在随机临床试验中报告医疗疾病的可靠性
Rachelle Morgenstern1, Avi Reichenberg2, Benjamin Kummer1
1Icahn School of Medicine at Mount Sinai, New York, New York, United States of America.
PloS one
|April 24, 2025
概括
临床试验中的病史往往低估了疾病. 将患者报告与体检,测试和药物相结合,可显著提高精神疾病和先前NAION等疾病的准确性.
科学领域:
- 临床流行病学临床流行病学
- 医疗信息学 医疗信息学
背景情况:
- 在人口调查,医疗记录和临床试验中报告的医疗疾病可能缺乏准确性.
- 需要改进的方法可靠的医疗疾病确认.
研究的目的:
- 在临床试验中报告自我报告的疾病的准确性.
- 将报告的流行率与验证方法进行比较.
主要方法:
- 在8个国家进行的试验中,对729名参与者评估了11种医疗疾病的患病率.
- 使用了四种方法:自我/记录报告 (M1),体检/测试 (M2),药物指示 (M3) 和M2+M3 (M4).
- 使用科恩卡帕 (K) 评估的M1和其他方法之间的一致性.
主要成果:
- 在大多数疾病中,自我报告的患病率 (M1) 低于M2,M3或M4.
- 在精神疾病 (K=0.52) 和先前非动脉炎前面缺血性视神经病 (NAION) (K=0.67) 中观察到M1和M4之间的中等一致性 (K ≥0.50).
- 贫血,高血压,糖尿病和精神疾病的流行率和一致性因性别而异;流行率在各国之间差异很大.
结论:
- 预期的医疗史本身并不能可靠地识别所有医疗疾病.
- 整合体检,实验室测试和药物数据可以提高报告准确度.
- 这种验证策略可以适应临床试验和电子健康记录数据挖掘.
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