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Verifying participant-reported clinical outcomes: challenges and implications.

Suzanne BreemanLynda ConstableAnne DuncanKath StarrAlison McDonaldSamantha WilemanSeonaidh Cotton
Published in: Trials (2020)
We used different approaches in our verification of participant-reported outcomes in clinical trials, and we believe there is no one optimal solution. Consideration of issues such as what information is sought from participants, the phrasing of questions, whether the medical records are a true 'gold standard' and costs and benefits to the RCT may help determine the appropriate approach.
Keyphrases
  • clinical trial
  • healthcare
  • type diabetes
  • randomized controlled trial
  • metabolic syndrome
  • phase ii
  • silver nanoparticles
  • skeletal muscle
  • adipose tissue
  • study protocol
  • placebo controlled