PMID- 34671666
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221109
IS  - 2312-0541 (Print)
IS  - 2312-0541 (Electronic)
IS  - 2312-0541 (Linking)
VI  - 7
IP  - 4
DP  - 2021 Oct
TI  - An updated approach to determine minimal clinically important differences in 
      idiopathic pulmonary fibrosis.
LID - 00142-2021 [pii]
LID - 10.1183/23120541.00142-2021 [doi]
AB  - 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 anchor-based 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.
CI  - Copyright (c)The authors 2021.
FAU - Kang, Mohleen
AU  - Kang M
AUID- ORCID: 0000-0003-0471-2884
AD  - Emory University School of Medicine, Division of Pulmonary, Allergy, Critical 
      Care and Sleep Medicine, Atlanta, GA, USA.
FAU - Veeraraghavan, Srihari
AU  - Veeraraghavan S
AD  - Emory University School of Medicine, Division of Pulmonary, Allergy, Critical 
      Care and Sleep Medicine, Atlanta, GA, USA.
FAU - Martin, Greg S
AU  - Martin GS
AD  - Emory University School of Medicine, Division of Pulmonary, Allergy, Critical 
      Care and Sleep Medicine, Atlanta, GA, USA.
FAU - Kempker, Jordan A
AU  - Kempker JA
AUID- ORCID: 0000-0002-6830-5201
AD  - Emory University School of Medicine, Division of Pulmonary, Allergy, Critical 
      Care and Sleep Medicine, Atlanta, GA, USA.
LA  - eng
GR  - K08 HS025240/HS/AHRQ HHS/United States
PT  - Journal Article
DEP - 20211018
PL  - England
TA  - ERJ Open Res
JT  - ERJ open research
JID - 101671641
PMC - PMC8521018
COIS- Provenance: Submitted article, peer reviewed. Conflict of interest: 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.
EDAT- 2021/10/22 06:00
MHDA- 2021/10/22 06:01
PMCR- 2021/10/18
CRDT- 2021/10/21 06:12
PHST- 2021/03/03 00:00 [received]
PHST- 2021/07/25 00:00 [accepted]
PHST- 2021/10/21 06:12 [entrez]
PHST- 2021/10/22 06:00 [pubmed]
PHST- 2021/10/22 06:01 [medline]
PHST- 2021/10/18 00:00 [pmc-release]
AID - 00142-2021 [pii]
AID - 10.1183/23120541.00142-2021 [doi]
PST - epublish
SO  - ERJ Open Res. 2021 Oct 18;7(4):00142-2021. doi: 10.1183/23120541.00142-2021. 
      eCollection 2021 Oct.