改善流产预防研究:一项调查探讨服务用户和利益相关者的期望 (IMPRESS) - 一项基于英国的调查调查的研究协议
Naomi Black1,2, Siobhan Quenby3,2, Joshua Odendaal3,2
1Division of Biomedical Sciences, Clinical Sciences Research Laboratories, Warwick Medical School, University of Warwick, Coventry, UK naomi.black@warwick.ac.uk.
BMJ open
|July 27, 2024
概括
这项研究对利益相关者进行了调查,以确定有意义的治疗效果,并确定反复流产试验的停止标准. 结果将为适应性试验设计提供信息,以在流产预防研究中获得更好的以患者为中心的结果.
科学领域:
- 生殖医学 生殖医学
- 临床试验设计 临床试验设计
- 患者报告的结果
背景情况:
- 经常性流产试验通常使用任意效果大小进行样本大小计算.
- 参与者对有意义的治疗效果的观点在试验设计中经常被忽视.
- 缺乏明确的标准来将利益相关者的观点纳入用于预防流产的适应性试验设计中.
研究的目的:
- 确定利益相关者定义的有价值的治疗效果,用于旨在预防反复流产的干预.
- 确定可接受的临床试验中断标准,以调查流产预防.
主要方法:
- 采用了一个横截面的在线匿名调查.
- 该调查提出了不同治疗效果大小和概率值的场景.
- 参与者包括有流产史的个人和医疗保健专业人员,通过方便,雪球和有目的抽样招募.
主要成果:
- 该研究目前处于数据收集阶段.
- 分析将涉及描述性和线性回归来合成调查答案.
- 结果将在伦理审批和调查完成后公布.
结论:
- 了解利益相关者的观点对于设计以患者为中心的流产预防试验至关重要.
- 这项研究旨在为适应性试验设计提供基于证据的标准.
- 这些发现将有助于对反复流产的更相关和更有效的临床试验.
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