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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.