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新生儿试验中报告初级结果的异质性和差距
Ami Baba1, James Webbe2, Nancy J Butcher1,3
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Pediatrics
|August 29, 2023
概括
新生儿试验中主要结果报告不一致. 关键细节,如最小重要的差异和缺失的数据经常被遗漏,阻碍了解释和基于证据的决策.
科学领域:
- 新生儿研究新生儿研究
- 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:
- 清晰的结果报告对于解释临床试验结果和为医疗决策提供信息至关重要.
- 新生儿试验的标准化核心结果存在,但初级结果报告实践需要进一步调查.
- 确定初级结果报告的优点和缺点对于提高新生儿试验透明度至关重要.
研究的目的:
- 评估最近新生儿临床试验中主要结果报告的完整性.
- 确定主要结果如何报告的具体优势和弱点.
- 为提高新生儿试验报告质量和透明度的战略提供信息.
主要方法:
- 进行了2015年至2020年间发表的36项新生儿试验的系统评估.
- 试验包括每组至少100名参与者,以及一个核心结果集中的主要结果.
- 经过培训的评级人员使用综合报告试验标准 (CONSORT) 准则评估结果报告的完整性.
主要成果:
- 在评估的新生儿试验中,结果报告的完整性差异很大.
- 虽然测量,统计方法和参与者流量得到了充分报告,但其他领域显示出缺陷.
- 报告不完整的关键领域包括最小重要的差异 (28%),缺失的数据 (24%),结果评估人员的盲目化 (66%) 和处理多重性 (42%).
结论:
- 在新生儿试验中,主要结果报告经常缺乏对结果解释和知识综合的基本信息.
- 不一致的报道阻碍了新生儿学中基于证据的决策.
- 建议研究人员,期刊和审稿人遵守现有的结果报告准则,以提高透明度.
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