人类健康的顺序多重分配随机试验 (SMARTs) 的设计特征:2009-2024年间研究的范围审查
medRxiv : the preprint server for health sciences
|June 12, 2025
概括
顺序多重分配随机试验 (SMARTs) 的报告显示了变化,大多数初级分析未充分利用其开发动态治疗方案的潜力. 需要标准化指导方针来改善SMART报告和影响.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 顺序多重分配随机试验 (SMARTs) 是可适应的临床试验设计,可以开发动态的治疗方案.
- 之前的审查发现了SMART报告中的不一致性,强调需要进行全面评估.
- 缺乏标准化的报告准则阻碍了SMARTs的全部潜力.
研究的目的:
- 描述人类健康研究中顺序多重分配随机试验 (SMART) 的报告实践.
- 确定SMART报告中的不一致性和需要改进的领域.
- 为制定标准化的SMART特定报告准则提供证据.
主要方法:
- 2009年1月至2024年1月期间发表的SMART协议和初级分析论文的范围审查.
- 系统的数据库搜索和双重独立审查员选和数据提取.
- 对动态治疗方案 (DTRs) 的研究特征,设计元素和分析方法的定性综合和描述性陈述.
主要成果:
- 88篇论文 (59个协议,29个初级分析) 符合纳入标准,主要涉及行为/心理健康和针对成人.
- 对干预描述和重新随机化标准的报告一致,但对盲目和随机化细节的文件不一致.
- 只有48.3%的初级分析评估了嵌入式DTR,没有一个研究了定制的DTR,这表明SMART功能未得到充分利用.
结论:
- 尽管采用越来越多的SMART设计,但在SMART设计中仍然存在大量的报告变化.
- 大多数初级分析并不能充分利用SMART来开发动态治疗方案.
- 制定标准化的SMART特定报告准则对于加速科学和临床影响至关重要.
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