摘要To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine(ICWM)for ulcerative colitis(UC),we aim to develop a customized core outcome set(COS)that incorporates input from various stake-holders.The study design of this COS has been informed by the Core Outcome Measures in Effectiveness Trials Initiative Handbook,with adherence to the guidelines from the Core Outcome Set-STAndards for Reporting statement and Core Outcome Set-STAndardised Protocol Items recommendations.Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC,including healthcare professionals,patients,COS developers,COS users,and methodologists.The pro-cess will involve five stages:(1)conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains;(2)conducting semi-structured interviews to obtain important outcomes;(3)choosing the most important outcomes by conducting three-round Delphi surveys;(4)achieving a consensus in a face-to-face meeting to discuss the final COS;and(5)pub-lication,dissemination and implementation of COS.Consequently,this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine(TCM)and ICWM interventions.