了解肝移植期间随机对照试验 (RCT) 的招募:一种观察性混合方法试验中的研究 (SWAT)
Katherine Elizabeth Sarah Coppack1, Ilya Kantsedikas2,3, Edgar Brodkin4
1North Central and East London Rotation, NHS Health Education England London School of Anaesthesia, London, England, UK katherine.coppack@nhs.net.
BMJ open
|January 7, 2026
概括
等待肝移植的患者的动机是利他主义和对临床试验参与的安全感. 障碍包括对随机化和缺乏家庭支持的担忧,强调需要改善沟通和信任.
科学领域:
- 移植研究 移植研究
- 临床试验招聘 临床试验招聘
- 手术瘤学手术瘤学
背景情况:
- 在肝移植中,外科手术期间的随机对照试验 (RCT) 是罕见的,面临着独特的招聘挑战.
- 移植中心的患者疾病严重程度,并发症,人口统计和地理限制会影响试验参与.
- 紧急情况和非正式入院进一步复杂化了患者准备参加试验的准备.
研究的目的:
- 探索患者的动机和障碍,以招募在术后随机对照试验 (RCTs) 肝移植.
- 收集对患者参与试验的观点的见解,以完善招聘策略.
- 增强对影响复杂外科试验招生因素的理解.
主要方法:
- 一个观察性混合方法"试验中的研究" (SWAT) 嵌入在可行性RCT中.
- 在两个高等国家卫生服务医院进行的双中心研究.
- 有资格接受肝移植的成年人填写了关于参与试验动机的18个问题验证问卷.
主要成果:
- 84个被填写的调查问卷确定了参与试验的关键动机.
- 激励因素包括对他人有益的信念,对研究的兴趣,感知到的好处超过风险,以及对最佳治疗的信念.
- 障碍包括对随机化的担忧,感觉过度负担,以及缺乏家庭/朋友支持的感觉.
结论:
- 这是第一个调查肝移植患者外科手术期RCT招募动机和障碍的研究.
- 利他主义和感知到的安全是主要的动机;对随机化和家庭支持的担忧是重要的障碍.
- 未来的招聘策略应侧重于中立,以患者为中心的咨询,清晰的信息,建立信任和参与支持网络.
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