Psychometric Validation and Determination of the Minimal Clinically Important Difference for the Bronchiectasis...

Rationale: The Bronchiectasis Health Questionnaire (BHQ) is a concise, self-administered, and disease-specific instrument for measuring health-related quality of life in bronchiectasis. Objectives: We sought to investigate the psychometric properties of a simplified Mandarin BHQ and determine the minimum clinically important difference (MCID) as a reliable clinical endpoint for assessing the efficacy of bronchiectasis treatments. Methods: A longitudinal, randomized controlled trial cohort of 357 patients treated with tobramycin inhalation solution or saline inhalation for Pseudomonas aeruginosa infection and a cross-sectional observational cohort of 436 patients with bronchiectasis were analyzed. Psychometric analyses encompassed convergent validity, known-groups validity, internal consistency, test-retest reliability, and responsiveness. Both anchor-based and distribution-based approaches were utilized to calculate the MCID for therapeutic response. Results: There were significant positive correlations between scores on the BHQ and those on the Quality of Life-Bronchiectasis Respiratory Symptom Scale, with correlation coefficients of 0.698 in the trial cohort and 0.567 in the clinical cohort (both Ps < 0.0001). Known-groups validity indicated significant differences in BHQ scores stratified by baseline Bronchiectasis Severity Index. BHQ scores correlated modestly with both forced expiratory volume in 1 second percent predicted and exacerbation frequency within the previous year. In the trial cohort, the BHQ demonstrated excellent internal consistency (Cronbach's α = 0.893) and test-retest reliability (intraclass correlation coefficient = 0.853). An 8-point improvement in scores on the Quality of Life-Bronchiectasis Respiratory Symptom Scale corresponded to a mean increase of 5.49 points in BHQ scores after 4-week treatment. The MCID for BHQ was consistently 3 points. Conclusions: The BHQ (MCID: 3 points) represents a clinically meaningful tool for evaluating therapeutic intervention outcomes and patient-centered outcomes in patients with bronchiectasis.