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妇女在慢性病患者的临床试验中的代表性
Ana-Catarina Pinho-Gomes1,2, Cheryl Carcel3,4, Mark Woodward1,3
1The George Institute for Global Health, Imperial College London, UK.
Clinical kidney journal
|September 4, 2023
概括
妇女在慢性病 (CKD) 临床试验中代表性不足,参与率低于她们在CKD人口中的患病率. 很少报告按性别分类的结果,这阻碍了对CKD治疗中的性别和性别差异的理解.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 临床试验 临床试验
- 医学中的性别和性别.
背景情况:
- 慢性病 (CKD) 流行病学和治疗反应中的性别和性别差异尚未得到充分理解.
- 调查CKD临床试验中的女性代表性对于解决知识差距至关重要.
研究的目的:
- 评估随机阶段3/4 CKD临床试验中的女性代表性.
- 为了确定这些试验中是否报告了按性别分类的结果.
主要方法:
- 在ClinicalTrials.gov (1995-2022) 登记的CKD临床试验的系统审查.
- 分析了192项具有≥100名参与者的试验,以计算女性的参与率:流行率 (PPR).
- 对性别分类数据报告结果的检查.
主要成果:
- 在192项CKD试验中,女性占参与者的45%,低于其全球流行率 (55%).
- 女性的参与率:流行率 (PPR) 为0.75,表明代表性不足.
- 只有20%的试验报告了按性别分类的疗效结果,没有报告安全结果.
结论:
- 与女性患病率相比,女性在CKD临床试验中的代表性较低.
- 缺乏按性别分类的结果报告限制了对CKD中性别和性别差异的理解.
- 增加妇女的入学率和分类数据的报告对于推进公平的CKD护理至关重要.
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