在心力衰竭中远程跟踪实用试验:来自CONNECT-HF的见解
Satoshi Shoji1, Lisa A Kaltenbach2, Bradi B Granger3
1Duke Clinical Research Institute, Durham, NC, USA; Department of Medicine, Duke University School of Medicine, Durham, NC, USA; Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Journal of cardiac failure
|April 10, 2024
概括
在心力衰竭试验中的远程跟踪可以提高数据的完整性. 结合参与者和现场报告对于准确记录住院病例,提高试验有效性和减少参与者负担至关重要.
科学领域:
- 临床试验 临床试验
- 心脏病学 心脏病学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 随机对照试验 (RCT) 通常需要亲自访问,增加参与者和现场负担.
- 远程跟踪方法,包括参与者报告结果 (PRO) 的集中呼叫中心,提供潜在的成本节省和改进的试验实用性.
- 本研究分析了CONNECT-HF试验,以评估远程跟踪过程的完整性和有效性.
研究的目的:
- 评估CONNECT-HF试验中远程随访的完整性和有效性.
- 为了比较参与者报告的与现场报告的医院住院事件数据.
- 确定捕捉和验证实用性心力衰竭试验结果的最佳策略.
主要方法:
- 对CONNECT-HF试验的二次分析,将质量改善干预与通常护理进行比较.
- 用于参与者/代理报告事件的集中呼叫中心和对现场报告事件的医疗记录查询.
- 对于怀疑住院事件的收集医疗记录的裁决.
主要成果:
- 在5942次潜在的住院治疗中,18%仅由参与者报告,50%仅由现场报告,28%由两者报告.
- 报告与所有原因住院治疗的裁决之间高度一致 (86-87%).
- 在所有报告方法中,判断心力衰竭住院率 (45-50%) 是一致的.
结论:
- 仅依靠仅参与者或仅现场报告就会错过重要的住院事件.
- 参与者和现场报告显示与裁定结果有相似的一致性.
- 整合参与者和现场报告的数据对于在实用性心力衰竭试验中有效的住院捕获和验证至关重要.
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