1999年至2022年在中国发表的儿科随机对照试验的质量评估:一个横截面研究
Bennian Huo1, Song Xu2, Yao Liu3
1Department of Pharmacy Children' s Hospital of Chongqing Medical University, National Clinical Research centre for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing Clinical pharmacy Key Specialty Construction Project, Chongqing, China.
BMC pediatrics
|May 27, 2024
概括
中国儿科随机对照试验 (RCT) 的数量和质量有所改善,但整体质量仍然很低. 诸如分配隐藏和盲目的关键领域需要注意更好的临床实践翻译.
科学领域:
- 儿科研究 儿科研究
- 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) 是基于证据的医学的基础.
- 随机试验的临床适用性取决于其报告的质量.
- 评估中国儿科RCT对于改善临床实践至关重要.
研究的目的:
- 评估在中国发表的儿科RCT的一般特征.
- 评估报告质量和中国儿科RCT中偏差风险.
- 为改善儿科RCT报告和临床应用提供证据.
主要方法:
- 在中国杂志上发表的儿科RCT (1999-2022) 的横截面观测研究.
- 包括涉及儿童 (<18岁) 的RCT.
- 使用Cochrane偏差风险工具进行质量评估.
主要成果:
- 分析了3545个儿科RCT,显示7.8%的年增长率.
- 大多数研究都是单中心药物试验,主要来自中国东部.
- 最近几年 (2017-2022) 在几个偏见领域观察到显著的质量改善,特别是在多中心试验和获得伦理委员会批准的试验中.
结论:
- 中国儿科RCT显示数量增加和质量改善,但总体上仍然相对较低.
- 需要改进的关键领域包括分配隐藏,蒙蔽和报告放弃,不良影响和样本大小.
- 建议包括政策推广,期刊标准化和临床试验注册.
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