The following is a summary of “Pragmatic trial design to compare real-world effectiveness of different treatments for inflammatory bowel diseases: the PRACTICE-IBD European consensus,” published in the February 2024 issue of Gastroenterology by Fantini et al.
Researchers conducted a retrospective study within PRACTICE-IBD to assess the effectiveness of interventions for inflammatory bowel diseases (IBDs) in real-world clinical settings.
They issued statements on four key topics: study design, eligibility, recruitment, organization flexibility, outcomes, and analysis. The consensus process was conducted by a panel of 11 European experts in IBD management and trial methodology. It followed a modified Delphi approach, with two rounds of assessment and rating by 18 additional European experts in IBD. Approval required a rating of 7 or higher on a scale of 1 to 9.
The results showed that in the initial voting round, 96% (25/6) of the statements achieved a mean score ≥7. After discussion preceding the second round, it was agreed to remove two statements and divide one into two. In the final round, 96% (25) of the statements were approved: 28% (7) for study design, 24% (6) for eligibility, recruitment, and organization flexibility, 32% (8) for outcomes, and 16% (4) for analysis.
Investigators concluded that a consensus effort established 25 critical principles for designing rigorous, pragmatic trials in IBD to inform treatment decisions with real-world evidence.
Source: academic.oup.com/ecco-jcc/advance-article-abstract/doi/10.1093/ecco-jcc/jjae026/7609924