自我报告的症状性石头复发在预防尿路结石与水化试验中的判断
Hunter Wessells1, John C Lieske2, H Henry Lai3
1Department of Urology, University of Washington School of Medicine, Seattle, WA.
Urology
|September 6, 2024
概括
在预防尿路结石与水分 (PUSH) 试验中,自我报告的石头事件非常准确. 判断证实大多数事件是临床或患者报告的传递,很少有非事件.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 临床试验 临床试验
背景情况:
- 预防尿路结石与水分 (PUSH) 试验调查了一种行为干预,以增加液体摄入量.
- 准确报告尿路结石事件对于临床试验终点至关重要.
- 临床试验的注册:NCT03244189.9. 临床试验的注册:NCT03244189. 临床试验的注册:NCT03244189.
研究的目的:
- 为了评估PUSH试验中自我报告的尿路结石事件的准确性.
- 为了比较自我报告的石头事件与石头通道或手术干预的记录证据.
主要方法:
- 参与PUSH试验的参与者被随机分配到干预组或对照组.
- 主要终点包括症状性石头通过或程序性干预.
- 一个独立的评审委员会,对治疗盲目,审查了所有报告的事件.
主要成果:
- 在217个自我报告的石头事件中,134个 (61.8%) 是确定的临床事件.
- 71个事件 (32.7%) 被归类为没有客观文档的患者报告的经历.
- 只有12个事件 (5.5%) 在裁决后被归类为非事件.
结论:
- 在PUSH试验中,自我报告的石头事件在很大程度上与临床记录的事件或患者报告的经历相对应.
- 低比例的自我报告事件未能满足裁决标准.
- 本试验中使用的判定和分类方法应考虑用于未来的石材研究.
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