一个系统的审查的样本大小估计准确度在疟疾集群随机试验测量流行病学结果的功率
Joseph Biggs1, Joseph D Challenger2, Joel Hellewell2
1Medical Research Council (MRC) International Statistics and Epidemiology Group, Department of Infectious Disease Epidemiology and International Health, London School of Hygiene and Tropical Medicine, London, UK. joseph.biggs1@lshtm.ac.uk.
BMC medical research methodology
|October 15, 2024
概括
疟疾集群随机试验 (CRT) 的样本大小计算通常不准确,导致研究不足. 改善这些疟疾试验的输入参数对于有效的干预评估至关重要.
科学领域:
- 流行病学 流行病学
- 生物统计学 生物统计学
- 公共卫生 公共卫生
背景情况:
- 集群随机试验 (CRT) 对于评估全社区疟疾控制干预措施至关重要.
- 准确的样本大小计算对于在CRT中检测统计学上显著的干预效应至关重要.
- 之前的研究表明,用于疟疾CRT样本大小估计的预测参数存在潜在的不准确性.
研究的目的:
- 审查用于疟疾CRT样本大小计算的预测参数的准确性.
- 评估不准确的样本大小估计对疟疾CRT研究功率和干预效应检测的影响.
主要方法:
- 在2022年3月,在四个数据库中对已公布的疟疾CRT和流行病学结果进行了系统的搜索.
- 提取了预测和观察到的样本大小参数,包括对照组的结果措施和效果大小.
- 使用斯皮尔曼相关系数来评估预测和观察参数之间的一致性;根据观察到的异质性,重新计算研究功率.
主要成果:
- 在71个符合条件的疟疾CRT中,91.5%包括样本大小计算,通常使用没有先前数据的变化系数.
- 预测的对照组患病率与观察值有中等相关性,在61.2%的病例中估计过高.
- 观察到的效果大小经常比预测小 (72.9%),总体效果大小在1995年至2021年期间下降,在许多试验中损害了研究能力.
结论:
- 不准确的样本大小参数在疟疾CRT中很常见,导致研究不足.
- 需要更具代表性的流行病学数据来为未来疟疾CRT的样本大小计算提供信息.
- 确保足够的研究能力对于旨在控制疟疾的干预措施的可靠评估至关重要.
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