Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials.
Theresa M ColesAdrian F HernandezBryce B ReeveKaron CookMichael C EdwardsMarc BoutinElizabeth BushArnold DegboeLothar RoessigAmy RudolphPauline McNultyNikunj PatelTrish Kay-MugfordMargaret VernonMichael WoloschakGustavo BucheleJohn A SpertusMatthew T RoeDenise BuryKevin WeinfurtPublished in: Health and quality of life outcomes (2021)
A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.