多中心试验RCT中的平衡流动性:对临床医生的决策影响,提供试验入门
Eleanor Molloy1, Nicole Pilarski2, Katie Morris2
1Institute for Applied Health Research, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT.
概括
临床平衡,或对治疗的真正不确定性,在紧急宫结膜 (ECC) 的研究中是流动的. 患者病史和临床医生的经验等因素影响了这种流动性,影响了试验招聘.
科学领域:
- 产科和妇科 产科和妇科
- 临床试验方法论 临床试验方法论
- 定性研究是指质量研究.
背景情况:
- 随机对照试验 (RCT) 的招募依赖于临床平衡的假设,定义为对干预的益处或危害的真正不确定性.
- 试验招聘人员有效地传达这种平衡的能力对于知情同意和参与者招募至关重要.
- 了解影响平衡的因素对于优化复杂临床试验的招聘策略至关重要.
研究的目的:
- 探索CSTICH-试点RCT中招聘的促进者和障碍.
- 对"平衡流动性"的总体主题及其对个人和社区临床平衡的影响进行二次分析.
主要方法:
- 在CSTICH-Pilot RCT中进行了嵌入式质量过程评估 (QPE).
- 与参与试验招聘的23名医疗保健专业人员 (HCP) 进行了半结构面试.
- 采访被录音,转录,并使用编码书主题分析进行分析.
主要成果:
- 发现,围绕ECC使用的临床平衡在医疗人员之间是可变的.
- 关键影响因素包括产科病史,妊娠年龄,标准场所实践,以及医疗保健工作人员以前与ECC的经验.
- 这种观察到的变异性被概念化为"平衡的流动性".
结论:
- 复杂妊娠状况中的临床平衡是流动的,受患者特定因素和妊娠阶段的影响.
- 医务人员之间的平衡流动性可以显著影响招聘细微差别,特别是在具有挑战性的试验中,如CSTICH-2.
- 建议专门研究的材料和培训,以提高对证据不确定性的认识,需要进一步研究均衡流动性的后果.
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