title: A preliminary quality of life questionnaire-bronchiectasis: a patient-reported outcome measure for bronchiectasis.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.
authors.affiliation: Department of Psychology and Pediatrics, Department of Medicine, University of Miami, Coral Gables, FL. Electronic address: AQuittner@Miami.edu.
authors.forename: Alexandra L
authors.initials: AL
authors.lastname: Quittner
authors.affiliation: Department of Psychology and Pediatrics, Department of Medicine, University of Miami, Coral Gables, FL.
authors.forename: Kristen K
authors.initials: KK
authors.lastname: Marciel
authors.affiliation: Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Miami, Coral Gables, FL.
authors.forename: Matthias A
authors.initials: MA
authors.lastname: Salathe
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Georgetown University, Washington, DC.
authors.forename: Anne E
authors.initials: AE
authors.lastname: O'Donnell
authors.affiliation: Pulmonary Associates, Phoenix, AZ; University of Arizona, Phoenix, AZ.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Gotfried
authors.affiliation: Department of Medicine, Division of Pulmonary and Critical Care, Winthrop University Hospital, Mineola, NY.
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Ilowite
authors.affiliation: Division of Pulmonary and Critical Care, University of Connecticut School of Medicine, University of Connecticut, Farmington, CT.
authors.forename: Mark L
authors.initials: ML
authors.lastname: Metersky
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Flume
authors.affiliation: Gilead Sciences, Seattle, WA.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Lewis
authors.affiliation: Gilead Sciences, Seattle, WA.
authors.forename: Matthew
authors.initials: M
authors.lastname: McKevitt
authors.affiliation: Gilead Sciences, Seattle, WA.
authors.forename: A Bruce
authors.initials: AB
authors.lastname: Montgomery
authors.affiliation: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Georgetown University, Washington, DC; Gilead Sciences, Seattle, WA; Seattle, WACardeas Pharma, Seattle, WA.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: O'Riordan
authors.affiliation: Department of Medicine, Division of Pulmonary and Critical Care, Oregon Health and Science University, Portland, OR.
authors.forename: Alan F
authors.initials: AF
authors.lastname: Barker
mesh_terms: D001987:Bronchiectasis / Q000175:diagnosis / Q000523:psychology*; D006304:Health Status; D006801:Humans; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D057566:Self Report; D011795:Surveys and Questionnaires