Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark.
Department of Respiratory Medicine, Vejle Hospital, Vejle, Denmark.
BMC Pulm Med. 2019 Dec 19;19(1):255. doi: 10.1186/s12890-019-1018-0.
Health-related quality of life (HRQL) is impaired in patients with idiopathic pulmonary fibrosis (IPF). The King's Brief Interstitial Lung Disease questionnaire (K-BILD) is a validated measure of HRQL, but no previous studies have focused on the validity of K-BILD in IPF. Moreover, the relationship between K-BILD and dyspnoea or the 6-min walk test (6MWT) has not been assessed. The aim of this study was to validate K-BILD in the largest cohort of patients with IPF to date and assess how K-BILD correlates to dyspnoea and 6MWT.
Firstly, K-BILD was translated into Danish using validated translation procedures. Consecutive patients with IPF were recruited. At baseline, patients completed K-BILD, the IPF-specific version of St. Georges Respiratory Questionnaire, University of California, San Diego Shortness of Breath Questionnaire (SOBQ) Short Form-36, and pulmonary function tests and 6MWT were performed. After 14 days, K-BILD and Global Rating of Change Scales were completed. Internal consistency, concurrent validity, test-retest reliability and known groups validity were assessed. Analyses were also performed in subgroups of patients with different time since diagnosis.
At baseline, 150 patients with IPF completed the questionnaires, and 139 patients completed the questionnaires after 14 days. K-BILD had a high internal consistency (Cronbach's α = 0.92). The concurrent validity was strong compared to SOBQ (r = - 0.66) and moderate compared to 6MWT (r = 0.43). Intraclass correlation coefficients (ICC = 0.91) and a Bland Altman plot demonstrated a good reliability. K-BILD was also able to discriminate between patients with different stages of disease (p < 0.002, Δscore > 7.4) and most results were comparable in patients with different time since diagnosis.
K-BILD is a valid and reliable instrument in patients with IPF and in patients with different time since diagnosis. To a major extent, K-BILD scores reflected the impact of dyspnoea on HRQL and the impact of physical functional capacity measured by the 6MWT to a moderate degree. Compared to PFTs alone, K-BILD provides additional information on the burden of living with IPF, and importantly, K-BILD is simple to implement in both research and clinical contexts.
Clinicaltrials.org (NCT02818712) on 30 June 2016.
特发性肺纤维化（IPF）患者的健康相关生活质量（HRQL）受损。King's 简短间质性肺疾病问卷（K-BILD）是一种经过验证的 HRQL 测量方法，但以前没有研究关注 K-BILD 在 IPF 中的有效性。此外，K-BILD 与呼吸困难或 6 分钟步行测试（6MWT）之间的关系尚未得到评估。本研究的目的是迄今为止在最大的 IPF 患者队列中验证 K-BILD，并评估 K-BILD 与呼吸困难和 6MWT 的相关性。
首先，使用经过验证的翻译程序将 K-BILD 翻译成丹麦语。连续招募 IPF 患者。在基线时，患者完成了 K-BILD、特发性肺纤维化特异性圣乔治呼吸问卷、加利福尼亚大学圣地亚哥呼吸困难问卷（SOBQ）短表-36 和肺功能测试以及 6MWT。14 天后，完成 K-BILD 和全球变化量表评分。评估了内部一致性、同时效度、测试-重测可靠性和已知组有效性。还在不同诊断后时间的患者亚组中进行了分析。
在基线时，150 名 IPF 患者完成了问卷，139 名患者在 14 天后完成了问卷。K-BILD 具有较高的内部一致性（Cronbach's α=0.92）。与 SOBQ（r=-0.66）相比，同时效度较强，与 6MWT（r=0.43）相比，中度有效。组内相关系数（ICC=0.91）和 Bland Altman 图表明可靠性良好。K-BILD 还能够区分不同疾病阶段的患者（p<0.002，Δ评分>7.4），并且在不同诊断后时间的患者中，大多数结果都是可比的。
K-BILD 是一种在 IPF 患者和不同诊断后时间的患者中有效且可靠的工具。在很大程度上，K-BILD 评分反映了呼吸困难对 HRQL 的影响，以及 6MWT 测量的身体功能能力对 HRQL 的中度影响。与单独的 PFT 相比，K-BILD 提供了有关 IPF 生活负担的额外信息，重要的是，K-BILD 在研究和临床环境中实施都很简单。
2016 年 6 月 30 日在 Clinicaltrials.org（NCT02818712）注册。
