开发一个国际核心结果集用于死性肠球炎的治疗试验 - - 一个研究协议
Daphne H Klerk1, Otis C van Varsseveld2, Martin Offringa3
1Division of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. d.h.klerk@umcg.nl.
Trials
|May 31, 2023
概括
这项研究旨在创建一个标准化的核心结果集 (COS) 死亡性肠球炎 (NEC),以提高早产婴儿临床试验的一致性. 该COS将确保更好地比较治疗方法和基于证据的NEC管理指南.
科学领域:
- 新生儿医学 新生儿医学
- 胃肠病学 胃肠病学
- 临床试验方法论 临床试验方法论
背景情况:
- 结核性肠球炎 (NEC) 是早产婴儿死亡的主要原因.
- 在NEC研究中不一致的结果报告阻碍了证据综合和指导方针开发.
- 在NEC研究中,需要标准化的结果衡量标准.
研究的目的:
- 开发一个国际核心成果集 (COS) 对于死角性肠球炎 (NEC).
- 包括与患者,家长和医疗保健专业人员相关的结果,从诊断到成年期.
- 在NEC干预试验中标准化结果报告.
主要方法:
- 这项研究遵循COS-STAD和COMET的建议.
- 一个由三个小组组成的Delphi过程,涉及来自不同收入国家的临床医生,研究人员,患者和家长.
- 通过在线回合和面对面会议达成最终共识.
主要成果:
- 该研究目前处于开发阶段,旨在最终确定一个COS.
- 该过程涉及对现有结果和利益相关者的投入进行系统审查.
- 将在NEC研究的基本成果上达成共识.
结论:
- 对NEC的国际COS将提高结果报告的一致性.
- 这将促进治疗策略的有效比较和试验结果的解释.
- 该COS将为优化早产婴儿NEC管理提供高质量的证据.
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