患者报告的结果作为临床试验招募的招聘策略
Nicholas P Verdini1, Karolina L Bryl2, Raymond E Baser3
1Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
JAMA oncology
|April 11, 2024
概括
电子患者报告结果 (ePROs) 可以显著增加癌症患者的临床试验入学率. 使用ePRO的提示性招聘策略,与标准推相比,导致更高的入学率.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 数字健康数字健康
背景情况:
- 临床试验参与率仍然很低,只有5%的成年癌症患者被纳入.
- 电子患者报告结果 (ePROs) 提供了一个潜在的途径,通过利用例行收集的数据来增强试验招聘.
研究的目的:
- 确定ePROs引发的招聘策略是否与增加临床试验入学率有关.
- 评估ePRO驱动的招聘在癌症相关疲劳的症状干预试验中的有效性.
主要方法:
- 在第三级癌症中心进行了一项随机副研究,涉及接受放射治疗的乳腺癌患者.
- 符合条件的患者被随机分配,接受一个门户消息邀请进行症状干预试验或标准护理 (医生转诊).
- 每周对ePRO问卷进行中度至重度疲劳的查,这是一个关键的纳入标准.
主要成果:
- 在394名中度至重度疲劳的患者中,210人接受了门户消息,184人接受了标准护理.
- 与标准护理组相比,门户消息组的响应率 (35%) 和入学率 (20%) 显著更高 (0.5%的响应率,0%的入学率;P < .001).
- 推服务消息的响应率高于初级放射瘤学服务 (44%对26%;P = .01),在招生方面没有显著差异.
结论:
- 使用常规的ePRO数据进行招聘与与医生推相比,在症状干预试验中招募人数增加有关.
- 来自推服务的直接消息可能会提高试验入学率,并减轻瘤学研究中的医生层面障碍.
- 由ePRO推动的策略有望改善患者获得症状管理临床试验的机会.
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