推进血管异常的随机对照试验:对试验废物进行分析
Hongrui Chen1, Rui Chang1, Yuxi Chen1
1Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China.
European journal of pediatrics
|September 24, 2024
概括
试验废物 (TW) 是血管异常 (VA) 研究中的一个重要问题. 这项研究发现,68.4%的VA随机对照试验 (RCT) 显示试验浪费,多中心参与是保护因素.
科学领域:
- 血管异常研究研究研究
- 临床试验方法论 临床试验方法论
- 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) 对于推进血管异常 (VA) 的治疗方法至关重要.
- 临床试验浪费 (TW),即临床试验的低效率,对将研究成果应用于患者护理构成了重大障碍.
- 与VA相关的RCT中TW的程度和特征以前没有被分析过.
研究的目的:
- 在过去的20年中,在全球范围内概述与VA相关的RCT的特点.
- 确定VA RCT中试验废弃物 (TW) 的流行率和特征.
- 确定与减少试验浪费相关的因素.
主要方法:
- 在2024年6月进行了对临床试验数据库的全面搜索,使用VA的ISSVA分类术语.
- 通过PubMed和Scopus评估出版状况,并使用CONSORT检查清单评估报告的充分性.
- 基于偏差风险和参考系统性审查,分析了设计局限性,其中159个RCT符合纳入标准.
主要成果:
- 大多数159项包含的RCT集中在良性VA (81.1%) 和使用药物治疗 (79.9%),主要在北美,欧洲和亚洲作为单中心研究 (68.6%) 进行.
- 在98个已发表的RCT中,67% (68.4%) 显示出至少一种试验废物的特征.
- 没有浪费的RCT更有可能招募更多的参与者,并在多个中心和国家进行;多中心参与是对TW的独立保护因素.
结论:
- 大量的VA RCT (68.4%) 遭受试验浪费.
- 识别和理解TW的各种指标对于提高未来VA RCT的合理性和效率至关重要.
- 多中心合作是减轻血管异常研究中试验浪费的关键策略.
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