Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set

Abstract

Treatment targets in both randomized controlled trials (RCTs) and daily practice have evolved for patients with ulcerative colitis (UC), motivated by changing regulatory requirements and efforts to alter the disease's natural history. Substantial heterogeneity in outcome definitions has been identified in UC RCTs.¹ To harmonize treatment outcomes that should be reported, we proposed the collaborative development of a core outcome set (COS).² A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials to facilitate reporting consistency, reduce selective reporting bias, and improve quality of evidence synthesis.³.