Clinimetric properties of outcome measures in bronchiectasis

Judy M Bradley*, Kathryn Ferguson, Andrew Bailey, Katherine O'Neill, Rebecca H McLeese, Adam T Hill, Michael R Loebinger, Mary Carroll, James D. Chalmers, Timothy Gatheral , Christopher Johnson, Anthony De Soyza , John R Hurst, Damian G. Downey, J. Stuart Elborn

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

Rationale: There are a lack of outcome measures with robust clinimetric properties in bronchiectasis. Objective: To determine the clinimetric properties (reliability over one year during clinical stability and responsiveness over a course of antibiotics for pulmonary exacerbation) of objective and patient-reported outcome measures. Methods: This multi-centre cohort study included adults with bronchiectasis from seven UK hospitals. Participants attended four visits, four months apart over one year while clinically stable and at the beginning/end of exacerbation and completed lung function (spirometry and multiple breath washout), provided a blood sample for C-reactive protein measurement and completed health-related quality of life (HRQoL) questionnaires (Quality of Life-Bronchiectasis (QoL-B), St. George’s Respiratory Questionnaire (SGRQ) and EuroQoL (EQ-5D-5L). Results: Participants (n=132) had a mean (SD) age of 66 (11) years, 64% were female. Lung function parameters (forced expiratory volume in one second (FEV1), lung clearance index (LCI2.5)) were reliable over time (coefficient of variation (CV):<10%). With regards to responsiveness, FEV1 demonstrated better properties than LCI, therefore a clear justification for use of LCI in future trials is needed. CRP was less reliable (CV>20%) over time than FEV1 and LCI2.5 and whilst CRP had a large mean change between the start and end of an exacerbation, this may have been driven by a small number of patients having a large change in CRP. Reliability of HRQoL questionnaires/ questionnaire domains ranged from acceptable (CV:20-30%) to good (CV:10-20%) and HRQoL were responsive to treatment of exacerbations. Considering the specific questionnaire domain relevant to the intervention and its associated clinimetric properties is important. Additional statistics will support future power/sample-size analysis. Conclusions: This information on the clinimetric properties of lung function parameters, CRP and HRQoL parameters should be used to inform the choice of outcome measures used in future bronchiectasis trials.

Original languageEnglish
JournalAnnals of the American Thoracic Society
Early online date22 Dec 2022
DOIs
Publication statusEarly online date - 22 Dec 2022

Keywords

  • Non-cystic fibrosis bronchiectasis
  • outcome measures
  • clinimetrics

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