Stakeholder engagement: a key component of integrating genomic information into electronic health records

Abstract

Integrating genomic information into clinical care and the electronic health record can facilitate personalized medicine through genetically guided clinical decision support. Stakeholder involvement is critical to the success of these implementation efforts. Prior work on implementation of clinical information systems provides broad guidance to inform effective engagement strategies. We add to this evidence-based recommendations that are specific to issues at the intersection of genomics and the electronic health record. We describe stakeholder engagement strategies employed by the Electronic Medical Records and Genomics Network, a national consortium of US research institutions funded by the National Human Genome Research Institute to develop, disseminate, and apply approaches that combine genomic and electronic health record data. Through select examples drawn from sites of the Electronic Medical Records and Genomics Network, we illustrate a continuum of engagement strategies to inform genomic integration into commercial and homegrown electronic health records across a range of health-care settings. We frame engagement as activities to consult, involve, and partner with key stakeholder groups throughout specific phases of health information technology implementation. Our aim is to provide insights into engagement strategies to guide genomic integration based on our unique network experiences and lessons learned within the broader context of implementation research in biomedical informatics. On the basis of our collective experience, we describe key stakeholder practices, challenges, and considerations for successful genomic integration to support personalized medicine.

Pragmatic Trials in Genomic Medicine: The Integrating Pharmacogenetics In Clinical Care (I‐PICC) Study

“…Key challenges for obtaining informed consent from patient‐participants in both genomic medicine research and PCTs have been described. Informed consent for genomic medicine studies are usually more involved as they often entail less rigorously tested interventions and must address specific issues associated with how, when, and in what form potentially sensitive genetic information should be integrated into the EHR or delivered to patients . Lengthy informed consent procedures may limit a trial's degree of pragmatism and have the potential to bias the engagement of some groups .…”

The path from big data to precision medicine

“…The eMERGE network has proved a testing ground in engaging groups ranging from organizational leadership, to clinicians, patients, research institutions, government, developers, and health-payers [138]. Popular support from patients and providers is critical to achieving precision medicine initiatives, for sharing data as well as participating in the research which will drive advances in learning health systems, predictive models for disease, and development of novel therapeutics.…”

Merging Electronic Health Record Data and Genomics for Cardiovascular Research

“…They must ensure that the needs of all stakeholders, including patients and their families, are considered in all aspects of the decision-making process. 57,58 One of the largest challenges in genomic medicine is developing a series of best practices that will unify local IRB policies to facilitate sharing of EHR data across national and international biorepositories. Two Electronic Medical Records and Genomics working groups have used cross-disciplinary strategies to approach this problem.…”

“…66 Therefore, engaging and educating all stakeholders, especially community members, in the biorepository planning and implementation processes are crucial for the successful integration of genomic medicine with EHRs. 57 …”