在临床试验中改善儿科气道管理结果报告 (IMPACT):核心结果和临床终点研究方案
Clyde T Matava1,2, Julia M Olsen1,2, Vanessa Marchesini3
1Department of Anesthesia and Pain Medicine, Hospital for Sick Children, Toronto, Ontario, Canada.
针对儿科呼吸道管理试验的标准化结果报告准则正在开发中,以提高研究质量和患者安全. 该倡议旨在提高临床试验数据的一致性和可比性,有利于系统审查和基于证据的实践.
科学领域:
- 儿科麻醉学 儿科麻醉学
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 结果报告中的异质性使系统审查和基于证据的实践变得复杂.
- 儿科呼吸道管理试验中不一致的报告妨碍了研究结果的综合.
- 人们认识到有必要提高儿科临床研究结果报告的质量.
研究的目的:
- 制定标准化,基于共识的结果定义和报告项目,用于儿科呼吸道管理试验.
- 创建指南,扩展SPIRIT和CONSORT框架,以提高试验透明度和可重复性.
- 加强儿科呼吸道研究,系统审查,患者护理和安全.
主要方法:
- 遵守EQUATOR网络的指导方针开发框架.
- 一个四阶段的方法,包括范围审查,德尔菲过程,共识会议和传播.
- 涉及多学科专家小组,并遵守既定的报告准则.
主要成果:
- 制定针对儿科呼吸道管理的标准化结果报告准则.
- 创建扩展到SPIRIT和CONSORT框架的内容.
- 建立基于共识的定义和报告项目.
结论:
- 最终准则将通过同行评审的出版物和会议传播.
- 这些指导方针将提交给相关注册机构,如EQUATOR,SPIRIT和CONSORT.
- 积极的利益相关者参与将最大限度地提高制定的报告标准的影响.
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