金氏间质性肺病问卷:反应性和最小临床重要差异。

King's Brief Interstitial Lung Disease questionnaire: responsiveness and minimum clinically important difference.

机构信息

Harefield Pulmonary Rehabilitation and Muscle Research Laboratory, Royal Brompton and Harefield NHS Foundation Trust, Harefield, UK

Harefield Pulmonary Rehabilitation Unit, Royal Brompton and Harefield NHS Foundation Trust, Harefield, UK.

出版信息

Eur Respir J. 2019 Sep 5;54(3). doi: 10.1183/13993003.00281-2019. Print 2019 Sep.

Abstract

Health status is increasingly used in clinical practice to quantify symptom burden and as a clinical trial end-point in patients with interstitial lung disease (ILD). The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a brief, validated 15-item, disease-specific, health-related quality of life questionnaire that is increasingly used in clinical trials, but little data exist regarding the minimum clinically important difference (MCID). Using pulmonary rehabilitation as a model, we aimed to determine the responsiveness of KBILD and provide estimates of the MCID.KBILD scores, Chronic Respiratory Questionnaire (CRQ) scores, Medical Research Council (MRC) Dyspnoea score and incremental shuttle walk test (ISWT) distance were measured in 209 patients with ILD (105 with idiopathic pulmonary fibrosis (IPF)) before and after an outpatient pulmonary rehabilitation programme. Changes with intervention and Cohen's effect size were calculated. Anchor-based (linear regression and receiver operating characteristic plots) or distribution-based approaches (0.5 sd and standard error of measurement) were used to estimate the MCID of KBILD domain and total scores.KBILD, CRQ, MRC Dyspnoea and ISWT improved with intervention, and the effect sizes of KBILD domain and total scores ranged from 0.28 to 0.38. Using anchor-based estimates, the MCID estimates for KBILD-Psychological, KBILD-Breathlessness and activities, and KBILD-Total were 5.4, 4.4 and 3.9 points, respectively. Using distribution-based methods, the MCID estimate for KBILD-Chest symptoms was 9.8 points. The MCID estimates for KBILD in IPF patients were similar.In patients with ILD and IPF, KBILD is responsive to intervention with an estimated MCID of 3.9 points for the total score.

摘要

健康状况越来越多地用于临床实践中,以量化症状负担,并作为间质性肺疾病(ILD)患者的临床试验终点。King's Brief Interstitial Lung Disease(KBILD)问卷是一种简短、经过验证的 15 项、疾病特异性、健康相关生活质量问卷,越来越多地用于临床试验,但关于最小临床重要差异(MCID)的数据很少。我们使用肺康复作为模型,旨在确定 KBILD 的反应能力并提供 MCID 的估计值。在一项门诊肺康复计划之前和之后,我们测量了 209 名ILD 患者(105 名特发性肺纤维化(IPF)患者)的 KBILD 评分、慢性呼吸问卷(CRQ)评分、呼吸困难量表(MRC)评分和递增穿梭步行测试(ISWT)距离。计算干预前后的变化和 Cohen 的效应量。使用基于锚的(线性回归和受试者工作特征图)或基于分布的方法(0.5sd 和测量标准误差)来估计 KBILD 域和总分的 MCID。KBILD、CRQ、呼吸困难量表和 ISWT 在干预后均得到改善,KBILD 域和总分的效应量范围从 0.28 到 0.38。使用基于锚的估计值,KBILD-心理、KBILD-呼吸困难和活动以及 KBILD-总分的 MCID 估计值分别为 5.4、4.4 和 3.9 分。使用基于分布的方法,KBILD-胸部症状的 MCID 估计值为 9.8 分。在ILD 患者和 IPF 患者中,KBILD 对干预有反应,总分为 3.9 分的 MCID 估计值。

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