Quality of Life Questionnaire-Bronchiectasis

Final psychometric analyses and determination of minimal important difference scores

Alexandra Quittner, Anne E. O'Donnell, Matthias A Salathe, Sandra A. Lewis, Xiaoming Li, A. Bruce Montgomery, Thomas G. O'Riordan, Alan F. Barker

Research output: Contribution to journalArticle

51 Citations (Scopus)

Abstract

Background: The Quality of Life-Bronchiectasis (QOL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Methods: Psychometric analyses of QOL-B V.3.0 used data from two double-blind, multicentre, randomised, placebo-controlled, phase III trials of aztreonam for inhalation solution (AZLI) in 542 patients with non-CF bronchiectasis and Gram-negative endobronchial infection. Results: Excellent internal consistency (Cronbach's α ≥0.70) and 2-week test-retest reliability (intraclass correlation coefficients ?0.72) were demonstrated for each scale. Convergent validity with 6 min walk test was observed for Physical and Role Functioning scores. No floor or ceiling effects (baseline scores of 0 or 100) were found for the Respiratory Symptoms scale (primary endpoint of trials). Baseline Respiratory Symptoms scores discriminated between patients based on baseline FEV1% predicted in only one trial. The minimal important difference score for the Respiratory Symptoms scale was 8.0 points. AZLI did not show efficacy in the two phase III trials. QOL-B responsivity to treatment was assessed by examining changes from baseline QOL-B scores at study visits at which protocol-defined pulmonary exacerbations were reported. Mean Respiratory Symptoms scores decreased 14.0 and 14.2 points from baseline for placebo-treated and AZLI-treated patients with exacerbations, indicating that worsening respiratory symptoms were reflected in clinically meaningful changes in QOL-B scores. Conclusions: Previously established content validity, reliability and responsivity of the QOL-B are confirmed by this final validation study. The QOL-B is available for use in clinical trials and routine clinical practice.

Original languageEnglish
Pages (from-to)12-20
Number of pages9
JournalThorax
Volume70
Issue number1
DOIs
StatePublished - Jan 1 2015

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Bronchiectasis
Psychometrics
Quality of Life
Reproducibility of Results
Fibrosis
Placebos
Aztreonam
Surveys and Questionnaires
Validation Studies
Inhalation
Clinical Trials
Lung
Health

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Quittner, A., O'Donnell, A. E., Salathe, M. A., Lewis, S. A., Li, X., Montgomery, A. B., ... Barker, A. F. (2015). Quality of Life Questionnaire-Bronchiectasis: Final psychometric analyses and determination of minimal important difference scores. Thorax, 70(1), 12-20. https://doi.org/10.1136/thoraxjnl-2014-205918

Quality of Life Questionnaire-Bronchiectasis : Final psychometric analyses and determination of minimal important difference scores. / Quittner, Alexandra; O'Donnell, Anne E.; Salathe, Matthias A; Lewis, Sandra A.; Li, Xiaoming; Montgomery, A. Bruce; O'Riordan, Thomas G.; Barker, Alan F.

In: Thorax, Vol. 70, No. 1, 01.01.2015, p. 12-20.

Research output: Contribution to journalArticle

Quittner, A, O'Donnell, AE, Salathe, MA, Lewis, SA, Li, X, Montgomery, AB, O'Riordan, TG & Barker, AF 2015, 'Quality of Life Questionnaire-Bronchiectasis: Final psychometric analyses and determination of minimal important difference scores', Thorax, vol. 70, no. 1, pp. 12-20. https://doi.org/10.1136/thoraxjnl-2014-205918
Quittner, Alexandra ; O'Donnell, Anne E. ; Salathe, Matthias A ; Lewis, Sandra A. ; Li, Xiaoming ; Montgomery, A. Bruce ; O'Riordan, Thomas G. ; Barker, Alan F. / Quality of Life Questionnaire-Bronchiectasis : Final psychometric analyses and determination of minimal important difference scores. In: Thorax. 2015 ; Vol. 70, No. 1. pp. 12-20.
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AU - Lewis, Sandra A.

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AU - Montgomery, A. Bruce

AU - O'Riordan, Thomas G.

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N2 - Background: The Quality of Life-Bronchiectasis (QOL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Methods: Psychometric analyses of QOL-B V.3.0 used data from two double-blind, multicentre, randomised, placebo-controlled, phase III trials of aztreonam for inhalation solution (AZLI) in 542 patients with non-CF bronchiectasis and Gram-negative endobronchial infection. Results: Excellent internal consistency (Cronbach's α ≥0.70) and 2-week test-retest reliability (intraclass correlation coefficients ?0.72) were demonstrated for each scale. Convergent validity with 6 min walk test was observed for Physical and Role Functioning scores. No floor or ceiling effects (baseline scores of 0 or 100) were found for the Respiratory Symptoms scale (primary endpoint of trials). Baseline Respiratory Symptoms scores discriminated between patients based on baseline FEV1% predicted in only one trial. The minimal important difference score for the Respiratory Symptoms scale was 8.0 points. AZLI did not show efficacy in the two phase III trials. QOL-B responsivity to treatment was assessed by examining changes from baseline QOL-B scores at study visits at which protocol-defined pulmonary exacerbations were reported. Mean Respiratory Symptoms scores decreased 14.0 and 14.2 points from baseline for placebo-treated and AZLI-treated patients with exacerbations, indicating that worsening respiratory symptoms were reflected in clinically meaningful changes in QOL-B scores. Conclusions: Previously established content validity, reliability and responsivity of the QOL-B are confirmed by this final validation study. The QOL-B is available for use in clinical trials and routine clinical practice.

AB - Background: The Quality of Life-Bronchiectasis (QOL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Methods: Psychometric analyses of QOL-B V.3.0 used data from two double-blind, multicentre, randomised, placebo-controlled, phase III trials of aztreonam for inhalation solution (AZLI) in 542 patients with non-CF bronchiectasis and Gram-negative endobronchial infection. Results: Excellent internal consistency (Cronbach's α ≥0.70) and 2-week test-retest reliability (intraclass correlation coefficients ?0.72) were demonstrated for each scale. Convergent validity with 6 min walk test was observed for Physical and Role Functioning scores. No floor or ceiling effects (baseline scores of 0 or 100) were found for the Respiratory Symptoms scale (primary endpoint of trials). Baseline Respiratory Symptoms scores discriminated between patients based on baseline FEV1% predicted in only one trial. The minimal important difference score for the Respiratory Symptoms scale was 8.0 points. AZLI did not show efficacy in the two phase III trials. QOL-B responsivity to treatment was assessed by examining changes from baseline QOL-B scores at study visits at which protocol-defined pulmonary exacerbations were reported. Mean Respiratory Symptoms scores decreased 14.0 and 14.2 points from baseline for placebo-treated and AZLI-treated patients with exacerbations, indicating that worsening respiratory symptoms were reflected in clinically meaningful changes in QOL-B scores. Conclusions: Previously established content validity, reliability and responsivity of the QOL-B are confirmed by this final validation study. The QOL-B is available for use in clinical trials and routine clinical practice.

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