Journal of Biomedical informatics ( IF 4.0 ) Pub Date : 2024-01-18 , DOI: 10.1016/j.jbi.2024.104587 Cynthia Hau 1 , Patricia A Woods 1 , Amanda S Guski 1 , Srihari I Raju 2 , Liang Zhu 1 , Patrick R Alba 3 , William C Cushman 4 , Peter A Glassman 5 , Areef Ishani 6 , Addison A Taylor 7 , Ryan E Ferguson 8 , Sarah M Leatherman 9
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Background
Pragmatic trials are gaining popularity as a cost-effective way to examine treatment effectiveness and generate timely comparative evidence. Incorporating supplementary real-world data is recommended for robust outcome monitoring. However, detailed operational guidelines are needed to inform effective use and integration of heterogeneous databases.
Objective
Lessons learned from the Veterans Affairs (VA) Diuretic Comparison Project (DCP) are reviewed, providing adaptable recommendations to capture clinical outcomes from real-world data.
Methods
Non-cancer deaths and major cardiovascular (CV) outcomes were determined using VA, Medicare, and National Death Index (NDI) data. Multiple ascertainment strategies were applied, including claims-based algorithms, natural language processing, and systematic chart review.
Results
During a mean follow-up of 2.4 (SD = 1.4) years, 907 CV events were identified within the VA healthcare system. Slight delays (∼1 year) were expected in obtaining Medicare data. An additional 298 patients were found having a CV event outside of the VA in 2016 - 2021, increasing the CV event rate from 3.5 % to 5.7 % (770 of 13,523 randomized). NDI data required ∼2 years waiting period. Such inclusion did not increase the number of deaths identified (all 894 deaths were captured by VA data) but enhanced the accuracy in determining cause of death.
Conclusion
Our experience supports the recommendation of integrating multiple data sources to improve clinical outcome ascertainment. While this approach is promising, hierarchical data aggregation is required when facing different acquisition timelines, information availability/completeness, coding practice, and system configurations. It may not be feasible to implement comparable applications and solutions to studies conducted under different constraints and practice. The recommendations provide guidance and possible action plans for researchers who are interested in applying cross-source data to ascertain all study outcomes.
中文翻译：
在实用临床试验中二次使用真实世界临床和管理数据来确定结果的策略
背景
实用试验作为检查治疗效果和及时生成比较证据的一种经济高效的方法而越来越受欢迎。建议纳入补充的现实世界数据以进行稳健的结果监测。然而，需要详细的操作指南来指导异构数据库的有效使用和集成。
客观的
回顾了从退伍军人事务部 (VA) 利尿剂比较项目 (DCP) 中汲取的经验教训，提供了适应性强的建议，以从真实世界数据中获取临床结果。
方法
非癌症死亡和主要心血管 (CV) 结局是使用 VA、医疗保险和国家死亡指数 (NDI) 数据确定的。应用了多种确定策略，包括基于声明的算法、自然语言处理和系统图表审查。
结果
在平均 2.4 (SD = 1.4) 年的随访期间，VA 医疗保健系统内发现了 907 起心血管事件。获取医疗保险数据预计会略有延迟（约 1 年）。 2016 年至 2021 年，另外 298 名患者被发现在 VA 之外发生了 CV 事件，将 CV 事件发生率从 3.5% 增加到 5.7%（13,523 名随机患者中的 770 名患者）。 NDI 数据需要 ∼2 年的等待期。这种纳入并没有增加已确定的死亡人数（VA 数据捕获了所有 894 例死亡），但提高了确定死因的准确性。
结论
我们的经验支持整合多个数据源以改善临床结果确定的建议。虽然这种方法很有前景，但当面临不同的采集时间线、信息可用性/完整性、编码实践和系统配置时，需要分层数据聚合。在不同的约束和实践下进行的研究实施可比较的应用程序和解决方案可能是不可行的。这些建议为有兴趣应用跨源数据来确定所有研究结果的研究人员提供了指导和可能的行动计划。
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