Psychometric properties of patient reported outcome measures in idiopathic pulmonary fibrosis

Jee Whang Kim, Allan Clark, Surinder S Birring, Christopher Atkins, Moira Whyte, Andrew M Wilson, Jee Whang Kim, Allan Clark, Surinder S Birring, Christopher Atkins, Moira Whyte, Andrew M Wilson

Abstract

Background: Various patient reported outcome measures (PROMs) are used in idiopathic pulmonary fibrosis (IPF). We aimed to describe their psychometric properties, assess their relationship with 1-year mortality and determine their minimal clinically important differences (MCIDs).

Methods: In a prospective multicentre study, participants with IPF completed the King's Brief Interstitial Lung Disease Questionnaire (K-BILD), the modified Medical Research Council (mMRC) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ) and University of California, San Diego shortness of breath questionnaire (UCSD-SOBQ) three-monthly intervals over a 12-month period. Forced vital capacity (FVC) was matched with questionnaires and mortality was captured. Anchor- and distribution-based methods were used to derive MCID.

Results: Data were available from 238 participants. All PROMs had good internal consistency and high degree of correlations with other tools (except UCSD-SOBQ correlated poorly with FVC). There were significant associations with mortality for K-BILD (hazard ratio 16.67; 95% CI 2.38-100) and SGRQ (hazard ratio 4.65; 95% CI 1.32-16.62) but not with the other PROMs or FVC. The median MCID (range) for K-BILD was 6.3 (4.1-7.0), SGRQ was 7.0 (3.8-9.6), mMRC was 0.4 (0.1-0.5) and UCSD-SOBQ was 9.6 (4.1-14.2).

Conclusions: The K-BILD was related to other severity measures and had the strongest relationship with mortality.

Keywords: Patient reported outcome measures; idiopathic lung disease; minimal clinically important difference; mortality.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JWK has nothing to disclose. AC has nothing to disclose. SB reports payment to King’s College Hospital for use of K-BILD from Roche Pharma, Boehringer Ingelheim, and Galapogos outside the submitted work. CA received course fees and travel to attend conference/course; April 2018 (ERS ILD School, Heidelberg) and November 2019 (Learner to Leader Course) from Boehringer Ingelheim outside the submitted work. MW has nothing to disclose. AMW reports grants from Intermune during the conduct of the study.

Figures

Figure 1.
Figure 1.
Survival curves for patient related outcome measures. Kaplan–Meier curves for survival (1-year mortality) for (a) SGRQ: St George’s Respiratory Questionnaire, (b) EQ5D: 5-Level Euroqol 5-dimension, (c) mMRC: modified Medical Research Council dyspnoea scale, (d) HADS: Hospital Anxiety and Depression Score, (e) K-BILD: King’s Brief Interstitial Lung Disease Questionnaire and (f) UCSD-SOBQ: University of California, San Diego shortness of breath questionnaire. Individuals were divided into three equal groups according to the baseline total score of each questionnaire: better, middle and worse health status. A comparison was made between tertile groups. Solid lines represent the better health status, dashed lines represent middle health status and dotted lines represent worse health status.

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