评估教育倡议在招募代表性不足的参与者参加SLE临床试验方面的有效性
Shivani Kottur1, Marie Maitre2, David Karp1
1University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA.
Lupus
|December 22, 2025
概括
教育研讨会改善了系统性红斑狼 (SLE) 临床试验中的患者和临床医生的舒适度,但没有显著增加招生人数. 需要进一步的研究,以克服在SLE随机临床试验 (RCT) 中多元参与的障碍.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 健康差异 在健康上的差异
背景情况:
- 系统性红斑狼 (SLE) 患者面临着严重的健康差异,但在临床试验中代表性不足.
- 对患者和临床医生来说,临床试验参与存在障碍.
- 招募不同参与者参加SLE临床试验的有效策略有限.
研究的目的:
- 调查教育课程在降低患者和临床医生的SLE临床试验参与障碍方面的有效性.
- 提高SLE患者和临床医生对临床试验参与的知识,态度和技能.
主要方法:
- 从类风湿病组织为患者和临床医生开发了教育材料.
- 举办了研讨会,以评估与临床试验参与相关的知识,态度和技能的变化.
- 评估了研讨会对舒适度和SLE临床试验知识的影响.
主要成果:
- 研讨会后,患者和临床医生对临床试验的态度仍然有利.
- 研讨会提高了患者参与试验的舒适性,以及临床医生对试验流程和转诊的舒适性.
- 关于患者保护和SLE差异的知识有所改善,但后勤/监管知识没有显著变化.
- 观察到的改善并没有转化为增加SLE临床试验或研究登记册的入学人数.
结论:
- 教育干预可以提高患者和临床医生的舒适度和有关SLE临床试验的技能.
- 这项研究的规模很小,因此无法观察到临床试验入学人数的显著增长.
- 需要进一步的策略来将改善的舒适性和知识转化为增加SLE随机临床试验 (RCT) 的招聘.
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