根据CONSORT检查清单:一项元研究研究,在外科手术中的试点和可行性试验报告不完全
Tyler McKechnie1, Tania Kazi2, Austine Wang2
1Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Journal of clinical epidemiology
|March 28, 2024
概括
在手术试点和可行性试验中,报告的完整性很差. 综合报告试验标准 (CONSORT) 的扩展并没有改善这些必要的外科研究报告的质量.
科学领域:
- 手术研究方法的方法论.
- 临床试验报告标准
- 基于证据的医学是基于证据的医学.
背景情况:
- 试点和可行性 (PAF) 试验对于手术研究的挑战至关重要.
- 在PAF试验中,充分的报告完整性对于其有效使用至关重要.
- 报告试验的综合标准 (CONSORT) 开发了PAF试验的扩展.
研究的目的:
- 评估外科PAF试验报告的完整性.
- 评估在手术研究中对PAF试验的CONSORT扩展的遵守情况.
主要方法:
- 根据系统审查和元分析 (PRISMA) 准则的首选报告项目进行了一项超级研究研究.
- 包括的研究是手术干预的试点或可行性随机试验,从2011年到2021年在MEDLINE,Embase和Cochrane Central中进行了搜索.
- 首要结果是对CONSORT扩展检查清单的总体遵守,Poisson回归被用于探索与报告因素的关联.
主要成果:
- 在1991年的引用中,包括了2011年的38项研究和2021年的34项研究.
- 平均CONSORT报告得分为21.5/34 (63%),平均报告的项目为20.1个 (59%) 在排除不适用的项目后.
- 与2011年相比,2021年发表的研究没有显示出报告的改善. 试验注册和>50名患者的随机化与更好的报告相关.
结论:
- 手术试点和可行性试验显示报告完整性不佳.
- 对于PAF试验的CONSORT扩展尚未导致PAF手术试验的报告得到改善.
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