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Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD): Consensus on Obesity and Cardiometabolic Comorbidities in Inflammatory Bowel Disease using Evidence Synthesis and the RAND/UCLA Appropriateness Method

Devi, J.; SAMAAN, S.; SEHGAL, P.; Mohamed, M.; VINCENT, M.; Coombs, S.; Doering, M.; BARNES, E. L.; JOHNSON, A. M.; YARUR, A. J.; Deepak, P.

2025-12-22 gastroenterology
10.64898/2025.12.20.25342738 medRxiv
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IntroductionObesity and related cardiometabolic comorbidities, including hypertension, dyslipidemia, diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD), and atherosclerotic cardiovascular disease (ASCVD), are increasingly prevalent among individuals with inflammatory bowel disease (IBD). These conditions influence disease activity, therapeutic response, surgical outcomes, and overall quality of life, yet evidence remains fragmented. The Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD) initiative aims to synthesize evidence and generate consensus recommendations to guide practice and future research in this area. Methods and analysisWe will conduct a structured evidence review organized into three domains: (1) the impact of obesity on IBD outcomes (2) burden of cardiometabolic complications in IBD, and (3) management of obesity and cardiometabolic comorbidities in IBD. Draft clinical statements will be generated and evidence summaries prepared using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) framework, with certainty of evidence rated where applicable. In the assessment of those statements where GRADE is not feasible, a multidisciplinary international panel of gastroenterologists, surgeons, endocrinologists, hepatologists, cardiologists, and dietitians will assess each statement using the RAND/UCLA Appropriateness Method. Panelists will rate the appropriateness of each statement (only those that fall into their area of expertise) on a 1-9 scale (1-3 = inappropriate, 4-6 = uncertain, 7-9 = appropriate), with medians rounded up (e.g., 6.5 = appropriate). Agreement will be assessed using the RAND Disagreement Index (DI <1.0 = agreement). Ethics and disseminationThis study will not involve direct patient participation, as it is based on evidence synthesis and expert consensus; therefore, formal Research Ethics Committee approval will not be required. Patient representatives will contribute to the consensus process to provide contextual perspectives, but no identifiable data will be collected. Findings will be disseminated through publication in peer-reviewed journals, presentation at major gastroenterology and IBD conferences, and communication with professional societies. A lay summary and patient-friendly infographic will also be developed to facilitate translation of recommendations into clinical practice. PROSPERO registration numberCRD420251178843: A systematic review of the impact of obesity on inflammatory bowel disease outcomes CRD420251178799: A Systematic Review of Cardiometabolic Complications in Inflammatory Bowel Disease CRD420251174653: Management of Overweight, Obesity, and Cardiometabolic Comorbidities in Inflammatory Bowel Disease: A Systematic Review Strengths and limitationsO_LIIntegrates systematic evidence synthesis with both GRADE and RAND/UCLA methods, an approach not previously applied to obesity and cardiometabolic comorbidities in IBD. C_LIO_LIInternational, multidisciplinary panel (gastroenterology, surgery, endocrinology, cardiology, dietetics, radiology) ensures broad expertise. C_LIO_LIAnonymous scoring and iterative re-rating reduce bias while enabling structured discussion. C_LIO_LIPatient and public involvement will inform priorities and dissemination, although RAND scoring remains expert-only. C_LIO_LIEvidence is largely observational and rapidly evolving (e.g., Glucagon-Like Peptide-1 Receptor Agonists [GLP-1Ras], endobariatric therapies), necessitating future updates. C_LI

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