Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.
Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, United States.
Autoimmun Rev. 2024 Nov;23(11):103645. doi: 10.1016/j.autrev.2024.103645. Epub 2024 Sep 19.
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.
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.
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.
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.
系统性红斑狼疮（SLE）在历史上处于边缘地位的人群中的死亡率比一般人群高四倍。临床试验准确地代表疾病人群对于有效地评估治疗方式至关重要。然而，目前的试验设计缺乏适当的多样性，限制了结果的普遍性。我们旨在评估 SLE 临床试验中历史上处于边缘地位的人群的招募和保留策略。
在这项横断面分析中，我们在 2024 年 5 月全面搜索了 MEDLINE（PubMed）和 Embase（Elsevier），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 SLE 干预措施。审查员 KR 和 SS 通过标准化的 Google 表单独立进行筛选和数据提取。主要的测量结果是针对资源匮乏人群的招募和保留策略的使用情况。所有的统计分析都是通过 Stata 18 SE 进行的。
我们最初的数据库搜索返回了 747 项试验，但只有 86 项被纳入本样本。其中，4/86（4.7%）实施了招募策略，6/86（7.0%）报告了特定的保留策略的使用。86 项研究中的 19 项（22.1%）报告了招募不平等人群的挑战，主要是识别出女性参与者的不成比例代表性和社会经济障碍是一个限制因素。
本研究的主要优势包括严格遵循 PRISMA 指南的方法和纳入国际试验的可推广性结果。局限性包括发表偏倚和排除非英语语言的试验。我们的研究强调需要切实启动有效的招募和保留策略，以吸引 SLE 临床试验中的历史上处于边缘地位的人群。解决这些差距对于优先考虑不平等人群的参与、提高 SLE 治疗的标准化程度以及提高 SLE 研究的相关性是必要的。
