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标题：Psychometric Validation of the EQ-5D-3L in Patients with Nontuberculous Mycobacterial (NTM) Lung Disease Caused by Mycobacterium avium Complex (MAC)
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作者：Anuj Shah ; Xinyi Ng ; Ruchit Shah 等
期刊名称：Patient Related Outcome Measures
印刷版ISSN：1179-271X
电子版ISSN：1179-271X
出版年度：2021
卷号：12
页码：45-54
DOI：10.2147/PROM.S272075
出版社：Dove Medical Press Ltd
摘要：Purpose :This analysis evaluated the psychometric properties of the EQ-5D-3L among patients with Mycobacterium avium complex lung disease (MAC-LD). Methods :Data from the Phase III CONVERT trial were analyzed. Study measures including the EQ-5D-3L, St. George's Respiratory Questionnaire (SGRQ), the 6-minute walk test (6MWT), and percent predicted forced expiratory volume in 1 second (ppFEV 1 ) were collected at baseline, month 3 (M3), month 4 (M4; only 6MWT), and month 6 (M6). Item characteristics and validity were evaluated at baseline. Test-retest reliability was assessed using intraclass correlation coefficients (ICC) and a weighted kappa statistic among a subgroup of stable patients. Validity was tested by evaluating correlations of the EQ-5D-3L index/visual analogue scale (VAS) scores with SGRQ and 6MWT and comparing mean index/VAS scores across known groups defined using 6MWT and ppFEV 1 . Responsiveness of the EQ-5D-3L was assessed using 6MWT, SGRQ, ppFEV 1 , and culture conversion as anchors. Results :The index score was subject to ceiling effects, with 32.6% of patients reporting perfect health at baseline. ICCs for the index (0.80) and VAS (0.85) scores and weighted kappas for the domains (0.5-0.72) indicated adequate test-retest reliability. Correlations between the index/VAS scores and related domains of the SGRQ and 6MWT were as hypothesized (0.31-0.62), and the mean index/VAS scores were significantly different between the 6MWT and ppFEV 1 known groups (p<0.05), supporting the validity of the EQ-5D-3L. No evidence was found supporting the responsiveness of the EQ-5D-3L to changes in any of the anchors. Conclusion :EQ-5D-3L exhibited evidence of validity and reliability but poor responsiveness to clinically meaningful changes in patients with MAC-LD. © 2021 Shah et al.
关键词：EQ-5D;NTM lung disease;psychometric validation;reliability;responsiveness;validity