试点集群随机对照试验的样本大小计算:2010-2020年审查
Rebecca M Simpson1, Jen Lewis2, Michael J Campbell2
1Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Sheffield, UK. r.simpson@sheffield.ac.uk.
Pilot and feasibility studies
|March 17, 2026
概括
试点集群随机对照试验 (cRCT) 的样本大小在2010-2020年期间保持不变,尽管理由不断变化. 这表明,样本大小的选择可能是由方便而不是既定目标驱动的.
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:
- 对于试点集群随机对照试验 (cRCT) 的样本大小,没有标准化的指导方针.
- 试点试验应关注可行性,而不是有效性,功率计算不适合样本大小的证明.
- CONSORT的指导方针要求对试点试验的样本大小进行证明.
研究的目的:
- 审查试点cRCT中的样本大小选择和理由.
- 分析随着时间的推移,cRCT试点样本大小的趋势.
- 探索CONSORT指南出版物对研究实践的影响.
主要方法:
- 在PubMed和Web of Science系统搜索2010年以后发布的试点/可行性cRCT.
- 数据提取的重点是计划样本大小 (每个手臂的集群),每个手臂的参与者以及注册样本大小.
- 使用了描述性和图形分析.
主要成果:
- 确定了170个试点或可行性cRCT.
- 平均样本大小始终为每个手臂的四个集群.
- 样本大小保持稳定,无论理由,计划的分析或研究特征如何.
结论:
- 在2010-2020年期间,cRCT试点样本大小一直保持不变.
- 陈述的研究目标和样本大小的理由似乎没有影响所选择的样本大小.
- 样本大小可以根据方便或实际考虑而不是研究目标来确定.
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