在与氨酸相关的随机对照试验中的试验废物
Hongrui Chen1, Qinqi Yu2, Zening Huang3
1Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Journal of oral rehabilitation
|November 1, 2024
概括
试验废弃物 (TW) 显著影响氨酸 (HA) 研究,73.3%的分析HA随机对照试验 (RCT) 显示TW. 早期注册和缺乏多重盲目是研究效率低下的关键风险因素.
科学领域:
- 医学研究方法论医学研究方法论.
- 临床试验分析临床试验分析
- 氨酸的应用 氨酸的应用
背景情况:
- 试验废物 (TW) 在将与氨酸 (HA) 相关的随机对照试验 (RCT) 的研究结果转化为临床实践方面存在重大挑战.
- 在HA-RCT中TW的程度以前没有得到量化.
研究的目的:
- 量化与氨酸 (HA) 相关的随机对照试验 (RCT) 中试验浪费 (TW) 的程度.
- 确定可能在HA-RCTs中保护或促进TW的因素.
主要方法:
- 在2024年7月,对HA相关的RCT进行了临床试验数据库的系统搜索.
- 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审查来确定TW指标,分析了设计局限性.
主要成果:
- 在包括的184个HA-RCT中,73.3% (96项研究) 呈现TW特征.
- 技术工作的关键指标包括未发表的研究 (53个RCT),报告不足 (47个RCT) 和设计限制 (19个RCT).
- 对TW的独立风险因素被确定为2014年之前的注册和开放标签或单盲设计.
结论:
- 大多数分析的HA-RCT表明试验浪费,突出了研究行为的低效率.
- 了解已识别的TW指标可以为未来HA-RCT的更合理,更有效的设计和执行提供信息.
- 解决注册时间和盲目的协议等因素对于优化HA研究结果至关重要.
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