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Patient-reported outcome measures in MS: Do development processes and patient involvement support valid quantification of clinically important variables?

Trishna BharadiaJo VandercappellenTanuja ChitinisPiet EelenBirgit BauerGiampaolo BrichettoAndrew LloydHollie SchmidtMiriam KingJennifer FitzgeraldThomas HachJeremy Hobart
Published in: Multiple sclerosis journal - experimental, translational and clinical (2022)
To date, the PRO development process has consistently lacked clear definitions of concepts of interest, use of conceptual frameworks and patient involvement, thereby compromising the validity of data they generate. PRO instrument development must be conducted more robustly to maximise the value of pivotal clinical trials.
Keyphrases
  • patient reported outcomes
  • clinical trial
  • case report
  • mass spectrometry
  • ms ms
  • anti inflammatory
  • randomized controlled trial
  • electronic health record
  • big data
  • open label