Abstract:
Background and Objectives: At present, there is no consensus definition of mild-to-moderate disease activity in patients with ulcerative colitis. The objective of the present study was to establish a reliable definition of mild-to-moderate disease activity in adult patients with ulcerative colitis. Materials and Methods: Twelve physicians from around the world participated in a virtual consensus meeting on 26 September 2022. All the physicians had expertise in the diagnosis and treatment of inflammatory bowel disease. After a systematic review of the literature and expert opinion, a modified version of the RAND/University of California, Los Angeles appropriateness method was applied. A total of 49 statements were identified and then anonymously rated (on a 9-point scale) as being appropriate (scores of 7 to 9), uncertain (4 to 6) or inappropriate (1 to 3). The survey results were reviewed and amended before a second round of voting. Results: Symptom and endoscopic-based measurements are of prime importance for assessing mild-to-moderate ulcerative colitis activity in clinical trials. The experts considered that clinical activity should be assessed in terms of stool frequency, rectal bleeding and fecal urgency, whereas endoscopic activity should be evaluated with regard to the vascular pattern, bleeding, erosions and ulcers. Fecal calprotectin was considered to be a suitable disease activity marker in mild-to-moderate ulcerative colitis. Lastly, mild-to-moderate ulcerative colitis should not have more than a small impact on the patient\'s daily activities. Conclusions: The present recommendations constitute a standardized framework for defining mild-to-moderate disease activity in clinical trials in the field of ulcerative colitis.
摘要:
背景和目标:目前,对于溃疡性结肠炎患者的轻度至中度疾病活动性,目前尚无一致的定义.本研究的目的是建立成人溃疡性结肠炎患者轻度至中度疾病活动的可靠定义。材料与方法:来自世界各地的12名医生参加了2022年9月26日的虚拟共识会议。所有医生都在炎症性肠病的诊断和治疗方面具有专业知识。在对文献和专家意见进行系统回顾后,RAND/加利福尼亚大学的修改版本,采用了洛杉矶适当性方法。总共确定了49条陈述,然后匿名评级(按9分制)为适当的(得分为7至9),不确定(4到6)或不适当(1到3)。在第二轮投票之前对调查结果进行了审查和修改。结果:在临床试验中,症状和基于内窥镜的测量对于评估轻度至中度溃疡性结肠炎活动至关重要。专家认为,临床活动应根据粪便频率进行评估,直肠出血和粪便急迫,而内窥镜活动应根据血管模式进行评估,出血,糜烂和溃疡。粪便钙卫蛋白被认为是轻度至中度溃疡性结肠炎的合适疾病活动标志物。最后,轻度至中度溃疡性结肠炎不应对患者的日常活动产生很小的影响。结论:本建议构成了在溃疡性结肠炎领域的临床试验中定义轻度至中度疾病活动性的标准化框架。