The Role of the Electronic Health Record in Medical Research

Mara Meyer Epstein, ScD

Electronic health records (EHRs) have changed the landscape of medical research by efficiently identifying, recruiting and consenting participants to facilitate larger studies of more diverse populations. As a clinical tool, EHRs allow for the electronic exchange of health information, leading to improved patient care, enhanced patient-provider communication and increased access to patients’ own health information. These benefits translate directly to research, where the EHR has become an important setting for studies ranging from pragmatic clinical trials to observational studies, and serves a key role in the translation of research into practice. Indeed, with the expanded adoption of the EHR there has been a rapid acceleration in the number of registered clinical trials (Figure 1). However, the use of the EHR for medical research has required a great deal of effort to implement, and also has some drawbacks, including the burden placed on providers in EHR-based intervention studies, and potential limited generalizability to people without access to technology or healthcare.

An increasing number of multi-site studies and research networks, including the National Institutes of Health (NIH) funded All of Us Research Program and the National Patient-Centered Clinical Research Network (PCORnet) rely on EHRs as a primary source of data collection. These networks—with participating sites across the United States including integrated healthcare systems and community health centers—must normalize large amounts of EHR-derived data before starting to analyze it. The structure, format and content of raw EHR data vary widely between organizations and institutions; however, tools exist to standardize EHR data across sites through the adoption of common data models. While some of these common data models are shared only among partners of a research network, others, like the international Observational Medical Outcomes Partnership (OMOP) model, may be applied more broadly beyond a specific research study. For example, the NIH All of Us Research Program standardizes participants’ EHR data collected from healthcare provider organizations across the United States using the OMOP common data model. Through this important step of aligning data sources with a common structure, and following vigorous data quality and integrity checks across participating sites, datasets derived from the All of Us Research Program can efficiently facilitate studies on a wide variety of topics using data collected from diverse populations. Importantly, observational and epidemiological studies using EHR data often do not rely on providers or patients for additional input and can be completed without a burden on the healthcare system.

The EHR is also an important tool for conducting clinical trials. Through patient data readily available in the EHR, and with proper approval in place, investigators can efficiently identify eligible participants for proposed or planned trials. The EHR is particularly useful for pragmatic clinical trials, which aim to test an intervention in a real-world clinical setting. Many studies also use the features of the EHR, including patient portals and electronic messaging, to recruit participants, initiate the consent process and even conduct the actual intervention. Electronic recruitment can reach a wide range of patients and may be cost- and time-effective. However, studies based in the EHR may rely on providers to initially contact potential participants, or participate in an EHR-based intervention themselves, which could add to the burden of already overwhelmed healthcare workers. Interventions requiring extra efforts on the part of providers or patients—for example, receiving additional EHR alerts or integrating patient-generated health data in the EHR— may contribute to feelings of burnout, particularly in the era of the COVID-19 pandemic.

EHRs have great potential to change the way medical research is conducted. However, researchers must also remember some key facts about the nature of EHRs to make sure research questions can be appropriately answered. By definition, EHR data are collected from people seeking healthcare, and are unlikely to capture the health of people without access to care. If a study relies on the use of patient portals or electronic messaging, the enrolled population may be limited to those who have access to the internet. As a result, we must be aware of the representativeness of the study population, and how it may affect the interpretation of study findings. Furthermore, EHR data are collected with the purpose of providing care to a patient, and not for a research study. As a result, certain information may be missing or incomplete (for example, data on patients’ diets or exercise habits), and that may introduce bias to a research study, depending on the question being asked.

In summary, EHRs have made it possible to conduct large, multisite studies with detailed clinical data, including in populations underrepresented in traditional medical research. These studies may require considerable efforts to standardize data from different health systems and different EHRs prior to analysis, including through the adoption of a common data model. Furthermore, the availability of data should be considered when deciding whether EHRs are the appropriate setting to answer a particular research question. In addition, the burden on providers and patients should be considered when an EHR-based intervention is being planned, both during the study, and when considering how the intervention will apply in the real world. Despite these potential drawbacks, with the proper procedures in place, EHRs represent a rich resource with the potential to assist in all aspects of medical and population health research, from assessing the feasibility of observational studies, to conducting pragmatic clinical trials and translating findings into practice. +

Figure 1: Number of studies registered at CinicalTrials.gov compared with EHR adoption over time.

Mara Meyer Epstein, ScD is a cancer epidemiologist and an Associate Professor of Medicine in the Division of Health Systems Science at the UMass Chan Medical School.