Publications

2020
Xi Li, Harlan M Krumholz, Winnie Yip, Kar Keung Cheng, Jan De Maeseneer, Qingyue Meng, Elias Mossialos, Chuang Li, Jiapeng Lu, Meng Su, Qiuli Zhang, Dong Roman Xu, Liming Li, Sharon-Lise T Normand, Richard Peto, Jing Li, Zengwu Wang, Hongbing Yan, Runlin Gao, Somsak Chunharas, Xin Gao, Raniero Guerra, Huijie Ji, Yang Ke, Zhigang Pan, Xianping Wu, Shuiyuan Xiao, Xinying Xie, Yujuan Zhang, Jun Zhu, Shanzhu Zhu, and Shengshou Hu. 2020. “Quality of primary health care in China: challenges and recommendations.” Lancet, 395, 10239, Pp. 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.
Sharon-Lise T Normand. 2020. “The RECOVERY Platform.” N Engl J Med.
Makoto Mori, David M Shahian, Chenxi Huang, Shu-Xia Li, Sharon-Lise T Normand, Arnar Geirsson, and Harlan M Krumholz. 2020. “Surgeons: Buyer beware-does "universal" risk prediction model apply to patients universally?” J Thorac Cardiovasc Surg, 160, 1, Pp. 176-179.e2.
Mariana F Lobo, Vanessa Azzone, Fernando Lopes, Alberto Freitas, Altamiro Costa-Pereira, Sharon-Lise Normand, and Armando Teixeira-Pinto. 2020. “Understanding the large heterogeneity in hospital readmissions and mortality for acute myocardial infarction.” Health Policy, 124, 7, Pp. 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.
2019
Sarah C Anoke, Sharon-Lise Normand, and Corwin M Zigler. 2019. “Approaches to treatment effect heterogeneity in the presence of confounding.” Stat Med, 38, 15, Pp. 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.
Pu Shang, Gordon G Liu, Xin Zheng, Michael P Ho, Shuang Hu, Jing Li, Zihan Jiang, Xi Li, Xueke Bai, Yan Gao, Chao Xing, Yun Wang, Sharon-Lise Normand, and Harlan M Krumholz. 2019. “Association Between Medication Adherence and 1-Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China.” J Am Heart Assoc, 8, 9, Pp. 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±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'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.
Harlan M Krumholz, Yongfei Wang, Kun Wang, Zhenqiu Lin, Susannah M Bernheim, Xiao Xu, Nihar R Desai, and Sharon-Lise T Normand. 2019. “Association of Hospital Payment Profiles With Variation in 30-Day Medicare Cost for Inpatients With Heart Failure or Pneumonia.” JAMA Netw Open, 2, 11, Pp. 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'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 < .001) lower for heart failure and $2907 (95% CI, $1760-$4054; P < .001) lower for pneumonia than at the highest-payment hospitals. More than half of the difference was associated with the payment during the index hospitalization ($1425 [95% CI, $695-$2154; P < .001] for heart failure and $1659 [95% CI, $731-$2588; P < .001] for pneumonia). Conclusions and Relevance: This study found that the same Medicare beneficiaries who were admitted with the same diagnosis to hospitals with the highest payment profiles incurred higher costs than when they were admitted to hospitals with the lowest payment profiles. The findings suggest that variations in payments to hospitals are, at least in part, associated with the hospitals independently of non-time-varying patient characteristics.
Jacob Spertus, Marcela Horvitz-Lennon, and Sharon-Lise T Normand. 2019. “Bayesian Meta-analysis of Multiple Continuous Treatments with Individual Participant-Level Data: An Application to Antipsychotic Drugs.” Med Decis Making, 39, 5, Pp. 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 × 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.
Matthew J Brennan, Lisa Wruck, Michael J Pencina, Robert M Clare, Renato D Lopes, John H Alexander, Sean O'Brien, Mitchell Krucoff, Sunil V Rao, Tracy Y Wang, Lesley H Curtis, Kristin L Newby, Christopher B Granger, Manesh Patel, Kenneth Mahaffey, Joseph S Ross, Sharon-Lise Normand, Benjamin C Eloff, Daniel A Caños, Yuliya V Lokhnygina, Matthew T Roe, Robert M Califf, Danica Marinac-Dabic, and Eric D Peterson. 2019. “Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.” Am Heart J, 218, Pp. 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.
Harlan M Krumholz, Andreas C Coppi, Frederick Warner, Elizabeth W Triche, Shu-Xia Li, Shiwani Mahajan, Yixin Li, Susannah M Bernheim, Jacqueline Grady, Karen Dorsey, Zhenqiu Lin, and Sharon-Lise T Normand. 2019. “Comparative Effectiveness of New Approaches to Improve Mortality Risk Models From Medicare Claims Data.” JAMA Netw Open, 2, 7, Pp. 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.
Arjun Majithia, Michael E Matheny, Jessica K Paulus, Danica Marinac-Dabic, Susan Robbins, Henry Ssemaganda, Kathleen Hewitt, Angelo Ponirakis, Nilsa Loyo-Berrios, Issam Moussa, Joseph Drozda, Sharon-Lise Normand, and Frederic S Resnic. 2019. “Comparative Safety of Aspiration Thrombectomy Catheters Utilizing Prospective, Active Surveillance of the NCDR CathPCI Registry.” Circ Cardiovasc Qual Outcomes, 12, 2, Pp. 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.
Harlan M Krumholz, Frederick Warner, Andreas Coppi, Elizabeth W Triche, Shu-Xia Li, Shiwani Mahajan, Yixin Li, Susannah M Bernheim, Jacqueline Grady, Karen Dorsey, Nihar R Desai, Zhenqiu Lin, and Sharon-Lise T Normand. 2019. “Development and Testing of Improved Models to Predict Payment Using Centers for Medicare & Medicaid Services Claims Data.” JAMA Netw Open, 2, 8, Pp. 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' 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.
David M Charytan, Katya Zelevinksy, Robert Wolf, and Sharon-Lise Normand. 2019. “Identification of ESRD in Cardiovascular Procedural Databases.” Kidney Int Rep, 4, 10, Pp. 1477-1482.
David M Shahian, David F Torchiana, Daniel T Engelman, Thoralf M Sundt, Richard S D'Agostino, Ann F Lovett, Matthew J Cioffi, James D Rawn, Vladimir Birjiniuk, Robert H Habib, and Sharon-Lise T Normand. 2019. “Mandatory public reporting of cardiac surgery outcomes: The 2003 to 2014 Massachusetts experience.” J Thorac Cardiovasc Surg, 158, 1, Pp. 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 < .001) and no different during 2008 to 2014 (P = .135). Adjusting for STS predicted risk of operative [in-hospital + 30-day] mortality, Massachusetts patients had significantly lower odds (odds ratio, 0.79; 99% confidence interval, 0.66-0.96) of 30-day mortality relative to national data. Outlier programs experienced inconsistent, transient influences on expected mortality and their percentage shares of Massachusetts coronary artery bypass graft cases. CONCLUSIONS: During 12 years of mandatory public reporting, Massachusetts risk-standardized coronary artery bypass graft mortality was consistently and significantly lower than national rates, expected rates were comparable or higher, and evidence for risk aversion was conflicting and inconclusive.
David Harrington, Ralph B D'Agostino, Constantine Gatsonis, Joseph W Hogan, David J Hunter, Sharon-Lise T Normand, Jeffrey M Drazen, and Mary Beth Hamel. 2019. “New Guidelines for Statistical Reporting in the .” N Engl J Med, 381, 3, Pp. 285-286.
Jennifer Cai Gillis, Shun-Chiao Chang, Wei Wang, Naomi M Simon, Sharon-Lise Normand, Bernard A Rosner, Deborah Blacker, Immaculata de Vivo, and Olivia I Okereke. 2019. “The relation of telomere length at midlife to subsequent 20-year depression trajectories among women.” Depress Anxiety, 36, 6, Pp. 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' 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.
Maritta Välimäki, Min Yang, Tero Vahlberg, Tella Lantta, Virve Pekurinen, Minna Anttila, and Sharon-Lise Normand. 2019. “Trends in the use of coercive measures in Finnish psychiatric hospitals: a register analysis of the past two decades.” BMC Psychiatry, 19, 1, Pp. 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.
Harlan M Krumholz, Sharon-Lise T Normand, and Yun Wang. 2019. “Twenty-Year Trends in Outcomes for Older Adults With Acute Myocardial Infarction in the United States.” JAMA Netw Open, 2, 3, Pp. 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.
2018
Paula A Rochon, Andrea Gruneir, Chaim M Bell, Rachel Savage, Sudeep S Gill, Wei Wu, Vasily Giannakeas, Nathan M Stall, Dallas P Seitz, Sharon-Lise T Normand, Lynn Zhu, Nathan Herrmann, Lisa McCarthy, Colin Faulkner, Jerry H Gurwitz, Peter C Austin, and Susan E Bronskill. 10/23/2018. “Comparison of prescribing practices for older adults treated by female versus male physicians: A retrospective cohort study.” PLoS ONE, 13, 10. Publisher's Version
Yun Wang, Jing Li, Xin Zheng, Zihan Jiang, Shuang Hu, Rishi K. Wadhera, Xueke Bai, Jiapeng Lu, Qianying Wang, Yetong Li, Chaoqun Wu, Chao Xing, Sharon-Lise T. Normand, Harlan M. Krumholz, and Lixin Jiang. 8/10/2018. “Risk Factors Associated With Major Cardiovascular Events 1 Year After Acute Myocardial Infarction.” JAMA Network Open, 1, 4, Pp. e181079. Publisher's Version

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