评估患者报告的结局在临床试验中报告的充血性心力衰竭的完整性
Drayton Rorah1, Jonathan Pollard1, Corbin Walters2
1Kansas City University-Joplin, Joplin, MO, USA.
Therapeutic advances in cardiovascular disease
|December 6, 2024
概括
在充血性心力衰竭试验中,患者报告的结果报告不佳,只有44.51%的人遵守ISOQOL标准. 提高报告质量对于基于证据的医学至关重要.
科学领域:
- 临床医学 临床医学
- 健康 结果 研究 研究 结果
背景情况:
- 充血性心力衰竭 (CHF) 管理依赖于随机对照试验 (RCT) 的证据.
- 患者报告结果 (PROs) 对于评估心血管衰竭治疗的有效性至关重要.
- 在CHF试验中PRO报告的质量需要进行批判性评估.
研究的目的:
- 评估CHF药物干预RCT中的PRO报告质量.
- 使用国际生活质量研究协会 (ISOQOL) 检查清单进行PRO评估.
主要方法:
- 针对CHF药物干预的65个RCT进行了横截面分析.
- 使用ISOQOL检查清单来评估PRO报告的完整性.
- 进行了统计分析,包括多变量回归.
主要成果:
- 对ISOQOL报告标准的平均遵守率为44.51%.
- 用PRO作为主要终点的试验显示了显著更好的报告率 (21.46%更高的完成率).
- 只有12.31%的试验符合PRO报告的最低标准.
结论:
- 在CHF药物干预RCT中,PRO报告率低于最佳,影响证据透明度.
- 报告不充分可能导致不完整或错误的证据的实施.
- 使用像ISOQOL检查清单这样的标准化工具可以提高PRO报告质量.
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