Could Pay-for-Performance Worsen Health Disparities?

Pay-for-performance (P4P) has become a prominent component of health care funding in the Affordable Care Act (ACA) era. Although the ACA's future remains unclear, these programs receive bipartisan support and will likely continue to be a part of payment policies. At the same time, racial and class disparities remain among the most pressing of the many challenges facing the US health system. We review evidence of the effects of P4P on disparities at the population and individual levels. Providers caring for predominantly minority patients or those with lower socioeconomic status are known to have poorer quality metrics. Financial penalties run the risk of exacerbating disparities along race and class lines and across hospitals. The evidence regarding P4P programs is mixed, with safety-net hospitals facing greater penalties but with some improvement in outcomes among minority patients. A better understanding of the longitudinal effects of these plans is needed, and policymakers should be conscious of the risks in expanding these programs.

Association between trial registration and positive study findings: cross sectional study (Epidemiological Study of Randomized Trials-ESORT).

Objective To assess whether randomised controlled trials (RCTs) that were registered were less likely to report positive study findings compared with RCTs that were not registered and whether the association varied by funding source.Design Cross sectional study.Study sample All primary RCTs published in December 2012 and indexed in PubMed by November 2013. Trial registration was determined based on the report of a trial registration number in published RCTs or the identification of the trial in a search of trial registries. Trials were separated into prospectively and retrospectively registered studies.Main outcome measure Association between trial registration and positive study findings.Results 1122 eligible RCTs were identified, of which 593 (52.9%) were registered and 529 (47.1%) were not registered. Overall, registration was marginally associated with positive study findings (adjusted risk ratio 0.87, 95% confidence interval 0.78 to 0.98), even with stratification as prospectively and retrospectively registered trials (0.87, 0.74 to 1.03 and 0.88, 0.78 to 1.00, respectively). The interaction term between overall registration and funding source was marginally statistically significant and relative risk estimates were imprecise (0.75, 0.63 to 0.89 for non-industry funded and 1.03, 0.79 to 1.36 for industry funded, P interaction=0.046). Furthermore, a statistically significant interaction was not maintained in sensitivity analyses. Within each stratum of funding source, relative risk estimates were also imprecise for the association between positive study findings and prospective and retrospective registration.Conclusion Among published RCTs, there was little evidence of a difference in positive study findings between registered and non-registered clinical trials, even with stratification by timing of registration. Relative risk estimates were imprecise in subgroups of non-industry and industry funded trials.

Reporting of a Publicly Accessible Protocol and Its Association With Positive Study Findings in Cardiovascular Trials (from the Epidemiological Study of Randomized Trials [ESORT]).

Selective outcome reporting is common among published randomized trials and is often associated with the reporting of positive study findings. We investigated whether publication of study protocols in publicly accessible formats is associated with the reporting of positive findings. An extended version of the Cochrane highly sensitive search strategy was used to identify reports of randomized trials on cardiovascular disease that were published in December 2012 and indexed in PubMed by November 2013. Study characteristics and methodologic characteristics were extracted in duplicate. The Fisher's exact test and multivariable logistic regression were used to compare characteristics between trials that reported a publicly accessible protocol and those that did not. One hundred ninety-one reports of cardiovascular randomized trials were identified, 23 (12%) of which reported an accessible protocol. Trials reporting an accessible protocol were significantly larger and more likely to report strong trial methods, including reporting a power calculation, attrition, and the use of an intention-to-treat analysis. Despite greater statistical power, trials reporting an accessible protocol were less likely to report positive findings after controlling for known confounders (odds ratio 0.35, 95% confidence interval 0.13 to 0.94). Reporting of an accessible protocol is associated with a reduced likelihood of reporting positive findings. Further investigation is needed to determine if this association is causal.

Association between randomised trial evidence and global burden of disease: cross sectional study (Epidemiological Study of Randomized Trials--ESORT).

OBJECTIVES: To determine whether an association exists between the number of published randomised controlled trials and the global burden of disease, whether certain diseases are under-investigated relative to their burden, and whether the relation between the output of randomised trials and global burden of disease can be explained by the relative disease burden in high and low income regions. DESIGN: Cross sectional investigation. STUDY SAMPLE: All primary reports of randomised trials published in December 2012 and indexed in PubMed by 17 November 2013. MAIN OUTCOME MEASURES: Number of trials conducted and number of participants randomised for each of 239 different diseases or injuries; variation in each outcome explainable by total disability adjusted life years (a measure of the overall burden of each disease) and the ratio of disability adjusted life years in low income to high income regions (a measure of whether a disease is more likely to affect people living in high income regions) quantified using multivariable regression. RESULTS: 4190 abstracts were reviewed and 1351 primary randomised trials identified, of which 1097 could be classified using the global burden of disease taxonomy. Total disability adjusted life years was poorly associated with number of randomised trials and number of participants randomised in univariable analysis (Spearman's r=0.35 and 0.33, respectively), although it was a significant predictor in the univariable and multivariable models (P<0.001). Diseases for which the burden was predominantly located in low income regions had sevenfold fewer trials per million disability adjusted life years than diseases predominantly located in high income regions. However, only 26% of the variation in number of trials among diseases could be explained by total disability adjusted life years and the ratio of disability adjusted life years in low income regions to high income regions. Many high income type diseases (for example, neck pain, glomerulonephritis) have proportionally fewer randomised trials compared with low income type diseases (for example, vitamin A deficiency). CONCLUSIONS: Overall, a weak association existed between global burden of disease and number of published randomised trials. A global observatory for research is needed to monitor and reduce the discordance between the output of randomised trials and global burden of disease.