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手术中的自适应性临床试验:对方法和报告质量的范围审查
Phillip Staibano1,2, Emily Oulousian1,3, Tyler McKechnie2,4
1Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
PloS one
|May 28, 2024
概括
适应性手术试验提供了潜在的改善,但面临着挑战. 这次审查发现,在现有的适应性手术试验中,存在偏差和异质报告质量的高风险,需要遵守指南.
科学领域:
- 手术研究的研究.
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 随机对照试验 (RCT) 对基于证据的医疗保健至关重要,但手术RCT仍然有限.
- 适应性临床试验 (ACT) 可以提高试验效率和报告质量.
- 本研究审查了适应性外科试验的方法和报告质量.
研究的目的:
- 评估适应性手术试验的方法和报告质量.
- 确定适应性外科研究的挑战和改进领域.
主要方法:
- 对Ovid,Web of Science和Cochrane协作进行了全面的搜索,用于适应性外科RCT,直到2023年10月.
- 使用RoB 2.0仪器评估了偏差风险.
- 报告质量使用CONSORT ACE 2020指南进行评估.
主要成果:
- 在1338项已识别的研究中,只有6项试验符合纳入标准.
- 在心胸外科,口腔外科,骨科外科和泌尿外科中发现了自适应性手术试验.
- 观察到高偏差风险 (50%) 和异质报告质量,特别是在随机化和盲目隐方面.
结论:
- 应考虑适应性试验组件,以改善手术试验的招募和持续时间.
- 未来的自适应性外科试验必须遵守CONSORT ACE 2020指南,以提供一致的报告.
- 需要进一步的研究来标准化手术中的适应性方法.
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