TY - JOUR
T1 - A preliminary quality of life questionnaire-bronchiectasis
T2 - A patient-reported outcome measure for bronchiectasis
AU - Quittner, Alexandra L.
AU - Marciel, Kristen K.
AU - Salathe, Matthias A.
AU - O'Donnell, Anne E.
AU - Gotfried, Mark H.
AU - Ilowite, Jonathan S.
AU - Metersky, Mark L.
AU - Flume, Patrick A.
AU - Lewis, Sandra A.
AU - McKevitt, Matthew
AU - Montgomery, A. Bruce
AU - O'Riordan, Thomas G.
AU - Barker, Alan F.
PY - 2014/8
Y1 - 2014/8
N2 - BACKGROUND: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first diseasespecific, 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 5 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N 5 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 5 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
AB - BACKGROUND: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first diseasespecific, 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 5 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N 5 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 5 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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U2 - 10.1378/chest.13-1891
DO - 10.1378/chest.13-1891
M3 - Article
C2 - 24626872
AN - SCOPUS:84904000178
VL - 146
SP - 437
EP - 448
JO - Diseases of the chest
JF - Diseases of the chest
SN - 0012-3692
IS - 2
ER -