基于人群的队列研究验证炎症性肠病残疾指数。
Validation of the Inflammatory Bowel Disease Disability Index in a population-based cohort.
机构信息
Public Health, Epidemiology and Economic Health, Registre Epimad, Maison Régionale de la Recherche Clinique, Centre Hospitalier Universitaire Régional, Lille Cedex, France.
Lille Inflammation Research International Center LIRIC-UMR 995 Inserm/Université Lille 2/CHRU de Lille; Equipe «IBD and environmental factors: epidemiology and functional analyses, Lille University, France.
出版信息
Gut. 2017 Apr;66(4):588-596. doi: 10.1136/gutjnl-2015-310151. Epub 2015 Dec 8.
BACKGROUND
IBDs are chronic destructive disorders that negatively affect the functional status of patients. Recently, the Inflammatory Bowel Disease Disability Index (IBD-DI) was developed according to standard WHO processes. The aims of the current study were to validate the IBD-DI in an independent patient cohort, to develop an index-specific scoring system and to describe the disability status of a well-defined population-based cohort of French patients with IBD.
METHODS
From February 2012 to March 2014, the IBD-DI questionnaire was administered to a random sample of adult patients with an established diagnosis of IBD issued from a French population-based registry. The IBD-DI consists of 28 items that evaluate the four domains of body functions, activity participation, body structures and environmental factors. Validation included item reduction and data structure, construct validity, internal consistency, interobserver and intraobserver reliability evaluations.
RESULTS
150 patients with Crohn's disease (CD) and 50 patients with UC completed the IBD-DI validation phase. The intraclass correlation coefficient for interobserver reliability was 0.91 and 0.54 for intraobserver reliability. Cronbach's α of internal consistency was 0.86. IBD-DI scores varied from 0 to 100 with a mean of 35.3 (Q1=19.6; Q3=51.8). IBD-DI scores were highly correlated with Inflammatory Bowel Disease Questionnaire (-0.82; p<0.001) and SF-36 (-0.61; p<0.05) scores. Female gender (p<0.001), clinical disease activity (p<0.0001) and disease duration (p=0.02) were associated with higher IBD-DI scores.
CONCLUSIONS
The IBD-DI has been validated for use in clinical trials and epidemiological studies. The IBD-DI showed high internal consistency, interobserver reliability and construct validity, and a moderate intraobserver reliability. It comprises 14 questions and ranges from 0 to 100. The mean IBD-DI score was 35.3 and was associated with gender, clinical disease activity and disease duration. Further research is needed to confirm the structural validity and to assess the responsiveness of IBD-DI.
TRIAL REGISTRATION NUMBER
2011-A00877-34.
背景
IBD 是一种慢性破坏性疾病，会对患者的功能状态产生负面影响。最近，根据世卫组织的标准程序制定了炎症性肠病残疾指数（IBD-DI）。本研究的目的是在独立的患者队列中验证 IBD-DI，制定特定于指数的评分系统，并描述法国基于人群的 IBD 患者队列的残疾状况。
方法
从 2012 年 2 月至 2014 年 3 月，向法国人群登记处登记的确诊为 IBD 的成年患者随机样本发放 IBD-DI 问卷。IBD-DI 由 28 个项目组成，评估身体功能、活动参与、身体结构和环境因素四个领域。验证包括项目减少和数据结构、构建有效性、内部一致性、观察者间和观察者内可靠性评估。
结果
150 例克罗恩病（CD）患者和 50 例溃疡性结肠炎（UC）患者完成了 IBD-DI 验证阶段。观察者间可靠性的组内相关系数为 0.91，观察者内可靠性为 0.54。内部一致性的 Cronbach's α 为 0.86。IBD-DI 评分从 0 到 100 分，平均 35.3 分（Q1=19.6；Q3=51.8）。IBD-DI 评分与炎症性肠病问卷（-0.82；p<0.001）和 SF-36（-0.61；p<0.05）评分高度相关。女性（p<0.001）、临床疾病活动（p<0.0001）和疾病持续时间（p=0.02）与更高的 IBD-DI 评分相关。
结论
IBD-DI 已在临床试验和流行病学研究中得到验证。IBD-DI 具有较高的内部一致性、观察者间可靠性和构建有效性，以及中等的观察者内可靠性。它由 14 个问题组成，范围从 0 到 100。平均 IBD-DI 评分为 35.3，与性别、临床疾病活动和疾病持续时间有关。需要进一步研究来确认结构有效性并评估 IBD-DI 的反应性。
试验注册号
2011-A00877-34。
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