电子健康记录系统在支持实用性临床试验方面的当前局限性:来自eMERGE联盟的见解
Current Limitations of Electronic Health Record Systems in Supporting Pragmatic Clinical Trials: Insights from the eMERGE Consortium.
作者信息
Wagholikar Kavishwar B, Pacheco Jennifer Allen, Gordon Adam S, Khan Atlas, Khales Bahram Namjou, Benoit Barbara, Kerman Benjamin J, Weng Chunhua, Ta Casey, Prows Cynthia A, Johnson Robert, Roden Dan M, Crosslin David, McNally Elizabeth M, Karlson Elizabeth W, Mentch Frank, Jarvik Gail P, Wiesner Georgia L, Hakonarson Hakon, Cimino James J, Thayer Jeritt G, Smoller Jordan W, Linder Jodell E, Connolly John, Peterson Josh F, Cortopassi Josh, Kiryluk Krzysztof, Hamed Marwan, Maradik Mary, Puckelwartz Megan J, Naderian Mohammadreza, Walton Nephi, Limdi Nita, Maripuri Devi Priyanka, Walunas Theresa, Gainer Vivian, Luo Yuan, Liu Cong, Kenny Eimear E, Espinoza Angelica, Rowley Robb, Wei Wei-Qi, Murphy Shawn N
机构信息
Massachusetts General Hospital.
Northwestern University Feinberg School of Medicine.
出版信息
medRxiv. 2025 Apr 3:2025.04.01.25325049. doi: 10.1101/2025.04.01.25325049.
Pragmatic clinical trials (PCTs) evaluate interventions in real-world settings, often using electronic health records (EHRs) for efficient data collection. We report on the challenges in performing EHR analysis of healthcare provider orders in a PCT within the eMERGE consortium, which investigates the impact of reporting genome-informed risk assessments (GIRA) to over 25,000 patients across 10 academic medical centers. Clinical informaticians conducted a landscape analysis to identify approaches for evaluating the outcomes of GIRA reporting through the EHR. Of 98 identified outcomes, 54 (55.1%) were determined to be difficult to extract because they involved provider orders, which are typically documented in free text or proprietary formats within the EHR and only mapped to standardized codes after the service is completed. These findings highlight a critical barrier in using EHRs to support PCTs. The authors recommend closer collaboration between clinicians and informaticians, improved EHR systems that support standardized order entry, and future use of machine learning to automate analysis of provider behavior in clinical trials.
实用临床试验(PCTs)在现实环境中评估干预措施,通常使用电子健康记录(EHRs)进行高效的数据收集。我们报告了在eMERGE联盟的一项实用临床试验中对医疗服务提供者医嘱进行电子健康记录分析时所面临的挑战,该联盟调查了向10个学术医疗中心的25000多名患者报告基因组信息风险评估(GIRA)的影响。临床信息学家进行了一项现状分析,以确定通过电子健康记录评估GIRA报告结果的方法。在确定的98项结果中,有54项(55.1%)被认为难以提取,因为它们涉及医疗服务提供者的医嘱,这些医嘱通常以自由文本或专有格式记录在电子健康记录中,并且只有在服务完成后才会映射到标准化代码。这些发现凸显了利用电子健康记录支持实用临床试验的一个关键障碍。作者建议临床医生和信息学家加强合作,改进支持标准化医嘱录入的电子健康记录系统,并在未来利用机器学习自动分析临床试验中医疗服务提供者的行为。