King's College London, Division of Asthma, Allergy and Lung Biology, Denmark Hill, London SE5 9RS, UK.
Respir Med. 2013 Sep;107(9):1438-43. doi: 10.1016/j.rmed.2013.06.009. Epub 2013 Jul 16.
Health status and forced vital capacity (FVC) are widely used outcome measures of interstitial lung disease (ILD) but there is a paucity of studies reporting the minimal clinically meaningful change in these parameters. A study was undertaken to assess the minimal important difference (MID) of an ILD specific health status questionnaire, the King's Brief ILD questionnaire (K-BILD) and that of FVC in a range of ILDs. 57 patients with ILD (17 idiopathic pulmonary fibrosis; IPF) completed the K-BILD (score range 0-100) at 2 separate clinic visits. Patients underwent spirometry at both visits. The MID was determined by a range of distribution methods (Standard error of mean: SEM and 0.3× Effect size: ES) and anchor based methods (objective: FVC and subjective: global rating of change questionnaires, GRCQ). The MID was derived by calculating an average of all methods. Health status was reduced at baseline in all patients, mean (SD) K-BILD total score 62(23). The average MID for K-BILD total score incorporating all methods was an 8 unit change (range 6-10). The average MID for FVC was a 6% change of baseline (range 4-7%). The K-BILD is a responsive patient reported outcome measure for patients with ILD. It can potentially be used to assess patients in the clinic and evaluate the response to therapy. The MID of the K-BILD total score is 8 units. The MID for FVC for a range of ILDs was 6%, similar to that reported recently for patients with IPF. Our findings will facilitate the clinical interpretation of health status and FVC data in ILD.
健康状况和用力肺活量(FVC)是广泛用于间质性肺疾病(ILD)的结局测量指标,但有关这些参数的临床意义最小变化的研究较少。本研究旨在评估ILD 特定健康状况问卷,即 King's Brief ILD 问卷(K-BILD)和 FVC 的最小临床意义差异(MID)在一系列 ILD 中的变化。57 名ILD 患者(17 名特发性肺纤维化;IPF)在 2 次单独的就诊时完成了 K-BILD(评分范围 0-100)。患者在两次就诊时都接受了肺量测定。MID 通过一系列分布方法(均数标准误:SEM 和 0.3×效应量:ES)和基于锚的方法(客观:FVC 和主观:全球变化评估问卷,GRCQ)来确定。MID 通过计算所有方法的平均值得出。所有患者的基线健康状况均下降,平均(SD)K-BILD 总分 62(23)。纳入所有方法的 K-BILD 总分平均 MID 为 8 个单位的变化(范围为 6-10)。FVC 的平均 MID 是基线的 6%变化(范围为 4-7%)。K-BILD 是一种对 ILD 患者有反应的患者报告结局测量指标。它可以潜在地用于评估诊所中的患者并评估治疗反应。K-BILD 总分的 MID 为 8 个单位。ILD 患者 FVC 的 MID 为 6%,与最近报道的 IPF 患者相似。我们的发现将有助于ILD 中健康状况和 FVC 数据的临床解释。