一个范围的审查集中在合作小组参与外科手术随机对照试验
Eloise Papet1, Grégoire Moutel2, Jean Pinson1
1Department of Digestive Surgery, Rouen University Hospital, Rouen, France.
The Journal of surgical research
|January 9, 2026
概括
合作小组参与手术试验的比例很低,但可能会提高质量. 更多的参与可以增强在手术随机对照试验 (RCT) 的研究基础设施和以患者为中心的结果.
科学领域:
- 手术 手术 手术 术 术
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
背景情况:
- 手术随机对照试验 (RCT) 在方法和伦理标准方面面临挑战,特别是在多中心环境中.
- 在瘤学领域建立的合作小组 (CGs) 提供了提高外科手术试验质量的潜力.
- 对手术RCT的CG的影响仍未得到充分研究.
研究的目的:
- 绘制2016-2020年发布的第三期手术RCT的方法和伦理质量.
- 评估合作小组 (CG) 参与对手术试验质量的潜在影响.
主要方法:
- 在2016年1月至2020年12月期间发表的RCT的十个主要外科期刊的系统搜索.
- 使用Jadad尺度评估方法质量,使用Berdeu评分评估道德质量.
- 分析研究特征,包括样本规模,资金,多中心设计和CG参与等.
主要成果:
- 包括520个手术RCT,平均Jadad分数为10.0和Berdeu分数为0.8.
- 只有10%的试验使用了CG,但这些试验显示了更高的方法质量 (Jadad 10.4 vs 9.97) 和更多的生活质量评估 (28% vs 13%) 的趋势.
- 以CG为主导的试验更有可能获得公共资金 (56%对33%).
结论:
- 合作小组参与手术RCT是有限的,但与改进的方法实践有关.
- CG的参与可能会导致更广泛的结果测量,例如生活质量评估.
- 增加CG参与可以加强外科研究基础设施,并促进以患者为中心的试验设计.
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