创伤外科手术随机对照试验的统计能力
Arthur Berg1, Nicole B Lyons1, Abbasali Badami1
1From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias).
Journal of the American College of Surgeons
|July 7, 2023
概括
许多创伤手术随机对照试验 (RCT) 缺乏足够的动力和报告. 很大一部分人没有报告样本大小计算或达到入学目标,影响研究可靠性.
科学领域:
- 创伤外科 手术 创伤外科
- 临床试验 临床试验
- 图书统计学 图书统计学
背景情况:
- 没有足够的随机对照试验 (RCT) 在医学研究中构成了挑战.
- 在创伤外科手术中评估RCT的质量对于基于证据的实践至关重要.
研究的目的:
- 在创伤外科手术中进行随机对照试验 (RCT) 的文献分析.
- 调查不足研究的流行情况,并评估报告标准.
主要方法:
- 一项系统的搜索确定了2000年至2021年间发表的创伤外科手术中的187个RCT.
- 提取了关于样本大小计算,功率分析,CONSORT依从性和脆弱性指数的数据.
- 进行了特设后功率计算,以评估各种效果大小的研究功率.
主要成果:
- 超过一半的研究 (51.3%) 没有报告样本大小计算,而27%的研究没有达到入学目标.
- 仅在57%和65%的研究中发现了足够的功率来检测中等和大效应大小.
- 只有11%的RCT完全遵守CONSORT报告准则,平均得分为19/25.
结论:
- 在创伤外科手术中,很大一部分RCT遭受了不足的权力和方法细节的不良报告.
- 显然需要改善创伤手术临床试验的设计,进行和报告.
- 解决这些问题对于提高创伤手术研究的可靠性和影响至关重要.
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