开发一个新生儿肺高血压核心结果集 (NeoPH COS) - 一个研究协议
Cara Ellen Morgan1,2, Kerry Woolfall3, Natasharazia Aikman1,2
1Liverpool Women's NHS Trust Liverpool UK.
Pulmonary circulation
|February 21, 2025
概括
制定新生儿肺高血压 (PH) 的核心结局集至关重要. 这种标准化的方法将改善研究的一致性和治疗新生儿这种罕见但严重疾病的证据.
科学领域:
- 新生儿科学 新生儿科学
- 儿童心脏病学 儿童心脏病学
- 临床试验方法论 临床试验方法论
背景情况:
- 新生儿肺高血压 (PH) 是一种罕见的疾病,死亡率高.
- 对于新生儿PH而言,存在有限的基于证据的治疗策略.
- 不一致的结果报告阻碍了研究之间的比较.
研究的目的:
- 开发一个基于共识的新生儿PH的核心结果集 (COS).
- 在临床试验中对PH的婴儿进行结果报告的标准化.
- 提高新生儿PH疗法的证据质量.
主要方法:
- 国际共识发展涉及利益相关者 (家长,临床医生,研究人员).
- 两阶段的方法:系统文献审查和定性访谈,随后是德尔菲调查和共识会议.
- 成立一个全球咨询小组,指导COS的发展.
主要成果:
- 新生儿肺高血压 (PH) 的核心结果集 (COS) 正在开发中.
- 该方法确保了跨学科的国际适用性和相关性.
- 该COS旨在加强试验设计和结果的一致性.
结论:
- 一个标准化的COS将提高新生儿PH治疗的证据质量.
- 这一举措将有助于更好地比较治疗策略.
- 预计COS将转化为改善PH新生儿的临床护理.
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