Abstract | BACKGROUND: The 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. METHODS: Reviews 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). RESULTS: Content validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure. CONCLUSIONS: This 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 REGISTRY: ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.
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Authors | 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, Alan F Barker |
Journal | Chest
(Chest)
Vol. 146
Issue 2
Pg. 437-448
(Aug 2014)
ISSN: 1931-3543 [Electronic] United States |
PMID | 24626872
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
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Topics |
- Bronchiectasis
(diagnosis, psychology)
- Health Status
- Humans
- Psychometrics
(methods)
- Quality of Life
- Self Report
- Surveys and Questionnaires
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