在随机对照的手术试验中定义非劣势边际:系统审查的协议
Christoph Kuemmerli1,2, Iain J Gallagher3, Richard Skipworth4
1Molecular, Genetic and Population Health Sciences, The University of Edinburgh Medical School, Edinburgh, UK Christoph.kuemmerli@clarunis.ch.
BMJ open
|August 24, 2024
概括
本系统性审查评估了手术试验中的非劣势 (NI) 利报告. 对NI保证金合理性的报告不足是常见的,影响了试验结论,并突出了对标准化方法的需求.
科学领域:
- 临床试验方法论 临床试验方法论
- 手术研究的研究.
- 生物统计学 生物统计学
背景情况:
- 报告的非劣势 (NI) 药物试验是不充分的,超过50%缺乏NI差额的理由.
- 报告试验综合标准 (CONSORT) 对NI和等效试验的扩展并没有改善报告质量.
- 选择NI边际对试验结论有重大影响,需要严格的定义和评估.
研究的目的:
- 系统地审查和评估在手术试验中的非劣势差额定义的报告和方法质量.
- 确定外科NI试验的设计和报告中的缺陷.
- 将手术NI试验与药物试验的报告进行比较.
主要方法:
- 使用NI设计的腹部外科手术随机对照试验的系统审查.
- 纳入标准:手术干预,成年患者,样本大小≥100.
- 对Ovid MEDLINE,EMBASE和Cochrane中央注册表进行搜索;对CONSORT建议进行评估;对边际估计进行基于模拟的可靠性检查.
主要成果:
- 预期结果包括手术NI试验的设计和报告的详细描述和评估.
- 识别报告和方法论中的常见缺陷.
- 结果与药物试验结果的比较.
结论:
- 结果将为研究人员提供适当的设计和使用NI设计进行手术随机对照试验的潜在陷.
- 促进在外科NI试验中对研究结果进行彻底和标准化的报告.
- 强调强有力的理由和估计非劣势差额的关键需求.
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