Abstract
IntroductionUnderstanding the psychometric properties of health-related quality of life (HRQoL) questionnaires can help inform selection in clinical trials. Our objective was to assess the psychometric properties of HRQoL questionnaires in bronchiectasis using a systematic review and meta-analysis of the literature.MethodsA literature search was conducted. HRQoL questionnaires were assessed for psychometric properties (reliability, validity, minimal clinically important difference (MCID) and floor/ceiling effects). Meta-analyses assessed the associations of HRQoL with clinical measures and responsiveness of HRQoL in clinical trials.Results166 studies and 12 HRQoL questionnaires were included. The Bronchiectasis Health Questionnaire (BHQ), Leicester Cough Questionnaire (LCQ), Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) and Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) had good internal consistency in all domains reported (Cronbach's α≥0.7) across all studies, and the Quality of Life-Bronchiectasis (QOL-B), St George's Respiratory Questionnaire (SGRQ), Chronic Respiratory Disease Questionnaire (CRDQ) and Seattle Obstructive Lung Disease Questionnaire (SOLQ) had good internal consistency in all domains in the majority of (but not all) studies. BHQ, SGRQ, LCQ and CAT had good test–retest reliability in all domains reported (intraclass correlation coefficient ≥0.7) across all studies, and QOL-B, CRDQ and SOLQ had good test–retest reliability in all domains in the majority of (but not all) studies. HRQoL questionnaires were able to discriminate between demographics, important markers of clinical status, disease severity, exacerbations and bacteriology. For HRQoL responsiveness, there was a difference between the treatment and placebo effect.ConclusionsSGRQ was the most widely used HRQoL questionnaire in bronchiectasis studies and it had good psychometric properties; however, good psychometric data are emerging on the bronchiectasis-specific HRQoL questionnaires QOL-B and BHQ. Future studies should focus on the medium- to long-term test–retest reliability, responsiveness and MCID in these HRQoL questionnaires which show potential in bronchiectasis.
Highlights
Understanding the psychometric properties of health related quality of life (HRQoL) questionnaires can help inform selection in clinical trials
Saint. George’s Respiratory Questionnaire (SGRQ) was the most widely used health-related quality of life (HRQoL) questionnaire in bronchiectasis studies and it had good psychometric properties, good psychometric data are growing on bronchiectasis specific HRQoL questionnaires, Quality of Life-Bronchiectasis (QoL-B) and Bronchiectasis Health Questionnaire (BHQ)
Future studies should focus on the medium-long term test-retest reliability, responsiveness and minimal clinically important difference (MCID) in these HRQoL questionnaires which show potential in bronchiectasis
Summary
Understanding the psychometric properties of health related quality of life (HRQoL) questionnaires can help inform selection in clinical trials. A number of other clinical trials have failed to demonstrate a clinically important or statistically significant change in their primary end-points including measures of quality of life [6,7,8,9]. The reasons for this are multifactorial including ineffective treatments, lack of consideration of treatable traits, underlying physiology and microbiome, and the inability of interventions to affect specific domain scores of health-related quality of life (HRQoL) questionnaires and a lack of bronchiectasis specific, clinically validated outcome measures. The need for robust outcome measures in clinical trials has been emphasised by regulators [10, 11], with particular emphasis on tools used to measure patient-reported outcomes (PROs)
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