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Abstract

Background & Aim: Increasing prevalence and significant medical expenses associated with Inflammatory Bowel Disease (IBD) necessitate high-quality clinical research to evaluate treatment effectiveness. Randomized control trials (RCTs) provide robust evidence, but the diversity of outcomes used in these trials poses challenges in summarizing outcomes for systematic reviews. Core Outcome Sets (COS) were established to improve the comparability of outcomes across studies. The aim of this study is to examine the uptake of the COS for IBD within clinical trials.

Methods: This cross-sectional analysis involved screening ClinicalTrials.gov for RCTs evaluating outcomes in patients with IBD. We extracted information on the four outcome domains — (1) symptoms, function, and quality of life; (2) disutility of care; (3) healthcare utilization; and (4) survival and disease control — and trial characteristics. Extraction was performed in a masked, duplicate manner.

Results: The initial search identified 3,205 trials from ClinicalTrials.gov, and after exclusions, the final sample included 177 clinical trials for analysis. The uptake of COS over time was not statistically significant. The most frequently reported outcomes were change in bowel symptoms (88.1%, 156/177) and pain or discomfort (83.1%, 147/177). In contrast, no trial reported on colorectal cancer, only 1% (2/177) reported overall survival, and 8% (15/177) reported cause of death.

Conclusion: Our study revealed no increase in adherence to COS in IBD clinical trials, before or after the publication of the IBD COS. We recommend that trialists make efforts to implement COS in clinical trials to improve the standardization across studies in the field of IBD.
Original languageAmerican English
StatePublished - 21 Jul 2023
Event7th Annual Joint Research Meeting - Oklahoma State University Center for Health Sciences, Tulsa, United States
Duration: 21 Jul 202321 Jul 2023

Conference

Conference7th Annual Joint Research Meeting
Country/TerritoryUnited States
CityTulsa
Period21/07/2321/07/23

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