Kaylyn Rowsey , Seth Sims , Merhawit Ghebrehiwet , Andrew Wilson , Josh Autaubo , Payton Clark , Simran Demla , Alicia Ito Ford , Matt Vassar
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We aim to assess the recruitment and retention strategies of historically marginalized populations in SLE clinical trials.</p></div><div><h3>Methods</h3><p>In this cross-sectional analysis, relevant clinical trials were obtained in a comprehensive search of MEDLINE (PubMed) and Embase (Elsevier) in May of 2024. Included trials were published between January 1, 2018, and December 31, 2023, with a focus on SLE interventions. Reviewers KR and SS independently performed screening and data extraction via a standardized Google Form. The main outcome measured was the usage of recruitment and retention strategies, concerning under-resourced populations. All statistical analyses were performed via Stata 18 SE.</p></div><div><h3>Findings</h3><p>Our initial database search returned 747 trials, but only 86 were included in this sample. Of these, 4/86 (4.7 %) implemented recruitment strategies while 6/86 (7.0 %) reported the use of specific retention strategies. 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引用次数: 0
摘要
背景系统性红斑狼疮(SLE)在历史边缘人群中的死亡率是普通人群的四倍。临床试验必须准确代表患病人群,才能有效评估治疗方法。然而,目前的试验设计缺乏适当的多样性,限制了试验结果的推广性。我们旨在评估系统性红斑狼疮临床试验中历来被边缘化的人群的招募和保留策略。在这项横断面分析中,我们于 2024 年 5 月对 MEDLINE(PubMed)和 Embase(Elsevier)进行了全面检索,获得了相关的临床试验。纳入的试验发表于 2018 年 1 月 1 日至 2023 年 12 月 31 日之间,重点关注系统性红斑狼疮干预措施。审稿人 KR 和 SS 通过标准化的谷歌表格独立进行筛选和数据提取。衡量的主要结果是招募和保留策略的使用情况,涉及资源不足的人群。所有统计分析均通过 Stata 18 SE 进行。其中,4/86(4.7%)实施了招募策略,6/86(7.0%)报告使用了特定的保留策略。86项研究中有19项(22.1%)报告了在招募不公平人群时遇到的挑战,主要指出女性参与者比例过高和社会经济障碍是限制因素之一。局限性包括发表偏差和排除了非英语语言的试验。我们的研究强调了切实启动有效招募和保留策略的必要性,这些策略旨在让历史上被边缘化的人群参与系统性红斑狼疮临床试验。要优先考虑不公平人群的参与、提高系统性红斑狼疮治疗的标准化程度以及改善系统性红斑狼疮研究的相关性,就必须解决这些差距。
Assessing recruitment and retention strategies in clinical trials for inequitable populations in systemic lupus erythematosus: A cross-sectional analysis
Background
Systemic lupus erythematosus (SLE) exhibits a mortality rate four times higher in historically marginalized populations compared to the general population. It is essential for clinical trials to accurately represent the disease population to effectively evaluate treatment modalities. However, the current trial design lacks appropriate diversity, limiting the generalizability of results. We aim to assess the recruitment and retention strategies of historically marginalized populations in SLE clinical trials.
Methods
In this cross-sectional analysis, relevant clinical trials were obtained in a comprehensive search of MEDLINE (PubMed) and Embase (Elsevier) in May of 2024. Included trials were published between January 1, 2018, and December 31, 2023, with a focus on SLE interventions. Reviewers KR and SS independently performed screening and data extraction via a standardized Google Form. The main outcome measured was the usage of recruitment and retention strategies, concerning under-resourced populations. All statistical analyses were performed via Stata 18 SE.
Findings
Our initial database search returned 747 trials, but only 86 were included in this sample. Of these, 4/86 (4.7 %) implemented recruitment strategies while 6/86 (7.0 %) reported the use of specific retention strategies. Nineteen of the 86 studies (22.1 %) reported challenges to the recruitment of inequitable populations, primarily identifying the disproportionate representation of female participants and socioeconomic obstacles as a limitation.
Interpretation
Key strengths include a thorough methodology from adherence to PRISMA guidelines and generalizable findings with the inclusion of international trials. Limitations include publication bias and exclusion of trials in non-English languages. Our study highlights the need for practical initiation of effective recruitment and retention strategies that aim to engage historically marginalized populations in SLE clinical trials. Addressing these gaps is necessary to prioritize the participation of inequitable populations, increase standardization of SLE treatments, and improve the relevance of SLE research.
期刊介绍:
Autoimmunity Reviews is a publication that features up-to-date, structured reviews on various topics in the field of autoimmunity. These reviews are written by renowned experts and include demonstrative illustrations and tables. Each article will have a clear "take-home" message for readers.
The selection of articles is primarily done by the Editors-in-Chief, based on recommendations from the international Editorial Board. The topics covered in the articles span all areas of autoimmunology, aiming to bridge the gap between basic and clinical sciences.
In terms of content, the contributions in basic sciences delve into the pathophysiology and mechanisms of autoimmune disorders, as well as genomics and proteomics. On the other hand, clinical contributions focus on diseases related to autoimmunity, novel therapies, and clinical associations.
Autoimmunity Reviews is internationally recognized, and its articles are indexed and abstracted in prestigious databases such as PubMed/Medline, Science Citation Index Expanded, Biosciences Information Services, and Chemical Abstracts.