Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
Alimentiv Inc., London, Ontario, Canada.
Inflamm Bowel Dis. 2022 Mar 30;28(4):622-638. doi: 10.1093/ibd/izab124.
Several indices exist to measure pouchitis disease activity; however, none are fully validated. As an initial step toward creating a validated instrument, we identified pouchitis disease activity indices, examined their operating properties, and assessed their value as outcome measures in clinical trials.
Electronic databases were searched to identify randomized controlled trials including indices that evaluated clinical, endoscopic, or histologic pouchitis disease activity. A second search identified studies that assessed the operating properties of pouchitis indices.
Eighteen randomized controlled trials utilizing 4 composite pouchitis disease activity indices were identified. The Pouchitis Disease Activity Index (PDAI) was most commonly used (12 of 18; 66.7%) to define both trial eligibility (8 of 12; 66.7%), and outcome measures (12 of 12; 100%). In a separate search, 21 studies evaluated the operating properties of 3 pouchitis indices; 90.5% (19 of 21) evaluated validity, of which 42.1% (8 of 19) evaluated the construct validity of the PDAI. Criterion validity (73.7%; 14 of 19) was evaluated through correlation of the PDAI with fecal calprotectin (FCP; r = 0.188 to 0.71), fecal lactoferrin (r = 0.570 to 0.582), and C-reactive protein (CRP; r = 0.584). Two studies assessed correlation of the modified PDAI (mPDAI) with FCP (r = 0.476 and r = 0.565, respectively). Fair to moderate inter-rater reliability of the PDAI (k = 0.440) and mPDAI (k = 0.389) was reported in a single study. Responsiveness of the PDAI pre-antibiotic and postantibiotic treatment was partially evaluated in a single study of 12 patients.
Development and validation of a specific pouchitis disease activity index is needed given that existing instruments are not valid, reliable, or responsive.
有几种用于衡量 pouchitis 疾病活动度的指标，但都没有完全验证。作为创建一个经过验证的工具的初步步骤，我们确定了 pouchitis 疾病活动度指标，检查了它们的操作特性，并评估了它们作为临床试验结果衡量指标的价值。
检索电子数据库，以确定包括评估临床、内镜或组织学 pouchitis 疾病活动度的指标的随机对照试验。第二次检索确定了评估 pouchitis 指数操作特性的研究。
确定了 18 项使用 4 种复合 pouchitis 疾病活动度指数的随机对照试验。最常用的是 Pouchitis Disease Activity Index (PDAI)（18 项研究中的 12 项；66.7%）来定义试验的纳入标准（12 项研究中的 8 项；66.7%）和结果衡量指标（12 项研究中的 12 项；100%）。在单独的搜索中，21 项研究评估了 3 种 pouchitis 指数的操作特性；90.5%（21 项研究中的 19 项）评估了有效性，其中 42.1%（19 项研究中的 8 项）评估了 PDAI 的结构有效性。通过 PDAI 与粪便钙卫蛋白（FCP；r=0.188 至 0.71）、粪便乳铁蛋白（r=0.570 至 0.582）和 C 反应蛋白（CRP；r=0.584）的相关性来评估临界有效性（73.7%；19 项研究中的 14 项）。两项研究评估了改良 PDAI（mPDAI）与 FCP 的相关性（r=0.476 和 r=0.565）。一项研究报告了 PDAI（k=0.440）和 mPDAI（k=0.389）的观察者间信度为中等至良好。在一项仅包括 12 名患者的研究中，部分评估了 PDAI 在抗生素治疗前和抗生素治疗后的反应性。
鉴于现有的工具无效、不可靠或无反应性，需要开发和验证特定的 pouchitis 疾病活动度指数。
