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This study exploited both the magic of randomization and generalizability of real-world data by linking the patient-level data from the DAPT trial with real-world registry data. However, in subgroup analyses in reweighted data from patients with DAPT score >=2, the significant reduction in stent thrombosis in the group receiving prolonged DAPT was retained without significant impact on bleeding. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). [Extracted from the article]

The article offers a perspective on the fundamental policy underlying the U.S. Cures 2.0 Act. The author suggests policymakers to help Cures 2.0 modernize the clinical research enterprise by focusing on acceleration of medical product development, reducing time to product marketing authorization, resolution of questions about real-world evidentiary requirements and standards for product premarketing and postmarketing, and addressing economic and safety implications of Medicare coverage.

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. [ABSTRACT FROM AUTHOR]

This study compares all-cause excess mortality and COVID-19–related mortality during the early pandemic period (March-July 2020) with unintentional drug overdoses, the usual leading cause of death in young adults, during the same period in 2018 among adults aged 25 to 44 years. [ABSTRACT FROM AUTHOR]

This study describes submissions, postings, abstract views, downloads, comments, and withdrawals on the medRxiv preprint server from June 2019 to June 2020 and compares submissions and postings before and after COVID-19. [ABSTRACT FROM AUTHOR]

• Qatar's COVID-19 mortality was driven by infection among vulnerable persons. • There was excess mortality in short-term and deficit mortality in medium-term. • Observed pattern was particularly evident in clinically vulnerable individuals. • Vaccination prevented early deaths, regardless of vulnerability status. We assessed short-, medium-, and long-term all-cause mortality risks after a primary SARS-CoV-2 infection. A national, matched, retrospective cohort study was conducted in Qatar to assess risk of all-cause mortality in the national SARS-CoV-2 primary infection cohort compared with the national infection-naïve cohort. Associations were estimated using Cox proportional-hazards regression models. Analyses were stratified by vaccination status and clinical vulnerability status. Among unvaccinated persons, within 90 days after primary infection, the adjusted hazard ratio (aHR) comparing mortality incidence in the primary-infection cohort with the infection-naïve cohort was 1.19 (95% confidence interval 1.02-1.39). aHR was 1.34 (1.11-1.63) in persons more clinically vulnerable to severe COVID-19 and 0.94 (0.72-1.24) in those less clinically vulnerable. Beyond 90 days after primary infection, aHR was 0.50 (0.37-0.68); aHR was 0.41 (0.28-0.58) at 3-7 months and 0.76 (0.46-1.26) at ≥8 months. The aHR was 0.37 (0.25-0.54) in more clinically vulnerable persons and 0.77 (0.48-1.24) in less clinically vulnerable persons. Among vaccinated persons, mortality incidence was comparable in the primary-infection versus infection-naïve cohorts, regardless of clinical vulnerability status. COVID-19 mortality was primarily driven by an accelerated onset of death among individuals who were already vulnerable to all-cause mortality, but vaccination prevented these accelerated deaths. [ABSTRACT FROM AUTHOR]

Keywords: angiotensin receptor antagonists; drug recalls; drug utilization; health services research; hypertension EN angiotensin receptor antagonists drug recalls drug utilization health services research hypertension 411 413 3 04/20/20 20200204 NES 200204 On July 9, 2018, Health Canada announced a voluntary recall of 6 generic valsartan products because a known carcinogen N-nitrosodimethylamine was detected.[1] In total, more than 22 countries, including the United States, initiated recalls. Before the recall, 0.11% of the cohort had ED visits for hypertension per month, with no monthly change in the rate of ED visits for hypertension before the recall ( I P i =0.68). Angiotensin receptor antagonists, drug recalls, drug utilization, health services research, hypertension. [Extracted from the article]

There are wide disparities in health across the US population. The identification of geographic health priority areas for Medicare could inform efforts to eliminate health disparities and improve health care. In a sample of 3,282 counties with more than 73 million unique Medicare beneficiaries in the period 1999-2014, we identified geographical areas--"hot spots"--with persistently higher adjusted mortality rates for older adults compared with the rest of the country. During the study period, the risk-standardized mortality rates decreased from 5.52 percent to 4.61 percent (a 0.91-percentage-point change) for the priority areas and from 5.16 percent to 4.11 percent (a 1.05-percentage-point change) for other areas. Faced with decisions surrounding allocation of scarce resources and marked geographic disparities, the identification and prioritization of hot spots may be one way to eliminate disparities and improve health care. [ABSTRACT FROM AUTHOR]

Background: To isolate hospital effects on risk-standardized hospital-readmission rates, we examined readmission outcomes among patients who had multiple admissions for a similar diagnosis at more than one hospital within a given year.Methods: We divided the Centers for Medicare and Medicaid Services hospital-wide readmission measure cohort from July 2014 through June 2015 into two random samples. All the patients in the cohort were Medicare recipients who were at least 65 years of age. We used the first sample to calculate the risk-standardized readmission rate within 30 days for each hospital, and we classified hospitals into performance quartiles, with a lower readmission rate indicating better performance (performance-classification sample). The study sample (identified from the second sample) included patients who had two admissions for similar diagnoses at different hospitals that occurred more than 1 month and less than 1 year apart, and we compared the observed readmission rates among patients who had been admitted to hospitals in different performance quartiles.Results: In the performance-classification sample, the median risk-standardized readmission rate was 15.5% (interquartile range, 15.3 to 15.8). The study sample included 37,508 patients who had two admissions for similar diagnoses at a total of 4272 different hospitals. The observed readmission rate was consistently higher among patients admitted to hospitals in a worse-performing quartile than among those admitted to hospitals in a better-performing quartile, but the only significant difference was observed when the patients were admitted to hospitals in which one was in the best-performing quartile and the other was in the worst-performing quartile (absolute difference in readmission rate, 2.0 percentage points; 95% confidence interval, 0.4 to 3.5; P=0.001).Conclusions: When the same patients were admitted with similar diagnoses to hospitals in the best-performing quartile as compared with the worst-performing quartile of hospital readmission performance, there was a significant difference in rates of readmission within 30 days. The findings suggest that hospital quality contributes in part to readmission rates independent of factors involving patients. (Funded by Yale-New Haven Hospital Center for Outcomes Research and Evaluation and others.). [ABSTRACT FROM AUTHOR]

Background: The risk of rehospitalization is elevated in the immediate post-discharge period and declines over time. It is not known if the extent and timing of risk vary across readmission diagnoses, suggesting that recovery and vulnerability after discharge differ by physiologic system. Objective: We compared risk trajectories for major readmission diagnoses in the year after discharge among all Medicare fee-for-service beneficiaries hospitalized with heart failure (HF), acute myocardial infarction (AMI), or pneumonia from 2008–2010. Methods: We estimated the daily risk of rehospitalization for 12 major readmission diagnostic categories after accounting for the competing risk of death after discharge. For each diagnostic category, we identified (1) the time required for readmission risk to peak and then decline 50% from maximum values after discharge; (2) the time required for readmission risk to approach plateau periods of minimal day-to-day change; and (3) the extent to which hospitalization risks are higher among patients recently discharged from the hospital compared with the general elderly population. Results: Among >3,000,000 hospitalizations, the yearly rate of rehospitalization was 67.0%, 49.5%, and 55.3% after hospitalization for HF, AMI, and pneumonia, respectively. The extent and timing of risk varied by readmission diagnosis and initial admitting condition. Risk of readmission for gastrointestinal bleeding/anemia peaked particularly late after hospital discharge, occurring 10, 6, and 7 days after hospitalization for HF, AMI, and pneumonia, respectively. Risk of readmission for trauma/injury declined particularly slowly, requiring 38, 20, and 38 days to decline by 50% after hospitalization for HF, AMI, and pneumonia, respectively. Conclusions: Patterns of vulnerability to different conditions that cause rehospitalization vary by time after hospital discharge. This finding suggests that recovery of various physiologic systems occurs at different rates and that post-discharge interventions to minimize vulnerability to specific conditions should be tailored to their underlying risks. [ABSTRACT FROM AUTHOR]

The article focuses on the implementation of the new Data Management and Sharing (DMS) Policy by the National Institutes of Health (NIH) in January 2023. Topics discussed include the profound impact of this shift on clinical research, citing examples from the National Heart, Lung, and Blood Institute's successful data-sharing initiatives, and the broader trend of data sharing in both the public and private sectors.

China has an immediate need to address the rapidly growing population with cardiovascular disease events and the increasing number of people living with this illness. Despite progress in increasing access to services, China faces the dual challenge of addressing gaps in quality of care and producing more evidence to support clinical practice. In this Review, we address opportunities to strengthen performance measurement, programmes to improve quality of care, and national capacity to produce high-impact knowledge for clinical practice. Moreover, we propose recommendations, with implications for other diseases, for how China can immediately make use of its Hospital Quality-Monitoring System and other existing national platforms to assess and improve performance of medical care, and to generate new knowledge to inform clinical decisions and national policies. [ABSTRACT FROM AUTHOR]

IMPORTANCE The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. OBJECTIVE To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. DESIGN AND SETTING All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. MAIN OUTCOMES AND MEASURES Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. RESULTS In 2010 and 2011.28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies. 30 (10.5%) pivotal premarket studies. 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR. 119-640), and 250 patients (IQR. 60-800) for nonpivotal premarket, pivotal. FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]: ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR. 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively. CONCLUSIONS AND RELEVANCE Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval. [ABSTRACT FROM AUTHOR]

IMPORTANCE In a period of dynamic change in health care technology, delivery, and behaviors, tracking trends in health and health care can provide a perspective on what is being achieved. OBJECTIVE To comprehensively describe national trends in mortality, hospitalizations, and expenditures in the Medicare fee-for-service population between 1999 and 2013. DESIGN, SETTING, AND PARTICIPANTS Serial cross-sectional analysis of Medicare beneficiaries aged 65 years or older between 1999 and 2013 using Medicare denominator and inpatient files. MAIN OUTCOMES AND MEASURES For all Medicare beneficiaries, trends in all-cause mortality; for fee-for-service beneficiaries, trends in all-cause hospitalization and hospitalization-associated outcomes and expenditures. Geographic variation, stratified by key demographic groups, and changes in the intensity of care for fee-for-service beneficiaries in the last 1, 3, and 6 months of life were also assessed. RESULTS The sample consisted of 68 374 904 unique Medicare beneficiaries (fee-for-service and Medicare Advantage). All-cause mortality for all Medicare beneficiaries declined from 5.30% in 1999 to 4.45% in 2013 (difference, 0.85 percentage points; 95% CI, 0.83-0.87). Among fee-for-service beneficiaries (n = 60 056 069), the total number of hospitalizations per 100 000 person-years decreased from 35 274 to 26 930 (difference, 8344; 95% CI, 8315-8374). Mean inflation-adjusted inpatient expenditures per Medicare fee-for-service beneficiary declined from $3290 to $2801 (difference, $489; 95% CI, $487-$490). Among fee-for-service beneficiaries in the last 6 months of life, the number of hospitalizations decreased from 131.1 to 102.9 per 100 deaths (difference, 28.2; 95% CI, 27.9-28.4). The percentage of beneficiaries with 1 or more hospitalizations decreased from 70.5 to 56.8 per 100 deaths (difference, 13.7; 95% CI, 13.5-13.8), while the inflation-adjusted inpatient expenditure per death increased from $15 312 in 1999 to $17 423 in 2009 and then decreased to $13 388 in 2013. Findings were consistent across geographic and demographic groups. CONCLUSIONS AND RELEVANCE Among Medicare fee-for-service beneficiaries aged 65 years or older, all-cause mortality rates, hospitalization rates, and expenditures per beneficiary decreased from 1999 to 2013. In the last 6 months of life, total hospitalizations and inpatient expenditures decreased in recent years. [ABSTRACT FROM AUTHOR]

Board certification is at a critical juncture. As physicians face increased regulation and pressures from both inside and outside the profession, board certification and Maintenance of Certification (MOC) are coming under increased scrutiny from the public and the medical community. At this challenging time, it is important to remind ourselves what board certification is (and what it is not) and revisit the origins of this tangible expression of professional self-regulation, even as we contemplate how it needs to improve. Board certification has evolved over time and must continue to evolve; it is our collective responsibility as physicians that peer-developed standards meet the needs of both the profession and the public. In this article, we will reflect on the history of the American Board of Internal Medicine (ABIM), especially which related to Cardiology, and describe some of ABIM's challenges and new directions. [ABSTRACT FROM AUTHOR]

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 (Cl), 37.2-38.8] for myocardial infarction, 83.8% [95% Cl, 83.3-84.4] for unstable angina, 30.5% [95% Cl, 29.3-31.6] for heart failure, and 33.6% [95% Cl, 32.9-34.4] for ischemic stroke compared with 10.2% [95% Cl, 10.1-10.2] for all other conditions). Adjusted 30-day mortality rates declined 29.4% (95% Cl, 28.1-30.6) for myocardial infarction, 13.1% (95% Cl, 1.1-23.7) for unstable angina, 16.4% (95% Cl, 15.1-17.7) for heart failure, and 4.7% (95% Cl, 3.0-6.4) for ischemic stroke. There were also reductions in rates o f 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. [ABSTRACT FROM AUTHOR]

The article presents insights on a proposal by the International Committee on Medical Journal Editors which require trial investigators to share patient-level data within 6 months of publication. Topics discussed include the question concerning its practical implementation, the challenge in the proposed data-sharing policy for editors, and the application of the escrow concept for facilitating data-sharing agreements.

As medical research moves toward the more open approach to data sharing from which physics, astronomy, and genetics currently benefit, the YODA Project offers one of several pioneering data-sharing mechanisms that are already in use. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This JAMA Guide to Statistics and Methods summarizes latent class analysis, a statistical technique that estimates the probability of patients belonging to a discrete group that shares specific combinations of observed variables, and explains how the technique is used and can be interpreted in observational research. [ABSTRACT FROM AUTHOR]

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of medical writers. Medical writers are likely to play a prominent role in standardising policies and procedures and have the opportunity to lead the development of an efficient and feasible system for promoting clinical trial data sharing. These efforts will ensure that the research community can derive the full benefit from the enormous resources devoted to human clinical trial research and will help build patient trust in the research process. [ABSTRACT FROM AUTHOR]

The article examines the association between hospital readmission and mortality rates for cardiac patients who were presented with clinical case of acute myocardial infarction, heart failure and pneumonia. It highlights the impact of quality of medical care provided by health care centers in resolving the risk associated with cardiac patients. The Centers for Medicare & Medicaid Services in the U.S. on the basis of a cohort analysis revealed that differences in performance of hospitals and diagnostic parameters implied by hospital were of immense use in determination of readmission rate and mortality rate of cardiac patients.

Background: Little is known about the association between financial stress and health care outcomes. Our objective was to examine the association between self-reported financial stress during initial hospitalization and long-term outcomes after acute myocardial infarction (AMI). Materials and Methods: We used Prospective Registry Evaluating Myocardial Infarction: Event and Recovery (PREMIER) data, an observational, multicenter US study of AMI patients discharged between January 2003 and June 2004. Primary outcomes were disease-specific and generic health status outcomes at 1 year (symptoms, function, and quality of life (QoL)), assessed by the Seattle Angina Questionnaire [SAQ] and Short Form [SF]-12. Secondary outcomes included 1-year rehospitalization and 4-year mortality. Hierarchical regression models accounted for patient socio-demographic, clinical, and quality of care characteristics, and access and barriers to care. Results: Among 2344 AMI patients, 1241 (52.9%) reported no financial stress, 735 (31.4%) reported low financial stress, and 368 (15.7%) reported high financial stress. When comparing individuals reporting low financial stress to no financial stress, there were no significant differences in post-AMI outcomes. In contrast, individuals reporting high financial stress were more likely to have worse physical health (SF-12 PCS mean difference -3.24, 95% Confidence Interval [CI]: -4.82, -1.66), mental health (SF-12 MCS mean difference: -2.44, 95% CI: -3.83, -1.05), disease-specific QoL (SAQ QoL mean difference: -6.99, 95% CI: -9.59, -4.40), and be experiencing angina (SAQ Angina Relative Risk = 1.66, 95%CI: 1.19, 2.32) at 1 year post-AMI. While 1-year readmission rates were increased (Hazard Ratio = 1.50; 95%CI: 1.20, 1.86), 4-year mortality was no different. Conclusions: High financial stress is common and an important risk factor for worse long-term outcomes post-AMI, independent of access and barriers to care. [ABSTRACT FROM AUTHOR]

Background: Medicaid, the primary source of insurance coverage for disadvantaged Americans, was originally designed as a temporary safety-net program. No studies have used long-run data to assess the recent use of the program by beneficiaries.Objective: To assess patterns of short- and long-term enrollment among beneficiaries, using a 10-year longitudinal panel of Michigan Medicaid eligibility data.Design: Primary analyses assessing trends in Medicaid enrollment among cohorts of existing and new beneficiaries.Setting: Administrative records from Michigan Medicaid for the period 2011 to 2020.Participants: 3.97 million Medicaid beneficiaries.Measurements: Short- and long-term enrollment in the program.Results: The sample includes 3.97 million unique beneficiaries enrolled at some point between 2011 and 2020. Among a cohort of 1.23 million beneficiaries enrolled in 2011, over half (53%) were also enrolled in Medicaid in June 2020, spending, on average, two-thirds of that period (67%) on Medicaid. These beneficiaries, however, experienced substantial lapses in coverage, as only 25% were continuously enrolled throughout the period. Enrollment was less stable when assessed from the perspective of newly enrolled beneficiaries, of whom only 37% remained enrolled at the end of the study period.Limitation: Primary estimates from a single state.Conclusion: For many beneficiaries, Medicaid has served as their primary source of coverage for at least a decade. This pattern would justify increasing investments in the program to improve long-term health outcomes.Primary Funding Source: Self-funded. [ABSTRACT FROM AUTHOR]

Background-Registry studies have suggested improvements in door-to-balloon times, but a national assessment of the trends in door-to-balloon times is lacking. Moreover, we do not know whether improvements in door-to-balloon times were shared equally among patient and hospital groups. Methods and Results-This analysis includes all patients reported by hospitals to the Centers for Medicare & Medicaid Services for inclusion in the time to percutaneous coronary intervention (acute myocardial infarction-8) inpatient measure from January 1, 2005, through September 30, 2010. For each calendar year, we summarized the characteristics of patients reported for the measure, including the number and percentage in each group, the median time to primary percutaneous coronary intervention, and the percentage with time to primary percutaneous coronary intervention within 75 minutes and within 90 minutes. Door-to-balloon time declined from a median of 96 minutes in the year ending December 31, 2005, to a median of 64 minutes in the 3 quarters ending September 30, 2010. There were corresponding increases in the percentage of patients who had times <90 minutes (44.2% to 91.4%) and <75 minutes (27.3% to 70.4%). The declines in median times were greatest among groups that had the highest median times during the first period: patients >75 years of age (median decline, 38 minutes), women (35 minutes), and blacks (42 minutes). Conclusion-National progress has been achieved in the timeliness of treatment of patients with ST-segment-elevation myocardial infarction who undergo primary percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

The article focuses on a study which evaluated the association between automated external defibrillators (AEDs) use and survival for in-hospital cardiac arrest. The researchers examined 11,695 hospitalized patients who experienced cardiac arrests between January 1, 2000 to August 26, 2008 at U.S. hospitals following the introduction of AEDs on general and hospital wards. Study results indicated that hospitalized patients with cardiac arrest and use of AED were not associated with improved survival.

The article presents a study which investigates the survival impact of regionalization of acute myocardial infarction (AMI) care on percutaneous coronary intervention (PCI) hospitals in the U.S. Risk-standardized mortality rates (RSMRs) between PCI hospitals and non-PCI hospitals within the same health care regions were analyzed. The study suggests that regionalizing AMI care to PCI hospitals can reduce mortality rates, however, survival outcomes varies across the regions.

Background: Although treating to lipid targets ("treat to target") is widely recommended for coronary artery disease (CAD) prevention, some have advocated administering fixed doses of statins based on a person's estimated net benefit ("tailored treatment"). Objective: To examine how a tailored treatment approach to statin therapy compares with a treat-to-target approach. Design: Simulated model of population-level effects of treat-totarget and tailored treatment approaches to statin therapy. Data Sources: Statin trials from 1994 to 2009 and nationally representative CAD risk factor data. Target Population: U.S. persons aged 30 to 75 years with no history of myocardial infarction. Time Horizon: Lifetime effects of 5 years of treatment. Perspective: Societal and patient. Intervention: Tailored treatment based on a person's 5-year CAD risk (simvastatin, 40 mg, for 5% to 15% CAD risk and atorvastatin, 40 mg, for CAD risk >15%) versus treat-to-target approaches that escalate statin dose per National Cholesterol Education Program [NCEP] III guidelines (including an intensive approach that advances treatment whenever intensification is optional by NCEP III criteria). Outcome Measures: Quality-adjusted life-years (QALYs). Results of Base-Case Analysis: Compared with the standard NCEP III approach, the intensive NCEP III approach treated 15 million more persons and saved 570 000 more QALYs over 5 years. The tailored strategy treated a similar number of persons, as did the intensive NCEP III approach, but saved 500 000 more QALYs and treated fewer persons with high-dose statins. Results of Sensitivity Analysis: No circumstances were found in which a treat-to-target approach was preferable to tailored treatment. Limitation: Model assumptions were based on available clinical data, which included few persons 75 years or older. Conclusion: A tailored treatment strategy prevents more CAD events while treating fewer persons with high-dose statins than low-density lipoprotein cholesterol-based target approaches. Results were robust, even with assumptions favoring a treat-to-target approach. Primary Funding Source: Department of Veteran Affairs Health Services Research & Development Service's Quality Enhancement Research Initiative. [ABSTRACT FROM AUTHOR]

A response by Reza Fazel, Harlan M. Krumholz and Brahmajee K. Nallamothu to a letter to the editor about their article "Exposure to Low-Dose Ionizing Radiation From Medical Imaging Procedures," in the August 27, 2009 issue is presented.

Background: The growing use of imaging procedures in the United States has raised concerns about exposure to low-dose ionizing radiation in the general population. Methods: We identified 952,420 nonelderly adults (between 18 and 64 years of age) in five health care markets across the United States between January 1, 2005, and December 31, 2007. Utilization data were used to estimate cumulative effective doses of radiation from imaging procedures and to calculate population-based rates of exposure, with annual effective doses defined as low (≤3 mSv), moderate (>3 to 20 mSv), high (>20 to 50 mSv), or very high (>50 mSv). Results: During the study period, 655,613 enrollees (68.8%) underwent at least one imaging procedure associated with radiation exposure. The mean (±SD) cumulative effective dose from imaging procedures was 2.4±6.0 mSv per enrollee per year; however, a wide distribution was noted, with a median effective dose of 0.1 mSv per enrollee per year (interquartile range, 0.0 to 1.7). Overall, moderate effective doses of radiation were incurred in 193.8 enrollees per 1000 per year, whereas high and very high doses were incurred in 18.6 and 1.9 enrollees per 1000 per year, respectively. In general, cumulative effective doses of radiation from imaging procedures increased with advancing age and were higher in women than in men. Computed tomographic and nuclear imaging accounted for 75.4% of the cumulative effective dose, with 81.8% of the total administered in outpatient settings. Conclusions: Imaging procedures are an important source of exposure to ionizing radiation in the United States and can result in high cumulative effective doses of radiation. N Engl J Med 2009;361:849-57. [ABSTRACT FROM AUTHOR]

The article focuses on an observational study which estimated hospital-level 30-day risk-standardized mortality rates (RSMRs) for patients discharged with acute myocardial infarction (AMI). Administrative data and a validated risk model were used to evaluate 3,195,672 discharges in 2,755,370 patients discharged from nonfederal acute care hospitals in the U.S. between January 1, 1995 to December 31, 2006. A significant decrease was observed in the risk-standardized hospital mortality rate for Medicare patients discharged with AMI, as well as between-hospital variation.

To improve hospital performance in door-to-balloon (DTB) times nationally, the American College of Cardiology D2B Alliance recently enrolled approximately 1,000 hospitals that perform percutaneous coronary intervention (PCI) across the United States in a large national quality improvement effort. We evaluated recent changes in DTB times in hospitals within the Get-With-The-Guidelines (GWTG) Coronary Artery Disease (CAD) program, a partner in the D2B Alliance. Within GWTG-CAD participating hospitals, we studied DTB in nontransferred patients with ST-elevation myocardial infarction treated with primary PCI from July 2006 to March 2008. We evaluated the percentage of patients treated within 90 minutes and used multivariable models with generalized estimating equations to examine trends over time after accounting for changes in patients'' characteristics. A total of 5,801 patients at 167 hospitals were included in our analysis, with 3,567 patients at 98 hospitals that joined the D2B Alliance. From July to September 2006, 54.1% of patients received primary PCI within 90 minutes. This number increased significantly during the study period: 335 (74.1%) of 452 patients at GWTG-CAD participating hospitals were treated within 90 minutes from January to March 2008, including 229 of 304 patients (75.3%) treated at hospitals that joined the D2B Alliance and 106 of 148 patients (71.6%) treated at other GWTG-CAD participating hospitals (p <0.001 for all comparisons over time). No statistically significant differences were noted in the rate of change between hospitals that joined the D2B Alliance and other GWTG-CAD participating hospitals. In conclusion, the percentage of patients treated with 90 minutes has dramatically increased at hospitals participating within the GWTG-CAD program, coinciding with the launch of the D2B Alliance. These improvements were broad and not limited to hospitals that joined the D2B Alliance. [Copyright &y& Elsevier]

The author reflects on the importance for clinical research funders, investigators, journals and policy makers to engage in international conversation about the culture of scientific communication to improve the quality of medical literature. He discusses the problems faced by the sector as a result of the changing practices that lead to longer times from completion of work to eventual publication. The author encourages the sector to adopt measures that will help it catch up.

Abstract: The assessment of medical practice is evolving rapidly in the United States. An initial focus on structure and process performance measures assessing the quality of medical care is now being supplemented with efficiency measures to quantify the “value” of healthcare delivery. This statement, building on prior work that articulated standards for publicly reported outcomes measures, identifies preferred attributes for measures used to assess efficiency in the allocation of healthcare resources. The attributes identified in this document combined with the previously published standards are intended to serve as criteria for assessing the suitability of efficiency measures for public reporting. This statement identifies the following attributes to be considered for publicly reported efficiency measures: integration of the quality and cost; valid cost measurement and analysis; minimal incentive to provide poor quality care; and proper attribution of the measure. The attributes described in this statement are relevant to a wide range of efforts to profile the efficiency of various healthcare providers, including hospitals, healthcare systems, managed-care organizations, physicians, group practices, and others that deliver coordinated care. [Copyright &y& Elsevier]

Background: Expert guidelines advocate defibrillation within 2 minutes after an in-hospital cardiac arrest caused by ventricular arrhythmia. However, empirical data on the prevalence of delayed defibrillation in the United States and its effect on survival are limited. Methods: We identified 6789 patients who had cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia at 369 hospitals participating in the National Registry of Cardiopulmonary Resuscitation. Using multivariable logistic regression, we identified characteristics associated with delayed defibrillation. We then examined the association between delayed defibrillation (more than 2 minutes) and survival to discharge after adjusting for differences in patient and hospital characteristics. Results: The overall median time to defibrillation was 1 minute (interquartile range, <1 to 3 minutes); delayed defibrillation occurred in 2045 patients (30.1%). Characteristics associated with delayed defibrillation included black race, noncardiac admitting diagnosis, and occurrence of cardiac arrest at a hospital with fewer than 250 beds, in an unmonitored hospital unit, and during after-hours periods (5 p.m. to 8 a.m. or weekends). Delayed defibrillation was associated with a significantly lower probability of surviving to hospital discharge (22.2%, vs. 39.3% when defibrillation was not delayed; adjusted odds ratio, 0.48; 95% confidence interval, 0.42 to 0.54; P<0.001). In addition, a graded association was seen between increasing time to defibrillation and lower rates of survival to hospital discharge for each minute of delay (P for trend <0.001). Conclusions: Delayed defibrillation is common and is associated with lower rates of survival after in-hospital cardiac arrest. N Engl J Med 2008;358:9-17. [ABSTRACT FROM AUTHOR]

The article presents the results of a literature review conducted by the authors that examined the putative genetic risk factors for acute coronary syndromes. The authors genotyped white patients with acute coronary syndromes and controls for variants in genes in an attempt to duplicate associations of the genetic variants with risk factors for acute coronary syndromes that had previously been reported. The authors found that none of the genetic variants tested were risk factors for acute coronary syndromes. The authors state that the previously reported studies linking the genetic variations to acute coronary syndromes need to be replicated before their findings are put into clinical practice.

To complement the current process measures for treating patients with heart attacks and with heart failure, which target gaps in quality but do not capture patient outcomes, the Centers for Medicare and Medicaid Services (CMS) has proposed the public reporting of hospital-level thirty-day mortality for these conditions in 2007. We present the case for including measurements of outcomes in the assessment of hospital performance, focusing on the care of patients with heart attacks and with heart failure. Recent developments in the methodology and standards for outcomes measurement have laid the ground-work for incorporating outcomes into performance monitoring efforts for these conditions. [ABSTRACT FROM AUTHOR]

The article discusses the underrepresentation of chronic renal disease in randomized controlled trials of cardiovascular disease. Nine million people in the United States population have chronic kidney disease. And of these many have cardiovascular disease (CVD), specifically coronary artery disease and chronic congestive heart failure. Recent studies suggest that renal disease independently portends increased morbidity and mortality in CVD. Because renal disease is so prevalent in CVD and the pathophysiologic processes so different from those with normal renal functions, it is important to have data on the subgroup of renal diseases. Patients with renal diseases must not be excluded, but included in CVD trials which need to be designated for this population of chronic renal patients.

BACKGROUND: Work hour regulations for house staff were intended in part to improve resident clinical and educational performance. OBJECTIVE: To characterize the effect of work hour regulation on internal medicine resident inpatient clinical experience and didactic education. DESIGN: Cross-sectional mall survey. PARTICIPANTS: Chief residents at all accredited U.S. internal medicine residency, programs outside New York. MEASUREMENTS AND MAIN RESULTS: The response rate was 62% (202/324). Most programs (72%) reported no change in average patient load per intern after work hour regulation. Many programs (48%) redistributed house staff admissions through the call cycle. The number of admissions per intern on long can (the day interns have the most admitting responsibility) decreased in 31% of programs, and the number of admissions on other days increased in 21% of programs. Residents on outpatient rotations were given new ward responsibilities in 36% of programs. Third-year resident ward and float time increased in 34% of programs, while third-year elective time decreased in 22% of programs. The mean weekly hours allotted to educational activities did not change significantly (12.7 vs 12.4. P=. 12). but 56% of programs reported a decrease in intern attendance at educational activities. CONCLUSIONS: In response to work hour regulation, many internal medicine programs redistributed rather than reduced residents' inpatient clinical experience. Hours allotted to educational activities did not change: however, most programs saw a decrease in intern attendance at conferences, and many reduced third-year elective time. [ABSTRACT FROM AUTHOR]

The article reports on the importance of the transfer of responsibility for patient care between physicians in the care of hospitalized patients. Clinical outcomes are affected by the systems of transfer management and transfer frequency. A self-administered survey to chief residents at accredited internal medicine residency programs outside the state of New York. Sign-out practices, skills training and transfer frequency were the main outcome measures.