Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Issue 1 (16th October 2014)

• Record Type: Journal Article
• Authors: Quittner, Alexandra L; O'Donnell, Anne E; Salathe, Matthias A; Lewis, Sandra A; Li, Xiaoming; Montgomery, A Bruce; O'Riordan, Thomas G; Barker, Alan F
• Is Part Of: Thorax. Volume 70:Issue 1(2015)
• Page Start: 12
• Page End: 20
• Publication Date: 2014-10-16
• Subjects: Respiratory Measurement -- Respiratory Infection -- Perception of Asthma/Breathlessness -- Bronchiectasis; Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2014-205918
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : Background: The Quality of Life-Bronchiectasis (QOL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Methods: Psychometric analyses of QOL-B V.3.0 used data from two double-blind, multicentre, randomised, placebo-controlled, phase III trials of aztreonam for inhalation solution (AZLI) in 542 patients with non-CF bronchiectasis and Gram-negative endobronchial infection. Results: Excellent internal consistency (Cronbach's α ≥0.70) and 2-week test–retest reliability (intraclass correlation coefficients ≥0.72) were demonstrated for each scale. Convergent validity with 6 min walk test was observed for Physical and Role Functioning scores. No floor or ceiling effects (baseline scores of 0 or 100) were found for the Respiratory Symptoms scale (primary endpoint of trials). Baseline Respiratory Symptoms scores discriminated between patients based on baseline FEV1 % predicted in only one trial. The minimal important difference score for the Respiratory Symptoms scale was 8.0 points. AZLI did not show efficacy in the two phase III trials. QOL-B responsivity to treatment was assessed by examining changes from baseline QOL-B scores at study visits at which protocol-defined pulmonary exacerbations were reported. Mean Respiratory Symptoms scores decreased 14.0 and 14.2 points from baseline for placebo-treated and AZLI-treated patients with exacerbations, indicating that worsening respiratory symptoms were reflected in clinically meaningful changes in QOL-B scores. Conclusions: Previously established content validity, reliability and responsivity of the QOL-B are confirmed by this final validation study. The QOL-B is available for use in clinical trials and routine clinical practice.