• Alexandra L Quittner, Kristen K Marciel, Matthias A Salathe, Anne E O'Donnell, Mark H Gotfried, Jonathan S Ilowite, Mark L Metersky, Patrick A Flume, Sandra A Lewis, Matthew McKevitt, A Bruce Montgomery, Thomas G O'Riordan, and Alan F Barker.
• Chest. 2014 Aug 1;146(2):437-48.

BackgroundThe Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first disease-specific, patient-reported outcome measure for patients with bronchiectasis. Content validity, cognitive testing, responsivity to open-label treatment, and psychometric analyses are presented.MethodsReviews of literature, existing measures, and physician input were used to generate the initial QOL-B. Modifications following preliminary cognitive testing (N = 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N = 28) provided additional information and was content analyzed to derive saturation matrices, which summarized all disease-related topics mentioned by each participant. This resulted in QOL-B V2.0. Psychometric analyses were carried out using results from an open-label phase 2 trial, in which 89 patients were enrolled and treated with aztreonam for inhalation solution. Responsivity to open-label treatment was observed. Additional analyses generated QOL-B V3.0, with 37 items on eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. No total score is calculated. A final cognitive testing study (N = 40) resulted in a minor change to one social functioning scale item (QOL-B V3.1).ResultsContent validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure.ConclusionsThis interim QOL-B is a promising tool for evaluating the efficacy of new therapies for patients with bronchiectasis and for measuring symptoms, functioning, and quality of life in these patients on a routine basis. A final psychometric validation study is needed and is forthcoming.Trial RegistryClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.

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