在实用体重增加预防试验中评估电子健康记录衍生结果:对未来试验的影响,可变性和影响
Hailey N Miller1, John A Gallis2, Sandy Askew3
1Hailey N. Miller, PhD, Assistant Professor, School of Nursing, Johns Hopkins University, Baltimore, Maryland.
The Journal of cardiovascular nursing
|January 28, 2026
概括
均衡干预最初改善了血压,但效果逐渐减弱. 试验中的电子健康记录 (EHR) 数据需要仔细考虑测量频率和可变性,以获得准确的结果.
科学领域:
- 临床试验 临床试验
- 医疗信息学 医疗信息学
- 数字健康干预措施 数字健康干预措施
背景情况:
- 由于测量不一致或不频繁,电子健康记录 (EHR) 数据对结局确定提出了挑战.
- 实用随机试验需要强大的方法来评估使用现实数据的干预效应.
研究的目的:
- 评估"平衡"数字体重增加预防干预措施对从EHR数据中获得的二次/探索性结果的影响.
- 在临床试验环境中分析EHR衍生结果测量的频率,时间和可变性.
主要方法:
- 这是一项为期12个月的实用性随机试验,涉及443名参与者.
- 使用线性混合模型从EHR中提取和分析心脏代谢结果 (血压,HbA1c,脂质).
主要成果:
- 干预组在6个月后表现出缩和腹缩血压的显著降低,该降低在12个月和24个月后减弱.
- 对于其他心脏代谢结果,没有发现显著差异.
- 血压测量频繁 (11.9次/参与者,间隔约4个月),而其他结果的间隔较长 (12-17.4个月).
结论:
- "平衡"干预证明了对血压的短期益处.
- 在临床试验中,EHR数据的变化和稀少性需要仔细的规划和分析.
- 未来的试验应主动解决电子健康记录系统固有的潜在数据限制.
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