Background
Randomized controlled trials (RCTs) provide high-quality evidence but often lack generalizability to real-world populations. Although real-world evidence (RWE) studies help to bridge this gap, retrospective design and heterogeneous outcome measures still limit their standardization in Crohn’s disease (CD). Building on the recent ECCO Position Paper, this study aimed to identify the most relevant outcomes for real-world CD studies.
Methods
An international panel of inflammatory bowel disease (IBD) specialists participated in a structured two-round Delphi e-survey using the RAND/UCLA Appropriateness Method. Experts rated outcomes across eight domains, including disease activity, patient-reported outcomes, and treatment safety. Agreement was assessed using the Disagreement Index (DI), where DI?>?1 indicated disagreement, and DI?=?1 indicated agreement or no disagreement. Weighted scoring prioritized key outcomes.
Results
A total of 51/85 experts (60%) completed Round 1 and 48/51 (94%) Round 2. No disagreement was observed (DI?
Conclusions
This expert-driven Delphi study provides a standardized framework for selecting outcomes in CD RWE studies, improving consistency and comparability across future research in this field.
Paula Leão Moreira, Axel Dignass, Maria Manuela Estevinho, Mafalda Santiago, Walter Reinisch, Bruce E Sands, Geert D’Haens, Gerassimos J Mantzaris, Silvio Danese, Laurent Peyrin-Biroulet, Iris Dotan, Vipul Jairath, Fernando Magro
Disease Category: Gastroenterology
Disease Name: Crohn's disease
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- COS for practice
- Delphi process
- Systematic review