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A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice.

Benjamin E ByrneLeila RooshenasHelen S LambertJane M Blazeby
Published in: BMC medical research methodology (2020)
This novel method for examining interpretation of an RCT in the clinical community showed that published responses identified limited issues with trial design. Responses did not provide coherent rationales for accepting (or not) trial results. Findings may suggest that authors lacked skills in appraisal of RCT design and conduct. Multiple case studies with cross-case analysis of other trials are needed.
Keyphrases
  • study protocol
  • phase iii
  • healthcare
  • phase ii
  • clinical trial
  • primary care
  • randomized controlled trial
  • mental health
  • open label
  • double blind