Carvalho Tânia, Franco Joana, Guimarães Andreia, Damasceno Costa José, Mendes Sofia, Leal Tiago, Rebelo Ana, Arroja Bruno, Gonçalves Raquel, Soares João Bruno
Gastroenterology Department, Unidade Local de Saúde de Braga, Braga, Portugal.
School of Medicine, University of Minho, Braga, Portugal.
GE Port J Gastroenterol. 2024 Oct 2;32(3):185-196. doi: 10.1159/000541219. eCollection 2025 Jun.
The IBD-Control questionnaire and IBD-Disk are two patient-reported outcome measures designed to evaluate the impact of inflammatory bowel disease (IBD) on different health domains. Unlike IBD-Disk, there is no fully published validated Portuguese version of IBD-Control. Furthermore, the two instruments have not yet been compared. We aimed to translate and validate IBD-Control in Portugal and compare it with IBD-Disk.
After translation into Portuguese, the IBD-Control was administered to IBD patients, at baseline (T0), after 1-4 weeks (T1), and >3 months (T2). Patients also completed the Portuguese versions of the PRO2, EQ-5D, SIBDQ, and IBD-Disk. We assessed the reliability, validity, responsiveness, and interpretability of IBD-Control. We compared the usability (3 questions) and the ability to identify good disease control (area under the curve [AUC]) of IBD-Control and IBD-Disk.
At T0, the IBD-Control was completed by 142 patients (108 Crohn's disease, 34 ulcerative colitis). At T1 and T2, 68 and 101 patients completed the questionnaire, respectively. Factor analysis confirmed the one-dimensionality of the scale with 8 items (IBD-Control-8). Internal consistency (Cronbach's alpha) was 0.80. Test-retest reproducibility for stable patients ( = 54) was high (intraclass correlation coefficient-0.86). IBD-Control-8 significantly correlated (r between 0.55 and 0.82; ≤ 0.001) with PRO2, EQ-5D, SIBDQ and IBD-Disk. The variation in IBD-Control-8 between T0 and T2 correlated significantly (r between 0.48 and 0.53; ≤ 0.01) with the variation in PRO2 (only for Crohn's disease), SIBDQ and IBD-Disk. The IBD-Control-8 significantly discriminated between well and poorly controlled disease (15 ± 2 vs. 11 ± 4; < 0.001). No significant differences were observed between IBD-Control-8 and IBD-Disk regarding usability and the ability to identify good disease control (AUC: -0.79 vs. 0.76, respectively).
The IBD-Control is reliable and valid for measuring disease control from the perspective of patients with IBD in Portugal, presenting no significant differences regarding usability and assessment of disease control when compared to IBD-Disk.
IBD-Control问卷和IBD-Disk是两种患者报告结局测量工具，旨在评估炎症性肠病（IBD）对不同健康领域的影响。与IBD-Disk不同，IBD-Control尚无完全发表的经过验证的葡萄牙语版本。此外，这两种工具尚未进行比较。我们旨在将IBD-Control翻译成葡萄牙语并进行验证，并将其与IBD-Disk进行比较。
将IBD-Control翻译成葡萄牙语后，在基线（T0）、1-4周后（T1）和3个月以上（T2）对IBD患者进行施测。患者还完成了PRO2、EQ-5D、SIBDQ和IBD-Disk的葡萄牙语版本。我们评估了IBD-Control的信度、效度、反应度和可解释性。我们比较了IBD-Control和IBD-Disk的易用性（3个问题）以及识别良好疾病控制的能力（曲线下面积[AUC]）。
在T0时，142例患者（108例克罗恩病，34例溃疡性结肠炎）完成了IBD-Control。在T1和T2时，分别有68例和101例患者完成了问卷。因子分析证实了该量表具有8个条目的单维度性（IBD-Control-8）。内部一致性（Cronbach's alpha）为0.80。稳定患者（n = 54）的重测信度很高（组内相关系数为0.86）。IBD-Control-8与PRO2、EQ-5D、SIBDQ和IBD-Disk显著相关（r在0.55至0.82之间；P≤0.001）。T0和T2之间IBD-Control-8的变化与PRO2（仅针对克罗恩病）、SIBDQ和IBD-Disk的变化显著相关（r在0.48至0.53之间；P≤0.01）。IBD-Control-8能够显著区分疾病控制良好和不佳的情况（15±2 vs. 11±4；P<0.001）。在易用性和识别良好疾病控制的能力方面，IBD-Control-8与IBD-Disk之间未观察到显著差异（AUC分别为0.79和0.76）。
IBD-Control在葡萄牙从IBD患者的角度测量疾病控制是可靠且有效的，与IBD-Disk相比，在易用性和疾病控制评估方面没有显著差异。
