PMID- 34764181
OWN - NLM
STAT- MEDLINE
DCOM- 20220606
LR  - 20220910
IS  - 1399-3003 (Electronic)
IS  - 0903-1936 (Print)
IS  - 0903-1936 (Linking)
VI  - 59
IP  - 6
DP  - 2022 Jun
TI  - The psychometric properties of the King's Brief Interstitial Lung Disease 
      questionnaire and thresholds for meaningful treatment response in patients with 
      progressive fibrosing interstitial lung diseases.
LID - 10.1183/13993003.01790-2021 [doi]
LID - 2101790
AB  - BACKGROUND: There is a lack of fully validated patient-reported outcome measures 
      for progressive fibrosing interstitial lung disease (ILD). We aimed to validate 
      the King's Brief Interstitial Lung Disease (K-BILD) questionnaire for measuring 
      health-related quality of life (HRQoL) in these patients. We also aimed to 
      estimate the meaningful change threshold for interpreting stabilisation of HRQoL 
      as a clinical end-point in progressive fibrosing ILD, where the current goal of 
      treatment is disease stability and slowing progression. METHODS: This analysis 
      evaluated data from 663 patients with progressive fibrosing ILD other than 
      idiopathic pulmonary fibrosis from the INBUILD trial. Validation of the 
      measurement properties was assessed for internal consistency, test-retest 
      reliability, construct validity, known-groups validity and responsiveness. We 
      calculated meaningful change thresholds for treatment response using anchor-based 
      (within-patient) and distribution-based methods. RESULTS: K-BILD had strong 
      internal consistency (Cronbach's alpha was 0.94 for total score, 0.88 for 
      breathlessness and activities, 0.91 for psychological, and 0.79 for chest 
      symptoms). The test-retest reliability intraclass correlation coefficient was 
      0.74 for K-BILD total score. K-BILD demonstrated weak correlations with forced 
      vital capacity (FVC) percent predicted. Known-groups validity showed significant 
      differences in K-BILD scores for patient groups with different disease severity 
      based on use of supplemental oxygen or baseline FVC % pred (</=70% or >70%). We 
      estimated a meaningful change threshold of >/= -2 units for K-BILD total score for 
      defining patients who remain stable/improved versus those with progressive 
      deterioration. CONCLUSIONS: Our results validate K-BILD as a tool for assessing 
      HRQoL in patients with progressive fibrosing ILD and set a meaningful change 
      threshold of >/= -2 units for K-BILD total score.
CI  - Copyright (c)The authors 2022.
FAU - Birring, Surinder S
AU  - Birring SS
AUID- ORCID: 0000-0003-2525-6291
AD  - Centre for Human and Applied Physiological Sciences, School of Basic and Medical 
      Biosciences, Faculty of Life Sciences and Medicine, King's College London, 
      London, UK surinder.birring@nhs.net.
FAU - Bushnell, Donald M
AU  - Bushnell DM
AD  - Evidera, PPD, Bethesda, MD, USA.
FAU - Baldwin, Michael
AU  - Baldwin M
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Mueller, Heiko
AU  - Mueller H
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Male, Natalia
AU  - Male N
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Rohr, Klaus B
AU  - Rohr KB
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Inoue, Yoshikazu
AU  - Inoue Y
AUID- ORCID: 0000-0003-3994-874X
AD  - Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical 
      Center, Osaka, Japan.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220602
PL  - England
TA  - Eur Respir J
JT  - The European respiratory journal
JID - 8803460
SB  - IM
MH  - Humans
MH  - *Lung Diseases, Interstitial/diagnosis
MH  - Psychometrics
MH  - *Quality of Life
MH  - Reproducibility of Results
MH  - Surveys and Questionnaires
PMC - PMC9160394
COIS- Conflict of interest: S.S. Birring reports personal fees from Boehringer 
      Ingelheim, during the conduct of the study, and has a patent K-BILD with 
      royalties paid to King's College Hospital. D.M. Bushnell is an employee of 
      Evidera. M. Baldwin, H. Mueller, N. Male and K.B. Rohr are employees of 
      Boehringer Ingelheim. Y. Inoue served on a steering committee for Boehringer 
      Ingelheim, during the conduct of the study; served on a steering committee for 
      Taiho; served on advisory committees for Galapagos, Shionogi, Roche/Promedior and 
      Savara; received grants from Japan Agency for Medical Research and Development; 
      and received grants from Japanese Ministry of Health, Labor and Welfare, outside 
      the submitted work.
EDAT- 2021/11/13 06:00
MHDA- 2022/06/07 06:00
PMCR- 2022/06/02
CRDT- 2021/11/12 06:00
PHST- 2021/06/24 00:00 [received]
PHST- 2021/10/06 00:00 [accepted]
PHST- 2021/11/13 06:00 [pubmed]
PHST- 2022/06/07 06:00 [medline]
PHST- 2021/11/12 06:00 [entrez]
PHST- 2022/06/02 00:00 [pmc-release]
AID - 13993003.01790-2021 [pii]
AID - ERJ-01790-2021 [pii]
AID - 10.1183/13993003.01790-2021 [doi]
PST - epublish
SO  - Eur Respir J. 2022 Jun 2;59(6):2101790. doi: 10.1183/13993003.01790-2021. Print 
      2022 Jun.