Irvine E J, Feagan B, Rochon J, Archambault A, Fedorak R N, Groll A, Kinnear D, Saibil F, McDonald J W
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Gastroenterology. 1994 Feb;106(2):287-96. doi: 10.1016/0016-5085(94)90585-1.
BACKGROUND/AIMS: Quality of life (QOL), a subjective index of health perception and function, embraces physical, social, and emotional performance but has not had a prominent role in clinical trials of inflammatory bowel disease (IBD). To test the robustness of the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific QOL index, this study assessed its validity, reliability, and responsiveness during a multicenter trial.
Three hundred five patients with stable Crohn's disease received cyclosporin or placebo for 18 months. IBDQ and dimensional scores (bowel, social, systemic, and emotional) were correlated with disease activity (Crohn's disease activity index [CDAI] and Harvey-Bradshaw index). Concordance of IBDQ scores was tested in 280 stable subjects. Linear regression evaluated change in IBDQ scores over time.
IBDQ scores correlated highly with CDAI (r = -0.67; P < 0.0001). The reliability coefficient for IBDQ score was 0.70 vs. 0.66 for CDAI and 0.55 for Harvey-Bradshaw index. Regression line slopes of IBDQ scores were significantly different in patients who deteriorated from those who remained stable ([b] < 0.15; P < 0.0001). QOL scores were lower in patients who required surgery.
The IBDQ is a valid reliable assessment tool that reflects important changes in the health status of patients with IBD. The IBDQ is a robust measure of therapeutic efficacy and should be used in future clinical trials in IBD.
背景/目的：生活质量（QOL）是健康认知和功能的主观指标，涵盖身体、社会和情感方面的表现，但在炎症性肠病（IBD）的临床试验中尚未发挥突出作用。为了检验炎症性肠病问卷（IBDQ）这一疾病特异性生活质量指标的稳健性，本研究在一项多中心试验中评估了其有效性、可靠性和反应性。
305例病情稳定的克罗恩病患者接受环孢素或安慰剂治疗18个月。IBDQ及其维度评分（肠道、社会、全身和情感）与疾病活动度（克罗恩病活动指数[CDAI]和哈维 - 布拉德肖指数）相关。在280例病情稳定的受试者中测试IBDQ评分的一致性。线性回归评估IBDQ评分随时间的变化。
IBDQ评分与CDAI高度相关（r = -0.67；P < 0.0001）。IBDQ评分的可靠性系数为0.70，而CDAI为0.66，哈维 - 布拉德肖指数为0.55。病情恶化的患者与病情保持稳定的患者相比，IBDQ评分的回归线斜率有显著差异（[b] < 0.15；P < 0.0001）。需要手术的患者生活质量评分较低。
IBDQ是一种有效、可靠的评估工具，可反映IBD患者健康状况的重要变化。IBDQ是衡量治疗效果的有力指标，应在未来IBD的临床试验中使用。
