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Background: There are increasing calls for regionalization of acute myocardial infarction (AMI) care in the United States to hospitals with the capacity to perform percutaneous coronary intervention (PCI). Whether regionalization will improve outcomes depends in part on the magnitude of existing differences in outcomes between PCI and non-PCI hospitals within the same health care region., Methods: A 100% sample of claims from Medicare fee-for-service beneficiaries 65 years or older hospitalized for AMI between January 1, 2004, and December 31, 2006, was used to calculate hospital-level, 30-day risk-standardized mortality rates (RSMRs). The RSMRs between PCI and local non-PCI hospitals were compared within local health care regions defined by hospital referral regions (HRRs)., Results: A total of 523 119 AMI patients was admitted to 1382 PCI hospitals, and 194 909 AMI patients were admitted to 2491 non-PCI hospitals in 295 HRRs with at least 1 PCI and 1 non-PCI hospital. Although PCI hospitals had lower RSMRs than non-PCI hospitals (mean, 16.1% vs 16.9%; P < .001), considerable overlap was seen in RSMRs between non-PCI and PCI hospitals within the same HRR. In 80 HRRs, the RSMRs at the best-performing PCI hospital were lower than those at local non-PCI hospitals by 3% or more. Among the remaining HRRs, the RSMRs at the best-performing PCI hospital were lower by 1.5% to 3.0% in 104 HRRs and by greater than 0 to 1.5% in 74 HRRs. In 37 HRRs, the RSMRs at the best-performing PCI hospital were no better or were higher than at local non-PCI hospitals., Conclusions: The magnitude of benefit from comprehensively regionalizing AMI care to PCI hospitals appears to vary greatly across HRRs. These findings support a tailored regionalization policy that targets areas with the greatest outcome differences between PCI and local non-PCI hospitals.

Background: The rankings of "America's Best Hospitals" by U.S. News & World Report are influential, but the performance of ranked hospitals in caring for patients with routine cardiac conditions such as heart failure is not known., Methods and Results: Using hierarchical regression models based on medical administrative data from the period July 1, 2005, to June 30, 2006, we calculated risk-standardized mortality rates and risk-standardized readmission rates for ranked and nonranked hospitals in the treatment of heart failure. The mortality analysis examined 14 813 patients in 50 ranked hospitals and 409 806 patients in 4761 nonranked hospitals. The readmission analysis included 16 641 patients in 50 ranked hospitals and 458 473 patients in 4627 nonranked hospitals. Mean 30-day risk-standardized mortality rates were lower in ranked versus nonranked hospitals (10.1% versus 11.2%, P<0.01), whereas mean 30-day risk-standardized readmission rates were no different between ranked and nonranked hospitals (23.6% versus 23.8%, P=0.40). The 30-day risk-standardized mortality rates varied widely for both ranked and nonranked hospitals, ranging from 7.9% to 12.4% for ranked hospitals and from 7.1% to 17.5% for nonranked hospitals. The 30-day risk-standardized readmission rates also spanned a large range, from 18.7% to 29.3% for ranked hospitals and from 19.2% to 29.8% for nonranked hospitals., Conclusions: Hospitals ranked by U.S. News & World Report as "America's Best Hospitals" in "Heart & Heart Surgery" are more likely than nonranked hospitals to have a significantly lower than expected 30-day mortality rate, but there was much overlap in performance. For readmission, the rates were similar in ranked and nonranked hospitals.

Background: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication., Methods and Findings: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006)., Conclusions: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited. Please see later in the article for the Editors' Summary.

Background: Readmission after heart failure (HF) hospitalization is an increasing focus for physicians and policy makers, but statistical models are needed to assess patient risk and to compare hospital performance. We performed a systematic review to describe models designed to compare hospital rates of readmission or to predict patients' risk of readmission, as well as to identify studies evaluating patient characteristics associated with hospital readmission, all among patients admitted for HF., Methods: We identified relevant studies published between January 1, 1950, and November 19, 2007, by searching MEDLINE, Scopus, PsycINFO, and all 4 Ovid Evidence-Based Medicine Reviews. Eligible English-language publications reported on readmission after HF hospitalization among adult patients. We excluded experimental studies and publications without original data or quantitative outcomes., Results: From 941 potentially relevant articles, 117 met inclusion criteria: none contained models to compare readmission rates among hospitals, 5 (4.3%) presented models to predict patients' risk of readmission, and 112 (95.7%) examined patient characteristics associated with readmission. Studies varied in case identification, used multiple types of data sources, found few patient characteristics consistently associated with readmission, and examined differing outcomes, often either readmission alone or a combined outcome of readmission or death, measured across varying periods (from 14 days to 4 years). Two articles reported model discriminations of patient readmission risk, both of which were modest (C statistic, 0.60 for both)., Conclusions: Our systematic review identified no model designed to compare hospital rates of readmission, while models designed to predict patients' readmission risk used heterogeneous approaches and found substantial inconsistencies regarding which patient characteristics were predictive. Clinically, patient risk stratification is challenging. From a policy perspective, a validated risk-standardized statistical model to accurately profile hospitals using readmission rates is unavailable in the published English-language literature to date.