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 nullPublished 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.