Mora Nallely, Mehall Madeline, Lennox Lindsay A, Pincus Harold A, Charron David, Morrato Elaine H
Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Chicago, IL, USA.
Institute for Translational Medicine, Loyola University Chicago, Chicago, IL, USA.
J Clin Transl Sci. 2024 Oct 3;8(1):e137. doi: 10.1017/cts.2024.609. eCollection 2024.
The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE).
We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks. Methods included surveys, interviews, and a focus group.
Thirty-two CTSA institutions contributed data for analysis. Fifty-four interviews and one focus group were conducted. The synthesis of our findings pivots around five emergent themes: (1) CTSA segmentation needs vary according to resources; (2) Team science is key for success; (3) Quality of data generates trust in the network; (4) Capacity building is defined differently by researcher career stage and CTSA existing resources; and (5) Researchers' unmet needs.
Based on the results, EHR data networks like ENACT that would like to meet the expectations of academic research centers within the CTSA consortium need to consider filling the gaps identified by our study: foster team science, improve workforce capacity, achieve data governance trust and efficiency of operation, and aid Learning Health Systems with validating, applying, and scaling the evidence to support quality improvement and high-value care. These findings align with the NIH NCATS Strategic Plan for Data Science.
在过去二十年中，电子健康记录（EHR）数据网络的扩展显著改善了数据共享的可及性和流程。然而，在满足临床与转化科学奖（CTSA）中心的需求方面仍存在差距，特别是在真实世界数据（RWD）和真实世界证据（RWE）方面。
我们采用混合方法构建了一项全面的需求评估，包括：（1）情境分析以了解竞争环境；（2）客户发现以识别利益相关者以及与EHR数据网络相关的价值主张。方法包括调查、访谈和焦点小组。
32个CTSA机构提供了分析数据。进行了54次访谈和1次焦点小组讨论。我们研究结果的综合围绕五个新出现的主题展开：（1）CTSA的细分需求因资源而异；（2）团队科学是成功的关键；（3）数据质量产生对网络的信任；（4）能力建设因研究人员职业阶段和CTSA现有资源而有不同定义；（5）研究人员未满足的需求。
基于研究结果，像ENACT这样希望满足CTSA联盟内学术研究中心期望的EHR数据网络，需要考虑填补我们研究中发现的差距：促进团队科学，提高劳动力能力，实现数据治理的信任和运营效率，并协助学习健康系统验证、应用和扩展证据以支持质量改进和高价值医疗。这些发现与美国国立卫生研究院国家推进转化科学中心（NIH NCATS）的数据科学战略计划一致。
