Statistical and Clinical Aspects of Hospital Outcomes Profiling

Hospital profiling involves a comparison of a health care provider's structure, processes of care, or outcomes to a standard, often in the form of a report card. Given the ubiquity of report cards and similar consumer ratings in contemporary American culture, it is notable that these are a relatively recent phenomenon in health care. Prior to the 1986 release of Medicare hospital outcome data, little such information was publicly available. We review the historical evolution of hospital profiling with special emphasis on outcomes; present a detailed history of cardiac surgery report cards, the paradigm for modern provider profiling; discuss the potential unintended negative consequences of public report cards; and describe various statistical methodologies for quantifying the relative performance of cardiac surgery programs. Outstanding statistical issues are also described.Comment: Published in at http://dx.doi.org/10.1214/088342307000000096 the Statistical Science (http://www.imstat.org/sts/) by the Institute of Mathematical Statistics (http://www.imstat.org

The Medical Treatment of Depression, 1991-1996: Productive Inefficiency, Expected Outcome Variations, and Price Indexes

We examine the price of treating episodes of acute phase major depression over the 1991-1996 time period. We combine data from a large retrospective medical claims data base (MarketScanTM, from the MedStat Group) with clinical literature and expert clinical opinion elicited from a two-state Delphi procedure. This enables us to construct a variety of treatment price indexes that include variations over time in the proportion of off-frontier' production, as well as the corresponding variations in expected treatment outcomes. We also incorporate the fact that the no treatment option ( waiting list') frequently results in spontaneous remission of depressive symptoms. We find that in general the incremental cost of successfully treating an episode of acute phase major depression has generally fallen over the 1991-96 time period. Based on hedonic regression equations that account for the effects of changing patient mix, we find price reductions that range from about -1.66% to -2.13% per year. An implication of this is that, since expenditures on depression are thought to be increasing since at least 1991, the source of the spending increases is volume (quantity) increases, and not price increases.

Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention

Introduction: During the past decade, the volume of percutaneous coronary intervention (PCI) in China has risen by more than 20-fold. Yet little is known about patterns of care and outcomes across hospitals, regions and time during this period of rising cardiovascular disease and dynamic change in the Chinese healthcare system. Methods and analysis Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, the Retrospective Study of Coronary Catheterisation and Percutaneous Coronary Intervention (China PEACE-Retrospective CathPCI Study) will examine a nationally representative sample of 11 900 patients who underwent coronary catheterisation or PCI at 55 Chinese hospitals during 2001, 2006 and 2011. We selected patients and study sites using a two-stage cluster sampling design with simple random sampling stratified within economical-geographical strata. A central coordinating centre will monitor data quality at the stages of case ascertainment, medical record abstraction and data management. We will examine patient characteristics, diagnostic testing patterns, procedural treatments and in-hospital outcomes, including death, complications of treatment and costs of hospitalisation. We will additionally characterise variation in treatments and outcomes by patient characteristics, hospital, region and study year. Ethics and dissemination The China PEACE collaboration is designed to translate research into improved care for patients. The study protocol was approved by the central ethics committee at the China National Center for Cardiovascular Diseases (NCCD) and collaborating hospitals. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of coronary catheterisation and PCI in China. Registration details http://www.clinicaltrials.gov (NCT01624896)

Effects of gender and ethnicity on outcomes after aortic valve replacement

ObjectiveTo evaluate the clinical outcomes after aortic valve replacement or aortic valve replacement and coronary artery bypass grafting in a large contemporary population, and to determine if outcomes are associated with patient ethnicity and gender status.MethodsUsing the Massachusetts Cardiac Surgery Database, we identified 6809 adults aged 18 years or older who had undergone isolated aortic valve replacement or aortic valve replacement and coronary artery bypass grafting in all non-federal acute-care Massachusetts hospitals from 2002 to 2008. Univariate and multivariate logistic regression analyses were used to identify differences in patient characteristics, major morbidity, and 30-day and 1-year mortality between men (n = 4043) and women (n = 2766) and between whites (n = 6481) and nonwhites (n = 328).ResultsThe unadjusted 30-day mortality rate was 2.6% for the men and 3.1% for the women (P = .296) and 2.8% for whites and 3.7% for nonwhites (P = .342). In adjusted logistic regression models, the 30-day mortality was not different between the female and male patients (odds ratio, 0.88; 95% confidence interval, 0.26–3.02, P = .84) nor between the nonwhites and whites (odds ratio, 1.57; 95% confidence interval, 0.45–5.44; P = .48). The incidence of postoperative stroke was greater in women (3.0% women and 2.2% men, P = .031), and the incidence of postoperative myocardial infarction (10.9% women and 13.6% men; P = .001) and septicemia (1.2% women and 2.0% men; P = .009) was greater in men.ConclusionsEthnicity and gender were not associated with greater 30-day and 1-year mortality after aortic valve replacement or aortic valve replacement and coronary artery bypass grafting. Differences in postoperative outcomes were not observed between ethnic groups

Regional Variation in Physician Adoption of Antipsychotics: Impact on US Medicare expenditures

Background—Regional variation in US Medicare prescription drug spending is driven by higher prescribing of costly brand-name drugs in some regions. This variation likely arises from differences in the speed of diffusion of newly-approved medications. Second-generation antipsychotics were widely adopted for treatment of severe mental illness and for several off-label uses. Rapid diffusion of new psychiatric drugs likely increases drug spending but its relationship to non-drug spending is unclear. The impact of antipsychotic diffusion on drug and medical spending is of great interest to public payers like Medicare, which finance a majority of mental health spending in the U.S.National Institute of Mental Health (U.S.) (R01 MH093359

Statistical Issues in Assessing Hospital Performance

From the Preface: The Centers for Medicare and Medicaid Services (CMS), through a subcontract with Yale New Haven Health Services Corporation, Center for Outcomes Research and Evaluation (YNHHSC/CORE), is supporting a committee appointed by the Committee of Presidents of Statistical Societies (COPSS) to address statistical issues identified by the CMS and stakeholders about CMS’s approach to modeling hospital quality based on outcomes. In the spring of 2011, with the direct support of YNHHSC/ CORE, COPSS formed a committee comprised of one member from each of its constituent societies, a chair, and a staff member from the American Statistical Association, and held a preliminary meeting in April. In June, YNHHSC/CORE executed a subcontract with COPSS under its CMS contract to support the development of a White Paper on statistical modeling. Specifically, YNHHSC/CORE contracted with COPSS to “provide guidance on statistical approaches . . .when estimating performance metrics,” and “consider and discuss concerns commonly raised by stakeholders (hospitals, consumer, and insurers) about the use of “hierarchical generalized linear models in profiling hospital quality. The committee convened in June and August of 2011, and exchanged a wide variety of materials. To ensure the committee’s independence, YNHHSC/CORE did not comment on the white paper findings, and CMS pre-cleared COPSS’ publication of an academic manuscript based on the White Paper

Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing

<p>Abstract</p> <p>Background</p> <p>Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery.</p> <p>Methods</p> <p>A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year.</p> <p>Results</p> <p>We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80).</p> <p>Conclusions</p> <p>The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.</p

Data sources and applied methods for paclitaxel safety signal discernment

BackgroundFollowing the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB) and drug-eluting stent (DES). The objective of this review is to (1) identify and summarize the existing clinical and cohort studies assessing paclitaxel-coated DCBs and DESs, (2) describe and determine the quality of the available data sources for the evaluation of these devices, and (3) present methodologies that can be leveraged for proper signal discernment within available data sources.MethodsStudies and data sources were identified through comprehensive searches. original research studies, clinical trials, comparative studies, multicenter studies, and observational cohort studies written in the English language and published from January 2007 to November 2021, with a follow-up longer than 36 months, were included in the review. Data quality of available data sources identified was assessed in three groupings. Moreover, accepted data-driven methodologies that may help circumvent the limitations of the extracted studies and data sources were extracted and described.ResultsThere were 39 studies and data sources identified. This included 19 randomized clinical trials, nine single-arm studies, eight registries, three administrative claims, and electronic health records. Methodologies focusing on the use of existing premarket clinical data, the incorporation of all contributed patient time, the use of aggregated data, approaches for individual-level data, machine learning and artificial intelligence approaches, Bayesian approaches, and the combination of various datasets were summarized.ConclusionDespite the multitude of available studies over the course of eleven years following the first clinical trial, the FDA-convened advisory panel found them insufficient for comprehensively assessing the late-mortality signal. High-quality data sources with the capabilities of employing advanced statistical methodologies are needed to detect potential safety signals in a timely manner and allow regulatory bodies to act quickly when a safety signal is detected