drugs were available sooner in the US, whereas 12 out of 16 medical devices were approved earlier in Portugal. Nevertheless, at least five of these devices were adopted first or diffused faster in the US. Mortality due to CHD and myocardial infarction (MI) was lower in Portugal (CHD: 72.8 vs. 168 and MI: 48.7 vs. 54.1 in Portugal and the US, respectively; age- and gender-adjusted deaths per 100000 population, 2010); but only CHD deaths exhibited a statistically significant difference between the countries.

CONCLUSIONS: Differences in regulatory mechanisms and price regulations have a significant impact on the types of health technologies available in the two countries. However, other factors may influence their adoption and diffusion, and this appears to have a greater impact on mortality, due to acute conditions.},
	issn = {2174-2030},
	doi = {10.1016/j.repc.2016.09.021},
	author = {Lobo, Mariana F and Azzone, Vanessa and Resnic, Frederic S and Melica, Bruno and Teixeira-Pinto, Armando and Azevedo, Lu{\'\i}s Filipe and Freitas, Alberto and Nisa, Cl{\'a}udia and Bacelar-Nicolau, Leonor and Rocha-Gon{\c c}alves, Francisco Nuno and Pereira-Miguel, Jos{\'e} and Costa-Pereira, Altamiro and Normand, Sharon-Lise}
}
@article {562626,
	title = {Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators},
	journal = {Med Devices (Auckl)},
	volume = {10},
	year = {2017},
	month = {2017},
	pages = {165-188},
	abstract = {BACKGROUND: Machine learning methods may complement traditional analytic methods for medical device surveillance.

METHODS AND RESULTS: Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8\%-20.9\%; nonfatal ICD-related adverse events, 19.3\%-26.3\%; and death from any cause or nonfatal ICD-related adverse event, 27.1\%-37.6\%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9\% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7\% (363 of 396, k=-0.028), and between the DELTA and embedded feature selection approaches was 88.1\% (349 of 396, k=-0.042).

CONCLUSION: Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.},
	issn = {1179-1470},
	doi = {10.2147/MDER.S138158},
	author = {Ross, Joseph S and Bates, Jonathan and Parzynski, Craig S and Akar, Joseph G and Curtis, Jeptha P and Desai, Nihar R. and Freeman, James V and Gamble, Ginger M and Kuntz, Richard and Li, Shu-Xia and Marinac-Dabic, Danica and Masoudi, Frederick A and Normand, Sharon-Lise T. and Ranasinghe, Isuru and Shaw, Richard E and Krumholz,Harlan M.}
}
@article {516071,
	title = {Cancer Rates in Adults After Cardiac Interventions: A Preliminary Observational Report},
	journal = {Am J Clin Oncol},
	volume = {40},
	number = {2},
	year = {2017},
	month = {2017 Apr},
	pages = {122-124},
	abstract = {BACKGROUND: The postprocedural state after cardiac revascularization interventions is characterized by intense inflammation and activation of inflammatory cytokines due to myonecrosis and ischemia/reperfusion injury. Involvement of similar processes also participates in cellular malignant transformation. In this study, the association between cardiac interventions and subsequent cancer risk development was therefore evaluated.

METHODS: The 5-year cumulative incidence of cancer was examined in 2 cardiac care cohorts: all patients undergoing either open heart surgery or percutaneous coronary interventions (PCI) at hospitals in the commonwealth of Massachusetts. The observed cases of cancer were compared with the number of expected cases based on the state cancer rates, adjusting for sex and 5-year age groups. The standardized morbidity ratio (SMR) was used for this comparison.

RESULTS: Of 10,301 patients in the surgical cohort, 804 (7.8\%) incident cancers developed over 5 years of follow-up, whereas 245.7 incident cancers were expected. This yielded an SMR of 3.27 (95\% CI, 3.05-3.51; P,
	issn = {1537-453X},
	doi = {10.1097/COC.0000000000000120},
	author = {Alameddine, Abdallah K and Visintainer, Paul and Normand, Sharon-Lise T. and Wolf, Robert E and Alameddine, Yvonne A}
}
@article {538186,
	title = {Comparing Outcomes of Coronary Artery Bypass Grafting Among Large Teaching and Urban Hospitals in China and the United States},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {10},
	number = {6},
	year = {2017},
	month = {2017 Jun},
	abstract = {BACKGROUND: Coronary artery disease is prevalent in China, with concomitant increases in the volume of coronary artery bypass grafting (CABG). The present study aims to compare CABG-related outcomes between China and the United States among large teaching and urban hospitals.

METHODS AND RESULTS: Observational analysis of patients aged >=18 years, discharged from acute-care, large teaching and urban hospitals in China and the United States after hospitalization for an isolated CABG surgery. Data were obtained from the Chinese Cardiac Surgery Registry in China and the National Inpatient Sample in the United States. Analysis was stratified by 2 periods: 2007, 2008, and 2010; and 2011 to 2013 periods. The primary outcome was in-hospital mortality, and the secondary outcome was length of stay. The sample included 51 408 patients: 32 040 from 77 hospitals in the China-CABG group and 19 368 from 303 hospitals in the US-CABG group. In the 2007 to 2008, 2010 period and for all-age and aged >=65 years, the China-CABG group had higher mortality than the US-CABG group (1.91\% versus 1.58\%, P=0.059; and 3.12\% versus 2.20\%, P=0.004) and significantly higher age-, sex-, and comorbidity-adjusted odds of death (odds ratio, 1.58; 95\% confidential interval, 1.22-2.04; and odds ratio, 1.73; 95\% confidential interval, 1.24-2.40). There were no significant mortality differences in the 2011 to 2013 period. For preoperative, postoperative, and total hospital stay, respectively, the median (interquartile range) length of stay across the entire study period between China-CABG and US-CABG groups were 9 (8) versus 1 (3), 9 (6) versus 6 (3), and 20 (12) versus 7 (5) days (all P,
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.116.003327},
	author = {Zheng, Zhe and Zhang, Heng and Yuan, Xin and Rao, Chenfei and Zhao, Yan and Wang, Yun and Normand, Sharon-Lise and Krumholz,Harlan M. and Hu, Shengshou}
}
@article {604142,
	title = {Comparison of Inappropriate Shocks and Other Health Outcomes Between Single- and Dual-Chamber Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death: Results From the Cardiovascular Research Network Longitudinal Study of Im},
	journal = {J Am Heart Assoc},
	volume = {6},
	number = {11},
	year = {2017},
	month = {2017 Nov 09},
	abstract = {BACKGROUND: In US clinical practice, many patients who undergo placement of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death receive dual-chamber devices. The superiority of dual-chamber over single-chamber devices in reducing the risk of inappropriate ICD shocks in clinical practice has not been established. The objective of this study was to compare risk of adverse outcomes, including inappropriate shocks, between single- and dual-chamber ICDs for primary prevention.

METHODS AND RESULTS: We identified patients receiving a single- or dual-chamber ICD for primary prevention who did not have an indication for pacing from 15 hospitals within 7 integrated health delivery systems in the Longitudinal Study of Implantable Cardioverter-Defibrillators from 2006 to 2009. The primary outcome was time to first inappropriate shock. ICD shocks were adjudicated for appropriateness. Other outcomes included all-cause hospitalization, heart failure hospitalization, and death. Patient, clinician, and hospital-level factors were accounted for using propensity score weighting methods. Among 1042 patients without pacing indications, 54.0\% (n=563) received a single-chamber device and 46.0\% (n=479) received a dual-chamber device. In a propensity-weighted analysis, device type was not significantly associated with inappropriate shock (hazard ratio, 0.91; 95\% confidence interval, 0.59-1.38 [=0.65]), all-cause hospitalization (hazard ratio, 1.03; 95\% confidence interval, 0.87-1.21 [=0.76]), heart failure hospitalization (hazard ratio, 0.93; 95\% confidence interval, 0.72-1.21 [=0.59]), or death (hazard ratio, 1.19; 95\% confidence interval, 0.93-1.53 [=0.17]).

CONCLUSIONS: Among patients who received an ICD for primary prevention without indications for pacing, dual-chamber devices were not associated with lower risk of inappropriate shock or differences in hospitalization or death compared with single-chamber devices. This study does not justify the use of dual-chamber devices to minimize inappropriate shocks.},
	issn = {2047-9980},
	doi = {10.1161/JAHA.117.006937},
	author = {Peterson, Pamela N and Greenlee, Robert T and Go, Alan S and Magid, David J and Cassidy-Bushrow, Andrea and Garcia-Montilla, Romel and Glenn, Karen A and Gurwitz, Jerry H and Hammill, Stephen C and Hayes, John and Kadish, Alan and Reynolds, Kristi and Sharma, Param and Smith, David H and Varosy, Paul D and Vidaillet, Humberto and Zeng, Chan X and Normand, Sharon-Lise T. and Masoudi, Frederick A}
}
@article {572926,
	title = {A comparison of in-hospital acute myocardial infarction management between Portugal and the United States: 2000-2010},
	journal = {Int J Qual Health Care},
	volume = {29},
	number = {5},
	year = {2017},
	month = {2017 Oct 01},
	pages = {669-678},
	abstract = {Objective: To compare healthcare in acute myocardial infarction (AMI) treatment between contrasting health systems using comparable representative data from Europe and USA.

Design: Repeated cross-sectional retrospective cohort study.

Setting: Acute care hospitals in Portugal and USA during 2000-2010.

Participants: Adults discharged with AMI.

Interventions: Coronary revascularizations procedures (percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) surgery).

Main Outcome Measures: In-hospital mortality and length of stay.

Results: We identified 1 566 601 AMI hospitalizations. Relative to the USA, more hospitalizations in Portugal presented with elevated ST-segment, and fewer had documented comorbidities. Age-sex-adjusted AMI hospitalization rates decreased in USA but increased in Portugal. Crude procedure rates were generally lower in Portugal (PCI: 44\% vs. 47\%; CABG: 2\% vs. 9\%, 2010) but only CABG rates differed significantly after standardization. PCI use increased annually in both countries but CABG decreased only in the USA (USA: 0.95 [0.94, 0.95], Portugal: 1.04 [1.02, 1.07], odds ratios). Both countries observed annual decreases in risk-adjusted mortality (USA: 0.97 [0.965, 0.969]; Portugal: 0.99 [0.979, 0.991], hazard ratios). While between-hospital variability in procedure use was larger in USA, the risk of dying in a high relative to a low mortality hospital (hospitals in percentiles 95 and 5) was 2.65 in Portugal when in USA was only 1.03.

Conclusions: Although in-hospital mortality due to an AMI improved in both countries, patient management in USA seems more effective and alarming disparities in quality of care across hospitals are more likely to exist in Portugal.},
	issn = {1464-3677},
	doi = {10.1093/intqhc/mzx092},
	author = {Lobo, Mariana F and Azzone, Vanessa and Azevedo, Lu{\'\i}s Filipe and Melica, Bruno and Freitas, Alberto and Bacelar-Nicolau, Leonor and Rocha-Gon{\c c}alves, Francisco N and Nisa, Cl{\'a}udia and Teixeira-Pinto, Armando and Pereira-Miguel, Jos{\'e} and Resnic, Frederic S and Costa-Pereira, Altamiro and Normand, Sharon-Lise}
}
@article {doi:10.1056/NEJMra1602774,
	title = {Health Policy Trials},
	journal = {New England Journal of Medicine},
	volume = {376},
	number = {22},
	year = {2017},
	note = {PMID: 28564562},
	pages = {2160-2167},
	doi = {10.1056/NEJMra1602774},
	url = {http://dx.doi.org/10.1056/NEJMra1602774},
	author = {Joseph P. Newhouse and Normand, Sharon-Lise T.}
}
@article {562621,
	title = {Hospital-Readmission Risk - Isolating Hospital Effects from Patient Effects},
	journal = {N Engl J Med},
	volume = {377},
	number = {11},
	year = {2017},
	month = {2017 Sep 14},
	pages = {1055-1064},
	abstract = {Background To isolate hospital effects on risk-standardized hospital-readmission rates, we examined readmission outcomes among patients who had multiple admissions for a similar diagnosis at more than one hospital within a given year. Methods We divided the Centers for Medicare and Medicaid Services hospital-wide readmission measure cohort from July 2014 through June 2015 into two random samples. All the patients in the cohort were Medicare recipients who were at least 65 years of age. We used the first sample to calculate the risk-standardized readmission rate within 30 days for each hospital, and we classified hospitals into performance quartiles, with a lower readmission rate indicating better performance (performance-classification sample). The study sample (identified from the second sample) included patients who had two admissions for similar diagnoses at different hospitals that occurred more than 1 month and less than 1 year apart, and we compared the observed readmission rates among patients who had been admitted to hospitals in different performance quartiles. Results In the performance-classification sample, the median risk-standardized readmission rate was 15.5\% (interquartile range, 15.3 to 15.8). The study sample included 37,508 patients who had two admissions for similar diagnoses at a total of 4272 different hospitals. The observed readmission rate was consistently higher among patients admitted to hospitals in a worse-performing quartile than among those admitted to hospitals in a better-performing quartile, but the only significant difference was observed when the patients were admitted to hospitals in which one was in the best-performing quartile and the other was in the worst-performing quartile (absolute difference in readmission rate, 2.0 percentage points; 95\% confidence interval, 0.4 to 3.5; P=0.001). Conclusions When the same patients were admitted with similar diagnoses to hospitals in the best-performing quartile as compared with the worst-performing quartile of hospital readmission performance, there was a significant difference in rates of readmission within 30 days. The findings suggest that hospital quality contributes in part to readmission rates independent of factors involving patients. (Funded by Yale-New Haven Hospital Center for Outcomes Research and Evaluation and others.).},
	issn = {1533-4406},
	doi = {10.1056/NEJMsa1702321},
	author = {Krumholz,Harlan M. and Wang, Kun and Lin, Zhenqiu and Dharmarajan, Kumar and Horwitz, Leora I and Ross, Joseph S and Drye, Elizabeth E and Bernheim, Susannah M and Normand, Sharon-Lise T.}
}
@article {515961,
	title = {Hospitals{\textquoteright} Role In Readmissions},
	journal = {Health Aff (Millwood)},
	volume = {36},
	number = {2},
	year = {2017},
	month = {2017 Feb 01},
	pages = {382},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.2016.1515},
	author = {Dharmarajan, Kumar and Lin, Zhenqiu and Normand, Sharon-Lise T.}
}
@article {608643,
	title = {Matching and Imputation Methods for Risk Adjustment in the Health Insurance Marketplaces},
	journal = {Stat Biosci},
	volume = {9},
	number = {2},
	year = {2017},
	month = {2017 Dec},
	pages = {525-542},
	abstract = {New state-level health insurance markets, denoted , created under the Affordable Care Act, use risk-adjusted plan payment formulas derived from a population  to participate in the Marketplaces. We develop methodology to derive a sample from the target population and to assemble information to generate improved risk-adjusted payment formulas using data from the Medical Expenditure Panel Survey and Truven MarketScan databases. Our approach requires multi-stage data selection and imputation procedures because both data sources have systemic missing data on crucial variables and arise from different populations. We present matching and imputation methods adapted to this setting. The long-term goal is to improve risk-adjustment estimation utilizing information found in Truven MarketScan data supplemented with imputed Medical Expenditure Panel Survey values.},
	issn = {1867-1764},
	doi = {10.1007/s12561-015-9135-7},
	author = {Rose, Sherri and Shi, Julie and Thomas G. McGuire and Normand, Sharon-Lise T.}
}
@article {515966,
	title = {Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry},
	journal = {J Am Geriatr Soc},
	volume = {65},
	number = {2},
	year = {2017},
	month = {2017 Feb},
	pages = {340-347},
	abstract = {OBJECTIVES: To evaluate the incidence and characteristics of nursing home (NH) use after implantable cardioverter-defibrillator (ICD) implantation.

DESIGN: Cohort study.

SETTING: Medicare beneficiaries in the National Cardiovascular Data Registry-ICD Registry.

PARTICIPANTS: Individuals aged 65 and older receiving ICDs between January 1, 2006, and March 31, 2010 (N = 192,483).

MEASUREMENTS: Proportion of ICD recipients discharged to NHs directly after device placement, cumulative incidence of long-term NH admission, and factors associated with immediate discharge to a NH and time to long-term NH admission.

RESULTS: Over 4 years, 40.6\% of the cohort died, and 35,939 (18.7\%) experienced at least one NH admission, including 4.0\% directly discharged to a NH after ICD implantation and 2.8\% admitted to long-term NH care during follow-up. The cumulative incidence of long-term NH admission, accounting for the competing risk of death, was 1.7\% at 1 year, 3.8\% at 3 years, and 4.6\% at 4 years; 20.1\% of individuals admitted to a NH died there. Factors most strongly associated with direct NH discharge and time to long-term NH care were older age (adjusted odds ratio (AOR) = 2.09, 95\% confidence interval (CI) = 2.01-2.17 per 10-year increment; adjusted hazard ratio (AHR) = 1.88, 95\% CI = 1.80-1.97, respectively), dementia (AOR = 2.60, 95\% CI = 2.25-3.01; AHR = 2.50, 95\% CI = 2.14-2.93, respectively), and Medicare Part A claim for NH stay in prior 6 months (AOR = 3.96, 95\% CI = 3.70-4.25; AHR = 2.88, 95\% CI = 2.65-3.14, respectively).

CONCLUSION: Nearly one in five individuals are admitted to NHs over a median of 1.6 years of follow-up after ICD implantation. Understanding these outcomes may help inform the clinical care of these individuals.},
	keywords = {Age Factors, Aged, Cohort Studies, Defibrillators, Implantable, Dementia, Diabetes Mellitus, Female, Humans, Male, Medicare Part A, Nursing Homes, Patient Admission, Registries, Sex Factors, United States},
	issn = {1532-5415},
	doi = {10.1111/jgs.14520},
	author = {Kramer, Daniel B and Reynolds, Matthew R and Normand, Sharon-Lise and Parzynski, Craig S and Spertus, John A and Mor, Vincent and Mitchell, Susan L}
}
@article {573746,
	title = {Quality of Care in the United States Territories, 1999{\textendash}2012},
	journal = {Medical care},
	volume = {55},
	number = {10},
	year = {2017},
	pages = {886-892},
	publisher = {LWW},
	isbn = {0025-7079},
	author = {Nuti, Sudhakar V and Wang, Yun and Masoudi, Frederick A and Nunez-Smith, Marcella and Normand, Sharon-Lise T. and Murugiah, Karthik and Rodr{\'\i}guez-Vil{\'a}, Orlando and Ross, Joseph S and Krumholz,Harlan M.}
}
@article {515956,
	title = {Registry-Based Prospective, Active Surveillance of Medical-Device Safety},
	journal = {N Engl J Med},
	volume = {376},
	number = {6},
	year = {2017},
	month = {2017 02 09},
	pages = {526-535},
	abstract = {BACKGROUND: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).

METHODS: We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.

RESULTS: We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2\% vs. 0.8\%; relative risk, 1.59; 95\% confidence interval [CI], 1.42 to 1.78; P,
	keywords = {Aged, Equipment Design, Equipment Safety, Female, Hemorrhage, Humans, Incidence, Male, Middle Aged, Percutaneous Coronary Intervention, Population Surveillance, Prospective Studies, Registries, Risk, Risk Assessment, Vascular Closure Devices},
	issn = {1533-4406},
	doi = {10.1056/NEJMoa1516333},
	author = {Resnic, Frederic S and Majithia, Arjun and Marinac-Dabic, Danica and Robbins, Susan and Ssemaganda, Henry and Hewitt, Kathleen and Ponirakis, Angelo and Loyo-Berrios, Nilsa and Moussa, Issam and Drozda, Joseph and Normand, Sharon-Lise and Matheny, Michael E}
}
@article {515971,
	title = {Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making},
	journal = {Med Decis Making},
	year = {2017},
	month = {2017 Jan 01},
	pages = {272989X16686767},
	abstract = {BACKGROUND: Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate.

OBJECTIVE: To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making.

METHODS: In the Hospital Cost and Utilization Project National Inpatient Sample, we select pediatric inpatient admissions and identify adverse medical device events (AMDEs). We fit hierarchical Bayesian models to the annual hospital-level AMDE rates, accounting for patient and hospital characteristics. These models produce expected AMDE rates (a safety target), against which we compare the observed rates in a test year to compute a safety signal. We specify a set of loss functions that quantify the costs and benefits of each action as a function of the safety signal. We integrate the loss functions over the posterior distribution of the safety signal to obtain the posterior (Bayes) risk; the preferred action has the smallest Bayes risk. Using simulation and an analysis of AMDE data, we compare our minimum-risk decisions to a conventional Z score approach for classifying safety signals.

RESULTS: The 2 rules produced different actions for nearly half of hospitals (45\%). In the simulation, decisions that minimize Bayes risk outperform Z score-based decisions, even when the loss functions or hierarchical models are misspecified.

LIMITATIONS: Our method is sensitive to the choice of loss functions; eliciting quantitative inputs to the loss functions from regulators is challenging.

CONCLUSIONS: A decision-theoretic approach to acting on safety signals is potentially promising but requires careful specification of loss functions in consultation with subject matter experts.},
	issn = {1552-681X},
	doi = {10.1177/0272989X16686767},
	author = {Hatfield, Laura A and Baugh, Christine M and Azzone, Vanessa and Normand, Sharon-Lise T.}
}
@article {604143,
	title = {Safety Culture and Mortality after Acute Myocardial Infarction: A Study of Medicare Beneficiaries at 171 Hospitals},
	journal = {Health Serv Res},
	year = {2017},
	month = {2017 Oct 09},
	abstract = {OBJECTIVES: To investigate the association between hospital safety culture and 30-day risk-adjusted mortality for Medicare patients with acute myocardial infarction (AMI) in a large, diverse hospital cohort.

SUBJECTS: The final analytic cohort consisted of 19,357 Medicare AMI discharges (MedPAR data) linked to 257 AHRQ Hospital Survey on Patient Safety Culture surveys from 171 hospitals between 2008 and 2013.

STUDY DESIGN: Observational, cross-sectional study using hierarchical logistic models to estimate the association between hospital safety scores and 30-day risk-adjusted patient mortality. Odds ratios of 30-day, all-cause mortality, adjusting for patient covariates, hospital characteristics (size and teaching status), and several different types of safety culture scores (composite, average, and overall) were determined.

PRINCIPAL FINDINGS: No significant association was found between any measure of hospital safety culture and adjusted AMI mortality.

CONCLUSIONS: In a large cross-sectional study from a diverse hospital cohort, AHRQ safety culture scores were not associated with AMI mortality. Our study adds to a growing body of investigations that have failed to conclusively demonstrate a safety culture-outcome association in health care, at least with widely used national survey instruments.},
	issn = {1475-6773},
	doi = {10.1111/1475-6773.12725},
	author = {Shahian, David M and Liu, Xiu and Rossi, Laura P and Mort, Elizabeth A and Normand, Sharon-Lise T.}
}
@article {562631,
	title = {Simulated Effects of Policies to Reduce Diabetes Risk Among Adults With Schizophrenia Receiving Antipsychotics},
	journal = {Psychiatr Serv},
	year = {2017},
	month = {2017 Sep 01},
	pages = {appips201500485},
	abstract = {OBJECTIVE: Second-generation antipsychotics increase the risk of diabetes and other metabolic conditions among individuals with schizophrenia. Although metabolic testing is recommended to reduce this risk, low testing rates have prompted concerns about negative health consequences and downstream medical costs. This study simulated the effect of increasing metabolic testing rates on ten-year prevalence rates of prediabetes and diabetes (diabetes conditions) and their associated health care costs.

METHODS: A microsimulation model (N=21,491 beneficiaries) with a ten-year time horizon was used to quantify the impacts of policies that increased annual testing rates in a Medicaid population with schizophrenia. Data sources included California Medicaid data, National Health and Nutrition Examination Survey data, and the literature. In the model, metabolic testing increased diagnosis of diabetes conditions and diagnosis prompted prescribers to switch patients to lower-risk antipsychotics. Key inputs included observed diagnoses, prescribing rates, annual testing rates, imputed rates of undiagnosed diabetes conditions, and literature-based estimates of policy effectiveness.

RESULTS: Compared with 2009 annual testing rates, ten-year outcomes for policies that achieved universal testing reduced exposure to higher-risk antipsychotics by 14\%, time to diabetes diagnosis by 57\%, and diabetes prevalence by .6\%. These policies were associated with higher spending because of testing and earlier treatment.

CONCLUSIONS: The model showed that policies promoting metabolic testing provided an effective approach to improve the safety of second-generation antipsychotic prescribing in a Medicaid population with schizophrenia; however, the policies led to additional costs at ten years. Simulation studies are a useful source of information on the potential impacts of these policies.},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.201500485},
	author = {Mulcahy, Andrew W and Normand, Sharon-Lise and Newcomer, John W and Colaiaco, Benjamin and Donohue, Julie M and Lave, Judith R and Keeler, Emmett and Sorbero, Mark J and Horvitz-Lennon, Marcela}
}
@article {579541,
	title = {Socioeconomic Background and Commercial Health Plan Spending},
	journal = {Pediatrics},
	year = {2017},
	month = {2017 Oct 03},
	abstract = {BACKGROUND: Risk-adjustment algorithms typically incorporate demographic and clinical variables to equalize compensation to insurers for enrollees who vary in expected cost, but including information about enrollees{\textquoteright} socioeconomic background is controversial.

METHODS: We studied 1 182 847 continuously insured 0 to 19-year-olds using 2008-2012 Blue Cross Blue Shield of Massachusetts and American Community Survey data. We characterized enrollees{\textquoteright} socioeconomic background using the validated area-based socioeconomic measure and calculated annual plan payments using paid claims. We evaluated the relationship between annual plan payments and geocoded socioeconomic background using generalized estimating equations (γ distribution and log link). We expressed outcomes as the percentage difference in spending and utilization between enrollees with high and low socioeconomic backgrounds.

RESULTS: Geocoded socioeconomic background had a significant, positive association with annual plan payments after applying standard adjusters. Every 1 SD increase in socioeconomic background was associated with a 7.8\% (95\% confidence interval, 7.2\% to 8.3\%; P < .001) increase in spending. High socioeconomic background enrollees used higher-priced outpatient and pharmacy services more frequently than their counterparts from low socioeconomic backgrounds (eg, 25\% more outpatient encounters annually; 8\% higher price per encounter; P < .001), which outweighed greater emergency department spending among low socioeconomic background enrollees.

CONCLUSIONS: Higher socioeconomic background is associated with greater levels of pediatric health care spending in commercially insured children. Including socioeconomic information in risk-adjustment algorithms may address concerns about adverse selection from an economic perspective, but it would direct funds away from those caring for children and adolescents from lower socioeconomic backgrounds who are at greater risk of poor health.},
	issn = {1098-4275},
	doi = {10.1542/peds.2017-1640},
	author = {Alyna T. Chien and Joseph P. Newhouse and Iezzoni, Lisa I and Petty, Carter R and Normand, Sharon-Lise T. and Mark A Schuster}
}
@article {557101,
	title = {Study protocol for a cluster randomised controlled trial to assess the effectiveness of user-driven intervention to prevent aggressive events in psychiatric services},
	journal = {BMC Psychiatry},
	volume = {17},
	number = {1},
	year = {2017},
	month = {2017 Apr 04},
	pages = {123},
	abstract = {BACKGROUND: People admitted to psychiatric hospitals with a diagnosis of schizophrenia may display behavioural problems. These may require management approaches such as use of coercive practices, which impact the well-being of staff members, visiting families and friends, peers, as well as patients themselves. Studies have proposed that not only patients{\textquoteright} conditions, but also treatment environment and ward culture may affect patients{\textquoteright} behaviour. Seclusion and restraint could possibly be prevented with staff education about user-centred, more humane approaches. Staff education could also increase collaboration between patients, family members and staff, which may further positively affect treatment culture and lower the need for using coercive treatment methods.

METHODS: This is a single-blind, two-arm cluster randomised controlled trial involving 28 psychiatric hospital wards across Finland. Units will be randomised to receive either a staff educational programme delivered by the team of researchers, or standard care. The primary outcome is the incidence of use of patient seclusion rooms, assessed from the local/national health registers. Secondary outcomes include use of other coercive methods (limb restraint, forced injection, and physical restraint), service use, treatment satisfaction, general functioning among patients, and team climate and employee turn-over (nursing staff).

DISCUSSION: The study, designed in close collaboration with staff members, patients and their relatives, will provide evidence for a co-operative and user-centred educational intervention aiming to decrease the prevalence of coercive methods and service use in the units, increase the functional status of patients and improve team climate in the units. We have identified no similar trials.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02724748 . Registered on 25(th) of April 2016.},
	keywords = {Adult, Aggression, Clinical Protocols, Female, Finland, Health Personnel, Hospitals, Psychiatric, Humans, Male, Patient Isolation, Registries, Restraint, Physical, Schizophrenic Psychology, Single-Blind Method, Young Adult},
	issn = {1471-244X},
	doi = {10.1186/s12888-017-1266-6},
	author = {V{\"a}lim{\"a}ki, Maritta and Yang, Min and Normand, Sharon-Lise and Lorig, Kate R and Anttila, Minna and Lantta, Tella and Pekurinen, Virve and Adams, Clive E}
}
@article {546481,
	title = {Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge},
	journal = {JAMA},
	volume = {318},
	number = {3},
	year = {2017},
	pages = {270-278},
	url = {http://jamanetwork.com/journals/jama/article-abstract/2643762},
	author = {Dharmarajan, Kumar and Wang, Yongfei and Lin, Zhenqiu and Normand, Sharon-Lise T. and Ross, Joseph S. and Horwitz, Leora I. and Desai, Nihar R. and Suter, Lisa G and Drye, Elizabeth E and Bernheim, Susannah M and Krumholz,Harlan M.}
}
@article {516001,
	title = {Accounting For Patients{\textquoteright} Socioeconomic Status Does Not Change Hospital Readmission Rates},
	journal = {Health Aff (Millwood)},
	volume = {35},
	number = {8},
	year = {2016},
	month = {2016 Aug 01},
	pages = {1461-70},
	abstract = {There is an active public debate about whether patients{\textquoteright} socioeconomic status should be included in the readmission measures used to determine penalties in Medicare{\textquoteright}s Hospital Readmissions Reduction Program (HRRP). Using the current Centers for Medicare and Medicaid Services methodology, we compared risk-standardized readmission rates for hospitals caring for high and low proportions of patients of low socioeconomic status (as defined by their Medicaid status or neighborhood income). We then calculated risk-standardized readmission rates after additionally adjusting for patients{\textquoteright} socioeconomic status. Our results demonstrate that hospitals caring for large proportions of patients of low socioeconomic status have readmission rates similar to those of other hospitals. Moreover, readmission rates calculated with and without adjustment for patients{\textquoteright} socioeconomic status are highly correlated. Readmission rates of hospitals caring for patients of low socioeconomic status changed by approximately 0.1~percent with adjustment for patients{\textquoteright} socioeconomic status, and only 3-4~percent fewer such hospitals reached the threshold for payment penalty in Medicare{\textquoteright}s HRRP. Overall, adjustment for socioeconomic status does not change hospital results in meaningful ways.},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.2015.0394},
	author = {Bernheim, Susannah M and Parzynski, Craig S and Horwitz, Leora and Lin, Zhenqiu and Araas, Michael J and Ross, Joseph S and Drye, Elizabeth E and Suter, Lisa G and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516026,
	title = {Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices},
	journal = {J Health Care Finance},
	volume = {2016},
	number = {Spec Features},
	year = {2016},
	month = {2016 Summer},
	abstract = {Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since PAS costs are funded through device manufacturers who do not share the costs with regulators, we sought to estimate the total PAS costs through interviews with a panel of experts in medical device clinical trial design in order to design a general cost model for PAS which was then applied to the FDA PAS. A total of 277 PAS were initiated between 3/1/05 through 6/30/13 and demonstrated a median cost of $2.16 million per study and an overall cost of $1.22 billion over the 8.25 years of study. While these costs are funded through manufacturers, the ultimate cost is borne by the healthcare system through the medical device costs. Given concerns regarding the informational value of PAS, the resources used to support mandated PAS may be better allocated to other approaches to assure safety.},
	keywords = {Costs and Cost Analysis, Device Approval, Equipment Design, Humans, Safety, United States, United States Food and Drug Administration},
	issn = {1078-6767},
	author = {Wimmer, Neil J and Robbins, Susan and Ssemaganda, Henry and Yang, Erin and Normand, Sharon-Lise and Matheny, Michael E and Herz, Naomi and Rising, Josh and Resnic, Frederic S}
}
@article {516011,
	title = {Association Between Hospital Performance on Patient Safety and 30-Day Mortality and Unplanned Readmission for Medicare Fee-for-Service Patients With Acute Myocardial Infarction},
	journal = {J Am Heart Assoc},
	volume = {5},
	number = {7},
	year = {2016},
	month = {2016 Jul 12},
	abstract = {BACKGROUND: Little is known regarding the relationship between hospital performance on adverse event rates and hospital performance on 30-day mortality and unplanned readmission rates for Medicare fee-for-service patients hospitalized for acute myocardial infarction (AMI).

METHODS AND RESULTS: Using 2009-2013 medical record-abstracted patient safety data from the Agency for Healthcare Research and Quality{\textquoteright}s Medicare Patient Safety Monitoring System and hospital mortality and readmission data from the Centers for Medicare \& Medicaid Services, we fitted a mixed-effects model, adjusting for hospital characteristics, to evaluate whether hospital performance on patient safety, as measured by the hospital-specific risk-standardized occurrence rate of 21 common adverse event measures for which patients were at risk, is associated with hospital-specific 30-day all-cause risk-standardized mortality and unplanned readmission rates for Medicare patients with AMI. The unit of analysis was at the hospital level. The final sample included 793 acute care hospitals that treated 30 or more Medicare patients hospitalized for AMI and had 40 or more adverse events for which patients were at risk. The occurrence rate of adverse events for which patients were at risk was 3.8\%. A 1\% point change in the risk-standardized occurrence rate of adverse events was associated with average changes in the same direction of 4.86\% points (95\% CI, 0.79-8.94) and 3.44\% points (95\% CI, 0.19-6.68) for the risk-standardized mortality and unplanned readmission rates, respectively.

CONCLUSIONS: For Medicare fee-for-service patients discharged with AMI, hospitals with poorer patient safety performance were also more likely to have poorer performance on 30-day all-cause mortality and on unplanned readmissions.},
	issn = {2047-9980},
	doi = {10.1161/JAHA.116.003731},
	author = {Wang, Yun and Eldridge, Noel and Metersky, Mark L and Sonnenfeld, Nancy and Fine, Jonathan M. and Pandolfi, Michelle M and Eckenrode, Sheila and Bakullari, Anila and Galusha, Deron H and Jaser, Lisa and Verzier, Nancy R and Nuti, Sudhakar V and Hunt, David and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516041,
	title = {Association of Guideline-Based Admission~Treatments and Life Expectancy After Myocardial Infarction in~Elderly Medicare Beneficiaries},
	journal = {J Am Coll Cardiol},
	volume = {67},
	number = {20},
	year = {2016},
	month = {2016 May 24},
	pages = {2378-91},
	abstract = {BACKGROUND: Guideline-based admission therapies for acute myocardial infarction (AMI) significantly improve 30-day survival, but little is known about their association with long-term outcomes.

OBJECTIVES: This study evaluated the association of 5 AMI admission therapies (aspirin, beta-blockers, acute reperfusion therapy, door-to-balloon [D2B] time~<=90 min, and time to fibrinolysis~<=30 min) with life expectancy and years of life saved after AMI.

METHODS: We analyzed data from the Cooperative Cardiovascular Project, a study of Medicare beneficiaries hospitalized for AMI, with 17 years of follow-up. Life expectancy and years of life saved after AMI were calculated using Cox proportional hazards regression with extrapolation using exponential models.

RESULTS: Survival for recipients and non-recipients of the 5 guideline-based therapies diverged early after admission and continued to diverge during 17-year follow-up. Receipt of aspirin, beta-blockers, and acute reperfusion therapy on admission was associated with longer life expectancy of 0.78 (standard error [SE]: 0.05), 0.55 (SE: 0.06), and 1.03 (SE: 0.12) years, respectively. Patients receiving primary percutaneous coronary intervention (PCI) within 90 min lived 1.08 (SE: 0.49) years longer than patients with D2B times >90 min, and door-to-needle (D2N) times~<=30 min were associated with 0.55 (SE: 0.12) more years of life. A dose-response relationship was observed between longer D2B and D2N times and shorter life expectancy after AMI.

CONCLUSIONS: Guideline-based therapy for AMI admission is associated with both early and late survival benefits, and~results in meaningful gains in life expectancy and large numbers of years of life saved in elderly patients.},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2016.03.507},
	author = {Bucholz, Emily M and Butala, Neel M and Normand, Sharon-Lise T. and Wang, Yun and Krumholz,Harlan M.}
}
@article {516066,
	title = {Challenges in the Use of Administrative Data for Heart Failure Services Research},
	journal = {J Card Fail},
	volume = {22},
	number = {1},
	year = {2016},
	month = {2016 Jan},
	pages = {61-3},
	keywords = {Databases, Factual, Heart Failure, Humans},
	issn = {1532-8414},
	doi = {10.1016/j.cardfail.2015.11.005},
	author = {Horvitz-Lennon, Marcela and Braun, Danielle and Normand, Sharon-Lise}
}
@article {516021,
	title = {Declining Admission Rates And Thirty-Day Readmission Rates Positively Associated Even Though Patients Grew Sicker Over Time},
	journal = {Health Aff (Millwood)},
	volume = {35},
	number = {7},
	year = {2016},
	month = {2016 Jul 01},
	pages = {1294-302},
	abstract = {Programs from the Centers for Medicare and Medicaid Services simultaneously promote strategies to lower hospital admissions and readmissions. However, there is concern that hospitals in communities that successfully reduce admissions may be penalized, as patients that are ultimately hospitalized may be sicker and at higher risk of readmission. We therefore examined the relationship between changes from 2010 to 2013 in admission rates and thirty-day readmission rates for elderly Medicare beneficiaries. We found that communities with the greatest decline in admission rates also had the greatest decline in thirty-day readmission rates, even though hospitalized patients did grow sicker as admission rates declined. The relationship between changing admission and readmission rates persisted in models that measured observed readmission rates, risk-standardized readmission rates, and the combined rate of readmission and death. Our findings suggest that communities can reduce admission rates and readmission rates in parallel, and that federal policy incentivizing reductions in both outcomes does not create contradictory incentives.},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.2015.1614},
	author = {Dharmarajan, Kumar and Qin, Li and Lin, Zhenqiu and Horwitz, Leora I and Ross, Joseph S and Drye, Elizabeth E and Keshawarz, Amena and Altaf, Faseeha and Normand, Sharon-Lise T. and Krumholz,Harlan M. and Bernheim, Susannah M}
}
@article {516046,
	title = {Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention},
	journal = {JAMA},
	volume = {315},
	number = {16},
	year = {2016},
	month = {2016 Apr 26},
	pages = {1735-49},
	abstract = {IMPORTANCE: Dual antiplatelet therapy after percutaneous coronary intervention (PCI) reduces ischemia but increases bleeding.

OBJECTIVE: To develop a clinical decision tool to identify patients expected to derive benefit vs harm from continuing thienopyridine beyond 1 year after PCI.

DESIGN, SETTING, AND PARTICIPANTS: Among 11,648 randomized DAPT Study patients from 11 countries (August 2009-May 2014), a prediction rule was derived stratifying patients into groups to distinguish ischemic and bleeding risk 12 to 30 months after PCI. Validation was internal via bootstrap resampling and external among 8136 patients from 36 countries randomized in the PROTECT trial (June 2007-July 2014).

EXPOSURES: Twelve months of open-label thienopyridine plus aspirin, then randomized to 18 months of continued thienopyridine plus aspirin vs placebo plus aspirin.

MAIN OUTCOMES AND MEASURES: Ischemia (myocardial infarction or stent thrombosis) and bleeding (moderate or severe) 12 to 30 months after PCI.

RESULTS: Among DAPT Study patients (derivation cohort; mean age, 61.3 years; women, 25.1\%), ischemia occurred in 348 patients (3.0\%) and bleeding in 215 (1.8\%). Derivation cohort models predicting ischemia and bleeding had c statistics of 0.70 and 0.68, respectively. The prediction rule assigned 1 point each for myocardial infarction at presentation, prior myocardial infarction or PCI, diabetes, stent diameter less than 3 mm, smoking, and paclitaxel-eluting stent; 2 points each for history of congestive heart failure/low ejection fraction and vein graft intervention; -1 point for age 65 to younger than 75 years; and -2 points for age 75 years or older. Among the high score group (score >=2, n = 5917), continued thienopyridine vs placebo was associated with reduced ischemic events (2.7\% vs 5.7\%; risk difference [RD], -3.0\% [95\% CI, -4.1\% to -2.0\%], P ,
	keywords = {Age Factors, Aged, Antineoplastic Agents, Phytogenic, Aspirin, Diabetes Mellitus, Drug-Eluting Stents, Female, Hemorrhage, Humans, Ischemia, Linear Models, Male, Middle Aged, Myocardial Infarction, Paclitaxel, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Pyridines, Risk Assessment, Risk Factors, Smoking, Thrombosis, Time Factors},
	issn = {1538-3598},
	doi = {10.1001/jama.2016.3775},
	author = {Yeh, Robert W and Secemsky, Eric A and Kereiakes, Dean J and Normand, Sharon-Lise T. and Gershlick, Anthony H and Cohen, David J and Spertus, John A and Steg, Philippe Gabriel and Cutlip, Donald E and Rinaldi, Michael J and Camenzind, Edoardo and Wijns, William and Apruzzese, Patricia K and Song, Yang and Massaro, Joseph M and Mauri, Laura}
}
@article {516006,
	title = {Geographic and Temporal Variation in Cardiac Implanted Electric Devices to Treat Heart Failure},
	journal = {J Am Heart Assoc},
	volume = {5},
	number = {8},
	year = {2016},
	month = {2016 Jul 28},
	abstract = {BACKGROUND: Cardiac implantable electric devices are commonly used to treat heart failure. Little is known about temporal and geographic variation in use of cardiac resynchronization therapy (CRT) devices in usual care settings.

METHODS AND RESULTS: We identified new CRT with pacemaker (CRT-P) or defibrillator generators (CRT-D) implanted between 2008 and 2013 in the United States from a commercial claims database. For each implant, we characterized prior medication use, comorbidities, and geography. Among 17~780 patients with CRT devices (median age 69, 31\% women), CRT-Ps were a small and increasing share of CRT devices, growing from 12\% to 20\% in this study period. Compared to CRT-D recipients, CRT-P recipients were older (median age 76 versus 67), and more likely to be female (40\% versus 30\%). Pre-implant use of β-blockers and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers was low in both CRT-D (46\%) and CRT-P (31\%) patients. The fraction of CRT-P devices among all new implants varied widely across states. Compared to the increasing national trend, the share of CRT-P implants was relatively increasing in Kansas and relatively decreasing in Minnesota and Oregon.

CONCLUSIONS: In this large, contemporary heart failure population, CRT-D use dwarfed CRT-P, though the latter nearly doubled over 6~years. Practice patterns vary substantially across states and over time. Medical therapy appears suboptimal in real-world practice.},
	issn = {2047-9980},
	doi = {10.1161/JAHA.116.003532},
	author = {Hatfield, Laura A and Kramer, Daniel B and Volya, Rita and Reynolds, Matthew R and Normand, Sharon-Lise T.}
}
@article {515996,
	title = {Handling incomplete correlated continuous and binary outcomes in meta-analysis of individual participant data},
	journal = {Stat Med},
	volume = {35},
	number = {21},
	year = {2016},
	month = {2016 Sep 20},
	pages = {3676-89},
	abstract = {Meta-analysis of individual participant data (IPD) is increasingly utilised to improve the estimation of treatment effects, particularly among different participant subgroups. An important concern in IPD meta-analysis relates to partially or completely missing outcomes for some studies, a problem exacerbated when interest is on multiple discrete and continuous outcomes. When leveraging information from incomplete correlated outcomes across studies, the fully observed outcomes may provide important information about the incompleteness of the other outcomes. In this paper, we compare two models for handling incomplete continuous and binary outcomes in IPD meta-analysis: a joint hierarchical model and a sequence of full conditional mixed models. We illustrate how these approaches incorporate the correlation across the multiple outcomes and the between-study heterogeneity when addressing the missing data. Simulations characterise the performance of the methods across a range of scenarios which differ according to the proportion and type of missingness, strength of correlation between outcomes and the number of studies. The joint model provided confidence interval coverage consistently closer to nominal levels and lower mean squared error compared with the fully conditional approach across the scenarios considered. Methods are illustrated in a meta-analysis of randomised controlled trials comparing the effectiveness of implantable cardioverter-defibrillator devices alone to implantable cardioverter-defibrillator combined with cardiac resynchronisation therapy for treating patients with chronic heart failure. {\textcopyright} 2016 The Authors. Statistics in Medicine Published by John Wiley \& Sons Ltd.},
	issn = {1097-0258},
	doi = {10.1002/sim.6969},
	author = {Gomes, Manuel and Laura Hatfield and Normand, Sharon-Lise}
}
@article {516036,
	title = {Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: Results From the National Cardiovascular Data Registry},
	journal = {Circulation},
	volume = {133},
	number = {21},
	year = {2016},
	month = {2016 May 24},
	pages = {2030-7},
	abstract = {BACKGROUND: Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown.

METHODS AND RESULTS: Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry - ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9\% of patients were either deceased or in hospice. Among decedents, 36.8\% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7\% (95\% confidence interval [CI], 4.6\%-4.8\%) within 1 year and 21.3\% (95\% CI, 20.7\%-21.8\%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95\% CI, 1.73-1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95\% CI, 1.66-1.94); ejection fraction ,
	keywords = {Aged, Aged, 80 and over, Cohort Studies, Databases, Factual, Death, Sudden, Cardiac, Defibrillators, Implantable, Female, Follow-Up Studies, Hospices, Humans, Male, Mortality, Registries},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.115.020677},
	author = {Kramer, Daniel B and Reynolds, Matthew R and Normand, Sharon-Lise and Parzynski, Craig S and Spertus, John A and Mor, Vincent and Mitchell, Susan L}
}
@article {515991,
	title = {Hospital Phenotypes in the Management of Patients Admitted for Acute Myocardial Infarction},
	journal = {Med Care},
	volume = {54},
	number = {10},
	year = {2016},
	month = {2016 Oct},
	pages = {929-36},
	abstract = {OBJECTIVES: To characterize hospital phenotypes by their combined utilization pattern of percutaneous coronary interventions (PCI), coronary artery bypass grafting (CABG) procedures, and intensive care unit (ICU) admissions for patients hospitalized for acute myocardial infarction (AMI).

RESEARCH DESIGN: Using the Premier Analytical Database, we identified 129,138 hospitalizations for AMI from 246 hospitals with the capacity for performing open-heart surgery during 2010-2013. We calculated year-specific, risk-standardized estimates of PCI procedure rates, CABG procedure rates, and ICU admission rates for each hospital, adjusting for patient clinical characteristics and within-hospital correlation of patients. We used a mixture modeling approach to identify groups of hospitals (ie, hospital phenotypes) that exhibit distinct longitudinal patterns of risk-standardized PCI, CABG, and ICU admission rates.

RESULTS: We identified 3 distinct phenotypes among the 246 hospitals: (1) high PCI-low CABG-high ICU admission (39.2\% of the hospitals), (2) high PCI-low CABG-low ICU admission (30.5\%), and (3) low PCI-high CABG-moderate ICU admission (30.4\%). Hospitals in the high PCI-low CABG-high ICU admission phenotype had significantly higher risk-standardized in-hospital costs and 30-day risk-standardized payment yet similar risk-standardized mortality and readmission rates compared with hospitals in the low PCI-high CABG-moderate ICU admission phenotype. Hospitals in these phenotypes differed by geographic region.

CONCLUSIONS: Hospitals differ in how they manage patients hospitalized for AMI. Their distinctive practice patterns suggest that some hospital phenotypes may be more successful in producing good outcomes at lower cost.},
	keywords = {Acute Disease, Aged, Coronary Artery Bypass, Hospital Costs, Hospitalization, Hospitals, Humans, Intensive Care Units, Myocardial Infarction, Percutaneous Coronary Intervention},
	issn = {1537-1948},
	doi = {10.1097/MLR.0000000000000571},
	author = {Xu, Xiao and Li, Shu-Xia and Lin, Haiqun and Normand, Sharon-Lise T. and Lagu, Tara and Desai, Nihar and Duan, Michael and Kroch, Eugene A and Krumholz,Harlan M.}
}
@article {515986,
	title = {Life Expectancy after Myocardial Infarction, According to Hospital Performance},
	journal = {N Engl J Med},
	volume = {375},
	number = {14},
	year = {2016},
	month = {2016 Oct 06},
	pages = {1332-1342},
	abstract = {Background Thirty-day risk-standardized mortality rates after acute myocardial infarction are commonly used to evaluate and compare hospital performance. However, it is not known whether differences among hospitals in the early survival of patients with acute myocardial infarction are associated with differences in long-term survival. Methods We analyzed data from the Cooperative Cardiovascular Project, a study of Medicare beneficiaries who were hospitalized for acute myocardial infarction between 1994 and 1996 and who had 17 years of follow-up. We grouped hospitals into five strata that were based on case-mix severity. Within each case-mix stratum, we compared life expectancy among patients admitted to high-performing hospitals with life expectancy among patients admitted to low-performing hospitals. Hospital performance was defined by quintiles of 30-day risk-standardized mortality rates. Cox proportional-hazards models were used to calculate life expectancy. Results The study sample included 119,735 patients with acute myocardial infarction who were admitted to 1824 hospitals. Within each case-mix stratum, survival curves of the patients admitted to hospitals in each risk-standardized mortality rate quintile separated within the first 30 days and then remained parallel over 17 years of follow-up. Estimated life expectancy declined as hospital risk-standardized mortality rate quintile increased. On average, patients treated at high-performing hospitals lived between 0.74 and 1.14 years longer, depending on hospital case mix, than patients treated at low-performing hospitals. When 30-day survivors were examined separately, there was no significant difference in unadjusted or adjusted life expectancy across hospital risk-standardized mortality rate quintiles. Conclusions In this study, patients admitted to high-performing hospitals after acute myocardial infarction had longer life expectancies than patients treated in low-performing hospitals. This survival benefit occurred in the first 30 days and persisted over the long term. (Funded by the National Heart, Lung, and Blood Institute and the National Institute of General Medical Sciences Medical Scientist Training Program.).},
	keywords = {Aged, Aged, 80 and over, Female, Follow-Up Studies, Hospitals, Humans, Life Expectancy, Male, Myocardial Infarction, Quality of Health Care, Survival Analysis, United States},
	issn = {1533-4406},
	doi = {10.1056/NEJMoa1513223},
	author = {Bucholz, Emily M and Butala, Neel M and Ma, Shuangge and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516061,
	title = {The National Cardiovascular Data Registry Voluntary Public Reporting Program: An Interim Report From the NCDR Public Reporting Advisory Group},
	journal = {J Am Coll Cardiol},
	volume = {67},
	number = {2},
	year = {2016},
	month = {2016 Jan 19},
	pages = {205-215},
	abstract = {Public reporting of health care data continues to proliferate as consumers and other stakeholders seek information on the quality and outcomes of care. Medicare{\textquoteright}s Hospital Compare website, the U.S. News \& World Report hospital rankings, and several state-level programs are well known. Many rely heavily on administrative data as a surrogate to reflect clinical reality. Clinical data are traditionally more difficult and costly to collect, but more accurately reflect patients{\textquoteright} clinical status, thus enhancing the validity of quality metrics. We describe the public reporting effort being launched by the American College of Cardiology and partnering professional organizations using clinical data from the National Cardiovascular Data Registry (NCDR) programs. This hospital-level voluntary effort will initially report process of care measures from the percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries of the NCDR. Over time, additional process, outcomes, and composite performance metrics will be reported.},
	keywords = {Defibrillators, Implantable, Hospitals, Humans, Medical Record Linkage, Outcome Assessment (Health Care), Percutaneous Coronary Intervention, Quality Assurance, Health Care, Quality Improvement, Registries, Research Design, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2015.11.001},
	author = {Dehmer, Gregory J and Jennings, Jonathan and Madden, Ruth A and Malenka, David J and Masoudi, Frederick A and McKay, Charles R and Ness, Debra L and Rao, Sunil V and Resnic, Frederic S and Ring, Michael E and Rumsfeld, John S and Shelton, Marc E and Simanowith, Michael C and Slattery, Lara E and Weintraub, William S and Lovett, Ann and Normand, Sharon-Lise}
}
@article {515981,
	title = {Patterns of Antipsychotic Prescribing by Physicians to Young Children},
	journal = {Psychiatr Serv},
	volume = {67},
	number = {12},
	year = {2016},
	month = {2016 Dec 01},
	pages = {1307-1314},
	abstract = {OBJECTIVE: Antipsychotic use among young children has grown rapidly despite a lack of approval by the U.S. Food and Drug Administration (FDA) for broad use in this age group. Characteristics of physicians who prescribed antipsychotics to young children were identified, and prescribing patterns involving young children and adults were compared.

METHODS: Physician-level prescribing data from IMS Health{\textquoteright}s Xponent database were linked with American Medical Association Masterfile data and analyzed. The sample included all U.S. psychiatrists and a random sample of 5\% of family medicine physicians who wrote at least ten antipsychotic prescriptions per year from 2008 to 2011 (N=31,713). Logistic and hierarchical binomial regression models were estimated to examine physician prescribing for children ages zero to nine, and the types and numbers of ingredients used for children versus adults ages 20 to 64 were compared.

RESULTS: Among antipsychotic prescribers, 42.2\% had written at least one antipsychotic prescription for young children. Such prescribing was more likely among physicians age <=39 versus >=60 (odds ratio [OR]=1.70) and physicians in rural versus nonrural areas (OR=1.11) and was less likely among males (OR=.93) and graduates of a top-25 versus a lower-ranked U.S. medical school (OR=.87). Among physicians who prescribed antipsychotics to young children and adults, 75.0\% of prescriptions for children and 35.7\% of those for adults were for drugs with an FDA-approved indication for that age. Fewer antipsychotic agents were prescribed for young children (median=2) versus adults (median=7).

CONCLUSIONS: Prescribing antipsychotics for young children was relatively common, but prescribing patterns differed between young children and adults.},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.201500224},
	author = {Huskamp, Haiden A. and Horvitz-Lennon, Marcela and Ernst R. Berndt and Normand, Sharon-Lise T. and Donohue, Julie M}
}
@article {516016,
	title = {Rating the Raters: The Inconsistent Quality of Health Care Performance Measurement},
	journal = {Ann Surg},
	volume = {264},
	number = {1},
	year = {2016},
	month = {2016 Jul},
	pages = {36-8},
	issn = {1528-1140},
	doi = {10.1097/SLA.0000000000001631},
	author = {Shahian, David M and Normand, Sharon-Lise T. and Friedberg, Mark W and Hutter, Matthew M and Pronovost, Peter J}
}
@article {516051,
	title = {Rationale and Design of the Women and Inclusion in Academic Medicine Study},
	journal = {Ethn Dis},
	volume = {26},
	number = {2},
	year = {2016},
	month = {2016 Apr 21},
	pages = {245-54},
	abstract = {BACKGROUND AND OBJECTIVE: Women of color (WOC) (African American, Hispanic, Native American/Alaskan Native, and Asian American) faculty remain disproportionately underrepresented among medical school faculty and especially at senior ranks compared with White female faculty. The barriers or facilitators to the career advancement of WOC are poorly understood. The Women and Inclusion in Academic Medicine (WIAM) study was developed to characterize individual, institutional and sociocultural factors that influence the entry, progression and persistence, and advancement of women faculty in academic medical careers with a focus on WOC.

METHODS: Using a purposive sample of 13 academic medical institutions, we collected qualitative interview data from 21 WOC junior faculty and quantitative data from 3,127 (38.9\% of 8,053 eligible women) respondents via an online survey. To gather institutional data, we used an online survey and conducted 23 key administrative informant interviews from the 13 institutions. Grounded theory methodology will be used to analyze qualitative data. Multivariable analysis including hierarchical linear modeling will be used to investigate outcomes, such as the inclusiveness of organizational gender climate and women faculty{\textquoteright}s intent to stay.

CONCLUSION: We describe the design, methods, rationale and limitations of one of the largest and most comprehensive studies of women faculty in academic medicine with a focus on WOC. This study will enhance our understanding of challenges that face women, and, especially WOC, faculty in academic medicine and will provide solutions at both the individual and institutional levels.},
	issn = {1049-510X},
	doi = {10.18865/ed.26.2.245},
	author = {Hill, Emorcia V and Wake, Michael and Carapinha, Ren{\'e} and Normand, Sharon-Lise and Wolf, Robert E and Norris, Keith and Reede, Joan Y}
}
@article {516031,
	title = {Regional Variation in Physician Adoption of Antipsychotics: Impact on US Medicare Expenditures},
	journal = {J Ment Health Policy Econ},
	volume = {19},
	number = {2},
	year = {2016},
	month = {2016 Jun},
	pages = {69-78},
	abstract = {BACKGROUND: Regional variation in US Medicare prescription drug spending is driven by higher prescribing of costly brand-name drugs in some regions. This variation likely arises from differences in the speed of diffusion of newly-approved medications. Second-generation antipsychotics were widely adopted for treatment of severe mental illness and for several off-label uses. Rapid diffusion of new psychiatric drugs likely increases drug spending but its relationship to non-drug spending is unclear. The impact of antipsychotic diffusion on drug and medical spending is of great interest to public payers like Medicare, which finance a majority of mental health spending in the US.

AIMS: We examine the association between physician adoption of new antipsychotics and antipsychotic spending and non-drug medical spending among disabled and elderly Medicare enrollees.

METHODS: We linked physician-level data on antipsychotic prescribing from an all-payer dataset (IMS Health{\textquoteright}s XponentTM) to patient-level data from Medicare. Our physician sample included 16,932 US. psychiatrists and primary care providers with > 10 antipsychotic prescriptions per year from 1997-2011. We constructed a measure of physician adoption of 3 antipsychotics introduced during this period (quetiapine, ziprasidone and aripiprazole) by estimating a shared frailty model of the time to first prescription for each drug. We then assigned physicians to one of 306 U.S. hospital referral regions (HRRs) and measured the average propensity to adopt per region. Using 2010 data for a random sample of 1.6 million Medicare beneficiaries, we identified 138,680 antipsychotic users. A generalized linear model with gamma distribution and log link was used to estimate the effect of region-level adoption propensity on beneficiary-level antipsychotic spending and non-drug medical spending adjusting for patient demographic and socioeconomic characteristics, health status, eligibility category, and whether the antipsychotic was for an on- vs. off-label use.

RESULTS: In our sample, mean patient age was 62 years, 42\% were male, and 86\% had low-income. Half of antipsychotic users in Medicare had an on-label indication. The weighted average propensity to adopt the three new antipsychotics varied four-fold across HRRs. For every one standard deviation increase in the propensity to adopt there was a 5\% increase in antipsychotic spending after adjusting for covariates (adjusted ratio of spending 1.05, 95\% CI 1.01-1.08, p = 0.005). Physician propensity to adopt new antipsychotics was not associated with non-drug medical spending (adjusted ratio 0.96, 95\% CI 0.91-1.01, p < 0.117).

DISCUSSION: These findings suggest wide regional variation in physicians{\textquoteright} propensity to adopt new antipsychotic medications. While physician adoption of new antipsychotics was positively associated with antipsychotic expenditures, it was not associated with non-drug spending. Our analysis is limited to Medicare and may not generalize to other payers. Also, claims data do not allow for the measurement of health outcomes, which would be important to evaluate when calculating the value of rapid vs. slow technology adoption.},
	keywords = {Adult, Aged, Antipsychotic Agents, Female, Health Expenditures, Humans, Male, Medicare, Middle Aged, Practice Patterns, Physicians{\textquoteright}, United States},
	issn = {1091-4358},
	author = {Donohue, Julie M and Normand, Sharon-Lise T. and Horvitz-Lennon, Marcela and Men, Aiju and Ernst R. Berndt and Huskamp, Haiden A.}
}
@article {516141,
	title = {Antipsychotic prescribing: do conflict of interest policies make a difference?},
	journal = {Med Care},
	volume = {53},
	number = {4},
	year = {2015},
	month = {2015 Apr},
	pages = {338-45},
	abstract = {BACKGROUND: Academic medical centers (AMCs) have increasingly adopted conflict of interest policies governing physician-industry relationships; it is unclear how policies impact prescribing.

OBJECTIVES: To determine whether 9 American Association of Medical Colleges (AAMC)-recommended policies influence psychiatrists{\textquoteright} antipsychotic prescribing and compare prescribing between academic and nonacademic psychiatrists.

RESEARCH DESIGN: We measured number of prescriptions for 10 heavily promoted and 9 newly introduced/reformulated antipsychotics between 2008 and 2011 among 2464 academic psychiatrists at 101 AMCs and 11,201 nonacademic psychiatrists. We measured AMC compliance with 9 AAMC recommendations. Difference-in-difference analyses compared changes in antipsychotic prescribing between 2008 and 2011 among psychiatrists in AMCs compliant with >= 7/9 recommendations, those whose institutions had lesser compliance, and nonacademic psychiatrists.

RESULTS: Ten centers were AAMC compliant in 2008, 30 attained compliance by 2011, and 61 were never compliant. Share of prescriptions for heavily promoted antipsychotics was stable and comparable between academic and nonacademic psychiatrists (63.0\%-65.8\% in 2008 and 62.7\%-64.4\% in 2011). Psychiatrists in AAMC-compliant centers were slightly less likely to prescribe these antipsychotics compared with those in never-compliant centers (relative odds ratio, 0.95; 95\% CI, 0.94-0.97; P < 0.0001). Share of prescriptions for new/reformulated antipsychotics grew from 5.3\% in 2008 to 11.1\% in 2011. Psychiatrists in AAMC-compliant centers actually increased prescribing of new/reformulated antipsychotics relative to those in never-compliant centers (relative odds ratio, 1.39; 95\% CI, 1.35-1.44; P < 0.0001), a relative increase of 1.1\% in probability.

CONCLUSIONS: Psychiatrists exposed to strict conflict of interest policies prescribed heavily promoted antipsychotics at rates similar to academic psychiatrists and nonacademic psychiatrists exposed to less strict or no policies.},
	keywords = {Academic Medical Centers, Antipsychotic Agents, Conflict of Interest, Drug Utilization, Female, Humans, Male, Practice Patterns, Physicians{\textquoteright}, Psychiatry},
	issn = {1537-1948},
	doi = {10.1097/MLR.0000000000000329},
	author = {Anderson, Timothy S and Huskamp, Haiden A. and Epstein, Andrew J and Barry, Colleen L and Men, Aiju and Ernst R. Berndt and Horvitz-Lennon, Marcela and Normand, Sharon-Lise and Donohue, Julie M}
}
@article {608645,
	title = {The Atlantic Divide In Coronary Heart Disease: Health Technologies Use In The Us And Portugal},
	journal = {Value Health},
	volume = {18},
	number = {7},
	year = {2015},
	month = {2015 Nov},
	pages = {A402},
	issn = {1524-4733},
	doi = {10.1016/j.jval.2015.09.930},
	author = {Lobo, M F and Azzone, V and Melica, B and Bacelar-Nicolau, L and Nisa, C and Freitas, A and Azevedo, L F and Rocha-Gon{\c c}alves, F N and Resnic, F S and Teixeira-Pinto, A and Pereira-Miguel, J and Normand, S T and Costa-Pereira, A}
}
@article {516081,
	title = {Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks},
	journal = {JAMA},
	volume = {314},
	number = {16},
	year = {2015},
	month = {2015 Oct 27},
	pages = {1691-2},
	keywords = {Advisory Committees, Bioethical Issues, Electronic Health Records, Equipment and Supplies, Equipment Safety, Humans, Information Services, Internationality, Medical Device Legislation, Pilot Projects, Product Surveillance, Postmarketing, Registries},
	issn = {1538-3598},
	doi = {10.1001/jama.2015.11036},
	author = {Krucoff, Mitchell W and Sedrakyan, Art and Normand, Sharon-Lise T.}
}
@article {516076,
	title = {Comparative effectiveness of cardiac implantable electrical devices},
	journal = {Heart},
	volume = {101},
	number = {22},
	year = {2015},
	month = {2015 Nov},
	pages = {1773-5},
	keywords = {Defibrillators, Implantable, Female, Heart Failure, Humans, Male},
	issn = {1468-201X},
	doi = {10.1136/heartjnl-2015-308295},
	author = {Kramer, Daniel B and Hatfield, Laura A and Normand, Sharon-Lise T.}
}
@article {516171,
	title = {The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {8},
	number = {1},
	year = {2015},
	month = {2015 Jan},
	pages = {38-46},
	abstract = {BACKGROUND: Current approaches for postmarket medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates.

METHODS AND RESULTS: The Data Extraction and Longitudinal Trend Analysis (DELTA) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronary interventions. All adult patients undergoing percutaneous coronary intervention from January 2008 to December 2012 at 5 participating Massachusetts sites were included. A safety alert was triggered if the cumulative observed adverse event rates for the study device exceeded the upper 95\% confidence interval of the event rates of propensity-matched control cohort. Prespecified sensitivity analyses were developed to validate any identified safety signal. A total of 23,805 consecutive percutaneous coronary intervention procedures were evaluated. Two of 24 safety analyses triggered safety alerts. Patients receiving Perclose vascular closure device experienced an increased risk of minor vascular complications (relative risk, 4.14; P,
	keywords = {Drug-Eluting Stents, Embolic Protection Devices, Equipment Design, Equipment Safety, Humans, Logistic Models, Longitudinal Studies, Massachusetts, Multivariate Analysis, Patient Safety, Percutaneous Coronary Intervention, Product Surveillance, Postmarketing, Propensity Score, Prospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Vascular Closure Devices},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.114.001123},
	author = {Kumar, Amit and Matheny, Michael E and Ho, Kalon K L and Yeh, Robert W and Piemonte, Thomas C and Waldman, Howard and Shah, Pinak B and Cope, Richard and Normand, Sharon-Lise T. and Donnelly, Sharon and Robbins, Susan and Resnic, Frederic S}
}
@article {516151,
	title = {Drug-eluting stents versus bare metal stents prior to noncardiac surgery},
	journal = {Catheter Cardiovasc Interv},
	volume = {85},
	number = {4},
	year = {2015},
	month = {2015 Mar},
	pages = {533-41},
	abstract = {BACKGROUND: The safety of drug-eluting stents (DES) vs. bare metal stents (BMS) in the perioperative setting, a heightened state of inflammation and thrombosis is not well defined.

METHODS: All adults undergoing noncardiac surgical (NCS) procedures within 1 year following percutaneous coronary intervention (PCI) in Massachusetts between April 1, 2004, and September 30, 2007, were identified from an administrative claims database. Patients were divided into those who received BMS vs. DES at index PCI. Primary net clinical outcome was death, myocardial infarction (MI) or bleeding within 30 days of NCS. Primary clinical outcome was 30-day death or MI.

RESULTS: Among 8,415 (22\% BMS) patients that satisfied our inclusion criteria, 1,838 BMS patients were matched with 3,565 DES patients with similar propensity scores. In the DES cohort, the 30-day primary net clinical outcome rate was lower with longer time from PCI to NCS (P = 0.02) with lowest rates if NCS was performed after 90 days from PCI (event rate 8.57, 7.53, 5.21, and 5.75\% for 1-30, 31-90, 91-180, and 181-365 days from PCI to NCS). However, in the BMS cohort, the event rate was uniformly high regardless of the time from PCI to NCS (P = 0.60) (event rate 8.20, 6.56, 8.05, and 8.82\% for 1-30, 31-90, 91-180, and 181-365 days from PCI to NCS). There was no significant difference between DES and the BMS group for 30-day primary net clinical outcome (6.64 vs. 7.89\%; P = 0.10), but there was a 26\% lower odds of primary clinical outcome (OR = 0.74, 95\% CI 0.58-0.94) with DES when compared with BMS, driven mainly by differences in event rates when NCS was performed >90 days post PCI.

CONCLUSION: DES implantation was not associated with higher adverse events after NCS. Moreover, the incidence of adverse events following NCS was lower when NCS was performed >90 days post-DES implantation suggesting that it may not be necessary to wait until 12 months post PCI with DES before NCS.},
	keywords = {Aged, Databases, Factual, Drug-Eluting Stents, Female, Humans, Logistic Models, Male, Massachusetts, Metals, Multivariate Analysis, Myocardial Infarction, Odds Ratio, Percutaneous Coronary Intervention, Postoperative Hemorrhage, Propensity Score, Prosthesis Design, Risk Assessment, Risk Factors, Stents, Surgical Procedures, Operative, Time, Treatment Outcome},
	issn = {1522-726X},
	doi = {10.1002/ccd.25617},
	author = {Bangalore, Sripal and Silbaugh, Treacy S and Normand, Sharon-Lise T. and Lovett, Ann F and Welt, Frederick G P and Resnic, Frederic S}
}
@article {516111,
	title = {Enhancing the Prediction of 30-Day Readmission After Percutaneous Coronary Intervention Using Data Extracted by Querying of the Electronic Health Record},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {8},
	number = {5},
	year = {2015},
	month = {2015 Sep},
	pages = {477-85},
	abstract = {BACKGROUND: Early readmission after percutaneous coronary intervention is an important quality metric, but prediction models from registry data have only moderate discrimination. We aimed to improve ability to predict 30-day readmission after percutaneous coronary intervention from a previously validated registry-based model.

METHODS AND RESULTS: We matched readmitted to non-readmitted patients in a 1:2 ratio by risk of readmission, and extracted unstructured and unconventional structured data from the electronic medical record, including need for medical interpretation, albumin level, medical nonadherence, previous number of emergency department visits, atrial fibrillation/flutter, syncope/presyncope, end-stage liver disease, malignancy, and anxiety. We assessed differences in rates of these conditions between cases/controls, and estimated their independent association with 30-day readmission using logistic regression conditional on matched groups. Among 9288 percutaneous coronary interventions, we matched 888 readmitted with 1776 non-readmitted patients. In univariate analysis, cases and controls were significantly different with respect to interpreter (7.9\% for cases and 5.3\% for controls; P=0.009), emergency department visits (1.12 for cases and 0.77 for controls; P,
	keywords = {Aged, Electronic Health Records, Female, Follow-Up Studies, Humans, Incidence, Male, Myocardial Infarction, Patient Readmission, Percutaneous Coronary Intervention, Postoperative Complications, Quality Assurance, Health Care, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.115.001855},
	author = {Wasfy, Jason H and Singal, Gaurav and O{\textquoteright}Brien, Cashel and Blumenthal, Daniel M and Kennedy, Kevin F and Strom, Jordan B and Spertus, John A and Mauri, Laura and Normand, Sharon-Lise T. and Yeh, Robert W}
}
@article {516176,
	title = {Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {8},
	number = {1},
	year = {2015},
	month = {2015 Jan},
	pages = {96-102},
	abstract = {BACKGROUND: The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed.

METHODS AND RESULTS: Within the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2\%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2\% versus 42.6\%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease.

CONCLUSIONS: Within the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained.

CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.},
	keywords = {Aged, Comorbidity, Coronary Artery Disease, Drug Therapy, Combination, Drug-Eluting Stents, Female, Hospital Bed Capacity, Hospitals, Hospitals, High-Volume, Hospitals, Urban, Humans, Male, Middle Aged, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Registries, Research Design, Sex Factors, Treatment Outcome, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.114.001239},
	author = {Yeh, Robert W and Czarny, Matthew J and Normand, Sharon-Lise T. and Kereiakes, Dean J and Holmes, David R and Brindis, Ralph G and Weaver, W Douglas and Rumsfeld, John S and Roe, Matthew T and Kim, Sunghee and Driscoll-Shempp, Priscilla and Mauri, Laura}
}
@article {516136,
	title = {Hospital variation in carotid stenting outcomes},
	journal = {JACC Cardiovasc Interv},
	volume = {8},
	number = {6},
	year = {2015},
	month = {2015 May},
	pages = {858-63},
	abstract = {OBJECTIVES: The aim of this study was to examine variation in outcomes for patients receiving carotid artery stenting (CAS) across a sample of U.S. hospitals and assess the extent to which this variation was attributable to differences in case mix and procedural volume.

BACKGROUND: As CAS is increasingly being used throughout the United States, assessing hospital variation in CAS outcomes is critical to understanding and improving the quality of care for patients with carotid artery disease.

METHODS: Hospitals participating in the National Cardiovascular Data Registry-Carotid Artery Endarterectomy and Revascularization Registry contributing more than 5 CAS procedures from 2005 through 2013 were eligible for inclusion. We estimated unadjusted and risk-standardized rates of in-hospital stroke or death for each participating hospital using a previously validated prediction model and applying hospital-level random effects.

RESULTS: There were 188 hospitals contributing 19,381 CAS procedures during the period of interest. Unadjusted and risk-standardized in-hospital stroke or death rates ranged from 0\% to 18.8\% and 1.2\% to 4.7\%, respectively. Operator and hospital volumes were not significant predictors of outcomes after adjustment for case mix (p = 0.15 and p = 0.09, respectively).

CONCLUSIONS: CAS outcomes vary 4-fold among hospitals, even after adjustment for differences in case mix. Future work is needed to identify the sources of this variation and develop initiatives to improve patient outcomes.},
	keywords = {Aged, Aged, 80 and over, Angioplasty, Carotid Artery Diseases, Female, Hospital Mortality, Hospitals, High-Volume, Hospitals, Low-Volume, Humans, Male, Middle Aged, Practice Patterns, Physicians{\textquoteright}, Process Assessment (Health Care), Registries, Risk Assessment, Risk Factors, Stents, Stroke, Time Factors, Treatment Outcome, United States},
	issn = {1876-7605},
	doi = {10.1016/j.jcin.2015.01.026},
	author = {Hawkins, Beau M and Kennedy, Kevin F and Aronow, Herbert D and Nguyen, Louis L and White, Christopher J and Rosenfield, Kenneth and Normand, Sharon-Lise T. and Spertus, John A and Yeh, Robert W}
}
@article {516121,
	title = {Life Expectancy and Years of Potential Life Lost After Acute Myocardial Infarction by Sex and Race: A Cohort-Based Study of Medicare Beneficiaries},
	journal = {J Am Coll Cardiol},
	volume = {66},
	number = {6},
	year = {2015},
	month = {2015 Aug 11},
	pages = {645-55},
	abstract = {BACKGROUND: Most studies of sex and race differences after acute myocardial infarction (AMI) have not taken into account differences in life expectancy in the general population. Years of potential life lost (YPLL) is a metric that takes into account the burden of disease and can be compared by sex and race.

OBJECTIVES: This study sought to determine sex and race differences in long-term survival after AMI using life expectancy and YPLL to account for differences in population-based life expectancy.

METHODS: Using data from the Cooperative Cardiovascular Project, a prospective cohort study of Medicare beneficiaries hospitalized for AMI between 1994 and 1995 (N = 146,743), we calculated life expectancy and YPLL using Cox proportional hazards regression with extrapolation using exponential models.

RESULTS: Of the 146,743 patients with AMI, 48.1\% were women and 6.4\% were black; the average age was 75.9 years. Post-AMI life expectancy estimates were similar for men and women of the same race but lower for black patients than white patients. On average, women lost 10.5\% (SE 0.3\%) more of their expected life than men, and black patients lost 6.2\% (SE 0.6\%) more of their expected life than white patients. After adjustment, women still lost an average of 7.8\% (0.3\%) more of their expected life than men, but black race became associated with a survival advantage, suggesting that racial differences in YPLL were largely explained by differences in clinical presentation and treatment between black and white patients.

CONCLUSIONS: Women and black patients lost more years of life after AMI, on average, than men and white patients, an effect that was not explained in women by clinical or treatment differences.},
	keywords = {African Continental Ancestry Group, Aged, Aged, 80 and over, Cohort Studies, Continental Population Groups, European Continental Ancestry Group, Female, Humans, Life Expectancy, Male, Medicare, Myocardial Infarction, Prospective Studies, Sex Characteristics, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2015.06.022},
	author = {Bucholz, Emily M and Normand, Sharon-Lise T. and Wang, Yun and Ma, Shuangge and Lin, Haiqun and Krumholz,Harlan M.}
}
@article {516181,
	title = {Likelihood-Based Random-Effect Meta-Analysis of Binary Events},
	journal = {J Biopharm Stat},
	volume = {25},
	number = {5},
	year = {2015},
	month = {2015},
	pages = {984-1004},
	abstract = {Meta-analysis has been used extensively for evaluation of efficacy and safety of medical interventions. Its advantages and utilities are well known. However, recent studies have raised questions about the accuracy of the commonly used moment-based meta-analytic methods in general and for rare binary outcomes in particular. The issue is further complicated for studies with heterogeneous effect sizes. Likelihood-based mixed-effects modeling provides an alternative to moment-based methods such as inverse-variance weighted fixed- and random-effects estimators. In this article, we compare and contrast different mixed-effect modeling strategies in the context of meta-analysis. Their performance in estimation and testing of overall effect and heterogeneity are evaluated when combining results from studies with a binary outcome. Models that allow heterogeneity in both baseline rate and treatment effect across studies have low type I and type II error rates, and their estimates are the least biased among the models considered.},
	keywords = {Biomedical Research, Cardiovascular Agents, Chi-Square Distribution, Computer Simulation, Coronary Disease, Data Interpretation, Statistical, Diabetes Mellitus, Type 2, Diabetes, Gestational, Female, Humans, Likelihood Functions, Logistic Models, Meta-Analysis as Topic, Numerical Analysis, Computer-Assisted, Odds Ratio, Percutaneous Coronary Intervention, Pregnancy, Research Design, Risk Assessment, Risk Factors, Treatment Outcome},
	issn = {1520-5711},
	doi = {10.1080/10543406.2014.920348},
	author = {Amatya, Anup and Bhaumik, Dulal K and Normand, Sharon-Lise and Greenhouse, Joel and Kaizar, Eloise and Neelon, Brian and Gibbons, Robert D}
}
@article {516106,
	title = {Meta-analysis of rate ratios with differential follow-up by treatment arm: inferring comparative effectiveness of medical devices},
	journal = {Stat Med},
	volume = {34},
	number = {21},
	year = {2015},
	month = {2015 Sep 20},
	pages = {2913-25},
	abstract = {Modeling events requires accounting for differential follow-up duration, especially when combining randomized and observational studies. Although events occur at any point over a follow-up period and censoring occurs throughout, most applied researchers use odds ratios as association measures, assuming follow-up duration is similar across treatment groups. We derive the bias of the rate ratio when incorrectly assuming equal follow-up duration in the single study binary treatment setting. Simulations illustrate bias, efficiency, and coverage and demonstrate that bias and coverage worsen rapidly as the ratio of follow-up duration between arms moves away from one. Combining study rate ratios with hierarchical Poisson regression models, we examine bias and coverage for the overall rate ratio via simulation in three cases: when average arm-specific follow-up duration is available for all studies, some studies, and no study. In the null case, bias and coverage are poor when the study average follow-up is used and improve even if some arm-specific follow-up information is available. As the rate ratio gets further from the null, bias and coverage remain poor. We investigate the effectiveness of cardiac resynchronization therapy devices compared with those with cardioverter-defibrillator capacity where three of eight studies report arm-specific follow-up duration.},
	keywords = {Bias (Epidemiology), Cardiac Resynchronization Therapy Devices, Computer Simulation, Defibrillators, Implantable, Epidemiologic Methods, Equipment and Supplies, Follow-Up Studies, Humans, Meta-Analysis as Topic, Odds Ratio, Poisson Distribution, Regression Analysis},
	issn = {1097-0258},
	doi = {10.1002/sim.6530},
	author = {Kunz, Lauren M and Normand, Sharon-Lise T. and Sedrakyan, Art}
}
@article {516126,
	title = {Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013},
	journal = {JAMA},
	volume = {314},
	number = {4},
	year = {2015},
	month = {2015 Jul 28},
	pages = {355-65},
	abstract = {IMPORTANCE: In a period of dynamic change in health care technology, delivery, and behaviors, tracking trends in health and health care can provide a perspective on what is being achieved.

OBJECTIVE: To comprehensively describe national trends in mortality, hospitalizations, and expenditures in the Medicare fee-for-service population between 1999 and 2013.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional analysis of Medicare beneficiaries aged 65 years or older between 1999 and 2013 using Medicare denominator and inpatient files.

MAIN OUTCOMES AND MEASURES: For all Medicare beneficiaries, trends in all-cause mortality; for fee-for-service beneficiaries, trends in all-cause hospitalization and hospitalization-associated outcomes and expenditures. Geographic variation, stratified by key demographic groups, and changes in the intensity of care for fee-for-service beneficiaries in the last 1, 3, and 6 months of life were also assessed.

RESULTS: The sample consisted of 68,374,904 unique Medicare beneficiaries (fee-for-service and Medicare Advantage). All-cause mortality for all Medicare beneficiaries declined from 5.30\% in 1999 to 4.45\% in 2013 (difference, 0.85 percentage points; 95\% CI, 0.83-0.87). Among fee-for-service beneficiaries (n = 60,056,069), the total number of hospitalizations per 100,000 person-years decreased from 35,274 to 26,930 (difference, 8344; 95\% CI, 8315-8374). Mean inflation-adjusted inpatient expenditures per Medicare fee-for-service beneficiary declined from $3290 to $2801 (difference, $489; 95\% CI, $487-$490). Among fee-for-service beneficiaries in the last 6 months of life, the number of hospitalizations decreased from 131.1 to 102.9 per 100 deaths (difference, 28.2; 95\% CI, 27.9-28.4). The percentage of beneficiaries with 1 or more hospitalizations decreased from 70.5 to 56.8 per 100 deaths (difference, 13.7; 95\% CI, 13.5-13.8), while the inflation-adjusted inpatient expenditure per death increased from $15,312 in 1999 to $17,423 in 2009 and then decreased to $13,388 in 2013. Findings were consistent across geographic and demographic groups.

CONCLUSIONS AND RELEVANCE: Among Medicare fee-for-service beneficiaries aged 65 years or older, all-cause mortality rates, hospitalization rates, and expenditures per beneficiary decreased from 1999 to 2013. In the last 6 months of life, total hospitalizations and inpatient expenditures decreased in recent years.},
	keywords = {Aged, Cause of Death, Cross-Sectional Studies, Fee-for-Service Plans, Health Expenditures, Hospitalization, Humans, Inflation, Economic, Medicare, Medicare Part C, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2015.8035},
	author = {Krumholz,Harlan M. and Nuti, Sudhakar V and Downing, Nicholas S and Normand, Sharon-Lise T. and Wang, Yun}
}
@article {516131,
	title = {Patient Activity and Survival Following Implantable Cardioverter-Defibrillator Implantation: The ALTITUDE Activity Study},
	journal = {J Am Heart Assoc},
	volume = {4},
	number = {5},
	year = {2015},
	month = {2015 May 15},
	abstract = {BACKGROUND: Physical activity data are collected automatically by implantable cardioverter-defibrillators (ICDs). Though these data potentially provide a quantifiable and easily accessible measure of functional status, its relationship with survival has not been well studied.

METHODS AND RESULTS: Patients enrolled in the Boston Scientific LATITUDE remote monitoring system from 2008 to 2012 with ICDs were eligible. Remote monitoring data were used to calculate mean daily activity at baseline (30 to 60 days after implantation), and longitudinally. Cox regression was used to examine the association between survival and increments of 30 minutes/day in both (1) mean baseline activity and (2) time-varying activity, with both adjusted for demographic and device characteristics. A total of 98 437 patients were followed for a median of 2.2 years (mean age of 67.7{\textpm}13.1 years; 71.7\% male). Mean baseline daily activity was 107.5{\textpm}66.2 minutes/day. The proportion of patients surviving after 4 years was significantly higher among those in the most versus least active quintile of mean baseline activity (90.5\% vs. 50.0\%; log-rank P value, ,
	keywords = {Activities of Daily Living, Aged, Aged, 80 and over, Arrhythmias, Cardiac, Boston, Defibrillators, Implantable, Female, Follow-Up Studies, Humans, Longitudinal Studies, Male, Middle Aged, Motor Activity, Survival Analysis, Time Factors, Treatment Outcome},
	issn = {2047-9980},
	doi = {10.1161/JAHA.115.001775},
	author = {Kramer, Daniel B and Mitchell, Susan L and Monteiro, Joao and Jones, Paul W and Normand, Sharon-Lise and Hayes, David L and Reynolds, Matthew R}
}
@article {516156,
	title = {Population trends in rates of coronary revascularization},
	journal = {JAMA Intern Med},
	volume = {175},
	number = {3},
	year = {2015},
	month = {2015 Mar},
	pages = {454-6},
	keywords = {Cohort Studies, Coronary Artery Bypass, Humans, Massachusetts, Myocardial Infarction, Percutaneous Coronary Intervention, Retrospective Studies},
	issn = {2168-6114},
	doi = {10.1001/jamainternmed.2014.7129},
	author = {Yeh, Robert W and Mauri, Laura and Wolf, Robert E and Romm, Iyah K and Lovett, Ann and Shahian, David and Normand, Sharon-Lise}
}
@article {516086,
	title = {Race, Socioeconomic Status, and Life Expectancy After Acute Myocardial Infarction},
	journal = {Circulation},
	volume = {132},
	number = {14},
	year = {2015},
	month = {2015 Oct 06},
	pages = {1338-46},
	abstract = {BACKGROUND: Previous studies have been unable to disentangle the negative associations of black race and low socioeconomic status (SES) with long-term outcomes of patients after acute myocardial infarction (AMI). Such information could assist in efforts to address both racial and socioeconomic disparities.

METHODS AND RESULTS: We used data from the Cooperative Cardiovascular Project, a prospective cohort study of Medicare beneficiaries hospitalized with AMI with 17 years of follow-up, to evaluate the relationship between race, area-level SES (measured by zip code-level median household income), and life expectancy after AMI. Life expectancy was estimated by using Cox proportional hazards regression with extrapolation using exponential models. Of the 141 095 patients with AMI, 6.3\% were black and 6.8\% resided in low-SES areas; 26\% of black patients lived in low-SES areas in comparison with 5.7\% of white patients. Post-myocardial infarction life expectancy estimates were shorter for black patients than for white patients across all socioeconomic levels in patients <= 75 years of age. After adjustment for patient and treatment characteristics, the association between race and life expectancy persisted but was attenuated. Younger black patients (,
	keywords = {African Continental Ancestry Group, Age Factors, Aged, Aged, 80 and over, European Continental Ancestry Group, Female, Follow-Up Studies, Humans, Income, Life Expectancy, Male, Medicare, Myocardial Infarction, Patient Admission, Poverty, Proportional Hazards Models, Prospective Studies, Sampling Studies, Social Class, Socioeconomic Factors, Survival Rate, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.115.017009},
	author = {Bucholz, Emily M and Ma, Shuangge and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516146,
	title = {Relation between door-to-balloon times and mortality after primary percutaneous coronary intervention over time: a retrospective study},
	journal = {Lancet},
	volume = {385},
	number = {9973},
	year = {2015},
	month = {2015 Mar 21},
	pages = {1114-22},
	abstract = {BACKGROUND: Recent reductions in average door-to-balloon (D2B) times have not been associated with decreases in mortality at the population level. We investigated this seemingly paradoxical finding by assessing components of this association at the individual and population levels simultaneously. We postulated that the changing population of patients undergoing primary percutaneous coronary intervention (pPCI) contributed to secular trends toward an increasing mortality risk, despite consistently decreased mortality in individual patients with shorter D2B times.

METHODS: This was a retrospective study of ST-elevation myocardial infarction (STEMI) patients who underwent pPCI between Jan 1, 2005, and Dec 31, 2011, in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. We looked for catheterisation laboratory visits associated with STEMI. We excluded patients not undergoing pPCI, transfer patients for pPCI, patients with D2B times less than 15 min or more than 3 h, and patients at hospitals that did not consistently report data across the study period. We assessed in-hospital mortality in the entire cohort and 6-month mortality in elderly patients aged 65 years or older matched to data from the Centers for Medicare and Medicaid Services. We built multilevel models to assess the relation between D2B time and in-hospital and 6-month mortality, including both individual and population-level components of this association after adjusting for patient and procedural factors.

FINDINGS: 423 hospitals reported data on 150,116 procedures with a 55\% increase in the number of patients undergoing pPCI at these facilities over time, as well as many changes in patient and procedural factors. Annual D2B times decreased significantly from a median of 86 min (IQR 65-109) in 2005 to 63 min (IQR 47-80) in 2011 (p,
	keywords = {Aged, Angioplasty, Balloon, Coronary, Cohort Studies, Female, Hospital Mortality, Humans, Male, Middle Aged, Myocardial Infarction, Percutaneous Coronary Intervention, Registries, Retrospective Studies, Time-to-Treatment, United States},
	issn = {1474-547X},
	doi = {10.1016/S0140-6736(14)61932-2},
	author = {Nallamothu, Brahmajee K and Normand, Sharon-Lise T. and Wang, Yongfei and Hofer, Timothy P and Brush, John E and Messenger, John C and Bradley, Elizabeth H and Rumsfeld, John S and Krumholz,Harlan M.}
}
@article {516091,
	title = {The Society of Thoracic Surgeons Composite Measure of Individual Surgeon Performance for Adult Cardiac Surgery: A Report of The Society of Thoracic Surgeons Quality Measurement Task Force},
	journal = {Ann Thorac Surg},
	volume = {100},
	number = {4},
	year = {2015},
	month = {2015 Oct},
	pages = {1315-24; discussion 1324-5},
	abstract = {BACKGROUND: Previous composite performance measures of The Society of Thoracic Surgeons (STS) were estimated at the STS participant level, typically a hospital or group practice. The STS Quality Measurement Task Force has now developed a multiprocedural, multidimensional composite measure suitable for estimating the performance of individual surgeons.

METHODS: The development sample from the STS National Database included 621,489 isolated coronary artery bypass grafting procedures, isolated aortic valve replacement, aortic valve replacement plus coronary artery bypass grafting, mitral, or mitral plus coronary artery bypass grafting procedures performed by 2,286 surgeons between July 1, 2011, and June 30, 2014. Each surgeon{\textquoteright}s composite score combined their aggregate risk-adjusted mortality and major morbidity rates (each weighted inversely by their standard deviations) and reflected the proportion of case types they performed. Model parameters were estimated in a Bayesian framework. Composite star ratings were examined using 90\%, 95\%, or 98\% Bayesian credible intervals. Measure reliability was estimated using various 3-year case thresholds.

RESULTS: The final composite measure was defined as 0.81 {\texttimes} (1 minus risk-standardized mortality rate) + 0.19 {\texttimes} (1 minus risk-standardized complication rate). Risk-adjusted mortality (median, 2.3\%; interquartile range, 1.7\% to 3.0\%), morbidity (median, 13.7\%; interquartile range, 10.8\% to 17.1\%), and composite scores (median, 95.4\%; interquartile range, 94.4\% to 96.3\%) varied substantially across surgeons. Using 98\% Bayesian credible intervals, there were 207 1-star (lower performance) surgeons (9.1\%), 1,701 2-star (as-expected performance) surgeons (74.4\%), and 378 3-star (higher performance) surgeons (16.5\%). With an eligibility threshold of 100 cases over 3 years, measure reliability was 0.81.

CONCLUSIONS: The STS has developed a multiprocedural composite measure suitable for evaluating performance at the individual surgeon level.},
	keywords = {Adult, Bayes Theorem, Cardiac Surgical Procedures, Clinical Competence, Coronary Artery Bypass, Humans, Risk Adjustment, Societies, Medical},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2015.06.122},
	author = {Shahian, David M and He, Xia and Jacobs, Jeffrey P and Kurlansky, Paul A and Badhwar, Vinay and Cleveland, Joseph C and Fazzalari, Frank L and Filardo, Giovanni and Normand, Sharon-Lise T. and Furnary, Anthony P and Magee, Mitchell J and Rankin, J Scott and Welke, Karl F and Han, Jane and O{\textquoteright}Brien, Sean M}
}
@article {572936,
	title = {ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data},
	journal = {Lancet},
	volume = {385},
	number = {9966},
	year = {2015},
	month = {2015 01 31},
	pages = {441-51},
	abstract = {BACKGROUND: Despite the importance of ST-segment elevation myocardial infarction (STEMI) in China, no nationally representative studies have characterised the clinical profiles, management, and outcomes of this cardiac event during the past decade. We aimed to assess trends in characteristics, treatment, and outcomes for patients with STEMI in China between 2001 and 2011.

METHODS: In a retrospective analysis of hospital records, we used a two-stage random sampling design to create a nationally representative sample of patients in China admitted to hospital for STEMI in 3 years (2001, 2006, and 2011). In the first stage, we used a simple random-sampling procedure stratified by economic-geographical region to generate a list of participating hospitals. In the second stage we obtained case data for rates of STEMI, treatments, and baseline characteristics from patients attending each sampled hospital with a systematic sampling approach. We weighted our findings to estimate nationally representative rates and assess changes from 2001 to 2011. This study is registered with ClinicalTrials.gov, number NCT01624883.

FINDINGS: We sampled 175 hospitals (162 participated in the study) and 18,631 acute myocardial infarction admissions, of which 13,815 were STEMI admissions. 12,264 patients were included in analysis of treatments, procedures, and tests, and 11,986 were included in analysis of in-hospital outcomes. Between 2001 and 2011, estimated national rates of hospital admission for STEMI per 100,000 people increased (from 3{\textperiodcentered}5 in 2001, to 7{\textperiodcentered}9 in 2006, to 15{\textperiodcentered}4 in 2011; ptrend,
	keywords = {Aged, Aspirin, China, Female, Fibrinolytic Agents, Healthcare Disparities, Hospital Mortality, Hospitals, Rural, Hospitals, Urban, Humans, Male, Middle Aged, Myocardial Infarction, Myocardial Reperfusion, Patient Admission, Percutaneous Coronary Intervention, Quality of Health Care, Retrospective Studies, Ticlopidine, Treatment Outcome},
	issn = {1474-547X},
	doi = {10.1016/S0140-6736(14)60921-1},
	author = {Jing Li and Li, Xi and Wang, Qing and Hu, Shuang and Wang, Yongfei and Masoudi, Frederick A and Spertus, John A and Krumholz,Harlan M. and Jiang, Lixin}
}
@article {516116,
	title = {Thirty-Day Hospital Readmission for Medicaid Enrollees with Schizophrenia: The Role of Local Health Care Systems},
	journal = {J Ment Health Policy Econ},
	volume = {18},
	number = {3},
	year = {2015},
	month = {2015 Sep},
	pages = {115-24},
	abstract = {BACKGROUND: Examining health care system characteristics possibly associated with 30-day readmission may reveal opportunities to improve healthcare quality as well as reduce costs.

AIMS OF THE STUDY: Examine the relationship between 30-day mental health readmission for persons with schizophrenia and county-level community treatment characteristics.

METHODS: Observational study of 18 state Medicaid programs (N=274 counties, representing 103,967 enrollees with schizophrenia 28,083 of whom received more than 1 mental health hospitalization) using Medicaid administrative and United States Area Health Resource File data from 2005. Medicaid is a federal-state program and major health insurance provider for low income and disabled individuals, and the predominant provider of insurance for individuals with schizophrenia. The Area Health Resource File provides county-level estimates of providers. We first fit a regression model examining the relationship between 30-day mental health readmission and enrollee characteristics (e.g., demographics, substance use disorder [SUD], and general medical comorbidity) from which we created a county-level demographic and comorbidity case-mix adjuster. The case-mix adjuster was included in a second regression model examining the relationship between 30-day readmission and county-level factors: (i) quality (antipsychotic/visit continuity, post-hospital follow-up); (ii) mental health hospitalization (length of stay, admission rates); and (iii) treatment capacity (e.g., population-based estimates of outpatient providers/clinics). We calculated predicted probabilities of readmission for significant patient and county-level variables.

RESULTS: Higher county rates of mental health visits within 7-days post-hospitalization were associated with lower readmission probabilities (e.g., county rates of 7-day follow up of 55\% versus 85\%, readmission predicted probability (PP) [95\%CI]=16.1\% [15.8\%-16.4\%] versus 13.3\% [12.9\%-13.6\%]). In contrast, higher county rates of mental health hospitalization were associated with higher readmission probabilities (e.g., country admission rates 10\% versus 30\%, readmission predicted probability=11.3\% [11.0\%-11.6\%] versus 16.7\% [16.4\%-17.0\%]). Although not our primary focus, enrollee comorbidity was associated with higher predicted probability of 30-day mental health readmission: PP [95\%CI] for enrollees with SUD=23.9\% [21.5\%-26.3\%] versus 14.7\% [13.9\%-15.4\%] for those without; PP [95\% CI] for those with=three chronic medical conditions=25.1\% [22.1\%-28.2\%] versus none=17.7\% [16.3\%-19.1].

DISCUSSION: County rates of hospitalization and 7-day follow-up post hospital discharge were associated with readmission, along with patient SUD and general medical comorbidity. This observational design limits causal inference and utilization patterns may have changed since 2005. However, overall funding for U.S. Medicaid programs remained constant since 2005, reducing the likelihood significant changes. Last, our inability to identify community capacity variables associated with readmission may reflect imprecision of some variables as measured in the Area Health Resource File. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE AND FOR HEALTH POLICIES: Healthcare policy and programming to reduce 30-day mental health readmissions should focus on county-level factors that contribute to hospitalization in general and improving transitions to community care, as well as patient comorbidity.

IMPLICATIONS FOR FURTHER RESEARCH: Given the likely importance of local care systems, to reduce readmission future research is needed to refine community-level capacity variables that are associated with reduced readmissions; and to evaluate models of care coordination in this population.},
	keywords = {Health Services, Humans, Medicaid, Patient Readmission, Schizophrenia, United States},
	issn = {1091-4358},
	author = {Alisa B. Busch and Arnold M. Epstein and Thomas G. McGuire and Normand, Sharon-Lise T. and Richard G. Frank}
}
@article {516161,
	title = {Trajectories of risk after hospitalization for heart failure, acute myocardial infarction, or pneumonia: retrospective cohort study},
	journal = {BMJ},
	volume = {350},
	year = {2015},
	month = {2015 Feb 05},
	pages = {h411},
	abstract = {OBJECTIVE: To characterize the absolute risks for older patients of readmission to hospital and death in the year after hospitalization for heart failure, acute myocardial infarction, or pneumonia.

DESIGN: Retrospective cohort study.

SETTING: 4767 hospitals caring for Medicare fee for service beneficiaries in the United States, 2008-10.

PARTICIPANTS: More than 3 million Medicare fee for service beneficiaries, aged 65 years or more, surviving hospitalization for heart failure, acute myocardial infarction, or pneumonia.

MAIN OUTCOME MEASURES: Daily absolute risks of first readmission to hospital and death for one year after discharge. To illustrate risk trajectories, we identified the time required for risks of readmission to hospital and death to decline 50\% from maximum values after discharge; the time required for risks to approach plateau periods of minimal day to day change, defined as 95\% reductions in daily changes in risk from maximum daily declines after discharge; and the extent to which risks are higher among patients recently discharged from hospital compared with the general elderly population.

RESULTS: Within one year of hospital discharge, readmission to hospital and death, respectively, occurred following 67.4\% and 35.8\% of hospitalizations for heart failure, 49.9\% and 25.1\% for acute myocardial infarction, and 55.6\% and 31.1\% for pneumonia. Risk of first readmission had declined 50\% by day 38 after hospitalization for heart failure, day 13 after hospitalization for acute myocardial infarction, and day 25 after hospitalization for pneumonia; risk of death declined 50\% by day 11, 6, and 10, respectively. Daily change in risk of first readmission to hospital declined 95\% by day 45, 38, and 45; daily change in risk of death declined 95\% by day 21, 19, and 21. After hospitalization for heart failure, acute myocardial infarction, or pneumonia, the magnitude of the relative risk for hospital admission over the first 90 days was 8, 6, and 6 times greater than that of the general older population; the relative risk of death was 11, 8, and 10 times greater.

CONCLUSIONS: Risk declines slowly for older patients after hospitalization for heart failure, acute myocardial infarction, or pneumonia and is increased for months. Specific risk trajectories vary by discharge diagnosis and outcome. Patients should remain vigilant for deterioration in health for an extended time after discharge. Health providers can use knowledge of absolute risks and their changes over time to better align interventions designed to reduce adverse outcomes after discharge with the highest risk periods for patients.},
	keywords = {Aged, Aged, 80 and over, Fee-for-Service Plans, Heart Failure, Hospital Mortality, Hospitalization, Humans, Incidence, Male, Medicare, Myocardial Infarction, Pneumonia, Retrospective Studies, Risk Assessment, Survival Rate, United States},
	issn = {1756-1833},
	doi = {10.1136/bmj.h411},
	author = {Dharmarajan, Kumar and Hsieh, Angela F and Kulkarni, Vivek T and Lin, Zhenqiu and Ross, Joseph S and Horwitz, Leora I and Kim, Nancy and Suter, Lisa G and Lin, Haiqun and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516096,
	title = {Use of Remote Monitoring Is Associated With Lower Risk of Adverse Outcomes Among Patients With Implanted Cardiac Defibrillators},
	journal = {Circ Arrhythm Electrophysiol},
	volume = {8},
	number = {5},
	year = {2015},
	month = {2015 Oct},
	pages = {1173-80},
	abstract = {BACKGROUND: We examined the association between the use of remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICD) and all-cause mortality and rehospitalization among patients undergoing initial ICD implant.

METHODS AND RESULTS: A limited data set was constructed from Boston Scientific ALTITUDE Registry and National Cardiovascular Data Registry ICD Registry between January 2006 and March 2010. Vital status was determined using the Social Security Death Master File. All-cause mortality up to 3 years was compared in patients who used RPM with those who did not use RPM. Time-dependent frailty Cox models quantified the association between RPM use and all-cause mortality. Analyses were repeated in subgroups based on age, sex, race, ICD type, indication, and cardiomyopathy pathogenesis. Similar methodology examined the association between RPM use and all-cause rehospitalization in patients enrolled in Medicare fee-for-service patients >=65 years. The study cohort (n=37,742, age 67{\textpm}13, 72\% male) had a 3-year mortality of 20.9\% (median follow-up 832 days). In multivariable analyses, patients using RPM (n=22,023, 58\%) had lower risk of mortality compared with those not using RPM (hazard ratio 0.67, 95\% confidence interval 0.64-0.71, P,
	keywords = {Adult, Aged, Aged, 80 and over, Cardiomyopathies, Comorbidity, Death, Sudden, Cardiac, Defibrillators, Implantable, Electrocardiography, Ambulatory, Female, Humans, Male, Middle Aged, Patient Readmission, Registries, Risk Factors, Survival Analysis},
	issn = {1941-3084},
	doi = {10.1161/CIRCEP.114.003030},
	author = {Akar, Joseph G and Bao, Haikun and Jones, Paul W and Wang, Yongfei and Varosy, Paul D and Masoudi, Frederick A and Stein, Kenneth M and Saxon, Leslie A and Normand, Sharon-Lise T. and Curtis, Jeptha P}
}
@article {516166,
	title = {What is a performance outlier?},
	journal = {BMJ Qual Saf},
	volume = {24},
	number = {2},
	year = {2015},
	month = {2015 Feb},
	pages = {95-9},
	keywords = {Quality Assurance, Health Care, Quality Improvement},
	issn = {2044-5423},
	doi = {10.1136/bmjqs-2015-003934},
	author = {Shahian, David M and Normand, Sharon-Lise T.}
}
@article {516101,
	title = {Where You Live Matters: Quality and Racial/Ethnic Disparities in Schizophrenia Care in Four State Medicaid Programs},
	journal = {Health Serv Res},
	volume = {50},
	number = {5},
	year = {2015},
	month = {2015 Oct},
	pages = {1710-29},
	abstract = {OBJECTIVE: To determine whether (a) quality in schizophrenia care varies by race/ethnicity and over time and (b) these patterns differ across counties within states.

DATA SOURCES: Medicaid claims data from California, Florida, New York, and North Carolina during 2002-2008.

STUDY DESIGN: We studied black, Latino, and white Medicaid beneficiaries with schizophrenia. Hierarchical regression models, by state, quantified person and county effects of race/ethnicity and year on a composite quality measure, adjusting for person-level characteristics.

PRINCIPAL FINDINGS: Overall, our cohort included 164,014 person-years (41-61 percent non-whites), corresponding to 98,400 beneficiaries. Relative to whites, quality was lower for blacks in every state and also lower for Latinos except in North Carolina. Temporal improvements were observed in California and North Carolina only. Within each state, counties differed in quality and disparities. Between-county variation in the black disparity was larger than between-county variation in the Latino disparity in California, and smaller in North Carolina; Latino disparities did not vary by county in Florida. In every state, counties differed in annual changes in quality; by 2008, no county had narrowed the initial disparities.

CONCLUSIONS: For Medicaid beneficiaries living in the same state, quality and disparities in schizophrenia care are influenced by county of residence for reasons beyond patients{\textquoteright} characteristics.},
	keywords = {Adult, African Americans, Age Factors, Continental Population Groups, Ethnic Groups, European Continental Ancestry Group, Female, Health Status, Healthcare Disparities, Hispanic Americans, Humans, Male, Medicaid, Middle Aged, Quality of Health Care, Residence Characteristics, Schizophrenia, Sex Factors, Socioeconomic Factors, United States},
	issn = {1475-6773},
	doi = {10.1111/1475-6773.12296},
	author = {Horvitz-Lennon, Marcela and Volya, Rita and Garfield, Rachel and Donohue, Julie M and Lave, Judith R and Normand, Sharon-Lise T.}
}
@article {516231,
	title = {On the accuracy of classifying hospitals on their performance measures},
	journal = {Stat Med},
	volume = {33},
	number = {7},
	year = {2014},
	month = {2014 Mar 30},
	pages = {1081-103},
	abstract = {The evaluation, comparison, and public report of health care provider performance is essential to improving the quality of health care. Hospitals, as one type of provider, are often classified into quality tiers (e.g., top or suboptimal) based on their performance data for various purposes. However, potential misclassification might lead to detrimental effects for both consumers and payers. Although such risk has been highlighted by applied health services researchers, a systematic investigation of statistical approaches has been lacking. We assess and compare the expected accuracy of several commonly used classification methods: unadjusted hospital-level averages, shrinkage estimators under a random-effects model accommodating between-hospital variation, and two others based on posterior probabilities. Assuming that performance data follow a classic one-way random-effects model with unequal sample size per hospital, we derive accuracy formulae for these classification approaches and gain insight into how the misclassification might be affected by various factors such as reliability of the data, hospital-level sample size distribution, and cutoff values between quality tiers. The case of binary performance data is also explored using Monte Carlo simulation strategies. We apply the methods to real data and discuss the practical implications.},
	keywords = {Bayes Theorem, Computer Simulation, Humans, Models, Statistical, Outcome and Process Assessment (Health Care), Reproducibility of Results},
	issn = {1097-0258},
	doi = {10.1002/sim.6012},
	author = {Yulei He and Selck, Frederic and Normand, Sharon-Lise T.}
}
@article {516221,
	title = {Assessing incentives for service-level selection in private health insurance exchanges},
	journal = {J Health Econ},
	volume = {35},
	year = {2014},
	month = {2014 May},
	pages = {47-63},
	abstract = {Even with open enrollment and mandated purchase, incentives created by adverse selection may undermine the efficiency of service offerings by plans in the new health insurance Exchanges created by the Affordable Care Act. Using data on persons likely to participate in Exchanges drawn from five waves of the Medical Expenditure Panel Survey, we measure plan incentives in two ways. First, we construct predictive ratios, improving on current methods by taking into account the role of premiums in financing plans. Second, relying on an explicit model of plan profit maximization, we measure incentives based on the predictability and predictiveness of various medical diagnoses. Among the chronic diseases studied, plans have the greatest incentive to skimp on care for cancer, and mental health and substance abuse.},
	keywords = {Adult, Choice Behavior, Female, Forecasting, Health Insurance Exchanges, Health Status, Humans, Insurance Benefits, Male, Mental Health, Middle Aged, Models, Theoretical, Motivation, Regression Analysis, United States, Young Adult},
	issn = {1879-1646},
	doi = {10.1016/j.jhealeco.2014.01.009},
	author = {Thomas G. McGuire and Joseph P. Newhouse and Normand, Sharon-Lise and Shi, Julie and Zuvekas, Samuel}
}
@article {516241,
	title = {Causes of short-term readmission after percutaneous coronary intervention},
	journal = {Circ Cardiovasc Interv},
	volume = {7},
	number = {1},
	year = {2014},
	month = {2014 Feb},
	pages = {97-103},
	abstract = {BACKGROUND: Rehospitalization within 30 days after an admission for percutaneous coronary intervention (PCI) is common, costly, and a future target for Medicare penalties. Causes of readmission after PCI are largely unknown.

METHODS AND RESULTS: To illuminate the causes of PCI readmissions, patients with PCI readmitted within 30 days of discharge between 2007 and 2011 at 2 hospitals were identified, and their medical records were reviewed. Of 9288 PCIs, 9081 (97.8\%) were alive at the end of the index hospitalization. Of these, 893 patients (9.8\%) were readmitted within 30 days of discharge and included in the analysis. Among readmitted patients, 341 patients (38.1\%) were readmitted for evaluation of recurrent chest pain or other symptoms concerning for angina, whereas 59 patients (6.6\%) were readmitted for staged PCI without new symptoms. Complications of PCI accounted for 60 readmissions (6.7\%). For cases in which chest pain or other symptoms concerning for angina prompted the readmission, 21 patients (6.2\%) met criteria for myocardial infarction, and repeat PCI was performed in 54 patients (15.8\%). The majority of chest pain patients (288; 84.4\%) underwent >=1 diagnostic imaging test, most commonly coronary angiography, and only 9 (2.6\%) underwent target lesion revascularization.

CONCLUSIONS: After PCI, readmissions within 30 days were seldom related to PCI complications but often for recurrent chest pain. Readmissions with recurrent chest pain infrequently met criteria for myocardial infarction but were associated with high rates of diagnostic testing.},
	keywords = {Aged, Aged, 80 and over, Chest Pain, Coronary Angiography, Coronary Artery Disease, Female, Humans, Male, Medicare, Middle Aged, Myocardial Infarction, Myocardial Revascularization, Outcome Assessment (Health Care), Patient Readmission, Percutaneous Coronary Intervention, Postoperative Complications, Reoperation, Root Cause Analysis, Survival Analysis, Time Factors, United States},
	issn = {1941-7632},
	doi = {10.1161/CIRCINTERVENTIONS.113.000988},
	author = {Wasfy, Jason H and Strom, Jordan B and O{\textquoteright}Brien, Cashel and Zai, Adrian H and Luttrell, Jennifer and Kennedy, Kevin F and Spertus, John A and Zelevinsky, Katya and Normand, Sharon-Lise T. and Mauri, Laura and Yeh, Robert W}
}
@article {516196,
	title = {Clinical preventability of 30-day readmission after percutaneous coronary intervention},
	journal = {J Am Heart Assoc},
	volume = {3},
	number = {5},
	year = {2014},
	month = {2014 Sep 26},
	pages = {e001290},
	abstract = {BACKGROUND: Early readmission after PCI is an important contributor to healthcare expenditures and a target for performance measurement. The extent to which 30-day readmissions after PCI are preventable is unknown yet essential to minimizing their occurrence.

METHODS AND RESULTS: PCI patients readmitted to hospital at which PCI was performed within 30 days of discharge at the Massachusetts General Hospital and Brigham and Women{\textquoteright}s Hospital were identified, and their medical records were independently reviewed by 2 physicians. Each reviewer used an ordinal scale (0, not; 1, possibly; 2, probably; and 3, definitely preventable) to rate clinical preventability, and a total sum score >=2 was considered preventable. Characteristics of preventable and unpreventable readmissions were compared, and predictors of clinical preventability were assessed by using multivariate logistic regression. Of 9288 PCIs performed, 9081 (97.8\%) patients survived to initial hospital discharge and 1007 (11.1\%) were readmitted to the index hospital within 30 days. After excluding repeat readmissions, 893 readmissions were reviewed. Fair agreement between physician reviewers was observed (weighted κ statistic 0.44 [95\% CI 0.39 to 0.49]). After aggregation of scores, 380 (42.6\%) readmissions were deemed preventable and 513 (57.4\%) were deemed not preventable. Common causes of preventable readmissions included staged PCI without new symptoms (14.7\%), vascular/bleeding complications of PCI (10.0\%), and congestive heart failure (9.7\%).

CONCLUSIONS: Nearly half of 30-day readmissions after PCI may have been prevented by changes in clinical decision-making. Focusing on these readmissions may reduce readmission rates.},
	keywords = {Age Factors, Aged, Aged, 80 and over, Cohort Studies, Coronary Angiography, Coronary Disease, Cost-Benefit Analysis, Databases, Factual, Female, Health Care Costs, Humans, Male, Medicare, Middle Aged, Observer Variation, Patient Discharge, Patient Readmission, Percutaneous Coronary Intervention, Primary Prevention, Risk Assessment, Sex Factors, Survival Analysis, Time Factors, United States},
	issn = {2047-9980},
	doi = {10.1161/JAHA.114.001290},
	author = {Wasfy, Jason H and Strom, Jordan B and Waldo, Stephen W and O{\textquoteright}Brien, Cashel and Wimmer, Neil J and Zai, Adrian H and Luttrell, Jennifer and Spertus, John A and Kennedy, Kevin F and Normand, Sharon-Lise T. and Mauri, Laura and Yeh, Robert W}
}
@article {516261,
	title = {Comparing teaching versus nonteaching hospitals: the association of patient characteristics with teaching intensity for three common medical conditions},
	journal = {Acad Med},
	volume = {89},
	number = {1},
	year = {2014},
	month = {2014 Jan},
	pages = {94-106},
	abstract = {PURPOSE: To quantify the role of teaching hospitals in direct patient care, the authors compared characteristics of patients served by hospitals of varying teaching intensity.

METHOD: The authors studied Medicare beneficiaries >= 66 years old, hospitalized in 2009-2010 for acute myocardial infarction, heart failure, or pneumonia. They categorized hospitals as nonteaching, teaching, or Council of Teaching Hospitals and Health Systems (COTH) members and performed secondary analyses using intern and resident-to-bed ratios. The authors used descriptive statistics, adjusted odds ratios, and linear propensity scores to compare patient characteristics among teaching intensity levels. They supplemented Medicare mortality model variables with race, transfer status, and distance traveled.

RESULTS: Adjusted for comorbidities, black patients had 2.44 (95\% confidence interval [CI] 2.36-2.52), 2.56 (95\% CI 2.51-2.60), and 2.58 (95\% CI 2.51-2.65) times the odds of COTH hospital admission compared with white patients for acute myocardial infarction, heart failure, and pneumonia, respectively. For patients transferred from another hospital{\textquoteright}s inpatient setting, the corresponding adjusted odds ratios of COTH hospital admission were 3.99 (95\% CI 3.85-4.13), 4.60 (95\% CI 4.34-4.88), and 4.62 (95\% CI 4.16-5.12). Using national data, distributions of propensity scores (probability of admission to a COTH hospital) varied markedly among teaching intensity levels. Data from Massachusetts and California illustrated between-state heterogeneity in COTH utilization.

CONCLUSIONS: Major teaching hospitals are significantly more likely to provide care for minorities and patients requiring transfer from other institutions for advanced care.Both are essential to an equitable and high-quality regional health care system.},
	keywords = {Aged, Comorbidity, Female, Heart Failure, Hospitals, Hospitals, Teaching, Humans, Male, Medicare, Myocardial Infarction, Outcome Assessment (Health Care), Patient Admission, Patient Transfer, Pneumonia, Practice Patterns, Physicians{\textquoteright}, Propensity Score, United States},
	issn = {1938-808X},
	doi = {10.1097/ACM.0000000000000050},
	author = {Shahian, David M and Liu, Xiu and Meyer, Gregg S and Normand, Sharon-Lise T.}
}
@article {516216,
	title = {Developing an African youth psychosocial assessment: an application of item response theory},
	journal = {Int J Methods Psychiatr Res},
	volume = {23},
	number = {2},
	year = {2014},
	month = {2014 Jun},
	pages = {142-60},
	abstract = {This study aimed to refine a dimensional scale for measuring psychosocial adjustment in African youth using item response theory (IRT). A 60-item scale derived from qualitative data was administered to 667 war-affected adolescents (55\% female). Exploratory factor analysis (EFA) determined the dimensionality of items based on goodness-of-fit indices. Items with loadings less than 0.4 were dropped. Confirmatory factor analysis (CFA) was used to confirm the scale{\textquoteright}s dimensionality found under the EFA. Item discrimination and difficulty were estimated using a graded response model for each subscale using weighted least squares means and variances. Predictive validity was examined through correlations between IRT scores (θ) for each subscale and ratings of functional impairment. All models were assessed using goodness-of-fit and comparative fit indices. Fisher{\textquoteright}s Information curves examined item precision at different underlying ranges of each trait. Original scale items were optimized and reconfigured into an empirically-robust 41-item scale, the African Youth Psychosocial Assessment (AYPA). Refined subscales assess internalizing and externalizing problems, prosocial attitudes/behaviors and somatic complaints without medical cause. The AYPA is a refined dimensional assessment of emotional and behavioral problems in African youth with good psychometric properties. Validation studies in other cultures are recommended.},
	keywords = {Adolescent, Adolescent Behavior, Adolescent Development, Africa, Factor Analysis, Statistical, Female, Humans, Male, Models, Theoretical, Psychometrics, Surveys and Questionnaires},
	issn = {1557-0657},
	doi = {10.1002/mpr.1420},
	author = {Betancourt, Theresa S and Yang, Frances and Bolton, Paul and Normand, Sharon-Lise}
}
@article {516206,
	title = {Disparities in quality of care among publicly insured adults with schizophrenia in four large U.S. states, 2002-2008},
	journal = {Health Serv Res},
	volume = {49},
	number = {4},
	year = {2014},
	month = {2014 Aug},
	pages = {1121-44},
	abstract = {OBJECTIVE: To examine racial/ethnic disparities in quality of schizophrenia care and assess the size of observed disparities across states and over time.

DATA SOURCES: Medicaid claims data from CA, FL, NY, and NC.

STUDY DESIGN: Observational repeated cross-sectional panel cohort study of white, black, and Latino fee-for-service adult beneficiaries with schizophrenia. Main outcome was the relationship of race/ethnicity and year with a composite measure of quality of schizophrenia care derived from 14 evidence-based quality indicators.

PRINCIPAL FINDINGS: Quality was assessed for 325,373 twelve-month person-episodes between 2002 and 2008, corresponding to 123,496 Medicaid beneficiaries. In 2002, quality was lowest for blacks in all states. With the exception of FL, quality was lower for Latinos than whites. In CA, blacks had about 43 percent of the individual indicators met compared to 58 percent for whites. Quality improved annually for all groups in CA, NY, and NC. While in CA the improvement was slightly larger for Latinos, in FL quality improved for blacks but declined for Latinos and whites.

CONCLUSIONS: Quality of schizophrenia care is poor and racial/ethnic disparities exist among Medicaid beneficiaries from four states. The size of the disparities varied across the states, and most of the initial disparities were unchanged by 2008.},
	keywords = {Adult, African Americans, Cohort Studies, Cross-Sectional Studies, Episode of Care, European Continental Ancestry Group, Fee-for-Service Plans, Female, Healthcare Disparities, Hispanic Americans, Humans, Insurance Claim Review, Male, Medicaid, Middle Aged, Quality Indicators, Health Care, Quality of Health Care, Schizophrenia, United States},
	issn = {1475-6773},
	doi = {10.1111/1475-6773.12162},
	author = {Horvitz-Lennon, Marcela and Volya, Rita and Donohue, Julie M and Lave, Judith R and Stein, Bradley D and Normand, Sharon-Lise T.}
}
@article {516211,
	title = {Early results of Massachusetts healthcare reform on racial, ethnic, and socioeconomic disparities in cardiovascular care},
	journal = {Circulation},
	volume = {129},
	number = {24},
	year = {2014},
	month = {2014 Jun 17},
	pages = {2528-38},
	abstract = {BACKGROUND: Insured adults receive invasive cardiovascular procedures more frequently than uninsured adults. We examined the impact of healthcare reform in Massachusetts on use of coronary revascularization procedures and in-hospital and 1-year mortality by race/ethnicity, education, and sex.

METHODS AND RESULTS: Using hospital claims data, we compared differences in coronary revascularization rates (coronary artery bypass grafting or percutaneous coronary intervention) and in-hospital mortality by race/ethnicity, education, and sex among Massachusetts residents aged 21 to 64 years hospitalized with a principal discharge diagnosis of ischemic heart disease before (November 1, 2004, to July 31, 2006) and after (December 1, 2006, to September 30, 2008) reform; 1-year mortality was calculated for those undergoing revascularization. Adjusted logistic regression assessed 24 216 discharges before reform and 20 721 discharges after reform. Blacks had 30\% lower odds of receiving coronary revascularization than whites in the prereform period. Compared with whites in the postreform period, blacks (odds ratio=0.73; 95\% confidence interval, 0.63-0.84) and Hispanics (odds ratio= 0.84; 95\% confidence interval, 0.74-0.97) were less likely and Asians (odds ratio=1.29; 95\% confidence interval, 1.01-1.65) were more likely to receive coronary revascularization. Patients living in more educated communities, men, and persons with private insurance were more likely to receive coronary revascularization before and after reform. Compared with the prereform period, the adjusted odds of in-hospital mortality were higher in patients living in less-educated communities in the postreform period. No differences in 1-year mortality by race/ethnicity, education, or sex for revascularized patients were observed before or after reform.

CONCLUSIONS: Reducing insurance barriers to receipt of coronary revascularization procedures has not yet eliminated preexisting demographic and educational disparities in access to these procedures.},
	keywords = {Adult, Coronary Artery Bypass, Coronary Artery Disease, Educational Status, Ethnic Groups, Female, Health Care Reform, Healthcare Disparities, Hospital Mortality, Humans, Insurance, Health, Male, Massachusetts, Middle Aged, Percutaneous Coronary Intervention, Prevalence, Socioeconomic Factors, Young Adult},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.113.005231},
	author = {Albert, Michelle A and John Z. Ayanian and Silbaugh, Treacy S and Lovett, Ann and Resnic, Fred and Jacobs, Aryana and Normand, Sharon-Lise T.}
}
@article {516226,
	title = {Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study)},
	journal = {Am J Cardiol},
	volume = {113},
	number = {7},
	year = {2014},
	month = {2014 Apr 01},
	pages = {1146-52},
	abstract = {In randomized trials, low-dose (LD) and high-dose (HD) aspirin (ASA) are equally effective in reducing ischemic complications, but HD ASA is associated with an increased risk of bleeding in the setting of dual antiplatelet therapy after percutaneous coronary intervention (PCI). ASA dose after PCI varies across countries, but little is known about variation within the United States (US) and whether this variation can be explained by clinical characteristics of patients. We used enrollment data from the Dual Antiplatelet Therapy Study, a randomized trial designed to compare 12 versus 30~months of dual antiplatelet therapy after PCI, to quantify the variation in ASA dosing after PCI in the US subjects and assess the extent to which dose variability was attributable to patient characteristics. Of the 23,336 patients enrolled in the US, 28.0\% were prescribed LD ASA at discharge after PCI. Patient characteristics explained 1.6\% of total variance in ASA dose, whereas the study site accounted for 45.9\% of the unexplained variability. The median odds ratio comparing sites was 5.05 (95\% confidence interval 4.29 to 5.85), which was greater than any individual predictor of ASA dose. In conclusion, LD ASA after PCI in the US was used in a minority of patients, and heterogeneity in its selection was mainly influenced by the site of enrollment rather than patient characteristics. As HD ASA may be associated with adverse events in the setting of dual antiplatelet therapy, reducing local practice variation in the dose of ASA may be a target for quality improvement.},
	keywords = {Aspirin, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Postoperative Period, Pyridines, Retrospective Studies, Stents, Treatment Outcome},
	issn = {1879-1913},
	doi = {10.1016/j.amjcard.2013.10.015},
	author = {Matteau, Alexis and Yeh, Robert W and Kereiakes, Dean and Orav, E. John and Massaro, Joseph and Steg, P Gabriel and Normand, Sharon-Lise and Cutlip, Donald E and Mauri, Laura}
}
@article {516271,
	title = {Hospital teaching intensity and mortality for acute myocardial infarction, heart failure, and pneumonia},
	journal = {Med Care},
	volume = {52},
	number = {1},
	year = {2014},
	month = {2014 Jan},
	pages = {38-46},
	abstract = {BACKGROUND: Under the Affordable Care Act, health care reimbursement will increasingly be linked to quality and costs. In this environment, teaching hospitals will be closely scrutinized, as their care is often more expensive. Furthermore, although they serve vital roles in education, research, management of complex diseases, and care of vulnerable populations, debate continues as to whether teaching hospitals deliver better outcomes for common conditions.

OBJECTIVE: To determine the association between risk-standardized mortality and teaching intensity for 3 common conditions.

RESEARCH DESIGN: Using CMS models, 30-day risk-standardized mortality rates were compared among US hospitals classified as Council of Teaching Hospital (COTH) members, non-COTH teaching hospitals, or nonteaching hospitals. These analyses were repeated using ratios of interns and residents to beds to classify teaching intensity.

SUBJECTS: The study cohort included Medicare fee-for-service beneficiaries aged 66 years or older hospitalized in acute care hospitals during 2009-2010 for acute myocardial infarction (N = 342,145), heart failure (N = 647,081), or pneumonia (N = 598,366).

OUTCOME MEASURE: The 30-day risk-standardized mortality rates for each condition, stratified by teaching intensity.

RESULTS: For each diagnosis, compared with nonteaching hospitals there was a 10\% relative reduction in the adjusted odds of mortality for patients admitted to COTH hospitals and a 6\%-7\% relative reduction for patients admitted to non-COTH teaching hospitals. These findings were insensitive to the method of classifying teaching intensity and only partially explained by higher teaching hospital volumes.

CONCLUSIONS: Health care reimbursement strategies designed to increase value should consider not only the costs but also the superior clinical outcomes at teaching hospitals for certain common conditions.},
	keywords = {Aged, Aged, 80 and over, Female, Heart Failure, Hospital Mortality, Hospitals, Teaching, Humans, Internship and Residency, Male, Medicare, Myocardial Infarction, Patient Transfer, Pneumonia, United States},
	issn = {1537-1948},
	doi = {10.1097/MLR.0000000000000005},
	author = {Shahian, David M and Liu, Xiu and Meyer, Gregg S and Torchiana, David F and Normand, Sharon-Lise T.}
}
@article {516266,
	title = {Instrumental variable analysis to compare effectiveness of stents in the extremely elderly},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {7},
	number = {1},
	year = {2014},
	month = {2014 Jan},
	pages = {118-24},
	abstract = {BACKGROUND: Evaluating novel therapies is challenging in the extremely elderly. Instrumental variable methods identify variables associated with treatment allocation to perform adjusted comparisons that may overcome limitations of more traditional approaches.

METHODS AND RESULTS: Among all patients aged >=85 years undergoing percutaneous coronary intervention in nonfederal hospitals in Massachusetts between 2003 and 2009 (n=2690), we identified quarterly drug-eluting stent (DES) use rates as an instrumental variable. We estimated risk-adjusted differences in outcomes for DES versus bare metal stents using a 2-stage least squares instrumental variable analysis method. Quarterly DES use ranged from 15\% to 88\%. Unadjusted 1-year mortality rates were 14.5\% for DES versus 23.0\% for bare metal stents (risk difference, -8.5\%; P,
	keywords = {Acute Coronary Syndrome, Aged, 80 and over, Data Interpretation, Statistical, Drug-Eluting Stents, Female, Hemorrhage, Humans, Incidence, Male, Massachusetts, Metals, Percutaneous Coronary Intervention, Retrospective Studies, Stents, Survival Rate, Treatment Outcome},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.113.000476},
	author = {Yeh, Robert W and Vasaiwala, Samip and Forman, Daniel E and Silbaugh, Treacy S and Zelevinski, Katya and Lovett, Ann and Normand, Sharon-Lise T. and Mauri, Laura}
}
@article {516246,
	title = {Mortality risk following replacement implantable cardioverter-defibrillator implantation at end of battery life: results from the NCDR},
	journal = {Heart Rhythm},
	volume = {11},
	number = {2},
	year = {2014},
	month = {2014 Feb},
	pages = {216-21},
	abstract = {BACKGROUND: Implantable cardioverter-defibrillator (ICD) generator replacement at the end of expected battery life accounts for a substantial proportion of all ICD implant procedures. However, little is known about the predictors of mortality following ICD generator replacement.

OBJECTIVE: The purpose of this study was to identify clinical and procedural factors associated with death following ICD generator replacement.

METHODS: Patients from the National Cardiovascular Data Registry (NCDR) ICD Registry receiving ICD generator replacements at the end of device battery life between January 1, 2005, and March 30, 2010, were eligible. Predictors of mortality were determined using multivariable Cox regression.

RESULTS: Analysis of 111,826 patients (mean age 70.7 {\textpm} 12.4, 75.5\% male) revealed 1-, 3-, and 5-year mortality of 9.8\%, 27.0\%, and 41.2\%, respectively. After adjustment, atrial fibrillation (hazard ratio [HR] 1.23, 95\% confidence interval [CI] 1.20-1.27) and congestive heart failure (HR 1.21, 95\% CI 1.16-1.27) predicted worse survival. In addition to older age (HR 1.43, 95\% CI 1.41-1.45), several noncardiac conditions were also associated with poorer survival, including chronic lung disease (HR 1.53, 95\% CI 1.49-1.57), cerebrovascular disease (HR 1.28, 95\% CI 1.24-1.32), diabetes (HR 1.27, 95\% CI 1.23-1.30), and lower glomerular filtration rate (HR 1.15 for each 10-unit increment decline, 95\% CI 1.14-1.16). In the absence of a non-ICD control group, risk reduction provided by ICD therapy in this cohort is not known.

CONCLUSION: In addition to age, atrial fibrillation, and congestive heart failure, noncardiac comorbidities are associated with higher mortality following ICD replacement, which should be considered in the decision to undergo this procedure.},
	keywords = {Aged, Comorbidity, Defibrillators, Implantable, Female, Heart Failure, Humans, Male, Prospective Studies, Regression Analysis},
	issn = {1556-3871},
	doi = {10.1016/j.hrthm.2013.10.046},
	author = {Kramer, Daniel B and Kennedy, Kevin F and Spertus, John A and Normand, Sharon-Lise and Noseworthy, Peter A and Buxton, Alfred E and Josephson, Mark E and Zimetbaum, Peter J and Mitchell, Susan L and Reynolds, Matthew R}
}
@article {516191,
	title = {"Phenotyping" hospital value of care for patients with heart failure},
	journal = {Health Serv Res},
	volume = {49},
	number = {6},
	year = {2014},
	month = {2014 Dec},
	pages = {2000-16},
	abstract = {OBJECTIVE: To characterize hospitals based on patterns of their combined financial and clinical outcomes for heart failure hospitalizations longitudinally.

DATA SOURCE: Detailed cost and administrative data on hospitalizations for heart failure from 424 hospitals in the 2005-2011 Premier database.

STUDY DESIGN: Using a mixture modeling approach, we identified groups of hospitals with distinct joint trajectories of risk-standardized cost (RSC) per hospitalization and risk-standardized in-hospital mortality rate (RSMR), and assessed hospital characteristics associated with the distinct patterns using multinomial logistic regression.

PRINCIPAL FINDINGS: During 2005-2011, mean hospital RSC decreased from $12,003 to $10,782, while mean hospital RSMR declined from 3.9 to 3.2 percent. We identified five distinct hospital patterns: highest cost and low mortality (3.2 percent of the hospitals), high cost and low mortality (20.4 percent), medium cost and low mortality (34.6 percent), medium cost and high mortality (6.2 percent), and low cost and low mortality (35.6 percent). Longer hospital stay and greater use of intensive care unit and surgical procedures were associated with phenotypes with higher costs or greater mortality.

CONCLUSIONS: Hospitals vary substantially in the joint longitudinal patterns of cost and mortality, suggesting marked difference in value of care. Understanding determinants of the variation will inform strategies for improving the value of hospital care.},
	keywords = {Costs and Cost Analysis, Economics, Hospital, Heart Failure, Hospital Mortality, Hospitalization, Hospitals, Humans, Quality of Health Care},
	issn = {1475-6773},
	doi = {10.1111/1475-6773.12197},
	author = {Xu, Xiao and Li, Shu-Xia and Lin, Haiqun and Normand, Sharon-Lise T. and Kim, Nancy and Ott, Lesli S and Lagu, Tara and Duan, Michael and Kroch, Eugene A and Krumholz,Harlan M.}
}
@article {516236,
	title = {Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention},
	journal = {BMJ Open},
	volume = {4},
	number = {3},
	year = {2014},
	month = {2014 Mar 07},
	pages = {e004595},
	abstract = {INTRODUCTION: During the past decade, the volume of percutaneous coronary intervention (PCI) in China has risen by more than 20-fold. Yet little is known about patterns of care and outcomes across hospitals, regions and time during this period of rising cardiovascular disease and dynamic change in the Chinese healthcare system.

METHODS AND ANALYSIS: Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, the Retrospective Study of Coronary Catheterisation and Percutaneous Coronary Intervention (China PEACE-Retrospective CathPCI Study) will examine a nationally representative sample of 11 900 patients who underwent coronary catheterisation or PCI at 55 Chinese hospitals during 2001, 2006 and 2011. We selected patients and study sites using a two-stage cluster sampling design with simple random sampling stratified within economical-geographical strata. A central coordinating centre will monitor data quality at the stages of case ascertainment, medical record abstraction and data management. We will examine patient characteristics, diagnostic testing patterns, procedural treatments and in-hospital outcomes, including death, complications of treatment and costs of hospitalisation. We will additionally characterise variation in treatments and outcomes by patient characteristics, hospital, region and study year.

ETHICS AND DISSEMINATION: The China PEACE collaboration is designed to translate research into improved care for patients. The study protocol was approved by the central ethics committee at the China National Center for Cardiovascular Diseases (NCCD) and collaborating hospitals. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of coronary catheterisation and PCI in China.

REGISTRATION DETAILS: http://www.clinicaltrials.gov (NCT01624896).},
	keywords = {Cardiac Catheterization, Cardiovascular Diseases, China, Clinical Protocols, Female, Hospitals, Humans, Patient Outcome Assessment, Patient-Centered Care, Percutaneous Coronary Intervention, Quality Improvement, Retrospective Studies},
	issn = {2044-6055},
	doi = {10.1136/bmjopen-2013-004595},
	author = {Jing Li and Dharmarajan, Kumar and Li, Xi and Lin, Zhenqiu and Normand, Sharon-Lise T. and Krumholz,Harlan M. and Jiang, Lixin}
}
@article {516256,
	title = {Response to letters regarding article, "Bayesian methods affirm the use of percutaneous coronary intervention to improve survival in patients with unprotected left main coronary artery disease"},
	journal = {Circulation},
	volume = {129},
	number = {4},
	year = {2014},
	month = {2014 Jan 28},
	pages = {e309},
	keywords = {Coronary Artery Bypass, Coronary Artery Disease, Female, Humans, Male, Percutaneous Coronary Intervention, Stents},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.113.007266},
	author = {Bittl, John A and Yulei He and Jacobs, Alice K and Yancy, Clyde W and Normand, Sharon-Lise T.}
}
@article {516251,
	title = {Transfer rates from nonprocedure hospitals after initial admission and outcomes among elderly patients with acute myocardial infarction},
	journal = {JAMA Intern Med},
	volume = {174},
	number = {2},
	year = {2014},
	month = {2014 Feb 01},
	pages = {213-22},
	abstract = {IMPORTANCE: It is unknown whether hospital transfer rates for patients with acute myocardial infarction admitted to nonprocedure hospitals (facilities that do not provide catheterization) vary and whether these rates further influence revascularization rates, length of stay, and mortality.

OBJECTIVES: To examine hospital differences in transfer rates for elderly patients with acute myocardial infarction across nonprocedure hospitals and to determine whether these rates are associated with revascularization rates, length of stay, and mortality.

DESIGN, SETTING, AND PARTICIPANTS: We used Medicare claims data from January 1, 2006, to December 31, 2008, to assess transfer rates in nonprocedure hospitals, stratified according to transfer rates as low (<= 20\%), mid-low (>20\%-30\%), mid-high (>30\%-40\%), or high (>40\%). Data were analyzed for 55,962 Medicare fee-for-service patients admitted to 901 nonprocedure US hospitals with more than 25 admissions per year for acute myocardial infarction.

MAIN OUTCOMES AND MEASURES: We compared rates of catheterization, percutaneous coronary intervention, and coronary artery bypass graft surgery during hospitalization and within 60 days, as well as hospital total length of stay, across groups. We measured risk-standardized mortality rates at 30 days and 1 year. RESULTS The median transfer rate was 29.4\% (interquartile range [25th-75th percentile], 21.8\%-37.8\%). Higher transfer rates were associated with higher rates of catheterization (P ,
	keywords = {Aged, Fee-for-Service Plans, Female, Hospital Mortality, Hospitals, Special, Humans, Male, Medicare, Myocardial Infarction, Myocardial Revascularization, Patient Admission, Patient Transfer, Survival Rate, United States},
	issn = {2168-6114},
	doi = {10.1001/jamainternmed.2013.11944},
	author = {Barreto-Filho, Jos{\'e} Augusto and Wang, Yongfei and Rathore, Saif S and Spatz, Erica S and Ross, Joseph S and Curtis, Jeptha P and Nallamothu, Brahmajee K and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516201,
	title = {Trends in hospitalizations and outcomes for acute cardiovascular disease and stroke, 1999-2011},
	journal = {Circulation},
	volume = {130},
	number = {12},
	year = {2014},
	month = {2014 Sep 16},
	pages = {966-75},
	abstract = {BACKGROUND: During the past decade, efforts focused intensely on improving the quality of care for people with, or at risk for, cardiovascular disease and stroke. We sought to quantify the changes in hospitalization rates and outcomes during this period.

METHODS AND RESULTS: We used national Medicare data to identify all Fee-for-Service patients >=65 years of age who were hospitalized with unstable angina, myocardial infarction, heart failure, ischemic stroke, and all other conditions from 1999 through 2011 (2010 for 1-year mortality). For each condition, we examined trends in adjusted rates of hospitalization per patient-year and, for each hospitalization, rates of 30-day mortality, 30-day readmission, and 1-year mortality overall and by demographic subgroups and regions. Rates of adjusted hospitalization declined for cardiovascular conditions (38.0\% for 2011 compared with 1999 [95\% confidence interval (CI), 37.2-38.8] for myocardial infarction, 83.8\% [95\% CI, 83.3-84.4] for unstable angina, 30.5\% [95\% CI, 29.3-31.6] for heart failure, and 33.6\% [95\% CI, 32.9-34.4] for ischemic stroke compared with 10.2\% [95\% CI, 10.1-10.2] for all other conditions). Adjusted 30-day mortality rates declined 29.4\% (95\% CI, 28.1-30.6) for myocardial infarction, 13.1\% (95\% CI, 1.1-23.7) for unstable angina, 16.4\% (95\% CI, 15.1-17.7) for heart failure, and 4.7\% (95\% CI, 3.0-6.4) for ischemic stroke. There were also reductions in rates of 1-year mortality and 30-day readmission and consistency in declines among the demographic subgroups.

CONCLUSIONS: Hospitalizations for acute cardiovascular disease and stroke from 1999 through 2011 declined more rapidly than for other conditions. For these conditions, mortality and readmission outcomes improved.},
	keywords = {Acute Disease, Aged, Aged, 80 and over, Cardiovascular Diseases, Fee-for-Service Plans, Female, Hospitalization, Humans, Male, Patient Readmission, Stroke, Time Factors},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.113.007787},
	author = {Krumholz,Harlan M. and Normand, Sharon-Lise T. and Wang, Yun}
}
@article {516186,
	title = {Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents},
	journal = {N Engl J Med},
	volume = {371},
	number = {23},
	year = {2014},
	month = {2014 Dec 04},
	pages = {2155-66},
	abstract = {BACKGROUND: Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain.

METHODS: Patients were enrolled after they had undergone a coronary stent procedure in which a drug-eluting stent was placed. After 12 months of treatment with a thienopyridine drug (clopidogrel or prasugrel) and aspirin, patients were randomly assigned to continue receiving thienopyridine treatment or to receive placebo for another 18 months; all patients continued receiving aspirin. The coprimary efficacy end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) during the period from 12 to 30 months. The primary safety end point was moderate or severe bleeding.

RESULTS: A total of 9961 patients were randomly assigned to continue thienopyridine treatment or to receive placebo. Continued treatment with thienopyridine, as compared with placebo, reduced the rates of stent thrombosis (0.4\% vs. 1.4\%; hazard ratio, 0.29 [95\% confidence interval {CI}, 0.17 to 0.48]; P,
	keywords = {Aged, Aspirin, Drug Administration Schedule, Drug Therapy, Combination, Drug-Eluting Stents, Female, Hemorrhage, Humans, Incidence, Male, Middle Aged, Myocardial Ischemia, Piperazines, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Thiophenes, Thrombosis, Ticlopidine, Time Factors},
	issn = {1533-4406},
	doi = {10.1056/NEJMoa1409312},
	author = {Mauri, Laura and Kereiakes, Dean J and Yeh, Robert W and Driscoll-Shempp, Priscilla and Cutlip, Donald E and Steg, P Gabriel and Normand, Sharon-Lise T. and Braunwald, Eugene and Wiviott, Stephen D and Cohen, David J and Holmes, David R and Krucoff, Mitchell W and Hermiller, James and Dauerman, Harold L and Simon, Daniel I and Kandzari, David E and Garratt, Kirk N and Lee, David P and Pow, Thomas K and Ver Lee, Peter and Rinaldi, Michael J and Massaro, Joseph M}
}
@article {516346,
	title = {ACCF/AHA clinical practice guideline methodology summit report: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines},
	journal = {Circulation},
	volume = {127},
	number = {2},
	year = {2013},
	month = {2013 Jan 15},
	pages = {268-310},
	keywords = {American Heart Association, Cardiology, Cardiovascular Diseases, Evidence-Based Medicine, Humans, Practice Guidelines as Topic, United States},
	issn = {1524-4539},
	doi = {10.1161/CIR.0b013e31827e8e5f},
	author = {Jacobs, Alice K and Kushner, Frederick G and Ettinger, Steven M and Guyton, Robert A and Anderson, Jeffrey L and Ohman, E Magnus and Albert, Nancy M and Antman, Elliott M. and Arnett, Donna K and Bertolet, Marnie and Bhatt, Deepak L and Brindis, Ralph G and Creager, Mark A and DeMets, David L and Dickersin, Kay and Fonarow, Gregg C and Gibbons, Raymond J and Halperin, Jonathan L and Hochman, Judith S and Koster, Marguerite A and Normand, Sharon-Lise T. and Ortiz, Eduardo and Peterson, Eric D and Roach, William H and Sacco, Ralph L and Smith, Sidney C and Stevenson, William G and Tomaselli, Gordon F and Yancy, Clyde W and Zoghbi, William A}
}
@article {516351,
	title = {ACCF/AHA clinical practice guideline methodology summit report: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines},
	journal = {J Am Coll Cardiol},
	volume = {61},
	number = {2},
	year = {2013},
	month = {2013 Jan 15},
	pages = {213-65},
	keywords = {American Heart Association, Cardiology, Cardiovascular Diseases, Diagnostic Techniques, Cardiovascular, Evidence-Based Medicine, Foundations, Humans, Peer Review, Practice Guidelines as Topic, Quality Assurance, Health Care, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2012.09.025},
	author = {Jacobs, Alice K and Kushner, Frederick G and Ettinger, Steven M and Guyton, Robert A and Anderson, Jeffrey L and Ohman, E Magnus and Albert, Nancy M and Antman, Elliott M. and Arnett, Donna K and Bertolet, Marnie and Bhatt, Deepak L and Brindis, Ralph G and Creager, Mark A and DeMets, David L and Dickersin, Kay and Fonarow, Gregg C and Gibbons, Raymond J and Halperin, Jonathan L and Hochman, Judith S and Koster, Marguerite A and Normand, Sharon-Lise T. and Ortiz, Eduardo and Peterson, Eric D and Roach, William H and Sacco, Ralph L and Smith, Sidney C and Stevenson, William G and Tomaselli, Gordon F and Yancy, Clyde W and Zoghbi, William A and Harold, John G and Yulei He and Mangu, Pamela B and Qaseem, Amir and Sayre, Michael R and Somerfield, Mark R}
}
@article {516306,
	title = {Association of single- vs dual-chamber ICDs with mortality, readmissions, and complications among patients receiving an ICD for primary prevention},
	journal = {JAMA},
	volume = {309},
	number = {19},
	year = {2013},
	month = {2013 May 15},
	pages = {2025-34},
	abstract = {IMPORTANCE: Randomized trials of implantable cardioverter-defibrillators (ICDs) for primary prevention predominantly used single-chamber devices. In clinical practice, patients often receive dual-chamber ICDs, even without clear indications for pacing. The outcomes of dual- vs single-chamber devices are uncertain.

OBJECTIVE: To compare outcomes of single- and dual-chamber ICDs for primary prevention of sudden cardiac death.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of admissions in the National Cardiovascular Data Registry{\textquoteright}s (NCDR) ICD registry from 2006-2009 that could be linked to Centers for Medicare \& Medicaid Services fee-for-service Medicare claims data. Patients were included if they received an ICD for primary prevention and did not have a documented indication for pacing.

MAIN OUTCOMES AND MEASURES: Adjusted risks of 1-year mortality, all-cause readmission, heart failure readmission, and device-related complications within 90 days were estimated with propensity-score matching based on patient, clinician, and hospital factors.

RESULTS: Among 32,034 patients, 12,246 (38\%) received a single-chamber device and 19,788 (62\%) received a dual-chamber device. In a propensity-matched cohort, rates of complications were lower for single-chamber devices (3.51\% vs 4.72\%; P < .001; risk difference, -1.20 [95\% CI, -1.72 to -0.69]), but device type was not significantly associated with 1-year mortality (unadjusted rate, 9.85\% vs 9.77\%; hazard ratio [HR], 0.99 [95\% CI, 0.91 to 1.07]; P = .79), 1-year all-cause hospitalization (unadjusted rate, 43.86\% vs 44.83\%; HR, 1.00 [95\% CI, 0.97-1.04]; P = .82), or hospitalization for heart failure (unadjusted rate, 14.73\% vs 15.38\%; HR, 1.05 [95\% CI, 0.99-1.12]; P = .19).

CONCLUSIONS AND RELEVANCE: Among patients receiving an ICD for primary prevention without indications for pacing, the use of a dual-chamber device compared with a single-chamber device was associated with a higher risk of device-related complications and similar 1-year mortality and hospitalization outcomes. Reasons for preferentially using dual-chamber ICDs in this setting remains unclear.},
	keywords = {Aged, Cohort Studies, Death, Sudden, Cardiac, Decision Making, Defibrillators, Implantable, Equipment Design, Female, Heart Failure, Humans, Male, Mortality, Patient Readmission, Primary Prevention, Registries, Retrospective Studies, Risk, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2013.4982},
	author = {Peterson, Pamela N and Varosy, Paul D and Heidenreich, Paul A and Wang, Yongfei and Dewland, Thomas A and Curtis, Jeptha P and Go, Alan S and Greenlee, Robert T and Magid, David J and Normand, Sharon-Lise T. and Masoudi, Frederick A}
}
@article {516301,
	title = {Bayesian methods affirm the use of percutaneous coronary intervention to improve survival in patients with unprotected left main coronary artery disease},
	journal = {Circulation},
	volume = {127},
	number = {22},
	year = {2013},
	month = {2013 Jun 04},
	pages = {2177-85},
	abstract = {BACKGROUND: Several randomized clinical trials support the use of coronary artery bypass grafting (CABG) for patients with unprotected left main coronary artery disease. Studies suggesting the equivalence of percutaneous coronary intervention (PCI) with CABG for this indication indirectly support the 2011 American College of Cardiology Foundation/American Heart Association Class IIa recommendation for PCI to improve survival in patients with unprotected left main coronary artery disease. We tested whether bayesian approaches uphold the new recommendation.

METHODS AND RESULTS: We performed a bayesian cross-design and network meta-analysis of 12 studies (4 randomized clinical trials and 8 observational studies) comparing CABG with PCI (n=4574 patients) and of 7 studies (2 randomized clinical trials and 5 observational studies) comparing CABG with medical therapy (n=3224 patients). The odds ratios of 1-year mortality after PCI compared with CABG using bayesian cross-design meta-analysis were not different among randomized clinical trials (odds ratio, 0.99; 95\% bayesian credible interval, 0.67-1.43), matched cohort studies (odds ratio, 1.10; 95\% bayesian credible interval, 0.76-1.73), and other types of cohort studies (odds ratio, 0.93; 95\% bayesian credible interval, 0.58-1.35). A network meta-analysis suggested that medical therapy is associated with higher 1-year mortality than the use of PCI for patients with unprotected left main coronary artery disease (odds ratio, 3.22; 95\% bayesian credible interval, 1.96-5.30).

CONCLUSIONS: Bayesian methods support the current guidelines, which were based on traditional statistical methods and have proposed that PCI, like CABG, improves survival for patients with unprotected left main coronary artery disease compared with medical therapy. An integrated approach using both direct and indirect evidence may yield new insights to enhance the translation of clinical trial data into practice.},
	keywords = {Aged, Bayes Theorem, Coronary Artery Bypass, Coronary Artery Disease, Female, Follow-Up Studies, Humans, Male, Middle Aged, Observation, Odds Ratio, Percutaneous Coronary Intervention, Practice Guidelines as Topic, Randomized Controlled Trials as Topic, Stents},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.112.000646},
	author = {Bittl, John A and Yulei He and Jacobs, Alice K and Yancy, Clyde W and Normand, Sharon-Lise T.}
}
@article {516296,
	title = {Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {6},
	number = {4},
	year = {2013},
	month = {2013 Jul},
	pages = {488-97},
	abstract = {BACKGROUND: Little is known about the clinical features, procedural risks, or survival of patients receiving replacement versus new implantable cardioverter-defibrillators (ICDs).

METHODS AND RESULTS: Entries in the National Cardiovascular Data Registry (NCDR) ICD Registry from 2005 through 2010 were eligible for inclusion (n=463,978). Baseline demographic data, clinical information, and procedural variables were compared between patients receiving new (n=359,993; 77.6\%) and replacement (n=103,985; 22.4\%) ICDs and entered into a propensity match model to determine adjusted survival rates. Patients receiving replacement ICDs were older (70.7 versus 67.5 years of age) and more likely to have atrial fibrillation (41.8\% versus 31.4\%; P,
	keywords = {Age Factors, Aged, Aged, 80 and over, Arrhythmias, Cardiac, Death, Sudden, Cardiac, Defibrillators, Implantable, Device Removal, Electric Countershock, Female, Humans, Kaplan-Meier Estimate, Logistic Models, Male, Middle Aged, Propensity Score, Prosthesis Failure, Registries, Risk Factors, Time Factors, Treatment Outcome, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.111.000054},
	author = {Kramer, Daniel B and Kennedy, Kevin F and Noseworthy, Peter A and Buxton, Alfred E and Josephson, Mark E and Normand, Sharon-Lise and Spertus, John A and Zimetbaum, Peter J and Reynolds, Matthew R and Mitchell, Susan L}
}
@article {516326,
	title = {The effect of race-ethnicity on the comparative effectiveness of clozapine among Medicaid beneficiaries},
	journal = {Psychiatr Serv},
	volume = {64},
	number = {3},
	year = {2013},
	month = {2013 Mar 01},
	pages = {230-7},
	abstract = {OBJECTIVE: Effectiveness trials have confirmed the superiority of clozapine in schizophrenia treatment, but little is known about whether the drug{\textquoteright}s superiority holds across racial-ethnic groups. This study examined the effectiveness by race-ethnicity of clozapine relative to other antipsychotics among adult patients in maintenance antipsychotic treatment.

METHODS: Black, Latino, and white Florida Medicaid beneficiaries with schizophrenia receiving maintenance treatment with clozapine or other antipsychotics between July 1, 2000, and June 30, 2005, were identified. Cox proportional hazard regression models were used to estimate associations between clozapine and race-ethnicity and their interaction; time to discontinuation for any cause was the primary measure of effectiveness.

RESULTS: The 20,122 members of the study cohort accounted for 20,122 antipsychotic treatment episodes; 3.7\% were treated with clozapine and 96.3\% with other antipsychotics. Blacks accounted for 23\% of episodes and Latinos for 36\%. Unadjusted analyses suggested that Latinos continued on clozapine longer than whites and that Latinos and blacks discontinued other antipsychotics sooner than whites. Adjusted analyses of 749 propensity score-matched sets of clozapine users and other antipsychotic users indicated that risk of discontinuation was lower for clozapine users (risk ratio [RR]=.45, 95\% confidence interval [CI]=.39-.52), an effect that was not moderated by race-ethnicity. Times to discontinuation were longer for clozapine users. Overall risk of antipsychotic discontinuation was higher for blacks (RR=1.56, CI=1.27-1.91) and Latinos (RR=1.23, CI=1.02-1.48).

CONCLUSIONS: The study confirmed clozapine{\textquoteright}s superior effectiveness and did not find evidence that race-ethnicity modified this effect. The findings highlight the need for efforts to increase clozapine use, particularly among minority groups.},
	keywords = {Adult, African Americans, Antipsychotic Agents, Clozapine, Comparative Effectiveness Research, Confidence Intervals, European Continental Ancestry Group, Female, Florida, Hispanic Americans, Humans, Male, Medicaid, Middle Aged, Odds Ratio, Schizophrenia, Sex Distribution, Treatment Outcome, United States},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.201200041},
	author = {Horvitz-Lennon, Marcela and Donohue, Julie M and Lave, Judith R and Alegr{\'\i}a, Margarita and Normand, Sharon-Lise T.}
}
@article {516336,
	title = {The effects of mental health parity on spending and utilization for bipolar, major depression, and adjustment disorders},
	journal = {Am J Psychiatry},
	volume = {170},
	number = {2},
	year = {2013},
	month = {2013 Feb},
	pages = {180-7},
	abstract = {OBJECTIVE: The Mental Health Parity and Addiction Equity Act requires insurance parity for mental health/substance use disorder and general medical services. Previous research found that parity did not increase mental health/substance use disorder spending and lowered out-of-pocket spending. Whether parity{\textquoteright}s effects differ by diagnosis is unknown. The authors examined this question in the context of parity implementation in the Federal Employees Health Benefits (FEHB) Program.

METHOD: The authors compared mental health/substance use disorder treatment use and spending before and after parity (2000 and 2002, respectively) for two groups: FEHB enrollees diagnosed in 1999 with bipolar disorder, major depression, or adjustment disorder (N=19,094) and privately insured enrollees unaffected by the policy in a comparison national sample (N=10,521). Separate models were fitted for each diagnostic group. A difference-in-difference design was used to control for secular time trends and to better reflect the specific impact of parity on spending and utilization.

RESULTS: Total spending was unchanged among enrollees with bipolar disorder and major depression but decreased for those with adjustment disorder (-$62, 99.2\% CI=-$133, -$11). Out-of-pocket spending decreased for all three groups (bipolar disorder: -$148, 99.2\% CI=-$217, -$85; major depression: -$100, 99.2\% CI=-$123, -$77; adjustment disorder: -$68, 99.2\% CI=-$84, -$54). Total annual utilization (e.g., medication management visits, psychotropic prescriptions, and mental health/substance use disorder hospitalization bed days) remained unchanged across all diagnoses. Annual psychotherapy visits decreased significantly only for individuals with adjustment disorders (-12\%, 99.2\% CI=-19\%, -4\%).

CONCLUSIONS: Parity implemented under managed care improved financial protection and differentially affected spending and psychotherapy utilization across groups. There was some evidence that resources were preferentially preserved for diagnoses that are typically more severe or chronic and reduced for diagnoses expected to be less so.},
	keywords = {Adjustment Disorders, Adult, Bipolar Disorder, Cost of Illness, Depressive Disorder, Major, Female, Health Benefit Plans, Employee, Health Care Costs, Health Care Rationing, Healthcare Disparities, Humans, Insurance Benefits, Male, Managed Care Programs, Mental Health, Mental Health Services, Middle Aged, Substance-Related Disorders, United States},
	issn = {1535-7228},
	doi = {10.1176/appi.ajp.2012.12030392},
	author = {Alisa B. Busch and Yoon, Frank and Barry, Colleen L and Azzone, Vanessa and Normand, Sharon-Lise T. and Goldman, Howard H and Huskamp, Haiden A.}
}
@article {516276,
	title = {Integrating risk adjustment and enrollee premiums in health plan payment},
	journal = {J Health Econ},
	volume = {32},
	number = {6},
	year = {2013},
	month = {2013 Dec},
	pages = {1263-77},
	abstract = {In two important health policy contexts - private plans in Medicare and the new state-run "Exchanges" created as part of the Affordable Care Act (ACA) - plan payments come from two sources: risk-adjusted payments from a Regulator and premiums charged to individual enrollees. This paper derives principles for integrating risk-adjusted payments and premium policy in individual health insurance markets based on fitting total plan payments to health plan costs per person as closely as possible. A least squares regression including both health status and variables used in premiums reveals the weights a Regulator should put on risk adjusters when markets determine premiums. We apply the methods to an Exchange-eligible population drawn from the Medical Expenditure Panel Survey (MEPS).},
	keywords = {Adolescent, Adult, Algorithms, Empirical Research, Female, Health Expenditures, Health Insurance Exchanges, Humans, Insurance, Health, Male, Medicare, Middle Aged, Patient Protection and Affordable Care Act, Private Sector, Regression Analysis, Risk Adjustment, United States, Young Adult},
	issn = {1879-1646},
	doi = {10.1016/j.jhealeco.2013.05.002},
	author = {Thomas G. McGuire and Glazer, Jacob and Joseph P. Newhouse and Normand, Sharon-Lise and Shi, Julie and Anna D. Sinaiko and Zuvekas, Samuel H}
}
@article {516341,
	title = {Measuring hospital clinical outcomes},
	journal = {BMJ},
	volume = {346},
	year = {2013},
	month = {2013 Jan 30},
	pages = {f620},
	keywords = {Hospitals, Humans, Outcome Assessment (Health Care)},
	issn = {1756-1833},
	doi = {10.1136/bmj.f620},
	author = {Krumholz,Harlan M. and Lin, Zhenqiu and Normand, Sharon-Lise T.}
}
@article {516316,
	title = {Nonemergency PCI at hospitals with or without on-site cardiac surgery},
	journal = {N Engl J Med},
	volume = {368},
	number = {16},
	year = {2013},
	month = {2013 Apr 18},
	pages = {1498-508},
	abstract = {BACKGROUND: Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain.

METHODS: We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness).

RESULTS: A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5\% in hospitals without on-site cardiac surgery and 9.4\% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95\% one-sided upper confidence limit, 1.22; P,
	keywords = {Aged, Angioplasty, Balloon, Coronary, Cardiology Service, Hospital, Coronary Artery Bypass, Coronary Artery Disease, Female, Humans, Male, Massachusetts, Middle Aged, Myocardial Infarction, Practice Patterns, Physicians{\textquoteright}, Prospective Studies, Retreatment, Risk},
	issn = {1533-4406},
	doi = {10.1056/NEJMoa1300610},
	author = {Jacobs, Alice K and Normand, Sharon-Lise T. and Massaro, Joseph M and Cutlip, Donald E and Carrozza, Joseph P and Marks, Anthony D and Murphy, Nancy and Romm, Iyah K and Biondolillo, Madeleine and Mauri, Laura}
}
@article {516356,
	title = {Older men with dementia are at greater risk than women of serious events after initiating antipsychotic therapy},
	journal = {J Am Geriatr Soc},
	volume = {61},
	number = {1},
	year = {2013},
	month = {2013 Jan},
	pages = {55-61},
	abstract = {OBJECTIVES: To understand how drug therapy differently affects older women and men.

DESIGN: Population-based, retrospective cohort study.

SETTING: Ontario, Canada.

PARTICIPANTS: Twenty-one thousand five hundred twenty-six older adults (13,760 women, 7,766 men) with dementia newly started on oral atypical antipsychotic therapy between April 1, 2007, and March 1, 2010.

MEASUREMENTS: Numbers and rates of serious events. Serious events were defined as a hospital admission or death within 30 days of treatment initiation. Unadjusted and adjusted odds ratios of women and men were compared in the full cohort and in strata based on setting of care, age, Charlson Comorbidity Index (CCI), and antipsychotic dose.

RESULTS: Of 21,526 older adults with a median age of 84, 1,889 (8.8\%) had a serious event (1,044 women, 7.6\%; 845 men, 10.9\%). Of these, 363 women (2.6\%) and 355 men (4.6\%) died. Men were more likely than women to be hospitalized or die during the 30-day follow-up period (adjusted odds ratio = 1.47, 95\% confidence interval = 1.33-1.62) and consistently more likely to experience a serious event in each stratum. A gradient of risk according to drug dose was found for the development of a serious event in women and men.

CONCLUSION: The risk of developing a serious event shortly after the initiation of antipsychotic therapy was high in women and men with dementia but was consistently higher in older men. This pattern remained the same in strata based on setting of care, age, CCI, and antipsychotic dose.},
	keywords = {Age Factors, Aged, Aged, 80 and over, Antipsychotic Agents, Confidence Intervals, Dementia, Emergencies, Female, Follow-Up Studies, Hospitalization, Humans, Male, Odds Ratio, Ontario, Retrospective Studies, Risk Factors},
	issn = {1532-5415},
	doi = {10.1111/jgs.12061},
	author = {Rochon, Paula A and Gruneir, Andrea and Gill, Sudeep S and Wu, Wei and Fischer, Hadas D and Bronskill, Susan E and Normand, Sharon-Lise T. and Austin, Peter C and Seitz, Dallas P and Bell, Chaim M and Fu, Longdi and Lipscombe, Lorraine and Anderson, Geoffrey M and Gurwitz, Jerry H}
}
@article {516321,
	title = {Parity and out-of-pocket spending for children with high mental health or substance abuse expenditures},
	journal = {Pediatrics},
	volume = {131},
	number = {3},
	year = {2013},
	month = {2013 Mar},
	pages = {e903-11},
	abstract = {OBJECTIVE: The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act required health plans to provide mental health and substance use disorder (MH/SUD) benefits on par with medical benefits beginning in 2010. Previous research found that parity significantly lowered average out-of-pocket (OOP) spending on MH/SUD treatment of children. No evidence is available on how parity affects OOP spending by families of children with the highest MH/SUD treatment expenditures.

METHODS: We used a difference-in-differences study design to examine whether parity reduced families{\textquoteright} (1) share of total MH/SUD treatment expenditures paid OOP or (2) average OOP spending among children whose total MH/SUD expenditures met or exceeded the 90th percentile. By using claims data, we compared changes 2 years before (1999-2000) and 2 years after (2001-2002) the Federal Employees Health Benefits Program implemented parity to a contemporaneous group of health plans that did not implement parity over the same 4-year period. We examined those enrolled in the Federal Employees Health Benefits Program because their parity directive is similar to and served as a model for the new federal parity law.

RESULTS: Parity led to statistically significant annual declines in the share of total MH/SUD treatment expenditures paid OOP (-5\%, 95\% confidence interval: -6\% to -4\%) and average OOP spending on MH/SUD treatment (-$178, 95\% confidence interval: -257 to -97).

CONCLUSIONS: This study provides the first empirical evidence that parity reduces the share and level of OOP spending by families of children with the highest MH/SUD treatment expenditures; however, these spending reductions were smaller than anticipated and unlikely to meaningfully improve families{\textquoteright} financial protection.},
	keywords = {Adolescent, Child, Child, Preschool, Female, Health Expenditures, Humans, Infant, Infant, Newborn, Male, Mental Disorders, Mental Health, Mental Health Services, Substance-Related Disorders, Young Adult},
	issn = {1098-4275},
	doi = {10.1542/peds.2012-1491},
	author = {Barry, Colleen L and Alyna T. Chien and Normand, Sharon-Lise T. and Alisa B. Busch and Azzone, Vanessa and Goldman, Howard H and Huskamp, Haiden A.}
}
@article {516281,
	title = {Patient-clinician ethnic concordance and communication in mental health intake visits},
	journal = {Patient Educ Couns},
	volume = {93},
	number = {2},
	year = {2013},
	month = {2013 Nov},
	pages = {188-96},
	abstract = {OBJECTIVE: This study examines how communication patterns vary across racial and ethnic patient-clinician dyads in mental health intake sessions and its relation to continuance in treatment, defined as attending the next scheduled appointment.

METHODS: Observational study of communication patterns among ethnically/racially concordant and discordant patient-clinician dyads. Primary analysis included 93 patients with 38 clinicians in race/ethnic concordant and discordant dyads. Communication was coded using the Roter Interaction Analysis System (RIAS) and the Working Alliance Inventory Observer (WAI-O) bond scale; continuance in care was derived from chart reviews.

RESULTS: Latino concordant dyad patients were more verbally dominant (p,
	keywords = {Adolescent, Adult, Aged, Communication, Continuity of Patient Care, Cultural Diversity, Female, Humans, Male, Mental Disorders, Middle Aged, Patient Satisfaction, Professional-Patient Relations},
	issn = {1873-5134},
	doi = {10.1016/j.pec.2013.07.001},
	author = {Alegr{\'\i}a, Margarita and Roter, Debra L and Valentine, Anne and Chen, Chih-nan and Li, Xinliang and Lin, Julia and Rosen, Daniel and Lapatin, Sheri and Normand, Sharon-Lise and Larson, Susan and Shrout, Patrick E}
}
@article {516286,
	title = {PCI at hospitals with or without on-site cardiac surgery},
	journal = {N Engl J Med},
	volume = {369},
	number = {4},
	year = {2013},
	month = {2013 Jul 25},
	pages = {392-3},
	keywords = {Angioplasty, Balloon, Coronary, Cardiology Service, Hospital, Coronary Artery Disease, Female, Humans, Male},
	issn = {1533-4406},
	doi = {10.1056/NEJMc1306996},
	author = {Jacobs, Alice K and Normand, Sharon-Lise T. and Mauri, Laura}
}
@article {516291,
	title = {A prediction model to identify patients at high risk for 30-day readmission after percutaneous coronary intervention},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {6},
	number = {4},
	year = {2013},
	month = {2013 Jul},
	pages = {429-35},
	abstract = {BACKGROUND: The Affordable Care Act creates financial incentives for hospitals to minimize readmissions shortly after discharge for several conditions, with percutaneous coronary intervention (PCI) to be a target in 2015. We aimed to develop and validate prediction models to assist clinicians and hospitals in identifying patients at highest risk for 30-day readmission after PCI.

METHODS AND RESULTS: We identified all readmissions within 30 days of discharge after PCI in nonfederal hospitals in Massachusetts between October 1, 2005, and September 30, 2008. Within a two-thirds random sample (Developmental cohort), we developed 2 parsimonious multivariable models to predict all-cause 30-day readmission, the first incorporating only variables known before cardiac catheterization (pre-PCI model), and the second incorporating variables known at discharge (Discharge model). Models were validated within the remaining one-third sample (Validation cohort), and model discrimination and calibration were assessed. Of 36,060 PCI patients surviving to discharge, 3760 (10.4\%) patients were readmitted within 30 days. Significant pre-PCI predictors of readmission included age, female sex, Medicare or State insurance, congestive heart failure, and chronic kidney disease. Post-PCI predictors of readmission included lack of β-blocker prescription at discharge, post-PCI vascular or bleeding complications, and extended length of stay. Discrimination of the pre-PCI model (C-statistic=0.68) was modestly improved by the addition of post-PCI variables in the Discharge model (C-statistic=0.69; integrated discrimination improvement, 0.009; P,
	keywords = {Aged, Aged, 80 and over, Decision Support Techniques, Discriminant Analysis, Female, Humans, Male, Massachusetts, Middle Aged, Multivariate Analysis, Patient Readmission, Percutaneous Coronary Intervention, Registries, Reproducibility of Results, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.111.000093},
	author = {Wasfy, Jason H and Rosenfield, Kenneth and Zelevinsky, Katya and Sakhuja, Rahul and Lovett, Ann and Spertus, John A and Wimmer, Neil J and Mauri, Laura and Normand, Sharon-Lise T. and Yeh, Robert W}
}
@article {516311,
	title = {Regional density of cardiologists and rates of mortality for acute myocardial infarction and heart failure},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {6},
	number = {3},
	year = {2013},
	month = {2013 May 01},
	pages = {352-9},
	abstract = {BACKGROUND: Cardiologists are distributed unevenly across regions of the United States. It is unknown whether patients in regions with fewer cardiologists have worse outcomes after hospitalization for acute myocardial infarction (AMI) or heart failure (HF).

METHODS AND RESULTS: Using Medicare administrative claims data from 2010, we examined the relationship between regional density of cardiologists and risk of death after hospitalization for AMI and HF using hospitalizations for pneumonia as a comparison. We defined density as the number of cardiologists divided by population aged>=65 years within hospital referral regions, categorized into quintiles. Among 171 126 admissions for AMI, 352 853 admissions for HF, and 343 053 admissions for pneumonia, we tested associations between density of cardiologists and 30-day and 1-year mortality for each condition. We used 2-level hierarchical logistic regression models that adjusted for characteristics of patients and hospital referral regions. Patients hospitalized for AMI (odds ratios [OR], 1.13; 95\% confidence interval [CI], 1.06-1.21) and HF (OR, 1.19; 95\% CI, 1.12-1.27) in the lowest quintile of density had modestly higher 30-day mortality risk compared with patients in the highest quintile, unlike patients hospitalized for pneumonia (OR, 1.02; 95\% CI, 0.96-1.09). Patients hospitalized for AMI (OR, 1.06; 95\% CI, 1.00-1.12) and HF (OR, 1.09; 95\% CI, 1.04-1.13) in the lowest quintile had slightly higher 1-year mortality risk, unlike patients hospitalized for pneumonia (OR, 1.00; 95\% CI, 0.95-1.05).

CONCLUSIONS: Patients hospitalized for AMI and HF in regions with a low density of cardiologists experienced modestly higher 30-day and 1-year mortality risk, unlike patients with pneumonia.},
	keywords = {Aged, Aged, 80 and over, Cardiology, Cohort Studies, Female, Health Services Accessibility, Health Services Needs and Demand, Healthcare Disparities, Heart Failure, Hospitalization, Humans, Linear Models, Logistic Models, Male, Medicare, Myocardial Infarction, Odds Ratio, Physicians, Pneumonia, Prognosis, Residence Characteristics, Risk Assessment, Risk Factors, Time Factors, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.113.000214},
	author = {Kulkarni, Vivek T and Ross, Joseph S and Wang, Yongfei and Nallamothu, Brahmajee K and Spertus, John A and Normand, Sharon-Lise T. and Masoudi, Frederick A and Krumholz,Harlan M.}
}
@article {516331,
	title = {Relationship between hospital readmission and mortality rates for patients hospitalized with acute myocardial infarction, heart failure, or pneumonia},
	journal = {JAMA},
	volume = {309},
	number = {6},
	year = {2013},
	month = {2013 Feb 13},
	pages = {587-93},
	abstract = {IMPORTANCE: The Centers for Medicare \& Medicaid Services publicly reports hospital 30-day, all-cause, risk-standardized mortality rates (RSMRs) and 30-day, all-cause, risk-standardized readmission rates (RSRRs) for acute myocardial infarction, heart failure, and pneumonia. The evaluation of hospital performance as measured by RSMRs and RSRRs has not been well characterized.

OBJECTIVE: To determine the relationship between hospital RSMRs and RSRRs overall and within subgroups defined by hospital characteristics.

DESIGN, SETTING, AND PARTICIPANTS: We studied Medicare fee-for-service beneficiaries discharged with acute myocardial infarction, heart failure, or pneumonia between July 1, 2005, and June 30, 2008 (4506 hospitals for acute myocardial infarction, 4767 hospitals for heart failure, and 4811 hospitals for pneumonia). We quantified the correlation between hospital RSMRs and RSRRs using weighted linear correlation; evaluated correlations in groups defined by hospital characteristics; and determined the proportion of hospitals with better and worse performance on both measures.

MAIN OUTCOME MEASURES: Hospital 30-day RSMRs and RSRRs.

RESULTS: Mean RSMRs and RSRRs, respectively, were 16.60\% and 19.94\% for acute myocardial infarction, 11.17\% and 24.56\% for heart failure, and 11.64\% and 18.22\% for pneumonia. The correlations between RSMRs and RSRRs were 0.03 (95\% CI, -0.002 to 0.06) for acute myocardial infarction, -0.17 (95\% CI, -0.20 to -0.14) for heart failure, and 0.002 (95\% CI, -0.03 to 0.03) for pneumonia. The results were similar for subgroups defined by hospital characteristics. Although there was a significant negative linear relationship between RSMRs and RSRRs for heart failure, the shared variance between them was only 2.9\% (r2 = 0.029), with the correlation most prominent for hospitals with RSMR ,
	keywords = {Aged, Cohort Studies, Fee-for-Service Plans, Female, Heart Failure, Hospital Mortality, Hospitals, Humans, Male, Medicare, Mortality, Myocardial Infarction, Patient Discharge, Patient Readmission, Pneumonia, Quality Indicators, Health Care, Risk Adjustment, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2013.333},
	author = {Krumholz,Harlan M. and Lin, Zhenqiu and Patricia S. Keenan and Chen, Jersey and Ross, Joseph S and Drye, Elizabeth E and Bernheim, Susannah M and Wang, Yun and Bradley, Elizabeth H and Han, Lein F and Normand, Sharon-Lise T.}
}
@article {516436,
	title = {Accurately predicting bipolar disorder mood outcomes: implications for the use of electronic databases},
	journal = {Med Care},
	volume = {50},
	number = {4},
	year = {2012},
	month = {2012 Apr},
	pages = {311-9},
	abstract = {BACKGROUND: Monitoring mental health treatment outcomes for populations requires an understanding as to which patient information is needed in electronic format and is feasible to obtain in routine care.

OBJECTIVE: To examine whether bipolar disorder outcomes can be accurately predicted and how much clinical detail is needed to do so. RESEARCH DESIGN, DATA SOURCES, AND PARTICIPANTS: Longitudinal study of bipolar disorder patients treated during 2000 to 2004 in the 19-site Systematic Treatment Enhancement Program for Bipolar Disorder observational study arm (N=3168). Clinical data were obtained at baseline and quarterly for over 1 year. We fit a "gold standard" longitudinal random-effects regression model using a detailed clinical information and estimated the area under the receiver operating characteristic curve (AUC) to predict accuracy using a validation sample. The model was then modified to include patient characteristics feasible in routinely collected electronic data (eg, administrative data). We compared the AUCs for the "limited-detail" and gold standard models, testing for differences between the AUCs using the validation sample.

MEASURE: Remission, defined as Montgomery-Asberg Depression Rating Scale score ,
	keywords = {Adolescent, Adult, Bipolar Disorder, Electronic Health Records, Female, Humans, Longitudinal Studies, Male, Middle Aged, Models, Psychological, Models, Statistical, Outcome Assessment (Health Care), Psychiatric Status Rating Scales, Remission Induction, Young Adult},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e3182422aec},
	author = {Alisa B. Busch and Neelon, Brian and Zelevinsky, Katya and Yulei He and Normand, Sharon-Lise T.}
}
@article {516411,
	title = {Autonomy, beneficence, justice, and the limits of provider profiling},
	journal = {J Am Coll Cardiol},
	volume = {59},
	number = {25},
	year = {2012},
	month = {2012 Jun 19},
	pages = {2383-6},
	keywords = {Access to Information, Cardiac Surgical Procedures, Humans, Moral Obligations, Outcome Assessment (Health Care), Physicians, Referral and Consultation},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2011.12.050},
	author = {Shahian, David M and Normand, Sharon-Lise T.}
}
@article {516396,
	title = {Based on key measures, care quality for Medicare enrollees at safety-net and non-safety-net hospitals was almost equal},
	journal = {Health Aff (Millwood)},
	volume = {31},
	number = {8},
	year = {2012},
	month = {2012 Aug},
	pages = {1739-48},
	abstract = {Safety-net hospitals, which include urban hospitals serving large numbers of low-income, uninsured, and otherwise vulnerable populations, have historically faced greater financial strains than hospitals that serve more affluent populations. These strains can affect hospitals{\textquoteright} quality of care, perhaps resulting in worse outcomes that are commonly used as indicators of care quality-mortality and readmission rates. We compared risk-standardized rates of both of these clinical outcomes among fee-for-service Medicare beneficiaries admitted for acute myocardial infarction, heart failure, or pneumonia. These beneficiaries were admitted to urban hospitals within Metropolitan Statistical Areas that contained at least one safety-net and at least one non-safety-net hospital. We found that outcomes varied across the urban areas for both safety-net and non-safety-net hospitals for all three conditions. However, mortality and readmission rates were broadly similar, with non-safety-net hospitals outperforming safety-net hospitals on average by less than one percentage point across most conditions. For heart failure mortality, there was no difference between safety-net and non-safety-net hospitals. These findings suggest that safety-net hospitals are performing better than many would have expected.},
	keywords = {Aged, Fee-for-Service Plans, Health Services Accessibility, Heart Failure, Hospital Mortality, Hospitals, Urban, Humans, Medically Uninsured, Medicare, Myocardial Infarction, Patient Readmission, Pneumonia, Quality Indicators, Health Care, Quality of Health Care, United States},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.2011.1028},
	author = {Ross, Joseph S and Bernheim, Susannah M and Lin, Zhenqiu and Drye, Elizabeth E and Chen, Jersey and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516486,
	title = {Bivalirudin therapy is associated with improved clinical and economic outcomes in ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention: results from an observational database},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {5},
	number = {1},
	year = {2012},
	month = {2012 Jan},
	pages = {52-61},
	abstract = {BACKGROUND: Randomized trials show improved outcomes among acute coronary syndrome patients treated with bivalirudin. The objective of this analysis was to compare clinical and economic outcomes in ST-elevation myocardial infarction (STEMI) patients encountered in routine clinical practice undergoing primary percutaneous coronary intervention (PPCI), treated with bivalirudin or heparin+GP IIb/IIIa receptor inhibitor (heparin+GPI).

METHODS AND RESULTS: STEMI admissions from January 1, 2004 through March 31, 2008 among patients receiving PPCI and bivalirudin or heparin+GPI in the Premier hospital database were identified. The probability of receiving bivalirudin was estimated using individual and hospital variables; using propensity scores, each bivalirudin patient was matched to 3 heparin+GPI treated patients. The primary outcome was in-hospital death. Rates of bleeding, transfusion, length of stay, and in-hospital cost were secondary outcomes. There were 59,917 STEMI PPCIs receiving bivalirudin (n=6735) or heparin+GPI (n=53,182). Seventy-nine percent of bivalirudin patients matched, resulting in 21,316 STEMI PPCIs for analysis. Compared with heparin+GPI patients, bivalirudin patients had fewer deaths (3.2\% versus 4.0\%; P=0.011) and less inpatient bleeding (clinically apparent bleeding [6.9\% versus 10.5\%, P,
	keywords = {Acute Coronary Syndrome, Adolescent, Adult, Aged, Aged, 80 and over, Angioplasty, Antithrombins, Coronary Vessels, Cost-Benefit Analysis, Electrocardiography, Female, Hemorrhage, Heparin, Hirudins, Humans, Male, Middle Aged, Myocardial Infarction, Peptide Fragments, Platelet Glycoprotein GPIIb-IIIa Complex, Recombinant Proteins, Retrospective Studies, Survival Analysis, Treatment Outcome, Young Adult},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.111.961938},
	author = {Pinto, Duane S and Ogbonnaya, Augustina and Sherman, Steven A and Tung, Patricia and Normand, Sharon-Lise T.}
}
@article {516366,
	title = {Comparative effectiveness research: does one size fit all?},
	journal = {Stat Med},
	volume = {31},
	number = {25},
	year = {2012},
	month = {2012 Nov 10},
	pages = {3062-5; discussion 3066-7},
	abstract = {In this commentary, we argue that although randomization has many benefits, not all questions we seek to answer fit into a randomized setting. Our argument utilizes the clinical setting of carotid atherosclerosis management where specific clinical questions are answered by using a variety of comparative effectiveness designs. Observational studies should not be ruled out when designing studies to address questions of comparative effectiveness.},
	keywords = {Comparative Effectiveness Research, Randomized Controlled Trials as Topic},
	issn = {1097-0258},
	doi = {10.1002/sim.5482},
	author = {Kunz, Lauren M and Yeh, Robert W and Normand, Sharon-Lise T.}
}
@article {516476,
	title = {Comparison of hospital risk-standardized mortality rates calculated by using in-hospital and 30-day models: an observational study with implications for hospital profiling},
	journal = {Ann Intern Med},
	volume = {156},
	number = {1 Pt 1},
	year = {2012},
	month = {2012 Jan 03},
	pages = {19-26},
	abstract = {BACKGROUND: In-hospital mortality measures, which are widely used to assess hospital quality, are not based on a standardized follow-up period and may systematically favor hospitals with shorter lengths of stay (LOSs).

OBJECTIVE: To assess the agreement between performance measures of U.S. hospitals by using risk-standardized in-hospital and 30-day mortality rates.

DESIGN: Observational study.

SETTING: Nonfederal acute care hospitals in the United States with at least 30 admissions for acute myocardial infarction (AMI), heart failure (HF), and pneumonia from 2004 to 2006.

PATIENTS: Medicare fee-for-service patients admitted for AMI, HF, or pneumonia from 2004 to 2006.

MEASUREMENTS: The primary outcomes were in-hospital and 30-day risk-standardized mortality rates (RSMRs).

RESULTS: Included patients comprised 718,508 admissions to 3135 hospitals for AMI, 1,315,845 admissions to 4209 hospitals for HF, and 1,415,237 admissions to 4498 hospitals for pneumonia. The hospital-level mean patient LOS varied across hospitals for each condition, ranging from 2.3 to 13.7 days for AMI, 3.5 to 11.9 days for HF, and 3.8 to 14.8 days for pneumonia. The mean RSMR differences (30-day RSMR minus in-hospital RSMR) were 5.3\% (SD, 1.3) for AMI, 6.0\% (SD, 1.3) for HF, and 5.7\% (SD, 1.4) for pneumonia; distributions varied widely across hospitals. Performance classifications differed between the in-hospital and 30-day models for 257 hospitals (8.2\%) for AMI, 456 (10.8\%) for HF, and 662 (14.7\%) for pneumonia. Hospital mean LOS was positively correlated with in-hospital RSMRs for all 3 conditions.

LIMITATION: Medicare claims data were used for risk adjustment.

CONCLUSION: In-hospital mortality measures provide a different assessment of hospital performance than 30-day mortality and are biased in favor of hospitals with shorter LOSs.

PRIMARY FUNDING SOURCE: The Centers for Medicare \& Medicaid Services and National Heart, Lung, and Blood Institute.},
	keywords = {Aged, Heart Failure, Hospital Mortality, Hospitals, Humans, Length of Stay, Medicare, Myocardial Infarction, Patient Transfer, Pneumonia, Quality of Health Care, United States},
	issn = {1539-3704},
	doi = {10.7326/0003-4819-156-1-201201030-00004},
	author = {Drye, Elizabeth E and Normand, Sharon-Lise T. and Wang, Yun and Ross, Joseph S and Schreiner, Geoffrey C and Han, Lein and Rapp, Michael and Krumholz,Harlan M.}
}
@article {516416,
	title = {Contemporary performance of U.S. teaching and nonteaching hospitals},
	journal = {Acad Med},
	volume = {87},
	number = {6},
	year = {2012},
	month = {2012 Jun},
	pages = {701-8},
	abstract = {PURPOSE: To compare the performance of U.S. teaching and nonteaching hospitals using a portfolio of contemporary, publicly reported metrics.

METHOD: The authors classified acute care general hospitals filing a Medicare Institutional Cost Report according to teaching intensity: nonteaching, teaching, or Council of Teaching Hospitals member. They compared aggregate results across categories for Hospital Compare process compliance, mortality, and readmission rates (acute myocardial infarction [AMI], heart failure, pneumonia); Surgical Care Improvement Project (SCIP) performance; compliance with Leapfrog standards; patient experience; patient services and key technologies; safety (computerized physician order entry, intensive care unit staffing, National Quality Forum safe practices, hospital-acquired conditions); and cost/resource utilization (Medicare-adjusted expense per case; Leapfrog efficiency and resource use standards).

RESULTS: Availability of patient services and advanced technologies were associated with teaching intensity (P < .0001), as were most hospital safety metrics. Teaching intensity was favorably associated with SCIP performance, AMI and heart failure process scores, and mortality (P < .0001). It was unfavorably associated with higher AMI and pneumonia readmission rates (P < .0001) and lower scores for individual patient satisfaction measures. Costs per case were similar (P = .4194) across hospital categories after correction for federally allowed adjustments (case mix, wages, and low-income patient care).

CONCLUSIONS: Teaching hospitals offer advanced clinical capabilities, educate the next generation of providers, care for disadvantaged urban populations, and are leaders in health care research and innovation. However, many stakeholders may be unaware of an additional value-relatively higher quality and safety in many areas, with similar adjusted costs.},
	keywords = {Guideline Adherence, Health Care Surveys, Health Resources, Hospital Costs, Hospital Mortality, Hospitals, Hospitals, Teaching, Humans, Outcome and Process Assessment (Health Care), Patient Readmission, Patient Safety, Patient Satisfaction, Practice Guidelines as Topic, Quality Indicators, Health Care, Quality of Health Care, United States},
	issn = {1938-808X},
	doi = {10.1097/ACM.0b013e318253676a},
	author = {Shahian, David M and Nordberg, Paul and Meyer, Gregg S and Blanchfield, Bonnie B and Mort, Elizabeth A and Torchiana, David F and Normand, Sharon-Lise T.}
}
@article {516451,
	title = {Coronary artery bypass graft: contemporary heart surgery center performance in China},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {5},
	number = {2},
	year = {2012},
	month = {2012 Mar 01},
	pages = {214-21},
	abstract = {BACKGROUND: The use of coronary artery bypass grafting (CABG) surgery in China is growing, but little is known about hospital-level performance. We sought to characterize the variation in performance across hospitals participating in a national registry in China.

METHODS AND RESULTS: The study sample was drawn from the Chinese Cardiac Surgery Registry, a national multicenter database that includes 43 hospitals across 13 provinces and 4 direct-controlled municipalities in China. We assessed consecutive patients undergoing isolated CABG surgery during the period of January 1, 2007, through December 31, 2008. Hierarchical generalized linear models were used to estimate hospital-level risk-standardized in-hospital all-cause mortality rates (RSMR) and major complication rates (RSMCR), which included death, myocardial infarction, reoperation for bleeding, mediastinal infection, stroke, reintubation, and renal failure. Among 8739 patients who underwent isolated CABG surgery, the mean age was 62.2 years (SD=9.2), and 78\% were male. Observed in-hospital mortality and complication rates were 2.2\% (95\% confidence interval [CI], 1.9-2.5\%) and 6.6\% (95\% CI, 6.1-7.1\%), respectively. The mean RSMR was 1.9\% (SD=1.1), with a range of 0.7-5.8\%, and the mean RSMCR was 6.4\% (SD=1.5), with a range of 3.8-10.1\%. The odds of dying and the odds of having a complication after CABG surgery at a hospital 1 SD below the average relative to a hospital 1 SD above the average were 2.06 (95\% CI, 1.40-3.04) and 1.53 (95\% CI, 1.31-1.79), respectively. The Eastern region had the lowest RSMR and RSMCR (1.6\% and 5.8\%, respectively), whereas the Central region had the highest RSMR (2.5\%) and the Southern region had the highest RSMCR (7.7\%).

CONCLUSIONS: Mortality and complication rates after CABG surgery in the Chinese Cardiac Surgery Registry are generally low but vary by hospital and region within China. These results suggest that there are opportunities to improve outcomes in some CABG facilities.},
	keywords = {Aged, China, Coronary Artery Bypass, Female, Hospital Mortality, Humans, Male, Middle Aged, Outcome Assessment (Health Care)},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.111.962365},
	author = {Hu, Shengshou and Zheng, Zhe and Yuan, Xin and Wang, Yun and Normand, Sharon-Lise T. and Ross, Joseph S and Krumholz,Harlan M.}
}
@article {516471,
	title = {Economic grand rounds: the price is right? Changes in the quantity of services used and prices paid in response to parity},
	journal = {Psychiatr Serv},
	volume = {63},
	number = {2},
	year = {2012},
	month = {2012 Feb 01},
	pages = {107-9},
	abstract = {The impact of parity coverage on the quantity of behavioral health services used by enrollees and on the prices of these services was examined in a set of Federal Employees Health Benefit (FEHB) Program plans. After parity implementation, the quantity of services used in the FEHB plans declined in five service categories, compared with plans that did not have parity coverage. The decline was significant for all service types except inpatient care. Because a previous study of the FEHB Program found that total spending on behavioral health services did not increase after parity implementation, it can be inferred that average prices must have increased over the period. The finding of a decline in service use and increase in prices provides an empirical window on what might be expected after implementation of the federal parity law and the parity requirement under the health care reform law.},
	keywords = {Health Benefit Plans, Employee, Health Care Costs, Health Care Reform, Humans, Insurance Coverage, Mental Health Services, Quality of Health Care, United States},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.20120p107},
	author = {Goldman, Howard H and Barry, Colleen L and Normand, Sharon-Lise T. and Azzone, Vanessa and Alisa B. Busch and Huskamp, Haiden A.}
}
@article {516361,
	title = {The effect of race-ethnicity and geography on adoption of innovations in the treatment of schizophrenia},
	journal = {Psychiatr Serv},
	volume = {63},
	number = {12},
	year = {2012},
	month = {2012 Dec},
	pages = {1171-7},
	abstract = {OBJECTIVE: This study evaluated the effect of race-ethnicity and geography on the adoption of a pharmacological innovation (long-acting injectable risperidone [LAIR]) among Medicaid beneficiaries with schizophrenia as well as the contribution of geographic location to observed racial-ethnic disparities.

METHODS: The data source was a claims data set from the Florida Medicaid program for the 2.5-year period that followed the launch of LAIR in the U.S. market. Study participants were beneficiaries with schizophrenia who had filled at least one antipsychotic prescription during the study period. The outcome variable was any use of LAIR; model variables were need indicators and random effects for 11 Medicaid areas, which are multicounty units used by the Medicaid program to administer benefits. Adjusted probability of use of LAIR for blacks and Latinos versus whites was estimated with logistic regression models.

RESULTS: The study cohort included 13,992 Medicaid beneficiaries: 25\% of the cohort was black, 37\% Latino, and 38\% white. Unadjusted probability of LAIR use was lower for Latinos than whites, and use varied across the state{\textquoteright}s geographic areas. Adjustment for need confirmed the unadjusted finding of a disparity between Latinos and whites (odds ratio=.58, 95\% confidence interval=.49-.70). The inclusion of geographic location in the model eliminated the Latino-white disparity but confirmed the unadjusted finding of geographic variation in adoption.

CONCLUSIONS: Within a state Medicaid program, the initial finding of a disparity between Latinos and whites in adopting LAIR was driven by geographic disparities in adoption rates and the geographic concentration of Latinos in a low-adoption area. Possible contributors and implications of these results are discussed.},
	keywords = {Adult, Antipsychotic Agents, Cohort Studies, Confidence Intervals, Diffusion of Innovation, Evidence-Based Medicine, Female, Florida, Geography, Medical, Healthcare Disparities, Humans, Insurance Claim Review, Male, Medicaid, Middle Aged, Odds Ratio, Risperidone, Schizophrenia, United States},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.201100408},
	author = {Horvitz-Lennon, Marcela and Alegr{\'\i}a, Margarita and Normand, Sharon-Lise T.}
}
@article {516401,
	title = {Effects of gender and ethnicity on outcomes after aortic valve replacement},
	journal = {J Thorac Cardiovasc Surg},
	volume = {144},
	number = {2},
	year = {2012},
	month = {2012 Aug},
	pages = {486-92},
	abstract = {OBJECTIVE: To evaluate the clinical outcomes after aortic valve replacement or aortic valve replacement and coronary artery bypass grafting in a large contemporary population, and to determine if outcomes are associated with patient ethnicity and gender status.

METHODS: Using the Massachusetts Cardiac Surgery Database, we identified 6809 adults aged 18 years or older who had undergone isolated aortic valve replacement or aortic valve replacement and coronary artery bypass grafting in all non-federal acute-care Massachusetts hospitals from 2002 to 2008. Univariate and multivariate logistic regression analyses were used to identify differences in patient characteristics, major morbidity, and 30-day and 1-year mortality between men (n=4043) and women (n=2766) and between whites (n=6481) and nonwhites (n=328).

RESULTS: The unadjusted 30-day mortality rate was 2.6\% for the men and 3.1\% for the women (P=.296) and 2.8\% for whites and 3.7\% for nonwhites (P=.342). In adjusted logistic regression models, the 30-day mortality was not different between the female and male patients (odds ratio, 0.88; 95\% confidence interval, 0.26-3.02, P=.84) nor between the nonwhites and whites (odds ratio, 1.57; 95\% confidence interval, 0.45-5.44; P=.48). The incidence of postoperative stroke was greater in women (3.0\% women and 2.2\% men, P=.031), and the incidence of postoperative myocardial infarction (10.9\% women and 13.6\% men; P=.001) and septicemia (1.2\% women and 2.0\% men; P=.009) was greater in men.

CONCLUSIONS: Ethnicity and gender were not associated with greater 30-day and 1-year mortality after aortic valve replacement or aortic valve replacement and coronary artery bypass grafting. Differences in postoperative outcomes were not observed between ethnic groups.},
	keywords = {Aged, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Coronary Artery Bypass, Coronary Disease, Diabetic Angiopathies, Ethnic Groups, Female, Heart Failure, Hospital Mortality, Humans, Logistic Models, Male, Massachusetts, Middle Aged, Myocardial Infarction, Outcome Assessment (Health Care), Postoperative Complications, Registries, Retrospective Studies, Sepsis, Sex Factors, Stroke},
	issn = {1097-685X},
	doi = {10.1016/j.jtcvs.2011.11.023},
	author = {Stamou, Sotiris C and Robich, Michael and Wolf, Robert E and Lovett, Ann and Normand, Sharon-Lise T. and Sellke, Frank W}
}
@article {516456,
	title = {Geographic disparities in the incidence and outcomes of hospitalized myocardial infarction: does a rising tide lift all boats?},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {5},
	number = {2},
	year = {2012},
	month = {2012 Mar 01},
	pages = {197-204},
	abstract = {BACKGROUND: Improvements in prevention have led to declines in incidence and mortality of myocardial infarction (MI) in selected populations. However, no studies have examined regional differences in recent trends in MI incidence, and few have examined whether known regional disparities in MI care have narrowed over time.

METHODS AND RESULTS: We compared trends in incidence rates of MI, associated procedures and mortality for all US Census Divisions (regions) in Medicare fee-for-service patients between 2000-2008 (292 773 151 patient-years). Two-stage hierarchical models were used to account for patient characteristics and state-level random effects. To assess trends in geographic disparities, we calculated changes in between-state variance for outcomes over time. Although the incidence of MI declined in all regions (P,
	keywords = {Aged, Aged, 80 and over, Female, Humans, Incidence, Male, Myocardial Infarction, Time Factors},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.111.962456},
	author = {Yeh, Robert W and Normand, Sharon-Lise T. and Wang, Yun and Barr, Christopher D and Francesca Dominici}
}
@article {516386,
	title = {Getting the methods right--the foundation of patient-centered outcomes research},
	journal = {N Engl J Med},
	volume = {367},
	number = {9},
	year = {2012},
	month = {2012 Aug 30},
	pages = {787-90},
	keywords = {Biomedical Research, Evidence-Based Medicine, Humans, Outcome Assessment (Health Care), Patient-Centered Care, United States},
	issn = {1533-4406},
	doi = {10.1056/NEJMp1207437},
	author = {Gabriel, Sherine E and Normand, Sharon-Lise T.}
}
@article {516376,
	title = {Hospital patterns of use of positive inotropic agents in patients with heart failure},
	journal = {J Am Coll Cardiol},
	volume = {60},
	number = {15},
	year = {2012},
	month = {2012 Oct 09},
	pages = {1402-9},
	abstract = {OBJECTIVES: This study sought to determine hospital variation in the use of positive inotropic agents in patients with heart failure.

BACKGROUND: Clinical guidelines recommend targeted use of positive inotropic agents in highly selected patients, but data are limited and the recommendations are not specific.

METHODS: We analyzed data from 376 hospitals including 189,948 hospitalizations for heart failure from 2009 through 2010. We used hierarchical logistic regression models to estimate hospital-level risk-standardized rates of inotrope use and risk-standardized in-hospital mortality rates.

RESULTS: The risk-standardized rates of inotrope use ranged across hospitals from 0.9\% to 44.6\% (median: 6.3\%, interquartile range: 4.3\% to 9.2\%). We identified various hospital patterns based on the type of agents: dobutamine-predominant (29\% of hospitals), dopamine-predominant (25\%), milrinone-predominant (1\%), mixed dobutamine and dopamine pattern (32\%), and mixed pattern including all 3 agents (13\%). When studying the factors associated with interhospital variation, the best model performance was with the hierarchical generalized linear models that adjusted for patient case mix and an individual hospital effect (receiver operating characteristic curves from 0.77 to 0.88). The intraclass correlation coefficients of the hierarchical generalized linear models (0.113 for any inotrope) indicated that a noteworthy proportion of the observed variation was related to an individual institutional effect. Hospital rates or patterns of use were not associated with differences in length of stay or risk-standardized mortality rates.

CONCLUSIONS: We found marked differences in the use of inotropic agents for heart failure patients among a diverse group of hospitals. This variability, occurring in the context of little clinical evidence, indicates an urgent need to define the appropriate use of these medications.},
	keywords = {Cardiotonic Agents, Cross-Sectional Studies, Heart Failure, Hospital Mortality, Hospitals, Humans, Length of Stay, Retrospective Studies, Survival Rate, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2012.07.011},
	author = {Partovian, Chohreh and Gleim, Scott R and Mody, Purav S and Li, Shu-Xia and Wang, Haiyan and Strait, Kelly M and Allen, Larry A and Lagu, Tara and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516446,
	title = {Hospital-wide mortality as a quality metric: conceptual and methodological challenges},
	journal = {Am J Med Qual},
	volume = {27},
	number = {2},
	year = {2012},
	month = {2012 Mar-Apr},
	pages = {112-23},
	abstract = {Hospital-wide mortality rates are used as a measure of overall hospital quality. However, their parsimony and apparent simplicity belie significant conceptual and methodological concerns. For many diagnoses included in hospital-wide mortality, the association between short-term mortality and quality of care is not well established. Furthermore, compared with condition-specific or procedure-specific mortality, hospital-wide mortality rates pose greater methodological challenges (ie, eligibility and exclusion criteria, risk adjustment, statistical techniques for aggregating across diagnoses, usability). Many of these result from substantial interprovider heterogeneity in diagnosis frequency, sample sizes, and patient severity. Hospital-wide mortality is problematic as a quality metric for public reporting, although hospitals may elect to use such measures for other purposes. Potential alternative approaches include multidimensional composite metrics or mortality measurement limited to selected conditions and procedures for which the link between hospital mortality and quality is clear, legitimate exclusions are uncommon, and sample sizes, end points, and risk adjustment are adequate.},
	keywords = {Bias (Epidemiology), Hospital Mortality, Humans, Quality Indicators, Health Care, Quality of Health Care, Risk Adjustment, Sample Size},
	issn = {1555-824X},
	doi = {10.1177/1062860611412358},
	author = {Shahian, David M and Iezzoni, Lisa I and Meyer, Gregg S and Kirle, Leslie and Normand, Sharon-Lise T.}
}
@article {516466,
	title = {Medication use and spending trends among children with ADHD in Florida{\textquoteright}s Medicaid program, 1996-2005},
	journal = {Psychiatr Serv},
	volume = {63},
	number = {2},
	year = {2012},
	month = {2012 Feb 01},
	pages = {115-21},
	abstract = {OBJECTIVE: How the introduction of new pharmaceuticals affects spending for treatment of children with attention-deficit hyperactivity disorder (ADHD) is unknown. This study examined trends in use of pharmaceuticals and their costs among children with ADHD from 1996 to 2005.

METHODS: This observational study used annual cohorts of children ages three to 17 with ADHD (N=107,486 unique individuals during the study period) from Florida Medicaid claims to examine ten-year trends in the predicted probability for medication use for children with ADHD with and without psychiatric comorbidities as well as mental health spending and its components. Additional outcome measures included average price per day and average number of days filled for medication classes.

RESULTS: Overall, the percentage of children with ADHD treated with ADHD drugs increased from 60\% to 63\%, and the percentage taking antipsychotics more than doubled, from 8\% to 18\%. In contrast, rates of antidepressant use declined from 21\% to 15\%, and alpha agonist use was constant, at 15\%. Mental health spending increased 61\%, with pharmaceutical spending representing the fastest-rising component (up 192\%). Stimulant spending increased 157\%, mostly because of increases in price per prescription. Antipsychotic spending increased 588\% because of increases in both price and quantity (number of days used). By 2005, long-acting ADHD drugs accounted for over 90\% of stimulant spending.

CONCLUSIONS: Long-acting ADHD drugs have rapidly replaced short-acting stimulant use among children with ADHD. The use of antipsychotics as a second-tier agent in treating ADHD has overtaken traditional agents such as antidepressants or alpha agonists, suggesting a need for research into the efficacy and side effects of second-generation antipsychotics among children with ADHD.},
	keywords = {Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Child, Preschool, Cohort Studies, Comorbidity, Drug Costs, Drug Therapy, Combination, Drug Utilization, Female, Florida, Humans, Male, Medicaid, Mental Disorders, Psychotropic Drugs, United States},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.201100095},
	author = {Fullerton, Catherine A and Arnold M. Epstein and Richard G. Frank and Normand, Sharon-Lise T. and Fu, Christina X and Thomas G. McGuire}
}
@article {516421,
	title = {Meta-Analysis of Rare Binary Adverse Event Data},
	journal = {J Am Stat Assoc},
	volume = {107},
	number = {498},
	year = {2012},
	month = {2012 Jun 01},
	pages = {555-567},
	abstract = {We examine the use of fixed-effects and random-effects moment-based meta-analytic methods for analysis of binary adverse event data. Special attention is paid to the case of rare adverse events which are commonly encountered in routine practice. We study estimation of model parameters and between-study heterogeneity. In addition, we examine traditional approaches to hypothesis testing of the average treatment effect and detection of the heterogeneity of treatment effect across studies. We derive three new methods, simple (unweighted) average treatment effect estimator, a new heterogeneity estimator, and a parametric bootstrapping test for heterogeneity. We then study the statistical properties of both the traditional and new methods via simulation. We find that in general, moment-based estimators of combined treatment effects and heterogeneity are biased and the degree of bias is proportional to the rarity of the event under study. The new methods eliminate much, but not all of this bias. The various estimators and hypothesis testing methods are then compared and contrasted using an example dataset on treatment of stable coronary artery disease.},
	issn = {0162-1459},
	doi = {10.1080/01621459.2012.664484},
	author = {Bhaumik, Dulal K and Amatya, Anup and Normand, Sharon-Lise and Greenhouse, Joel and Kaizar, Eloise and Neelon, Brian and Gibbons, Robert D}
}
@article {572941,
	title = {Methodological standards and patient-centeredness in comparative effectiveness research: the PCORI perspective},
	journal = {JAMA},
	volume = {307},
	number = {15},
	year = {2012},
	month = {2012 Apr 18},
	pages = {1636-40},
	abstract = {Rigorous methodological standards help to ensure that medical research produces information that is valid and generalizable, and are essential in patient-centered outcomes research (PCOR). Patient-centeredness refers to the extent to which the preferences, decision-making needs, and characteristics of patients are addressed, and is the key characteristic differentiating PCOR from comparative effectiveness research. The Patient Protection and Affordable Care Act signed into law in 2010 created the Patient-Centered Outcomes Research Institute (PCORI), which includes an independent, federally appointed Methodology Committee. The Methodology Committee is charged to develop methodological standards for PCOR. The 4 general areas identified by the committee in which standards will be developed are (1) prioritizing research questions, (2) using appropriate study designs and analyses, (3) incorporating patient perspectives throughout the research continuum, and (4) fostering efficient dissemination and implementation of results. A Congressionally mandated PCORI methodology report (to be issued in its first iteration in May 2012) will begin to provide standards in each of these areas, and will inform future PCORI funding announcements and review criteria. The work of the Methodology Committee is intended to enable generation of information that is relevant and trustworthy for patients, and to enable decisions that improve patient-centered outcomes.},
	keywords = {Chronic Disease, Comparative Effectiveness Research, Decision Making, Humans, Information Dissemination, Outcome Assessment (Health Care), Patient Participation, Patient Preference, Patient Protection and Affordable Care Act, Practice Guidelines as Topic, Research, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2012.466}
}
@article {516371,
	title = {Postmarket surveillance for medical devices: America{\textquoteright}s new strategy},
	journal = {BMJ},
	volume = {345},
	year = {2012},
	month = {2012 Oct 11},
	pages = {e6848},
	keywords = {Consumer Product Safety, Equipment and Supplies, Equipment Safety, Government Regulation, Humans, Information Services, Product Surveillance, Postmarketing, United States, United States Food and Drug Administration},
	issn = {1756-1833},
	doi = {10.1136/bmj.e6848},
	author = {Normand, Sharon-Lise T. and Laura Hatfield and Drozda, Joseph and Resnic, Frederic S}
}
@article {516441,
	title = {Postmarketing surveillance of medical devices--filling in the gaps},
	journal = {N Engl J Med},
	volume = {366},
	number = {10},
	year = {2012},
	month = {2012 Mar 08},
	pages = {875-7},
	keywords = {Databases, Factual, Device Approval, Equipment Failure, Humans, Patient Safety, Product Surveillance, Postmarketing, Registries, United States, United States Food and Drug Administration},
	issn = {1533-4406},
	doi = {10.1056/NEJMp1114865},
	author = {Resnic, Frederic S and Normand, Sharon-Lise T.}
}
@article {516461,
	title = {Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report},
	journal = {Value Health},
	volume = {15},
	number = {2},
	year = {2012},
	month = {2012 Mar-Apr},
	pages = {217-30},
	abstract = {OBJECTIVE: In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials.

METHODS: This report details the recommendations of a Good Research Practice Task Force on Prospective Observational Studies for comparative effectiveness research. Key issues discussed include how to decide when to do a prospective observational study in light of its advantages and disadvantages with respect to alternatives, and the report summarizes the challenges and approaches to the appropriate design, analysis, and execution of prospective observational studies to make them most valuable and relevant to health-care decision makers.

RECOMMENDATIONS: The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in prospective observational studies. The use of inception cohorts, new user designs, multiple comparator groups, matching designs, and assessment of outcomes thought not to be impacted by the therapies being compared are several strategies that should be given strong consideration recognizing that there may be feasibility constraints. The reasoning behind all study design and analytic choices should be transparent and explained in study protocol. Execution of prospective observational studies is as important as their design and analysis in ensuring that results are valuable and relevant, especially capturing the target population of interest, having reasonably complete and nondifferential follow-up. Similar to the concept of the importance of declaring a prespecified hypothesis, we believe that the credibility of many prospective observational studies would be enhanced by their registration on appropriate publicly accessible sites (e.g., clinicaltrials.gov and encepp.eu) in advance of their execution.},
	keywords = {Advisory Committees, Comparative Effectiveness Research, Europe, Family Planning Policy, Guidelines as Topic, Health Policy, Prospective Studies, Research Design, United States},
	issn = {1524-4733},
	doi = {10.1016/j.jval.2011.12.010},
	author = {Berger, Marc L. and Dreyer, Nancy and Anderson, Fred and Towse, Adrian and Sedrakyan, Art and Normand, Sharon-Lise}
}
@article {516426,
	title = {Regional associations between Medicare Advantage penetration and administrative claims-based measures of hospital outcomes},
	journal = {Med Care},
	volume = {50},
	number = {5},
	year = {2012},
	month = {2012 May},
	pages = {406-9},
	abstract = {BACKGROUND: Risk-standardized measures of hospital outcomes reported by the Centers for Medicare and Medicaid Services include Medicare fee-for-service (FFS) patients and exclude Medicare Advantage (MA) patients due to data availability. MA penetration varies greatly nationwide and seems to be associated with increased FFS population risk. Whether variation in MA penetration affects the performance on the Centers for Medicare and Medicaid Service measures is unknown.

OBJECTIVE: To determine whether the MA penetration rate is associated with outcomes measures based on FFS patients.

RESEARCH DESIGN: In this retrospective study, 2008 MA penetration was estimated at the Hospital Referral Region (HRR) level. Risk-standardized mortality rates and risk-standardized readmission rates for heart failure, acute myocardial infarction, and pneumonia from 2006 to 2008 were estimated among HRRs, along with several markers of FFS population risk. Weighted linear regression was used to test the association between each of these variables and MA penetration among HRRs.

RESULTS: Among 304 HRRs, MA penetration varied greatly (median, 17.0\%; range, 2.1\%-56.6\%). Although MA penetration was significantly (P,
	keywords = {Fee-for-Service Plans, Heart Failure, Hospital Mortality, Hospitals, Humans, Insurance Claim Review, Medicare Part C, Myocardial Infarction, Outcome Assessment (Health Care), Patient Readmission, Pneumonia, Quality Indicators, Health Care, Residence Characteristics, Retrospective Studies, Risk Factors, United States},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e318245a0f9},
	author = {Kulkarni, Vivek T and Shah, Sachin J and Bernheim, Susannah M and Wang, Yongfei and Normand, Sharon-Lise T. and Han, Lein F and Rapp, Michael T and Drye, Elizabeth E and Krumholz,Harlan M.}
}
@article {516381,
	title = {Registry studies for improving the quality of cardiovascular care: the role of variance components},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {5},
	number = {5},
	year = {2012},
	month = {2012 Sep 01},
	pages = {e42-3},
	keywords = {Cardiac Output, Low, Coronary Artery Bypass, Female, Heart Diseases, Heart Failure, Hospitals, Humans, Male, Outcome and Process Assessment (Health Care), Percutaneous Coronary Intervention, Perioperative Care, Practice Patterns, Physicians{\textquoteright}, Quality Indicators, Health Care},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.112.968792},
	author = {Normand, Sharon-Lise T.}
}
@article {516481,
	title = {Skilled nursing facility referral and hospital readmission rates after heart failure or myocardial infarction},
	journal = {Am J Med},
	volume = {125},
	number = {1},
	year = {2012},
	month = {2012 Jan},
	pages = {100.e1-9},
	abstract = {BACKGROUND: Substantial hospital-level variation in the risk of readmission after hospitalization for heart failure (HF) or acute myocardial infarction (AMI) has been reported. Prior studies have documented considerable state-level variation in rates of discharge to skilled nursing facilities (SNFs), but evaluation of hospital-level variation in SNF rates and its relationship to hospital-level readmission rates is limited.

METHODS: Hospital-level 30-day all-cause risk-standardized readmission rates (RSRRs) were calculated using claims data for fee-for-service Medicare patients hospitalized with a principal diagnosis of HF or AMI from 2006-2008. Medicare claims were used to calculate rates of discharge to SNF following HF-specific or AMI-specific admissions in hospitals with >=25 HF or AMI patients, respectively. Weighted regression was used to quantify the relationship between RSRRs and SNF rates for each condition.

RESULTS: Mean RSRR following HF admission among 4101 hospitals was 24.7\%, and mean RSRR after AMI admission among 2453 hospitals was 19.9\%. Hospital-level SNF rates ranged from 0\% to 83.8\% for HF and from 0\% to 77.8\% for AMI. No significant relationship between RSRR after HF and SNF rate was found in adjusted regression models (P=.15). RSRR after AMI increased by 0.03 percentage point for each 1 absolute percentage point increase in SNF rate in adjusted regression models (P=.001). Overall, HF and AMI SNF rates explained ,
	keywords = {Aged, Aged, 80 and over, Female, Heart Failure, Humans, Male, Medicare, Myocardial Infarction, Patient Readmission, Referral and Consultation, Skilled Nursing Facilities, United States},
	issn = {1555-7162},
	doi = {10.1016/j.amjmed.2011.06.011},
	author = {Chen, Jersey and Ross, Joseph S and Carlson, Melissa D A and Lin, Zhenqiu and Normand, Sharon-Lise T. and Bernheim, Susannah M and Drye, Elizabeth E and Ling, Shari M and Han, Lein F and Rapp, Michael T and Krumholz,Harlan M.}
}
@article {516431,
	title = {Sources of hospital variation in short-term readmission rates after percutaneous coronary intervention},
	journal = {Circ Cardiovasc Interv},
	volume = {5},
	number = {2},
	year = {2012},
	month = {2012 Apr},
	pages = {227-36},
	abstract = {BACKGROUND: Risk-standardized all-cause 30-day readmission rates (RSRRs) after percutaneous coronary intervention (PCI) have been endorsed as a national measure of hospital quality. Little is known about variation in the performance of hospitals on this measure, and whether high hospital rates of readmission after PCI are due to modifiable deficiencies in quality of care has not been assessed.

METHODS AND RESULTS: We estimated 30-day, all-cause RSRRs for all nonfederal PCI-performing hospitals in Massachusetts, adjusted for clinical and angiographic variables, between 2005 and 2008. We assessed if differences in race, insurance type, and PCI and post-PCI characteristics, including procedural complications and discharge characteristics, could explain variation between hospitals using nested hierarchical logistic regression models. Of 36 060 patients undergoing PCI at 24 hospitals and surviving to discharge, 4469 (12.4\%) were readmitted within 30 days of discharge. Hospital RSRRs ranged from 9.5\% to 17.9\%, with 8 of 24 hospitals being identified as outliers (4 lower than expected and 4 higher than expected). Differences in race, insurance, PCI, and post-PCI factors accounted for 10.4\% of the between-hospital variance in RSRRs.

CONCLUSIONS: We observed wide variation in hospital 30-day all-cause RSRRs after PCI, most of which could not be explained by identifiable differences in procedural and postprocedural factors. A better understanding of etiologies of hospital variation is necessary to determine whether this measure is an actionable assessment of hospital quality, and, if so, how hospitals might improve their performance.},
	keywords = {Aged, Angioplasty, Continental Population Groups, Coronary Artery Disease, Coronary Vessels, Female, Humans, Insurance, Health, Male, Middle Aged, Observer Variation, Patient Readmission, Postoperative Complications, Practice Patterns, Physicians{\textquoteright}, Quality of Health Care, Risk, Time Factors, United States},
	issn = {1941-7632},
	doi = {10.1161/CIRCINTERVENTIONS.111.967638},
	author = {Yeh, Robert W and Rosenfield, Kenneth and Zelevinsky, Katya and Mauri, Laura and Sakhuja, Rahul and Shivapour, Daniel M and Lovett, Ann and Weiner, Bonnie H and Jacobs, Alice K and Normand, Sharon-Lise T.}
}
@article {516391,
	title = {Use of drug-eluting stents as a function of predicted benefit: clinical and economic implications of current practice},
	journal = {Arch Intern Med},
	volume = {172},
	number = {15},
	year = {2012},
	month = {2012 Aug 13},
	pages = {1145-52},
	abstract = {BACKGROUND: Benefits of drug-eluting stents (DES) in percutaneous coronary intervention (PCI) are greatest in those at the highest risk of target-vessel revascularization (TVR). Drug-eluting stents cost more than bare-metal stents (BMS) and necessitate prolonged dual antiplatelet therapy (DAPT), which increases costs, bleeding risk, and risk of complications if DAPT is prematurely discontinued. Our objective was to assess whether DES are preferentially used in patients with higher predicted TVR risk and to estimate if lower use of DES in low-TVR-risk patients would be more cost-effective than the existing DES use pattern.

METHODS: We analyzed more than 1.5 million PCI procedures in the National Cardiovascular Data Registry (NCDR) CathPCI registry from 2004 through 2010 and estimated 1-year TVR risk with BMS using a validated model. We examined the association between TVR risk and DES use and the cost-effectiveness of lower DES use in low-TVR-risk patients (50\% less DES use among patients with ,
	keywords = {Aged, Angioplasty, Balloon, Coronary, Comparative Effectiveness Research, Coronary Restenosis, Cost-Benefit Analysis, Drug-Eluting Stents, Female, Health Care Costs, Humans, Male, Middle Aged, Models, Statistical, Outcome and Process Assessment (Health Care), Platelet Aggregation Inhibitors, Postoperative Hemorrhage, Practice Patterns, Physicians{\textquoteright}, Registries, Risk Assessment, Risk Factors},
	issn = {1538-3679},
	doi = {10.1001/archinternmed.2012.3093},
	author = {Amin, Amit P and Spertus, John A and Cohen, David J and Chhatriwalla, Adnan and Kennedy, Kevin F and Vilain, Katherine and Salisbury, Adam C and Venkitachalam, Lakshmi and Lai, Sue Min and Mauri, Laura and Normand, Sharon-Lise T. and Rumsfeld, John S and Messenger, John C and Yeh, Robert W}
}
@article {516406,
	title = {Vascular closure device failure in contemporary practice},
	journal = {JACC Cardiovasc Interv},
	volume = {5},
	number = {8},
	year = {2012},
	month = {2012 Aug},
	pages = {837-44},
	abstract = {OBJECTIVES: The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs.

BACKGROUND: VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications.

METHODS: From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n = 18,533), a nitinol clip-based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis.

RESULTS: Among 23,813 procedures, the VCD failed in 781 (3.3\%) procedures (2.1\% of collagen plug-based, 6.1\% of suture-based, 9.5\% of nitinol clip-based VCDs). Patients with VCD failure had an excess risk of "any" (7.7\% vs. 2.8\%; p < 0.001), major (3.3\% vs. 0.8\%; p < 0.001), or minor (5.8\% vs. 2.1\%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score-adjusted analysis, when compared with collagen plug-based VCD (reference odds ratio [OR] = 1.0), nitinol clip-based VCD had 2-fold increased risk (OR: 2.0, 95\% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95\% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD.

CONCLUSIONS: VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.},
	keywords = {Aged, Equipment Failure, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention, Retrospective Studies, Vascular Surgical Procedures, Wound Closure Techniques},
	issn = {1876-7605},
	doi = {10.1016/j.jcin.2012.05.005},
	author = {Vidi, Venkatesan D and Matheny, Michael E and Govindarajulu, Usha S and Normand, Sharon-Lise T. and Robbins, Susan L and Agarwal, Vikram V and Bangalore, Sripal and Resnic, Frederic S}
}
@article {516576,
	title = {An administrative claims measure suitable for profiling hospital performance based on 30-day all-cause readmission rates among patients with acute myocardial infarction},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {4},
	number = {2},
	year = {2011},
	month = {2011 Mar},
	pages = {243-52},
	abstract = {BACKGROUND: National attention has increasingly focused on readmission as a target for quality improvement. We present the development and validation of a model approved by the National Quality Forum and used by the Centers for Medicare \& Medicaid Services for hospital-level public reporting of risk-standardized readmission rates for patients discharged from the hospital after an acute myocardial infarction.

METHODS AND RESULTS: We developed a hierarchical logistic regression model to calculate hospital risk-standardized 30-day all-cause readmission rates for patients hospitalized with acute myocardial infarction. The model was derived using Medicare claims data for a 2006 cohort and validated using claims and medical record data. The unadjusted readmission rate was 18.9\%. The final model included 31 variables and had discrimination ranging from 8\% observed 30-day readmission rate in the lowest predictive decile to 32\% in the highest decile and a C statistic of 0.63. The 25th and 75th percentiles of the risk-standardized readmission rates across 3890 hospitals were 18.6\% and 19.1\%, with fifth and 95th percentiles of 18.0\% and 19.9\%, respectively. The odds of all-cause readmission for a hospital 1 SD above average were 1.35 times that of a hospital 1 SD below average. Hospital-level adjusted readmission rates developed using the claims model were similar to rates produced for the same cohort using a medical record model (correlation, 0.98; median difference, 0.02 percentage points).

CONCLUSIONS: This claims-based model of hospital risk-standardized readmission rates for patients with acute myocardial infarction produces estimates that are excellent surrogates for those produced from a medical record model.},
	keywords = {Aged, Aged, 80 and over, Cohort Studies, Female, Humans, Insurance Claim Review, Logistic Models, Male, Medicare, Models, Statistical, Myocardial Infarction, Outcome and Process Assessment (Health Care), Outcome Assessment (Health Care), Patient Readmission, Quality of Health Care, Reproducibility of Results, Risk Factors, Time Factors, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.110.957498},
	author = {Krumholz,Harlan M. and Lin, Zhenqiu and Drye, Elizabeth E and Desai, Mayur M and Han, Lein F and Rapp, Michael T and Mattera, Jennifer A and Normand, Sharon-Lise T.}
}
@article {516566,
	title = {An administrative claims model for profiling hospital 30-day mortality rates for pneumonia patients},
	journal = {PLoS One},
	volume = {6},
	number = {4},
	year = {2011},
	month = {2011 Apr 12},
	pages = {e17401},
	abstract = {BACKGROUND: Outcome measures for patients hospitalized with pneumonia may complement process measures in characterizing quality of care. We sought to develop and validate a hierarchical regression model using Medicare claims data that produces hospital-level, risk-standardized 30-day mortality rates useful for public reporting for patients hospitalized with pneumonia.

METHODOLOGY/PRINCIPAL FINDINGS: Retrospective study of fee-for-service Medicare beneficiaries age 66 years and older with a principal discharge diagnosis of pneumonia. Candidate risk-adjustment variables included patient demographics, administrative diagnosis codes from the index hospitalization, and all inpatient and outpatient encounters from the year before admission. The model derivation cohort included 224,608 pneumonia cases admitted to 4,664 hospitals in 2000, and validation cohorts included cases from each of years 1998-2003. We compared model-derived state-level standardized mortality estimates with medical record-derived state-level standardized mortality estimates using data from the Medicare National Pneumonia Project on 50,858 patients hospitalized from 1998-2001. The final model included 31 variables and had an area under the Receiver Operating Characteristic curve of 0.72. In each administrative claims validation cohort, model fit was similar to the derivation cohort. The distribution of standardized mortality rates among hospitals ranged from 13.0\% to 23.7\%, with 25(th), 50(th), and 75(th) percentiles of 16.5\%, 17.4\%, and 18.3\%, respectively. Comparing model-derived risk-standardized state mortality rates with medical record-derived estimates, the correlation coefficient was 0.86 (Standard Error = 0.032).

CONCLUSIONS/SIGNIFICANCE: An administrative claims-based model for profiling hospitals for pneumonia mortality performs consistently over several years and produces hospital estimates close to those using a medical record model.},
	keywords = {Aged, Cohort Studies, Hospital Mortality, Humans, Medicare, Models, Statistical, Pneumonia, Retrospective Studies, United States},
	issn = {1932-6203},
	doi = {10.1371/journal.pone.0017401},
	author = {Bratzler, Dale W and Normand, Sharon-Lise T. and Wang, Yun and O{\textquoteright}Donnell, Walter J and Metersky, Mark and Han, Lein F and Rapp, Michael T and Krumholz,Harlan M.}
}
@article {516551,
	title = {Alternative methods for testing treatment effects on the basis of multiple outcomes: simulation and case study},
	journal = {Stat Med},
	volume = {30},
	number = {16},
	year = {2011},
	month = {2011 Jul 20},
	pages = {1917-32},
	abstract = {In clinical trials multiple outcomes are often used to assess treatment interventions. This paper presents an evaluation of likelihood-based methods for jointly testing treatment effects in clinical trials with multiple continuous outcomes. Specifically, we compare the power of joint tests of treatment effects obtained from joint models for the multiple outcomes with univariate tests based on modeling the outcomes separately. We also consider the power and bias of tests when data are missing, a common feature of many trials, especially in psychiatry. Our results suggest that joint tests capitalize on the correlation of multiple outcomes and are more powerful than standard univariate methods, especially when outcomes are missing completely at random. When outcomes are missing at random, test procedures based on correctly specified joint models are unbiased, while standard univariate procedures are not. Results of a simulation study are reported, and the methods are illustrated in an example from the Clinical Antipsychotic Trials of Intervention Effectiveness for schizophrenia.},
	keywords = {Antipsychotic Agents, Biostatistics, Clinical Trials as Topic, Dibenzothiazepines, Humans, Likelihood Functions, Linear Models, Metabolic Syndrome X, Models, Statistical, Multivariate Analysis, Outcome Assessment (Health Care), Perphenazine, Quetiapine Fumarate, Randomized Controlled Trials as Topic, Schizophrenia, Treatment Outcome},
	issn = {1097-0258},
	doi = {10.1002/sim.4262},
	author = {Yoon, Frank B and Fitzmaurice, Garrett M and Lipsitz, Stuart R and Horton, Nicholas J and Laird, Nan M and Normand, Sharon-Lise T.}
}
@article {516571,
	title = {A bayesian two-part latent class model for longitudinal medical expenditure data: assessing the impact of mental health and substance abuse parity},
	journal = {Biometrics},
	volume = {67},
	number = {1},
	year = {2011},
	month = {2011 Mar},
	pages = {280-9},
	abstract = {In 2001, the U.S. Office of Personnel Management required all health plans participating in the Federal Employees Health Benefits Program to offer mental health and substance abuse benefits on par with general medical benefits. The initial evaluation found that, on average, parity did not result in either large spending increases or increased service use over the four-year observational period. However, some groups of enrollees may have benefited from parity more than others. To address this question, we propose a Bayesian two-part latent class model to characterize the effect of parity on mental health use and expenditures. Within each class, we fit a two-part random effects model to separately model the probability of mental health or substance abuse use and mean spending trajectories among those having used services. The regression coefficients and random effect covariances vary across classes, thus permitting class-varying correlation structures between the two components of the model. Our analysis identified three classes of subjects: a group of low spenders that tended to be male, had relatively rare use of services, and decreased their spending pattern over time; a group of moderate spenders, primarily female, that had an increase in both use and mean spending after the introduction of parity; and a group of high spenders that tended to have chronic service use and constant spending patterns. By examining the joint 95\% highest probability density regions of expected changes in use and spending for each class, we confirmed that parity had an impact only on the moderate spender class.},
	keywords = {Computer Simulation, Humans, Longitudinal Studies, Mental Health Services, Models, Economic, Resource Allocation, Substance-Related Disorders, United States},
	issn = {1541-0420},
	doi = {10.1111/j.1541-0420.2010.01439.x},
	author = {Neelon, Brian and A. James O{\textquoteright}Malley and Normand, Sharon-Lise T.}
}
@article {516501,
	title = {Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence},
	journal = {BMJ},
	volume = {343},
	year = {2011},
	month = {2011 Nov 29},
	pages = {d7434},
	abstract = {OBJECTIVE: To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants.

DESIGN: Systematic review of clinical trials, observational studies, and registries.

DATA SOURCES: Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration.

STUDY SELECTION: Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed.

RESULTS: There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88\% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding.

CONCLUSIONS: There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.},
	keywords = {Ceramics, Chromium Alloys, Female, Hip Prosthesis, Humans, Joint Diseases, Male, Polyethylene, Prosthesis Design, Recovery of Function, Reoperation, Safety, Treatment Outcome},
	issn = {1756-1833},
	doi = {10.1136/bmj.d7434},
	author = {Sedrakyan, Art and Normand, Sharon-Lise T. and Dabic, Stefan and Jacobs, Samantha and Graves, Stephen and Marinac-Dabic, Danica}
}
@article {516591,
	title = {Continuing medical education program in the journal of hospital medicine},
	journal = {J Hosp Med},
	volume = {6},
	number = {3},
	year = {2011},
	month = {2011 Mar},
	pages = {141},
	keywords = {Curriculum, Education, Medical, Continuing, Hospitalists, Humans, Periodicals as Topic},
	issn = {1553-5606},
	doi = {10.1002/jhm.912},
	author = {Baudendistel, Thomas E and Lindenauer, Peter K and Normand, Sharon-Lise T. and Drye, Elizabeth E and Lin, Zhenqiu and Goodrich, Katherine and Desai, Mayur M and Bratzler, Dale W and O{\textquoteright}Donnell, Walter J and Metersky, Mark L and Krumholz,Harlan M.}
}
@article {516541,
	title = {Crowd-out and exposure effects of physical comorbidities on mental health care use: implications for racial-ethnic disparities in access},
	journal = {Health Serv Res},
	volume = {46},
	number = {4},
	year = {2011},
	month = {2011 Aug},
	pages = {1259-80},
	abstract = {OBJECTIVES: In disparities models, researchers adjust for differences in "clinical need," including indicators of comorbidities. We reconsider this practice, assessing (1) if and how having a comorbidity changes the likelihood of recognition and treatment of mental illness; and (2) differences in mental health care disparities estimates with and without adjustment for comorbidities.

DATA: Longitudinal data from 2000 to 2007 Medical Expenditure Panel Survey (n=11,083) split into pre and postperiods for white, Latino, and black adults with probable need for mental health care.

STUDY DESIGN: First, we tested a crowd-out effect (comorbidities decrease initiation of mental health care after a primary care provider [PCP] visit) using logistic regression models and an exposure effect (comorbidities cause more PCP visits, increasing initiation of mental health care) using instrumental variable methods. Second, we assessed the impact of adjustment for comorbidities on disparity estimates.

PRINCIPAL FINDINGS: We found no evidence of a crowd-out effect but strong evidence for an exposure effect. Number of postperiod visits positively predicted initiation of mental health care. Adjusting for racial/ethnic differences in comorbidities increased black-white disparities and decreased Latino-white disparities.

CONCLUSIONS: Positive exposure findings suggest that intensive follow-up programs shown to reduce disparities in chronic-care management may have additional indirect effects on reducing mental health care disparities.},
	keywords = {Adolescent, Adult, Age Factors, Aged, Comorbidity, Continental Population Groups, Ethnic Groups, Female, Health Services Accessibility, Health Services Research, Healthcare Disparities, Humans, Longitudinal Studies, Male, Mental Health Services, Middle Aged, Quality of Health Care, Socioeconomic Factors, Young Adult},
	issn = {1475-6773},
	doi = {10.1111/j.1475-6773.2011.01253.x},
	author = {Cook, Benjamin L{\^e} and Thomas G. McGuire and Alegr{\'\i}a, Margarita and Normand, Sharon-Lise}
}
@article {516586,
	title = {Development, validation, and results of a measure of 30-day readmission following hospitalization for pneumonia},
	journal = {J Hosp Med},
	volume = {6},
	number = {3},
	year = {2011},
	month = {2011 Mar},
	pages = {142-50},
	abstract = {BACKGROUND: Readmission following hospital discharge has become an important target of quality improvement.

OBJECTIVE: To describe the development, validation, and results of a risk-standardized measure of hospital readmission rates among elderly patients with pneumonia employed in federal quality measurement and efficiency initiatives.

DESIGN: A retrospective cohort study using hospital and outpatient Medicare claims from 2005 and 2006.

SETTING: A total of 4675 hospitals in the United States.

PATIENTS: Medicare beneficiaries aged >65 years with a principal discharge diagnosis of pneumonia.

INTERVENTION: None.

MEASUREMENTS: Hospital-specific, risk-standardized 30-day readmission rates calculated as the ratio of predicted-to-expected readmissions, multiplied by the national unadjusted rate. Comparison of the areas under the receiver operating curve (ROC) and measurement of correlation coefficient in development and validation samples.

RESULTS: The development sample consisted of 226,545 hospitalizations at 4675 hospitals, with an overall unadjusted 30-day readmission rate of 17.4\%. The median risk-standardized hospital readmission rate was 17.3\%, and the odds of readmission for a hospital one standard deviation above average was 1.4 times that of a hospital one standard deviation below average. Performance of the medical record and administrative models was similar (areas under the ROC curve 0.59 and 0.63, respectively) and the correlation coefficient of estimated state-specific standardized readmission rates from the administrative and medical record models was 0.96.

CONCLUSIONS: Rehospitalization within 30 days of treatment for pneumonia is common, and rates vary across hospitals. A risk-standardized measure of hospital readmission rates derived from administrative claims has similar performance characteristics to one based on medical record review.},
	keywords = {Aged, Cohort Studies, Female, Hospitalization, Humans, Male, Medical Records, Medicare, Middle Aged, Patient Readmission, Pneumonia, Retrospective Studies, United States},
	issn = {1553-5606},
	doi = {10.1002/jhm.890},
	author = {Lindenauer, Peter K and Normand, Sharon-Lise T. and Drye, Elizabeth E and Lin, Zhenqiu and Goodrich, Katherine and Desai, Mayur M and Bratzler, Dale W and O{\textquoteright}Donnell, Walter J and Metersky, Mark L and Krumholz,Harlan M.}
}
@article {516611,
	title = {Effect of insurance parity on substance abuse treatment},
	journal = {Psychiatr Serv},
	volume = {62},
	number = {2},
	year = {2011},
	month = {2011 Feb},
	pages = {129-34},
	abstract = {OBJECTIVE: This study examined the impact of insurance parity on the use, cost, and quality of substance abuse treatment.

METHODS: The authors compared substance abuse treatment spending and utilization from 1999 to 2002 for continuously enrolled beneficiaries covered by Federal Employees Health Benefit (FEHB) plans, which require parity coverage of mental health and substance use disorders, with spending and utilization among beneficiaries in a matched set of health plans without parity coverage. Logistic regression models estimated the probability of any substance abuse service use. Conditional on use, linear models estimated total and out-of-pocket spending. Logistic regression models for three quality indicators for substance abuse treatment were also estimated: identification of adult enrollees with a new substance abuse diagnosis, treatment initiation, and treatment engagement. Difference-in-difference estimates were computed as (postparity - preparity) differences in outcomes in plans without parity subtracted from those in FEHB plans.

RESULTS: There were no significant differences between FEHB and non-FEHB plans in rates of change in average utilization of substance abuse services. Conditional on service utilization, the rate of substance abuse treatment out-of-pocket spending declined significantly in the FEHB plans compared with the non-FEHB plans (mean difference=-$101.09, 95\% confidence interval [CI]=-$198.06 to -$4.12), whereas changes in total plan spending per user did not differ significantly. With parity, more patients had new diagnoses of a substance use disorder (difference-in-difference risk=.10\%, CI=.02\% to .19\%). No statistically significant differences were found for rates of initiation and engagement in substance abuse treatment.

CONCLUSIONS: Findings suggest that for continuously enrolled populations, providing parity of substance abuse treatment coverage improved insurance protection but had little impact on utilization, costs for plans, or quality of care.},
	keywords = {Adolescent, Adult, Aged, Female, Financing, Personal, Healthcare Disparities, Humans, Logistic Models, Male, Middle Aged, National Health Insurance, United States, Quality of Health Care, Substance-Related Disorders, United States, Young Adult},
	issn = {1557-9700},
	doi = {10.1176/ps.62.2.pss6202_0129},
	author = {Azzone, Vanessa and Richard G. Frank and Normand, Sharon-Lise T. and Burnam, M Audrey}
}
@article {572946,
	title = {Estimating cost-offsets of new medications: use of new antipsychotics and mental health costs for schizophrenia},
	journal = {Stat Med},
	volume = {30},
	number = {16},
	year = {2011},
	month = {2011 Jul 20},
	pages = {1971-88},
	abstract = {Estimation of the effect of one treatment compared to another in the absence of randomization is a common problem in biostatistics. An increasingly popular approach involves instrumental variables-variables that are predictive of who received a treatment yet not directly predictive of the outcome. When treatment is binary, many estimators have been proposed: method-of-moments estimators using a two-stage least-squares procedure, generalized-method-of-moments estimators using two-stage predictor substitution or two-stage residual inclusion procedures, and likelihood-based latent variable approaches. The critical assumptions to the consistency of two-stage procedures and of the likelihood-based procedures differ. Because neither set of assumptions can be completely tested from the observed data alone, comparing the results from the different approaches is an important sensitivity analysis. We provide a general statistical framework for estimation of the casual effect of a binary treatment on a continuous outcome using simultaneous equations to specify models. A comparison of health care costs for adults with schizophrenia treated with newer atypical antipsychotics and those treated with conventional antipsychotic medications illustrates our methods. Surprisingly large differences in the results among the methods are investigated using a simulation study. Several new findings concerning the performance in terms of precision and robustness of each approach in different situations are obtained. We illustrate that in general supplemental information is needed to determine which analysis, if any, is trustworthy and reaffirm that comparing results from different approaches is a valuable sensitivity analysis.},
	keywords = {Adult, Antipsychotic Agents, Bayes Theorem, Biostatistics, Drug Costs, Female, Humans, Least-Squares Analysis, Likelihood Functions, Male, Models, Statistical, Regression Analysis, Schizophrenia, Treatment Outcome},
	issn = {1097-0258},
	doi = {10.1002/sim.4245},
	author = {A. James O{\textquoteright}Malley and RG Frank and Normand, S-L T}
}
@article {516491,
	title = {Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing},
	journal = {BMC Med Inform Decis Mak},
	volume = {11},
	year = {2011},
	month = {2011 Dec 14},
	pages = {75},
	abstract = {BACKGROUND: Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery.

METHODS: A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year.

RESULTS: We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100\% (5/5) and specificity of 98.8\% (79/80).

CONCLUSIONS: The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.},
	keywords = {Adult, Benchmarking, Coronary Artery Bypass, Decision Support Techniques, Humans, Markov Chains, Massachusetts, Medical Errors, Medical Records, Models, Statistical, Monte Carlo Method, Odds Ratio, Outcome Assessment (Health Care), Patient Admission, Point-of-Care Systems, Retrospective Studies, Risk Adjustment, Safety Management, Sentinel Surveillance},
	issn = {1472-6947},
	doi = {10.1186/1472-6947-11-75},
	author = {Matheny, Michael E and Normand, Sharon-Lise T. and Gross, Thomas P and Marinac-Dabic, Danica and Loyo-Berrios, Nilsa and Vidi, Venkatesan D and Donnelly, Sharon and Resnic, Frederic S}
}
@article {516546,
	title = {Gender differences in the association between family conflict and adolescent substance use disorders},
	journal = {J Adolesc Health},
	volume = {49},
	number = {2},
	year = {2011},
	month = {2011 Aug},
	pages = {187-92},
	abstract = {PURPOSE: The objectives of this study were (1) to examine whether the association between childhood family conflict and the risk of substance use disorders (SUDs) in adolescence differs by gender, and (2) to determine whether anxious/depressive symptoms and conduct problems explain this association among adolescent males and females.

METHODS: Data were obtained from 1,421 children aged 10-16 years at the time of enrollment in the Project on Human Development in Chicago Neighborhoods. We assessed gender differences in the association between childhood family conflict and adolescent SUDs by fitting a logistic regression model that included the interaction of gender and family conflict. We also investigated whether conduct problems and anxious/depressive symptoms explained the association between family conflict and SUDs differently for males and females through gender-specific mediation analyses.

RESULTS: The association between childhood family conflict and SUDs in adolescence differed by gender (p = .04). Family conflict was significantly associated with SUDs among females (OR: 1.61; CI: 1.20-2.15), but not among males (OR: 1.00; CI: .76-1.32). The elevated risk of SUDs among females exposed to family conflict was partly explained by girls{\textquoteright} conduct problems, but not by anxious/depressive symptoms.

CONCLUSIONS: Females living in families with elevated levels of conflict were more likely to engage in acting out behaviors, which was associated with the development of SUDs. Future epidemiologic research is needed to help determine when this exposure is most problematic with respect to subsequent mental health outcomes and the most crucial time to intervene.},
	keywords = {Adolescent, Adolescent Behavior, Anxiety, Child, Conflict (Psychology), Depression, Family, Female, Humans, Logistic Models, Male, Negotiating, Parent-Child Relations, Sex Factors, Substance-Related Disorders},
	issn = {1879-1972},
	doi = {10.1016/j.jadohealth.2010.12.003},
	author = {Skeer, Margie R and McCormick, Marie C. and Normand, Sharon-Lise T. and Mimiaga, Matthew J and Buka, Stephen L. and Gilman, Stephen E.}
}
@article {516616,
	title = {Impact of independent data adjudication on hospital-specific estimates of risk-adjusted mortality following percutaneous coronary interventions in massachusetts},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {4},
	number = {1},
	year = {2011},
	month = {2011 Jan 01},
	pages = {92-8},
	abstract = {BACKGROUND: As part of state-mandated public reporting of outcomes after percutaneous coronary interventions (PCIs) in Massachusetts, procedural and clinical data were prospectively collected. Variables associated with higher mortality were audited to ensure accuracy of coding. We examined the impact of adjudication on identifying hospitals with possible deficiencies in the quality of PCI care.

METHODS AND RESULTS: From October 2005 to September 2006, 15 721 admissions for PCI occurred in 21 hospitals. Of the 864 high-risk variables from 822 patients audited by committee, 201 were changed, with reassignment to lower acuities in 97 (30\%) of the 321 shock cases, 24 (43\%) of the 56 salvage cases, and 73 (15\%) of the 478 emergent cases. Logistic regression models were used to predict patient-specific in-hospital mortality. Of 241 (1.5\%) patients who died after PCI, 30 (12.4\%) had a lower predicted mortality with adjudicated than with unadjudicated data. Model accuracy was excellent with either adjudicated or unadjudicated data. Hospital-specific risk-standardized mortality rates were estimated using both adjudicated and unadjudicated data through hierarchical logistic regression. Although adjudication reduced between-hospital variation by one third, risk-standardized mortality rates were similar using unadjudicated and adjudicated data. None of the hospitals were identified as statistical outliers. However, cross-validated posterior-predicted P values calculated with adjudicated data increased the number of borderline hospital outliers compared with unadjudicated data.

CONCLUSIONS: Independent adjudication of site-reported high-risk features may increase the ability to identify hospitals with higher risk-adjusted mortality after PCI despite having little impact on the accuracy of risk prediction for the entire population.},
	keywords = {Angioplasty, Balloon, Coronary, Hospital Mortality, Humans, Logistic Models, Massachusetts, Prospective Studies, Risk Adjustment},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.110.957597},
	author = {Barringhaus, Kurt G and Zelevinsky, Katya and Lovett, Ann and Normand, Sharon-Lise T. and Ho, Kalon K L}
}
@article {516601,
	title = {Improvement in mortality risk prediction after percutaneous coronary intervention through the addition of a "compassionate use" variable to the National Cardiovascular Data Registry CathPCI dataset: a study from the Massachusetts Angioplasty Registry},
	journal = {J Am Coll Cardiol},
	volume = {57},
	number = {8},
	year = {2011},
	month = {2011 Feb 22},
	pages = {904-11},
	abstract = {OBJECTIVES: This study investigated the impact of adding novel elements to models predicting in-hospital mortality after percutaneous coronary interventions (PCIs).

BACKGROUND: Massachusetts mandated public reporting of hospital-specific PCI mortality in 2003. In 2006, a physician advisory group recommended adding to the prediction models 3 attributes not collected by the National Cardiovascular Data Registry instrument. These "compassionate use" (CU) features included coma on presentation, active hemodynamic support during PCI, and cardiopulmonary resuscitation at PCI initiation.

METHODS: From October 2005 through September 2007, PCI was performed during 29,784 admissions in Massachusetts nonfederal hospitals. Of these, 5,588 involved patients with ST-segment elevation myocardial infarction or cardiogenic shock. Cases with CU criteria identified were adjudicated by trained physician reviewers. Regression models with and without the CU composite variable (presence of any of the 3 features) were compared using areas under the receiver-operator characteristic curves.

RESULTS: Unadjusted mortality in this high-risk subset was 5.7\%. Among these admissions, 96 (1.7\%) had at least 1 CU feature, with 69.8\% mortality. The adjusted odds ratio for in-hospital death for CU PCIs (vs. no CU criteria) was 27.3 (95\% confidence interval: 14.5 to 47.6). Discrimination of the model improved after including CU, with areas under the receiver-operating characteristic curves increasing from 0.87 to 0.90 (p < 0.01), while goodness of fit was preserved.

CONCLUSIONS: A small proportion of patients at extreme risk of post-PCI mortality can be identified using pre-procedural factors not routinely collected, but that heighten predictive accuracy. Such improvements in model performance may result in greater confidence in reporting of risk-adjusted PCI outcomes.},
	keywords = {Adult, Age Factors, Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary, Coronary Disease, Databases, Factual, Female, Follow-Up Studies, Hospital Mortality, Humans, Male, Massachusetts, Middle Aged, Myocardial Infarction, Percutaneous Coronary Intervention, Predictive Value of Tests, Quality Improvement, Radiography, Registries, Risk Assessment, Sex Factors, Shock, Cardiogenic, Survival Analysis},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2010.09.057},
	author = {Resnic, Frederic S and Normand, Sharon-Lise T. and Piemonte, Thomas C and Shubrooks, Samuel J and Zelevinsky, Katya and Lovett, Ann and Ho, Kalon K L}
}
@article {516606,
	title = {Long-term clinical outcomes following drug-eluting or bare-metal stent placement in patients with severely reduced GFR: Results of the Massachusetts Data Analysis Center (Mass-DAC) State Registry},
	journal = {Am J Kidney Dis},
	volume = {57},
	number = {2},
	year = {2011},
	month = {2011 Feb},
	pages = {202-11},
	abstract = {BACKGROUND: Patients with chronic kidney disease have been under-represented in randomized trials of drug-eluting stents relative to bare-metal stents and are at high risk of mortality.

STUDY DESIGN: Cohort study with propensity score matching.

SETTINGS \& PARTICIPANTS: All adults with chronic kidney disease and severely decreased glomerular filtration rate (GFR; serum creatinine >2.0 mg/dL or dialysis dependence) undergoing percutaneous coronary intervention with stent placement between April 1, 2003, and September 30, 2005, at all acute-care nonfederal hospitals in Massachusetts.

PREDICTOR: Patients were classified as drug-eluting stent-treated if all stents were drug eluting and bare-metal stent-treated if all stents were bare metal. Patients treated with both types of stents were excluded from the primary analysis.

OUTCOMES \& MEASUREMENTS: 2-year crude mortality risk differences (drug-eluting - bare-metal stents) were determined from vital statistics records, and risk-adjusted mortality, myocardial infraction (MI), and revascularization differences were estimated using propensity score matching of patients with severely reduced GFR based on clinical and procedural information collected at the index admission.

RESULTS: 1,749 patients with severely reduced GFR (24\% dialysis dependent) were treated with drug-eluting (n = 1,256) or bare-metal stents (n = 493) during the study. Overall 2-year mortality was 32.8\% (unadjusted drug-eluting stent vs bare-metal stent; 30.1\% vs 39.8\%; P < 0.001). After propensity score matching 431 patients with a drug-eluting stent to 431 patients with a bare-metal stent, 2-year risk-adjusted mortality, MI, and target-vessel revascularization rates were 39.4\% versus 37.4\% (risk difference, 2.1\%; 95\% CI, -4.3 to 8.5; P = 0.5), 16.0\% versus 19.0\% (risk difference, -3.0\%; 95\% CI, -8.2 to 2.1; P = 0.3), and 13.0\% versus 17.6\% (risk difference, -4.6\%; 95\% CI, -9.5 to 0.3; P = 0.06).

LIMITATIONS: Observational design, ascertainment of serum creatinine level >2.0 mg/dL and dialysis dependence from case report forms.

CONCLUSIONS: In patients with severely decreased GFR, treatment with drug-eluting stents was associated with a modest decrease in target-vessel revascularization not reaching statistical significance and was not associated with a difference in risk-adjusted rates of mortality or MI at 2 years compared with bare-metal stents.},
	keywords = {Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary, Chronic Disease, Cohort Studies, Comorbidity, Coronary Artery Disease, Drug-Eluting Stents, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Kidney Diseases, Male, Massachusetts, Metals, Middle Aged, Myocardial Infarction, Registries, Renal Replacement Therapy, Retrospective Studies, Risk Factors, Severity of Illness Index, Stents, Treatment Outcome},
	issn = {1523-6838},
	doi = {10.1053/j.ajkd.2010.09.017},
	author = {Charytan, David M and Varma, Manu R and Silbaugh, Treacy S and Lovett, Ann F and Normand, Sharon-Lise T. and Mauri, Laura}
}
@article {516596,
	title = {MISSING DATA IN REGRESSION MODELS FOR NON-COMMENSURATE MULTIPLE OUTCOMES},
	journal = {Revstat Stat J},
	volume = {9},
	number = {1},
	year = {2011},
	month = {2011 Mar 01},
	pages = {37-55},
	abstract = {Biomedical research often involves the measurement of multiple outcomes in different scales (continuous, binary and ordinal). A common approach for the analysis of such data is to ignore the potential correlation among the outcomes and model each outcome separately. This can lead not only to loss of efficiency but also to biased estimates in the presence of missing data. We address the problem of missing data in the context of multiple non-commensurate outcomes. The consequences of missing data when using likelihood and quasi-likelihood methods are described, and an extension of these methods to the situation of missing observations in the outcomes is proposed. Two real data examples illustrate the methodology.},
	issn = {1645-6726},
	author = {Teixeira-Pinto, Armando and Normand, Sharon-Lise}
}
@article {516511,
	title = {Multiple outcomes and multiple sources of evidence: best statistical practices},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {4},
	number = {6},
	year = {2011},
	month = {2011 Nov 01},
	pages = {579-80},
	keywords = {Bayes Theorem, Biometry, Blood Vessel Prosthesis Implantation, Cardiomyopathies, Cardiovascular Diseases, Female, Humans, Male, Multivariate Analysis, Postoperative Complications, Stroke},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.111.963751},
	author = {Normand, Sharon-Lise T.}
}
@article {516516,
	title = {National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008},
	journal = {JAMA},
	volume = {306},
	number = {15},
	year = {2011},
	month = {2011 Oct 19},
	pages = {1669-78},
	abstract = {CONTEXT: It is not known whether recent declines in ischemic heart disease and its risk factors have been accompanied by declines in heart failure (HF) hospitalization and mortality.

OBJECTIVE: To examine changes in HF hospitalization rate and 1-year mortality rate in the United States, nationally and by state or territory.

DESIGN, SETTING, AND PARTICIPANTS: From acute care hospitals in the United States and Puerto Rico, 55,097,390 fee-for-service Medicare beneficiaries hospitalized between 1998 and 2008 with a principal discharge diagnosis code for HF.

MAIN OUTCOME MEASURES: Changes in patient demographics and comorbidities, HF hospitalization rates, and 1-year mortality rates.

RESULTS: The HF hospitalization rate adjusted for age, sex, and race declined from 2845 per 100,000 person-years in 1998 to 2007 per 100,000 person-years in 2008 (P < .001), a relative decline of 29.5\%. Age-adjusted HF hospitalization rates declined over the study period for all race-sex categories. Black men had the lowest rate of decline (4142 to 3201 per 100,000 person-years) among all race-sex categories, which persisted after adjusting for age (incidence rate ratio, 0.81; 95\% CI, 0.79-0.84). Heart failure hospitalization rates declined significantly faster than the national mean in 16 states and significantly slower in 3 states. Risk-adjusted 1-year mortality decreased from 31.7\% in 1999 to 29.6\% in 2008 (P < .001), a relative decline of 6.6\%. One-year mortality rates declined significantly in 4 states but increased in 5 states.

CONCLUSIONS: The overall HF hospitalization rate declined substantially from 1998 to 2008 but at a lower rate for black men. The overall 1-year mortality rate declined slightly over the past decade but remains high. Changes in HF hospitalization and 1-year mortality rates were uneven across states.},
	keywords = {African Americans, Age Factors, Aged, Aged, 80 and over, Cohort Studies, Comorbidity, Female, Heart Failure, Hospitalization, Hospitals, Humans, Male, Medicare, Mortality, Retrospective Studies, Sex Factors, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2011.1474},
	author = {Chen, Jersey and Normand, Sharon-Lise T. and Wang, Yun and Krumholz,Harlan M.}
}
@article {516521,
	title = {Predicting the restenosis benefit of drug-eluting versus bare metal stents in percutaneous coronary intervention},
	journal = {Circulation},
	volume = {124},
	number = {14},
	year = {2011},
	month = {2011 Oct 04},
	pages = {1557-64},
	abstract = {BACKGROUND: Drug-eluting stents (DES) for percutaneous coronary intervention decrease the risk of restenosis compared with bare metal stents. However, they are costlier, require prolonged dual antiplatelet therapy, and provide the most benefit in patients at highest risk for restenosis. To assist physicians in targeting DES use in patients at the highest risk for target vessel revascularization (TVR), we developed and validated a model to predict TVR.

METHODS AND RESULTS: Preprocedural clinical and angiographic data from 27 107 percutaneous coronary intervention hospitalizations between October 1, 2004, and September 30, 2007, in Massachusetts were used to develop prediction models for TVR at 1 year. Models were developed from a two-thirds random sample and validated in the remaining third. The overall rate of TVR was 7.6\% (6.7\% with DES, 11\% with bare metal stents). Significant predictors of TVR included prior percutaneous coronary intervention, emergency or salvage percutaneous coronary intervention, prior coronary bypass surgery, peripheral vascular disease, diabetes mellitus, and angiographic characteristics. The model was superior to a 3-variable model of diabetes mellitus, stent diameter, and stent length (c statistic, 0.66 versus 0.60; P,
	keywords = {Aged, Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Restenosis, Coronary Stenosis, Cost-Benefit Analysis, Drug-Eluting Stents, Female, Humans, Male, Massachusetts, Middle Aged, Models, Cardiovascular, Registries, Stents},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.111.045229},
	author = {Yeh, Robert W and Normand, Sharon-Lise T. and Wolf, Robert E and Jones, Philip G and Ho, Kalon K L and Cohen, David J and Cutlip, Donald E and Mauri, Laura and Kugelmass, Aaron D and Amin, Amit P and Spertus, John A}
}
@article {516531,
	title = {Public reporting of cardiac surgery performance: Part 1--history, rationale, consequences},
	journal = {Ann Thorac Surg},
	volume = {92},
	number = {3 Suppl},
	year = {2011},
	month = {2011 Sep},
	pages = {S2-11},
	abstract = {Cardiac surgical report cards have historically been mandatory. This paradigm changed when The Society of Thoracic Surgeons recently implemented a voluntary public reporting program based on benchmark analyses from its National Cardiac Database. The primary rationale is to provide transparency and accountability, thus affirming the fundamental ethical right of patient autonomy. Previous studies suggest that public reporting facilitates quality improvement, although other approaches such as confidential feedback of results and regional quality improvement initiatives are also effective. Public reporting has not substantially impacted patient referral patterns or market share. However, this may change with implementation of healthcare reform and with refinement of public reporting formats to enhance consumer interpretability. Finally, the potential unintended adverse consequences of public reporting must be monitored, particularly to assure that hospitals and surgeons remain willing to care for high-risk patients.},
	keywords = {Benchmarking, Cardiac Surgical Procedures, Consumer Behavior, Ethics, Medical, Feedback, Forecasting, Health Care Reform, Health Status Indicators, Humans, National Practitioner Data Bank, Outcome Assessment (Health Care), Personal Autonomy, Quality Improvement, Quality Indicators, Health Care, Social Responsibility, United States},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2011.06.100},
	author = {Shahian, David M and Edwards, Fred H and Jacobs, Jeffrey P and Prager, Richard L and Normand, Sharon-Lise T. and Shewan, Cynthia M and O{\textquoteright}Brien, Sean M and Peterson, Eric D and Grover, Frederick L}
}
@article {516536,
	title = {Public reporting of cardiac surgery performance: Part 2--implementation},
	journal = {Ann Thorac Surg},
	volume = {92},
	number = {3 Suppl},
	year = {2011},
	month = {2011 Sep},
	pages = {S12-23},
	abstract = {Appropriate implementation is essential to create a credible public reporting system. Ideally, data should be obtained from an audited clinical data registry, and structure, process, or outcomes metrics may be reported. Composite measures are increasingly used, as are measures of appropriateness, patient satisfaction, functional status, and health-related quality of life. Classification of provider performance should use statistical criteria appropriate to the policy objectives and to the desired balance of sensitivity and specificity. Public reports should use simplified visual or tabular presentation aids that maximize correct interpretation of numerical data. Because of sample size issues, and to emphasize that cardiac surgery requires team-based care, public reporting should generally be focused at the program rather than individual surgeon level. This may also help to mitigate risk aversion, the avoidance of high-risk patients.},
	keywords = {Benchmarking, Cardiac Surgical Procedures, Cooperative Behavior, Data Display, Disability Evaluation, Health Plan Implementation, Humans, Interdisciplinary Communication, Medical Audit, National Practitioner Data Bank, Patient Care Team, Patient Satisfaction, Quality Improvement, Quality Indicators, Health Care, Quality of Life, United States},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2011.06.101},
	author = {Shahian, David M and Edwards, Fred H and Jacobs, Jeffrey P and Prager, Richard L and Normand, Sharon-Lise T. and Shewan, Cynthia M and O{\textquoteright}Brien, Sean M and Peterson, Eric D and Grover, Frederick L}
}
@article {516526,
	title = {Quality of care in the US territories},
	journal = {Arch Intern Med},
	volume = {171},
	number = {17},
	year = {2011},
	month = {2011 Sep 26},
	pages = {1528-40},
	abstract = {BACKGROUND: Health care quality in the US territories is poorly characterized. We used process measures to compare the performance of hospitals in the US territories and in the US states.

METHODS: Our sample included nonfederal hospitals located in the United States and its territories discharging Medicare fee-for-service (FFS) patients with a principal discharge diagnosis of acute myocardial infarction (AMI), heart failure (HF), or pneumonia (PNE) (July 2005-June 2008). We compared risk-standardized 30-day mortality and readmission rates between territorial and stateside hospitals, adjusting for performance on core process measures and hospital characteristics.

RESULTS: In 57 territorial hospitals and 4799 stateside hospitals, hospital mean 30-day risk-standardized mortality rates were significantly higher in the US territories (P,
	keywords = {Aged, Fee-for-Service Plans, Female, Guam, Heart Failure, Hospital Mortality, Humans, Male, Medicare, Micronesia, Middle Aged, Myocardial Infarction, Pneumonia, Puerto Rico, Quality of Health Care, United States, United States Virgin Islands},
	issn = {1538-3679},
	doi = {10.1001/archinternmed.2011.284},
	author = {Nunez-Smith, Marcella and Bradley, Elizabeth H and Herrin, Jeph and Santana, Calie and Curry, Leslie A and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {516561,
	title = {Racial and ethnic service use disparities among homeless adults with severe mental illnesses receiving ACT},
	journal = {Psychiatr Serv},
	volume = {62},
	number = {6},
	year = {2011},
	month = {2011 Jun},
	pages = {598-604},
	abstract = {OBJECTIVE: Case management-based interventions aimed at improving quality of care have the potential to narrow racial and ethnic disparities among people with chronic illnesses. The aim of this study was to assess the equity effects of assertive community treatment (ACT), an evidence-based case management intervention, among homeless adults with severe mental illness.

METHODS: This study used baseline, three-, and 12-month data for 6,829 black, Latino, and white adults who received ACT services through the ACCESS study (Access to Community Care and Effective Services and Support). Zero-inflated Poisson random regression models were used to estimate the adjusted probability of use of outpatient psychiatric services and, among service users, the intensity of use. Odds ratios and rate ratios (RRs) were computed to assess disparities at baseline and over time.

RESULTS: No disparities were found in probability of use at baseline or over time. Compared with white users, baseline intensity of use was lower for black users (RR=.89; 95\% confidence interval [CI]=.83-.96) and Latino users (RR=.65; CI=.52-.81]). Intensity did not change over time for whites, but it did for black and Latino users. Intensity increased for blacks between baseline and three months (RR=1.11, CI=1.06-1.17]) and baseline and 12 months (RR=1.17, CI=1.11-1.22]). Intensity of use dropped for Latinos between baseline and three months (RR=.83, CI=.70-.98).

CONCLUSIONS: Receipt of ACT was associated with a reduction in service use disparities for blacks but not for Latinos. Findings suggest that ACT{\textquoteright}s equity effects differ depending on race-ethnicity.},
	keywords = {Adult, African Continental Ancestry Group, Case Management, Chronic Disease, Cohort Studies, Community Mental Health Services, European Continental Ancestry Group, Female, Health Services Accessibility, Healthcare Disparities, Hispanic Americans, Homeless Persons, Humans, Longitudinal Studies, Male, Multivariate Analysis, Patient Dropouts, Pennsylvania, Probability, Psychotic Disorders, Utilization Review},
	issn = {1557-9700},
	doi = {10.1176/ps.62.6.pss6206_0598},
	author = {Horvitz-Lennon, Marcela and Zhou, Dongli and Normand, Sharon-Lise T. and Alegr{\'\i}a, Margarita and Thompson, Wes K}
}
@article {516506,
	title = {Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site},
	journal = {Am Heart J},
	volume = {162},
	number = {5},
	year = {2011},
	month = {2011 Nov},
	pages = {826-31},
	abstract = {BACKGROUND: Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI.

STUDY DESIGN: The MASS COMM trial (ClinicalTrials.gov no. NCT01116882) is a randomized trial comparing the safety and effectiveness of nonemergency PCI at hospitals without surgery on-site (SOS) (non-SOS hospitals) and hospitals with SOS (SOS hospitals). A total of 3,690 subjects will be randomized in a 3:1 fashion to undergo PCI at non-SOS and SOS hospitals, with follow-up at hospital discharge, 30 days, and 12 months after PCI. The rate of major adverse cardiac events (all-cause mortality, myocardial infarction, repeat revascularization, and stroke) will serve as the primary safety end point at 30 days and the primary effectiveness end point at 12 months. The design is a 1-way randomized trial with a statistical hypothesis of noninferiority of nonemergency PCI at non-SOS hospitals for both safety and effectiveness end points.

CONCLUSIONS: This multicenter, randomized trial will compare the relative safety and effectiveness of nonemergency PCI at sites with and without cardiac SOS.},
	keywords = {Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Artery Disease, Coronary Care Units, Emergency Service, Hospital, Health Services Accessibility, Hospitals, Community, Humans, Massachusetts, Patient Selection, Research Design, Treatment Outcome},
	issn = {1097-6744},
	doi = {10.1016/j.ahj.2011.08.018},
	author = {Mauri, Laura and Normand, Sharon-Lise T. and Pencina, Michael and Cutlip, Donald E and Jeon, Cathy and Dreyer, Paul and Kuntz, Richard E and Baim, Donald S and Jacobs, Alice K}
}
@article {516496,
	title = {Ten-year trends in quality of care and spending for depression: 1996 through 2005},
	journal = {Arch Gen Psychiatry},
	volume = {68},
	number = {12},
	year = {2011},
	month = {2011 Dec},
	pages = {1218-26},
	abstract = {CONTEXT: During the past decade, the introduction of generic versions of newer antidepressants and the release of Food and Drug Administration warnings regarding suicidality in children, adolescents, and young adults may have had an effect on cost and quality of depression treatment.

OBJECTIVES: To examine longitudinal trends in health service utilization, spending, and quality of care for depression.

DESIGN: Observational trend study.

SETTING: Florida Medicaid enrollees, between July 1, 1996, and June 30, 2006. Patients~ Annual cohorts aged 18 to 64 years diagnosed as having depression.

MAIN OUTCOME MEASURES: Mental health care spending (adjusted for inflation and case mix), as well as its components, including inpatient, outpatient, and medication expenditures. Quality-of-care measures included medication adherence, psychotherapy, and follow-up visits.

RESULTS: Mental health care spending increased from a mean of $2802 per enrollee to $3610 during this period (29\% increase). This increase occurred despite a mean decrease in inpatient spending from $641 per enrollee to $373 and was driven primarily by an increase in pharmacotherapy spending (up 110\%), the bulk of which was due to spending on antipsychotics (949\% increase). The percentage of enrollees with depression who were hospitalized decreased from 9.1\% to 5.1\%, and the percentage who received psychotherapy decreased from 56.6\% to 37.5\%. Antidepressant use increased from 80.6\% to 86.8\%, anxiety medication use was unchanged at 62.7\% and 64.4\%, and antipsychotic use increased from 25.9\% to 41.9\%. Changes in quality of care were mixed, with antidepressant use improving slightly, psychotherapy utilization fluctuating, and follow-up visits decreasing.

CONCLUSIONS: During a 10-year period, spending for Medicaid enrollees with depression increased substantially, with minimal improvements in quality of care. Antipsychotic use contributed significantly to the increase in spending, while contributing little to traditional measures of quality of care.},
	keywords = {Adolescent, Adult, Depressive Disorder, Female, Florida, Health Expenditures, Humans, Male, Medicaid, Mental Health Services, Middle Aged, Quality Indicators, Health Care, Quality of Health Care, United States, Young Adult},
	issn = {1538-3636},
	doi = {10.1001/archgenpsychiatry.2011.146},
	author = {Fullerton, Catherine A and Alisa B. Busch and Normand, Sharon-Lise T. and Thomas G. McGuire and Arnold M. Epstein}
}
@article {516581,
	title = {The use and abuse of multiple outcomes in randomized controlled depression trials},
	journal = {Contemp Clin Trials},
	volume = {32},
	number = {2},
	year = {2011},
	month = {2011 Mar},
	pages = {299-304},
	abstract = {OBJECTIVE: Multiple outcomes are commonly analyzed in randomized trials. Interpretation of the results of trials with many outcomes is not always straightforward. We characterize the prevalence and factors associated with multiple outcomes in reports of clinical trials of depression, methods used to account for these outcomes, and concordance between published analyses and original protocol specifications.

METHODS: A PubMed search for randomized controlled depression trials that included multiple outcomes published between January 2007 and October 2008 in 6 medical journals. Original study protocols were reviewed where available. Parallel data collection by 2 abstractors was used to determine trial registration information, the number of outcomes, and analytical method.

RESULTS: Of the 55 included trials, nearly half of the papers reported more than 1 primary outcome, while almost all (90.9\%, n = 50) reported more than 2 combined primary or secondary outcomes. Relatively few of the studies (5.8\%, n = 3) adjusted for multiple outcomes. While most studies had published protocols in clinical trial registries (76.4\%, n = 42), many did not specify outcomes in the protocol (n = 11) and a number had discrepancies with the published report.

CONCLUSIONS: Multiple outcomes are prevalent in randomized controlled depression trials and appropriate statistical analyses to account for these methods are rarely used. Not all studies filed protocols, and there were discrepancies between these protocols and published reports. These issues complicate interpretability of trial results, and in some cases may lead to spurious conclusions. Promulgation of guidelines to improve analysis and reporting of multiple outcomes is warranted.},
	keywords = {Bias (Epidemiology), Depressive Disorder, Humans, Psychiatric Status Rating Scales, Randomized Controlled Trials as Topic, Registries, Treatment Outcome},
	issn = {1559-2030},
	doi = {10.1016/j.cct.2010.12.007},
	author = {Tyler, Kristin M and Normand, Sharon-Lise T. and Horton, Nicholas J}
}
@article {516556,
	title = {Using Multiple Control Groups and Matching to Address Unobserved Biases in Comparative Effectiveness Research: An Observational Study of the Effectiveness of Mental Health Parity},
	journal = {Stat Biosci},
	volume = {3},
	number = {1},
	year = {2011},
	month = {2011 Jun 21},
	pages = {63-78},
	abstract = {Studies of large policy interventions typically do not involve randomization. Adjustments, such as matching, can remove the bias due to observed covariates, but residual confounding remains a concern. In this paper we introduce two analytical strategies to bolster inferences of the effectiveness of policy interventions based on observational data. First, we identify how study groups may differ and then select a second comparison group on this source of difference. Second, we match subjects using a strategy that finely balances the distributions of key categorical covariates and stochastically balances on other covariates. An observational study of the effect of parity on the severely ill subjects enrolled in the Federal Employees Health Benefits (FEHB) Program illustrates our methods.},
	issn = {1867-1764},
	doi = {10.1007/s12561-011-9035-4},
	author = {Yoon, Frank B and Huskamp, Haiden A. and Alisa B. Busch and Normand, Sharon-Lise T.}
}
@article {572966,
	title = {ACCF/AHA new insights into the methodology of performance measurement: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures},
	journal = {J Am Coll Cardiol},
	volume = {56},
	number = {21},
	year = {2010},
	month = {2010 Nov 16},
	pages = {1767-82},
	keywords = {American Heart Association, Cardiology, Health Policy, Outcome Assessment (Health Care), Quality Indicators, Health Care, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2010.09.009},
	author = {Spertus, John A and Bonow, Robert O and Chan, Paul and Diamond, George A and Drozda, Joseph P and Kaul, Sanjay and Krumholz,Harlan M. and Masoudi, Frederick A and Normand, Sharon-Lise T. and Peterson, Eric D and Radford, Martha J and Rumsfeld, John S}
}
@article {572976,
	title = {ACCF/AHA new insights into the methodology of performance measurement: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures},
	journal = {Circulation},
	volume = {122},
	number = {20},
	year = {2010},
	month = {2010 Nov 16},
	pages = {2091-106},
	keywords = {American Heart Association, Cardiology, Health Policy, Outcome Assessment (Health Care), Quality Indicators, Health Care, United States},
	issn = {1524-4539},
	doi = {10.1161/CIR.0b013e3181f7d78c},
	author = {Spertus, John A and Bonow, Robert O and Chan, Paul and Diamond, George A and Drozda, Joseph P and Kaul, Sanjay and Krumholz,Harlan M. and Masoudi, Frederick A and Normand, Sharon-Lise T. and Peterson, Eric D and Radford, Martha J and Rumsfeld, John S}
}
@article {573101,
	title = {Association of hospital coronary artery bypass volume with processes of care, mortality, morbidity, and the Society of Thoracic Surgeons composite quality score},
	journal = {J Thorac Cardiovasc Surg},
	volume = {139},
	number = {2},
	year = {2010},
	month = {2010 Feb},
	pages = {273-82},
	abstract = {OBJECTIVE: This study examines the association of hospital coronary artery bypass procedural volume with mortality, morbidity, evidence-based care processes, and Society of Thoracic Surgeons composite score.

METHODS: The study population consisted of 144,526 patients from 733 hospitals that submitted data to the Society of Thoracic Surgeons Adult Cardiac Database in 2007. End points included use of National Quality Forum-endorsed process measures (internal thoracic artery graft; preoperative beta-blockade; and discharge beta-blockade, antiplatelet agents, and lipid drugs), operative mortality (in-hospital or 30-day), major morbidity (stroke, renal failure, reoperation, sternal infection, and prolonged ventilation), and Society of Thoracic Surgeons composite score. Procedural volume was analyzed as a continuous variable and by volume strata (< 100, 100-149, 150-199, 200-299, 300-449, and > or = 450). Analyses were performed with logistic and multivariate hierarchical regression modeling.

RESULTS: Unadjusted mortality decreased across volume categories from 2.6\% (< 100 cases) to 1.7\% (> 450 cases, P < .0001), and these differences persisted after risk factor adjustment (odds ratio for lowest- vs highest-volume group, 1.49). Care processes and morbidity end points were not associated with hospital procedural volume except for a trend (P = .0237) toward greater internal thoracic artery use in high-volume hospitals. The average composite score for the lowest volume (< 100 cases) group was significantly lower than that of the 2 highest-volume groups, but only 1\% of composite score variation was explained by volume.

CONCLUSION: A volume-performance association exists for coronary artery bypass grafting but is weaker than that of other major complex procedures. There is considerable outcomes variability not explained by hospital volume, and low volume does not preclude excellent performance. Except for internal thoracic artery use, care processes and morbidity rates were not associated with volume.},
	keywords = {Adult, Aged, Aged, 80 and over, Cardiology Service, Hospital, Clinical Competence, Coronary Artery Bypass, Databases, Factual, Female, Hospital Mortality, Hospitals, Humans, Male, Middle Aged, Models, Statistical, Morbidity, Odds Ratio, Outcome and Process Assessment (Health Care), Regression Analysis, Respiration, Artificial, Time Factors, United States, Young Adult},
	issn = {1097-685X},
	doi = {10.1016/j.jtcvs.2009.09.007},
	author = {Shahian, David M and O{\textquoteright}Brien, Sean M and Normand, Sharon-Lise T. and Peterson, Eric D and Edwards, Fred H}
}
@article {572971,
	title = {Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices},
	journal = {JAMA},
	volume = {304},
	number = {18},
	year = {2010},
	month = {2010 Nov 10},
	pages = {2019-27},
	abstract = {CONTEXT: Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.

OBJECTIVE: To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices.

DESIGN, SETTING, AND PATIENTS: Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts.

MAIN OUTCOME MEASURE: Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95\% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered.

RESULTS: We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87\% vs 2.25\%; absolute risk increase, 0.62\% [95\% CI, 0.25\%-0.99\%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24\% vs 3.50\%; absolute increase, 0.74\% [95\% CI, 0.29\%-1.19\%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09\% vs 0.72\%; absolute increased risk, 0.37\% [95\% CI, 0.03\%-0.71\%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device.

CONCLUSION: Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.},
	keywords = {Adult, Aged, Automation, Cardiovascular Diseases, Equipment Safety, Female, Humans, Male, Massachusetts, Middle Aged, Product Surveillance, Postmarketing, Prospective Studies, Prostheses and Implants, Registries, Safety, United States, United States Food and Drug Administration},
	issn = {1538-3598},
	doi = {10.1001/jama.2010.1633},
	author = {Resnic, Frederic S and Gross, Thomas P and Marinac-Dabic, Danica and Loyo-Berrios, Nilsa and Donnelly, Sharon and Normand, Sharon-Lise T. and Matheny, Michael E}
}
@article {572951,
	title = {A Bayesian model for repeated measures zero-inflated count data with application to outpatient psychiatric service use},
	journal = {Stat Modelling},
	volume = {10},
	number = {4},
	year = {2010},
	month = {2010 Dec},
	pages = {421-439},
	abstract = {In applications involving count data, it is common to encounter an excess number of zeros. In the study of outpatient service utilization, for example, the number of utilization days will take on integer values, with many subjects having no utilization (zero values). Mixed-distribution models, such as the zero-inflated Poisson (ZIP) and zero-inflated negative binomial (ZINB), are often used to fit such data. A more general class of mixture models, called hurdle models, can be used to model zero-deflation as well as zero-inflation. Several authors have proposed frequentist approaches to fitting zero-inflated models for repeated measures. We describe a practical Bayesian approach which incorporates prior information, has optimal small-sample properties, and allows for tractable inference. The approach can be easily implemented using standard Bayesian software. A study of psychiatric outpatient service use illustrates the methods.},
	issn = {1471-082X},
	doi = {10.1177/1471082X0901000404},
	author = {Neelon, Brian H and A. James O{\textquoteright}Malley and Normand, Sharon-Lise T.}
}
@article {573016,
	title = {Comparative effectiveness of ST-segment-elevation myocardial infarction regionalization strategies},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {3},
	number = {5},
	year = {2010},
	month = {2010 Sep},
	pages = {506-13},
	abstract = {BACKGROUND: Primary percutaneous coronary intervention (PCI) is more effective on average than fibrinolytic therapy in the treatment of ST-segment-elevation myocardial infarction. Yet, most US hospitals are not equipped for PCI, and fibrinolytic therapy is still widely used. This study evaluated the comparative effectiveness of ST-segment-elevation myocardial infarction regionalization strategies to increase the use of PCI against standard emergency transport and care.

METHODS AND RESULTS: We estimated incremental treatment costs and quality-adjusted life expectancies of 2000 patients with ST-segment-elevation myocardial infarction who received PCI or fibrinolytic therapy in simulations of emergency care in a regional hospital system. To increase access to PCI across the system, we compared a base case strategy with 12 hospital-based strategies of building new PCI laboratories or extending the hours of existing laboratories and 1 emergency medical services-based strategy of transporting all patients with ST-segment-elevation myocardial infarction to existing PCI-capable hospitals. The base case resulted in 609 (95\% CI, 569-647) patients getting PCI. Hospital-based strategies increased the number of patients receiving PCI, the costs of care, and quality-adjusted life years saved and were cost-effective under a variety of conditions. An emergency medical services-based strategy of transporting every patient to an existing PCI facility was less costly and more effective than all hospital expansion options.

CONCLUSION: Our results suggest that new construction and staffing of PCI laboratories may not be warranted if an emergency medical services strategy is both available and feasible.},
	keywords = {Angioplasty, Balloon, Coronary, Costs and Cost Analysis, Electrocardiography, Emergency Medical Services, Health Services Accessibility, Humans, Life Expectancy, Myocardial Infarction, Patient Transfer, Regional Health Planning, Surgery Department, Hospital, Thrombolytic Therapy},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.109.908541},
	author = {Concannon, Thomas W and Kent, David M and Normand, Sharon-Lise and Joseph P. Newhouse and Griffith, John L and Joshua Cohen and Beshansky, Joni R and John B Wong and Aversano, Thomas and Selker, Harry P}
}
@article {572986,
	title = {The comprehensive care project: measuring physician performance in ambulatory practice},
	journal = {Health Serv Res},
	volume = {45},
	number = {6 Pt 2},
	year = {2010},
	month = {2010 Dec},
	pages = {1912-33},
	abstract = {OBJECTIVE: To investigate the feasibility, reliability, and validity of comprehensively assessing physician-level performance in ambulatory practice.

DATA SOURCES/STUDY SETTING: Ambulatory-based general internists in 13 states participated in the assessment.

STUDY DESIGN: We assessed physician-level performance, adjusted for patient factors, on 46 individual measures, an overall composite measure, and composite measures for chronic, acute, and preventive care. Between- versus within-physician variation was quantified by intraclass correlation coefficients (ICC). External validity was assessed by correlating performance on a certification exam.

DATA COLLECTION/EXTRACTION METHODS: Medical records for 236 physicians were audited for seven chronic and four acute care conditions, and six age- and gender-appropriate preventive services.

PRINCIPAL FINDINGS: Performance on the individual and composite measures varied substantially within (range 5-86 percent compliance on 46 measures) and between physicians (ICC range 0.12-0.88). Reliabilities for the composite measures were robust: 0.88 for chronic care and 0.87 for preventive services. Higher certification exam scores were associated with better performance on the overall (r = 0.19; p,
	keywords = {Acute Disease, Adult, Age Factors, Aged, Chronic Disease, Female, Humans, Male, Middle Aged, Practice Patterns, Physicians{\textquoteright}, Preventive Health Services, Primary Health Care, Quality Indicators, Health Care, Quality of Health Care, Retrospective Studies, Sex Factors},
	issn = {1475-6773},
	doi = {10.1111/j.1475-6773.2010.01160.x},
	author = {Holmboe, Eric S and Weng, Weifeng and Arnold, Gerald K and Kaplan, Sherrie H and Normand, Sharon-Lise and Greenfield, Sheldon and Hood, Sarah and Lipner, Rebecca S}
}
@article {573066,
	title = {Differences in patient survival after acute myocardial infarction by hospital capability of performing percutaneous coronary intervention: implications for regionalization},
	journal = {Arch Intern Med},
	volume = {170},
	number = {5},
	year = {2010},
	month = {2010 Mar 08},
	pages = {433-9},
	abstract = {BACKGROUND: There are increasing calls for regionalization of acute myocardial infarction (AMI) care in the United States to hospitals with the capacity to perform percutaneous coronary intervention (PCI). Whether regionalization will improve outcomes depends in part on the magnitude of existing differences in outcomes between PCI and non-PCI hospitals within the same health care region.

METHODS: A 100\% sample of claims from Medicare fee-for-service beneficiaries 65 years or older hospitalized for AMI between January 1, 2004, and December 31, 2006, was used to calculate hospital-level, 30-day risk-standardized mortality rates (RSMRs). The RSMRs between PCI and local non-PCI hospitals were compared within local health care regions defined by hospital referral regions (HRRs).

RESULTS: A total of 523 119 AMI patients was admitted to 1382 PCI hospitals, and 194 909 AMI patients were admitted to 2491 non-PCI hospitals in 295 HRRs with at least 1 PCI and 1 non-PCI hospital. Although PCI hospitals had lower RSMRs than non-PCI hospitals (mean, 16.1\% vs 16.9\%; P < .001), considerable overlap was seen in RSMRs between non-PCI and PCI hospitals within the same HRR. In 80 HRRs, the RSMRs at the best-performing PCI hospital were lower than those at local non-PCI hospitals by 3\% or more. Among the remaining HRRs, the RSMRs at the best-performing PCI hospital were lower by 1.5\% to 3.0\% in 104 HRRs and by greater than 0 to 1.5\% in 74 HRRs. In 37 HRRs, the RSMRs at the best-performing PCI hospital were no better or were higher than at local non-PCI hospitals.

CONCLUSIONS: The magnitude of benefit from comprehensively regionalizing AMI care to PCI hospitals appears to vary greatly across HRRs. These findings support a tailored regionalization policy that targets areas with the greatest outcome differences between PCI and local non-PCI hospitals.},
	keywords = {Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary, Female, Hospitals, Humans, Male, Myocardial Infarction, Outcome Assessment (Health Care), Registries, Survival Analysis, Survival Rate, Treatment Outcome, United States},
	issn = {1538-3679},
	doi = {10.1001/archinternmed.2009.538},
	author = {Chen, Jersey and Krumholz,Harlan M. and Wang, Yun and Curtis, Jeptha P and Rathore, Saif S and Ross, Joseph S and Normand, Sharon-Lise T. and Schreiner, Geoffrey C and Mulvey, Gregory and Nallamothu, Brahmajee K}
}
@article {573046,
	title = {A framework for evidence evaluation and methodological issues in implantable device studies},
	journal = {Med Care},
	volume = {48},
	number = {6 Suppl},
	year = {2010},
	month = {2010 Jun},
	pages = {S121-8},
	abstract = {Implantable medical devices (IMD) are frequently used in interventional medicine. There are a host of complex methodological issues to consider in conducting device studies. A general conceptual framework for evidence evaluation is needed to help investigators conduct comparative studies in this setting. It is known that clinical trials of implants require study design planning and creative execution that are quite different from those in pharmaceutical setting. Important study design issues such as randomization, masking and allocation concealment require unique approaches for each device. In addition, device comparative studies must cope with sources of variability different from pharmaceutical studies. These include operator learning curve effects, hospital-operator-patient interactions, and issues related to device technical characteristics. Observational studies of IMDs are particularly challenging. Selection of comparison groups, adjusting for confounding and addressing learning curve issues needs careful planning. We propose a general framework for IMD evaluation and provide an outline of the methodological issues that require further discussion. We hope this article will inspire and help to inform those interested in advancing comparative safety and effectiveness of IMDs and to plan and pursue future methodological work in this area.},
	keywords = {Bias (Epidemiology), Clinical Trials as Topic, Comparative Effectiveness Research, Humans, Prostheses and Implants, Research Design, Treatment Outcome},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e3181d991c4},
	author = {Sedrakyan, Art and Marinac-Dabic, Danica and Normand, Sharon-Lise T. and Mushlin, Alvin and Gross, Tom}
}
@article {573056,
	title = {Hospital volume and 30-day mortality for three common medical conditions},
	journal = {N Engl J Med},
	volume = {362},
	number = {12},
	year = {2010},
	month = {2010 Mar 25},
	pages = {1110-8},
	abstract = {BACKGROUND: The association between hospital volume and the death rate for patients who are hospitalized for acute myocardial infarction, heart failure, or pneumonia remains unclear. It is also not known whether a volume threshold for such an association exists.

METHODS: We conducted cross-sectional analyses of data from Medicare administrative claims for all fee-for-service beneficiaries who were hospitalized between 2004 and 2006 in acute care hospitals in the United States for acute myocardial infarction, heart failure, or pneumonia. Using hierarchical logistic-regression models for each condition, we estimated the change in the odds of death within 30 days associated with an increase of 100 patients in the annual hospital volume. Analyses were adjusted for patients{\textquoteright} risk factors and hospital characteristics. Bootstrapping procedures were used to estimate 95\% confidence intervals to identify the condition-specific volume thresholds above which an increased volume was not associated with reduced mortality.

RESULTS: There were 734,972 hospitalizations for acute myocardial infarction in 4128 hospitals, 1,324,287 for heart failure in 4679 hospitals, and 1,418,252 for pneumonia in 4673 hospitals. An increased hospital volume was associated with reduced 30-day mortality for all conditions (P,
	keywords = {Aged, Cross-Sectional Studies, Heart Failure, Hospital Bed Capacity, Hospital Mortality, Hospitalization, Hospitals, Hospitals, Teaching, Humans, Logistic Models, Medicare, Myocardial Infarction, Pneumonia, Risk Adjustment, United States},
	issn = {1533-4406},
	doi = {10.1056/NEJMsa0907130},
	author = {Ross, Joseph S and Normand, Sharon-Lise T. and Wang, Yun and Ko, Dennis T and Chen, Jersey and Drye, Elizabeth E and Patricia S. Keenan and Lichtman, Judith H and Bueno, H{\'e}ctor and Schreiner, Geoffrey C and Krumholz,Harlan M.}
}
@article {573076,
	title = {Missing data and convenient assumptions},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {3},
	number = {1},
	year = {2010},
	month = {2010 Jan},
	pages = {2-3},
	keywords = {Causality, Clinical Trials as Topic, Data Interpretation, Statistical, Empirical Research, Health Services Research, Humans, Outcome and Process Assessment (Health Care), Registries, Reproducibility of Results, Treatment Outcome},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.109.931543},
	author = {Normand, Sharon-Lise T.}
}
@article {572996,
	title = {National patterns of risk-standardized mortality and readmission for acute myocardial infarction and heart failure. Update on publicly reported outcomes measures based on the 2010 release},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {3},
	number = {5},
	year = {2010},
	month = {2010 Sep},
	pages = {459-67},
	abstract = {BACKGROUND: Patient outcomes provide a critical perspective on quality of care. The Centers for Medicare and Medicaid Services (CMS) is publicly reporting hospital 30-day risk-standardized mortality rates (RSMRs) and risk-standardized readmission rates (RSRRs) for patients hospitalized with acute myocardial infarction (AMI) and heart failure (HF). We provide a national perspective on hospital performance for the 2010 release of these measures.

METHODS AND RESULTS: The hospital RSMRs and RSRRs are calculated from Medicare claims data for fee-for-service Medicare beneficiaries, 65 years or older, hospitalized with AMI or HF between July 1, 2006, and June 30, 2009. The rates are calculated using hierarchical logistic modeling to account for patient clustering, and are risk-adjusted for age, sex, and patient comorbidities. The median RSMR for AMI was 16.0\% and for HF was 10.8\%. Both measures had a wide range of hospital performance with an absolute 5.2\% difference between hospitals in the 5th versus 95th percentile for AMI and 5.0\% for HF. The median RSRR for AMI was 19.9\% and for HF was 24.5\% (3.9\% range for 5th to 95th percentile for AMI, 6.7\% for HF). Distinct regional patterns were evident for both measures and both conditions.

CONCLUSIONS: High RSRRs persist for AMI and HF and clinically meaningful variation exists for RSMRs and RSRRs for both conditions. Our results suggest continued opportunities for improvement in patient outcomes for HF and AMI.},
	keywords = {Aged, Aged, 80 and over, Female, Heart Failure, Hospital Mortality, Humans, Male, Myocardial Infarction, Outcome and Process Assessment (Health Care), Patient Readmission, Practice Patterns, Physicians{\textquoteright}, Quality Assurance, Health Care, Risk, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.110.957613},
	author = {Bernheim, Susannah M and Grady, Jacqueline N and Lin, Zhenqiu and Wang, Yun and Wang, Yongfei and Savage, Shantal V and Bhat, Kanchana R and Ross, Joseph S and Desai, Mayur M and Merrill, Angela R and Han, Lein F and Rapp, Michael T and Drye, Elizabeth E and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {573571,
	title = {Natural orifice transluminal endoscopic surgery versus laparoscopic surgery for inadvertent colon injury repair: feasibility, risk of abdominal adhesions, and peritoneal contamination in a porcine survival model},
	journal = {Gastrointest Endosc},
	volume = {71},
	number = {4},
	year = {2010},
	month = {2010 Apr},
	pages = {817-23},
	abstract = {BACKGROUND: Adhesions are common after conventional surgery; natural orifice transluminal endoscopic surgery (NOTES) avoids peritoneal disruption and may reduce adhesions.

OBJECTIVES: To determine whether adhesions (and peritoneal contamination) are less common with NOTES transgastric colon injury and repair (TGCR) than with laparoscopic colon repair (LCR).

DESIGN/SETTING: Porcine survival study.

INTERVENTIONS: After colon preparation and administration of antibiotics, forty 25-kg male pigs were randomly assigned to either TGCR or LCR. TGCR involved an endoscopic gastrotomy (needle-knife plus balloon dilation), CO(2) pneumoperitoneum, and a 2-cm needle-knife transmural incision of spiral colon. Colotomies were repaired with clips; gastrotomies were closed with clips and a detachable snare.

MAIN OUTCOME MEASUREMENTS: Adhesions were assessed at necropsy at 21 days; biopsy specimens were blindly reviewed. A 9-point adhesion score (density/vascularity, width, and extent) was averaged from 3 reviewers. Peritoneal lavage was sent for cell count and culture.

RESULTS: Two of 20 TGCR pigs died immediately (unrecognized preoperative autopsy-proven pneumonia). The median procedure times were 70.5 and 19.0 minutes for TGCR and LCR, respectively; weight gains were 7.1 and 8.2 kg, respectively. The median adhesion scores were 4.3 and 3.7, respectively (P = .26); subscores were similar (1.9, 1.5, 1.3 vs 1.7, 1.1, 1.0, respectively (P = .3-.6)). Peritoneal lavage bacterial growth was nonsignificantly lower after TGCR than after LCR (38.9\% vs 60.0\%, respectively; P = .30); administration of intragastric antibiotics did not decrease contamination. Three TGCR (vs no LCR) pigs had histologic peritonitis.

LIMITATIONS: Animal model, colon prepped, injury immediately recognized.

CONCLUSION: NOTES colon repair is feasible after transmural injury. Adhesions, histologic peritonitis, and contamination were similar to those with laparoscopy and were not helped by intragastric antibiotics.},
	keywords = {Animals, Bacterial Infections, Colon, Colony-Forming Units Assay, Enterococcus, Feasibility Studies, Female, Gram-Positive Bacterial Infections, Laparoscopy, Male, Peritonitis, Risk Factors, Streptococcal Infections, Surgical Wound Infection, Suture Techniques, Swine, Tissue Adhesions, Wound Healing},
	issn = {1097-6779},
	doi = {10.1016/j.gie.2009.10.052},
	author = {Romagnuolo, Joseph and Morris, John and Palesch, Seth and Hawes, Robert and Lewin, David and Morgan, Katherine}
}
@article {573576,
	title = {Oblique abdominal muscle activity in response to external perturbations when pushing a cart},
	journal = {J Biomech},
	volume = {43},
	number = {7},
	year = {2010},
	month = {2010 May 07},
	pages = {1364-72},
	abstract = {Cyclic activation of the external and internal oblique muscles contributes to twisting moments during normal gait. During pushing while walking, it is not well understood how these muscles respond to presence of predictable (cyclic push-off forces) and unpredictable (external) perturbations that occur in pushing tasks. We hypothesized that the predictable perturbations due to the cyclic push-off forces would be associated with cyclic muscle activity, while external perturbations would be counteracted by cocontraction of the oblique abdominal muscles. Eight healthy male subjects pushed at two target forces and two handle heights in a static condition and while walking without and with external perturbations. For all pushing tasks, the median, the static (10th percentile) and the peak levels (90th percentile) of the electromyographic amplitudes were determined. Linear models with oblique abdominal EMGs and trunk angles as input were fit to the twisting moments, to estimate trunk stiffness. There was no significant difference between the static EMG levels in pushing while walking compared to the peak levels in pushing while standing. When pushing while walking, the additional dynamic activity was associated with the twisting moments, which were actively modulated by the pairs of oblique muscles as in normal gait. The median and static levels of trunk muscle activity and estimated trunk stiffness were significantly higher when perturbations occurred than without perturbations. The increase baseline of muscle activity indicated cocontraction of the antagonistic muscle pairs. Furthermore, this cocontraction resulted in an increased trunk stiffness around the longitudinal axis.},
	keywords = {Abdominal Muscles, Adult, Exercise, Humans, Male, Models, Biological, Walking},
	issn = {1873-2380},
	doi = {10.1016/j.jbiomech.2010.01.022},
	author = {Lee, Yun-Ju and Hoozemans, Marco J M and van Die{\"e}n, Jaap H}
}
@article {573011,
	title = {The performance of US hospitals as reflected in risk-standardized 30-day mortality and readmission rates for medicare beneficiaries with pneumonia},
	journal = {J Hosp Med},
	volume = {5},
	number = {6},
	year = {2010},
	month = {2010 Jul-Aug},
	pages = {E12-8},
	abstract = {BACKGROUND: Pneumonia is a leading cause of hospitalization and death in the elderly, and remains the subject of both local and national quality improvement efforts.

OBJECTIVE: To describe patterns of hospital and regional performance in the outcomes of elderly patients with pneumonia.

DESIGN: Cross-sectional study using hospital and outpatient Medicare claims between 2006 and 2009.

SETTING: A total of 4,813 nonfederal acute care hospitals in the United States and its organized territories.

PATIENTS: Hospitalized fee-for-service Medicare beneficiaries age 65 years and older who received a principal diagnosis of pneumonia.

INTERVENTION: None.

MEASUREMENTS: Hospital and regional level risk-standardized 30-day mortality and readmission rates.

RESULTS: Of the 1,118,583 patients included in the mortality analysis 129,444 (11.6\%) died within 30 days of hospital admission. The median (Q1, Q3) hospital 30-day risk-standardized mortality rate for patients with pneumonia was 11.1\% (10.0\%, 12.3\%), and despite controlling for differences in case mix, ranged from 6.7\% to 20.9\%. Among the 1,161,817 patients included in the readmission analysis 212,638 (18.3\%) were readmitted within 30 days of hospital discharge. The median (Q1, Q3) 30-day risk-standardized readmission rate was 18.2\% (17.2\%, 19.2\%) and ranged from 13.6\% to 26.7\%. Risk-standardized mortality rates varied across hospital referral regions from a high of 14.9\% to a low of 8.7\%. Risk-standardized readmission rates varied across hospital referral regions from a high of 22.2\% to a low of 15\%.

CONCLUSIONS: Risk-standardized 30-day mortality and, to a lesser extent, readmission rates for patients with pneumonia vary substantially across hospitals and regions and may present opportunities for quality improvement, especially at low performing institutions and areas.},
	keywords = {Aged, Cluster Analysis, Cross-Sectional Studies, Fee-for-Service Plans, Hospital Mortality, Hospitals, Humans, Medicare, Outcome Assessment (Health Care), Patient Readmission, Pneumonia, Risk Assessment, United States},
	issn = {1553-5606},
	doi = {10.1002/jhm.822},
	author = {Lindenauer, Peter K and Bernheim, Susannah M and Grady, Jacqueline N and Lin, Zhenqiu and Wang, Yun and Wang, Yongfei and Merrill, Angela R and Han, Lein F and Rapp, Michael T and Drye, Elizabeth E and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {572961,
	title = {Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary},
	journal = {Am Heart J},
	volume = {160},
	number = {6},
	year = {2010},
	month = {2010 Dec},
	pages = {1035-41, 1041.e1},
	abstract = {BACKGROUND: Dual antiplatelet therapy with aspirin and thienopyridines (clopidogrel or prasugrel) is required after placement of coronary stents to prevent thrombotic complications. Although current clinical practice guidelines recommend 12-month treatment after drug-eluting stent placement, even longer durations may prevent thrombotic events.

STUDY DESIGN: The Dual Antiplatelet Therapy (DAPT) Study is comparing the benefits and risks of 12 versus 30 months of dual antiplatelet therapy in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention (PCI) for the treatment of coronary artery obstructive lesions. The DAPT Study is a multicenter, international, randomized, double-blind, placebo-controlled trial that will enroll 15,245 subjects treated with drug-eluting stent (DES) and 5,400 subjects treated with bare-metal stents (BMS). All subjects will receive 12 months of open-label thienopyridine treatment in addition to aspirin. After 12 months, subjects who are free from death, myocardial infarction, or stroke (MACCE), repeat revascularization, and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events will be randomized to receive either 18 additional months of thienopyridine (clopidogrel or prasugrel) (30 month DAPT arm) or placebo (12 month DAPT arm) plus aspirin. Coprimary end points are MACCE and stent thrombosis. The primary safety end point is GUSTO moderate or severe bleeding.

CONCLUSIONS: This randomized trial is designed to define the relative safety and effectiveness of 12 versus 30 months of dual antiplatelet therapy across the broad spectrum of patients receiving coronary stents.},
	keywords = {Aged, Angioplasty, Balloon, Coronary, Coronary Angiography, Coronary Stenosis, Dose-Response Relationship, Drug, Double-Blind Method, Drug-Eluting Stents, Female, Follow-Up Studies, Humans, Male, Platelet Aggregation Inhibitors, Prospective Studies, Time Factors, Treatment Outcome},
	issn = {1097-6744},
	doi = {10.1016/j.ahj.2010.07.038},
	author = {Mauri, Laura and Kereiakes, Dean J and Normand, Sharon-Lise T. and Wiviott, Stephen D and Cohen, David J and Holmes, David R and Bangalore, Sripal and Cutlip, Donald E and Pencina, Michael and Massaro, Joseph M}
}
@article {573061,
	title = {Recent declines in hospitalizations for acute myocardial infarction for Medicare fee-for-service beneficiaries: progress and continuing challenges},
	journal = {Circulation},
	volume = {121},
	number = {11},
	year = {2010},
	month = {2010 Mar 23},
	pages = {1322-8},
	abstract = {BACKGROUND: Amid recent efforts to reduce cardiovascular risk, whether rates of acute myocardial infarction (AMI) in the United States have declined for elderly patients is unknown.

METHODS AND RESULTS: Medicare fee-for-service patients hospitalized in the United States with a principal discharge diagnosis of AMI were identified through the use of data from the Centers for Medicare and Medicaid Services from 2002 to 2007, a time period selected to reduce changes arising from the new definition of AMI. The Medicare beneficiary denominator file was used to determine the population at risk. AMI hospitalization rates were calculated annually per 100,000 beneficiary-years with Poisson regression analysis and stratified according to age, sex, and race. The annual AMI hospitalization rate in the fee-for-service Medicare population fell from 1131 per 100,000 beneficiary-years in 2002 to 866 in 2007, a relative 23.4\% decline. After adjustment for age, sex, and race, the AMI hospitalization rate declined by 5.8\%/y. From 2002 to 2007, white men experienced a 24.4\% decrease in AMI hospitalizations, whereas black men experienced a smaller decline (18.0\%; P,
	keywords = {African Continental Ancestry Group, Aged, Aged, 80 and over, European Continental Ancestry Group, Fee-for-Service Plans, Female, Hospitalization, Humans, Male, Medicare, Myocardial Infarction, Prevalence, Regression Analysis, Retrospective Studies, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.109.862094},
	author = {Chen, Jersey and Normand, Sharon-Lise T. and Wang, Yun and Drye, Elizabeth E and Schreiner, Geoffrey C and Krumholz,Harlan M.}
}
@article {573106,
	title = {Recent national trends in readmission rates after heart failure hospitalization},
	journal = {Circ Heart Fail},
	volume = {3},
	number = {1},
	year = {2010},
	month = {2010 Jan},
	pages = {97-103},
	abstract = {BACKGROUND: In July 2009, Medicare began publicly reporting hospitals{\textquoteright} risk-standardized 30-day all-cause readmission rates (RSRRs) among fee-for-service beneficiaries discharged after hospitalization for heart failure from all the US acute care nonfederal hospitals. No recent national trends in RSRRs have been reported, and it is not known whether hospital-specific performance is improving or variation in performance is decreasing.

METHODS AND RESULTS: We used 2004-2006 Medicare administrative data to identify all fee-for-service beneficiaries admitted to a US acute care hospital for heart failure and discharged alive. We estimated mean annual RSRRs, a National Quality Forum-endorsed metric for quality, using 2-level hierarchical models that accounted for age, sex, and multiple comorbidities; variation in quality was estimated by the SD of the RSRRs. There were 570 996 distinct hospitalizations for heart failure in which the patient was discharged alive in 4728 hospitals in 2004, 544 550 in 4694 hospitals in 2005, and 501 234 in 4674 hospitals in 2006. Unadjusted 30-day all-cause readmission rates were virtually identical over this period: 23.0\% in 2004, 23.3\% in 2005, and 22.9\% in 2006. The mean and SD of RSRRs were also similar: mean (SD) of 23.7\% (1.3) in 2004, 23.9\% (1.4) in 2005, and 23.8\% (1.4) in 2006, suggesting similar hospital variation throughout the study period.

CONCLUSIONS: National mean and RSRR distributions among Medicare beneficiaries discharged after hospitalization for heart failure have not changed in recent years, indicating that there was neither improvement in hospital readmission rates nor in hospital variations in rates over this time period.},
	keywords = {Aged, Aged, 80 and over, Female, Heart Failure, Humans, Male, Patient Readmission},
	issn = {1941-3297},
	doi = {10.1161/CIRCHEARTFAILURE.109.885210},
	author = {Ross, Joseph S and Chen, Jersey and Lin, Zhenqiu and Bueno, H{\'e}ctor and Curtis, Jeptha P and Patricia S. Keenan and Normand, Sharon-Lise T. and Schreiner, Geoffrey and Spertus, John A and Vid{\'a}n, Maria T and Wang, Yongfei and Wang, Yun and Krumholz,Harlan M.}
}
@article {573041,
	title = {Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty},
	journal = {Med Care},
	volume = {48},
	number = {6 Suppl},
	year = {2010},
	month = {2010 Jun},
	pages = {S58-67},
	abstract = {BACKGROUND: Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients. Some of the most common and challenging devices are those used in hip replacement. Artificial hips are implanted in thousands to alleviate pain caused by noninflammatory joint disease and to restore patient mobility. During 2004 in the United States, although 68\% of hospital stays for partial or total hip replacements were for those aged 65 years and older, younger patients will account for 52\% by 2030.

METHODS: Using hierarchical modeling, we propose a framework for combining information from premarket and postmarket settings. Our key assumption is that device performance characteristics and outcomes obtained from 1 cohort are related to device characteristics and outcomes of the same or similar devices observed in other cohorts. We illustrate methods by jointly modeling Harris Hip Scores (HHSs) and revision-success data from 1851 subjects who participated in 3 pivotal randomized or observational studies of artificial hips.

RESULTS AND CONCLUSIONS: Subjects participating in randomized studies had better 2-year HHS than those in observational studies (posterior mean increase in HHS = 4.1, posterior standard deviation = 0.6). Patients implanted with ceramic-on-polyethylene hip used in 1 study had higher 2-year HHS than those implanted with a different ceramic-on-polyethylene hip in another study (mean difference = 4.2, standard deviation = 0.6). Our approach is feasible and will advance regulatory science using a transparent and dynamic new paradigm for knowledge management throughout the total product life cycle.},
	keywords = {Arthroplasty, Replacement, Hip, Clinical Trials as Topic, Hip Prosthesis, Humans, Product Surveillance, Postmarketing, Treatment Outcome},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e3181de9cfa},
	author = {Normand, Sharon-Lise and Marinac-Dabic, Danica and Sedrakyan, Art and Kaczmarek, Ronald}
}
@article {573051,
	title = {Is same-hospital readmission rate a good surrogate for all-hospital readmission rate?},
	journal = {Med Care},
	volume = {48},
	number = {5},
	year = {2010},
	month = {2010 May},
	pages = {477-81},
	abstract = {BACKGROUND: The Centers for Medicare \& Medicaid Services (CMS) readmission measure is based on all-cause readmissions to any hospital within 30 days of discharge. Whether a measure based on same-hospital readmission, an outcome that is easier for hospitals and some systems to track, could serve as a proxy for the all-hospital measure is not known.

OBJECTIVES: Evaluate whether same-hospital readmission rate is a good surrogate for all-hospital readmission rate.

RESEARCH DESIGN: The study population was derived from the Medicare inpatient, outpatient, and carrier (physician) Standard Analytic Files. Thirty-day risk-standardized readmission rates (RSRRs) for heart failure (HF) for both all-hospital readmission and same-hospital readmission were assessed by using hierarchical logistic regression models.

SUBJECTS: The sample consisted of 501,234 hospitalizations in 4674 hospitals with at least 1 hospitalization.

MEASURES: Thirty-day readmission was defined as occurrence of at least 1 hospitalization in any US acute care hospital for any cause within 30 days of discharge after an index hospitalization. Same-hospital readmission was considered if the patient was admitted to the hospital that produced the original discharge within 30 days.

RESULTS: Overall, 80.9\% of all HF readmissions occurred in the same- hospital, whereas 19.1\% of readmissions occurred in a different hospital. The mean difference between all- versus same-hospital RSRR was 4.7 +/- 1.0\%, ranging from 0.9\% to 10.5\% across these hospitals with 25th, 50th, and 75th percentiles of 4.1\%, 4.7\%, and 5.2\%, respectively, and was variable across the range of average RSRR.

CONCLUSION: Same-hospital readmission rate is an unreliable and biased indicator of all-hospital readmission rate with limited value as a benchmark for quality of care processes.},
	keywords = {Centers for Medicare and Medicaid Services (U.S.), Heart Failure, Humans, Insurance Claim Review, Patient Readmission, Quality Indicators, Health Care, United States},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e3181d5fb24},
	author = {Nasir, Khurram and Lin, Zhenqiu and Bueno, Hector and Normand, Sharon-Lise T. and Drye, Elizabeth E and Patricia S. Keenan and Krumholz,Harlan M.}
}
@article {572991,
	title = {Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement},
	journal = {J Clin Psychiatry},
	volume = {71},
	number = {8},
	year = {2010},
	month = {2010 Aug},
	pages = {e1-e21},
	abstract = {OBJECTIVE: To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009.

PARTICIPANTS: This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies of major depression, bipolar disorder, schizophrenia, substance abuse/dependence, and other psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest.

EVIDENCE: Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted.

CONSENSUS PROCESS: Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this scholarly article, which has been developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement have been noted.

CONCLUSIONS: The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA{\textquoteright}s effort to promote standard definitions and definable expectations for investigators and industry sponsors by endorsing the terminology in the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to build upon its new authority to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk within informative large health care-related databases in the United States and abroad. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the current Agency requirement that all CNS clinical drug trials must include a C-CASA-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed, and they need to be included to enable premarket assessments of the risks and benefits of medications related to suicidal ideation, suicidal behavior, and suicide in such patients.},
	keywords = {Adolescent, Adult, Age Factors, Antidepressive Agents, Child, Clinical Trials as Topic, Consensus Development Conferences as Topic, Depressive Disorder, Major, Drug Discovery, Drug-Related Side Effects and Adverse Reactions, Humans, Mental Disorders, Meta-Analysis as Topic, Psychometrics, Randomized Controlled Trials as Topic, Reproducibility of Results, Risk Assessment, Suicide, Suicide, Attempted, Terminology as Topic, United States, United States Food and Drug Administration},
	issn = {1555-2101},
	doi = {10.4088/JCP.10cs06070blu},
	author = {Meyer, Roger E and Salzman, Carl and Youngstrom, Eric A and Clayton, Paula J and Goodwin, Frederick K and J John Mann and Alphs, Larry D and Broich, Karl and Goodman, Wayne K and Greden, John F and Meltzer, Herbert Y and Normand, Sharon-Lise T. and Posner, Kelly and Shaffer, David and Maria A Oquendo and Stanley, Barbara and Trivedi, Madhukar H and Turecki, Gustavo and Beasley, Charles M and Beautrais, Annette L and Bridge, Jeffrey A and Brown, Gregory K and Revicki, Dennis A and Ryan, Neal D and Sheehan, David V}
}
@article {573006,
	title = {Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a brief report},
	journal = {J Clin Psychiatry},
	volume = {71},
	number = {8},
	year = {2010},
	month = {2010 Aug},
	pages = {1040-6},
	abstract = {OBJECTIVE: To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009.

PARTICIPANTS: This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest.

EVIDENCE: Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted.

CONSENSUS PROCESS: Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text.

CONCLUSIONS: The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA{\textquoteright}s encouragement of standard definitions and definable expectations for investigators and industry sponsors. Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (C-CASA)-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed.},
	keywords = {Adolescent, Adult, Antidepressive Agents, Cause of Death, Child, Consensus Development Conferences as Topic, Drug Discovery, Drug-Related Side Effects and Adverse Reactions, Humans, Mental Disorders, Meta-Analysis as Topic, Middle Aged, Risk Factors, Serotonin Uptake Inhibitors, Suicide, Terminology as Topic, United States, United States Food and Drug Administration},
	issn = {1555-2101},
	doi = {10.4088/JCP.10cs06070ablu},
	author = {Meyer, Roger E and Salzman, Carl and Youngstrom, Eric A and Clayton, Paula J and Goodwin, Frederick K and J John Mann and Alphs, Larry D and Broich, Karl and Goodman, Wayne K and Greden, John F and Meltzer, Herbert Y and Normand, Sharon-Lise T. and Posner, Kelly and Shaffer, David and Maria A Oquendo and Stanley, Barbara and Trivedi, Madhukar H and Turecki, Gustavo and Beasley, Charles M and Beautrais, Annette L and Bridge, Jeffrey A and Brown, Gregory K and Revicki, Dennis A and Ryan, Neal D and Sheehan, David V}
}
@article {573726,
	title = {Synthesis, physico-chemical properties and complexing abilities of new amphiphilic ligands from D-galacturonic acid},
	journal = {Carbohydr Res},
	volume = {345},
	number = {6},
	year = {2010},
	month = {2010 Apr 19},
	pages = {731-9},
	abstract = {This paper describes a convenient and efficient synthesis of new complexing surfactants from d-galacturonic acid and n-octanol as renewable raw materials in a two-step sequence. In the first step, simultaneous O-glycosidation-esterification under Fischer conditions was achieved. The anomeric ratio of the products was studied based on the main experimental parameters and the activation mode (thermal or microwave). In the second step, aminolysis of the n-octyl ester was achieved with various functionalized primary amines under standard thermal or microwave activation. The physico-chemical properties of these new amphiphilic ligands were measured and these compounds were found to exhibit interesting surface properties. Complexing abilities of one uronamide ligand functionalized with a pyridine moiety toward Cu(II) ions was investigated in solution by EPR titrations. A solid compound was also synthesized and characterized, its relative structure was deduced from spectroscopic data.},
	keywords = {Electron Spin Resonance Spectroscopy, Hexuronic Acids, Ligands, Microwaves, Models, Chemical, Molecular structure},
	issn = {1873-426X},
	doi = {10.1016/j.carres.2010.01.009},
	author = {Allam, Anas and Behr, Jean-Bernard and Dupont, Laurent and Nardello-Rataj, V{\'e}ronique and Plantier-Royon, Richard}
}
@article {573081,
	title = {Thirty-day outcomes in Medicare patients with heart failure at heart transplant centers},
	journal = {Circ Heart Fail},
	volume = {3},
	number = {2},
	year = {2010},
	month = {2010 Mar},
	pages = {244-52},
	abstract = {BACKGROUND: Heart transplant centers are generally considered "centers of excellence" for heart failure care. However, their overall performance has not previously been evaluated in a broad population of elderly patients with heart failure, many of whom are not transplant candidates.

METHODS AND RESULTS: We identified >1 million elderly Medicare beneficiaries who were hospitalized for heart failure between 2004 and 2006 at >4500 hospitals. We calculated 30-day risk-standardized mortality rates and standardized mortality ratios as well as 30-day risk-standardized readmission rates and standardized readmission ratios at heart transplant centers and non-heart transplant hospitals using risk-standardization models that the Centers for Medicare \& Medicaid Services uses for public reporting. The 30-day risk-standardized mortality rates were lower at heart transplant centers than non-heart transplant hospitals nationally (10.6\% versus 11.5\%, P,
	keywords = {Aged, Aged, 80 and over, Algorithms, Analysis of Variance, Female, Heart Failure, Heart Transplantation, Hospitals, Special, Humans, Linear Models, Male, Medicare, Patient Readmission, Risk, United States},
	issn = {1941-3297},
	doi = {10.1161/CIRCHEARTFAILURE.109.884098},
	author = {Hummel, Scott L and Pauli, Natalie P and Krumholz,Harlan M. and Wang, Yun and Chen, Jersey and Normand, Sharon-Lise T. and Nallamothu, Brahmajee K}
}
@article {573031,
	title = {Trends in length of stay and short-term outcomes among Medicare patients hospitalized for heart failure, 1993-2006},
	journal = {JAMA},
	volume = {303},
	number = {21},
	year = {2010},
	month = {2010 Jun 02},
	pages = {2141-7},
	abstract = {CONTEXT: Whether decreases in the length of stay during the past decade for patients with heart failure (HF) may be associated with changes in outcomes is unknown.

OBJECTIVE: To describe the temporal changes in length of stay, discharge disposition, and short-term outcomes among older patients hospitalized for HF.

DESIGN, SETTING, AND PARTICIPANTS: An observational study of 6,955,461 Medicare fee-for-service hospitalizations for HF between 1993 and 2006, with a 30-day follow-up.

MAIN OUTCOME MEASURES: Length of hospital stay, in-patient and 30-day mortality, and 30-day readmission rates.

RESULTS: Between 1993 and 2006, mean length of stay decreased from 8.81 days (95\% confidence interval [CI], 8.79-8.83 days) to 6.33 days (95\% CI, 6.32-6.34 days). In-hospital mortality decreased from 8.5\% (95\% CI, 8.4\%-8.6\%) in 1993 to 4.3\% (95\% CI, 4.2\%-4.4\%) in 2006, whereas 30-day mortality decreased from 12.8\% (95\% CI, 12.8\%-12.9\%) to 10.7\% (95\% CI, 10.7\%-10.8\%). Discharges to home or under home care service decreased from 74.0\% to 66.9\% and discharges to skilled nursing facilities increased from 13.0\% to 19.9\%. Thirty-day readmission rates increased from 17.2\% (95\% CI, 17.1\%-17.3\%) to 20.1\% (95\% CI, 20.0\%-20.2\%; all P < .001). Consistent with the unadjusted analyses, the 2005-2006 risk-adjusted 30-day mortality risk ratio was 0.92 (95\% CI, 0.91-0.93) compared with 1993-1994, and the 30-day readmission risk ratio was 1.11 (95\% CI, 1.10-1.11).

CONCLUSION: For patients admitted with HF during the past 14 years, reductions in length of stay and in-hospital mortality, less marked reductions in 30-day mortality, and changes in discharge disposition accompanied by increases in 30-day readmission rates were observed.},
	keywords = {Aged, Aged, 80 and over, Fee-for-Service Plans, Female, Heart Failure, Hospital Mortality, Hospitalization, Humans, Length of Stay, Male, Medicare, Patient Discharge, Patient Readmission, Treatment Outcome, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2010.748},
	author = {Bueno, H{\'e}ctor and Ross, Joseph S and Wang, Yun and Chen, Jersey and Vid{\'a}n, Mar{\'\i}a T and Normand, Sharon-Lise T. and Curtis, Jeptha P and Drye, Elizabeth E and Lichtman, Judith H and Patricia S. Keenan and Kosiborod, Mikhail and Krumholz,Harlan M.}
}
@article {573026,
	title = {Use of administrative claims models to assess 30-day mortality among Veterans Health Administration hospitals},
	journal = {Med Care},
	volume = {48},
	number = {7},
	year = {2010},
	month = {2010 Jul},
	pages = {652-8},
	abstract = {BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) publicly reports hospital-specific risk-standardized, 30-day, all-cause, mortality rates (RSMRs) for all hospitalizations among fee-for-service Medicare beneficiaries for acute myocardial infarction (AMI), heart failure (HF), and pneumonia at non-Federal hospitals.

OBJECTIVE: To examine the performance of the statistical models used by CMS among veterans at least 65 years of age hospitalized for AMI, HF, and pneumonia in Veterans Health Administration (VHA) hospitals.

RESEARCH DESIGN: Cross-sectional analysis of VHA administrative claims data between October 1, 2006 and September 30, 2009.

SUBJECTS: Thirteen thousand forty-six veterans hospitalized for AMI among 123 VHA hospitals; 26,379 veterans hospitalized for HF among 124 VHA hospitals; and 31,126 veterans hospitalized for pneumonia among 124 VHA hospitals.

MEASURES: Hospital-specific RSMR for AMI, HF, and pneumonia hospitalizations calculated using hierarchical generalized linear models.

RESULTS: Median number of AMI hospitalizations per VHA hospital was 87. Average AMI RSMR was 14.3\% [95\% confidence interval (CI), 13.9\%-14.6\%] with modest heterogeneity among VHA hospitals (RSMR range: 8.4\%-20.3\%). The c-statistic for the AMI RSMR statistical model was 0.79. Median number of HF hospitalizations was 188. Average HF RSMR was 10.1\% (95\% CI, 9.9\%-10.4\%) with modest heterogeneity (RSMR range: 6.1\%-14.9\%). The c-statistic for the HF RSMR statistical model was 0.73. Median number of pneumonia hospitalizations was 221.5. Average pneumonia RSMR was 13.0\% (95\% CI, 12.7\%-13.3\%) with modest heterogeneity (RSMR range: 9.0\%-18.4\%). The c-statistic for the pneumonia RSMR statistical model was 0.72.

CONCLUSIONS: The statistical models used by CMS to estimate RSMRs for AMI, HF, and pneumonia hospitalizations at non-Federal hospitals demonstrate similar discrimination when applied to VHA hospitals.},
	keywords = {Aged, Confidence Intervals, Cross-Sectional Studies, Female, Heart Failure, Hospital Mortality, Hospitals, Veterans, Humans, Insurance Claim Reporting, Linear Models, Male, Myocardial Infarction, Odds Ratio, Pneumonia, Quality of Health Care},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e3181dbe35d},
	author = {Ross, Joseph S and Charles Maynard and Krumholz,Harlan M. and Sun, Haili and Rumsfeld, John S and Normand, Sharon-Lise T. and Wang, Yun and Fihn, Stephan D}
}
@article {572956,
	title = {Variability in the measurement of hospital-wide mortality rates},
	journal = {N Engl J Med},
	volume = {363},
	number = {26},
	year = {2010},
	month = {2010 Dec 23},
	pages = {2530-9},
	abstract = {BACKGROUND: Several countries use hospital-wide mortality rates to evaluate the quality of hospital care, although the usefulness of this metric has been questioned. Massachusetts policymakers recently requested an assessment of methods to calculate this aggregate mortality metric for use as a measure of hospital quality.

METHODS: The Massachusetts Division of Health Care Finance and Policy provided four vendors with identical information on 2,528,624 discharges from Massachusetts acute care hospitals from October 1, 2004, through September 30, 2007. Vendors applied their risk-adjustment algorithms and provided predicted probabilities of in-hospital death for each discharge and for hospital-level observed and expected mortality rates. We compared the numbers and characteristics of discharges and hospitals included by each of the four methods. We also compared hospitals{\textquoteright} standardized mortality ratios and classification of hospitals with mortality rates that were higher or lower than expected, according to each method.

RESULTS: The proportions of discharges that were included by each method ranged from 28\% to 95\%, and the severity of patients{\textquoteright} diagnoses varied widely. Because of their discharge-selection criteria, two methods calculated in-hospital mortality rates (4.0\% and 5.9\%) that were twice the state average (2.1\%). Pairwise associations (Pearson correlation coefficients) of discharge-level predicted mortality probabilities ranged from 0.46 to 0.70. Hospital-performance categorizations varied substantially and were sometimes completely discordant. In 2006, a total of 12 of 28 hospitals that had higher-than-expected hospital-wide mortality when classified by one method had lower-than-expected mortality when classified by one or more of the other methods.

CONCLUSIONS: Four common methods for calculating hospital-wide mortality produced substantially different results. This may have resulted from a lack of standardized national eligibility and exclusion criteria, different statistical methods, or fundamental flaws in the hypothesized association between hospital-wide mortality and quality of care. (Funded by the Massachusetts Division of Health Care Finance and Policy.).},
	keywords = {Algorithms, Data Interpretation, Statistical, Hospital Mortality, Hospitals, Humans, Massachusetts, Patient Discharge, Quality of Health Care},
	issn = {1533-4406},
	doi = {10.1056/NEJMsa1006396},
	author = {Shahian, David M and Wolf, Robert E and Iezzoni, Lisa I and Kirle, Leslie and Normand, Sharon-Lise T.}
}
@article {572981,
	title = {Variation in hospital mortality rates for patients with acute myocardial infarction},
	journal = {Am J Cardiol},
	volume = {106},
	number = {8},
	year = {2010},
	month = {2010 Oct 15},
	pages = {1108-12},
	abstract = {Hospitals vary by twofold in their hospital-specific 30-day risk-stratified mortality rates (RSMRs) for Medicare beneficiaries with acute myocardial infarction (AMI). However, we lack a comprehensive investigation of hospital characteristics associated with 30-day RSMRs and the degree to which the variation in 30-day RSMRs is accounted for by these characteristics, including the socioeconomic status (SES) profile of hospital patient populations. We conducted a cross-sectional national study of hospitals with >=15 AMI discharges from July 1, 2005 to June 20, 2008. We estimated a multivariable weighted regression using Medicare claims data for hospital-specific 30-day RSMRs, American Hospital Association Survey of Hospitals for hospital characteristics, and the United States Census data reported by Neilsen Claritas, Inc., for zip-code level estimates of SES status. Analysis included 2,908 hospitals with 513,202 AMI discharges. Mean hospital 30-day RSMR was 16.5\% (SD 1.7 percentage points). Our multivariable model explained 17.1\% of the variation in hospital-specific 30-day RSMRs. Teaching status, number of hospital beds, AMI volume, cardiac facilities available, urban/rural location, geographic region, ownership type, and SES profile of patients were significantly (p < 0.05) associated with 30-day RSMRs. In conclusion, substantial variation in hospital outcomes for patients with AMI remains unexplained by measurements of hospital characteristics including SES patient profile.},
	keywords = {Hospital Mortality, Hospitals, Humans, Myocardial Infarction, Retrospective Studies, Survival Analysis, United States},
	issn = {1879-1913},
	doi = {10.1016/j.amjcard.2010.06.014},
	author = {Bradley, Elizabeth H and Herrin, Jeph and Curry, Leslie and Cherlin, Emily J and Wang, Yongfei and Webster, Tashonna R and Drye, Elizabeth E and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {573001,
	title = {What is evidence?},
	journal = {Stat Med},
	volume = {29},
	number = {19},
	year = {2010},
	month = {2010 Aug 30},
	pages = {1985-8; discussion 1996-7},
	abstract = {The assumption that comparative effectiveness research will provide timely, relevant evidence rests on changing the current framework for assembling evidence. In this commentary, we provide the background of how coverage decisions for new medical technologies are currently made in the United States. We focus on the statistical issues regarding how to use the ensemble of information for inferring comparative effectiveness. It is clear a paradigm shift in how clinical information is integrated in real-world settings to establish effectiveness is required.},
	keywords = {Biomedical Technology, Centers for Medicare and Medicaid Services (U.S.), Comparative Effectiveness Research, Decision Making, Organizational, Evidence-Based Medicine, Humans, Insurance Coverage, United States},
	issn = {1097-0258},
	doi = {10.1002/sim.3933},
	author = {Normand, Sharon-Lise T. and McNeil, Barbara J}
}
@article {573036,
	title = {When less is more: using shrinkage to increase accuracy},
	journal = {Ann Emerg Med},
	volume = {55},
	number = {6},
	year = {2010},
	month = {2010 Jun},
	pages = {553-5},
	keywords = {Bayes Theorem, Clinical Trials as Topic, Data Interpretation, Statistical, Humans, Models, Statistical, Odds Ratio, Reproducibility of Results, Sample Size},
	issn = {1097-6760},
	doi = {10.1016/j.annemergmed.2010.04.010},
	author = {Wears, Robert L and Normand, Sharon-Lise}
}
@article {573181,
	title = {Antidepressant reformulations: who uses them, and what are the benefits?},
	journal = {Health Aff (Millwood)},
	volume = {28},
	number = {3},
	year = {2009},
	month = {2009 May-Jun},
	pages = {734-45},
	abstract = {The Hatch-Waxman Act of 1984 provides pharmaceutical manufacturers with an incentive to introduce reformulations of existing products that are about to lose patent protection, to extend marketing exclusivity and maintain high prices. Antidepressant reformulations are particularly common. To determine whether the use of reformulations confers benefits, we examined who uses them and whether they affect the duration of medication use. We found some evidence of benefit for subgroups of antidepressant users, although benefits varied across reformulations.},
	keywords = {Antidepressive Agents, Second-Generation, Depressive Disorder, Major, Drug Compounding, Drug Costs, Drug Utilization Review, Economic Competition, Humans, Patents as Topic, Serotonin Uptake Inhibitors, Treatment Outcome, United States, United States Food and Drug Administration},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.28.3.734},
	author = {Huskamp, Haiden A. and Alisa B. Busch and Domino, Marisa E and Normand, Sharon-Lise T.}
}
@article {573201,
	title = {Bipolar-I patient characteristics associated with differences in antimanic medication prescribing},
	journal = {Psychopharmacol Bull},
	volume = {42},
	number = {1},
	year = {2009},
	month = {2009},
	pages = {35-49},
	abstract = {OBJECTIVE: Second-generation antipsychotics offer more choice in antimanic pharmacologic treatment. Unclear though is whether they are expanding antimanic treatment, replacing mood stabilizers, or if/which patient characteristics influence prescribing choices. We studied the association between patient characteristics and patient-reported antimanic medication use upon entry in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).

EXPERIMENTAL DESIGN: Observational study using STEP-BD baseline data from bipolar-I patients (N = 1,943) during years 2000-2004. Two logistic regression models (binomial and multinomial) were estimated to examine associations between patient characteristics and patient-reported drug use: 1) any antimanic medication (antipsychotic or mood stabilizer), and 2) mood stabilizer, antipsychotic monotherapy, or neither.

PRINCIPAL OBSERVATIONS: At study entry over 80\% of participants reported receiving at least one antimanic medication; 73\% a mood stabilizer specifically. In general, there was no association between study year and the odds of entering on antimanic medication. Measures of psychiatric severity or complexity were more likely to be associated with differences in the drugs used; co-occurring medical conditions were not. Depressed states were associated with similar odds of antipsychotic monotherapy as elevated or mixed states. Compared to whites, blacks had greater odds of entering on antipsychotic monotherapy relative to a mood stabilizer.

CONCLUSIONS: Despite increasing pharmacotherapy options, we found no evidence that over time more patients received antimanic medication. Not all prescribing differences were consistent with the medical literature. Also, blacks were more likely to receive antipsychotic monotherapy, even after adjusting for clinical characteristics. Future research examining provider characteristics that influence prescribing is needed.},
	keywords = {Adult, African Continental Ancestry Group, Antimanic Agents, Antipsychotic Agents, Bipolar Disorder, European Continental Ancestry Group, Female, Humans, Logistic Models, Longitudinal Studies, Male, Middle Aged, Practice Patterns, Physicians{\textquoteright}, Severity of Illness Index, Time Factors},
	issn = {0048-5764},
	author = {Alisa B. Busch and Richard G. Frank and Sachs, Gary and Normand, Sharon-Lise T.}
}
@article {573161,
	title = {Cardiac rehabilitation and survival in older coronary patients},
	journal = {J Am Coll Cardiol},
	volume = {54},
	number = {1},
	year = {2009},
	month = {2009 Jun 30},
	pages = {25-33},
	abstract = {OBJECTIVES: This study assessed the effects of cardiac rehabilitation (CR) on survival in a large cohort of older coronary patients.

BACKGROUND: Randomized controlled trials and meta-analyses have shown that CR improves survival. However, trial participants have been predominantly middle-aged, low- or moderate-risk, white men.

METHODS: The population consisted of 601,099 U.S. Medicare beneficiaries who were hospitalized for coronary conditions or cardiac revascularization procedures. One- to 5-year mortality rates were examined in CR users and nonusers using Medicare claims and 3 analytic techniques: propensity-based matching, regression modeling, and instrumental variables. The first method used 70,040 matched pairs, and the other 2 techniques used the entire cohort.

RESULTS: Only 12.2\% of the cohort used CR, and those users averaged 24 sessions. Each technique showed significantly lower (p < 0.001) 1- to 5-year mortality rates in CR users than nonusers. Five-year mortality relative reductions were 34\% in propensity-based matching, 26\% from regression modeling, and 21\% with instrumental variables. Mortality reductions extended to all demographic and clinical subgroups including patients with acute myocardial infarctions, those receiving revascularization procedures, and those with congestive heart failure. The CR users with 25 or more sessions were 19\% relatively less likely to die over 5 years than matched CR users with 24 or fewer sessions (p < 0.001).

CONCLUSIONS: Mortality rates were 21\% to 34\% lower in CR users than nonusers in this socioeconomically and clinically diverse, older population after extensive analyses to control for potential confounding. These results are of similar magnitude to those observed in published randomized controlled trials and meta-analyses in younger, more selected populations.},
	keywords = {Aged, Aged, 80 and over, Cohort Studies, Coronary Disease, Exercise Therapy, Female, Humans, Male, Myocardial Revascularization, Regression Analysis, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2009.01.078},
	author = {Suaya, Jose A and Stason, William B and Ades, Philip A and Normand, Sharon-Lise T. and Shepard, Donald S}
}
@article {573111,
	title = {Comments on {\textquoteright}The BUGS project: Evolution, critique, and future directions{\textquoteright}},
	journal = {Stat Med},
	volume = {28},
	number = {25},
	year = {2009},
	month = {2009 Nov 10},
	pages = {3075-8},
	keywords = {Bayes Theorem, History, 20th Century, Models, Statistical, Software Design},
	issn = {1097-0258},
	doi = {10.1002/sim.3679},
	author = {Teixeira-Pinto, Armando and Normand, Sharon-Lise T.}
}
@article {573206,
	title = {Composite measures for hospital quality using quality-adjusted life years},
	journal = {Stat Med},
	volume = {28},
	number = {8},
	year = {2009},
	month = {2009 Apr 15},
	pages = {1238-54},
	abstract = {Developing clinically meaningful summary measures of health-care quality is key to inferring quality of care. Current summary measures use a number of different approaches to weight their individual measures but rarely use weights based on clinical {\textquoteright}importance{\textquoteright}. Such an approach would help to focus quality improvement efforts on areas likely to have the largest impact on health outcomes. Using coronary artery bypass graft (CABG) surgery as a case study, we weight and combine 11 process, complication, and survival measures to summarize differences in quality-adjusted life expectancy 1 year following surgery for a sample of hospitals. We use a fully Bayesian analysis to estimate 1-year survival outcomes using a hierarchical exponential survival model. We then estimate the expected utility of the year following surgery for each patient using complication probabilities fitted from hierarchical models and utility values from the literature. We estimate quality-adjusted life years (QALYs) for each hospital as the utility-weighted average 1-year survival probability and then estimate {\textquoteright}incremental QALYs{\textquoteright} by taking the difference in QALYs for each hospital relative to a comparison group that reflects the average performance of all hospitals in the state. We illustrate our framework by estimating incremental QALYs for 14 hospitals performing CABG surgery in Massachusetts in 2003 and find that a composite measure based on QALYs can change the classification of quality outliers relative to conventional mortality measures.},
	keywords = {Bayes Theorem, Coronary Artery Bypass, Hospitals, Humans, Models, Statistical, Quality Assurance, Health Care, Quality-Adjusted Life Years},
	issn = {0277-6715},
	doi = {10.1002/sim.3539},
	author = {Timbie, Justin W and Shahian, David M and Joseph P. Newhouse and Meredith B. Rosenthal and Normand, Sharon-Lise T.}
}
@article {573196,
	title = {Correlated bivariate continuous and binary outcomes: issues and applications},
	journal = {Stat Med},
	volume = {28},
	number = {13},
	year = {2009},
	month = {2009 Jun 15},
	pages = {1753-73},
	abstract = {Increasingly multiple outcomes are collected in order to characterize treatment effectiveness or to evaluate the impact of large policy initiatives. Often the multiple outcomes are non-commensurate, e.g. measured on different scales. The common approach to inference is to model each outcome separately ignoring the potential correlation among the responses. We describe and contrast several full likelihood and quasi-likelihood multivariate methods for non-commensurate outcomes. We present a new multivariate model to analyze binary and continuous correlated outcomes using a latent variable. We study the efficiency gains of the multivariate methods relative to the univariate approach. For complete data, all approaches yield consistent parameter estimates. When the mean structure of all outcomes depends on the same set of covariates, efficiency gains by adopting a multivariate approach are negligible. In contrast, when the mean outcomes depend on different covariate sets, large efficiency gains are realized. Three real examples illustrate the different approaches.},
	keywords = {Algorithms, Analysis of Variance, Biometry, Confidence Intervals, Coronary Artery Disease, Coronary Restenosis, Humans, Interferon Type I, Likelihood Functions, Macular Degeneration, Managed Care Programs, Models, Statistical, Monte Carlo Method, Multivariate Analysis, Recombinant Proteins, Schizophrenia, Stents, Treatment Outcome},
	issn = {0277-6715},
	doi = {10.1002/sim.3588},
	author = {Teixeira-Pinto, Armando and Normand, Sharon-Lise T.}
}
@article {573191,
	title = {Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association},
	journal = {Circulation},
	volume = {119},
	number = {17},
	year = {2009},
	month = {2009 May 05},
	pages = {2408-16},
	abstract = {There is increasing interest in utilizing novel markers of cardiovascular disease risk, and consequently, there is a need to assess the value of their use. This scientific statement reviews current concepts of risk evaluation and proposes standards for the critical appraisal of risk assessment methods. An adequate evaluation of a novel risk marker requires a sound research design, a representative at-risk population, and an adequate number of outcome events. Studies of a novel marker should report the degree to which it adds to the prognostic information provided by standard risk markers. No single statistical measure provides all the information needed to assess a novel marker, so measures of both discrimination and accuracy should be reported. The clinical value of a marker should be assessed by its effect on patient management and outcomes. In general, a novel risk marker should be evaluated in several phases, including initial proof of concept, prospective validation in independent populations, documentation of incremental information when added to standard risk markers, assessment of effects on patient management and outcomes, and ultimately, cost-effectiveness.},
	keywords = {American Heart Association, Biomarkers, Cardiovascular Diseases, Evaluation Studies as Topic, Humans, Prognosis, Risk Assessment, Sensitivity and Specificity, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.109.192278},
	author = {Hlatky, Mark A and Greenland, Philip and Arnett, Donna K and Ballantyne, Christie M and Criqui, Michael H and Elkind, Mitchell S V and Go, Alan S and Harrell, Frank E and Hong, Yuling and Barbara V Howard and Howard, Virginia J and Hsue, Priscilla Y and Christopher M Kramer and McConnell, Joseph P and Normand, Sharon-Lise T. and O{\textquoteright}Donnell, Christopher J and Smith, Sidney C and Wilson, Peter W F}
}
@article {573096,
	title = {Elapsed time in emergency medical services for patients with cardiac complaints: are some patients at greater risk for delay?},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {2},
	number = {1},
	year = {2009},
	month = {2009 Jan},
	pages = {9-15},
	abstract = {BACKGROUND: In patients with a major cardiac event, the first priority is to minimize time to treatment. For many patients, first contact with the health system is through emergency medical services (EMS). We set out to identify patient-level and neighborhood-level factors that were associated with elapsed time in EMS.

METHODS AND RESULTS: A retrospective cohort study was conducted in 10 municipalities in Dallas County, Tex, from January 1 through December 31, 2004. The data set included 5887 patients with suspected cardiac-related symptoms. The region was served by 29 hospitals and 98 EMS depots. Multivariate models included measures of distance traveled, time of day, day of week, and patient and neighborhood characteristics. The main outcomes were elapsed time in EMS (continuous; in minutes) and delay in EMS (dichotomous; >15 minutes beyond median elapsed time). We found positive associations between patient characteristics and both average elapsed time and delay in EMS care. Variation in average elapsed time was not large enough to be clinically meaningful. However, approximately 11\% (n=647) of patients were delayed >or=15 minutes. Women were more likely to be delayed (adjusted odds ratio, 1.52; 95\% confidence interval, 1.32 to 1.74), and this association did not change after adjusting for other characteristics, including neighborhood socioeconomic composition.

CONCLUSIONS: Compared with otherwise similar men, women have 50\% greater odds of being delayed in the EMS setting. The determinants of delay should be a special focus of EMS studies in which time to treatment is a priority.},
	keywords = {Adult, Aged, Emergency Medical Services, Female, Health Services Accessibility, Healthcare Disparities, Heart Diseases, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Residence Characteristics, Retrospective Studies, Risk Assessment, Risk Factors, Sex Factors, Texas, Time Factors, Transportation of Patients, Triage},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.108.813741},
	author = {Concannon, Thomas W and Griffith, John L and Kent, David M and Normand, Sharon-Lise and Joseph P. Newhouse and Atkins, James and Beshansky, Joni R and Selker, Harry P}
}
@article {573211,
	title = {Engagement of health plans and employers in addressing racial and ethnic disparities in health care},
	journal = {Med Care Res Rev},
	volume = {66},
	number = {2},
	year = {2009},
	month = {2009 Apr},
	pages = {219-31},
	abstract = {Disparities in access to and quality of health care along racial and ethnic lines are an important national problem. Health care purchasers and payers have a potentially important role to play in alleviating this problem. Using national surveys of 609 employers and 252 health plans with HMO products in 41 U.S. markets, we examined awareness of racial and ethnic disparities in health care access and quality, perceptions of employer and health plan role in addressing disparities, and reported efforts to measure and reduce disparities. Our findings suggest that most health plans and many employers are aware of the existence of substantial disparities and that health plans, but not employers, have taken steps to examine and influence patterns of care by race and ethnicity among their members.},
	keywords = {Attitude to Health, Continental Population Groups, Ethnic Groups, Health Care Surveys, Health Maintenance Organizations, Health Services Accessibility, Healthcare Disparities, Humans, Insurance, Health, Logistic Models, Sampling Studies, Surveys and Questionnaires, United States},
	issn = {1077-5587},
	doi = {10.1177/1077558708328816},
	author = {Meredith B. Rosenthal and Landon, Bruce E and Normand, Sharon-Lise T. and Ahmad, Thaniyyah S and Arnold M. Epstein}
}
@article {573186,
	title = {Improving quality and diffusing best practices: the case of schizophrenia},
	journal = {Health Aff (Millwood)},
	volume = {28},
	number = {3},
	year = {2009},
	month = {2009 May-Jun},
	pages = {701-12},
	abstract = {The slow spread of treatments supported by empirical evidence and the rapid diffusion of treatments lacking such support play major roles in the lower quality of mental health care received by people with severe mental illnesses compared with the care of less severely ill people. Further, the rapid spread of treatments that are of low cost-effectiveness limits the system{\textquoteright}s ability to provide the full gamut of high-value treatments available to treat this vulnerable population. Using the case of schizophrenia, we review the context in which these paradoxical patterns of diffusion have occurred, and we propose policy solutions.},
	keywords = {Antipsychotic Agents, Chronic Disease, Comorbidity, Cost-Benefit Analysis, Cross-Sectional Studies, Diffusion of Innovation, Drug Costs, Evidence-Based Medicine, Financing, Government, Forecasting, Health Policy, Health Services Needs and Demand, Humans, Medicaid, Medicare, Quality Assurance, Health Care, Schizophrenia, United States},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.28.3.701},
	author = {Horvitz-Lennon, Marcela and Donohue, Julie M and Domino, Marisa E and Normand, Sharon-Lise T.}
}
@article {573156,
	title = {Integrating statistical and clinical research elements in intervention-related grant applications: summary from an NIMH workshop},
	journal = {Acad Psychiatry},
	volume = {33},
	number = {3},
	year = {2009},
	month = {2009 May-Jun},
	pages = {221-8},
	abstract = {OBJECTIVE: The authors summarize points for consideration generated in a National Institute of Mental Health (NIMH) workshop convened to provide an opportunity for reviewers from different disciplines-specifically clinical researchers and statisticians-to discuss how their differing and complementary expertise can be well integrated in the review of intervention-related grant applications.

METHODS: A 1-day workshop was convened in October, 2004. The workshop featured panel presentations on key topics followed by interactive discussion. This article summarizes the workshop and subsequent discussions, which centered on topics including weighting the statistics/data analysis elements of an application in the assessment of the application{\textquoteright}s overall merit; the level of statistical sophistication appropriate to different stages of research and for different funding mechanisms; some key considerations in the design and analysis portions of applications; appropriate statistical methods for addressing essential questions posed by an application; and the role of the statistician in the application{\textquoteright}s development, study conduct, and interpretation and dissemination of results.

RESULTS: A number of key elements crucial to the construction and review of grant applications were identified. It was acknowledged that intervention-related studies unavoidably involve trade-offs. Reviewers are helped when applications acknowledge such trade-offs and provide good rationale for their choices. Clear linkage among the design, aims, hypotheses, and data analysis plan and avoidance of disconnections among these elements also strengthens applications.

CONCLUSION: The authors identify multiple points to consider when constructing intervention-related grant applications. The points are presented here as questions and do not reflect institute policy or comprise a list of best practices, but rather represent points for consideration.},
	keywords = {Data Interpretation, Statistical, Education, Humans, National Institute of Mental Health (U.S.), Peer Review, Research, Research Design, Research Support as Topic, United States},
	issn = {1545-7230},
	doi = {10.1176/appi.ap.33.3.221},
	author = {Sherrill, Joel T and Sommers, David I and Andrew A Nierenberg and Leon, Andrew C and Arndt, Stephan and Bandeen-Roche, Karen and Greenhouse, Joel and Guthrie, Donald and Normand, Sharon-Lise and Phillips, Katharine A and Shear, M Katherine and Woolson, Robert}
}
@article {573136,
	title = {Investigation of racial and ethnic disparities in service utilization among homeless adults with severe mental illnesses},
	journal = {Psychiatr Serv},
	volume = {60},
	number = {8},
	year = {2009},
	month = {2009 Aug},
	pages = {1032-8},
	abstract = {OBJECTIVE: This study examined whether there are service disparities among homeless adults with severe mental illnesses, a vulnerable population with a high level of unmet need.

METHODS: Data were collected at baseline for 6,829 black, Latino, and non-Latino white participants in the Access to Community Care and Effective Services and Support study. Outcome variables were measures of utilization of psychiatric outpatient, housing, and case management services in the previous 60 days. The sample was divided into white-black and white-Latino cohorts. Within each cohort, participants were stratified into comparable groups by propensity scores that estimated log-odds of being black or Latino as a function of several confounding variables. White-black and white-Latino differences in mean number of visits (a measure of intensity) and in the mean probability of at least one visit (a measure of access) were subsequently estimated for each of the three services.

RESULTS: The composition of the sample was 50\% black, 6\% Latino, and 44\% white. Service utilization was low for the three services regardless of race-ethnicity. On multivariate analyses of service utilization in the previous 60 days, blacks made fewer psychiatric outpatient visits than whites (mean difference=.46, 95\% confidence interval [CI]=.10 to .81]), yet Latinos had more case management visits than whites (mean difference=-.51, CI=-1.03 to -.05]). Analyses of access did not reveal racial-ethnic disparities.

CONCLUSIONS: Whereas blacks used psychiatric outpatient services less frequently than whites, hence experiencing a service disparity, Latinos used case management services more than whites did. Possible contributors and clinical and methodological implications of these results are discussed.},
	keywords = {Adult, African Americans, Cohort Studies, European Continental Ancestry Group, Female, Health Services Accessibility, Healthcare Disparities, Hispanic Americans, Homeless Persons, Humans, Male, Mental Disorders, Mental Health Services, Middle Aged, Multivariate Analysis, Severity of Illness Index, United States},
	issn = {1557-9700},
	doi = {10.1176/appi.ps.60.8.1032},
	author = {Horvitz-Lennon, Marcela and Richard G. Frank and Thompson, Wesley and Baik, Seo Hyon and Alegr{\'\i}a, Margarita and Rosenheck, Robert A and Normand, Sharon-Lise T.}
}
@article {573116,
	title = {Longitudinal racial/ethnic disparities in antimanic medication use in bipolar-I disorder},
	journal = {Med Care},
	volume = {47},
	number = {12},
	year = {2009},
	month = {2009 Dec},
	pages = {1217-28},
	abstract = {OBJECTIVE: To examine racial/ethnic longitudinal disparities in antimanic medication use among adults with bipolar-I disorder.

METHODS: Observational study using administrative data from Florida{\textquoteright}s Medicaid program, July 1997 to June 2005, for enrollees diagnosed with bipolar-I disorder (N = 13,497 persons; 126,413 person-quarters). We examined the likelihood of receiving one of the following during a given quarter: (1) any antimanic agent (antipsychotic or mood stabilizer) or none, and (2) mood stabilizers, antipsychotic monotherapy, or neither. Binary and multinomial logistic regression models predicted the association between race/ethnicity and prescription fills, adjusting for clinical and demographic characteristics. Cohort indicators for year that the enrollee met study criteria were included to account for cohort effects.

RESULTS: Averaging over all cohorts and quarters, compared with whites, blacks had lower odds of filling any antimanic and mood stabilizer prescriptions specifically (40\%-49\% and 47\%-63\%, respectively), but similar odds of filling prescriptions for antipsychotic monotherapy. After Bonferroni adjustment, compared with whites, there were no statistically significant disparities for Hispanics in filling prescriptions for any, or specific antimanic medications.

CONCLUSIONS: Rates of antimanic medication use were low regardless of race/ethnicity. However, we found disparities in antimanic medication use for blacks compared with whites and these disparities persisted over time. We found no Hispanic-white disparities. Quality improvement efforts should focus on all individuals with bipolar disorder, but particular attention should be paid to understanding disparities in medication use for blacks.},
	keywords = {Antimanic Agents, Bipolar Disorder, Continental Population Groups, Drug Utilization, Ethnic Groups, Female, Healthcare Disparities, Humans, Longitudinal Studies, Male, Medicaid, United States},
	issn = {1537-1948},
	doi = {10.1097/MLR.0b013e3181adcc4f},
	author = {Alisa B. Busch and Huskamp, Haiden A. and Neelon, Brian and Manning, Tim and Normand, Sharon-Lise T. and Thomas G. McGuire}
}
@article {573086,
	title = {Mortality and readmission for patients with heart failure among U.S. News \& World Report{\textquoteright}s top heart hospitals},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {2},
	number = {6},
	year = {2009},
	month = {2009 Nov},
	pages = {558-65},
	abstract = {BACKGROUND: The rankings of "America{\textquoteright}s Best Hospitals" by U.S. News \& World Report are influential, but the performance of ranked hospitals in caring for patients with routine cardiac conditions such as heart failure is not known.

METHODS AND RESULTS: Using hierarchical regression models based on medical administrative data from the period July 1, 2005, to June 30, 2006, we calculated risk-standardized mortality rates and risk-standardized readmission rates for ranked and nonranked hospitals in the treatment of heart failure. The mortality analysis examined 14 813 patients in 50 ranked hospitals and 409 806 patients in 4761 nonranked hospitals. The readmission analysis included 16 641 patients in 50 ranked hospitals and 458 473 patients in 4627 nonranked hospitals. Mean 30-day risk-standardized mortality rates were lower in ranked versus nonranked hospitals (10.1\% versus 11.2\%, P,
	keywords = {Aged, Aged, 80 and over, Cardiology Service, Hospital, Female, Heart Failure, Hospital Mortality, Hospitals, Humans, Logistic Models, Male, Outcome Assessment (Health Care), Patient Readmission, Quality of Health Care, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.108.826784},
	author = {Mulvey, Gregory K and Wang, Yun and Lin, Zhenqiu and Wang, Oliver J and Chen, Jersey and Patricia S. Keenan and Drye, Elizabeth E and Rathore, Saif S and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {573091,
	title = {Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {2},
	number = {5},
	year = {2009},
	month = {2009 Sep},
	pages = {407-13},
	abstract = {BACKGROUND: In 2009, the Centers for Medicare \& Medicaid Services is publicly reporting hospital-level risk-standardized 30-day mortality and readmission rates after acute myocardial infarction (AMI) and heart failure (HF). We provide patterns of hospital performance, based on these measures.

METHODS AND RESULTS: We calculated the 30-day mortality and readmission rates for all Medicare fee-for-service beneficiaries ages 65 years or older with a primary diagnosis of AMI or HF, discharged between July 2005 and June 2008. We compared weighted risk-standardized mortality and readmission rates across Hospital Referral Regions and hospital structural characteristics. The median 30-day mortality rate was 16.6\% for AMI (range, 10.9\% to 24.9\%; 25th to 75th percentile, 15.8\% to 17.4\%; 10th to 90th percentile, 14.7\% to 18.4\%) and 11.1\% for HF (range, 6.6\% to 19.8\%; 25th to 75th percentile, 10.3\% to 12.0\%; 10th to 90th percentile, 9.4\% to 13.1\%). The median 30-day readmission rate was 19.9\% for AMI (range, 15.3\% to 29.4\%; 25th to 75th percentile, 19.5\% to 20.4\%; 10th to 90th percentile, 18.8\% to 21.1\%) and 24.4\% for HF (range, 15.9\% to 34.4\%; 25th to 75th percentile, 23.4\% to 25.6\%; 10th to 90th percentile, 22.3\% to 27.0\%). We observed geographic differences in performance across the country. Although there were some differences in average performance by hospital characteristics, there were high and low hospital performers among all types of hospitals.

CONCLUSIONS: In a recent 3-year period, 30-day risk-standardized mortality rates for AMI and HF varied among hospitals and across the country. The readmission rates were particularly high.},
	keywords = {Aged, Aged, 80 and over, Fee-for-Service Plans, Geographic Information Systems, Health Policy, Health Services Accessibility, Heart Failure, Hospital Mortality, Hospitals, Humans, Medicare, Myocardial Infarction, Patient Readmission, Risk Factors, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.109.883256},
	author = {Krumholz,Harlan M. and Merrill, Angela R and Schone, Eric M and Schreiner, Geoffrey C and Chen, Jersey and Bradley, Elizabeth H and Wang, Yun and Wang, Yongfei and Lin, Zhenqiu and Straube, Barry M and Rapp, Michael T and Normand, Sharon-Lise T. and Drye, Elizabeth E}
}
@article {573171,
	title = {A prospective study of familial conflict, psychological stress, and the development of substance use disorders in adolescence},
	journal = {Drug Alcohol Depend},
	volume = {104},
	number = {1-2},
	year = {2009},
	month = {2009 Sep 01},
	pages = {65-72},
	abstract = {BACKGROUND: Exposure to adverse family environments in childhood can influence the risk trajectory for developing substance use disorders in adolescence. Evidence for this is largely based on cross-sectional studies which have been unable to establish the temporality of this association and investigate underlying pathways.

METHODS: The sample consisted of 1421 adolescents from the Project on Human Development in Chicago Neighborhoods, a three wave longitudinal study conducted between 1994 and 2001 that followed children from ages 10 to 22. Logistic regression analyses with multiple imputation were conducted to examine the relation between familial conflict in childhood and substance use disorders in late adolescence and emerging adulthood. We conducted mediational analyses to determine if internalizing and externalizing problems explain this relationship, and we investigated whether external social support mitigates the adverse effects of familial conflict on the development of substance use disorders.

RESULTS: Familial conflict was significantly associated with the risk of substance use disorders during adolescence (odds ratio: 1.23; 95\% CI: 1.02-1.47), and 30\% of this effect was due to higher levels of externalizing problems (but not internalizing problems). External social support in childhood did not buffer the effects of familial conflict on substance use disorders during adolescence.

CONCLUSION: Exposure to familial conflict early in life increases the risk of substance use disorders during late adolescence and emerging adulthood, due partly to higher levels of externalizing problems, but not internalizing problems. Future research is needed to identify additional pathways underlying this association, and the extent to which these pathways are modifiable.},
	keywords = {Adolescent, Child, Cohort Studies, Family Conflict, Female, Humans, Longitudinal Studies, Male, Parents, Prospective Studies, Psychiatric Status Rating Scales, Risk, Social Support, Stress, Psychological, Substance-Related Disorders, Treatment Outcome},
	issn = {1879-0046},
	doi = {10.1016/j.drugalcdep.2009.03.017},
	author = {Skeer, Margie and McCormick, Marie C. and Normand, Sharon-Lise T. and Buka, Stephen L. and Gilman, Stephen E.}
}
@article {573166,
	title = {Racial and ethnic disparities in access to higher and lower quality cardiac surgeons for coronary artery bypass grafting},
	journal = {Am J Cardiol},
	volume = {103},
	number = {12},
	year = {2009},
	month = {2009 Jun 15},
	pages = {1682-6},
	abstract = {To determine whether Hispanic and African-American patients are treated by cardiac surgeons with better or worse risk-standardized outcomes than surgeons of white patients, clinical data from the Massachusetts Data Analysis Center Registry were analyzed on all patients who underwent isolated coronary artery bypass grafting (CABG) from 2002 to 2004 by surgeons who performed >or=10 operations. Surgeons were divided into 4 groups based on their risk-standardized 30-day all-cause mortality incidence rates (top decile, top quartile, bottom quartile, and bottom decile). A total of 12,973 isolated CABGs were performed by 56 surgeons for 11,800 whites (91\%), 413 Hispanics (3.2\%), and 251 African-Americans (1.9\%). White patients were more likely to be treated by surgeons in the top decile than by surgeons in the bottom decile (odds ratio [OR] 1.37, 95\% confidence interval [CI] 1.07 to 1.76). In contrast, Hispanic patients were almost 3 times more likely to be treated by surgeons in the bottom decile compared with the top decile (OR 2.85, 95\% CI 1.82 to 4.47). Compared with whites, Hispanic patients were about 1/2 as less likely to be treated by surgeons in the top decile (OR 0.51, 95\% CI 0.35 to 0.75). African-American and white patients were similarly likely to be treated by surgeons in the top- and bottom-quality performance groups. In conclusion, Hispanics undergoing isolated CABG in Massachusetts were more likely to be operated on by cardiac surgeons with higher risk-standardized mortality rates than by surgeons with lower rates.},
	keywords = {Aged, Cause of Death, Clinical Competence, Coronary Artery Bypass, Ethnic Groups, Female, Follow-Up Studies, Humans, Male, Massachusetts, Middle Aged, Myocardial Ischemia, Physicians, Prognosis, Retrospective Studies, Risk Assessment, Surveys and Questionnaires, Survival Rate, Time Factors},
	issn = {1879-1913},
	doi = {10.1016/j.amjcard.2009.02.019},
	author = {Castellanos, Luis R and Normand, Sharon-Lise T. and John Z. Ayanian}
}
@article {573126,
	title = {Reduction in acute myocardial infarction mortality in the United States: risk-standardized mortality rates from 1995-2006},
	journal = {JAMA},
	volume = {302},
	number = {7},
	year = {2009},
	month = {2009 Aug 19},
	pages = {767-73},
	abstract = {CONTEXT: During the last 2 decades, health care professional, consumer, and payer organizations have sought to improve outcomes for patients hospitalized with acute myocardial infarction (AMI). However, little has been reported about improvements in hospital short-term mortality rates or reductions in between-hospital variation in short-term mortality rates.

OBJECTIVE: To estimate hospital-level 30-day risk-standardized mortality rates (RSMRs) for patients discharged with AMI.

DESIGN, SETTING, AND PATIENTS: Observational study using administrative data and a validated risk model to evaluate 3,195,672 discharges in 2,755,370 patients discharged from nonfederal acute care hospitals in the United States between January 1, 1995, and December 31, 2006. Patients were 65 years or older (mean, 78 years) and had at least a 12-month history of fee-for-service enrollment prior to the index hospitalization. Patients discharged alive within 1 day of an admission not against medical advice were excluded, because it is unlikely that these patients had sustained an AMI.

MAIN OUTCOME MEASURE: Hospital-specific 30-day all-cause RSMR.

RESULTS: At the patient level, the odds of dying within 30 days of admission if treated at a hospital 1 SD above the national average relative to that if treated at a hospital 1 SD below the national average were 1.63 (95\% CI, 1.60-1.65) in 1995 and 1.56 (95\% CI, 1.53-1.60) in 2006. In terms of hospital-specific RSMRs, a decrease from 18.8\% in 1995 to 15.8\% in 2006 was observed (odds ratio, 0.76; 95\% CI, 0.75-0.77). A reduction in between-hospital heterogeneity in the RSMRs was also observed: the coefficient of variation decreased from 11.2\% in 1995 to 10.8\%, the interquartile range from 2.8\% to 2.1\%, and the between-hospital variance from 4.4\% to 2.9\%.

CONCLUSION: Between 1995 and 2006, the risk-standardized hospital mortality rate for Medicare patients discharged with AMI showed a significant decrease, as did between-hospital variation.},
	keywords = {Aged, Aged, 80 and over, Centers for Medicare and Medicaid Services (U.S.), Female, Hospital Mortality, Humans, Length of Stay, Male, Myocardial Infarction, Risk, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.2009.1178},
	author = {Krumholz,Harlan M. and Wang, Yun and Chen, Jersey and Drye, Elizabeth E and Spertus, John A and Ross, Joseph S and Curtis, Jeptha P and Nallamothu, Brahmajee K and Lichtman, Judith H and Havranek, Edward P and Masoudi, Frederick A and Radford, Martha J and Han, Lein F and Rapp, Michael T and Straube, Barry M and Normand, Sharon-Lise T.}
}
@article {573151,
	title = {The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1--coronary artery bypass grafting surgery},
	journal = {Ann Thorac Surg},
	volume = {88},
	number = {1 Suppl},
	year = {2009},
	month = {2009 Jul},
	pages = {S2-22},
	abstract = {BACKGROUND: The first version of The Society of Thoracic Surgeons National Adult Cardiac Surgery Database (STS NCD) was developed nearly 2 decades ago. Since its inception, the number of participants has grown dramatically, patient acuity has increased, and overall outcomes have consistently improved. To adjust for these and other changes, all STS risk models have undergone periodic revisions. This report provides a detailed description of the 2008 STS risk model for coronary artery bypass grafting surgery (CABG).

METHODS: The study population consisted of 774,881 isolated CABG procedures performed on adult patients aged 20 to 100 years between January 1, 2002, and December 31, 2006, at 819 STS NCD participating centers. This cohort was randomly divided into a 60\% training (development) sample and a 40\% test (validation) sample. The development sample was used to identify predictor variables and estimate model coefficients. The validation sample was used to assess model calibration and discrimination. Model outcomes included operative mortality, renal failure, stroke, reoperation for any cause, prolonged ventilation, deep sternal wound infection, composite major morbidity or mortality, prolonged length of stay (> 14 days), and short length of stay (< 6 days and alive). Candidate predictor variables were selected based on their availability in versions 2.35, 2.41, and 2.52.1 of the STS NCD and their presence in (or ability to be mapped to) version 2.61. Potential predictor variables were screened for overall prevalence in the study population, missing data frequency, coding concerns, bivariate relationships with outcomes, and their presence in previous STS or other CABG risk models. Supervised backwards selection was then performed with input from an expert panel of cardiac surgeons and biostatisticians. After successfully validating the fit of the models, the development and validation samples were subsequently combined, and the final regression coefficients were estimated using the overall combined (development plus validation) sample.

RESULTS: The c-index for the mortality model was 0.812, and the c-indices for other endpoints ranged from 0.653 for reoperation to 0.793 for renal failure in the validation sample. Plots of observed versus predicted event rates revealed acceptable calibration in the overall population and in numerous subgroups. When patients were grouped into categories of predicted risk, the absolute difference between the observed and expected event rates was less than 1.5\% for each endpoint. The final model intercept and coefficients are provided.

CONCLUSIONS: New STS risk models have been developed for CABG mortality and eight other endpoints. Detailed descriptions of model development and testing are provided, together with the final algorithm. Overall model performance is excellent.},
	keywords = {Adult, Advisory Committees, Age Factors, Aged, Aged, 80 and over, Algorithms, Cardiac Surgical Procedures, Cause of Death, Coronary Artery Bypass, Databases, Factual, Female, Humans, Male, Middle Aged, Models, Cardiovascular, Models, Statistical, Postoperative Complications, Prognosis, Risk Adjustment, Sensitivity and Specificity, Sex Factors, Societies, Medical, Survival Analysis, Young Adult},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2009.05.053},
	author = {Shahian, David M and O{\textquoteright}Brien, Sean M and Filardo, Giovanni and Ferraris, Victor A and Haan, Constance K and Rich, Jeffrey B and Normand, Sharon-Lise T. and DeLong, Elizabeth R and Shewan, Cynthia M and Dokholyan, Rachel S and Peterson, Eric D and Edwards, Fred H and Anderson, Richard P}
}
@article {573146,
	title = {The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery},
	journal = {Ann Thorac Surg},
	volume = {88},
	number = {1 Suppl},
	year = {2009},
	month = {2009 Jul},
	pages = {S23-42},
	abstract = {BACKGROUND: Adjustment for case-mix is essential when using observational data to compare surgical techniques or providers. That is most often accomplished through the use of risk models that account for preoperative patient factors that may impact outcomes. The Society of Thoracic Surgeons (STS) uses such risk models to create risk-adjusted performance reports for participants in the STS National Adult Cardiac Surgery Database (NCD). Although risk models were initially developed for coronary artery bypass surgery, similar models have now been developed for use with heart valve surgery, particularly as the proportion of such procedures has increased. The last published STS model for isolated valve surgery was based on data from 1994 to 1997 and did not include patients undergoing mitral valve repair. STS has developed new valve surgery models using contemporary data that include both valve repair as well as replacement. Expanding upon existing valve models, the new STS models include several nonfatal complications in addition to mortality.

METHODS: Using STS data from 2002 to 2006, isolated valve surgery risk models were developed for operative mortality, permanent stroke, renal failure, prolonged ventilation (> 24 hours), deep sternal wound infection, reoperation for any reason, a major morbidity or mortality composite endpoint, prolonged postoperative length of stay, and short postoperative length of stay. The study population consisted of adult patients who underwent one of three types of valve surgery: isolated aortic valve replacement (n = 67,292), isolated mitral valve replacement (n = 21,229), or isolated mitral valve repair (n = 21,238). The population was divided into a 60\% development sample and a 40\% validation sample. After an initial empirical investigation, the three surgery groups were combined into a single logistic regression model with numerous interactions to allow the covariate effects to differ across these groups. Variables were selected based on a combination of automated stepwise selection and expert panel review.

RESULTS: Unadjusted operative mortality (in-hospital regardless of timing, and 30-day regardless of venue) for all isolated valve procedures was 3.4\%, and unadjusted in-hospital morbidity rates ranged from 0.3\% for deep sternal wound infection to 11.8\% for prolonged ventilation. The number of predictors in each model ranged from 10 covariates in the sternal infection model to 24 covariates in the composite mortality plus morbidity model. Discrimination as measured by the c-index ranged from 0.639 for reoperation to 0.799 for mortality. When patients in the validation sample were grouped into 10 categories based on deciles of predicted risk, the average absolute difference between observed versus predicted events within these groups ranged from 0.06\% for deep sternal wound infection to 1.06\% for prolonged postoperative stay.

CONCLUSIONS: The new STS risk models for valve surgery include mitral valve repair as well as multiple endpoints other than mortality. Model coefficients are provided and an online risk calculator is publicly available from The Society of Thoracic Surgeons website.},
	keywords = {Advisory Committees, Age Factors, Aged, Cause of Death, Databases, Factual, Female, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Humans, Male, Middle Aged, Models, Cardiovascular, Models, Statistical, Postoperative Complications, Reproducibility of Results, Risk Adjustment, Sensitivity and Specificity, Sex Factors, Societies, Medical, Survival Analysis, Thoracic Surgery, Treatment Outcome},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2009.05.056},
	author = {O{\textquoteright}Brien, Sean M and Shahian, David M and Filardo, Giovanni and Ferraris, Victor A and Haan, Constance K and Rich, Jeffrey B and Normand, Sharon-Lise T. and DeLong, Elizabeth R and Shewan, Cynthia M and Dokholyan, Rachel S and Peterson, Eric D and Edwards, Fred H and Anderson, Richard P}
}
@article {573141,
	title = {The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery},
	journal = {Ann Thorac Surg},
	volume = {88},
	number = {1 Suppl},
	year = {2009},
	month = {2009 Jul},
	pages = {S43-62},
	abstract = {BACKGROUND: Since 1999, The Society of Thoracic Surgeons (STS) has published two risk models that can be used to adjust the results of valve surgery combined with coronary artery bypass graft surgery (CABG). The most recent was developed from data for patients who had surgery between 1994 and 1997 using operative mortality as the only endpoint. Furthermore, this model did not specifically consider mitral valve repair plus CABG, an increasingly common procedure. Consistent with STS policy of periodically updating and improving its risk models, new models for valve surgery combined with CABG have been developed. These models specifically address both perioperative morbidity and mitral valve repair, and they are based on contemporary data.

METHODS: The final study population consisted of 101,661 procedures, including aortic valve replacement (AVR) plus CABG, mitral valve replacement (MVR) plus CABG, or mitral valve repair (MVRepair) plus CABG between January 1, 2002, and December 31, 2006. Model outcomes included operative mortality, stroke, deep sternal wound infection, reoperation, prolonged ventilation, renal failure, composite major morbidity or mortality, prolonged postoperative length of stay, and short postoperative length of stay. Candidate variables were screened for frequency of missing data, and imputation techniques were used where appropriate. Stepwise variable selection was employed, supplemented by advice from an expert panel of cardiac surgeons and biostatisticians. Several variables were forced into models to insure face validity (eg, atrial fibrillation for the permanent stroke model, sex for all models). Based on preliminary analyses of the data, a single model was employed for valve plus CABG, with indicator variables for the specific type of procedure. Interaction terms were included to allow for differential impact of predictor variables depending on procedure type. After validating the model in the 40\% validation sample, the development and validation samples were then combined, and the final model coefficients were estimated using the overall 100\% combined sample. The final logistic regression model was estimated using generalized estimating equations to account for clustering of patients within institutions.

RESULTS: The c-index for mortality prediction for the overall valve plus CABG population was 0.75. Morbidity model c-indices for specific complications (permanent stroke, renal failure, prolonged ventilation > 24 hours, deep sternal wound infection, reoperation for any reason, major morbidity or mortality composite, and prolonged postoperative length of stay) for the overall group of valve plus CABG procedures ranged from 0.622 to 0.724, and calibration was excellent.

CONCLUSIONS: New STS risk models have been developed for heart valve surgery combined with CABG. These are the first valve plus CABG models that also include risk prediction for individual major morbidities, composite major morbidity or mortality, and short and prolonged length of stay.},
	keywords = {Advisory Committees, Age Factors, Aged, Aged, 80 and over, Aortic Valve, Cause of Death, Combined Modality Therapy, Coronary Artery Bypass, Databases, Factual, Female, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Humans, Male, Middle Aged, Mitral Valve, Models, Cardiovascular, Models, Statistical, Postoperative Complications, Predictive Value of Tests, Prognosis, Risk Adjustment, Sensitivity and Specificity, Sex Factors, Societies, Medical, Survival Analysis, Thoracic Surgery},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2009.05.055},
	author = {Shahian, David M and O{\textquoteright}Brien, Sean M and Filardo, Giovanni and Ferraris, Victor A and Haan, Constance K and Rich, Jeffrey B and Normand, Sharon-Lise T. and DeLong, Elizabeth R and Shewan, Cynthia M and Dokholyan, Rachel S and Peterson, Eric D and Edwards, Fred H and Anderson, Richard P}
}
@article {573071,
	title = {Statistical Approaches to Modeling Multiple Outcomes In Psychiatric Studies},
	journal = {Psychiatr Ann},
	volume = {39},
	number = {7},
	year = {2009},
	month = {2009 Jul 01},
	pages = {729-735},
	abstract = {Increasingly, multiple outcomes are collected in order to characterize treatment effectiveness or to evaluate risk factors. These outcomes tend to be correlated because they are measuring related quantities in the same individuals. While the analysis of outcomes measured in the same scale (commensurate outcomes) can be undertaken with standard statistical methods, outcomes measured in different scales (non-commensurate outcomes), such as mixed binary and continuous outcomes, present more difficult challenges.In this paper we contrast some statistical approaches to analyze non-commensurate multiple outcomes. We discuss the advantages of a multivariate method for the analysis of non-commensurate outcomes including situations of missing data. A real data example from a clinical trial, comparing different treatments for depression in low-income women, is used to illustrate the differences between the statistical approaches.},
	issn = {0048-5713},
	doi = {10.3928/00485713-20090625-08},
	author = {Teixeira-Pinto, Armando and Siddique, Juned and Robert Gibbons and Normand, Sharon-Lise}
}
@article {573176,
	title = {Syncope and its consequences in patients with dementia receiving cholinesterase inhibitors: a population-based cohort study},
	journal = {Arch Intern Med},
	volume = {169},
	number = {9},
	year = {2009},
	month = {2009 May 11},
	pages = {867-73},
	abstract = {BACKGROUND: Cholinesterase inhibitors are commonly prescribed to treat dementia, but their adverse effect profile has received little attention. These drugs can provoke symptomatic bradycardia and syncope, which may lead to permanent pacemaker insertion. Drug-induced syncope may also precipitate fall-related injuries, including hip fracture.

METHODS: In a population-based cohort study, we investigated the relationship between cholinesterase inhibitor use and syncope-related outcomes using health care databases from Ontario, Canada, with accrual from April 1, 2002, to March 31, 2004. We identified 19 803 community-dwelling older adults with dementia who were prescribed cholinesterase inhibitors and 61 499 controls who were not.

RESULTS: Hospital visits for syncope were more frequent in people receiving cholinesterase inhibitors than in controls (31.5 vs 18.6 events per 1000 person-years; adjusted hazard ratio [HR], 1.76; 95\% confidence interval [CI], 1.57-1.98). Other syncope-related events were also more common among people receiving cholinesterase inhibitors compared with controls: hospital visits for bradycardia (6.9 vs 4.4 events per 1000 person-years; HR, 1.69; 95\% CI, 1.32-2.15), permanent pacemaker insertion (4.7 vs 3.3 events per 1000 person-years; HR, 1.49; 95\% CI, 1.12-2.00), and hip fracture (22.4 vs 19.8 events per 1000 person-years; HR, 1.18; 95\% CI, 1.04-1.34). Results were consistent in additional analyses in which subjects were either matched on their baseline comorbidity status or matched using propensity scores.

CONCLUSIONS: Use of cholinesterase inhibitors is associated with increased rates of syncope, bradycardia, pacemaker insertion, and hip fracture in older adults with dementia. The risk of these previously underrecognized serious adverse events must be weighed carefully against the drugs{\textquoteright} generally modest benefits.},
	keywords = {Aged, Aged, 80 and over, Bradycardia, Case-Control Studies, Cholinesterase Inhibitors, Cohort Studies, Databases, Factual, Dementia, Female, Hip Fractures, Hospitalization, Humans, Male, Ontario, Pacemaker, Artificial, Syncope},
	issn = {1538-3679},
	doi = {10.1001/archinternmed.2009.43},
	author = {Gill, Sudeep S and Anderson, Geoffrey M and Fischer, Hadas D and Bell, Chaim M and Li, Ping and Normand, Sharon-Lise T. and Rochon, Paula A}
}
@article {573021,
	title = {Using Non-experimental Data to Estimate Treatment Effects},
	journal = {Psychiatr Ann},
	volume = {39},
	number = {7},
	year = {2009},
	month = {2009 Jul 01},
	pages = {41451},
	abstract = {While much psychiatric research is based on randomized controlled trials (RCTs), where patients are randomly assigned to treatments, sometimes RCTs are not feasible. This paper describes propensity score approaches, which are increasingly used for estimating treatment effects in non-experimental settings. The primary goal of propensity score methods is to create sets of treated and comparison subjects who look as similar as possible, in essence replicating a randomized experiment, at least with respect to observed patient characteristics. A study to estimate the metabolic effects of antipsychotic medication in a sample of Florida Medicaid beneficiaries with schizophrenia illustrates methods.},
	issn = {0048-5713},
	doi = {10.3928/00485713-20090625-07},
	author = {Elizabeth A. Stuart and Marcus, Sue M and Horvitz-Lennon, Marcela V and Gibbons, Robert D and Normand, Sharon-Lise T.}
}
@article {573261,
	title = {An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure},
	journal = {Circ Cardiovasc Qual Outcomes},
	volume = {1},
	number = {1},
	year = {2008},
	month = {2008 Sep},
	pages = {29-37},
	abstract = {BACKGROUND: Readmission soon after hospital discharge is an expensive and often preventable event for patients with heart failure. We present a model approved by the National Quality Forum for the purpose of public reporting of hospital-level readmission rates by the Centers for Medicare \& Medicaid Services.

METHODS AND RESULTS: We developed a hierarchical logistic regression model to calculate hospital risk-standardized 30-day all-cause readmission rates for patients hospitalized with heart failure. The model was derived with the use of Medicare claims data for a 2004 cohort and validated with the use of claims and medical record data. The unadjusted readmission rate was 23.6\%. The final model included 37 variables, had discrimination ranging from 15\% observed 30-day readmission rate in the lowest predictive decile to 37\% in the upper decile, and had a c statistic of 0.60. The 25th and 75th percentiles of the risk-standardized readmission rates across 4669 hospitals were 23.1\% and 24.0\%, with 5th and 95th percentiles of 22.2\% and 25.1\%, respectively. The odds of all-cause readmission for a hospital 1 standard deviation above average was 1.30 times that of a hospital 1 standard deviation below average. State-level adjusted readmission rates developed with the use of the claims model are similar to rates produced for the same cohort with the use of a medical record model (correlation, 0.97; median difference, 0.06 percentage points).

CONCLUSIONS: This claims-based model of hospital risk-standardized readmission rates for heart failure patients produces estimates that may serve as surrogates for those derived from a medical record model.},
	keywords = {Female, Heart Failure, Humans, Insurance Claim Review, Male, Medical Records, Medicare, Models, Statistical, Outcome Assessment (Health Care), Patient Readmission, Software Validation, United States},
	issn = {1941-7705},
	doi = {10.1161/CIRCOUTCOMES.108.802686},
	author = {Patricia S. Keenan and Normand, Sharon-Lise T. and Lin, Zhenqiu and Drye, Elizabeth E and Bhat, Kanchana R and Ross, Joseph S and Schuur, Jeremiah D and Stauffer, Brett D and Bernheim, Susannah M and Epstein, Andrew J and Wang, Yongfei and Herrin, Jeph and Chen, Jersey and Federer, Jessica J and Mattera, Jennifer A and Wang, Yun and Krumholz,Harlan M.}
}
@article {573291,
	title = {Antipsychotic therapy and short-term serious events in older adults with dementia},
	journal = {Arch Intern Med},
	volume = {168},
	number = {10},
	year = {2008},
	month = {2008 May 26},
	pages = {1090-6},
	abstract = {BACKGROUND: Antipsychotic therapy is widely used to treat behavioral problems in older adults with dementia. Cohort studies evaluating the safety of antipsychotic therapy generally focus on a single adverse event. We compared the rate of developing any serious event, a composite outcome defined as an event serious enough to lead to an acute care hospital admission or death within 30 days of initiating antipsychotic therapy, to better estimate the overall burden of short-term harm associated with these agents.

METHODS: In this population-based, retrospective cohort study, we identified 20 682 matched older adults with dementia living in the community and 20 559 matched individuals living in a nursing home between April 1, 1997, and March 31, 2004. Propensity-based matching was used to balance differences between the drug exposure groups in each setting. To examine the effects of antipsychotic drug use on the composite outcome of any serious event we used a conditional logistic regression model. We also estimated adjusted odds ratios using models that included all covariates with a standard difference greater than 0.10.

RESULTS: Relative to those who received no antipsychotic therapy, community-dwelling older adults newly dispensed an atypical antipsychotic therapy were 3.2 times more likely (95\% confidence interval, 2.77-3.68) and those who received conventional antipsychotic therapy were 3.8 times more likely (95\% confidence interval, 3.31-4.39) to develop any serious event during the 30 days of follow-up. The pattern of serious events was similar but less pronounced among older adults living in a nursing home.

CONCLUSIONS: Serious events, as indicated by a hospital admission or death, are frequent following the short-term use of antipsychotic drugs in older adults with dementia. Antipsychotic drugs should be used with caution even when short-term therapy is being prescribed.},
	keywords = {Aged, Antipsychotic Agents, Cohort Studies, Dementia, Female, Humans, Male, Retrospective Studies, Treatment Outcome},
	issn = {1538-3679},
	doi = {10.1001/archinte.168.10.1090},
	author = {Rochon, Paula A and Normand, Sharon-Lise and Gomes, Tara and Gill, Sudeep S and Anderson, Geoffrey M and Melo, Magda and Sykora, Kathy and Lipscombe, Lorraine and Bell, Chaim M and Gurwitz, Jerry H}
}
@article {573131,
	title = {Balancing Treatment Comparisons in Longitudinal Studies},
	journal = {Psychiatr Ann},
	volume = {38},
	number = {12},
	year = {2008},
	month = {2008 Dec 01},
	pages = {805-811},
	issn = {0048-5713},
	author = {Marcus, Sue M and Siddique, Juned and Have, Thomas R Ten and Gibbons, Robert D and Elizabeth Stuart and Normand, Sharon-Lise T.}
}
@article {573266,
	title = {Cardiology patient pages. How are our hospitals measuring up?: "hospital compare": a resource for hospital quality of care},
	journal = {Circulation},
	volume = {118},
	number = {13},
	year = {2008},
	month = {2008 Sep 23},
	pages = {e498-500},
	keywords = {Databases, Factual, Hospitals, Humans, Internet, Quality Indicators, Health Care, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.804872},
	author = {Johnson, Maria A and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {573381,
	title = {A comparison of methods for combining quality and efficiency performance measures: profiling the value of hospital care following acute myocardial infarction},
	journal = {Stat Med},
	volume = {27},
	number = {9},
	year = {2008},
	month = {2008 Apr 30},
	pages = {1351-70},
	abstract = {Health plans have begun to combine data on the quality and cost of medical providers in an attempt to identify and reward those that offer the greatest {\textquoteright}value.{\textquoteright} The analytical methods used to combine these measures in the context of provider profiling have not been rigorously studied. We propose three methods to measure and compare the value of hospital care following acute myocardial infarction by combining a single measure of quality, in-hospital survival, and the cost of an episode of acute care. To illustrate these methods, we use administrative data for heart attack patients treated at 69 acute care hospitals in Massachusetts in fiscal year 2003. In the first method we reproduce a common approach to value profiling by modeling the two case mix-standardized outcomes independently. In the second approach, survival is regressed on patient risk factors and the average cost of care at each hospital. The third method models survival and cost for each hospital jointly and combines the outcomes on a common scale using a cost-effectiveness framework. For each method we use the resulting parameter estimates or functions of the estimates to compute posterior tail probabilities, representing the probability of being classified in the upper or lower quartile of the statewide distribution. Hospitals estimated to have the highest and lowest value according to each method are compared for consistency, and the advantages and disadvantages of each approach are discussed.},
	keywords = {Cost-Benefit Analysis, Efficiency, Organizational, Health Care Costs, Hospitals, Humans, Massachusetts, Models, Statistical, Myocardial Infarction, Outcome Assessment (Health Care), Quality of Health Care, Regression Analysis, Sensitivity and Specificity},
	issn = {0277-6715},
	doi = {10.1002/sim.3082},
	author = {Timbie, Justin W and Normand, Sharon-Lise T.}
}
@article {573311,
	title = {Comparison of "risk-adjusted" hospital outcomes},
	journal = {Circulation},
	volume = {117},
	number = {15},
	year = {2008},
	month = {2008 Apr 15},
	pages = {1955-63},
	abstract = {BACKGROUND: A frequent challenge in outcomes research is the comparison of rates from different populations. One common example with substantial health policy implications involves the determination and comparison of hospital outcomes. The concept of "risk-adjusted" outcomes is frequently misunderstood, particularly when it is used to justify the direct comparison of performance at 2 specific institutions.

METHODS AND RESULTS: Data from 14 Massachusetts hospitals were analyzed for 4393 adults undergoing isolated coronary artery bypass graft surgery in 2003. Mortality estimates were adjusted using clinical data prospectively collected by hospital personnel and submitted to a data coordinating center designated by the state. The primary outcome was hospital-specific, risk-standardized, 30-day all-cause mortality after surgery. Propensity scores were used to assess the comparability of case mix (covariate balance) for each Massachusetts hospital relative to the pool of patients undergoing coronary artery bypass grafting surgery at the remaining hospitals and for selected pairwise comparisons. Using hierarchical logistic regression, we indirectly standardized the mortality rate of each hospital using its expected rate. Predictive cross-validation was used to avoid underidentification of true outlying hospitals. Overall, there was sufficient overlap between the case mix of each hospital and that of all other Massachusetts hospitals to justify comparison of individual hospital performance with that of the remaining hospitals. As expected, some pairwise hospital comparisons indicated lack of comparability. This finding illustrates the fallacy of assuming that risk adjustment per se is sufficient to permit direct side-by-side comparison of healthcare providers. In some instances, such analyses may be facilitated by the use of propensity scores to improve covariate balance between institutions and to justify such comparisons.

CONCLUSIONS: Risk-adjusted outcomes, commonly the focus of public report cards, have a specific interpretation. Using indirect standardization, these outcomes reflect a provider{\textquoteright}s performance for its specific case mix relative to the expected performance of an average provider for that same case mix. Unless study design or post hoc adjustments have resulted in reasonable overlap of case-mix distributions, such risk-adjusted outcomes should not be used to directly compare one institution with another.},
	keywords = {Adult, Aged, Aged, 80 and over, Causality, Cause of Death, Coronary Artery Bypass, Diagnosis-Related Groups, Female, Hospital Mortality, Hospitals, Humans, Male, Massachusetts, Middle Aged, Outcome Assessment (Health Care), Quality Assurance, Health Care, Risk Adjustment},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.107.747873},
	author = {Shahian, David M and Normand, Sharon-Lise T.}
}
@article {573296,
	title = {A cost-effectiveness framework for profiling the value of hospital care},
	journal = {Med Decis Making},
	volume = {28},
	number = {3},
	year = {2008},
	month = {2008 May-Jun},
	pages = {419-34},
	abstract = {Provider profiling and performance-based incentive programs have expanded in recent years but need a theoretical framework for measuring and comparing the "value{\textquoteright}{\textquoteright} of clinical care across medical providers. Cost-effectiveness analysis provides such a framework but has rarely been used outside of the treatment choice context. The authors present a profiling framework based on cost-effectiveness methods and illustrate their approach using data on in-hospital survival and the cost of care for a heart attack from a sample of Massachusetts hospitals during fiscal year 2003. They model each outcome using hierarchical models that allow performance to vary across hospitals as a function of a latent quality effect and an effect of case mix. They also estimate incremental outcomes by conditioning on each hospital{\textquoteright}s pair of random effects, using indirect standardization to estimate "expected{\textquoteright}{\textquoteright} outcomes, and then taking their difference. Incremental cost and effectiveness outcomes are combined using incremental net monetary benefits. Using cost-effectiveness methods to profile hospital "value{\textquoteright}{\textquoteright} permits the comparison of the benefit of a service relative to the cost using existing societal weights.},
	keywords = {Aged, Cost-Benefit Analysis, Female, Financing, Personal, Hospitalization, Humans, Male, Massachusetts, Models, Statistical, Myocardial Infarction, Outcome Assessment (Health Care), Quality of Health Care, Risk Adjustment, Survival Analysis},
	issn = {0272-989X},
	doi = {10.1177/0272989X07312476},
	author = {Timbie, Justin W and Joseph P. Newhouse and Meredith B. Rosenthal and Normand, Sharon-Lise T.}
}
@article {573306,
	title = {Differential item functioning between ethnic groups in the epidemiological assessment of depression},
	journal = {J Nerv Ment Dis},
	volume = {196},
	number = {4},
	year = {2008},
	month = {2008 Apr},
	pages = {297-306},
	abstract = {A potential explanation for the finding that disadvantaged minority status is associated with a lower lifetime risk for depression is that individuals from minority ethnic groups may be less likely to endorse survey questions about depression even when they have the same level of depression. We examine this possibility using a nonparametric item response theory approach to assess differential item functioning (DIF) in a national survey of psychiatric disorders, the National Comorbidity Survey. Of 20 questions used to assess depression symptoms, we found evidence of DIF in 3 questions when comparing non-Hispanic blacks with non-Hispanic whites and in 3 questions when comparing Hispanics with non-Hispanic whites. However, removal of the questions with DIF did not alter the relative prevalence of depression between ethnic groups. Ethnic differences do exist in response to questions concerning depression, but these differences do not account for the finding of relatively low prevalence of depression among minority groups.},
	keywords = {Adolescent, Adult, African Continental Ancestry Group, Bias (Epidemiology), Cross-Cultural Comparison, Cross-Sectional Studies, Depressive Disorder, European Continental Ancestry Group, Female, Health Surveys, Hispanic Americans, Humans, Interview, Psychological, Male, Middle Aged, Statistics, Nonparametric, United States},
	issn = {1539-736X},
	doi = {10.1097/NMD.0b013e31816a490e},
	author = {Breslau, Joshua and Javaras, Kristin N and Blacker, Deborah and Murphy, Jane M and Normand, Sharon-Lise T.}
}
@article {573331,
	title = {Discriminating quality of hospital care in the United States},
	journal = {Med Decis Making},
	volume = {28},
	number = {3},
	year = {2008},
	month = {2008 May-Jun},
	pages = {308-22},
	abstract = {BACKGROUND AND OBJECTIVE: The Centers for Medicare and Medicaid Services (CMS) report quality of care for patients hospitalized with acute myocardial infarction (AMI), congestive heart failure (CHF), and community-acquired pneumonia (CAP) with the intention of rewarding superior performing hospitals. The aim of the study was to compare identification of superior hospitals for providing financial rewards using 2 different scoring systems: a latent score that weights individual clinical performance measures according to how well each discriminated hospital quality and a raw sum score (the system adopted by CMS).

METHODS: This observational cohort study used 2761 acute care hospitals in the United States reporting AMI clinical performance measures, 3271 reporting CHF measures, and 3714 hospitals reporting CAP measures. For each clinical condition, the main outcome measures included the average raw sum score, the latent score estimated from an item response theory (IRT) model, and the percentage of false negative superior designations made on the basis of raw sum scores relative to latent scores.

RESULTS: The average raw sum score was highest for AMI (88.8\%) and lower for CHF (73.1\%) and CAP (76.3\%). AMI measures were equally nondiscriminating of hospital quality; hospital discharge instruction was most discriminating of CHF quality; pneumococcal vaccination was most discriminating of CAP quality. False negative rates varied 2-fold: AMI (10\%), CHF (16\%), and CAP (24\%).

CONCLUSIONS: Neither the AMI raw sum score nor latent score discriminates hospital quality due to ceiling effects. Current methods for aggregating measures result in different hospital superior designations than those based on the latent score. Organizations that financially reward hospitals on the basis of such scores need to assess predictive validity of scores and determine a minimum level of classification accuracy.},
	keywords = {Community-Acquired Infections, Heart Failure, Hospitals, Humans, Inpatients, Models, Theoretical, Myocardial Infarction, Quality Indicators, Health Care, Quality of Health Care, Reimbursement, Incentive, United States},
	issn = {0272-989X},
	doi = {10.1177/0272989X07312710},
	author = {Normand, Sharon-Lise T. and Wolf, Robert E and McNeil, Barbara J}
}
@article {573226,
	title = {Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts Data Analysis Center Registry},
	journal = {Circulation},
	volume = {118},
	number = {22},
	year = {2008},
	month = {2008 Nov 25},
	pages = {2277-85, 7p following 2285},
	abstract = {BACKGROUND: Patients with diabetes mellitus (DM) are at high risk for restenosis, myocardial infarction, and cardiac mortality after coronary stenting, and the long-term safety of drug-eluting stents (DES) relative to bare-metal stents (BMS) in DM is uncertain. We report on a large consecutive series of patients with DM followed up for 3 years after DES and BMS from a regional contemporary US practice with mandatory reporting.

METHODS AND RESULTS: All adults with DM undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at all acute care nonfederal hospitals in Massachusetts were identified from a mandatory state database. According to index admission stent type, patients were classified as DES treated if all stents were drug eluting and as BMS treated if all stents were bare metal; patients treated with both types of stents were excluded from the primary analysis. Mortality rates were obtained from vital statistics records, and myocardial infarction and revascularization rates were obtained from the state database with complete 3 years of follow-up on the entire cohort. Risk-adjusted mortality, myocardial infarction, and revascularization differences (DES-BMS) were estimated with propensity-score matching based on clinical, procedural, hospital, and insurance information collected at the index admission. DM was present in 5051 patients (29\% of the population) treated with DES or BMS during the study. Patients with DM were more likely to receive DES than BMS (66.1\% versus 33.9\%; P,
	keywords = {Adolescent, Adult, Aged, Cause of Death, Cohort Studies, Coronary Disease, Databases, Factual, Diabetes Complications, Diabetes Mellitus, Drug-Eluting Stents, Equipment Design, Female, Follow-Up Studies, Humans, Male, Massachusetts, Metals, Middle Aged, Myocardial Infarction, Myocardial Ischemia, Safety, Young Adult},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.820159},
	author = {Garg, Pallav and Normand, Sharon-Lise T. and Silbaugh, Treacy S and Wolf, Robert E and Zelevinsky, Katya and Lovett, Ann and Varma, Manu R and Zhou, Zheng and Mauri, Laura}
}
@article {573256,
	title = {Drug-eluting or bare-metal stents for acute myocardial infarction},
	journal = {N Engl J Med},
	volume = {359},
	number = {13},
	year = {2008},
	month = {2008 Sep 25},
	pages = {1330-42},
	abstract = {BACKGROUND: Studies comparing percutaneous coronary intervention (PCI) with drug-eluting and bare-metal coronary stents in acute myocardial infarction have been limited in size and duration.

METHODS: We identified all adults undergoing PCI with stenting for acute myocardial infarction between April 1, 2003, and September 30, 2004, at any acute care, nonfederal hospital in Massachusetts with the use of a state-mandated database of PCI procedures. We performed propensity-score matching on three groups of patients: all patients with acute myocardial infarction, all those with acute myocardial infarction with ST-segment elevation, and all those with acute myocardial infarction without ST-segment elevation. Propensity-score analyses were based on clinical, procedural, hospital, and insurance information collected at the time of the index procedure. Differences in the risk of death between patients receiving drug-eluting stents and those receiving bare-metal stents were determined from vital-statistics records.

RESULTS: A total of 7217 patients were treated for acute myocardial infarction (4016 with drug-eluting stents and 3201 with bare-metal stents). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for drug-eluting stents than for bare-metal stents among all patients with myocardial infarction (10.7\% vs. 12.8\%, P=0.02), among patients with myocardial infarction with ST-segment elevation (8.5\% vs. 11.6\%, P=0.008), and among patients with myocardial infarction without ST-segment elevation (12.8\% vs. 15.6\%, P=0.04). The 2-year, risk-adjusted rates of recurrent myocardial infarction were reduced in patients with myocardial infarction without ST-segment elevation who were treated with drug-eluting stents, and repeat revascularization rates were significantly reduced with the use of drug-eluting stents as compared with bare-metal stents in all groups.

CONCLUSIONS: In patients presenting with acute myocardial infarction, treatment with drug-eluting stents is associated with decreased 2-year mortality rates and a reduction in the need for repeat revascularization procedures as compared with treatment with bare-metal stents.},
	keywords = {Aged, Cohort Studies, Confounding Factors (Epidemiology), Data Interpretation, Statistical, Drug-Eluting Stents, Female, Humans, Male, Middle Aged, Myocardial Infarction, Recurrence, Retrospective Studies, Stents, Survival Analysis, Treatment Outcome},
	issn = {1533-4406},
	doi = {10.1056/NEJMoa0801485},
	author = {Mauri, Laura and Silbaugh, Treacy S and Garg, Pallav and Wolf, Robert E and Zelevinsky, Katya and Lovett, Ann and Varma, Manu R and Zhou, Zheng and Normand, Sharon-Lise T.}
}
@article {573316,
	title = {Evaluation of a patient activation and empowerment intervention in mental health care},
	journal = {Med Care},
	volume = {46},
	number = {3},
	year = {2008},
	month = {2008 Mar},
	pages = {247-56},
	abstract = {BACKGROUND: Evidence suggests that minority populations have lower levels of attendance and retention in mental health care than non-Latino whites. Patient activation and empowerment interventions may be effective in increasing minority patients{\textquoteright} attendance and retention.

OBJECTIVES: This study developed and evaluated a patient self-reported activation and empowerment strategy in mental health care.

RESEARCH DESIGN: The Right Question Project-Mental Health (RQP-MH) trainings consisted of 3 individual sessions using a pre/post test comparison group design with patients from 2 community mental health clinics. The RQP-MH intervention taught participants to identify questions that would help them consider their role, process and reasons behind a decision; and empowerment strategies to better manage their care.

SUBJECTS: A total of 231 participated, completing at least the pretest interview (n = 141 intervention site, 90 comparison site).

MEASURES: Four main outcomes were linked to the intervention: changes in self-reported patient activation; changes in self-reported patient empowerment; treatment attendance; and retention in treatment.

RESULTS: Findings show that intervention participants were over twice as likely to be retained in treatment and over 3 times more likely than comparison participants to have scheduled at least 1 visit during the 6-month follow-up period. Similarly, intervention participants demonstrated 29\% more attendance to scheduled visits than comparison patients. There was no evidence of an effect on self-reported patient empowerment, only on self-reported patient activation.

CONCLUSIONS: Results demonstrate the intervention{\textquoteright}s potential to increase self-reported patient activation, retention, and attendance in mental health care for minority populations. By facilitating patient-provider communication, the RQP-MH intervention may help minorities effectively participate in mental health care.},
	keywords = {Adolescent, Adult, Female, Health Services Accessibility, Humans, Male, Mental Health Services, Middle Aged, Minority Groups, Office Visits, Patient Acceptance of Health Care, Power (Psychology)},
	issn = {0025-7079},
	doi = {10.1097/MLR.0b013e318158af52},
	author = {Alegr{\'\i}a, Margarita and Polo, Antonio and Gao, Shan and Santana, Luz and Rothstein, Dan and Jimenez, Aida and Hunter, Mary Lyons and Mendieta, Frances and Oddo, Vanessa and Normand, Sharon-Lise}
}
@article {573346,
	title = {A geospatial analysis of emergency transport and inter-hospital transfer in ST-segment elevation myocardial infarction},
	journal = {Am J Cardiol},
	volume = {101},
	number = {1},
	year = {2008},
	month = {2008 Jan 01},
	pages = {69-74},
	abstract = {Primary percutaneous coronary intervention (PCI) yields better outcomes than thrombolytic therapy in the treatment of patients with ST-segment elevation myocardial infarctions (STEMIs). Emergency medical service systems are potentially important partners in efforts to expand the use of PCI. This study was conducted to explore the probable impact on patient mortality and hospital volumes of competing strategies for the emergency transport of patients with STEMIs. Emergency transport was simulated for 2,000 patients with STEMIs from the Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) trial in a geospatial model of Dallas County, Texas. Patient mortality estimates were obtained from a recently developed predictive model comparing PCI and thrombolytic therapy. A strategy of transporting patients to the closest hospital and treating with PCI if available and thrombolytic therapy if not yielded a 5.2\% 30-day mortality rate (95\% confidence interval [CI] 4.2\% to 6.3\%). A strategy of universal PCI, in which patients were transported only to PCI-capable hospitals, yielded 4.4\% (95\% CI 3.6\% to 5.4\%) mortality and an increase in patient volume at 2 full-time PCI hospitals of >1,000\%. A strategy of targeted PCI, in which high-benefit patients were transported or transferred to PCI-capable hospitals, yielded 4.5\% (95\% CI 3.8\% to 5.5\%) mortality if transfers were decided in the emergency department and 4.2\% (95\% CI 3.4\% to 5.1\%) if transport was decided in the emergency vehicle. Targeted PCI strategies increased patient volumes at full-time PCI hospitals by about 700\%. In conclusion, the selection of high-benefit patients for transport or transfer to PCI-capable hospitals can reduce mortality while minimizing major shifts in hospital patient volumes.},
	keywords = {Aged, Angioplasty, Balloon, Coronary, Computer Simulation, Decision Making, Hospitals, Humans, Middle Aged, Models, Cardiovascular, Myocardial Infarction, Patient Transfer, Thrombolytic Therapy, Triage},
	issn = {0002-9149},
	doi = {10.1016/j.amjcard.2007.07.050},
	author = {Concannon, Thomas W and Kent, David M and Normand, Sharon-Lise and Joseph P. Newhouse and Griffith, John L and Ruthazer, Robin and Beshansky, Joni R and John B Wong and Aversano, Thomas and Selker, Harry P}
}
@article {573231,
	title = {Hospital remoteness and thirty-day mortality from three serious conditions},
	journal = {Health Aff (Millwood)},
	volume = {27},
	number = {6},
	year = {2008},
	month = {2008 Nov-Dec},
	pages = {1707-17},
	abstract = {Rural U.S. communities face major challenges in ensuring the availability of high-quality health care. We examined whether hospital-specific, all-cause, thirty-day risk-standardized mortality rates (RSMRs) following acute myocardial infarction, heart failure, and pneumonia varied by hospitals{\textquoteright} geographic remoteness. We analyzed 2001-2003 Medicare administrative data, comparing RSMRs among hospitals located in urban, large rural, small rural, or remote small rural regions. We found only small mortality differences across remoteness regions for hospitalizations for the three conditions. We examine the implications of these findings for the millions of Americans who rely upon rural hospitals for their care.},
	keywords = {Aged, Fee-for-Service Plans, Geography, Health Facility Size, Health Services Accessibility, Hospital Mortality, Hospitals, Rural, Humans, Quality of Health Care, Severity of Illness Index, United States},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.27.6.1707},
	author = {Ross, Joseph S and Normand, Sharon-Lise T. and Wang, Yun and Nallamothu, Brahmajee K and Lichtman, Judith H and Krumholz,Harlan M.}
}
@article {573241,
	title = {How missing information in diagnosis can lead to disparities in the clinical encounter},
	journal = {J Public Health Manag Pract},
	volume = {14 Suppl},
	year = {2008},
	month = {2008 Nov},
	pages = {S26-35},
	abstract = {Previous studies have documented diagnostic bias and noted that its reduction could eliminate misdiagnosis and improve mental health service delivery. Few studies have investigated clinicians{\textquoteright} methods of obtaining and using information during the initial clinical encounter. We describe a study examining contributions to clinician bias during diagnostic assessment of ethnic/racial minority patients. A total of 129 mental health intakes were videotaped, involving 47 mental health clinicians from 8 primarily safety-net clinics. Videos were coded by another clinician using an information checklist, blind to the diagnoses provided by the original clinician. We found high levels of concordance between clinicians for substance-related disorders, low levels for depressive disorders, and anxiety disorders except panic. Most clinicians rely on patients{\textquoteright} mention of depression, anxiety, or substance use to identify disorders, without assessing specific criteria. With limited diagnostic information, clinicians can optimize the clinical intake time to establish rapport with patients. We found Latino ethnicity to be a modifying factor of the association between symptom reports and likelihood of a depression diagnosis. Differential discussion of symptom areas, depending on patient ethnicity, may lead to differential diagnosis and increased likelihood of diagnostic bias.},
	keywords = {Adult, Diagnostic Errors, Female, Healthcare Disparities, Humans, Male, Mental Disorders, Mental Health Services, Middle Aged, New England, Prejudice},
	issn = {1550-5022},
	doi = {10.1097/01.PHH.0000338384.82436.0d},
	author = {Alegr{\'\i}a, Margarita and Nakash, Ora and Lapatin, Sheri and Oddo, Vanessa and Gao, Shan and Lin, Julia and Normand, Sharon-Lise}
}
@article {573216,
	title = {Intent-to-Treat vs. Non-Intent-to-Treat Analyses under Treatment Non-Adherence in Mental Health Randomized Trials},
	journal = {Psychiatr Ann},
	volume = {38},
	number = {12},
	year = {2008},
	month = {2008 Dec},
	pages = {772-783},
	issn = {0048-5713},
	doi = {10.3928/00485713-20081201-10},
	author = {Ten Have, Thomas R and Normand, Sharon-Lise T. and Marcus, Sue M and Brown, C Hendricks and Lavori, Philip and Duan, Naihua}
}
@article {573246,
	title = {Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts},
	journal = {Circulation},
	volume = {118},
	number = {18},
	year = {2008},
	month = {2008 Oct 28},
	pages = {1817-27},
	abstract = {BACKGROUND: Drug-eluting stents (DES) reduce the need for repeat revascularization, but their long-term safety relative to that of bare-metal stents (BMS) in general use remains uncertain. We sought to compare the clinical outcome of patients treated with DES with that of BMS.

METHODS AND RESULTS: All adults undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at non-US government hospitals in Massachusetts were identified from a mandatory state database. Patients were classified from the index admission according to stent types used. Clinical and procedural risk factors were collected prospectively. Risk-adjusted mortality, myocardial infarction, and revascularization rate differences (DES-BMS) were estimated through propensity score matching without replacement. A total of 11 556 patients were treated with DES, and 6237 were treated with BMS, with unadjusted 2-year mortality rates of 7.0\% and 12.6\%, respectively (P,
	keywords = {Aged, Angioplasty, Balloon, Coronary, Comorbidity, Coronary Artery Disease, Coronary Restenosis, Databases, Factual, Drug-Eluting Stents, Female, Follow-Up Studies, Humans, Incidence, Male, Mandatory Reporting, Massachusetts, Middle Aged, Myocardial Infarction, Risk Factors, Stents, Treatment Outcome},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.781377},
	author = {Mauri, Laura and Silbaugh, Treacy S and Wolf, Robert E and Zelevinsky, Katya and Lovett, Ann and Zhou, Zheng and Resnic, Frederic S and Normand, Sharon-Lise T.}
}
@article {573286,
	title = {Low-volume coronary artery bypass surgery: measuring and optimizing performance},
	journal = {J Thorac Cardiovasc Surg},
	volume = {135},
	number = {6},
	year = {2008},
	month = {2008 Jun},
	pages = {1202-9},
	keywords = {Coronary Artery Bypass, Coronary Artery Bypass, Off-Pump, Coronary Disease, Female, Health Care Surveys, Hospital Mortality, Humans, Incidence, Japan, Male, Postoperative Complications, Practice Patterns, Physicians{\textquoteright}, Quality Indicators, Health Care, Radiography, Risk Assessment, Sensitivity and Specificity, Severity of Illness Index, Survival Analysis, Total Quality Management, Treatment Outcome},
	issn = {1097-685X},
	doi = {10.1016/j.jtcvs.2007.12.037},
	author = {Shahian, David M and Normand, Sharon-Lise T.}
}
@article {573341,
	title = {Mitigating the Problem of Unmeasured Outcomes in Quality Reports},
	journal = {B E J Econom Anal Policy},
	volume = {8},
	number = {2},
	year = {2008},
	month = {2008 Jan},
	pages = {7},
	abstract = {Quality reports or profiles of health care providers are inevitably based on only a measurable subset of the "outputs" of the organization. Hospitals, for example, are being profiled on their mortality in the cardiac area but not in some other areas where mortality does not seem to be the appropriate measure of quality. If inputs used for outputs included in the profile also affect outputs outside the scope of the profile, it can be taken into account in constructing a profile of the measured outputs. This paper presents a theory for how such a commonality in production should be taken into account in designing a profile for a hospital or other health care provider. We distinguish between "conventional" weights in a quality profile, and "optimal" weights that take into account a commonality in the production process. The basic idea is to increase the weights on discharges for which output is measured that use inputs that are important to other discharges whose outputs are not included in the profile.},
	issn = {1935-1682},
	doi = {10.2202/1935-1682.1738},
	author = {Glazer, Jacob and McGuire, Thomas and Normand, Sharon-Lise T.}
}
@article {573236,
	title = {Myocardial infarction and quality of care},
	journal = {CMAJ},
	volume = {179},
	number = {9},
	year = {2008},
	month = {2008 Oct 21},
	pages = {875-6},
	keywords = {Humans, Myocardial Infarction, Quality Indicators, Health Care, Quality of Health Care},
	issn = {1488-2329},
	doi = {10.1503/cmaj.081438},
	author = {Chen, Jersey and Normand, Sharon-Lise T.}
}
@article {573326,
	title = {Performance measurement in the small office practice: challenges and potential solutions},
	journal = {Ann Intern Med},
	volume = {148},
	number = {5},
	year = {2008},
	month = {2008 Mar 04},
	pages = {353-7},
	abstract = {Great strides have been made in the creation of programs aimed at improving the safety and quality of health care in the United States, including measurement systems and corresponding standards in the ambulatory setting that are used for public reporting or pay-for-performance. The diversity of physician practices in the United States makes measurement challenging. In many parts of the country, substantial proportions of both primary care and specialist physicians continue to practice in solo or small group practices. This article reviews the practice landscape in the United States; describes performance measurement challenges in small practice settings, including financial and staffing implications; discusses statistical issues that affect assessment of practice quality; and describes potential solutions to the issues raised. Challenges of performance measurement in small practice settings include lack of infrastructure and health information technology, lack of support staff, and increased burden. These issues are compounded by the difficulty of assessing a smaller number of patients spread over multiple payers. To overcome some of these challenges, design and measure selection recommendations for the performance assessment system are presented and practice-level and health plan-level interventions are suggested that might facilitate the inclusion of small practice settings in performance assessment programs. Because a high proportion of U.S. physicians practice in small settings, programs and policies based on physician performance measurement should incorporate features that facilitate the inclusion of these physicians.},
	keywords = {Group Practice, Insurance Claim Review, Medical Records, Medical Records Systems, Computerized, Patient Care, Private Practice, Quality Assurance, Health Care, United States},
	issn = {1539-3704},
	author = {Landon, Bruce E and Normand, Sharon-Lise T.}
}
@article {573271,
	title = {Public reporting of 30-day mortality for patients hospitalized with acute myocardial infarction and heart failure},
	journal = {Circulation},
	volume = {118},
	number = {13},
	year = {2008},
	month = {2008 Sep 23},
	pages = {1394-7},
	keywords = {Databases, Factual, Heart Failure, Hospital Mortality, Humans, Information Dissemination, Myocardial Infarction, Quality Indicators, Health Care},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.804880},
	author = {Krumholz,Harlan M. and Normand, Sharon-Lise T.}
}
@article {573281,
	title = {Quality monitoring and management in commercial health plans},
	journal = {Am J Manag Care},
	volume = {14},
	number = {6},
	year = {2008},
	month = {2008 Jun},
	pages = {377-86},
	abstract = {OBJECTIVE: To examine the current state of quality monitoring and management activities of US health plans.

STUDY DESIGN: Cross-sectional survey.

METHODS: We surveyed medical directors of 252 commercial HMOs (96\% response rate) drawn from 41 nationally representative markets in the United States. We randomly sampled healthcare markets with at least 100,000 HMO enrollees. The markets in our sampling frame include an estimated 91\% of US HMO enrollees and represent 78\% of the metropolitan population.

RESULTS: There was near-universal collection of data at the health plan level for each of the 7 outpatient measures we examined (ranging from 92.1\% of health plans that collect data on hypertension control and cholesterol management (see p. 379) to 99.2\% that collect data on patient satisfaction). There also was substantial data collection at the level of the individual provider or physician group (ranging from 50.4\% for hypertension control to 81.4\% for diabetes care); this was more common in health plans that primarily use capitation to reimburse primary care physicians. Health plans that collected data typically fed these data back to physician groups, but public reporting to enrollees was infrequent.

CONCLUSIONS: Almost all health plans measured their performance on multiple indicators of quality. The majority of health plans also collected data at the level of the individual physician or group and used these data in quality improvement activities, but not in public reporting. Thus, adoption of physician-level performance measurement and reporting by the Centers for Medicare \& Medicaid Services will likely entail a major change for individual physicians.},
	keywords = {Cross-Sectional Studies, Humans, Managed Care Programs, Physician Executives, Quality Indicators, Health Care, United States},
	issn = {1936-2692},
	author = {Landon, Bruce E and Meredith B. Rosenthal and Normand, Sharon-Lise T. and Richard G. Frank and Arnold M. Epstein}
}
@article {573356,
	title = {Reducing asthma health disparities in poor Puerto Rican children: the effectiveness of a culturally tailored family intervention},
	journal = {J Allergy Clin Immunol},
	volume = {121},
	number = {3},
	year = {2008},
	month = {2008 Mar},
	pages = {665-70},
	abstract = {BACKGROUND: Island and mainland Puerto Rican children have the highest rates of asthma and asthma morbidity of any ethnic group in the United States.

OBJECTIVE: We evaluated the effectiveness of a culturally adapted family asthma management intervention called CALMA (an acronym of the Spanish for "Take Control, Empower Yourself and Achieve Management of Asthma") in reducing asthma morbidity in poor Puerto Rican children with asthma.

METHODS: Low-income children with persistent asthma were selected from a national health plan insurance claims database by using a computerized algorithm. After baseline, families were randomly assigned to either the intervention or a control group.

RESULTS: No significant differences between control and intervention group were found for the primary outcome of symptom-free days. However, children in the CALMA intervention group had 6.5\% more symptom-free nights, were 3 times more likely to have their asthma under control, and were less likely to visit the emergency department and be hospitalized as compared to the control group. Caregivers receiving CALMA were significantly less likely to feel helpless, frustrated, or upset because of their child{\textquoteright}s asthma and more likely to feel confident to manage their child{\textquoteright}s asthma.

CONCLUSION: A home-based asthma intervention program tailored to the cultural needs of low income Puerto Rican families is a promising intervention for reducing asthma morbidity.},
	keywords = {Anti-Asthmatic Agents, Asthma, Caregivers, Child, Child, Preschool, Culture, Family, Health Knowledge, Attitudes, Practice, Hispanic Americans, Humans, Patient Education as Topic, Poverty, Puerto Rico, Socioeconomic Factors},
	issn = {1097-6825},
	doi = {10.1016/j.jaci.2007.10.022},
	author = {Canino, Glorisa and Vila, Doryliz and Normand, Sharon-Lise T. and Acosta-P{\'e}rez, Edna and Ram{\'\i}rez, Rafael and Garc{\'\i}a, Pedro and Rand, Cynthia}
}
@article {573351,
	title = {The relationship between medical practice characteristics and quality of care for cardiovascular disease},
	journal = {Med Care Res Rev},
	volume = {65},
	number = {2},
	year = {2008},
	month = {2008 Apr},
	pages = {167-86},
	abstract = {The settings in which health care services are delivered have the potential to influence the quality of health care services in numerous ways, but little is known about the relationship between characteristics of medical practices and quality of care. In this study, the authors studied patients with coronary heart disease (CHD). The authors surveyed 225 medical practices in 2000 and 2001 and obtained information on quality measures from the medical records for more than 1,600 of their patients with CHD. Results suggest that quality of care, at least for common conditions with agreed-on measures, is not strongly influenced by financial characteristics of medical practices, although there does seem to be some relationship with practice structure such as size and quality.},
	keywords = {Aged, Boston, Capitation Fee, Cardiotonic Agents, Coronary Disease, Female, Humans, Male, Medical Records Systems, Computerized, Middle Aged, Oregon, Practice Patterns, Physicians{\textquoteright}, Quality Assurance, Health Care},
	issn = {1077-5587},
	doi = {10.1177/1077558707310208},
	author = {Landon, Bruce E and Normand, Sharon Lise T and Ellen Meara and Ellen Meara and Simon, Steven R and Frank, Richard and McNeil, Barbara J}
}
@article {573121,
	title = {Sample Size Determination for Studies with Repeated Continuous Outcomes},
	journal = {Psychiatr Ann},
	volume = {38},
	number = {12},
	year = {2008},
	month = {2008 Dec 01},
	pages = {765-771},
	issn = {0048-5713},
	author = {Bhaumik, Dulal K and Roy, Anindya and Aryal, Subhash and Hur, Kwan and Duan, Naihua and Normand, Sharon-Lise T. and Brown, C Hendricks and Gibbons, Robert D}
}
@article {573276,
	title = {Some old and some new statistical tools for outcomes research},
	journal = {Circulation},
	volume = {118},
	number = {8},
	year = {2008},
	month = {2008 Aug 19},
	pages = {872-84},
	keywords = {Biomedical Research, Cluster Analysis, Confounding Factors (Epidemiology), Data Interpretation, Statistical, Humans, Models, Statistical, Statistics as Topic, Treatment Outcome},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.766907},
	author = {Normand, Sharon-Lise T.}
}
@article {573251,
	title = {Standards for measures used for public reporting of efficiency in health care: a scientific statement from the American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research and the American College of Cardiology Foundation},
	journal = {Circulation},
	volume = {118},
	number = {18},
	year = {2008},
	month = {2008 Oct 28},
	pages = {1885-93},
	abstract = {The assessment of medical practice is evolving rapidly in the United States. An initial focus on structure and process performance measures assessing the quality of medical care is now being supplemented with efficiency measures to quantify the "value" of healthcare delivery. This statement, building on prior work that articulated standards for publicly reported outcomes measures, identifies preferred attributes for measures used to assess efficiency in the allocation of healthcare resources. The attributes identified in this document combined with the previously published standards are intended to serve as criteria for assessing the suitability of efficiency measures for public reporting. This statement identifies the following attributes to be considered for publicly reported efficiency measures: integration of the quality and cost; valid cost measurement and analysis; minimal incentive to provide poor quality care; and proper attribution of the measure. The attributes described in this statement are relevant to a wide range of efforts to profile the efficiency of various healthcare providers, including hospitals, healthcare systems, managed-care organizations, physicians, group practices, and others that deliver coordinated care.},
	keywords = {American Heart Association, Cardiology, Health Policy, Humans, Outcome Assessment (Health Care), Public Health Informatics, Quality of Health Care, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.190500},
	author = {Krumholz,Harlan M. and Patricia S. Keenan and Brush, John E and Bufalino, Vincent J and Michael E. Chernew and Epstein, Andrew J and Heidenreich, Paul A and Ho, Vivian and Masoudi, Frederick A and Matchar, David B and Normand, Sharon-Lise T. and Rumsfeld, John S and Schuur, Jeremiah D and Smith, Sidney C and Spertus, John A and Walsh, Mary Norine}
}
@article {573221,
	title = {Standards for measures used for public reporting of efficiency in health care: a scientific statement from the American Heart Association Interdisciplinary Council on Quality of Care and Outcomes research and the American College of Cardiology Foundation},
	journal = {J Am Coll Cardiol},
	volume = {52},
	number = {18},
	year = {2008},
	month = {2008 Oct 28},
	pages = {1518-26},
	abstract = {The assessment of medical practice is evolving rapidly in the United States. An initial focus on structure and process performance measures assessing the quality of medical care is now being supplemented with efficiency measures to quantify the "value" of healthcare delivery. This statement, building on prior work that articulated standards for publicly reported outcomes measures, identifies preferred attributes for measures used to assess efficiency in the allocation of healthcare resources. The attributes identified in this document combined with the previously published standards are intended to serve as criteria for assessing the suitability of efficiency measures for public reporting. This statement identifies the following attributes to be considered for publicly reported efficiency measures: integration of the quality and cost; valid cost measurement and analysis; minimal incentive to provide poor quality care; and proper attribution of the measure. The attributes described in this statement are relevant to a wide range of efforts to profile the efficiency of various healthcare providers, including hospitals, healthcare systems, managed-care organizations, physicians, group practices, and others that deliver coordinated care.},
	keywords = {American Heart Association, Cardiovascular Diseases, Efficiency, Organizational, Health Policy, Humans, Quality Indicators, Health Care, Quality of Health Care, Societies, Medical, Treatment Outcome, United States},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2008.09.004},
	author = {Krumholz,Harlan M. and Patricia S. Keenan and Brush, John E and Bufalino, Vincent J and Michael E. Chernew and Epstein, Andrew J and Heidenreich, Paul A and Ho, Vivian and Masoudi, Frederick A and Matchar, David B and Normand, Sharon-Lise T. and Rumsfeld, John S and Schuur, Jeremiah D and Smith, Sidney C and Spertus, John A and Walsh, Mary Norine}
}
@article {573336,
	title = {Statistical methodology for classifying units on the basis of multiple-related measures},
	journal = {Stat Med},
	volume = {27},
	number = {9},
	year = {2008},
	month = {2008 Apr 30},
	pages = {1329-50},
	abstract = {Both the private and public sectors have begun giving financial incentives to healthcare providers, such as hospitals, delivering superior {\textquoteright}quality of care{\textquoteright}. Quality of care is assessed through a set of disease-specific measures that characterize the performance of healthcare providers. These measures are then combined into a unidimensional composite score. Most of the programs that reward superior performance use raw averages of the measures as the composite score. The scores based on raw averages fail to take into account typical characteristics of data used for performance evaluation, such as within-patient and within-hospital correlations, variable number of measures available in different hospitals, and missing data. In this paper, we contrast two different versions of composites based on raw average scores with a model-based score constructed using a latent variable model. We also present two methods to identify hospitals with superior performance. The methods are illustrated using national data collected to evaluate quality of care delivered by the U.S. acute care hospitals.},
	keywords = {Bayes Theorem, Heart Failure, Hospitals, Humans, Models, Statistical, Motivation, Myocardial Infarction, Outcome Assessment (Health Care), Quality of Health Care, United States},
	issn = {0277-6715},
	doi = {10.1002/sim.3187},
	author = {Teixeira-Pinto, Armando and Normand, Sharon-Lise T.}
}
@article {573301,
	title = {Studies of drug-eluting stents: to each his own?},
	journal = {Circulation},
	volume = {117},
	number = {16},
	year = {2008},
	month = {2008 Apr 22},
	pages = {2047-50},
	keywords = {Angioplasty, Balloon, Coronary, Coronary Restenosis, Drug-Eluting Stents, Humans, Myocardial Ischemia, Randomized Controlled Trials as Topic},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.108.770164},
	author = {Mauri, Laura and Normand, Sharon-Lise T.}
}
@article {573371,
	title = {Acute myocardial infarction and congestive heart failure outcomes at specialty cardiac hospitals},
	journal = {Circulation},
	volume = {116},
	number = {20},
	year = {2007},
	month = {2007 Nov 13},
	pages = {2280-7},
	abstract = {BACKGROUND: Outcomes of patients with acute myocardial infarction (AMI) and congestive heart failure (CHF) at specialty cardiac hospitals are uncertain.

METHODS AND RESULTS: From 2003 Medicare data, we used hierarchical regression to calculate 30-day standardized mortality ratios and risk-standardized mortality rates for AMI and CHF at 16 cardiac and 121 peer general hospitals in 15 healthcare markets. We then compared cardiac and general hospitals by determining (1) the proportion of facilities with statistically higher, no different, or lower than expected mortality based on 95\% interval estimates of standardized mortality ratios and (2) differences in risk-standardized mortality rates between the types of facilities after stratification within healthcare markets. We identified 1912 patients with AMI and 1275 patients with CHF at cardiac hospitals and 13,158 patients with AMI and 18,295 patients with CHF at general hospitals. Patients at cardiac hospitals were younger, were more likely to be male, and had a much lower prevalence of noncardiovascular diseases. After adjustment for patient differences, standardized mortality ratios were significantly better than expected for 4 (25\%) and 5 (31\%) cardiac hospitals for AMI and CHF, respectively, compared with 5 (4\%) and 6 (5\%) general hospitals. Risk-standardized mortality rates were modestly lower at cardiac hospitals (15.0\% versus 16.2\% for AMI, P,
	keywords = {Acute Disease, Age Distribution, Aged, Aged, 80 and over, Female, Heart Failure, Hospital Mortality, Hospitals, General, Hospitals, Special, Humans, Male, Myocardial Infarction, Outcome Assessment (Health Care), Quality of Health Care, Risk Assessment, Sex Distribution},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.107.709220},
	author = {Nallamothu, Brahmajee K and Wang, Yongfei and Peter Cram and Birkmeyer, John D and Ross, Joseph S and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {573391,
	title = {"America{\textquoteright}s Best Hospitals" in the treatment of acute myocardial infarction},
	journal = {Arch Intern Med},
	volume = {167},
	number = {13},
	year = {2007},
	month = {2007 Jul 09},
	pages = {1345-51},
	abstract = {BACKGROUND: The ranking of "America{\textquoteright}s Best Hospitals" by U.S. News \& World Report for "Heart and Heart Surgery" is a popular hospital profiling system, but it is not known if hospitals ranked by the magazine vs nonranked hospitals have lower risk-standardized, 30-day mortality rates (RSMRs) for patients with acute myocardial infarction (AMI).

METHODS: Using a hierarchical regression model based on 2003 Medicare administrative data, we calculated RSMRs for ranked and nonranked hospitals in the treatment of AMI. We identified ranked and nonranked hospitals with standardized mortality ratios (SMRs) significantly less than the mean expected for all hospitals in the study.

RESULTS: We compared 13 662 patients in 50 ranked hospitals with 254 907 patients in 3813 nonranked hospitals. The RSMRs were lower in ranked vs nonranked hospitals (16.0\% vs 17.9\%, P,
	keywords = {Aged, Aged, 80 and over, Cardiology Service, Hospital, Female, Hospital Mortality, Hospitals, Humans, Male, Medicare, Myocardial Infarction, Outcome Assessment (Health Care), Quality of Health Care, Regression Analysis, United States},
	issn = {0003-9926},
	doi = {10.1001/archinte.167.13.1345},
	author = {Wang, Oliver J and Wang, Yun and Lichtman, Judith H and Bradley, Elizabeth H and Normand, Sharon-Lise T. and Krumholz,Harlan M.}
}
@article {573401,
	title = {Antipsychotic drug use and mortality in older adults with dementia},
	journal = {Ann Intern Med},
	volume = {146},
	number = {11},
	year = {2007},
	month = {2007 Jun 05},
	pages = {775-86},
	abstract = {BACKGROUND: Antipsychotic drugs are widely used to manage behavioral and psychological symptoms in dementia despite concerns about their safety.

OBJECTIVE: To examine the association between treatment with antipsychotics (both conventional and atypical) and all-cause mortality.

DESIGN: Population-based, retrospective cohort study.

SETTING: Ontario, Canada.

PATIENTS: Older adults with dementia who were followed between 1 April 1997 and 31 March 2003.

MEASUREMENTS: The risk for death was determined at 30, 60, 120, and 180 days after the initial dispensing of antipsychotic medication. Two pairwise comparisons were made: atypical versus no antipsychotic use and conventional versus atypical antipsychotic use. Groups were stratified by place of residence (community or long-term care). Propensity score matching was used to adjust for differences in baseline health status.

RESULTS: A total of 27,259 matched pairs were identified. New use of atypical antipsychotics was associated with a statistically significant increase in the risk for death at 30 days compared with nonuse in both the community-dwelling cohort (adjusted hazard ratio, 1.31 [95\% CI, 1.02 to 1.70]; absolute risk difference, 0.2 percentage point) and the long-term care cohort (adjusted hazard ratio, 1.55 [CI, 1.15 to 2.07]; absolute risk difference, 1.2 percentage points). Excess risk seemed to persist to 180 days, but unequal rates of censoring over time may have affected these results. Relative to atypical antipsychotic use, conventional antipsychotic use was associated with a higher risk for death at all time points. Sensitivity analysis revealed that unmeasured confounders that increase the risk for death could diminish or eliminate the observed associations.

LIMITATIONS: Information on causes of death was not available. Many patients did not continue their initial treatments after 1 month of therapy. Unmeasured confounders could affect associations.

CONCLUSIONS: Atypical antipsychotic use is associated with an increased risk for death compared with nonuse among older adults with dementia. The risk for death may be greater with conventional antipsychotics than with atypical antipsychotics.},
	keywords = {Aged, Aged, 80 and over, Antipsychotic Agents, Dementia, Female, Humans, Male, Matched-Pair Analysis, Ontario, Risk Assessment, Sensitivity and Specificity, Time Factors},
	issn = {1539-3704},
	author = {Gill, Sudeep S and Bronskill, Susan E and Normand, Sharon-Lise T. and Anderson, Geoffrey M and Sykora, Kathy and Lam, Kelvin and Bell, Chaim M and Lee, Philip E and Fischer, Hadas D and Herrmann, Nathan and Gurwitz, Jerry H and Rochon, Paula A}
}
@article {573436,
	title = {Assessing the accuracy of hospital clinical performance measures},
	journal = {Med Decis Making},
	volume = {27},
	number = {1},
	year = {2007},
	month = {2007 Jan-Feb},
	pages = {9-20},
	abstract = {OBJECTIVE: To control costs and improve quality, payers are designing new hospital reimbursement policies that link payment to quality. The authors determine the extent to which quality measures discriminate hospitals into tiers in 2 geographic areas.

DATA SOURCES: Administrative and medical record data for patients discharged with acute myocardial infarction (AMI) in 368 California and 81 Massachusetts hospitals.

METHODS: Through simulation, the minimum numbers of patients per hospital needed to identify high-quality hospitals with sensitivity ranging from 75\% to 95\% under a variety of clinical scenarios are determined.

RESULTS: Massachusetts hospitals had twice the number of eligible patients per hospital than California hospitals. Regardless of state, few hospitals had sufficient sample size needed to achieve >85\% sensitivity for high-variation quality measures.

CLINICAL IMPLICATIONS: Reliability of quality-based reimbursement systems relies on the distribution of the hospital sample sizes within geographic areas and the size of practice differences. Selection of conformance thresholds and sensitivity levels depends on the user of the information. To assess the usefulness of performance measures to tier hospitals, information regarding between-hospital variation in quality for specific clinical measures needs to be collected and reported.},
	keywords = {California, Hospitals, Humans, Massachusetts, Myocardial Infarction, Patient Discharge, Quality Indicators, Health Care, Sensitivity and Specificity},
	issn = {0272-989X},
	doi = {10.1177/0272989X06298028},
	author = {Normand, Sharon-Lise T. and Wolf, Robert E and John Z. Ayanian and McNeil, Barbara J}
}
@article {573416,
	title = {Comparison of clinical and administrative data sources for hospital coronary artery bypass graft surgery report cards},
	journal = {Circulation},
	volume = {115},
	number = {12},
	year = {2007},
	month = {2007 Mar 27},
	pages = {1518-27},
	abstract = {BACKGROUND: Regardless of statistical methodology, public performance report cards must use the highest-quality validated data, preferably from a prospectively maintained clinical database. Using logistic regression and hierarchical models, we compared hospital cardiac surgery profiling results based on clinical data with those derived from contemporaneous administrative data.

METHODS AND RESULTS: Fiscal year 2003 isolated coronary artery bypass grafting surgery results based on an audited and validated Massachusetts clinical registry were compared with those derived from a contemporaneous state administrative database, the latter using the inclusion/exclusion criteria and risk model of the Agency for Healthcare Research and Quality. There was a 27.4\% disparity in isolated coronary artery bypass grafting surgery volume (4440 clinical, 5657 administrative), a 0.83\% difference in observed in-hospital mortality (2.05\% versus 2.88\%), corresponding differences in risk-adjusted mortality calculated by various statistical methodologies, and 1 hospital classified as an outlier only with the administrative data-based approach. The discrepancies in volumes and risk-adjusted mortality were most notable for higher-volume programs that presumably perform a higher proportion of combined procedures that were misclassified as isolated coronary artery bypass grafting surgery in the administrative cohort. Subsequent analyses of a patient cohort common to both databases revealed the smoothing effect of hierarchical models, a 9\% relative difference in mortality (2.21\% versus 2.03\%) resulting from nonstandardized mortality end points, and 1 hospital classified as an outlier using logistic regression but not using hierarchical regression.

CONCLUSIONS: Cardiac surgery report cards using administrative data are problematic compared with those derived from audited and validated clinical data, primarily because of case misclassification and nonstandardized end points.},
	keywords = {Algorithms, Biomarkers, Cardiology Service, Hospital, Cohort Studies, Commission on Professional and Hospital Activities, Community Participation, Comorbidity, Coronary Artery Bypass, Databases, Factual, Hospital Mortality, Humans, International Classification of Diseases, Massachusetts, Medical Audit, Medical Records, Models, Theoretical, Patient Discharge, Prospective Studies, Quality Assurance, Health Care, Registries, Risk Adjustment, Treatment Outcome, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.106.633008},
	author = {Shahian, David M and Silverstein, Treacy and Lovett, Ann F and Wolf, Robert E and Normand, Sharon-Lise T.}
}
@article {573491,
	title = {Conditioning on the propensity score can result in biased estimation of common measures of treatment effect: a Monte Carlo study},
	journal = {Stat Med},
	volume = {26},
	number = {4},
	year = {2007},
	month = {2007 Feb 20},
	pages = {754-68},
	abstract = {Propensity score methods are increasingly being used to estimate causal treatment effects in the medical literature. Conditioning on the propensity score results in unbiased estimation of the expected difference in observed responses to two treatments. The degree to which conditioning on the propensity score introduces bias into the estimation of the conditional odds ratio or conditional hazard ratio, which are frequently used as measures of treatment effect in observational studies, has not been extensively studied. We conducted Monte Carlo simulations to determine the degree to which propensity score matching, stratification on the quintiles of the propensity score, and covariate adjustment using the propensity score result in biased estimation of conditional odds ratios, hazard ratios, and rate ratios. We found that conditioning on the propensity score resulted in biased estimation of the true conditional odds ratio and the true conditional hazard ratio. In all scenarios examined, treatment effects were biased towards the null treatment effect. However, conditioning on the propensity score did not result in biased estimation of the true conditional rate ratio. In contrast, conventional regression methods allowed unbiased estimation of the true conditional treatment effect when all variables associated with the outcome were included in the regression model. The observed bias in propensity score methods is due to the fact that regression models allow one to estimate conditional treatment effects, whereas propensity score methods allow one to estimate marginal treatment effects. In several settings with non-linear treatment effects, marginal and conditional treatment effects do not coincide.},
	keywords = {Bias (Epidemiology), Computer Simulation, Data Interpretation, Statistical, Humans, Monte Carlo Method, Treatment Outcome},
	issn = {0277-6715},
	doi = {10.1002/sim.2618},
	author = {Austin, Peter C and Grootendorst, Paul and Normand, Sharon-Lise T. and Anderson, Geoffrey M}
}
@article {573421,
	title = {Designs for mechanical circulatory support device studies},
	journal = {J Card Fail},
	volume = {13},
	number = {1},
	year = {2007},
	month = {2007 Feb},
	pages = {63-74},
	abstract = {BACKGROUND: There is increased interest in mechanical circulatory support devices (MCSDs), such as implantable left ventricular assist devices (LVADs), as "destination" therapy for patients with advanced heart failure. Because patient availability to evaluate these devices is limited and randomized trials have been slow in enrolling patients, a workshop was convened to consider designs for MCSD development including alternatives to randomized trials.

METHODS AND RESULTS: A workshop was jointly planned by the Heart Failure Society of America and the US Food and Drug Administration and was convened in March 2006. One of the panels was asked to review different designs for evaluating new MCSDs. Randomized trials have many advantages over studies with no controls or with nonrandomized concurrent or historical controls. These advantages include the elimination of bias in the assignment of treatments and the balancing, on average, of known and unknown baseline covariates that influence response. These advantages of randomization are particularly important for studies in which the treatments may not differ from one another by a large amount (eg, a head-to-head study of an approved LVAD with a new LVAD). However, researchers have found it difficult to recruit patients to randomized studies because the number of clinical sites that can carry out the studies is not large. Also, there is a reluctance to randomize patients when the control device is considered technologically inferior. Thus ways of improving the design of randomized trials were discussed, and the advantages and disadvantages of alternative designs were considered.

CONCLUSIONS: The panel concluded that designs should include a randomized component. Randomized designs might be improved by allowing the control device to be chosen before randomization, by first conducting smaller vanguard studies, and by allowing crossovers in trials with optimal medical management controls. With use of data from completed trials, other databases, and registries, alternative designs that include both a randomized component (eg, 2:1 allocation for new device versus control) and a nonrandomized component (eg, concurrent nonrandomized control, historical control, or a comprehensive cohort design) should be evaluated. This will require partnerships among academic, government, and industry scientists.},
	keywords = {Equipment Design, Heart Failure, Heart-Assist Devices, Humans, Randomized Controlled Trials as Topic},
	issn = {1532-8414},
	doi = {10.1016/j.cardfail.2006.12.003},
	author = {Neaton, James D and Normand, Sharon-Lise and Gelijns, Annetine and Starling, Randall C and Mann, Douglas L and Konstam, Marvin A}
}
@article {573366,
	title = {Employers{\textquoteright} use of value-based purchasing strategies},
	journal = {JAMA},
	volume = {298},
	number = {19},
	year = {2007},
	month = {2007 Nov 21},
	pages = {2281-8},
	abstract = {CONTEXT: Value-based purchasing by employers has often been portrayed as the lynchpin to quality improvement in a market-based health care system. Although a small group of the largest national employers has been actively engaged in promoting quality measurement, reporting, and pay for performance, it is unknown whether these ideas have significantly permeated employer-sponsored health benefit purchasing.

OBJECTIVE: To provide systematic descriptions and analyses of value-based purchasing and related efforts to improve quality of care by health care purchasers.

DESIGN, SETTING, AND PARTICIPANTS: We conducted telephone interviews with executives at 609 of the largest employers across 41 US markets between July 2005 and March 2006. The 41 randomly selected markets have at least 100,000 persons enrolled in health maintenance organizations, include approximately 91\% of individuals enrolled in health maintenance organizations nationally, and represent roughly 78\% of the US metropolitan population. Using the Dun \& Bradstreet database of US employers, we identified the 26 largest firms in each market. Firms ranged in size from 60 to 250,000 employees.

MAIN OUTCOME MEASURE: The degree to which value-based purchasing and related strategies are reported being used by employers. Percentages were weighted by number of employees.

RESULTS: Of 1041 companies contacted, 609 employer representatives completed the survey (response rate, 64\%). A large percentage of surveyed executives reported that they examine health plan quality data (269 respondents; 65\% [95\% confidence interval {CI}, 57\%-74\%]; P,
	keywords = {Data Collection, Decision Making, Organizational, Employment, Group Purchasing, Health Benefit Plans, Employee, Marketing of Health Services, Quality of Health Care, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.298.19.2281},
	author = {Meredith B. Rosenthal and Landon, Bruce E and Normand, Sharon-Lise T. and Richard G. Frank and Ahmad, Thaniyyah S and Arnold M. Epstein}
}
@article {573361,
	title = {Evaluating the optimal timing of angiography: landmark or off the mark?},
	journal = {Circulation},
	volume = {116},
	number = {23},
	year = {2007},
	month = {2007 Dec 04},
	pages = {2656-7},
	keywords = {Acute Coronary Syndrome, Aged, Blood Transfusion, Coronary Angiography, Enoxaparin, Female, Fibrinolytic Agents, Hemorrhage, Hospital Mortality, Hospitalization, Humans, Male, Middle Aged, Myocardial Infarction, Randomized Controlled Trials as Topic, Streptokinase, Thrombolytic Therapy, Time Factors, Tissue Plasminogen Activator},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.107.741132},
	author = {Normand, Sharon-Lise T.}
}
@article {573426,
	title = {Impact of full mental health and substance abuse parity for children in the Federal Employees Health Benefits Program},
	journal = {Pediatrics},
	volume = {119},
	number = {2},
	year = {2007},
	month = {2007 Feb},
	pages = {e452-9},
	abstract = {OBJECTIVE: The Federal Employees Health Benefits Program implemented full mental health and substance abuse parity in January 2001. Evaluation of this policy revealed that parity increased adult beneficiaries{\textquoteright} financial protection by lowering mental health and substance abuse out-of-pocket costs for service users in most plans studied but did not increase rates of service use or spending among adult service users. This study examined the effects of full mental health and substance abuse parity for children.

METHODS: Employing a quasiexperimental design, we compared children in 7 Federal Employees Health Benefits plans from 1999 to 2002 with children in a matched set of plans that did not have a comparable change in mental health and substance abuse coverage. Using a difference-in-differences analysis, we examined the likelihood of child mental health and substance abuse service use, total spending among child service users, and out-of-pocket spending.

RESULTS: The apparent increase in the rate of children{\textquoteright}s mental health and substance abuse service use after implementation of parity was almost entirely due to secular trends of increased service utilization. Estimates for children{\textquoteright}s mental health and substance abuse spending conditional on this service use showed significant decreases in spending per user attributable to parity for 2 plans; spending estimates for the other plans were not statistically significant. Children using these services in 3 of 7 plans experienced statistically significant reductions in out-of-pocket spending attributable to the parity policy, and the average dollar savings was sizeable for users in those 3 plans. In the remaining 4 plans, out-of-pocket spending also decreased, but these decreases were not statistically significant.

CONCLUSIONS: Full mental health and substance abuse parity for children, within the context of managed care, can achieve equivalence of benefits in health insurance coverage and improve financial protection without adversely affecting health care costs but may not expand access for children who need these services.},
	keywords = {Adolescent, Child, Child Health Services, Female, Humans, Insurance Coverage, Male, Mental Health Services, National Health Insurance, United States, Substance-Related Disorders, United States},
	issn = {1098-4275},
	doi = {10.1542/peds.2006-0673},
	author = {Azrin, Susan T and Huskamp, Haiden A. and Azzone, Vanessa and Goldman, Howard H and Richard G. Frank and Burnam, M Audrey and Normand, Sharon-Lise T. and Ridgely, M Susan and Young, Alexander S and Barry, Colleen L and Alisa B. Busch and Moran, Garrett}
}
@article {573396,
	title = {Incentive formularies and changes in prescription drug spending},
	journal = {Am J Manag Care},
	volume = {13},
	number = {6 Pt 2},
	year = {2007},
	month = {2007 Jun},
	pages = {360-9},
	abstract = {OBJECTIVES: To examine the impact of incentive formularies on prescription drug spending shifts in formulary compliance, use of generic medications, and mail-order fulfillment in the year after introduction of a new pharmacy benefit strategy.

STUDY DESIGN: Pre-post comparison study with matched concurrent control group (difference-indifferences analysis).

METHODS: Study subjects were continuously enrolled patients from a single large health plan in the northeastern United States. Health plan administrative data were used to determine the total, health plan, and out-of-pocket spending in the year before and the year after the introduction of 12 different benefit changes, including 1 in which copayments decreased.

RESULTS: Overall, changing from a single-tier or 2-tier formulary to a 3-tier formulary was associated with a decrease in total drug spending of about 5\% to 15\%. Plan spending decreased more dramatically, about 20\%, whereas out-of-pocket spending that resulted from higher copayments increased between 20\% and >100\%. Changing to an incentive formulary with higher copayments was accompanied by a small but inconsistent decrease in use of nonformulary selections and a concomitant increase in both generic and formulary preferred utilization. Mail-order fulfillment doubled, albeit from a low baseline level.

CONCLUSIONS: Switching to incentive formulary arrangements with higher levels of copayments generally led to overall lower drug costs and vice versa. These effects varied with the degree of change, level of baseline spending, and magnitude of the copayments. Whether these effects are beneficial overall depends on potential health effects and spillover effects on medical spending.},
	keywords = {Adult, Cohort Studies, Deductibles and Coinsurance, Drug Utilization Review, Female, Formularies as Topic, Health Care Surveys, Humans, Insurance, Pharmaceutical Services, Male, Patient Compliance, Prescription Fees, United States},
	issn = {1936-2692},
	author = {Landon, Bruce E and Meredith B. Rosenthal and Normand, Sharon-Lise T. and Spettell, Claire and Lessler, Adam and Underwood, Howard R and Joseph P. Newhouse}
}
@article {573446,
	title = {Measuring performance for treating heart attacks and heart failure: the case for outcomes measurement},
	journal = {Health Aff (Millwood)},
	volume = {26},
	number = {1},
	year = {2007},
	month = {2007 Jan-Feb},
	pages = {75-85},
	abstract = {To complement the current process measures for treating patients with heart attacks and with heart failure, which target gaps in quality but do not capture patient outcomes, the Centers for Medicare and Medicaid Services (CMS) has proposed the public reporting of hospital-level thirty-day mortality for these conditions in 2007. We present the case for including measurements of outcomes in the assessment of hospital performance, focusing on the care of patients with heart attacks and with heart failure. Recent developments in the methodology and standards for outcomes measurement have laid the groundwork for incorporating outcomes into performance monitoring efforts for these conditions.},
	keywords = {Cardiology Service, Hospital, Centers for Medicare and Medicaid Services (U.S.), Disclosure, Guideline Adherence, Heart Failure, Humans, Myocardial Infarction, Outcome and Process Assessment (Health Care), Practice Guidelines as Topic, Quality Indicators, Health Care, Risk Adjustment, United States},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.26.1.75},
	author = {Krumholz,Harlan M. and Normand, Sharon-Lise T. and Spertus, John A and Shahian, David M and Bradley, Elizabeth H}
}
@article {573406,
	title = {Quality measurement in adult cardiac surgery: part 1--Conceptual framework and measure selection},
	journal = {Ann Thorac Surg},
	volume = {83},
	number = {4 Suppl},
	year = {2007},
	month = {2007 Apr},
	pages = {S3-12},
	keywords = {Adult, Advisory Committees, Benchmarking, Evidence-Based Medicine, Humans, Outcome and Process Assessment (Health Care), Quality Assurance, Health Care, Quality Indicators, Health Care, Quality of Health Care, Risk Assessment, Societies, Medical, Thoracic Surgery, Total Quality Management, United States},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2007.01.053},
	author = {Shahian, David M and Edwards, Fred H and Ferraris, Victor A and Haan, Constance K and Rich, Jeffrey B and Normand, Sharon-Lise T. and DeLong, Elizabeth R and O{\textquoteright}Brien, Sean M and Shewan, Cynthia M and Dokholyan, Rachel S and Peterson, Eric D}
}
@article {573411,
	title = {Quality measurement in adult cardiac surgery: part 2--Statistical considerations in composite measure scoring and provider rating},
	journal = {Ann Thorac Surg},
	volume = {83},
	number = {4 Suppl},
	year = {2007},
	month = {2007 Apr},
	pages = {S13-26},
	keywords = {Adult, Guideline Adherence, Health Status Indicators, Humans, Models, Statistical, Outcome Assessment (Health Care), Practice Guidelines as Topic, Quality of Health Care, Societies, Medical, Thoracic Surgery, United States},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2007.01.055},
	author = {O{\textquoteright}Brien, Sean M and Shahian, David M and DeLong, Elizabeth R and Normand, Sharon-Lise T. and Edwards, Fred H and Ferraris, Victor A and Haan, Constance K and Rich, Jeffrey B and Shewan, Cynthia M and Dokholyan, Rachel S and Anderson, Richard P and Peterson, Eric D}
}
@article {573441,
	title = {Quality of care for acute myocardial infarction at urban safety-net hospitals},
	journal = {Health Aff (Millwood)},
	volume = {26},
	number = {1},
	year = {2007},
	month = {2007 Jan-Feb},
	pages = {238-48},
	abstract = {Safety-net hospitals are experiencing increasing financial strains, possibly affecting their quality of care. We compare quality at safety-net and non-safety-net urban hospitals for Medicare beneficiaries admitted with acute myocardial infarction (AMI). Although safety-net hospitals had modestly higher risk-standardized thirty-day all-cause mortality rates and modestly lower adherence to quality-of-care performance measures than non-safety-net hospitals, there was much heterogeneity among safety-net hospitals and substantial overlap with non-safety-net hospitals. We examine the implications of these findings for the millions of vulnerable Americans who rely on safety-net hospitals for their care.},
	keywords = {Acute Disease, Aged, Aged, 80 and over, Female, Health Care Surveys, Health Services Accessibility, Hospital Mortality, Hospitals, Urban, Humans, Male, Medicare, Myocardial Infarction, Patient Admission, Patient Transfer, Prospective Payment System, Quality of Health Care, Reimbursement, Disproportionate Share, Retrospective Studies, Risk Assessment, United States, Vulnerable Populations},
	issn = {1544-5208},
	doi = {10.1377/hlthaff.26.1.238},
	author = {Ross, Joseph S and Cha, Stephen S and Epstein, Andrew J and Wang, Yongfei and Bradley, Elizabeth H and Herrin, Jeph and Lichtman, Judith H and Normand, Sharon-Lise T. and Masoudi, Frederick A and Krumholz,Harlan M.}
}
@article {573376,
	title = {Quality of care in Medicaid managed care and commercial health plans},
	journal = {JAMA},
	volume = {298},
	number = {14},
	year = {2007},
	month = {2007 Oct 10},
	pages = {1674-81},
	abstract = {CONTEXT: In contrast to the commercially insured population, the proportion of Medicaid beneficiaries enrolling in health maintenance organizations continues to increase.

OBJECTIVE: To compare quality of care within and between the Medicaid and commercial populations in 3 types of managed care plans: Medicaid-only plans (serving predominantly Medicaid enrollees), commercial-only plans (serving predominantly commercial enrollees), and Medicaid/commercial plans (serving substantial numbers of both types of enrollees).

DESIGN, SETTING, AND PARTICIPANTS: All 383 health plans that reported quality-of-care data to the National Committee for Quality Assurance for 2002 and 2003, including 204 commercial-only plans, 142 Medicaid/commercial plans (plans reported data for the Medicaid and commercial populations separately); and 37 Medicaid-only plans.

MAIN OUTCOME MEASURES: Eleven quality indicators from the Healthcare Effectiveness Data and Information Set (HEDIS) applicable to the Medicaid population.

RESULTS: Among Medicaid enrollees, performance on the 11 measures observed in this study were comparable for Medicaid-only plans and Medicaid/commercial plans. Similarly, among commercial enrollees, there was virtually no difference in performance between health plans that served only the commercial population and those that also served the Medicaid population. Overall across all health plan types, the performance for the commercial population exceeded the performance for the Medicaid population on all measures except 1, ranging from a difference of 4.9\% for controlling hypertension (58.4\% for commercial vs 53.5\% for Medicaid; P = .002) to 24.5\% for rates of appropriate postpartum care (77.2\% for commercial vs 52.7\% for Medicaid; P = .001). Differences of similar magnitude were observed for commercial and Medicaid populations treated within the same health plan.

CONCLUSIONS: Medicaid managed care enrollees receive lower-quality care than that received by commercial managed care enrollees. There were no differences in quality of care for the Medicaid population between Medicaid-only plans and commercial plans that also served the Medicaid population.},
	keywords = {Commerce, Health Benefit Plans, Employee, Humans, Managed Care Programs, Medicaid, Quality Indicators, Health Care, Quality of Health Care, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.298.14.1674},
	author = {Landon, Bruce E and Schneider, Eric C. and Normand, Sharon-Lise T. and Scholle, Sarah Hudson and Pawlson, L Gregory and Arnold M. Epstein}
}
@article {573431,
	title = {Socioeconomic disparities in outcomes after acute myocardial infarction},
	journal = {Am Heart J},
	volume = {153},
	number = {2},
	year = {2007},
	month = {2007 Feb},
	pages = {313-9},
	abstract = {BACKGROUND: Patients of low socioeconomic status (SES) have higher mortality after acute myocardial infarction (AMI). Little is known about the underlying mechanisms or the relationship between SES and rehospitalization after AMI.

METHODS: We analyzed data from the PREMIER observational study, which included 2142 patients hospitalized with AMI from 18 US hospitals. Socioeconomic status was measured by self-reported household income and education level. Sequential multivariable modeling assessed the relationship of socioeconomic factors with 1-year all-cause mortality and all-cause rehospitalization after adjustment for demographics, clinical factors, and quality-of-care measures.

RESULTS: Both household income and education level were associated with higher risk of mortality (hazard ratio 2.80, 95\% CI 1.37-5.72, lowest to highest income group) and rehospitalization after AMI (hazard ratio 1.55, 95\% CI 1.17-2.05). Patients with low SES had worse clinical status at admission and received poorer quality of care. In multivariable modeling, the relationship between household income and mortality was attenuated by adjustment for demographic and clinical factors (hazard ratio 1.19, 95\% CI 0.54-2.62), with a further small decrement in the hazard ratio after adjustment for quality of care. The relationship between income and rehospitalization was only partly attenuated by demographic and clinical factors (hazard ratio 1.38, 95\% CI 1.01-1.89) and was not influenced by adjustment for quality of care.

CONCLUSIONS: Patients{\textquoteright} baseline clinical status largely explained the relationship between SES and mortality, but not rehospitalization, among patients with AMI.},
	keywords = {Female, Humans, Male, Middle Aged, Multivariate Analysis, Myocardial Infarction, Patient Readmission, Socioeconomic Factors, Treatment Outcome},
	issn = {1097-6744},
	doi = {10.1016/j.ahj.2006.10.037},
	author = {Bernheim, Susannah M and Spertus, John A and Reid, Kimberly J and Bradley, Elizabeth H and Desai, Rani A and Peterson, Eric D and Rathore, Saif S and Normand, Sharon-Lise T. and Jones, Philip G and Rahimi, Ali and Krumholz,Harlan M.}
}
@article {573386,
	title = {Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery},
	journal = {Circulation},
	volume = {116},
	number = {15},
	year = {2007},
	month = {2007 Oct 09},
	pages = {1653-62},
	abstract = {BACKGROUND: Cardiac rehabilitation (CR) is effective in prolonging survival and reducing disability in patients with coronary heart disease. However, national use patterns and predictors of CR use have not been evaluated thoroughly.

METHODS AND RESULTS: Using Medicare claims, we analyzed outpatient (phase II) CR use after hospitalizations for acute myocardial infarctions or coronary artery bypass graft surgery in 267,427 fee-for-service beneficiaries aged > or = 65 years who survived for at least 30 days after hospital discharge. We used multivariable analyses to identify predictors of CR use and to quantify geographic variations in its use. We obtained unadjusted, adjusted-smoothed, and standardized rates of CR use by state. Overall, CR was used in 13.9\% of patients hospitalized for acute myocardial infarction and 31.0\% of patients who underwent coronary artery bypass graft surgery. Older individuals, women, nonwhites, and patients with comorbidities (including congestive heart failure, previous stroke, diabetes mellitus, or cancer) were significantly less likely to receive CR. Coronary artery bypass graft surgery during the index hospitalization, higher median household income, higher level of education, and shorter distance to the nearest CR facility were important predictors of higher CR use. Adjusted CR use varied 9-fold among states, ranging from 6.6\% in Idaho to 53.5\% in Nebraska. The highest CR use rates were clustered in the north central states of the United States.

CONCLUSIONS: CR use is relatively low among Medicare beneficiaries despite convincing evidence of its benefits and recommendations for its use by professional organizations. Use is higher after coronary artery bypass graft surgery than with acute myocardial infarctions not treated with revascularization procedures and varies dramatically by state and region of the United States.},
	keywords = {Aged, Cohort Studies, Coronary Artery Bypass, Demography, Health Services, Heart Diseases, Humans, Medicare, Myocardial Infarction, Patient Discharge, Socioeconomic Factors, Survivors, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.107.701466},
	author = {Suaya, Jose A and Shepard, Donald S and Normand, Sharon-Lise T. and Ades, Philip A and Prottas, Jeffrey and Stason, William B}
}
@article {573526,
	title = {ACC/AHA clinical performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Perfo},
	journal = {Circulation},
	volume = {113},
	number = {5},
	year = {2006},
	month = {2006 Feb 07},
	pages = {732-61},
	keywords = {American Heart Association, Angioplasty, Balloon, Coronary, Electrocardiography, Humans, Myocardial Infarction, Outcome and Process Assessment (Health Care), Thrombolytic Therapy},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.106.172860},
	author = {Krumholz,Harlan M. and Anderson, Jeffrey L and Brooks, Neil H and Fesmire, Francis M and Lambrew, Costas T and Mary Beth Landrum and Weaver, W Douglas and Whyte, John and Bonow, Robert O and Bennett, Susan J and Burke, Gregory and Eagle, Kim A and Linderbaum, Jane and Masoudi, Frederick A and Normand, Sharon-Lise T. and Pi{\~n}a, Ileana L and Radford, Martha J and Rumsfeld, John S and Ritchie, James L and Spertus, John A}
}
@article {573531,
	title = {ACC/AHA clinical performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Perfo},
	journal = {J Am Coll Cardiol},
	volume = {47},
	number = {1},
	year = {2006},
	month = {2006 Jan 03},
	pages = {236-65},
	keywords = {Cardiology, Electrocardiography, Humans, Myocardial Infarction, Quality Indicators, Health Care},
	issn = {1558-3597},
	doi = {10.1016/j.jacc.2005.10.020},
	author = {Krumholz,Harlan M. and Anderson, Jeffrey L and Brooks, Neil H and Fesmire, Francis M and Lambrew, Costas T and Mary Beth Landrum and Weaver, W Douglas and Whyte, John and Bonow, Robert O and Bennett, Susan J and Burke, Gregory and Eagle, Kim A and Linderbaum, Jane and Masoudi, Frederick A and Normand, Sharon-Lise T. and Pi{\~n}a, Ileana L and Radford, Martha J and Rumsfeld, John S and Ritchie, James L and Spertus, John A}
}
@article {573511,
	title = {An administrative claims model suitable for profiling hospital performance based on 30-day mortality rates among patients with heart failure},
	journal = {Circulation},
	volume = {113},
	number = {13},
	year = {2006},
	month = {2006 Apr 04},
	pages = {1693-701},
	abstract = {BACKGROUND: A model using administrative claims data that is suitable for profiling hospital performance for heart failure would be useful in quality assessment and improvement efforts.

METHODS AND RESULTS: We developed a hierarchical regression model using Medicare claims data from 1998 that produces hospital risk-standardized 30-day mortality rates. We validated the model by comparing state-level standardized estimates with state-level standardized estimates calculated from a medical record model. To determine the stability of the model over time, we used annual Medicare cohorts discharged in 1999-2001. The final model included 24 variables and had an area under the receiver operating characteristic curve of 0.70. In the derivation set from 1998, the 25th and 75th percentiles of the risk-standardized mortality rates across hospitals were 11.6\% and 12.8\%, respectively. The 95th percentile was 14.2\%, and the 5th percentile was 10.5\%. In the validation samples, the 5th and 95th percentiles of risk-standardized mortality rates across states were 9.9\% and 13.9\%, respectively. Correlation between risk-standardized state mortality rates from claims data and rates derived from medical record data was 0.95 (SE=0.015). The slope of the weighted regression line from the 2 data sources was 0.76 (SE=0.04) with intercept of 0.03 (SE=0.004). The median difference between the claims-based state risk-standardized estimates and the chart-based rates was ,
	keywords = {Aged, Cardiac Output, Low, Cohort Studies, Hospital Mortality, Hospitals, Humans, Insurance Claim Review, Medical Records, Medicare, Models, Statistical, Outcome and Process Assessment (Health Care), Quality of Health Care, Regression Analysis, Risk Assessment},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.105.611194},
	author = {Krumholz,Harlan M. and Wang, Yun and Mattera, Jennifer A and Wang, Yongfei and Han, Lein Fang and Ingber, Melvin J and Roman, Sheila and Normand, Sharon-Lise T.}
}
@article {573506,
	title = {An administrative claims model suitable for profiling hospital performance based on 30-day mortality rates among patients with an acute myocardial infarction},
	journal = {Circulation},
	volume = {113},
	number = {13},
	year = {2006},
	month = {2006 Apr 04},
	pages = {1683-92},
	abstract = {BACKGROUND: A model using administrative claims data that is suitable for profiling hospital performance for acute myocardial infarction would be useful in quality assessment and improvement efforts. We sought to develop a hierarchical regression model using Medicare claims data that produces hospital risk-standardized 30-day mortality rates and to validate the hospital estimates against those derived from a medical record model.

METHODS AND RESULTS: For hospital estimates derived from claims data, we developed a derivation model using 140,120 cases discharged from 4664 hospitals in 1998. For the comparison of models from claims data and medical record data, we used the Cooperative Cardiovascular Project database. To determine the stability of the model over time, we used annual Medicare cohorts discharged in 1995, 1997, and 1999-2001. The final model included 27 variables and had an area under the receiver operating characteristic curve of 0.71. In a comparison of the risk-standardized hospital mortality rates from the claims model with those of the medical record model, the correlation coefficient was 0.90 (SE=0.003). The slope of the weighted regression line was 0.95 (SE=0.007), and the intercept was 0.008 (SE=0.001), both indicating strong agreement of the hospital estimates between the 2 data sources. The median difference between the claims-based hospital risk-standardized mortality rates and the chart-based rates was ,
	keywords = {Aged, Cohort Studies, Hospital Mortality, Hospitals, Humans, Insurance Claim Review, Medical Records, Medicare, Models, Statistical, Myocardial Infarction, Outcome and Process Assessment (Health Care), Quality of Health Care, Regression Analysis, Risk Assessment},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.105.611186},
	author = {Krumholz,Harlan M. and Wang, Yun and Mattera, Jennifer A and Wang, Yongfei and Han, Lein Fang and Ingber, Melvin J and Roman, Sheila and Normand, Sharon-Lise T.}
}
@article {573461,
	title = {Associations between adherence to guidelines for antipsychotic dose and health status, side effects, and patient care experiences},
	journal = {Med Care},
	volume = {44},
	number = {9},
	year = {2006},
	month = {2006 Sep},
	pages = {827-34},
	abstract = {BACKGROUND: One approach to improving quality of care is to encourage physicians to follow evidence-based practice guidelines. Examples of evidence-based guidelines are the PORT recommendations for the treatment of schizophrenia. However, few studies have examined the relationship between adherence to guidelines and patient outcomes in clinical settings.

OBJECTIVE: The purpose of this article is to report the relationship between guideline adherence to antipsychotic medication dose and self-reported health status, side effects, and perceptions of care.

RESEARCH DESIGN: This report is based on a subsample of patients from a larger prospective observational study of disabled Massachusetts Medicaid beneficiaries treated for schizophrenia.

SUBJECTS: Participants were 329 acutely ill, vulnerable, high-risk Medicaid adult beneficiaries enrolled after visiting any 1 of 8 psychiatric emergency screening teams for hospital admission evaluation.

MEASURES: Dose levels, symptoms, and functioning from medical records; self-reports as data collected from BASIS-32, SF-12, and CABHS; and paid health benefit claims for psychiatric treatment were measured.

RESULTS: Approximately 40\% of the patients in this study had daily antipsychotic doses well above the recommended range, but there was no evidence that their health status was better than those on doses below 1000 CPZ units recommended for acute episodes. High-dose levels had no relationship to baseline symptom profile or referral source.

CONCLUSIONS: There was no evidence that health status was better on higher-than-recommended doses, but we cannot conclude that lower doses for some would have led to poorer outcomes. Physicians who believe that higher doses are more therapeutic for patients need to demand rigorous effectiveness research that tests whether there are benefits of higher doses and determine the ratio of those benefits to the clinical costs, including the risk of side effects.},
	keywords = {Adult, Antipsychotic Agents, Dose-Response Relationship, Drug, Drug Utilization, Female, Guideline Adherence, Health Status, Humans, Male, Medicaid, Middle Aged, Practice Guidelines as Topic, Practice Patterns, Physicians{\textquoteright}, Prospective Studies, Quality of Health Care, Schizophrenia},
	issn = {0025-7079},
	doi = {10.1097/01.mlr.0000215806.11805.6c},
	author = {Dickey, Barbara and Normand, Sharon-Lise T. and Eisen, Sue and Hermann, Richard and Cleary, Paul and Cort{\'e}s, Dharma and Norma Ware}
}
@article {573501,
	title = {Behavioral health insurance parity for federal employees},
	journal = {N Engl J Med},
	volume = {354},
	number = {13},
	year = {2006},
	month = {2006 Mar 30},
	pages = {1378-86},
	abstract = {BACKGROUND: To improve insurance coverage of mental health and substance-abuse services, the Federal Employees Health Benefits (FEHB) Program offered mental health and substance-abuse benefits on a par with general medical benefits beginning in January 2001. The plans were encouraged to manage care.

METHODS: We compared seven FEHB plans from 1999 through 2002 with a matched set of health plans that did not have benefits on a par with mental health and substance-abuse benefits (parity of mental health and substance-abuse benefits). Using a difference-in-differences analysis, we compared the claims patterns of matched pairs of FEHB and control plans by examining the rate of use, total spending, and out-of-pocket spending among users of mental health and substance-abuse services.

RESULTS: The difference-in-differences analysis indicated that the observed increase in the rate of use of mental health and substance-abuse services after the implementation of the parity policy was due almost entirely to a general trend in increased use that was observed in comparison health plans as well as FEHB plans. The implementation of parity was associated with a statistically significant increase in use in one plan (+0.78 percent, P,
	keywords = {Cost Sharing, Federal Government, Health Benefit Plans, Employee, Health Care Costs, Humans, Insurance Benefits, Mental Health Services, Substance-Related Disorders, United States},
	issn = {1533-4406},
	doi = {10.1056/NEJMsa053737},
	author = {Goldman, Howard H and Richard G. Frank and Burnam, M Audrey and Huskamp, Haiden A. and Ridgely, M Susan and Normand, Sharon-Lise T. and Young, Alexander S and Barry, Colleen L and Azzone, Vanessa and Alisa B. Busch and Azrin, Susan T and Moran, Garrett and Lichtenstein, Carolyn and Blasinsky, Margaret}
}
@article {573486,
	title = {Comparison of self-report and clinician-rated measures of psychiatric symptoms and functioning in predicting 1-year hospital readmission},
	journal = {Adm Policy Ment Health},
	volume = {33},
	number = {5},
	year = {2006},
	month = {2006 Sep},
	pages = {568-77},
	abstract = {This study compared the self-report Behavior and Symptom Identification Scale (BASIS-32) and clinician-rated Global Assessment of Functioning (GAF) in their ability to predict a measure of psychiatric outcome, 1-year psychiatric hospital readmission. BASIS-32 and GAF were completed at admission for 1034 patients in an inpatient psychiatric facility. Multiple informants analysis was used to determine the difference between the two in predicting readmission within 1 year. We also examined sensitivity, specificity, and predictive value positive of the two measures, and whether self-report added information above clinician rating in predicting outcome. While the odds of 1-year readmission decreased with increasing BASIS-32 score, there was no association between change in GAF score and 1-year readmission. Although neither measure used alone demonstrated high predictive value, using both scores improved predictive ability over using clinician rating alone. In this setting, self-report was better than clinician rating in predicting psychiatric outcome. Differences between the two in relation to other outcomes need to be examined.},
	keywords = {Adolescent, Adult, Cohort Studies, Female, Hospitals, Psychiatric, Humans, Male, Medical Audit, Mental Disorders, Middle Aged, Patient Readmission, Retrospective Studies, Self Disclosure},
	issn = {0894-587X},
	doi = {10.1007/s10488-006-0066-y},
	author = {Clements, Karen M and Murphy, Jane M and Eisen, Susan V and Normand, Sharon-Lise T.}
}
@article {573481,
	title = {Hospital quality for acute myocardial infarction: correlation among process measures and relationship with short-term mortality},
	journal = {JAMA},
	volume = {296},
	number = {1},
	year = {2006},
	month = {2006 Jul 05},
	pages = {72-8},
	abstract = {CONTEXT: The Centers for Medicare \& Medicaid Services (CMS) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) measure and report quality process measures for acute myocardial infarction (AMI), but little is known about how these measures are correlated with each other and the degree to which inferences about a hospital{\textquoteright}s outcomes can be made from its performance on publicly reported processes.

OBJECTIVE: To determine correlations among AMI core process measures and the degree to which they explain the variation in hospital-specific, risk-standardized, 30-day mortality rates.

DESIGN, SETTING, AND PARTICIPANTS: We assessed hospital performance in the CMS/JCAHO AMI core process measures using 2002-2003 data from 962 hospitals participating in the National Registry of Myocardial Infarction (NRMI) and correlated these measures with each other and with hospital-level, risk-standardized, 30-day mortality rates derived from Medicare claims data.

MAIN OUTCOME MEASURES: Hospital performance on AMI core measures; hospital-specific, risk-standardized, 30-day mortality rates for AMI patients aged 66 years or older.

RESULTS: We found moderately strong correlations (correlation coefficients > or =0.40; P values ,
	keywords = {Aged, Centers for Medicare and Medicaid Services (U.S.), Cross-Sectional Studies, Hospital Mortality, Hospitals, Humans, Joint Commission on Accreditation of Healthcare Organizations, Medicare, Myocardial Infarction, Outcome and Process Assessment (Health Care), Quality Indicators, Health Care, Registries, Risk Assessment, United States},
	issn = {1538-3598},
	doi = {10.1001/jama.296.1.72},
	author = {Bradley, Elizabeth H and Herrin, Jeph and Elbel, Brian and McNamara, Robert L and Magid, David J and Nallamothu, Brahmajee K and Wang, Yongfei and Normand, Sharon-Lise T. and Spertus, John A and Krumholz,Harlan M.}
}
@article {573521,
	title = {Impact of adverse events on prescribing warfarin in patients with atrial fibrillation: matched pair analysis},
	journal = {BMJ},
	volume = {332},
	number = {7534},
	year = {2006},
	month = {2006 Jan 21},
	pages = {141-5},
	abstract = {OBJECTIVES: To quantify the influence of physicians{\textquoteright} experiences of adverse events in patients with atrial fibrillation who were taking warfarin.

DESIGN: Population based, matched pair before and after analysis.

SETTING: Database study in Ontario, Canada.

PARTICIPANTS: The physicians of patients with atrial fibrillation admitted to hospital for adverse events (major haemorrhage while taking warfarin and thromboembolic strokes while not taking warfarin). Pairs of other patients with atrial fibrillation treated by the same physicians were selected.

MAIN OUTCOME MEASURES: Odds of receiving warfarin by matched pairs of a given physician{\textquoteright}s patients (one treated after and one treated before the event) were compared, with adjustment for stroke and bleeding risk factors that might also influence warfarin use. The odds of prescriptions for angiotensin converting enzyme (ACE) inhibitor before and after the event was assessed as a neutral control.

RESULTS: For the 530 physicians who had a patient with an adverse bleeding event (exposure) and who treated other patients with atrial fibrillation during the 90 days before and the 90 days after the exposure, the odds of prescribing warfarin was 21\% lower for patients after the exposure (adjusted odds ratio 0.79, 95\% confidence interval 0.62 to 1.00). Greater reductions in warfarin prescribing were found in analyses with patients for whom more time had elapsed between the physician{\textquoteright}s exposure and the patient{\textquoteright}s treatment. There were no significant changes in warfarin prescribing after a physician had a patient who had a stroke while not on warfarin or in the prescribing of ACE inhibitors by physicians who had patients with either bleeding events or strokes.

CONCLUSIONS: A physician{\textquoteright}s experience with bleeding events associated with warfarin can influence prescribing warfarin. Adverse events that are possibly associated with underuse of warfarin may not affect subsequent prescribing.},
	keywords = {Adult, Aged, Anticoagulants, Atrial Fibrillation, Attitude to Health, Clinical Competence, Epidemiologic Methods, Female, Hemorrhage, Humans, Male, Medical Staff, Hospital, Middle Aged, Physician-Patient Relations, Practice Patterns, Physicians{\textquoteright}, Stroke, Thromboembolism, Warfarin},
	issn = {1756-1833},
	doi = {10.1136/bmj.38698.709572.55},
	author = {Choudhry, Niteesh K. and Anderson, Geoffrey M and Laupacis, Andreas and Ross-Degnan, Dennis and Normand, Sharon-Lise T. and Soumerai, Stephen B}
}
@article {573496,
	title = {The impact of parity on major depression treatment quality in the Federal Employees{\textquoteright} Health Benefits Program after parity implementation},
	journal = {Med Care},
	volume = {44},
	number = {6},
	year = {2006},
	month = {2006 Jun},
	pages = {506-12},
	abstract = {BACKGROUND: Since the 1990s, parity laws have been implemented to reduce inequities in mental health coverage compared with that for general medical conditions. It is unclear if parity under managed care is associated with improvements in mental health treatment quality. Major depressive disorder (MDD) is a prevalent but often undetected and undertreated and thus could potentially benefit from parity implementation.

OBJECTIVE: The objective of this study was to examine the association between parity implementation and changes in MDD treatment quality in the Federal Employees{\textquoteright} Health Benefits (FEHB) Program.

METHODS: We conducted retrospective analyses of insurance claims data. Logistic regression models estimated quality changes for MDD-diagnosed enrollees from pre- to postparity.

SUBJECTS: Subjects included MDD-diagnosed FEHB insured enrollees, aged 18-64, across multiple states and 6 FEHB plans before (1999-2000) and after (2001-2002) parity implementation.

MEASURES: Measures included receipt of any antidepressant or psychotherapy within a given calendar year of diagnosis; receipt of appropriate psychotherapy frequency/intensity and duration; and pharmacotherapy duration during acute-phase treatment episodes.

RESULTS: Postparity, several plans improved significantly in the likelihood of receiving antidepressant medication. In the acute-phase episodes, the greatest improvement was seen in the likelihood of follow up >or=4 months. Few or no other changes were observed in the acute-phase treatment intensity or duration quality measures.

CONCLUSIONS: Parity under managed care was associated with modest improvements. The observed improvements were consistent with secular trends in MDD treatment. Whereas mental health parity is an important policy goal, these results highlight its limitations: improving the financing of care may not be sufficient to improve quality.},
	keywords = {Adolescent, Adult, Antidepressive Agents, Depressive Disorder, Major, Drug Utilization, Federal Government, Health Benefit Plans, Employee, Health Services Accessibility, Humans, Insurance Coverage, Mental Health Services, Middle Aged, Quality of Health Care, Retrospective Studies, United States},
	issn = {0025-7079},
	doi = {10.1097/01.mlr.0000215890.30756.b2},
	author = {Alisa B. Busch and Huskamp, Haiden A. and Normand, Sharon-Lise T. and Young, Alexander S and Goldman, Howard and Richard G. Frank}
}
@article {573516,
	title = {A meta-analysis of labor supply effects of interventions for major depressive disorder},
	journal = {Psychiatr Serv},
	volume = {57},
	number = {2},
	year = {2006},
	month = {2006 Feb},
	pages = {212-8},
	abstract = {OBJECTIVE: The aims of this study were to examine labor supply effects of interventions for major depressive disorder and to compare these effects with a summary measure of clinical effectiveness.

METHODS: Research articles published in English-language journals from 1980 through May 2004 were searched by using five research databases. Only randomized trials that included a placebo group or a usual care group were eligible for the study, regardless of the specific type of intervention. Valid trials were those that enrolled adult patients with major depressive disorder and assessed changes in labor output by using a measure of time worked or labor market participation. From a total of 706 trials uncovered from the database searches, only four met all inclusion criteria. Trial outcomes were transformed into standardized effect sizes on the basis of Cohen{\textquoteright}s d. Hierarchical linear models were used to separately pool work outcomes and clinical outcomes.

RESULTS: An improvement of .34 standard deviation was found in the size of the clinical effect of interventions compared with placebo or usual care among 1,261 unique patients with depression. An improvement of .12 standard deviation was found in the size of the effect on labor supply among 1,848 unique patients.

CONCLUSIONS: Although the interventions studied were associated with reduced symptoms of depression and increased labor output, the labor benefits were small according to standard benchmarks used in interpreting the substantive significance of values of Cohen{\textquoteright}s d. The difference in effects may have been due to different underlying efficacies, brief durations of follow-up, or extrinsic factors that affect labor supply.},
	keywords = {Depressive Disorder, Major, Employment, Humans, Mental Health Services, United States},
	issn = {1075-2730},
	doi = {10.1176/appi.ps.57.2.212},
	author = {Timbie, Justin W and Horvitz-Lennon, Marcela and Richard G. Frank and Normand, Sharon-Lise T.}
}
@article {573471,
	title = {National trends in outcomes among elderly patients with heart failure},
	journal = {Am J Med},
	volume = {119},
	number = {7},
	year = {2006},
	month = {2006 Jul},
	pages = {616.e1-7},
	abstract = {PURPOSE: Despite dramatic changes in heart failure management during the 1990s, little is known about the national heart failure mortality trends during this time period, particularly among the elderly. The purpose of this study was to determine temporal trends in outcomes of elderly patients with heart failure between 1992 and 1999.

SUBJECTS AND METHODS: We analyzed a national sample of 3,957,520 Medicare beneficiaries aged 65 years or more who were hospitalized with heart failure between 1992 and 1999, assessing temporal trends in 30-day and 1-year all-cause mortality and 30-day and 6-month all-cause hospital readmission. In risk-adjusted analyses, mortality and readmission for each year between 1994 and 1999 were compared with the referent year of 1993.

RESULTS: Crude 30-day and 1-year mortality decreased slightly (range for 1992-1999: 11.0\%-10.3\% and 32.5\%-31.7\%, respectively), whereas 30-day and 6-month readmission increased (10.2\%-13.8\% and 35.4\%-40.3\%, respectively). After risk adjustment, there was no change in 30-day mortality between 1993 and 1999 (eg, for 1999 vs 1993, odds ratio [OR] 1.01, 95\% confidence interval [CI], 1.00-1.02). One-year mortality was lower in 1994 compared with 1993 (OR 0.91, 95\% CI, 0.90-0.92), but data from subsequent years suggested no continuous improvement after 1994 (1999 vs 1993: OR 0.93, 95\% CI, 0.92-0.94). Thirty-day readmission increased (1999 vs 1993: OR 1.09, 95\% CI, 1.07-1.10), but there was no change in 6-month readmission (1999 vs 1993: OR 1.00, 95\% CI, 0.99-1.01).

CONCLUSION: We found no substantial improvement in mortality and hospital readmission during the 1990s among elderly patients hospitalized with heart failure. These findings suggest that recent innovations in heart failure management have not yet translated into better outcomes in this population.},
	keywords = {Aged, Cohort Studies, Female, Heart Failure, Humans, Male, Medicare, Mortality, Odds Ratio, Outcome Assessment (Health Care), Retrospective Studies},
	issn = {1555-7162},
	doi = {10.1016/j.amjmed.2005.11.019},
	author = {Kosiborod, Mikhail and Lichtman, Judith H and Heidenreich, Paul A and Normand, Sharon-Lise T. and Wang, Yun and Brass, Lawrence M and Krumholz,Harlan M.}
}
@article {573456,
	title = {Pay for performance in commercial HMOs},
	journal = {N Engl J Med},
	volume = {355},
	number = {18},
	year = {2006},
	month = {2006 Nov 02},
	pages = {1895-902},
	abstract = {BACKGROUND: Pay for performance has increasingly become the subject of intense interest and debate, both of which have been heightened as the Centers for Medicare and Medicaid Services moves closer to adopting this approach for Medicare. Although many claims have been made for the effectiveness of this approach, the extent of its national penetration remains unknown.

METHODS: We surveyed a sample of 252 health maintenance organizations (HMOs) (response rate, 96\%) drawn from 41 metropolitan areas across the nation about use of pay for performance. We determined the prevalence of pay-for-performance programs, detailed the features of such programs, and examined the adoption of pay for performance as a function of the characteristics of both the health plans and markets.

RESULTS: More than half the HMOs, representing more than 80\% of persons enrolled, use pay for performance in their provider contracts. Of the 126 health plans with pay-for-performance programs, nearly 90\% had programs for physicians and 38\% had programs for hospitals. Use of pay for performance was statistically associated with geographic region, use of primary care providers (PCPs) as gatekeepers, use of capitation to pay PCPs, and whether the plans themselves received bonuses or penalties according to performance.

CONCLUSIONS: Pay for performance is now commonly used by HMOs, especially those that are situated to assign responsibility for a particular patient to a PCP or medical group. As the design of Medicare with pay for performance moves forward, it will be important to leverage the early experience of pay for performance in the commercial market.},
	keywords = {Contracts, Data Collection, Economics, Hospital, Health Maintenance Organizations, Hospitals, Humans, Physician Incentive Plans, Regression Analysis, Reimbursement, Incentive, Salaries and Fringe Benefits, United States},
	issn = {1533-4406},
	doi = {10.1056/NEJMsa063682},
	author = {Meredith B. Rosenthal and Landon, Bruce E and Normand, Sharon-Lise T. and Richard G. Frank and Arnold M. Epstein}
}
@article {573451,
	title = {Quality of care for the treatment of acute medical conditions in US hospitals},
	journal = {Arch Intern Med},
	volume = {166},
	number = {22},
	year = {2006},
	month = {2006 Dec 11-25},
	pages = {2511-7},
	abstract = {BACKGROUND: The Joint Commission on Accreditation of Healthcare Organizations and the Centers for Medicare and Medicaid Services recently began reporting on quality of care for acute myocardial infarction, congestive heart failure, and pneumonia.

METHODS: We linked performance data submitted for the first half of 2004 to American Hospital Association data on hospital characteristics. We created composite scales for each disease and used factor analysis to identify 2 additional composites based on underlying domains of quality. We estimated logistic regression models to examine the relationship between hospital characteristics and quality.

RESULTS: Overall, 75.9\% of patients hospitalized with these conditions received recommended care. The mean composite scores and their associated interquartile ranges were 0.85 (0.81-0.95), 0.64 (0.52-0.78), and 0.88 (0.80-0.97) for acute myocardial infarction, congestive heart failure, and pneumonia, respectively. After adjustment, for-profit hospitals consistently underperformed not-for-profit hospitals for each condition, with odds ratios (ORs) ranging from 0.79 (95\% confidence interval [CI], 0.78-0.80) for the congestive heart failure composite measure to 0.90 (95\% CI, 0.89-0.91) for the pneumonia composite. Major teaching hospitals had better performance on the treatment and diagnosis composite (OR, 1.37; 95\% CI, 1.34-1.39) but worse performance on the counseling and prevention composite (OR, 0.83; 95\% CI, 0.82-0.84). Hospitals with more technology available, higher registered nurse staffing, and federal/military designation had higher performance.

CONCLUSIONS: Patients are more likely to receive high-quality care in not-for-profit hospitals and in hospitals with high registered nurse staffing ratios and more investment in technology. Because payments and sources of payments affect some of these factors (eg, investments in technology and staffing ratios), policy makers should evaluate the effect of alternative payment approaches on quality.},
	keywords = {Acute Disease, Heart Failure, Hospitalization, Hospitals, Teaching, Humans, Logistic Models, Multivariate Analysis, Myocardial Infarction, Nursing Staff, Hospital, Odds Ratio, Pneumonia, Quality Indicators, Health Care, Quality of Health Care, United States},
	issn = {0003-9926},
	doi = {10.1001/archinte.166.22.2511},
	author = {Landon, Bruce E and Normand, Sharon-Lise T. and Lessler, Adam and A. James O{\textquoteright}Malley and Schmaltz, Stephen and Loeb, Jerod M and McNeil, Barbara J}
}
@article {573466,
	title = {Selection and plan switching behavior},
	journal = {Inquiry},
	volume = {43},
	number = {1},
	year = {2006},
	month = {2006 Spring},
	pages = {10-22},
	abstract = {A majority of employees can choose among health insurance plans of varying generosity. They may switch plans if prices, information, or their health status change. This paper analyzes switching behavior presumptively caused by changes in health status. We show that people who move to a less generous plan have lower medical spending prior to the switch than the average for the generous plan in which they started, while those who move to a more generous plan appear to anticipate higher spending, which they delay until after the switch. This transfer of costs from a less to a more generous plan increases the burden of adverse selection. Our data suggest that switching may be more important to the level of premiums than previously documented.},
	keywords = {Adult, Cohort Studies, Female, Health Benefit Plans, Employee, Health Expenditures, Health Services, Health Status, Humans, Insurance Claim Review, Male, Middle Aged, Models, Psychological},
	issn = {0046-9580},
	doi = {10.5034/inquiryjrnl_43.1.10},
	author = {Tchernis, Rusty and Normand, Sharon-Lise T. and Pakes, Juliana and Gaccione, Peter and Joseph P. Newhouse}
}
@article {573536,
	title = {Standards for statistical models used for public reporting of health outcomes: an American Heart Association Scientific Statement from the Quality of Care and Outcomes Research Interdisciplinary Writing Group: cosponsored by the Council on Epidemiology an},
	journal = {Circulation},
	volume = {113},
	number = {3},
	year = {2006},
	month = {2006 Jan 24},
	pages = {456-62},
	abstract = {With the proliferation of efforts to report publicly the outcomes of healthcare providers and institutions, there is a growing need to define standards for the methods that are being employed. An interdisciplinary writing group identified 7 preferred attributes of statistical models used for publicly reported outcomes. These attributes include (1) clear and explicit definition of an appropriate patient sample, (2) clinical coherence of model variables, (3) sufficiently high-quality and timely data, (4) designation of an appropriate reference time before which covariates are derived and after which outcomes are measured, (5) use of an appropriate outcome and a standardized period of outcome assessment, (6) application of an analytical approach that takes into account the multilevel organization of data, and (7) disclosure of the methods used to compare outcomes, including disclosure of performance of risk-adjustment methodology in derivation and validation samples.},
	keywords = {American Heart Association, Humans, Models, Statistical, Outcome Assessment (Health Care), Public Health Informatics, Quality of Health Care, Risk Assessment, Stroke, United States},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.105.170769},
	author = {Krumholz,Harlan M. and Brindis, Ralph G and Brush, John E and Cohen, David J and Epstein, Andrew J and Furie, Karen and Howard, George and Peterson, Eric D and Rathore, Saif S and Smith, Sidney C and Spertus, John A and Wang, Yun and Normand, Sharon-Lise T.}
}
@article {573476,
	title = {Warfarin prescribing in atrial fibrillation: the impact of physician, patient, and hospital characteristics},
	journal = {Am J Med},
	volume = {119},
	number = {7},
	year = {2006},
	month = {2006 Jul},
	pages = {607-15},
	abstract = {PURPOSE: The study investigated the determinants of warfarin use in patients with atrial fibrillation (AF).

METHODS: We assembled a retrospective cohort of community-dwelling elderly patients (aged > or = 66 years) with AF using linked administrative databases. We identified the physicians responsible for the ambulatory care of these patients using physician service claims and compared patients who did and did not have an identifiable provider. For those patients with an identifiable provider, we assessed the association between patient, physician, and hospital factors and warfarin use.

RESULTS: Our cohort consisted of 140,185 patients, of whom 116,200 (83\%) had an identifiable cardiac provider. Patients without a provider were significantly more likely to have comorbid conditions that increase their risk of warfarin-associated bleeding. After adjustment for clinical factors, patients without a provider were significantly less likely to receive warfarin (odds ratio 0.37, 95\% confidence interval: 0.36-0.38). Of patients with providers, 50,551 patients (43.5\%) received warfarin within 180 days after hospital discharge. Warfarin use was positively associated with AF-associated stroke risk factors (eg, prior stroke, congestive heart failure) and negatively associated with warfarin-associated bleeding risk factors (eg, history of intracerebral hemorrhage). After controlling for patient and hospital factors, patients cared for by noncardiologist physicians with cardiology consultation were more likely to receive warfarin then patients treated in noncollaborative environments.

CONCLUSIONS: Warfarin continues to be substantially underprescribed to patients who are at high risk for AF-associated cardioembolic stroke. Our findings highlight the need for targeted quality improvement interventions and suggest preferred models of AF care involving routine collaboration between cardiologists and other physicians.},
	keywords = {Aged, Anticoagulants, Atrial Fibrillation, Cohort Studies, Female, Hospitals, Humans, Male, Physicians, Practice Patterns, Physicians{\textquoteright}, Quality of Health Care, Retrospective Studies, Risk Factors, Stroke, Warfarin},
	issn = {1555-7162},
	doi = {10.1016/j.amjmed.2005.09.052},
	author = {Choudhry, Niteesh K. and Soumerai, Stephen B and Normand, Sharon-Lise T. and Ross-Degnan, Dennis and Laupacis, Andreas and Anderson, Geoffrey M}
}
@article {573541,
	title = {Massachusetts cardiac surgery report card: implications of statistical methodology},
	journal = {Ann Thorac Surg},
	volume = {80},
	number = {6},
	year = {2005},
	month = {2005 Dec},
	pages = {2106-13},
	abstract = {BACKGROUND: Choice of statistical methodology may significantly impact the results of provider profiling, including cardiac surgery report cards. Because of sample size and clustering issues, logistic regression may overestimate systematic interprovider variability, leading to false outlier classification. Theoretically, the use of hierarchical models should result in more accurate representation of provider performance.

METHODS: Extensively validated and audited data were available for all 4,603 isolated coronary artery bypass grafting procedures performed at 13 Massachusetts hospitals during 2002. To produce the official Massachusetts cardiac surgery report card, a 19-variable predictor set and a hierarchical generalized linear model were employed. For the current study, this same analysis was repeated with the 14 predictors used in the New York Cardiac Surgery Reporting System. Two additional analyses were conducted using each set of predictor variables and applying standard logistic regression. For each of the four combinations of predictors and models, the point estimates of risk-adjusted 30-day mortality, 95\% confidence or probability intervals, and outlier status were determined for each hospital.

RESULTS: Overall unadjusted mortality for coronary bypass operations was 2.19\%. For most hospitals, there was wide variability in the point estimates and confidence or probability intervals of risk-adjusted mortality depending on statistical model, but little variability relative to the choice of predictors. There were no hospital outliers using hierarchical models, but there was one outlier using logistic regression with either predictor set.

CONCLUSIONS: When used to compare provider performance, logistic regression increases the possibility of false outlier classification. The use of hierarchical models is recommended.},
	keywords = {Aged, Coronary Artery Bypass, Female, Humans, Linear Models, Male, Massachusetts, Quality Assurance, Health Care},
	issn = {1552-6259},
	doi = {10.1016/j.athoracsur.2005.06.078},
	author = {Shahian, David M and Torchiana, David F and Shemin, Richard J and Rawn, James D and Normand, Sharon-Lise T.}
}
@article {573546,
	title = {Optimal timing of intervention in non-ST-segment elevation acute coronary syndromes: insights from the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines) Regist},
	journal = {Circulation},
	volume = {112},
	number = {20},
	year = {2005},
	month = {2005 Nov 15},
	pages = {3049-57},
	abstract = {BACKGROUND: Recent studies indicate that a routine invasive approach for patients with unstable angina (UA) and non-ST-segment elevation myocardial infarction (NSTEMI) yields improved outcomes compared with a conservative approach, but the optimal timing of this approach remains open to debate.

METHODS AND RESULTS: We used day of hospital presentation as an instrumental variable to study the impact of timing of cardiac catheterization and revascularization therapy on acute outcomes (death, reinfarction, stroke, cardiogenic shock, or congestive heart failure) among patients with UA and NSTEMI. Between January 2001 and September 2003, 56,352 patients with UA or NSTEMI were treated at 310 US hospitals participating in the CRUSADE national quality improvement initiative. Weekend patients were defined as those who presented to the hospital between 5 PM on Friday and 7 AM on Sunday. All other patients were classified as weekday. Weekday patients were similar to weekend patients in terms of demographics, clinical characteristics, and the use of medical therapies in the first 24 hours. Although overall rates of cardiac catheterization and revascularization were similar for the 2 groups, median time to catheterization was significantly longer for weekend than for weekday patients (46.3 versus 23.4 hours, P,
	keywords = {Aged, Angina, Unstable, Cardiology, Coronary Disease, Databases, Factual, Female, Hospitalization, Humans, Male, Middle Aged, Registries, Retrospective Studies, Risk Assessment, Societies, Medical, Time Factors},
	issn = {1524-4539},
	doi = {10.1161/CIRCULATIONAHA.105.582346},
	author = {Ryan, Jason W and Peterson, Eric D and Chen, Anita Y and Roe, Matthew T and Ohman, E Magnus and Cannon, Christopher P and Berger, Peter B and Saucedo, Jorge F and DeLong, Elizabeth R and Normand, Sharon-Lise and Pollack, Charles V and Cohen, David J}
}
@article {573321,
	title = {Treatment of long-term psychiatric disorders in the managed care environment: an observational longitudinal study},
	journal = {Clin Drug Investig},
	volume = {15},
	number = {4},
	year = {1998},
	month = {1998},
	pages = {303-8},
	abstract = {In the USA, mental health expenditures have been rising at a rate that exceeds other medical expenditures. To control these costs, insurance companies and governmental agencies responsible for health benefit plans have turned to managed care companies who review utilisation of services and who negotiate fee reductions with providers. In this study, we examined changes in patterns of care and per person expenditures among Medicaid enrollees with major mental illness. We found that after the introduction of managed care, per person expenditures were reduced by about 25\%, accomplished primarily by limiting hospital admissions. We also found that admissions (and the associated costs) were not shifted to the Department of Mental Health, which funds state hospital long-term care for the indigent. Measures of continuity of care were unchanged during the study period. We conclude that managed care met its cost-containment goals without shifting costs to another state agency.},
	issn = {1173-2563},
	author = {Dickey, B and Normand, S. L. and Norton, E C and Azeni, H and Fisher, W}
}
@article {573731,
	title = {Compliance is poor among HIV-infected children with unmet dental needs},
	journal = {Pediatr Dent},
	volume = {18},
	number = {2},
	year = {1996},
	month = {1996 Mar-Apr},
	pages = {137-8},
	keywords = {Adolescent, Appointments and Schedules, Child, Child, Preschool, Clinical Protocols, Dental Care for Children, Dental Caries, Facial Pain, Family Health, Gingivitis, Health Services Needs and Demand, HIV Infections, HIV Seronegativity, HIV Seropositivity, Humans, Longitudinal Studies, Patient Compliance, Referral and Consultation},
	issn = {0164-1263},
	author = {Broder, H L and Catalanotto, F A and Reisine, S and Variagiannis, E}
}
@article {573721,
	title = {Drugs and the high cost of health care},
	journal = {Am Pharm},
	volume = {18},
	number = {10},
	year = {1978},
	month = {1978 Sep},
	pages = {20-1},
	keywords = {Drug Therapy, Drug Utilization, Health Expenditures},
	issn = {0160-3450},
	author = {Roffe, B D and Lamy, P P}
}
@article {573626,
	title = {European Society of Human Genetics. Abstracts from symposium on "Chromosome Structure and Function". Vienna, Austria, May 5-7, 1978},
	journal = {Clin Genet},
	volume = {14},
	number = {5},
	year = {1978},
	month = {1978 Nov},
	pages = {273-316},
	keywords = {Animals, Austria, Chromosome Aberrations, Chromosome Disorders, Chromosomes, Human, Congresses as Topic, Europe, Female, Genetics, Medical, Humans, Male, Societies, Medical},
	issn = {0009-9163}
}
@article {546461,
	title = {Charge transfer mediated by nigericin in black lipid membranes},
	journal = {J Bioenerg},
	volume = {8},
	number = {1},
	year = {1976},
	month = {1976 Feb},
	pages = {19-26},
	abstract = {Nigericin, in the concentration range (10(-6) M or higher) at which it uncouples intact mitochondria, was found to increase the conductance of black lipid membranes (BLM) by several orders of magnitude. The dependence of the membrane conductance on pH and K+ concentration suggests a mechanism for the transfer of charge mediated by this ionophore based on a mobile dimer with both nigericin molecules protonated and complexed with one K+. This charged complex accounts for the uncoupling effect observed in intact mitochondria.},
	keywords = {Anti-Bacterial Agents, Electric Conductivity, Hydrogen-Ion Concentration, Membranes, Artificial, Mitochondria, Models, Biological, Nigericin, Phosphatidylcholines, Potassium},
	issn = {0449-5705},
	author = {Toro, M and G{\'o}mez-Lojero, C and Montal, M and Estrada-O, S}
}
@article {546466,
	title = {[Study of the mechanism of the effect of extracellular pH on the synthesis of the oxidative complex (cytochrome a+a3) of Bacillus coagulans: relationship to the "glucose effect" and role of excreted coproporphyrin III (author{\textquoteright}s transl)]},
	journal = {Biochim Biophys Acta},
	volume = {423},
	number = {3},
	year = {1976},
	month = {1976 Mar 12},
	pages = {573-85},
	abstract = {During the "respiratory adaptation" of Bacillus coagulans, it was possible to dissociate the kinetics of cytochrome a and a3 synthesis with carbon monoxide. The synthesis of cytochrome a3 is preferentially repressed when the pH of the incubation medium is pH 6.5 instead of pH 5.5. However, though the total synthesis of tetrapyrrole compounds is the same at both pH values, the excretion of coproporphyrin III is much increased at pH 6.5. Bacillus coagulans, sensitive to the "glucose effect", shows the "pH effect" only in the presence of high glucose concentrations. The repression of the oxidase complex synthesis by a slight increase of the extracellular pH appears directly related to the increase of the extracellular coproporphyrin III.},
	keywords = {Aerobiosis, Animals, Bacillus, Coproporphyrinogens, Coproporphyrins, Cytochromes, Glucose, Hydrogen-Ion Concentration, Kinetics, Oxygen Consumption, Porphyrins, Time Factors},
	issn = {0006-3002},
	author = {Frade, R and Chaix, P}
}
@article {573676,
	title = {Acid-base balance in amphibian gastric mucosa},
	journal = {Am J Physiol},
	volume = {229},
	number = {3},
	year = {1975},
	month = {1975 Sep},
	pages = {721-30},
	abstract = {It has been established that H+ secretion can be maintained in frog stomach in the absence of exogenous CO2 by using a nutrient bathing fluid containing 25 mM H2PO4 (pH approximately equal to 4.5) or by lowering the pH of a nonbuffered nutrient solution to about 3.0-3.6. Exogenous CO2 in the presence of these nutrient solutions uniformly caused a marked decrease in H+ secretion, PD, adn short-circuit current (Isc) and an increase in transmucosal resistance (R). Elevation of nutrient [k+] to 83 mM reduced R significantly but transiently without change in H+ when nutrient pH less than 5.0, whereas R returned to base line and H+ increased when nutrient pH greater than 5.0. Acidification of the nutrient medium in the presence of exogenous CO2 results in inhibition of the secretory pump, probably by decreasing intracellular pH, and also interferes with conductance at the nutrient membrane. Removal of exogenous CO2 from standard bicarbonate nutrient solution reduced by 50\% the H+, PD, and Isc without change in R; K+-free nutrient solutions reverse these changes in Isc and PD but not in H+. The dropping PD and rising R induced by K+-free nutrient solutions in 5\% CO2 - 95\% O2 are returned toward normal by 100\% O2. Our findings support an important role for exogenous CO2 in maintaining normal acid-base balance in frog mucosa by acting as an acidifying agent.},
	keywords = {Acid-Base Equilibrium, Animals, Anura, Bicarbonates, Carbon Dioxide, Electrophysiology, Gastric Mucosa, Hydrogen-Ion Concentration, Phosphates, Potassium, Rana catesbeiana, Solutions},
	issn = {0002-9513},
	author = {Silen, W and Machen, T E and Forte, J G}
}
@article {546441,
	title = {The adolescent who has lost a significant other},
	journal = {IMJ Ill Med J},
	volume = {148},
	number = {6},
	year = {1975},
	month = {1975 Dec},
	pages = {614-5},
	keywords = {Acting Out, Adolescent, Child Reactive Disorders, Female, Grief, Humans, Male, Stress, Psychological},
	author = {Bauer, W}
}
@article {546456,
	title = {The amino acid sequence of Neurospora NADP-specific glutamate dehydrogenase. Peptides from digestion with a staphylococcal proteinase},
	journal = {Biochem J},
	volume = {149},
	number = {3},
	year = {1975},
	month = {1975 Sep},
	pages = {749-55},
	abstract = {The extracellular proteinase of Staphylococcus aureus strain V8 was used to digest the NADP-specific glutamate dehydrogenase of Neurospora crassa. Of 35 non-overlapping peptides expected from the glutamate content of the polypeptide chain, 29 were isolated and substantially sequenced. The sequences obtained were valuable in providing overlaps for the alignment of about two-thirds of the sequences found in tryptic peptides [Wootton, J. C., Taylor, J, G., Jackson, A. A., Chambers, G. K. \& Fincham, J. R. S. (1975) Biochem. J. 149, 739-748]. The blocked N-terminal peptide of the protein was isolated. This peptide was sequenced by mass spectrometry, and found to have N-terminal N-acetylserine by Howard R. Morris and Anne Dell, whose results are presented as an Appendix to the main paper. The staphylococcal proteinase showed very high specificity for glutamyl bonds in the NH4HCO3 buffer used. Partial splits of two aspartyl bonds, both Asp-Ile, were probably attributable to the proteinase. No cleavage of glutaminyl or S-carboxymethylcysteinyl bonds was found. Additional experimental detail has been deposited as Supplementary Publication SUP 50053 (5 pages) with the British Library (Lending Division), Boston Spa, Wetherby, W. Yorkshire LS23 7BQ, U.K, from whom copies may be obtained under the terms given in Biochem. J. (1975) 1458 5.},
	keywords = {Amino Acid Sequence, Glutamate Dehydrogenase, NADP, Neurospora, Neurospora crassa, Peptide Fragments, Peptide Hydrolases, Staphylococcus aureus},
	issn = {0264-6021},
	author = {Wootton, J C and Baron, A J and Fincham, J R}
}
@article {573586,
	title = {Analytical studies on crotamine hydrochloride},
	journal = {Anal Biochem},
	volume = {69},
	number = {1},
	year = {1975},
	month = {1975 Nov},
	pages = {207-21},
	keywords = {Amino Acid Sequence, Amino Acids, Animals, Calorimetry, Hydrogen-Ion Concentration, Proteins, Snake Venoms, Tryptophan, Tyrosine},
	issn = {0003-2697},
	author = {Giglio, J R}
}
@article {573671,
	title = {The biochemical pathology of aspirin-induced gastric damage},
	journal = {Agents Actions},
	volume = {5},
	number = {4},
	year = {1975},
	month = {1975 Oct},
	pages = {326-44},
	keywords = {Age Factors, Alcohol Drinking, Animals, Anti-Inflammatory Agents, Ascorbic Acid Deficiency, Aspirin, Blood Group Antigens, Female, Food, Gastric Mucosa, Gastrointestinal Hemorrhage, Humans, Hydrogen-Ion Concentration, Male, Nutritional Physiological Phenomena, Particle Size, Permeability, Prostaglandins, Regional Blood Flow, Salicylates, Sex Factors, Stomach Diseases, Stomach Ulcer, Structure-Activity Relationship},
	issn = {0065-4299},
	author = {Rainsford, K D}
}
@article {573646,
	title = {[Biochemical studies on camomile components/III. In vitro studies about the antipeptic activity of (--)-alpha-bisabolol (author{\textquoteright}s transl)]},
	journal = {Arzneimittelforschung},
	volume = {25},
	number = {9},
	year = {1975},
	month = {1975 Sep},
	pages = {1352-4},
	abstract = {(--)-alpha-Bisabolol has a primary antipeptic action depending on dosage, which is not caused by an alteration of the pH-value. The proteolytic activity of pepsin is reduced by 50 percent through addition of bisabolol in the ratio of 1/0.5. The antipeptic action of bisabolol only occurs in case of direct contact. In case of a previous contact with the substrate, the inhibiting effect is lost.},
	keywords = {Dose-Response Relationship, Drug, Hemoglobins, Hydrogen-Ion Concentration, In Vitro Techniques, methods, Pepsin A, Plants, Medicinal, Sesquiterpenes, Spectrophotometry, Ultraviolet, Trichloroacetic Acid, Tyrosine},
	issn = {0004-4172},
	author = {Isaac, O and Thiemer, K}
}
@article {546436,
	title = {[Biphasic (ulcer-forming and ulcer-preventing) effect of adrenaline in rats]},
	journal = {Nihon Yakurigaku Zasshi},
	volume = {71},
	number = {5},
	year = {1975},
	month = {1975 Jul},
	pages = {405-14},
	abstract = {Adrenaline-induced gastric ulceration was studied in rats. Adrenaline in high doses caused gastric ulcer, which was completely blocked by pretreatment with alpha-blockers (phenoxybenzamine, dibenamine), but not by pretreatment with propranolol or atropine, nor by vagotomy, hypophysectomy or adrenalectomy. After successive administration of adrenaline, once daily for 7 days, however, no gastric ulcer was observed. Recovery from the ulcerogenic action of adrenaline was seen after 4 weeks withdrawal. Pretreatment with a small dose of adrenaline inhibited the ulcerogenic action of a high dose of adrenaline. Pretreatment with reserpine, pyrogallol or iproniazid inhibited the action of adrenaline. It is concluded that adrenaline has a biphasic effect on gastric ulceration, the ulcerogenic action is due to its alpha-action and antiulcerogenic effect is due to development of tachyphylaxis.},
	keywords = {Adrenalectomy, Adrenergic alpha-Antagonists, Adrenergic beta-Antagonists, Animals, Atropine, Catecholamines, Dose-Response Relationship, Drug, Epinephrine, Histamine H1 Antagonists, Hypophysectomy, Iproniazid, Male, Pyrogallol, Rats, Reserpine, Stomach Ulcer, Vagotomy},
	issn = {0015-5691},
	author = {Dozaki, T and K. Imai and Mizukami, S}
}
@article {546431,
	title = {Chromosomal basis of the merozygosity in a partially deploid mutant of Pneumococcus},
	journal = {Genetics},
	volume = {80},
	number = {4},
	year = {1975},
	month = {1975 Aug},
	pages = {667-78},
	abstract = {A sulfonamide-resistant mutant of pneumococcus, sulr-c, displays a genetic instability, regularly segregating to wild type. DNA extracts of derivatives of the strain possess transforming activities for both the mutant and wild-type alleles, establishing that the strain is a partial diploid. The linkage of sulr-c to strr-61, a stable chromosomal marker, was established, thus defining a chromosomal locus for sulr-c. DNA isolated from sulr-c cells transforms two mutant recipient strains at the same low efficiency as it does a wild-type recipient, although the mutant property of these strains makes them capable of integrating classical "low-efficiency" donor markers equally as efficiently as "high efficiency" markers. Hence sulr-c must have a different basis for its low efficiency than do classical low efficiency point mutations. We suggest that the DNA in the region of the sulr-c mutation has a structural abnormality which leads both to its frequent segregation during growth and its difficulty in efficiently mediating genetic transformation.},
	keywords = {Chromosome Mapping, Chromosomes, Bacterial, Crosses, Genetic, Diploidy, DNA Replication, Drug Resistance, Microbial, Genetic Linkage, Haploidy, Mutation, Streptococcus pneumoniae, Sulfonamides, Transformation, Genetic},
	issn = {0016-6731},
	author = {Ledbetter, M L and Hotchkiss, R D}
}
@article {573696,
	title = {Comparison between procaine and isocarboxazid metabolism in vitro by a liver microsomal amidase-esterase},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {16},
	year = {1975},
	month = {1975 Aug 15},
	pages = {1517-21},
	keywords = {Amidohydrolases, Animals, Esterases, Hydrogen-Ion Concentration, In Vitro Techniques, Isocarboxazid, Kinetics, Male, Metals, Microsomes, Liver, Phospholipids, Procaine, Proteins, Rats, Subcellular Fractions, Temperature},
	issn = {1873-2968},
	author = {Moroi, K and Sato, T.}
}
@article {573636,
	title = {A comparison of the substrate specificities of endo-beta-N-acetylglucosaminidases from Streptomyces griseus and Diplococcus Pneumoniae},
	journal = {Biochem Biophys Res Commun},
	volume = {67},
	number = {1},
	year = {1975},
	month = {1975 Nov 03},
	pages = {455-62},
	keywords = {Acetylglucosaminidase, Fucose, Hexosaminidases, Kinetics, Oligosaccharides, Species Specificity, Streptococcus pneumoniae, Streptomyces griseus, Structure-Activity Relationship},
	issn = {0006-291X},
	author = {Tarentino, A L and Maley, F}
}
@article {573611,
	title = {[Coronary heart disease and its differential treatment]},
	journal = {Med Welt},
	volume = {26},
	number = {43},
	year = {1975},
	month = {1975 Oct 24},
	pages = {1980-8},
	keywords = {Adrenergic beta-Antagonists, Aorta, Blood Pressure, Calcium, Coronary Disease, Digitalis Glycosides, Heart, Hematocrit, Hemodynamics, Humans, Nitro Compounds, Oxygen Consumption, Vasodilator Agents},
	issn = {0025-8512},
	author = {Diewitz, M}
}
@article {546426,
	title = {Coronary vascular and myocardial responses to carotid body stimulation in the dog},
	journal = {Am J Physiol},
	volume = {229},
	number = {3},
	year = {1975},
	month = {1975 Sep},
	pages = {754-60},
	abstract = {Coronary vascular and myocardial responses to selective hypoxic and/or hypercapnic carotid chemoreceptor stimulation were investigated in constantly ventilated, pentobarbital or urethan-chloralose anesthetized dogs. Bilaterally isolated carotid chemoreceptors were perfused with autologous blood of varying O2 and CO2 tensions via an extracorporeal lung circuit. Systemic gas tensions were unchanged. Effects of carotid chemoreceptor stimulation on coronary vascular resistance, left ventricular dP/dt, and strain-gauge arch output were studied at natural coronary blood flow with the chest closed and during constant-flow perfusion of the left common coronary artery with the chest open. Carotid chemoreceptor stimulation slightly increased left ventricular dP/dt and slightly decreased the strain-gauge arch output, while markedly increasing systemic pressure. Coronary blood flow increased; however, coronary vascular resistance wa.as not affected. These studies show that local carotid body stimulation increases coronary blood flow but has little effect on the myocardium. The increase in coronary blood flow results mainly from an increase in systemic arterial pressure. Thus these data provide little evidence for increased sympathetic activity of the heart during local stimulation of the carotid chemoreceptors with hypoxic and hypercapnic blood.},
	keywords = {Animals, Blood Pressure, Carbon Dioxide, Carotid Body, Carotid Sinus, Chemoreceptor Cells, Coronary Circulation, Dogs, Female, Heart, Heart Rate, Hydrogen-Ion Concentration, Male, Oxygen, Perfusion, Pressure, Vagotomy, Vascular Resistance, Ventricular Function},
	issn = {0002-9513},
	author = {Ehrhart, I C and Parker, P E and Weidner, W J and Dabney, J M and Scott, J B and Haddy, F J}
}
@article {546451,
	title = {Digitoxin metabolism by rat liver microsomes},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {17},
	year = {1975},
	month = {1975 Sep 01},
	pages = {1639-41},
	keywords = {Animals, Chromatography, Thin Layer, Digitoxigenin, Digitoxin, Hydroxylation, In Vitro Techniques, Male, Microsomes, Liver, NADP, Rats, Time Factors},
	issn = {1873-2968},
	author = {Schmoldt, A and Benthe, H F and Haberland, G}
}
@article {573686,
	title = {The effect of adrenaline and of alpha- and beta-adrenergic blocking agents on ATP concentration and on incorporation of 32Pi into ATP in rat fat cells},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {18},
	year = {1975},
	month = {1975 Sep 15},
	pages = {1659-62},
	keywords = {Adenosine Triphosphate, Adipose Tissue, Adrenergic alpha-Antagonists, Adrenergic beta-Antagonists, Animals, Epinephrine, Hexokinase, In Vitro Techniques, Luciferases, Male, Oxygen Consumption, Phenoxybenzamine, Phosphorus, Phosphorus Radioisotopes, Propranolol, Rats, Time Factors},
	issn = {0006-2952},
	author = {Stein, J M}
}
@article {573741,
	title = {Effect of chloroquine on cultured fibroblasts: release of lysosomal hydrolases and inhibition of their uptake},
	journal = {Biochem Biophys Res Commun},
	volume = {66},
	number = {4},
	year = {1975},
	month = {1975 Oct 27},
	pages = {1338-43},
	keywords = {Biological Transport, Cells, Cultured, Cerebroside-Sulfatase, Chloroquine, Dextrans, Fibroblasts, Glucuronidase, Humans, Leukodystrophy, Metachromatic, Lysosomes, Pinocytosis, Skin, Sulfatases},
	issn = {1090-2104},
	author = {Wiesmann, U N and DiDonato, S and Herschkowitz, N N}
}
@article {573641,
	title = {Effect of sodium nitrate loading on electrolyte transport by the renal tubule},
	journal = {Am J Physiol},
	volume = {229},
	number = {3},
	year = {1975},
	month = {1975 Sep},
	pages = {746-53},
	abstract = {Effects of sodium nitrate were compared with sodium chloride loading on transport of electrolytes by the nephron. Maximal levels of free water clearance/clomerular filtration rate (CH2O/GFR) averaged 8.4\% with nitrate loading and 14.4\% with saline loading. Since ethacrynic acid and chlorothiazide exert their major natriuretic effect in the distal nephron, the increment in Na ad Cl reabsorbed beyond the proximal tubule. The administration of these agents resulted in an increase in fractional sodium excretion (CNa/GFR) of 21.1\%, urinary sodium excretion (UNaV) of 1,126 mueq/min, and urinary chloride excretion (UClV) of 848 mueq/min during nitrate loading compared with an increase in CNa/GFR of 37.6\%, UNaV of 2,362 mueq/min, and UClV of 2,397 mueq/min during saline loading. The smaller diuretic-induced increment in Na and Cl excretion in the nitrate studies suggests, as do the hydrated studies, that less Cl and Na are reabsorbed in the distal nephron during nitrate than saline loading. At every level of UNaV, fractional bicarbonate reabsorption was higher, urine pH was lower, and urinary potassium excretion (UKV) was higher in the nitrate studies. Thus, compared with saline loading, sodium nitrate decreases chloride and sodium reabsorption in the distal nephron. The higher hydrogen and potassium secretion in the nitrate studies may be consequent to the decreased ability of the distal nephron to reabsorb chloride.},
	keywords = {Animals, Bicarbonates, Biological Transport, Chlorides, Chlorothiazide, Diuresis, Dogs, Electrolytes, Ethacrynic Acid, Glomerular Filtration Rate, Hydrogen-Ion Concentration, Kidney Tubules, Nitrates, Potassium, Sodium, Sodium Chloride, Urine},
	issn = {0002-9513},
	author = {Kahn, T and Bosch, J and Levitt, M F and Goldstein, M H}
}
@article {573621,
	title = {Effects of 5,6-dihydroxytryptamine on tyrosine-hydroxylase activity in central catecholaminergic neurons of the rat},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {18},
	year = {1975},
	month = {1975 Sep 15},
	pages = {1739-42},
	keywords = {5,6-Dihydroxytryptamine, Animals, Brain, Catecholamines, Cerebral Cortex, Cisterna Magna, Corpus Striatum, In Vitro Techniques, Injections, Male, Neurons, Rats, Rats, Inbred Strains, Stimulation, Chemical, Substantia Nigra, Time Factors, Tryptamines, Tyrosine 3-Monooxygenase},
	issn = {0006-2952},
	author = {Renaud, B and Buda, M and Lewis, B D and Pujol, J F}
}
@article {573701,
	title = {Effects of graded infusions of monomethylmethacrylate on coagulation, blood lipids, respiration and circulation. An experimental study in dogs},
	journal = {Clin Orthop Relat Res},
	number = {113},
	year = {1975},
	month = {1975 Nov-Dec},
	pages = {187-97},
	abstract = {In 4 dogs injected intravenously (i.v.) with 125I labeled fibrinogen, 51Cr labeled platelets and 99mTc labeled albumin, and subjected to successively increasing amounts of i.v. infused monomethylmethacrylate, doses corresponding to the amounts released into the blood stream following implantation of acrylic cement during total hip replacements did not affect the clotting mechanism, did not cause trapping of platelets and fibrin in the lungs, did not generate fat emboli, and did not cause depression of the arterial oxygen tension or blood pressure. Monomethylmethacrylate in whole blood was associated with both blood cells and plasma.},
	keywords = {Animals, Blood Coagulation, Blood Pressure, Bone Cements, Collateral Circulation, Dogs, Hydrogen-Ion Concentration, Infusions, Parenteral, Lipids, Lung, Methylmethacrylates, Respiration},
	issn = {0009-921X},
	author = {Modig, J and Busch, C and Waernbaum, G}
}
@article {573601,
	title = {The effects of processing of barley-based supplements on rumen pH, rate of digestion of voluntary intake of dried grass in sheep},
	journal = {Br J Nutr},
	volume = {34},
	number = {3},
	year = {1975},
	month = {1975 Nov},
	pages = {493-500},
	abstract = {1. In one experiment the effect on rumen pH of feeding with restricted amounts of whole or pelleted barley was studied. With whole barley there was little variation in rumen pH associated with feeding time, but with pelleted barley the pH decreased from about 7-0 before feeding to about 5-3, 2--3 h after feeding. 2. The rate of disappearance of dried grass during incubation in the rumens of sheep receiving either whole or pelleted barley was studied in a second experiment. After 24 h incubation only 423 mg/g incubated had disappeared in the rumen of sheep receiving pelleted barley while 625 mg/g incubated had disappeared when it was incubated in the rumen of sheep receiving whole barley. 3. The voluntary intake of dried grass of lambs was studied in a third experiment when they received supplements of either 25 or 50 g whole or pelleted barley/kg live weight 0-75. At the high level, pelleted barley reduced intake of dried grass by 534 g/kg but whole barley reduced it by only 352 g/kg. The digestibility of acid-detergent fibre was reduced more by pelleted barley than by whole barley but there was a tendency for a small increase in digestibility of the barley due to processing. 4. The implications of these findings on supplementation of roughages with cereals are discussed.},
	keywords = {Animal Feed, Animals, Digestion, Edible Grain, Gastric Juice, Hordeum, Hydrogen-Ion Concentration, Rumen, Sheep},
	issn = {0007-1145},
	author = {Orskov, E R and Fraser, C}
}
@article {573716,
	title = {Formate assay in body fluids: application in methanol poisoning},
	journal = {Biochem Med},
	volume = {13},
	number = {2},
	year = {1975},
	month = {1975 Jun},
	pages = {117-26},
	keywords = {Aldehyde Oxidoreductases, Animals, Body Fluids, Carbon Dioxide, Formates, Haplorhini, Humans, Hydrogen-Ion Concentration, Kinetics, Methanol, methods, Pseudomonas},
	issn = {0006-2944},
	author = {Makar, A B and McMartin, K E and Palese, M and Tephly, T R}
}
@article {573591,
	title = {Growth of Staphylococcus aureus, experimentally inoculated in Damietta cheese},
	journal = {Zentralbl Bakteriol Parasitenkd Infektionskr Hyg},
	volume = {130},
	number = {5},
	year = {1975},
	month = {1975},
	pages = {468-76},
	keywords = {Cell Count, Cheese, Food Microbiology, Hot Temperature, Hydrogen-Ion Concentration, Lactobacillus, Sodium Chloride, Staphylococcus aureus},
	issn = {0044-4057},
	author = {Helmy, Z A and Abd-el-Malek, Y and Mahmoud, A A}
}
@article {573661,
	title = {Inhibition of aldehyde reductase by acidic metabolites of the biogenic amines},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {18},
	year = {1975},
	month = {1975 Sep 15},
	pages = {1731-3},
	keywords = {Aldehyde Oxidoreductases, Animals, Biogenic Amines, Brain, Homovanillic Acid, In Vitro Techniques, Kinetics, NADP, Pyrimidines, Sheep},
	issn = {0006-2952},
	author = {Turner, A J and Hick, P E}
}
@article {546471,
	title = {Inhibition of aldehyde reductase isoenzymes in human and rat brain},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {20},
	year = {1975},
	month = {1975 Oct 15},
	pages = {1865-9},
	keywords = {Aldehyde Oxidoreductases, Animals, Anticonvulsants, Barbiturates, Brain, Glutethimide, Humans, Hydantoins, In Vitro Techniques, Isoenzymes, Kinetics, NAD, NADP, Rats, Succinimides},
	issn = {0006-2952},
	author = {Ris, M M and Deitrich, R A and Von Wartburg, J P}
}
@article {573666,
	title = {Malathion A and B esterases of mouse liver-I},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {18},
	year = {1975},
	month = {1975 Sep 15},
	pages = {1713-7},
	keywords = {Animals, Drug Stability, Esterases, Female, Hydrogen-Ion Concentration, Liver, Malathion, Male, Metals, Mice, Sex Factors, Sulfhydryl Compounds},
	issn = {0006-2952},
	author = {Bhagwat, V M and Ramachandran, B V}
}
@article {573631,
	title = {Maturation of the adrenal medulla--IV. Effects of morphine},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {16},
	year = {1975},
	month = {1975 Aug 15},
	pages = {1469-74},
	keywords = {Adrenal Medulla, Aging, Animals, Animals, Newborn, Body Weight, Catecholamines, Dopamine beta-Hydroxylase, Epinephrine, Female, Humans, In Vitro Techniques, Maternal-Fetal Exchange, Metaraminol, Morphine, Morphine Dependence, Pregnancy, Rats, Tyrosine 3-Monooxygenase},
	issn = {1873-2968},
	author = {Anderson, T R and Slotkin, T A}
}
@article {546446,
	title = {Metal substitutions incarbonic anhydrase: a halide ion probe study},
	journal = {Biochem Biophys Res Commun},
	volume = {66},
	number = {4},
	year = {1975},
	month = {1975 Oct 27},
	pages = {1281-6},
	keywords = {Animals, Binding Sites, Cadmium, Carbonic Anhydrases, Cattle, Humans, Hydrogen-Ion Concentration, Magnetic Resonance Spectroscopy, Mercury, Protein Binding, Protein Conformation, Zinc},
	issn = {0006-291X},
	author = {Smith, R J and Bryant, R G}
}
@article {573581,
	title = {Modifications of citrate and isocitrate metabolism in liver mitochondria of ethanol-fed rats},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {22},
	year = {1975},
	month = {1975 Nov 15},
	pages = {2061-8},
	keywords = {Aconitate Hydratase, Animals, Biological Transport, Citrates, Diet, Ethanol, Fatty Liver, In Vitro Techniques, Isocitrate Dehydrogenase, Isocitrates, Liver, Magnesium, Malates, Male, Mitochondria, Liver, NAD, NADP, Oxygen Consumption, Rats},
	issn = {0006-2952},
	author = {Lostanlen, D and Oudea, M C and Godard-Launay, A N and Oudea, P}
}
@article {573706,
	title = {Monoanion inhibition and 35Cl nuclear magnetic resonance studies of renal dipeptidase},
	journal = {Biochemistry},
	volume = {14},
	number = {24},
	year = {1975},
	month = {1975 Dec 02},
	pages = {5280-5},
	abstract = {Kinetic analyses of monoanion inhibition and 15Cl nuclear magnetic resonance at 5.88 MHz were employed to study monoanion interactions with the zinc metalloenzyme, renal dipeptidase. The enzyme-catalyzed hydrolysis of glycyldehydrophenylalanine exhibited competitive inhibition when the reaction rate was determined in the presence of the monovalent anions fluoride, chloride, bromide, iodide, azide, nitrate, or thiocyanate or upon the addition of the divalent anion, sulfate. Competitive inhibition was produced by these anions. One anion was bound per enzyme molecule, and except in the case of fluoride all of the anions appeared to bind at the same site. Cyanide ion produced a much more effective inhibition of renal dipeptidase than the other monoanions, and it was shown that two cyanide ions were bound per enzyme molecule. An investigation of the effect of pH upon monoanion inhibition suggested that the anion inhibitors bind to the group with a pK of approximately 7.8. Complete dissociation of this group (approximately pH 8.4) eliminates the inhibitory effect of anions. The 35Cl line broadening produced by renal dipeptidase in 0.5 M NaCl solutions was 100 times more effective than that produced by equivalent concentrations of aquozinc(II). The line broadening was dependent upon the concentration of the metalloenzyme and independent of the frequency of the exciting radiation. When zinc ion was removed from the metalloenzyme by dialysis or when chloride was titrated from the metalloenzyme by cyanide, line broadening was decreased. Treatment of renal dipeptidase with saturating concentrations of the competitive inhibitor, guanosine triphosphate, in the presence of 0.5 M NaCl also produced a significant decrease in the 35Cl line width. The 35Cl line broadening produced by renal dipeptidase was shown to decrease with increasing pH through the range pH 5.8-10.8. This line-width variation with pH appeared to result from the titration of a site on the metalloprotein with an approximate pK of 7.4. Temperature studies of 35Cl line broadening by the metalloenzyme in the presence of chloride and cyanide inhibitors suggest that the fast exchange process pertains and that the dominant relaxation mechanism is quadrupolar in nature.},
	keywords = {Animals, Anions, Azides, Bromides, Chlorides, Cyanides, Dipeptidases, Fluorides, Hydrogen-Ion Concentration, Iodides, Kidney Cortex, Kinetics, Magnetic Resonance Spectroscopy, Mathematics, Nitrates, Protein Conformation, Sulfates, Swine, Temperature, Thiocyanates},
	issn = {0006-2960},
	author = {Ferren, L G and Ward, R L and Campbell, B J}
}
@article {573711,
	title = {Phospholipase A2 as a probe of phospholipid distribution in erythrocyte membranes. Factors influencing the apparent specificity of the reaction},
	journal = {Biochemistry},
	volume = {14},
	number = {25},
	year = {1975},
	month = {1975 Dec 16},
	pages = {5400-8},
	abstract = {The action of snake venom phospholipases A2 in intact human erythrocytes was investigated in detail. The basis phospholipase from Agkistrodon halys blomhifii was found to induce both hydrolysis of membrane phospholipids and total cell hemolysis under certain experimental conditions. The hydrolytic action of the basic enzyme was found to consist of two sequential events: (a) hydrolysis of 70\% of the total cell ph osphatidylcholine without any evident hemolysis; and (b) complete hydrolysis of the remaining phosphatidylcholine, followed closely by extensive phosphatidylethanolamine hydrolysis and finally with onset of hemolysis, attack on the phosphatidylserine. At pH 7.4 and 10 mM Ca2+ only stage (a) occurred. However, a slight elevation of the pH of incubation to pH 8.0 and/or inclusion of 40 mM Ca2+ in the reaction mixture caused both events (a) and (b) to occur. The addition of glucose limited the action of the enzyme to stage (a) under any reaction conditions. An investigation showed that enzymically induced hemolysis occurred under conditions where the intracellular ATP levels were lowered. Data are presented which suggest that stage (b) is mediated by in influx of Ca2+ into the cell when the levels of ATP are low. Interestingly the phosphllipase from Naja naja venom (Pakistan) yielded results similar to those observed with the basic enzyme from Agkistrodon venom. However, the enzyme from Crotalus adamanteus and the acidic enzyme also present in the Agkistrodon venom produced only slight hydrolysis or hemolysis under any of the conditions studied. Other species of erythrocytes, e.g., guinea pig, monkey, pig, and rat, were tested but only those from guinea pig behaved similarly to the human cells. Pig, monkey, and rat erythrocytes underwent very limited hydrolysis and hemolysis. It is evident that the use of these phospholipases to probe the localization of phospholipds in erythrocyte membranes must be approached with caution. Certain facets of this problem are discussed.},
	keywords = {Adenosine Triphosphate, Animals, Calcium, Cell Membrane, Citrates, Erythrocyte Aging, Erythrocytes, Glucose, Guinea Pigs, Haplorhini, Hemolysis, Humans, Hydrogen-Ion Concentration, Magnesium, Phosphatidylcholines, Phospholipases, Phospholipids, Potassium, Rats, Snake Venoms, Swine, Time Factors},
	issn = {0006-2960},
	author = {J. K. Martin and Luthra, M G and Wells, M A and Watts, R P and Hanahan, D J}
}
@article {573651,
	title = {Precipitation of phase I antigen of Coxiella burnetii by sodium sulfite},
	journal = {Acta Virol},
	volume = {19},
	number = {6},
	year = {1975},
	month = {1975 Nov},
	pages = {500},
	keywords = {Animals, Antibodies, Bacterial, Antibody Formation, Antigens, Bacterial, Bacterial Vaccines, Chemical Precipitation, Complement Fixation Tests, Coxiella, Edetic Acid, Guinea Pigs, Q Fever, Solubility, Sulfites, Trichloroacetic Acid},
	issn = {0001-723X},
	author = {Wachter, R F and Briggs, G P and Pedersen, C E}
}
@article {573691,
	title = {Preparation and characterization of an enzymatically active immobilized derivative of myosin},
	journal = {Biochim Biophys Acta},
	volume = {410},
	number = {1},
	year = {1975},
	month = {1975 Nov 20},
	pages = {178-92},
	abstract = {Purified skeletal muscle myosin (EC 3.6.1.3) has been covalently bound to Sepharose 4B by the cyanogen bromide procedure. The resulting complex, Sepharose-Myosin, possesses adenosine triphosphatase activity and is relatively stable for long periods of time. Under optimal binding conditions, approximately 33\% of the specific ATPase activity of the bound myosin is retained. Polyacrylamide gel electrophoresis of polypeptides released from denatured Sepharose-Myosin indicates that 85\% of the myosin is attached to the agarose beads through the heavy chains and the remainder through the light chains, in agreement with predictions of binding and release based upon either the lysine contents or molecular weights of themyosin subunits. The adenosine triphosphatase of the immobilized myosin has been investigated under conditions of varying pH, ionic strength, and cation concentration. The ATPase profiles of immobilized myosin are quite similar to those for free myosin, however subtle differences are found. The Sepharose-Myosin ATPase is not as sensitive as myosin to alterations in salt concentration and the apparent KM is approximately two-fold higher than that of myosin. These differences are probably due to chemical modification in the region of the attachment site(s) to the agarose beads and hydration and diffusion limitations imposed by the polymeric agarose matrix.},
	keywords = {Actins, Adenosine Triphosphatases, Animals, Calcium, Chickens, Chromatography, Affinity, Edetic Acid, Enzyme Activation, Female, Hydrogen-Ion Concentration, Molecular Weight, Muscles, Myosins, Osmolar Concentration, Potassium Chloride, Protein Binding, Sepharose},
	issn = {0006-3002},
	author = {Elgart, E S and Gusovsky, T and Rosenberg, M D}
}
@article {573616,
	title = {[Pulmonary involvement in collagen diseases]},
	journal = {Med Klin},
	volume = {70},
	number = {45},
	year = {1975},
	month = {1975 Nov 07},
	pages = {1801-14},
	keywords = {Adolescent, Anti-Glomerular Basement Membrane Disease, Arthritis, Rheumatoid, Collagen Diseases, Dermatomyositis, Female, Granulomatosis with Polyangiitis, Humans, Lung Diseases, Lupus Erythematosus, Systemic, Male, Middle Aged, Pleural Diseases, Polyarteritis Nodosa, Polymyalgia Rheumatica, Pulmonary Fibrosis, Radiography, Scleroderma, Systemic, Sjogren{\textquoteright}s Syndrome},
	issn = {0025-8458},
	author = {Siegenthaler, W and Leutenegger, H and Siegenethaler, G and Medici, T}
}
@article {573606,
	title = {Radiochemical assay of glutathione S-epoxide transferase and its enhancement by phenobarbital in rat liver in vivo},
	journal = {Biochem Pharmacol},
	volume = {24},
	number = {17},
	year = {1975},
	month = {1975 Sep 01},
	pages = {1569-72},
	keywords = {Animals, Carrier Proteins, Epoxy Compounds, Glutathione, Glutathione Transferase, Hydrogen-Ion Concentration, Liver, Male, Methylcholanthrene, Phenobarbital, Rats, Stimulation, Chemical, Styrenes},
	issn = {0006-2952},
	author = {Marniemi, J and Parkki, M G}
}
@article {573681,
	title = {Specificity studies on alpha-mannosidases using oligosaccharides from mannosidosis urine as substrates},
	journal = {Biochim Biophys Acta},
	volume = {410},
	number = {1},
	year = {1975},
	month = {1975 Nov 20},
	pages = {156-63},
	abstract = {Oligosaccharides containing terminal non-reducing alpha(1 leads to 2)-, alpha(1 leads to 3)-, and alpha(1 leads to 6)-linked mannose residues, isolated from human and bovine mannosidosis urines were used as substrates to test the specificities of acidic alpha-mannosidases isolated from human and bovine liver. The enzymes released all the alpha-linked mannose residues from each oligosaccharide and were most effective on the smallest substrate. Enzyme A in each case was less active on the oligosaccharides than alpha-mannosidase B2, even though the apparent Km value for the substrates was the same with each enzyme. The human acidic alpha-mannosidases were also found to be more active on substrates isolated from human rather than bovine mannosidosis urine. Human alpha-mannosidase C, which has a neutral pH optimum when assayed with a synthetic substrate, did not hydrolyse any of the oligosaccharides at neutral pH, but was found to be active at an acidic pH.},
	keywords = {Animals, Carbohydrate Metabolism, Inborn Errors, Cattle, Disaccharidases, Humans, Hydrogen-Ion Concentration, Kinetics, Liver, Mannose, Mannosidases, Oligosaccharides, Species Specificity},
	issn = {0006-3002},
	author = {Hultberg, B and Lundblad, A and Masson, P K and Ockerman, P A}
}
@article {573736,
	title = {Studies of oxygen binding energy to hemoglobin molecule},
	journal = {Biochem Biophys Res Commun},
	volume = {66},
	number = {4},
	year = {1975},
	month = {1975 Oct 27},
	pages = {1424-31},
	keywords = {Binding Sites, cobalt, Hemoglobins, Humans, Hydrogen-Ion Concentration, Iron, Ligands, Mathematics, Oxygen, Oxyhemoglobins, Protein Binding, Spectrum Analysis},
	issn = {0006-291X},
	author = {Chow, Y W and Pietranico, R and Mukerji, A}
}
@article {573596,
	title = {A study of parasites in domestic pests in households of patients with tropical pulmonary eosinophilia},
	journal = {Indian J Chest Dis},
	volume = {17},
	number = {3},
	year = {1975},
	month = {1975 Jul},
	pages = {119-23},
	keywords = {Animals, Culicidae, Eosinophilia, Humans, insects, Lung Diseases, Wuchereria, Wuchereria bancrofti},
	issn = {0019-5111},
	author = {Saran, R and Kishore, K and Viswanathan, R}
}
@article {573656,
	title = {Use of the latent image technique to develop and evaluate problem-solving skills},
	journal = {Am J Med Technol},
	volume = {41},
	number = {12},
	year = {1975},
	month = {1975 Dec},
	pages = {457-62},
	abstract = {This project involved designing, developing and evaluating a simulation module, utilizing the latent image technique. The general topic chosen for this simulation was the laboratory characterization of anemias. Target learner populations included medical technology students, physician assistant students, and pathology residents. Members of all three groups participated in the evaluation of the module and responded to its use in varied settings.},
	keywords = {Anemia, Hematuria, Humans, Iowa, Medical Laboratory Science, Models, Psychological, Physician Assistants, Problem Solving, Teaching, Teaching Materials},
	issn = {0002-9335},
	author = {Schwabbauer, M L}
}
