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核心结果集用于瘤性肠结肠炎治疗试验.
Daphne H Klerk1, Otis C van Varsseveld2, Martin Offringa3
1Division of Neonatology, Beatrix Children's Hospital.
Pediatrics
|May 10, 2024
概括
开发了一种新的核心结果集 (COS) 用于结核性肠球炎 (NEC) 治疗试验. 这种标准化的方法确保患者和医生相关的结果始终报告,改善NEC护理.
科学领域:
- 新生儿医学 新生儿医学
- 儿科手术 儿科手术
- 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) 治疗试验在结果报告中表现出显著的变化.
- 这种不一致性阻碍了元分析和新型治疗策略的实施.
- 标准化结果报告对于推进NEC研究和临床实践至关重要.
研究的目的:
- 为了开发一个基于共识的核心结果集 (COS) 结核性肠球炎 (NEC) 治疗试验.
- COS旨在涵盖与患者和医生最相关的结果,从诊断到成年期.
- 该倡议旨在在NEC临床研究中标准化结果测量.
主要方法:
- 一项系统性审查确定了NEC研究的45个潜在结果.
- 为了达成共识,进行了三个在线Delphi轮,涉及临床医生,研究人员,患者和家长.
- 与包括患者和家属代表在内的国际利益相关者举行的最终共识会议最终确定了结果.
主要成果:
- 来自25个国家的71名参与者,包括15名患者/家庭代表,完成了Delphi轮.
- 13个结果在至少一个利益相关者群体中达成共识; 6个在两个群体中达成共识.
- 选择了五个结果:死亡率,与NEC相关的死亡率,短肠综合征,生活质量和神经发育障碍.
结论:
- 已经建立了NEC治疗试验的国际核心结果集 (COS),包括5个关键结果.
- 这种由临床医生,患者和家人同意的COS主要关注长期结果.
- 该COS的实施将标准化结果选择,提高试验相关性,并最终改善NEC的婴儿护理.
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