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International guidance on the selection of patient-reported outcome measures in clinical trials: a review.

Norah L CrossnohereMichael BrundageMelanie J CalvertMadeleine KingBryce B ReeveElissa ThornerAlbert W WuClaire Snyder
Published in: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation (2020)
The consistency in recommendations suggests an emerging consensus in the field and supports use of any of the major guidance documents available to guide PROM selection for clinical trials without concern of conflicting recommendations. This work represents an important first step in the international PROTEUS Consortium's ongoing efforts to optimize the use of PROs in clinical trials.
Keyphrases
  • clinical trial
  • patient reported outcomes
  • clinical practice
  • phase ii
  • phase iii
  • double blind
  • study protocol
  • placebo controlled