一项随机研究,比较患者门户和电子邮件通信,用于试验招聘
Jeanette Y Ziegenfuss1, Elanadora U Sour1, Erica J Roelofs1
1Center for Evaluation and Survey Research, HealthPartners Institute, Bloomington, MN, USA.
Clinical trials (London, England)
|August 21, 2025
概括
患者门户外宣传增加了初始临床试验参与度,但与电子邮件相比,并没有显著改善整体随机化率. 这表明,在没有相应增加成功的试验入学人数的情况下,可能会增加努力.
科学领域:
- 临床试验 临床试验
- 生物医学研究生物医学研究
- 医疗信息学 医疗信息学
背景情况:
- 临床试验招聘对于确保代表性研究人群至关重要.
- 电子健康记录 (EHR) 患者门户提供了一个有希望的招聘策略.
- 对于EHR门户外宣传与传统电子邮件招聘的有效性尚不清楚.
研究的目的:
- 为了比较EHR患者门户外宣传与临床试验招聘电子邮件的有效性.
- 评估不同沟通策略的招聘率和人口代表性.
- 确定调节沟通类型对招聘成功影响的因素.
主要方法:
- 17,989名可能有资格的参与者被随机分配到LEAP研究的EHR门户或电子邮件外展.
- 招聘成功被衡量在六个里程碑,从自我选启动研究随机化.
- 多变量分析检查了通讯类型有效性的人口调节因素.
主要成果:
- 患者门户外展导致了更高的初始自我选完成率 (OR=2.4),但最终随机化并没有显著增加 (OR=1.43).
- 在控制先前步骤完成时,随后的里程碑差异并不显著.
- 性别调节了响应率,女性和男性更有可能响应门户消息.
结论:
- 虽然患者门户外展增强了初始参与者激活,但它并没有显著改善整体临床试验随机化率.
- 该策略可能会增加研究人员和参与者的努力,而不会在招生方面产生相应的收益.
- 招聘策略的选择可能取决于组织背景和研究主题的敏感性.
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