Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Aug 12:14:999-1010.
doi: 10.2147/JAA.S320817. eCollection 2021.

Use of Health Related Quality of Life in Clinical Trials for Severe Asthma: A Systematic Review

Joseph W Lanario  1 , Lorna Burns  1
Affiliations
Review

Use of Health Related Quality of Life in Clinical Trials for Severe Asthma: A Systematic Review

Joseph W Lanario et al. J Asthma Allergy. .

Abstract

Background: Asthma Health Related Quality of Life (HRQoL) is an outcome important to patients with severe asthma and can provide clinicians with additional insight into the benefits of treatment. The aim of this systematic review is to examine the use and reporting of HRQoL questionnaires within randomised controlled trials (RCTs) of biologics, fevipiprant and bronchial thermoplasty.

Methods: We followed the guidelines on the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement. Of the 2380 retrieved articles, 52 studies were identified for inclusion.

Results: Sixty-three percent included an asthma HRQoL questionnaire. It was a secondary outcome in the majority of cases (73%). The proportion of studies including an asthma HRQoL questionnaire did not change significantly over a 20-year period. While the Asthma Quality of Life Questionnaire (AQLQ) was used in 45% of studies, 55% used a variety of 4 questionnaires. Most (70%) of the studies that included a HRQoL questionnaire did not report its subscale scores. Approximately half (52%) of studies that used HRQoL reported this in the abstract of the paper. A higher proportion of studies used an asthma control questionnaire compared to a HRQoL questionnaire (71% vs 63%).

Conclusion: In order to increase the use of asthma HRQoL questionnaires in RCTs of severe asthma treatments, the drivers and barriers to their use must first be understood. At present, the patients' perspective is underrepresented in RCTs of biologics, fevipiprant and bronchial thermoplasty for severe asthma.

Keywords: quality of life; severe asthma; systematic review.

PubMed Disclaimer

Conflict of interest statement

Mr. Lanario reports personal fees from Novartis, outside the submitted work and reports royalties paid to him and University of Plymouth for being a co-author of the pending patent for “Severe Asthma Questionnaire”. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Search results and study selection.
Figure 2
Figure 2
Number and proportion (%) of studies reporting of asthma HRQoL questionnaires and where this data is reported.
See this image and copyright information in PMC

References

    1. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;2:55. - PubMed
    1. O’Neill S, Sweeney J, Patterson CC, et al. The cost of treating severe refractory asthma in the UK: an economic analysis from the British Thoracic Society Difficult Asthma Registry. Thorax. 2015;70:376–378. doi: 10.1136/thoraxjnl-2013-204114 - DOI - PubMed
    1. Sweeney J, Patterson CC, Menzies-Gow A, et al. British thoracic society difficult asthma n: comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the optimum patient care research database and the British thoracic difficult asthma registry. Thorax. 2016;71:339–346. doi: 10.1136/thoraxjnl-2015-207630 - DOI - PubMed
    1. von Bülow A, Kriegbaum M, Backer V, Porsbjerg C. The prevalence of severe asthma and low asthma control among Danish adults. J Allergy Clin Immunol. 2014;2:759–767. e752. - PubMed
    1. Clark VL, Gibson PG, McDonald VM. What matters to people with severe asthma? Exploring add-on asthma medication and outcomes of importance. ERJ Open Res. 2020;7:254. - PMC - PubMed

LinkOut - more resources