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mkang30@emory.edu

M. Kang was supported by her division's T-32 grant 5T32HL116271-07 (principal investigator: David Guidot) during this study. S. Veeraraghavan has received personal fees from Boehringer Ingelheim for serving on their advisory board, and has received research grant support from Fibrogen, Bellerophon, Biogen, Nitto Denko, Pliant, Galapagos and Galecto. G.S. Martin received support from the National Institutes of Health through the National Center for Advancing Translational Sciences grant UL1TR002378, National Institute of Biomedical Imaging and Bioengineering grant U54 EB-027690, and the Office of the Director grant OT2 OD-026551, as well as serving as a consultant to Genentech and Grifols. J.A. Kempker received support from the Agency for Healthcare Quality and Research under Award Number K08HS025240 and has worked as a consultant for Grifols Inc.

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Research Funding:

This work was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

An updated approach to determine minimal clinically important differences in idiopathic pulmonary fibrosis

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Journal Title:

ERJ Open Research

Volume:

Volume 7, Number 4

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Type of Work:

Article | Final Publisher PDF

Abstract:

Introduction Current medications for idiopathic pulmonary fibrosis (IPF) have not been shown to impact patient-reported outcome measures (PROMs), highlighting the need for accurate minimal clinically important difference (MCID) values. Recently published consensus standards for MCID studies support using anchor-based over distribution-based methods. The aim of this study was to estimate MCID values for worsening in IPF using only an anchor-based approach. Methods We conducted secondary analyses of three randomised controlled trials with different inclusion criteria and follow-up intervals. The health transition question in the 36-Item Short-Form Health Survey (SF-36) questionnaire was used as the anchor. We used receiver operating curves to assess responsiveness between the anchor and 10 variables (four physiological measures and six PROMs). We used an anchorbased method to determine the MCID values of variables that met the responsiveness criteria (area under the curve ⩾0.70). Results 6-min walk distance (6MWD), the St George’s Respiratory Questionnaire (SGRQ), physical component score (PCS) of SF-36 and University of California, San Diego, Shortness of Breath Questionnaire (UCSD SOBQ) met the responsiveness criteria. The MCID value for 6MWD was −75 m; the MCID value for SF-36 PCS was −7 points; the MCID value for SGRQ was 11 points; and the MCID value for the UCSD SOBQ was 11 points. Conclusions The MCID estimates of 6MWD, SGRQ, SF-36 and UCSD SOBQ using only anchor-based methods were considerably higher compared to previously proposed values. A single MCID value may not be applicable across all classes of disease severity or durations of follow-up time.

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©The authors 2021

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/).
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