RESUMEN
Higher mortality in Blacks than Whites has been consistently reported in the US, but previous investigations have not accounted for poverty at the individual level. The health of its population is an important part of the capital of a nation. We examined the association between individual level poverty and disability and racial mortality differences in a 5% Medicare beneficiary random sample from 2004 to 2010. Cox regression models examined associations of race with all-cause mortality, adjusted for demographics, comorbidities, disability, neighborhood income, and Medicare "Buy-in" status (a proxy for individual level poverty) in 1,190,510 Black and White beneficiaries between 65 and 99 years old as of January 1, 2014, who had full and primary Medicare Part A and B coverage in 2004, and lived in one of the 50 states or Washington DC. Overall, black beneficiaries had higher sex-and-age adjusted mortality than Whites (hazard ratio [HR] 1.18). Controlling for health-related measures and disability reduced the HR for Black beneficiaries to 1.03. Adding "Buy-in" as an individual level covariate lowered the HR for Black beneficiaries to 0.92. Neither of the residential measures added to the predictive model. We conclude that poorer health status, excess disability, and most importantly, greater poverty among Black beneficiaries accounts for racial mortality differences in the aged US Medicare population. Poverty fosters social and health inequalities, including mortality disparities, notwithstanding national health insurance for the US elderly. Controlling for individual level poverty, in contrast to the common use of area level poverty in previous analyses, accounts for the White survival advantage in Medicare beneficiaries, and should be a covariate in analyses of administrative databases.
RESUMEN
BACKGROUND: Randomized controlled trials (RCTs) reflect priorities established by regulators. Recently, pragmatic clinical trials (PCTs) have begun to attract interest. Unlike RCTs, PCTs aim to better inform post-regulatory decision making by using head-to-head comparisons of alternative treatments, diverse patient populations, and outcomes meaningful to patients, prescribers, and payers. OBJECTIVES: To describe how U.S. insurers and public payers perceive the value of PCTs for assessment of new prescription drugs. STUDY DESIGN: Criterion-based sample of U.S. insurers and public payers. METHODS: We gathered qualitative evidence from intensive interviews with formulary decision makers at 15 payers, representing 10 major types of U.S. payers. Prior literature and exploratory interviews informed our question selection. RESULTS: Payers viewed PCTs favorably despite wariness of drug company-sponsored trials. Payers would accept results from PCTs as part of payers' synthesis of multiple sources of evidence. Payers were enthusiastic about 2 PCT features-a diverse population (compared with the more homogeneous populations typical of RCTs) and an active comparator drug (not placebo). Payers did not anticipate that PCTs would displace their own analyses of internal data. Pharmaceutical companies' financial interest in obtaining trial results that favor their own drugs reduces PCTs' perceived value and dampens their appeal to payers; nonetheless, payers would seek PCT results and review them carefully, as they do other evidence. CONCLUSIONS: Recommendations to trial designers based on payers' views include tailoring different types of PCTs to different disease conditions, building in head-to-head comparisons in phase IIIb PCTs, and designing phase IV PCTs to include broader populations.