Guo Bingmei, Li Haihong, Cui Qing, Li Jie, Yu Yanbo, Li Zhen, Wang Junwen
Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, People's Republic of China.
Nursing Theory & Practice Innovation Research Center of Shandong University, Jinan, People's Republic of China.
PLoS One. 2024 Dec 12;19(12):e0311529. doi: 10.1371/journal.pone.0311529. eCollection 2024.
A demand exists for user-friendly patient-reported outcome measures for patients with inflammatory bowel disease (IBD). The IBD-Control Questionnaire has been recently developed to assess overall disease control from the patient's view but has not been available in China.
Translation and cultural adaption of the IBD-Control into Chinese was conducted through four steps (forward translation, backward translation, expert panel, and pilot testing). Afterwards, a prospective validation study was conducted from February 2022 to February 2023. The translated IBD-Control, Short Health Scale, EQ-5D-5L, and disease activity measurements using either the Physician Global Assessment and Simple Clinical Colitis Activity Index or the Crohn's Disease Activity Index were used. Acceptability, test-retest reliability, internal consistency, content validity, convergent validity, structural validity, discriminant ability, and receiver operating characteristic curves were analyzed.
Questionnaires were completed by 150 participants with IBD (31 with Crohn's disease [CD] and 119 with ulcerative colitis [UC]). The Cronbach's alpha coefficient was 0.823 for the IBD-Control-8 scale. The correlations between individual item and total score varied from 0.485 to 0.892 among CD patients and from 0.588 to 0.712 among UC patients. The S-CVI/Ave was 0.98. Convergent validity analyses exhibited moderate to strong correlations between other measurements and IBD-Control-8-subscore (0.555-0.675) or IBD-Control VAS (0.503-0.671). Test-retest analysis showed that the mean scores were 75.23±17.33 versus 72.10±14.99 (r = 0.894, p<0.01) for VAS scores and 12.75±3.49versus 12.80±3.29 for IBD-Control-8 subscore (r = 0.963, p<0.01), respectively. The IBD-Control-8-subscore and IBD-Control-VAS exhibited significant discriminative capability among the PGA categories (ANOVA, p < .001). The ROC analysis revealed an optimal cut-off point for the IBD-Control-8 subscore of 14 points (sensitivity: 70.9%, specificity 83.5%), versus a cut-off of 70 on the IBD-Control VAS score (sensitivity: 84.4%, specificity 69.3%).
The Chinese IBD-Control proves to be a disease-specific, reliable, and valid tool for revealing overall disease control from the patient's viewpoint. Both healthcare professionals and patients may find it to be a useful patient-reported outcome measurement for triaging IBD patients in China or complementing routine care.
炎症性肠病（IBD）患者需要用户友好型的患者报告结局指标。IBD控制问卷最近已开发出来，用于从患者角度评估整体疾病控制情况，但在中国尚未可用。
通过四个步骤（正向翻译、反向翻译、专家小组和预试验）将IBD控制问卷翻译成中文并进行文化调适。之后，于2022年2月至2023年2月进行了一项前瞻性验证研究。使用翻译后的IBD控制问卷、简短健康量表、EQ-5D-5L以及使用医师整体评估和简单临床结肠炎活动指数或克罗恩病活动指数进行的疾病活动测量。分析了可接受性、重测信度、内部一致性、内容效度、收敛效度、结构效度、判别能力和受试者工作特征曲线。
150名IBD患者（31名克罗恩病[CD]患者和119名溃疡性结肠炎[UC]患者）完成了问卷。IBD控制-8量表的克朗巴哈α系数为0.823。CD患者中单个项目与总分的相关性在0.485至0.892之间，UC患者中在0.588至0.712之间。S-CVI/Ave为0.98。收敛效度分析显示，其他测量与IBD控制-8子分数（0.555-0.675）或IBD控制视觉模拟量表（VAS）（0.503-0.671）之间存在中度至强相关性。重测分析表明，VAS分数的平均分为75.23±17.33对72.10±14.99（r = 0.894，p<0.01），IBD控制-8子分数的平均分为12.75±3.49对12.80±3.29（r = 0.963，p<0.01）。IBD控制-8子分数和IBD控制-VAS在医师整体评估类别中表现出显著的判别能力（方差分析，p <.001）。ROC分析显示，IBD控制-8子分数的最佳截断点为14分（敏感性：70.9%，特异性83.5%），而IBD控制VAS分数的截断点为70分（敏感性：84.4%，特异性69.3%）。
中文IBD控制问卷被证明是一种针对疾病的、可靠且有效的工具，可从患者角度揭示整体疾病控制情况。医疗保健专业人员和患者可能会发现它是在中国对IBD患者进行分类或补充常规护理的有用的患者报告结局测量工具。
