对集群随机试验的统计分析计划报告质量的审查
Jacqueline Y Thompson1, Julia Shaw2, Samuel I Watson1
1Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Journal of clinical epidemiology
|February 17, 2025
概括
这项研究评估了集群随机试验 (CRT) 的统计分析计划 (SAP),发现关键项目和CRT特定分析的报告不一致. 在CRT中对SAP的指导需要改进,以提高报告质量.
科学领域:
- 生物统计学 生物统计学
- 临床试验方法论 临床试验方法论
- 流行病学 流行病学
背景情况:
- 现有的统计分析计划 (SAP) 准则缺乏针对集群随机试验 (CRT) 的具体定制.
- 对于CRT的SAP的报告质量以前没有根据当前的指南进行评估.
- 需要评估遵守关键报告项目以及CRT的重要附加方面.
研究的目的:
- 评估CRT的SAP样本是否符合当前的报告准则.
- 确定CRT的SAP如何报告对此试验设计至关重要的额外分析方面.
- 确定SAP报告指南中需要改进的领域.
主要方法:
- 对独立的SAP和作为补充材料发布的SAP进行了系统的搜索.
- 已识别的SAP被分析为遵守当前报告准则和特定CRT考虑.
- 该审查包括通过Ovid-MEDLINE识别的SAP和现有的CRT数据库.
主要成果:
- 在审查的85个独特的SAP中,报告的清晰度在关键项目上有很大差异.
- 虽然大多数SAP计划进行集群 (93%),但很少有针对小集群数量 (25%) 或集群内相关性估计 (6%) 的详细方法.
- 在大多数SAP中,推断的统计目标报告不清楚 (例如,个人与集群级目标).
结论:
- 该审查确定了CRT的SAP中报告质量不佳的特定领域.
- 目前的报告准则可能需要对CRT进行特定的补充或修改.
- 在CRT中开发SAP需要加强指导,以提高报告的质量和清晰度.
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