在艾滋病毒临床试验中的可行性结果的经验性进展标准值:一项方法学研究
Lawrence Mbuagbaw1,2,3,4,5,6,7, Lucy Huizhu Chen8, Eunice Aluko9
1Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON, L8S4L8, Canada. mbuagblc@mcmaster.ca.
Pilot and feasibility studies
|June 14, 2023
概括
这项研究提供了艾滋病毒随机试验中关键可行性结果的经验估计,有助于未来的研究设计. 结果为艾滋病毒研究的招聘,保留和分析提供了数据驱动的基准.
科学领域:
- 临床试验方法论 临床试验方法论
- 艾滋病毒研究 艾滋病毒研究
- 公共卫生 公共卫生
背景情况:
- 试点和可行性试验依赖于预定义的成功值.
- 这些门通常基于文献,观察数据或临床经验.
- 建立经验估计对于为未来的HIV试点随机试验设计提供信息至关重要.
研究的目的:
- 确定艾滋病毒临床试验中可行性结果的经验估计.
- 为招聘,随机化和保留率提供数据驱动的基准.
- 为未来艾滋病毒试点随机试验的设计和规划提供信息.
主要方法:
- 一项方法研究分析了PubMed.2017-2021年间发表的艾滋病毒临床试验.
- 包括为艾滋病毒感染者进行的个人随机试验,不包括试点和集群试验.
- 随机效应的比例元分析被用来估计招聘,随机化,不合规,失去后续,停药和分析比例.
主要成果:
- 对394项试验的分析产生了以下估计:招募 (64.1%),随机化 (97.1%),不合规 (3.8%),失去了后续 (5.8%),停止 (6.5%) 和分析比例 (94.2%).
- 在各种子组中观察到这些估计的显著差异,包括干预类型,收入水平和世卫组织地区.
- 报告了所有估计的置信区间,为准确性提供了一种衡量标准.
结论:
- 从这项研究中得出的经验估计可以为HIV试点随机试验的设计提供信息.
- 在应用这些估计时,建议仔细考虑子组变化.
- 这项研究为规划和评估未来艾滋病毒干预研究的可行性提供了有价值的基准.
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