试点和可行性研究如何为手术中的随机化安慰剂对照试验提供信息? 一个系统的审查
Sian Cousins1, Alexander Gormley2, Katy Chalmers3
1Surgical Innovation theme, Bristol National Institute for Health and Care Research (NIHR) Biomedical Research Centre; Royal College of Surgeons of England (RCSEng) Bristol Surgical Trials Centre, Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK sian.cousins@bristol.ac.uk.
BMJ open
|November 21, 2023
概括
对安慰剂控制的手术试验的试点和可行性研究很少. 需要更多的报告来优化这些复杂的随机对照试验 (RCT) 的设计和进行.
科学领域:
- 手术研究方法的方法论.
- 临床试验的设计.
- 基于证据的医学是基于证据的医学.
背景情况:
- 随机对照试验 (RCT) 与安慰剂比较器是评估医疗干预措施的黄金标准.
- 设计和进行外科RCT带来了独特的挑战.
- 建议进行试点和可行性工作,以优化主要试验设计和进行,但其在手术中的范围尚不清楚.
研究的目的:
- 系统地审查和确定试点和可行性研究,为安慰剂控制的外科试验的设计和进行提供信息.
- 评估该领域的试点/可行性工作的特点和报告结果.
主要方法:
- 进行了一项系统性审查,以确定安慰剂控制的手术RCT和相关的试点/可行性研究.
- 搜索的数据库包括Ovid-MEDLINE,Ovid-EMBASE,以及CENTRAL. 这些数据库的搜索内容包括:
- 包括试点/可行性研究,明确旨在为主要的安慰剂控制手术试验的设计或进行提供信息.
主要成果:
- 确定了131个安慰剂控制的手术RCT.
- 只有四个试点/可行性研究被列入真正为主要试验提供信息的研究.
- 这四项研究主要涉及整形外科和口腔/面部外科手术,探讨了招募,侵入性安慰剂可接受性和盲目的可行性.
结论:
- 发表的试点/可行性研究对于安慰剂控制的手术试验特别稀缺.
- 鉴于这些挑战,开展和报告更多的试点/可行性研究至关重要.
- 增加报告将有助于优化未来的主要随机对照试验的设计和进行.
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