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.
N1 - Funding Information:
Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Quittner has been a consultant to Gilead Sciences, Inc; Bayer HealthCare Pharmaceuticals; and Abbott Pharmaceuticals (now AbVie). Dr Marciel has been a consultant to Gilead Sciences, Inc. Dr O'Donnell has received research funding from, and has been a consultant to, Gilead Sciences, Inc. Dr Gotfried has received research support from Gilead Sciences, Inc, and Bayer HealthCare Pharmaceuticals. Dr Flume has participated as an investigator in a clinical trial of non-CF bronchiectasis sponsored by Gilead Sciences, Inc. Ms Lewis and Drs McKevitt, Montgomery, and O'Riordan were employees of Gilead Sciences, Inc, while these studies were conducted and are shareholders in Gilead Sciences, Inc. Dr Barker has been a consultant to Bayer; conducted clinical research for Gilead Sciences, Inc; and received an honorarium from UpToDate. Drs Salathe, Ilowite, and Metersky have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
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
SN - 0012-3692
VL - 146
SP - 437
EP - 448
JO - CHEST
JF - CHEST
IS - 2
ER -