肺康复临床试验的多样性:文献系统回顾。

Expert review of respiratory medicine Pub Date : 2024-01-01 Epub Date: 2024-03-06 DOI:10.1080/17476348.2024.2324086
Sunaina Chopra, Shivani Rana, Reenal Patel, Tessa Hamilton, Alyssa Dalip, Paramvir Malhi, Pat G Camp
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引用次数: 0

摘要

背景:少数群体在临床试验中的代表性不足可能会阻碍肺康复 (PR) 项目为慢性阻塞性肺病 (COPD) 患者带来的潜在益处。这项工作旨在确定在美国、加拿大、英国和澳大利亚进行的肺康复随机对照试验(RCT)的参与者在种族、性别和社会人口特征方面是否具有代表性:对从开始到 2022 年 12 月的相关文献进行了系统检索。在进行全文审阅之前,对标题和摘要进行了筛选。提取了报告参与者年龄、性别、民族和社会人口特征的相关数据:结果:36 篇研究性临床试验符合纳入标准。只有 6% 的论文报告了种族情况,其中≥ 90% 的参与者被报告为 "白人"。所有 36 篇论文都报告了年龄,平均年龄在 60-69 岁之间。35 项研究报告了性别(97%),其中大多数(67%)报告的男性参与者多于女性参与者。没有一篇论文提到不同的性别。7篇论文(19%)报告了其他社会人口因素:临床试验的包容性和代表性对于确保研究结果的普遍性至关重要。临床试验人员在招募过程中需要考虑当今社会的人口统计学因素。
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Diversity in pulmonary rehabilitation clinical trials: a systematic review of the literature.

Background: Underrepresentation of minority groups in clinical trials may hinder the potential benefits of pulmonary rehabilitation (PR) programs for individuals with chronic obstructive pulmonary disease (COPD). The aim of this work was to determine whether participants in PR randomized control trials (RCTs) conducted in the U.S.A., Canada, the UK, and Australia are representative of ethnicity, sex, gender, and sociodemographic characteristics.

Research design: A systematic search was performed for relevant literature from inception to December 2022. Titles and abstracts were screened before undergoing a full article review. Relevant data on reporting of age, sex, gender, ethnicity, and sociodemographic characteristics of participants was extracted.

Results: Thirty-six RCTs met the inclusion criteria. Only 6% of publications reported on ethnicity, with ≥90% of participants reported as 'White.' All 36 papers reported on age, with the mean between 60 and 69 years old. Thirty-five studies reported on sex (97%), with the majority (67%) reporting more male than female participants. There was no mention of different genders in any paper. Other sociodemographic factors were reported in 7 (19%) papers.

Conclusions: Inclusivity and representation in clinical trials are essential to ensure that research findings are generalizable. Clinical trialists need to consider the demographics of today's society during recruitment.

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