Swigris Jeffrey J, Wilson Hilary, Esser Dirk, Conoscenti Craig S, Stansen Wibke, Kline Leidy Nancy, Brown Kevin K
National Jewish Health, Denver, Colorado, USA.
Evidera Inc, Bethesda, Maryland, USA.
BMJ Open Respir Res. 2018 May 18;5(1):e000278. doi: 10.1136/bmjresp-2018-000278. eCollection 2018.
We evaluated the psychometric properties of the St George's Respiratory Questionnaire (SGRQ) in patients with idiopathic pulmonary fibrosis (IPF) using data from the two INPULSIS trials.
Data from 1061 patients treated with nintedanib or placebo were pooled. Internal consistency, test-retest reliability, construct validity, known-groups validity, responsiveness and responder thresholds were examined.
Cronbach's α was 0.93 for SGRQ total score and >0.75 for domain scores. In patients with stable disease based on change in forced vital capacity (FVC) ≤5% predicted or 'no change' on Patient's Global Impression of Change, intraclass correlation coefficients for the SGRQ total score were 0.72 or 0.76, respectively. Moderate to strong correlations were observed between SGRQ total and domain scores and the Cough and Sputum Assessment Questionnaire cough domains (-0.34 to -0.65), University of California San Diego Shortness of Breath Questionnaire (0.56 to 0.83) and EuroQol 5-Dimensional Quality of Life Questionnaire Visual Analogue Scale (-0.41 to -0.55); correlations with FVC % predicted were weak (-0.24 to -0.30). Longitudinal correlations between changes in SGRQ total score and these patient-reported outcomes over 52 weeks were moderate. Changes in SGRQ total, impact and activity scores were sensitive to detecting improvement or deterioration in FVC >10% predicted at week 52. Collectively, distribution-based and anchor-based approaches suggested using a change of 4-5 points in SGRQ total score as a starting point for responder analyses.
The psychometric properties of the SGRQ support its use as a measure of health-related quality of life in patients with IPF.
我们使用两项INPULSIS试验的数据，评估了圣乔治呼吸问卷（SGRQ）在特发性肺纤维化（IPF）患者中的心理测量特性。
汇总了1061例接受尼达尼布或安慰剂治疗患者的数据。检查了内部一致性、重测信度、结构效度、已知组效度、反应性和反应阈值。
SGRQ总分的Cronbach's α为0.93，各领域得分>0.75。根据用力肺活量（FVC）变化≤预测值的5%或患者整体变化印象为“无变化”判定为病情稳定的患者，SGRQ总分的组内相关系数分别为0.72或0.76。SGRQ总分及各领域得分与咳嗽和痰液评估问卷咳嗽领域（-0.34至-0.65）、加利福尼亚大学圣地亚哥分校气短问卷（0.56至0.83）以及欧洲五维生活质量问卷视觉模拟量表（-0.41至-0.55）之间存在中度至高度相关性；与预测FVC%的相关性较弱（-0.24至-0.30）。SGRQ总分变化与这些患者报告结局在52周内的纵向相关性为中度。SGRQ总分、影响和活动得分的变化对检测第52周时预测FVC>10%的改善或恶化较为敏感。总体而言，基于分布和基于锚定的方法建议将SGRQ总分变化4 - 5分作为反应者分析的起点。
SGRQ的心理测量特性支持将其用作IPF患者健康相关生活质量的衡量指标。
