Development and Validation of the IBD-REFER Criteria: Early Referral for Suspected Inflammatory Bowel Diseases in Adults and Children

BACKGROUND: Early treatment of inflammatory bowel disease (IBD) is associated with positive outcomes but a significant diagnostic delay has been reported in most countries. AIM: We aimed to develop and validate IBD-REFER criteria, intended for primary care physicians, to screen patients at risk for IBD. METHODS: A Delphi group of 10 experts generated a list of symptoms associated with the onset of IBD, supplemented by a review of the literature. The list was reduced in an iterative process and graded based on importance. For data-driven statistical formatting, the charts of 200 IBD (100 children, 100 adults) and 100 non-IBD controls but with gastrointestinal symptoms were reviewed. The IBD-REFER items were scored for each subject, as well as the contending Red Flag criteria from the International Organization for the Study of IBD. External validation was performed on additionally enrolled cohorts of 100 IBD patients and 50 controls. RESULTS: The Delphi process retained 5 items as major criteria (≥1 item required for early referral) and 11 as minor (≥2 items required). Following the removal of uninformative items and further formatting in the data-driven stage, 10 core items were retained: 3 as major and 7 as minor. In the external validation, the final IBD-REFER criteria had a sensitivity/specificity of 98%/96% in adults and 96%/96% in children, significantly higher than achieved by the Red Flag criteria (71%/84% and 60%/88%, respectively; P < 0.001). CONCLUSION: The IBD-REFER criteria may guide the selection of patients for expedited gastrointestinal investigation.