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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 Weinfurt
Published 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.
Keyphrases
  • patient reported outcomes
  • clinical trial
  • phase ii
  • phase iii
  • study protocol
  • open label
  • healthcare
  • mental health
  • double blind
  • randomized controlled trial