Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
J Clin Epidemiol. 2019 Dec;116:49-61. doi: 10.1016/j.jclinepi.2019.07.015. Epub 2019 Jul 27.
Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD).
Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor- and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative for Obstructive Lung Disease (GOLD) classification, comorbidities, and baseline health status.
In total, 658 patients were included with 2,299 change score measurements. MCID estimates for improvement and deterioration ranged for all subgroups 0.50-6.30 (CAT), 0.10-0.84 (CCQ), and 0.33-12.86 (SGRQ). Larger MCID estimates for improvement and smaller ones for deterioration were noted in patients with worse baseline health status, females, elderly, GOLD I/II patients, and patients with less comorbidities. Estimates from PR were larger.
Baseline health status and setting affected MCID estimates of COPD health status questionnaires. Patterns were observed for gender, age, spirometry classification, and comorbidity levels. These outcomes would advocate the need for tailored MCIDs.
最小临床重要差异 (MCID) 常被用作临床试验解释的固定数值。但其动态变化鲜为人知。本研究旨在探讨基线评分、研究环境和患者特征对慢性阻塞性肺疾病 (COPD) 健康状况 MCID 的影响。
回顾性分析了来自肺康复 (PR) 和常规临床实践 (RCP) 的 COPD 评估测试 (CAT)、临床 COPD 问卷 (CCQ) 和圣乔治呼吸问卷 (SGRQ) 的基线和随访数据。在环境、性别、年龄、全球倡议性阻塞性肺病 (GOLD) 分类、合并症和基线健康状况之间，计算并测试了基于锚定和分布的 MCID 估计值。
共纳入 658 例患者，共 2299 例变化评分测量值。所有亚组的改善和恶化 MCID 估计值范围为 0.50-6.30（CAT）、0.10-0.84（CCQ）和 0.33-12.86（SGRQ）。基线健康状况较差、女性、老年人、GOLD I/II 患者和合并症较少的患者，其改善 MCID 估计值较大，而恶化 MCID 估计值较小。PR 的估计值更大。
基线健康状况和环境影响了 COPD 健康状况问卷的 MCID 估计值。性别、年龄、肺功能分类和合并症水平存在一定模式。这些结果表明需要制定针对性的 MCID。
