慢性阻塞性肺疾病患者肺康复后疲劳的患者报告结局测量的最小临床重要差异。
Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation.
机构信息
Lab3R-Respiratory Research and Rehabilitation Laboratory, School of Health Sciences, University of Aveiro, Aveiro, Portugal; iBiMED-Institute of Biomedicine, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.
Lab3R-Respiratory Research and Rehabilitation Laboratory, School of Health Sciences, University of Aveiro, Aveiro, Portugal; iBiMED-Institute of Biomedicine, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal; West Park Healthcare Centre, Toronto, ON, Canada; School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada.
出版信息
Chest. 2020 Aug;158(2):550-561. doi: 10.1016/j.chest.2020.02.045. Epub 2020 Mar 14.
BACKGROUND
Fatigue is a burdensome and prevailing symptom in patients with COPD. Pulmonary rehabilitation (PR) improves fatigue; however, interpreting when such improvement is clinically relevant is challenging. Minimal clinically important differences (MCIDs) for instruments assessing fatigue are warranted to better tailor PR and guide clinical decisions.
RESEARCH QUESTION
This study estimated MCIDs for the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS), the modified FACIT-FS, and the Checklist Individual Strength-Fatigue Subscale in patients with COPD following PR.
STUDY DESIGN AND METHODS
Data from patients with COPD who completed a 12-week community-based PR program were used to compute the MCIDs. The pooled MCID was estimated by calculating the arithmetic weighted mean, resulting from the combination of anchor-based (weight, two-thirds) and distribution-based (weight, one-third) methods. Anchors were patients' and physiotherapists' Global Rating of Change Scale, COPD Assessment Test, St. George's Respiratory Questionnaire (SGRQ), and exacerbations. To estimate MCIDs, we used mean change, receiver-operating characteristic curves, and linear regression analysis for anchor-based approaches, and 0.5 × SD, SE of measurement, 1.96 × SE of measurement, and minimal detectable change for distribution-based approaches.
RESULTS
Fifty-three patients with COPD (79% male, 68.4 ± 7.6 years of age, and FEV 48.7 ± 17.4% predicted) were included in the analysis. Exacerbations and the SGRQ-impact and the SGRQ-total scores fulfilled the requirements to be used as anchors. Pooled MCIDs were 4.7 for FACIT-FS, 3.8 for the modified FACIT-FS, and 9.3 for the Checklist Individual Strength-Fatigue Subscale.
INTRPRETATION
The MCIDs proposed in this study can be used by different stakeholders to interpret PR effectiveness.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov; No.: NCT03799666; URL: www.clinicaltrials.gov.
背景
疲劳是 COPD 患者的一种负担性和普遍存在的症状。肺康复（PR）可改善疲劳；然而，解释这种改善何时具有临床意义是具有挑战性的。需要评估疲劳的仪器的最小临床重要差异（MCIDs），以便更好地调整 PR 并指导临床决策。
研究问题
本研究旨在评估 COPD 患者接受 PR 治疗后，功能评估慢性疾病治疗-疲劳量表（FACIT-FS）、改良 FACIT-FS 和个体力量检查表疲劳量表的 MCIDs。
研究设计和方法
使用完成为期 12 周社区基础 PR 项目的 COPD 患者的数据来计算 MCIDs。通过计算基于锚定（权重，三分之二）和基于分布（权重，三分之一）方法的算术加权平均值来估计汇总 MCID。锚定为患者和物理治疗师的总体变化量表、COPD 评估测试、圣乔治呼吸问卷（SGRQ）和加重。为了估计 MCIDs，我们使用基于锚定的方法的平均变化、受试者工作特征曲线和线性回归分析，以及基于分布的方法的 0.5×SD、测量标准差、1.96×测量标准差和最小可检测变化。
结果
纳入分析的 53 名 COPD 患者（79%男性，68.4±7.6 岁，FEV 48.7±17.4%预计值）。加重和 SGRQ 影响和 SGRQ 总分满足作为锚定的要求。FACIT-FS、改良 FACIT-FS 和个体力量检查表疲劳量表的汇总 MCIDs 分别为 4.7、3.8 和 9.3。
解释
本研究提出的 MCIDs 可被不同利益相关者用于解释 PR 的效果。
临床试验注册
ClinicalTrials.gov；编号：NCT03799666；网址：www.clinicaltrials.gov。
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