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Pragmatic Trial Design to Compare Real-world Effectiveness of Different Treatments for Inflammatory Bowel Diseases: The PRACTICE-IBD European Consensus.

Massimo Claudio FantiniGionata FiorinoAgostino ColliDavid LaharieAlessandro ArmuzziFlavio Andrea CaprioliFrancisco Javier García-AlonsoJulien KirchgesnerFabio Salvatore MacalusoFernando MagroSubrata Ghoshnull null
Published in: Journal of Crohn's & colitis (2024)
Pragmatic, randomised, clinical trials can address important questions in IBD clinical practice, and may provide complementary, high-level evidence, as long as they follow a methodologically rigorous approach. These 25 statements intend to offer practical guidance in the design of high-quality, pragmatic, clinical trials that can aid decision making in choosing a management strategy for IBDs.
Keyphrases
  • clinical trial
  • study protocol
  • clinical practice
  • phase ii
  • randomized controlled trial
  • open label
  • phase iii
  • double blind
  • healthcare
  • primary care
  • placebo controlled
  • ulcerative colitis
  • quality improvement