Abstract
Introduction Existing quality-of-life and symptom tools used in bronchiectasis trials are either not disease specific or are complex and have not been consistently responsive. We developed a simple patient-reported visual analogue outcome measure, the Bronchiectasis Impact Measure (BIM), for use in clinical research, including clinical trials.
Methods Patients with bronchiectasis attending a tertiary referral clinic in the east of Scotland were invited to complete the BIM questionnaire and the quality-of-life bronchiectasis questionnaire at baseline with repeat questionnaires after 2 weeks and 6 months. We assessed internal consistency, test–retest reliability, construct validity and responsiveness by evaluating change during an acute exacerbation.
Results 173 patients were included. The eight domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) showed excellent internal consistency (Cronbach's α 0.93). The intraclass correlation coefficient demonstrated excellent reliability over a 2-week period: cough (0.79, 95% CI 0.70–0.85), sputum (0.86, 95% CI 0.80–0.90), dyspnoea (0.82, 95% CI 0.74–0.87), tiredness (0.88, 95% CI 0.82–0.91), activity (0.84, 95% CI 0.77–0.89), general health (0.81, 95% CI 0.74–0.87), control (0.83, 95% CI 0.75–0.88) and exacerbation (0.71, 95% CI 0.60–0.79). Domains correlated strongly with bronchiectasis severity and exacerbation history. Both distribution and patient-based methods estimated the minimal clinically important difference for each domain as 1.5 points on a 10-point scale. Statistically significant changes in all BIM domains were observed during an acute exacerbation.
Conclusion The BIM is a simple patient-reported outcome. This study validates the internal consistency, reliability, construct validity and response of the tool at acute exacerbation. Further validation of the tool is now required.
Abstract
This study validates a novel patient-reported outcome for patients with bronchiectasis. The Bronchiectasis Impact Measure (BIM) is repeatable, content valid and responsive to change, and may be a useful outcome measure for testing new therapies. https://bit.ly/3pean44
Footnotes
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Conflict of interest: M.L. Crichton reports personal fees from AstraZeneca, outside the submitted work.
Conflict of interest: E.K. Dudgeon has nothing to disclose.
Conflict of interest: A. Shoemark has nothing to disclose.
Conflict of interest: J.D. Chalmers reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Insmed, personal fees from Chiesi, Novartis and Zambon, grants from Gilead Sciences, outside the submitted work.
Support statement: This work was funded by the European Respiratory Society through the EMBARC2 consortium. EMBARC2 is supported by project partners Chiesi, Grifols, Insmed, Novartis and Zambon. This work was supported by the Innovative Medicines Initiative (IMI) and EFPIA companies under the European Commission funded project, iABC (grant 115721). Funding information for this article has been deposited with the Crossref Funder Registry.
- Received August 15, 2020.
- Accepted November 5, 2020.
- Copyright ©ERS 2021