Lesnovska Katarina Pihl, Münch Andreas, Bonderup Ole, Magro Fernando, Kupcinskas Juozas, Zabana Yamile, Tontini Gian Eugenio, Munck Lars Kristian, Guagnozzi Danila, Latella Giovanni, Fernandez-Banares Fernando, Miehlke Stephan, Madisch Ahmed, Wildt Signe, Hjortswang Henrik
Department of Gastroenterology and Hepatology in Linköping, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden.
Diagnostik Center, Hospitalenhed Midt, Regionhospitalet Silkeborg, Silkeborg, Denmark.
J Crohns Colitis. 2022 Mar 14;16(3):452-459. doi: 10.1093/ecco-jcc/jjab170.
Patient-reported outcome measures [PROMs] aim to measure patients' perception of how their disorder influences everyday functioning. The objective of this study was to develop a PROM to assess disease activity in microscopic colitis [MC] fulfilling the requirements of the Food and Drug Administration [FDA].
The European Microscopic Colitis Activity Index [E-MCAI] was developed in four steps. [1] A list of symptoms associated with active MC was created by a group of experts in the field. [2] Content validity of the symptoms was performed by experts [n = 14] and patients [n = 79] using the Content Validity Index. [3] Questions and response alternatives were created for each symptom, and validity of the E-MCAI was evaluated with cognitive interviews with patients [n = 7] and by the experts. [4] A pilot postal survey was performed to ensure usability.
Seven of the symptoms related to active MC fulfilled the criteria for content validity and were included in the E-MCAI: stool consistency, stool frequency, stools at night, feel a need to pass more stools shortly after a bowel movement, urgent need to empty the bowel, leakage of stool and abdominal pain. The development and validation process resulted in the current version of the E-MCAI consisting of six questions related to MC.
The E-MCAI was developed using the methods advocated by the FDA. The evaluation indicates good content validity. Further evaluation will be performed to achieve construct validity, reliability and responsiveness in future cross-sectional and longitudinal studies.
患者报告结局测量指标（PROMs）旨在衡量患者对其疾病如何影响日常功能的认知。本研究的目的是开发一种符合美国食品药品监督管理局（FDA）要求的PROM，以评估显微镜下结肠炎（MC）的疾病活动度。
欧洲显微镜下结肠炎活动指数（E-MCAI）分四个步骤制定。[1]由该领域的一组专家列出与活动性MC相关的症状清单。[2]专家（n = 14）和患者（n = 79）使用内容效度指数对症状的内容效度进行评估。[3]为每个症状创建问题和回答选项，并通过对患者（n = 7）进行认知访谈以及由专家评估E-MCAI的效度。[4]进行了一次试点邮寄调查以确保其可用性。
与活动性MC相关的七个症状符合内容效度标准，并被纳入E-MCAI：大便性状、大便频率、夜间排便、排便后不久感觉需要再排便、急需排便、大便失禁和腹痛。开发和验证过程产生了当前版本的E-MCAI，它由六个与MC相关的问题组成。
E-MCAI是采用FDA倡导的方法开发的。评估表明其具有良好的内容效度。未来将在横断面和纵向研究中进行进一步评估，以实现结构效度、信度和反应度。
