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 8 domains (Cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) showed excellent internal consistency (Cronbach α 0.93). The intraclass correlation coefficient (ICC) 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 MCID 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.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Crichton reports personal fees from AstraZeneca, outside the submitted work.
Conflict of interest: Dr. Dudgeon has nothing to disclose.
Conflict of interest: Dr. Shoemark has nothing to disclose.
Conflict of interest: Dr. Chalmers reports grants and personal fees from Astrazeneca, grants and personal fees from Boehringer Ingelheim, personal fees from Chiesi, grants and personal fees from Glaxosmithkline, grants from Gilead Sciences, grants and personal fees from Insmed, personal fees from Novartis, personal fees from Zambon, outside the submitted work.
- Received August 15, 2020.
- Accepted November 5, 2020.
- Copyright ©ERS 2020
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