利用行政数据提高临床试验的实用性：来自妇女健康倡议的见解。
Use of administrative data to increase the practicality of clinical trials: Insights from the Women's Health Initiative.
作者信息
Anderson Garnet L, Burns Carolyn J, Larsen Joseph, Shaw Pamela A
机构信息
WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
出版信息
Clin Trials. 2016 Oct;13(5):519-26. doi: 10.1177/1740774516656579. Epub 2016 Jun 30.
Abstract
BACKGROUND
To reduce research costs in the context of pragmatic trials, consideration is given to using administrative data (Medicare claims) to ascertain clinical outcomes.
METHODS
In the historical context of the Women's Health Initiative, the correspondence between selected cardiovascular events derived from Medicare claims was compared to those documented and adjudicated in this large-scale prevention trial.
RESULTS
Classification performance varies somewhat by type of outcome, but hazard ratios and confidence intervals derived from the two data sources were quite comparable.
CONCLUSION
These encouraging results provided the needed support to launch a new embedded pragmatic trial of physical activity that will rely heavily on Medicare claims to ascertain cardiovascular disease incidence in the majority of those randomized.
摘要
背景
为在务实试验的背景下降低研究成本，人们考虑使用行政数据（医疗保险理赔数据）来确定临床结局。
方法
在妇女健康倡议的历史背景下，将从医疗保险理赔数据中选取的心血管事件与在这项大规模预防试验中记录和判定的事件进行了对比。
结果
分类表现因结局类型而略有不同，但来自两个数据源的风险比和置信区间相当可比。
结论
这些令人鼓舞的结果为开展一项新的关于体育活动的嵌入式务实试验提供了所需支持，该试验将严重依赖医疗保险理赔数据来确定大多数随机分组者的心血管疾病发病率。
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