Publications

2014
David M Shahian, Xiu Liu, Gregg S Meyer, and Sharon-Lise T Normand. 2014. “Comparing teaching versus nonteaching hospitals: the association of patient characteristics with teaching intensity for three common medical conditions.” Acad Med, 89, 1, Pp. 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'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.
Theresa S Betancourt, Frances Yang, Paul Bolton, and Sharon-Lise Normand. 2014. “Developing an African youth psychosocial assessment: an application of item response theory.” Int J Methods Psychiatr Res, 23, 2, Pp. 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'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'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.
Marcela Horvitz-Lennon, Rita Volya, Julie M Donohue, Judith R Lave, Bradley D Stein, and Sharon-Lise T Normand. 2014. “Disparities in quality of care among publicly insured adults with schizophrenia in four large U.S. states, 2002-2008.” Health Serv Res, 49, 4, Pp. 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.
Michelle A Albert, John Z Ayanian, Treacy S Silbaugh, Ann Lovett, Fred Resnic, Aryana Jacobs, and Sharon-Lise T Normand. 2014. “Early results of Massachusetts healthcare reform on racial, ethnic, and socioeconomic disparities in cardiovascular care.” Circulation, 129, 24, Pp. 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.
Alexis Matteau, Robert W Yeh, Dean Kereiakes, John E Orav, Joseph Massaro, Gabriel P Steg, Sharon-Lise Normand, Donald E Cutlip, and Laura Mauri. 2014. “Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study).” Am J Cardiol, 113, 7, Pp. 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.
David M Shahian, Xiu Liu, Gregg S Meyer, David F Torchiana, and Sharon-Lise T Normand. 2014. “Hospital teaching intensity and mortality for acute myocardial infarction, heart failure, and pneumonia.” Med Care, 52, 1, Pp. 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.
Robert W Yeh, Samip Vasaiwala, Daniel E Forman, Treacy S Silbaugh, Katya Zelevinski, Ann Lovett, Sharon-Lise T Normand, and Laura Mauri. 2014. “Instrumental variable analysis to compare effectiveness of stents in the extremely elderly.” Circ Cardiovasc Qual Outcomes, 7, 1, Pp. 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<0.001), an implausible finding compared with randomized trial results. Using instrumental variable analysis, DES were associated with no difference in 1-year mortality (risk difference, -0.8%; P=0.76) or bleeding (risk difference, 2.3%; P=0.33) and with significant reduction in target vessel revascularization (risk difference, -8.3%; P<0.0001). CONCLUSIONS: Using an instrumental variable analysis, DES were associated with similar mortality and bleeding and a significant reduction in target vessel revascularization compared with bare metal stents in the extremely elderly. Variation in use rates may be useful as an instrumental variable to facilitate comparative effectiveness in groups underrepresented in randomized trials.
Daniel B Kramer, Kevin F Kennedy, John A Spertus, Sharon-Lise Normand, Peter A Noseworthy, Alfred E Buxton, Mark E Josephson, Peter J Zimetbaum, Susan L Mitchell, and Matthew R Reynolds. 2014. “Mortality risk following replacement implantable cardioverter-defibrillator implantation at end of battery life: results from the NCDR.” Heart Rhythm, 11, 2, Pp. 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 ± 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.
Xiao Xu, Shu-Xia Li, Haiqun Lin, Sharon-Lise T Normand, Nancy Kim, Lesli S Ott, Tara Lagu, Michael Duan, Eugene A Kroch, and Harlan M Krumholz. 2014. “"Phenotyping" hospital value of care for patients with heart failure.” Health Serv Res, 49, 6, Pp. 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.
Jing Li, Kumar Dharmarajan, Xi Li, Zhenqiu Lin, Sharon-Lise T Normand, Harlan M Krumholz, and Lixin Jiang. 2014. “Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention.” BMJ Open, 4, 3, Pp. 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).
John A Bittl, Yulei He, Alice K Jacobs, Clyde W Yancy, and Sharon-Lise T Normand. 2014. “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".” Circulation, 129, 4, Pp. e309.
José Augusto Barreto-Filho, Yongfei Wang, Saif S Rathore, Erica S Spatz, Joseph S Ross, Jeptha P Curtis, Brahmajee K Nallamothu, Sharon-Lise T Normand, and Harlan M Krumholz. 2014. “Transfer rates from nonprocedure hospitals after initial admission and outcomes among elderly patients with acute myocardial infarction.” JAMA Intern Med, 174, 2, Pp. 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 < .001), percutaneous coronary intervention (P < .001), and coronary artery bypass graft surgery (P < .001). Median length of stay was not meaningfully different across the groups. There was no meaningful evidence of associations between transfer rates and risk-standardized mortality at 30 days (mean [SD], 22.3% [2.6%], 22.1% [2.3%], 22.3% [2.4%], and 21.7% [2.1%], respectively; P = .054) or 1 year (43.9% [2.3%], 43.6% [2.2%], 43.5% [2.4%], and 42.8% [2.2%], respectively; P < .001) for low, mid-low, mid-high, and high transfer groups. CONCLUSIONS AND RELEVANCE: Nonprocedure hospitals vary substantially in their use of the transfer process for elderly patients admitted with acute myocardial infarction. High-transfer hospitals had greater use of invasive cardiac procedures after admission compared with low-transfer hospitals. However, higher transfer rates were not associated with a significantly lower risk-standardized mortality rate at 30 days. Moreover, at 1 year there was only a 1.1% difference (42.8% vs 43.9%) between hospitals with higher and lower transfer rates. These findings suggest that, as a single intervention, promoting the transfer of patients admitted with acute myocardial infarction may not improve hospital outcomes.
Harlan M Krumholz, Sharon-Lise T Normand, and Yun Wang. 2014. “Trends in hospitalizations and outcomes for acute cardiovascular disease and stroke, 1999-2011.” Circulation, 130, 12, Pp. 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.
Laura Mauri, Dean J Kereiakes, Robert W Yeh, Priscilla Driscoll-Shempp, Donald E Cutlip, Gabriel P Steg, Sharon-Lise T Normand, Eugene Braunwald, Stephen D Wiviott, David J Cohen, David R Holmes, Mitchell W Krucoff, James Hermiller, Harold L Dauerman, Daniel I Simon, David E Kandzari, Kirk N Garratt, David P Lee, Thomas K Pow, Peter Ver Lee, Michael J Rinaldi, and Joseph M Massaro. 2014. “Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.” N Engl J Med, 371, 23, Pp. 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<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%; hazard ratio, 0.71 [95% CI, 0.59 to 0.85]; P<0.001). The rate of myocardial infarction was lower with thienopyridine treatment than with placebo (2.1% vs. 4.1%; hazard ratio, 0.47; P<0.001). The rate of death from any cause was 2.0% in the group that continued thienopyridine therapy and 1.5% in the placebo group (hazard ratio, 1.36 [95% CI, 1.00 to 1.85]; P=0.05). The rate of moderate or severe bleeding was increased with continued thienopyridine treatment (2.5% vs. 1.6%, P=0.001). An elevated risk of stent thrombosis and myocardial infarction was observed in both groups during the 3 months after discontinuation of thienopyridine treatment. CONCLUSIONS: Dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but was associated with an increased risk of bleeding. (Funded by a consortium of eight device and drug manufacturers and others; DAPT ClinicalTrials.gov number, NCT00977938.).
2013
Alice K Jacobs, Frederick G Kushner, Steven M Ettinger, Robert A Guyton, Jeffrey L Anderson, Magnus E Ohman, Nancy M Albert, Elliott M Antman, Donna K Arnett, Marnie Bertolet, Deepak L Bhatt, Ralph G Brindis, Mark A Creager, David L DeMets, Kay Dickersin, Gregg C Fonarow, Raymond J Gibbons, Jonathan L Halperin, Judith S Hochman, Marguerite A Koster, Sharon-Lise T Normand, Eduardo Ortiz, Eric D Peterson, William H Roach, Ralph L Sacco, Sidney C Smith, William G Stevenson, Gordon F Tomaselli, Clyde W Yancy, William A Zoghbi, John G Harold, Yulei He, Pamela B Mangu, Amir Qaseem, Michael R Sayre, and Mark R Somerfield. 2013. “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.” J Am Coll Cardiol, 61, 2, Pp. 213-65.
Alice K Jacobs, Frederick G Kushner, Steven M Ettinger, Robert A Guyton, Jeffrey L Anderson, Magnus E Ohman, Nancy M Albert, Elliott M Antman, Donna K Arnett, Marnie Bertolet, Deepak L Bhatt, Ralph G Brindis, Mark A Creager, David L DeMets, Kay Dickersin, Gregg C Fonarow, Raymond J Gibbons, Jonathan L Halperin, Judith S Hochman, Marguerite A Koster, Sharon-Lise T Normand, Eduardo Ortiz, Eric D Peterson, William H Roach, Ralph L Sacco, Sidney C Smith, William G Stevenson, Gordon F Tomaselli, Clyde W Yancy, and William A Zoghbi. 2013. “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.” Circulation, 127, 2, Pp. 268-310.
Pamela N Peterson, Paul D Varosy, Paul A Heidenreich, Yongfei Wang, Thomas A Dewland, Jeptha P Curtis, Alan S Go, Robert T Greenlee, David J Magid, Sharon-Lise T Normand, and Frederick A Masoudi. 2013. “Association of single- vs dual-chamber ICDs with mortality, readmissions, and complications among patients receiving an ICD for primary prevention.” JAMA, 309, 19, Pp. 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'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.
John A Bittl, Yulei He, Alice K Jacobs, Clyde W Yancy, and Sharon-Lise T Normand. 2013. “Bayesian methods affirm the use of percutaneous coronary intervention to improve survival in patients with unprotected left main coronary artery disease.” Circulation, 127, 22, Pp. 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.
Daniel B Kramer, Kevin F Kennedy, Peter A Noseworthy, Alfred E Buxton, Mark E Josephson, Sharon-Lise Normand, John A Spertus, Peter J Zimetbaum, Matthew R Reynolds, and Susan L Mitchell. 2013. “Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR.” Circ Cardiovasc Qual Outcomes, 6, 4, Pp. 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<0.001) and ventricular tachycardia (60.5% versus 33.9%; P<0.001) compared with patients receiving new ICDs. Median battery life was only 4.6 years (25%-75% interquartile range, 3.7-5.8) for all replaced devices, 5.8 (25%-75% interquartile range, 4.2-7.5) for single-chamber, 5.1 (25%-75% interquartile range, 4.1-6.1) for dual-chamber, and 3.9 (25%-75% interquartile range, 3.2-4.6) years for biventricular devices. Patients receiving replacement ICDs had lower rates of index admission complications (0.9% versus 3.2%; P<0.001) but greater risk for death compared receiving patients receiving new ICDs in unadjusted analysis (hazard ratio, 1.18; 95% confidence interval, 1.16-1.20; P<0.0001) and after propensity-score matching (hazard ratio, 1.28; 95% confidence interval, 1.25-1.30; P<0.0001). CONCLUSIONS: Patients receiving replacement ICDs are older and at greater risk for death compared with those receiving initial ICD implants. The battery life of initial ICDs is shorter than previously reported.
Marcela Horvitz-Lennon, Julie M Donohue, Judith R Lave, Margarita Alegría, and Sharon-Lise T Normand. 2013. “The effect of race-ethnicity on the comparative effectiveness of clozapine among Medicaid beneficiaries.” Psychiatr Serv, 64, 3, Pp. 230-7.Abstract
OBJECTIVE: Effectiveness trials have confirmed the superiority of clozapine in schizophrenia treatment, but little is known about whether the drug'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'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.

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