针对儿科 inguinal hernia 治疗试验的国际核心结果集的开发:包括系统性审查和Delphi调查在内的三阶段研究的协议
Sanne C Maat1,2,3, Ramon R Gorter2, Ernest L W van Heurn4,3
1Department of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Emma Childrens' Hospital UMC, Amsterdam, The Netherlands s.c.maat@amsterdamumc.nl.
BMJ open
|December 14, 2023
概括
本研究旨在为儿科 inguinal hernia 修复建立一个核心结果集,以标准化报告和改善治疗比较. 发展这种共识将解决当前研究中的异质性,从而使手术方法的证据更加清晰.
科学领域:
- 儿科外科手术 儿科外科手术
- 临床试验方法论 临床试验方法论
背景情况:
- 在儿童中,开放的 inguinal 的修复是标准的,但正在出现腹腔镜技术.
- 缺乏关于外科手术优势的共识源于试验中不一致的结果报告.
- 需要一个核心结果集 (COS) 标准化结果测量和报告在儿科 inguinal hernia修复.
研究的目的:
- 为了达成国际共识,对儿科 inguinal 修复试验的最低一组结果.
- 减少跨研究结果选择,测量和报告的异质性.
- 促进手术治疗策略的基于证据的决策.
主要方法:
- 系统的文献审查,以从患者和文献角度确定结果领域.
- 三轮德尔菲研究涉及利益相关者优先考虑核心成果.
- 专家达成共识会议,最终确定COS并制定实施策略.
主要成果:
- 该项目目前处于开发阶段,旨在建立一个COS.
- 该方法包括系统审查,Delphi研究和专家共识.
- 最终的COS将按照COS报告标准进行报告.
结论:
- 一个标准化的核心结果集对于推进儿科 inguinal hernia 修复的研究至关重要.
- 这一举措将提高临床试验的质量和可比性.
- 开发的COS将指导未来的研究和临床实践,最终有利于患者的结果.
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