Centrally adjudicated vs. investigator-reported outcomes in randomized heart failure trials.

ABSTRACT:

Background and aims

Heart failure endpoints in cardiovascular outcome trials are commonly identified through centralized adjudication of investigator-reported events. It remains unclear whether central adjudication improves the accuracy of treatment effect estimates in terms of log[hazard ratios (HR)].

Methods

Data from seven cardiovascular outcome trials with >1000 patients that included centrally adjudicated heart failure outcomes were utilized to assess (i) the concordance between investigator-reported and centrally adjudicated heart failure and cardiovascular death events; (ii) rates of subsequent all-cause mortality following positively vs. negatively adjudicated heart failure events; and (iii) the correlation of log(HR) based on centrally adjudicated vs. investigator-r

SUBMITTER: Wandel S 

PROVIDER: S-EPMC11646619 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature