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.



中文翻译：

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健康相关生活质量在严重哮喘临床试验中的应用：系统评价

背景：哮喘健康相关的生活质量（HRQoL）对于严重哮喘患者来说是一个重要的结果，可以为临床医生提供更多关于治疗益处的见解。本系统评价的目的是检查 HRQoL 问卷在生物制剂、非维匹兰和支气管热成形术的随机对照试验 (RCT) 中的使用和报告。
方法：我们遵循系统评价和荟萃分析（PRISMA）声明的首选报告项目指南。在检索到的 2380 篇文章中，确定纳入 52 项研究。
结果： 63% 的人包含哮喘 HRQoL 问卷。在大多数病例（73%）中，这是次要结果。包括哮喘 HRQoL 问卷的研究比例在 20 年间没有显着变化。虽然 45% 的研究使用了哮喘生活质量问卷 (AQLQ)，但 55% 的研究使用了 4 种不同的问卷。大多数（70%）包含 HRQoL 问卷的研究没有报告其子量表分数。大约一半 (52%) 使用 HRQoL 的研究在论文摘要中报告了这一点。与 HRQoL 问卷相比，使用哮喘控制问卷的研究比例更高（71% vs 63%）。
结论：为了增加哮喘 HRQoL 问卷在严重哮喘治疗随机对照试验中的使用，必须首先了解其使用的驱动因素和障碍。目前，在生物制剂、非维匹兰和支气管热成形术治疗严重哮喘的随机对照试验中，患者的观点代表性不足。