Showing papers by "Harlan M. Krumholz published in 2014"
TL;DR: Three main actions are warranted: academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets, and standards for the content of protocols and full study reports should be rigorously developed and adopted for all types of health research.
668 citations
TL;DR: The ways in which big data can be harnessed to advance prediction, performance, discovery, and comparative effectiveness research to address the complexity of patients, populations, and organizations are explored.
Abstract: Big data in medicine—massive quantities of health care data accumulating from patients and populations and the advanced analytics that can give those data meaning—hold the prospect of becoming an engine for the knowledge generation that is necessary to address the extensive unmet information needs of patients, clinicians, administrators, researchers, and health policy makers. This article explores the ways in which big data can be harnessed to advance prediction, performance, discovery, and comparative effectiveness research to address the complexity of patients, populations, and organizations. Incorporating big data and next-generation analytics into clinical and population health research and practice will require not only new data sources but also new thinking, training, and tools. Adequately utilized, these reservoirs of data can be a practically inexhaustible source of knowledge to fuel a learning health care system.
458 citations
TL;DR: Young women with AMIs have more comorbidity, longer LOS, and higher in-hospital mortality than young men, although their mortality rates are decreasing, according to a large national dataset of U.S. hospital discharges.
354 citations
TL;DR: The quality of clinical trial evidence used by the FDA as the basis for recent approvals of novel therapeutic agents varied widely across indications, having important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents.
Abstract: on the basis of a single pivotal trial. Nearly all trials were randomized (89.3% [95% CI, 86.4%-92.2%]), double-blinded (79.5% [95% CI, 75.7%-83.2%]), and used either an active or placebo comparator (87.1% [95% CI, 83.9%-90.2%]). The median number of patients enrolled per indication among all pivotal trials was 760 (interquartile range, 270-1550). At least 1 pivotal trial with a duration of 6 months or greater supported the approval of 68 indications (33.8% [95% CI, 27.2%-40.4%]). Pivotal trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 91 indications (45.3% [95% CI, 38.3%-52.2%]), clinical outcomes for 67 (33.3% [95% CI, 26.8%-39.9%]), and clinical scales for 36 (17.9% [95% CI, 12.6%-23.3%]). Trial features differed by therapeutic and indication characteristics, such as therapeutic area, expected length of treatment, orphan status, and accelerated approval.
329 citations
TL;DR: Hospital admission rates for hypoglycemia now exceed those for hyperglycemia among older adults, and rates among black Medicare beneficiaries and those older than 75 years remain high, suggesting new opportunities for improvement in care of persons with diabetes mellitus.
Abstract: Importance The increasing intensity of diabetes mellitus management over the past decade may have resulted in lower rates of hyperglycemic emergencies but higher rates of hospital admissions for hypoglycemia among older adults. Trends in these hospitalizations and subsequent outcomes are not known. Objective To characterize changes in hyperglycemia and hypoglycemia hospitalization rates and subsequent mortality and readmission rates among older adults in the United States over a 12-year period, and to compare these results according to age, sex, and race. Design, Setting, and Patients Retrospective observational study using data from 33 952 331 Medicare fee-for-service beneficiaries 65 years or older from 1999 to 2011. Main Outcomes and Measures Hospitalization rates for hyperglycemia and hypoglycemia, 30-day and 1-year mortality rates, and 30-day readmission rates. Results A total of 279 937 patients experienced 302 095 hospitalizations for hyperglycemia, and 404 467 patients experienced 429 850 hospitalizations for hypoglycemia between 1999 and 2011. During this time, rates of admissions for hyperglycemia declined by 38.6% (from 114 to 70 admissions per 100 000 person-years), while admissions for hypoglycemia increased by 11.7% (from 94 to 105 admissions per 100 000 person-years). In analyses designed to account for changing diabetes mellitus prevalence, admissions for hyperglycemia and hypoglycemia declined by 55.2% and 9.5%, respectively. Trends were similar across age, sex, and racial subgroups, but hypoglycemia rates were 2-fold higher for older patients (≥75 years) when compared with younger patients (65-74 years), and admission rates for both hyperglycemia and hypoglycemia were 4-fold higher for black patients compared with white patients. The 30-day and 1-year mortality and 30-day readmission rates improved during the study period and were similar after an index hospitalization for either hyperglycemia or hypoglycemia (5.4%, 17.1%, and 15.3%, respectively, after hyperglycemia hospitalizations in 2010; 4.4%, 19.9%, and 16.3% after hypoglycemia hospitalizations). Conclusions and Relevance Hospital admission rates for hypoglycemia now exceed those for hyperglycemia among older adults. Although admissions for hypoglycemia have declined modestly since 2007, rates among black Medicare beneficiaries and those older than 75 years remain high. Hospital admissions for severe hypoglycemia seem to pose a greater health threat than those for hyperglycemia, suggesting new opportunities for improvement in care of persons with diabetes mellitus.
324 citations
TL;DR: Among individuals at the extremes of RF burden, the distribution of CAC is heterogeneous, and the presence of a high CAC burden, even among individuals without RFs, is associated with an elevated event rate, whereas the absence of Cac,even among those with many RF, isassociated with a low event rate.
Abstract: Aims We sought to evaluate the impact of coronary artery calcium (CAC) in individuals at the extremes of risk factor (RF) burden.
Methods and results 6698 individuals from the Multi-Ethnic Study of Atherosclerosis (MESA) were followed for coronary heart disease (CHD) events over mean 7.1 ± 1 years. Annualized CHD event rates were compared among each RF category (0, 1, 2, or ≥3) after stratification by CAC score (0, 1–100, 101–300, and >300). The following traditional modifiable RFs were considered: cigarette smoking, LDL cholesterol ≥3.4 mmol/L, low HDL cholesterol, hypertension, and diabetes. There were 1067 subjects (16%) with 0 RFs, whereas 1205 (18%) had ≥3 RFs. Among individuals with 0 RFs, 68% had CAC 0, whereas 12 and 5% had CAC >100 and >300, respectively. Among individuals with ≥3 RFs, 35% had CAC 0, whereas 34 and 19% had CAC >100 and >300, respectively. Overall, 339 (5.1%) CHD events occurred. Individuals with 0 RFs and CAC >300 had an event rate 3.5 times higher than individuals with ≥3 RFs and CAC 0 (10.9/1000 vs. 3.1/1000 person-years). Similar results were seen across categories of Framingham risk score.
Conclusion Among individuals at the extremes of RF burden, the distribution of CAC is heterogeneous. The presence of a high CAC burden, even among individuals without RFs, is associated with an elevated event rate, whereas the absence of CAC, even among those with many RF, is associated with a low event rate. Coronary artery calcium has the potential to further risk stratify asymptomatic individuals at the extremes of RF burden.
258 citations
TL;DR: From 2005 through 2011, adverse-event rates declined substantially among patients hospitalized for acute myocardial infarction or congestive heart failure but not among those hospitalized for pneumonia or conditions requiring surgery.
Abstract: Background Changes in adverse-event rates among Medicare patients with common medical conditions and conditions requiring surgery remain largely unknown. Methods We used Medicare Patient Safety Monitoring System data abstracted from medical records on 21 adverse events in patients hospitalized in the United States between 2005 and 2011 for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery. We estimated trends in the rate of occurrence of adverse events for which patients were at risk, the proportion of patients with one or more adverse events, and the number of adverse events per 1000 hospitalizations. Results The study included 61,523 patients hospitalized for acute myocardial infarction (19%), congestive heart failure (25%), pneumonia (30%), and conditions requiring surgery (27%). From 2005 through 2011, among patients with acute myocardial infarction, the rate of occurrence of adverse events declined from 5.0% to 3.7% (difference, 1.3 percentage points; 9...
221 citations
TL;DR: Hospitalizations for acute cardiovascular disease and stroke from 1999 through 2011 declined more rapidly than for other conditions and, for these conditions, mortality and readmission outcomes improved.
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, ...
207 citations
TL;DR: In this paper, a systematic review of studies of sex differences in long-term mortality after acute myocardial infarction has reported mixed results, with women having higher unadjusted mortality for women compared with men at both 5 and 10 years.
Abstract: Background—Studies of sex differences in long-term mortality after acute myocardial infarction have reported mixed results. A systematic review is needed to characterize what is known about sex differences in long-term outcomes and to define gaps in knowledge. Methods and Results—We searched the Medline database from 1966 to December 2012 to identify all studies that provided sex-based comparisons of mortality after acute myocardial infarction. Only studies with at least 5 years of follow-up were reviewed. Of the 1877 identified abstracts, 52 studies met the inclusion criteria, of which 39 were included in this review. Most studies included fewer than one-third women. There was significant heterogeneity across studies in patient populations, methodology, and risk adjustment, which produced substantial variability in risk estimates. In general, most studies reported higher unadjusted mortality for women compared with men at both 5 and 10 years after acute myocardial infarction; however, many of the differe...
163 citations
TL;DR: In conclusion, urinary biomarkers of kidney injury, particularly IL-18 and KIM-1, in the immediate postoperative period provide additional prognostic information for 3-year mortality risk in patients with and without clinical AKI.
Abstract: Urinary biomarkers of AKI provide prognostic value for in-hospital outcomes, but little is known about their association with longer-term mortality after surgery. We sought to assess the association between kidney injury biomarkers and all-cause mortality in an international, multicenter, prospective long-term follow-up study from six clinical centers in the United States and Canada composed of 1199 adults who underwent cardiac surgery between 2007 and 2009 and were enrolled in the Translational Research in Biomarker Endpoints in AKI cohort. On postoperative days 1–3, we measured the following five urinary biomarkers: neutrophil gelatinase-associated lipocalin, IL-18, kidney injury molecule-1 (KIM-1), liver fatty acid binding protein, and albumin. During a median follow-up of 3.0 years (interquartile range, 2.2–3.6 years), 139 participants died (55 deaths per 1000 person-years). Among patients with clinical AKI, the highest tertiles of peak urinary neutrophil gelatinase-associated lipocalin, IL-18, KIM-1, liver fatty acid binding protein, and albumin associated independently with a 2.0- to 3.2-fold increased risk for mortality compared with the lowest tertiles. In patients without clinical AKI, the highest tertiles of peak IL-18 and KIM-1 also associated independently with long-term mortality (adjusted hazard ratios [95% confidence intervals] of 1.2 [1.0 to 1.5] and 1.8 [1.4 to 2.3] for IL-18 and KIM-1, respectively), and yielded continuous net reclassification improvements of 0.26 and 0.37, respectively, for the prediction of 3-year mortality. In conclusion, urinary biomarkers of kidney injury, particularly IL-18 and KIM-1, in the immediate postoperative period provide additional prognostic information for 3-year mortality risk in patients with and without clinical AKI.
145 citations
TL;DR: The first national unplanned readmission results demonstrating declining rates for all three conditions between 2009–2012 are reported, with AMI mortality continued to decline, pneumonia mortality was stable, and HF mortality experienced a small increase.
Abstract: BACKGROUND
The Centers for Medicare & Medicaid Services publicly reports risk-standardized mortality rates (RSMRs) within 30-days of admission and, in 2013, risk-standardized unplanned readmission rates (RSRRs) within 30-days of discharge for patients hospitalized with acute myocardial infarction (AMI), heart failure (HF), and pneumonia. Current publicly reported data do not focus on variation in national results or annual changes.
TL;DR: There was more than a fourfold difference in risk-standardized complication rates across U.S. hospitals in which elective THA and TKA procedures are performed, and a continued need to monitor for disparities in outcomes.
Abstract: Background: Little is known about the variation in complication rates among U.S. hospitals that perform elective total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures. The purpose of this study was to use National Quality Forum (NQF)-endorsed hospital-level risk-standardized complication rates to describe variations in, and disparities related to, hospital quality for elective primary THA and TKA procedures performed in U.S. hospitals.
Methods: We conducted a cross-sectional analysis of national Medicare Fee-for-Service data. The study cohort included 878,098 Medicare fee-for-service beneficiaries, sixty-five years or older, who underwent elective THA or TKA from 2008 to 2010 at 3479 hospitals. Both medical and surgical complications were included in the composite measure. Hospital-specific complication rates were calculated from Medicare claims with use of hierarchical logistic regression to account for patient clustering and were risk-adjusted for age, sex, and patient comorbidities. We determined whether hospitals with higher proportions of Medicaid patients and black patients had higher risk-standardized complication rates.
Results: The crude rate of measured complications was 3.6%. The most common complications were pneumonia (0.86%), pulmonary embolism (0.75%), and periprosthetic joint infection or wound infection (0.67%). The median risk-standardized complication rate was 3.6% (range, 1.8% to 9.0%). Among hospitals with at least twenty-five THA and TKA patients in the study cohort, 103 (3.6%) were better and seventy-five (2.6%) were worse than expected. Hospitals with the highest proportion of Medicaid patients had slightly higher but similar risk-standardized complication rates (median, 3.6%; range, 2.0% to 7.1%) compared with hospitals in the lowest decile (3.4%; 1.7% to 6.2%). Findings were similar for the analysis involving the proportion of black patients.
Conclusions: There was more than a fourfold difference in risk-standardized complication rates across U.S. hospitals in which elective THA and TKA are performed. Although hospitals with higher proportions of Medicaid and black patients had rates similar to those of hospitals with lower proportions, there is a continued need to monitor for disparities in outcomes. These findings suggest there are opportunities for quality improvement among hospitals in which elective THA and TKA procedures are performed.
Level of Evidence: Therapeutic Level III. See Instruction to Authors for a complete description of levels of evidence.
TL;DR: Hospitals vary in their use of noninvasive cardiac imaging in patients with suspected ischemia who do not have AMI, and hospitals with higher imaging rates did not have substantially different rates of therapeutic interventions or lower readmission rates for AMI but were more likely to admit patients and perform angiography.
Abstract: Importance Current guidelines allow substantial discretion in use of noninvasive cardiac imaging for patients without acute myocardial infarction (AMI) who are being evaluated for ischemia. Imaging use may affect downstream testing and outcomes. Objective To characterize hospital variation in use of noninvasive cardiac imaging and the association of imaging use with downstream testing, interventions, and outcomes. Design, Setting, and Participants Cross-sectional study of hospitals using 2010 administrative data from Premier, Inc, including patients with suspected ischemia on initial evaluation who were seen in the emergency department, observation unit, or inpatient ward; received at least 1 cardiac biomarker test on day 0 or 1; and had a principal discharge diagnosis for a common cause of chest discomfort, a sign or symptom of cardiac ischemia, and/or a comorbidity associated with coronary disease. We excluded patients with AMI. Main Outcomes and Measures At each hospital, the proportion of patients who received noninvasive imaging to identify cardiac ischemia and the subsequent rates of admission, coronary angiography, and revascularization procedures. Results We identified 549 078 patients at 224 hospitals. The median (interquartile range) hospital noninvasive imaging rate was 19.8% (10.9%-27.7%); range, 0.2% to 55.7%. Median hospital imaging rates by quartile were Q1, 6.0%; Q2, 15.9%; Q3, 23.5%; Q4, 34.8%. Compared with Q1, Q4 hospitals had higher rates of admission (Q1, 32.1% vs Q4, 40.0%), downstream coronary angiogram (Q1, 1.2% vs Q4, 4.9%), and revascularization procedures (Q1, 0.5% vs Q4, 1.9%). Hospitals in Q4 had a lower yield of revascularization for noninvasive imaging (Q1, 7.6% vs Q4, 5.4%) and for angiograms (Q1, 41.2% vs Q4, 38.8%). P P = .51). Approximately 23% of variation in imaging use was attributable to the behavior of individual hospitals. Conclusions and Relevance Hospitals vary in their use of noninvasive cardiac imaging in patients with suspected ischemia who do not have AMI. Hospitals with higher imaging rates did not have substantially different rates of therapeutic interventions or lower readmission rates for AMI but were more likely to admit patients and perform angiography.
TL;DR: Readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia in adults aged 18 to 64 years with readmissions in those aged 65 and older are compared.
Abstract: Background
Patients aged ≥65 years are vulnerable to readmissions due to a transient period of generalized risk after hospitalization. However, whether young and middle-aged adults share a similar risk pattern is uncertain. We compared the rate, timing, and readmission diagnoses following hospitalization for heart failure (HF), acute myocardial infarction (AMI), and pneumonia among patients aged 18–64 years with patients aged ≥65 years.
Methods and Findings
We used an all-payer administrative dataset from California consisting of all hospitalizations for HF (n = 206,141), AMI (n = 107,256), and pneumonia (n = 199,620) from 2007–2009. The primary outcomes were unplanned 30-day readmission rate, timing of readmission, and readmission diagnoses. Our findings show that the readmission rate among patients aged 18–64 years exceeded the readmission rate in patients aged ≥65 years in the HF cohort (23.4% vs. 22.0%, p<0.001), but was lower in the AMI (11.2% vs. 17.5%, p<0.001) and pneumonia (14.4% vs. 17.3%, p<0.001) cohorts. When adjusted for sex, race, comorbidities, and payer status, the 30-day readmission risk in patients aged 18–64 years was similar to patients ≥65 years in the HF (HR 0.99; 95%CI 0.97–1.02) and pneumonia (HR 0.97; 95%CI 0.94–1.01) cohorts and was marginally lower in the AMI cohort (HR 0.92; 95%CI 0.87–0.96). For all cohorts, the timing of readmission was similar; readmission risks were highest between days 2 and 5 and declined thereafter across all age groups. Diagnoses other than the index admission diagnosis accounted for a substantial proportion of readmissions among age groups <65 years; a non-cardiac diagnosis represented 39–44% of readmissions in the HF cohort and 37–45% of readmissions in the AMI cohort, while a non-pulmonary diagnosis represented 61–64% of patients in the pneumonia cohort.
Conclusion
When adjusted for differences in patient characteristics, young and middle-aged adults have 30-day readmission rates that are similar to elderly patients for HF, AMI, and pneumonia. A generalized risk after hospitalization is present regardless of age.
Please see later in the article for the Editors' Summary
TL;DR: There is a pressing need for research in multiple areas to better identify methods and metrics to evaluate outcomes of stroke care and there are a number of important methodological challenges in undertaking risk-adjusted outcome comparisons to assess the quality of strokes care in different hospitals.
Abstract: Background and Purpose— Stroke is the fourth-leading cause of death and a leading cause of long-term major disability in the United States. Measuring outcomes after stroke has important policy implications. The primary goals of this consensus statement are to (1) review statistical considerations when evaluating models that define hospital performance in providing stroke care; (2) discuss the benefits, limitations, and potential unintended consequences of using various outcome measures when evaluating the quality of ischemic stroke care at the hospital level; (3) summarize the evidence on the role of specific clinical and administrative variables, including patient preferences, in risk-adjusted models of ischemic stroke outcomes; (4) provide recommendations on the minimum list of variables that should be included in risk adjustment of ischemic stroke outcomes for comparisons of quality at the hospital level; and (5) provide recommendations for further research.
Methods and Results— This statement gives an overview of statistical considerations for the evaluation of hospital-level outcomes after stroke and provides a systematic review of the literature for the following outcome measures for ischemic stroke at 30 days: functional outcomes, mortality, and readmissions. Data on outcomes after stroke have primarily involved studies conducted at an individual patient level rather than a hospital level. On the basis of the available information, the following factors should be included in all hospital-level risk-adjustment models: age, sex, stroke severity, comorbid conditions, and vascular risk factors. Because stroke severity is the most important prognostic factor for individual patients and appears to be a significant predictor of hospital-level performance for 30-day mortality, inclusion of a stroke severity measure in risk-adjustment models for 30-day outcome measures is recommended. Risk-adjustment models that do not include stroke severity or other recommended variables must provide comparable classification of hospital performance as models that include these variables. Stroke severity and other variables that are included in risk-adjustment models should be standardized across sites, so that their reliability and accuracy are equivalent. There is a pressing need for research in multiple areas to better identify methods and metrics to evaluate outcomes of stroke care.
Conclusions— There are a number of important methodological challenges in undertaking risk-adjusted outcome comparisons to assess the quality of stroke care in different hospitals. It is important for stakeholders to recognize these challenges and for there to be a concerted approach to improving the methods for quality assessment and improvement.
01 Aug 2014
TL;DR: The proportion of patients rehospitalised among 1-year survivors remained high with increasing index hospitalisation cost, but decreasing post-implantation costs over time, and LVAD implantations increased over time.
Abstract: Objective To characterise the trends in the left ventricular assist device (LVAD) implantation rates and outcomes between 2004 and 2011 in the Medicare population. Since the approval of the HeartMate II in 2008, the use of LVADs has steadily climbed. Given the increase in LVAD use, issues around discharge disposition, post-implant hospitalisations and costs require further understanding. Methods We examined LVAD implantation rates and short-term and long-term outcomes among Medicare fee-for-service beneficiaries hospitalised for LVAD implantation. We also conducted analyses among survivors 1-year post-discharge to examine rehospitalisation rates. Lastly, we reported Centers for Medicare & Medicaid Services (CMS) payments for both index hospitalisation and rehospitalisations 1 year post-discharge. Results A total of 2152 LVAD implantations were performed with numbers increasing from 107 in 2004 to 612 in 2011. The 30-day mortality rate decreased from 52% to 9%, and 1-year mortality rate decreased from 69% to 31%. We observed no change in overall length of stay, but post-procedure length of stay increased. We also found an increase in home discharge dispositions from 26% to 53%. Between 2004 and 2010, the rehospitalisation rate increased and the number of hospital days decreased. The adjusted CMS payment for the index hospitalisation increased from $188 789 to $225 697 over time but decreased for rehospitalisation from $60 647 to $53 630. Conclusions LVAD implantations increased over time. We found decreasing 30-day and 1-year mortality rates and increasing home discharge disposition. The proportion of patients rehospitalised among 1-year survivors remained high with increasing index hospitalisation cost, but decreasing post-implantation costs over time.
TL;DR: US health policy analysts and payers are currently focused on the high rate of hospital readmission for patients who have been recently discharged, and many suggest that rates could be reduced if hospitals only increased efforts to improve transitional care.
Abstract: US health policy analysts and payers are currently focused on the high rate of hospital readmission for patients who have been recently discharged. This issue is a particular concern for people older than 65 years and thus has become a focus of Medicare, which has implemented incentives to reduce 30-day readmission rates. Hospitals that fail to meet targets will be financially penalized.1 Acting on common sense, rather than evidence and a firm understanding of the causes of readmission, many suggest that rates could be reduced if hospitals only increased efforts to improve transitional care. Work began with greater attention to the cause of hospitalization and also on improved communication at the time of discharge and shortly thereafter.
TL;DR: Lower social support is associated with worse health status and more depressive symptoms 12 months after AMI in both young men and women.
Abstract: Background Social support is an important predictor of health outcomes after acute myocardial infarction (AMI), but social support varies by sex and age. Differences in social support could account for sex differences in outcomes of young patients with AMI.
Methods and Results Data from the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study, an observational study of AMI patients aged ≤55 years in the United States and Spain, were used for this study. Patients were categorized as having low versus moderate/high perceived social support using the ENRICHD Social Support Inventory. Outcomes included health status (Short Form-12 physical and mental component scores), depressive symptoms (Patient Health Questionnaire), and angina-related quality of life (Seattle Angina Questionnaire) evaluated at baseline and 12 months. Among 3432 patients, 21.2% were classified as having low social support. Men and women had comparable levels of social support at baseline. On average, patients with low social support reported lower functional status and quality of life and more depressive symptoms at baseline and 12 months post-AMI. After multivariable adjustment, including baseline health status, low social support was associated with lower mental functioning, lower quality of life, and more depressive symptoms at 12 months (all P <0.001). The relationship between low social support and worse physical functioning was nonsignificant after adjustment ( P =0.6). No interactions were observed between social support, sex, or country.
Conclusion Lower social support is associated with worse health status and more depressive symptoms 12 months after AMI in both young men and women. Sex did not modify the effect of social support.
TL;DR: Trial information and results reported on ClinicalTrials.gov is fairly complete, although there are concerns about its specificity; optional trial registration information is less complete.
Abstract: The 2007 Food and Drug Administration (FDA) Amendments Act expanded requirements for ClinicalTrials.gov, a public clinical trial registry maintained by the National Library of Medicine, mandating results reporting within 12 months of trial completion for all FDA-regulated medical products. Reporting of mandatory trial registration information on ClinicalTrials.gov is fairly complete, although there are concerns about its specificity; optional trial registration information is less complete.1- 4 To our knowledge, no studies have examined reporting and accuracy of trial results information. Accordingly, we compared trial information and results reported on ClinicalTrials.gov with corresponding peer-reviewed publications.
TL;DR: Women, regardless of age, experience more complications after percutaneous coronary intervention than men; young women are at increased mortality risk after an elective PCI.
TL;DR: The development of a claims-based, risk-standardized hospital-wide readmission measure that includes the great majority of adult inpatients, accounts for diverse conditions and their prevalence at different institutions, excludes planned readmissions, and is a composite of 5 specialty cohort models to make the measure more informative to hospitals is described.
Abstract: Background: Existing publicly reported readmission measures are condition-specific, representing less than 20% of adult hospitalizations. An all-condition measure may better measure quality and pro...
TL;DR: Although AD hospitalization rates remained stable, improvement in mortality was noted, particularly in patients undergoing surgical repair, particularly on the day of type A dissections.
Abstract: Background—The epidemiology of aortic dissection (AD) has not been well described among older persons in the United States. It is not known whether advancements in AD care over the last decade have been accompanied by changes in outcomes. Methods and Results—The Inpatient Medicare data from 2000 to 2011 were used to determine trends in hospitalization rates for AD. Mortality rates were ascertained through corresponding vital status files. A total of 32 057 initial AD hospitalizations were identified. The overall hospitalization rate for AD remained unchanged at 10 per 100 000 person-years. For 30-day and 1-year mortality associated with AD, the observed rate decreased from 31.8% to 25.4% (difference, 6.4%; 95% confidence interval [CI], 6.2–6.5; adjusted, 6.4%; 95% CI, 5.7–6.9) and from 42.6% to 37.4% (difference, 5.2%; 95% CI, 5.1–5.2; adjusted, 6.2%; 95% CI, 5.3–6.7), respectively. For patients undergoing surgical repair for type A dissections, the observed 30-day mortality decreased from 30.7% to 21.4% ...
TL;DR: Among patients with heart failure, neighborhood SES was significantly associated with 6-month all-cause readmission even after adjusting for other patient-level factors, including individual SES.
Abstract: Background—Recent studies show an association between neighborhood-level measures of socioeconomic status (SES) and outcomes for patients with heart failure. We do not know whether neighborhood SES has a primary effect or is a marker for individual SES. Methods and Results—We used the data from participants of the Telemonitoring to Improve Heart Failure Outcomes (Tele-HF) trial, recruited from 33 US internal medicine and cardiology practices and examined the association between neighborhood SES and outcomes of patients with heart failure. We used census tracts as proxies for neighborhoods and constructed summary SES scores that included information about wealth and income, education, and occupation. The primary end points were readmission and all-cause mortality at 6 months. We conducted patient interviews and medical chart reviews to obtain demographic information, clinical factors, therapies, and individual SES. We included 1557 patients: 524, 516, and 517 from low, medium, and high SES neighborhoods, r...
TL;DR: Well-conducted randomizedclinical trials (RCTs) are thegold standard for evaluating the safety and efficacy of medical therapeutics, yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results.
Abstract: Well-conducted randomizedclinical trials (RCTs) are thegold standard for evaluating the safety and efficacy of medical therapeutics. Yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results. This limited access does not typically allow others to replicate the trial findings. Given the time and expense required to conduct an RCT, it is often unlikely that others will independently repeat a similar experiment. Thus, the scientific community and the public often accept the results produced and published by the original research team without an opportunity for reanalysis. Increasingly, however, opinions and empirical data are challenging the assumption that the analysis of a clinical trial is straightforward and that analysis by any other group would obtain the same results.1-3 In this issue of JAMA, Ebrahim et al4 report their findings based on a rigorous search of previously published reanalyses of RCTs. Their first surprising and discomforting finding was just how infrequently data reanalysis has occurred in medical research. Searching the literature from 1966 to present, the authors found only 37 reports that met their criteria as an RCT reanalysis. Of these few reanalyses performed, the majority (84%) had overlapping authors from the original report. Thus, reanalyses are not only rare, but the majority that were reported were not fully independent of the original research group. Despite this overlap, Ebrahim et al report that about half of the reanalyses differed in statistical or analytic approaches, a third differed in the definitions or measurements of outcomes, and most important, a third led to interpretations and conclusions different than those in the original article. While the definition of what constituted different trial analyses, study end points, findings, and interpretations is subjective, the authors’ general conclusions were consistent with an emerging literature that indicates RCT reanalysis can yield different results and conclusions from those originally published. Even when the original investigators are presenting evidence in different venues it is not always consistent. For example, there is evidence from trials that data presented to the US Food and Drug Administration (FDA)may differ in important ways from those originally presented at scientific sessions or published in medical journals. Rising et al5 assessed clinical trial information provided to the FDA and reported a 9% discordance between the conclusions in the report to the FDA and in the published article. Not unexpectedly, all were in the direction favoring the drug. Another example is discordance between what is reported in ClinicalTrials.gov and what is published in journal articles.Hartungetal2 showedthat inarandomsampleofphase 3 and 4 trials, in 15% the primary end point in themain article was different from the primary end point the trialists reported in ClinicalTrials.gov. Moreover, 22% reported the primaryoutcomevalue inconsistently,withsomeevenhavingdifferences in the number of deaths. Other studies have found similar rates of discordance.6 When reanalyses by different groups obtain somewhat different results or reach alternative conclusions, the cause is not necessarily bias. Independent groups with individual patient-level data from trials will not always reach the same conclusions because every study involves discretionary decisions. This situation was exemplified in the evaluation of Medtronic’s bone morphogenetic protein 2 (BMP-2) product. Two expert organizations with international reputations in the conduct of systematic reviews were given the same individual patient-level data from the BMP-2 trials, the same task, the same resources, and the same timeline.7,8 Nevertheless, in their final reports, their methods were not identical and their results and conclusions differed in important ways. Consistent with these findings, meta-analyses on similar topics and using similar data do not always show concordant results.9 The current reviewbyEbrahimet al, aswell as other cited work, suggests several important next steps needed to ensure transparencyandopenaccess inRCTs.First, allRCTs, their prespecified study protocols and analytic plans, and their results should be registered and reported to the medical community, fulfilling the ethical promise made to those enrolled in the scientific experiment. Such a step would contribute to improvements in the standardization of trial registration and reportingof results,which remainsvarieddespitegovernmental regulation and journal policies.10-12 Full availability of trial registration data is essential to allowpeer reviewers and journals tomonitor trial protocols andanalyticplans toensureconsistencyand thereby reduce someof thevariation thatmayoccur in the reporting of results, particularly with respect to primary, secondary, and exploratory outcomes. Second, rawdata andmetadata (all the information about the data) from the original trial should ideally bemade available to those who seek the opportunity to replicate the findings. Such independent verification would markedly increase the scientific community’s confidence in the study findings. Evenwhen results differed importantly, it would allow for open dialogue that would promote a deeper understanding of the study and its interpretation. While the current study by Ebrahim et al demonstrates how infrequently Related article page 1024 Opinion
TL;DR: It is reported that few variables have been found to consistently predict the occurrence of 30-day readmission and that risk prediction models lack strong discriminative ability.
Abstract: Readmission within 30 days after hospital discharge for common cardiovascular conditions such as heart failure and acute myocardial infarction is extremely common among older persons. To incentivize investment in reducing preventable rehospitalizations, the United States federal government has directed increasing financial penalties to hospitals with higher-than-expected 30-day readmission rates. Uncertainty exists, however, regarding the best approaches to reducing these adverse outcomes. In this review, we summarize the literature on predictors of 30-day readmission, the utility of risk prediction models, and strategies to reduce short-term readmission after hospitalization for heart failure and acute myocardial infarction. We report that few variables have been found to consistently predict the occurrence of 30-day readmission and that risk prediction models lack strong discriminative ability. We additionally report that the literature on interventions to reduce 30-day rehospitalization has significant limitations due to heterogeneity, susceptibility to bias, and lack of reporting on important contextual factors and details of program implementation. New information is characterizing the period after hospitalization as a time of high generalized risk, which has been termed the post-hospital syndrome. This framework for characterizing inherent post-discharge instability suggests new approaches to reducing readmissions.
TL;DR: Readmission measures for the Centers for Medicare & Medicaid Services were developed with the goal of illuminating hospital performance and stimulating efforts to improve patient care, and it was believed that such efforts could improve patient recovery and reduce the occurrence of adverse health events after discharge.
Abstract: In this issue, Kind and Keyhani and their colleagues evaluated the effects of neighborhood and individual socioeconomic status and clinical factors on 30-day rehospitalization rates and hospital pe...
TL;DR: In a national sample of Medicare beneficiaries hospitalized for AMI from 1999 to 2010, hospitalization for recurrent AMI decreased, as did subsequent mortality, albeit to a lesser extent, and the risk of recurrent AMi hospitalization declined less in black patients than in whites, increasing observed racial disparities by the end of the study period.
Abstract: BackgroundThere are few data characterizing temporal changes in hospitalization for recurrent acute myocardial infarction (AMI) after AMI. Methods and ResultsUsing a national sample of 2 305 441 Me...
TL;DR: The Yale University Open Data Access Project developed policies and procedures to share data from all published and unpublished clinical trials, and Medtronic fully transferred the decision-making authority on how to share the data and who could receive the data to the project.
Abstract: With remarkable speed, the landscape of open science and data sharing is changing. Fueled by recent evidence that the results of many clinical trials of interventions in common use are never published or reported and that these studies are not missing at random, a persuasive argument has been made that all data from human trials should be available to inform clinical practice.1–6 This would also promote higher quality and higher integrity science, although some urge caution as a result of concerns about unintended adverse consequences.7
In response to these calls for action, some companies have stepped forward and demonstrated leadership. GlaxoSmithKline, in coordination with other companies such as Roche and ViiV, committed early to data sharing.8 Medtronic contracted with our research team, the Yale University Open Data Access Project,9 to conduct external reviews of its clinical trial data for a single product. In addition, we developed policies and procedures to share these data with other investigators. Importantly, Medtronic fully transferred the decision-making authority on how to share the data and who could receive the data to the Yale University Open Data Access Project. Janssen, the pharmaceutical companies of Johnson & Johnson, has now contracted to do the same for the trials under its auspices. Increasingly, other companies are announcing their intention to share data from all published and unpublished clinical trials.
On July 24, 2013, the …
TL;DR: After much delay, deliberation, and drama, the long-awaited updates of the cholesterol and blood pressure guidelines were released during the last 6 months, intended to distill the wisdom that emerged since the last versions of these authoritative documents were released more than a decade ago.
Abstract: After much delay, deliberation, and drama, the long-awaited updates of the cholesterol and blood pressure guidelines were released during the last 6 months.1,2 These guidelines were intended to distill the wisdom that emerged since the last versions of these authoritative documents were released more than a decade ago. In 2008, the National Institutes of Health (NIH) appointed some of the nation’s top experts to these respective committees and provided guidance throughout almost the entirety of their 5-year development. These documents were designed to provide instructions to the nation and the world about how to manage these common risk factors for cardiovascular disease. The decision by the NIH not to oversee the final release of the documents only intensified the interest in them.
TL;DR: Evaluated gender differences in baseline sexual activity, function, and patient experience with physician counseling about sexual activity after an AMI found women in Spain were significantly more likely to be given restrictions than U.S. women.
Abstract: Background—United States and European cardiovascular society guidelines recommend physicians counsel patients about resuming sexual activity after acute myocardial infarction (AMI), but little is known about patients’ experience with counseling about sexual activity after AMI. Methods and Results—The prospective, longitudinal Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study, conducted at 127 hospitals in the United States and Spain, was designed, in part, to evaluate gender differences in baseline sexual activity, function, and patient experience with physician counseling about sexual activity after an AMI. This study used baseline and 1-month data collected from the 2:1 sample of women (N=2349) and men (N=1152) ages 18 to 55 years with AMI. Median age was 48 years. Among those who reported discussing sexual activity with a physician in the month after AMI (12% of women, 19% of men), 68% were given restrictions: limit sex (35%), take a more passive role (26%), and/or k...