ISPOR Good Practices Report Offers Guidance for Using Real-World Data From EHRs in Health Technology Assessments

Lawrenceville, NJ, USA—June 17, 2024—ISPOR—The Professional Society for Health Economics and Outcomes Research announced today the publication of an ISPOR Good Practices Report that proposes a framework for assessing the suitability of electronic health records data for use in health technology assessments. The report, “Assessing Real-World Data from Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force” was published in the June 2024 issue of Value in Health.

“The widespread proliferation and availability of electronic health record (EHR) data systems provide new opportunities and great potential to inform and improve a host of critical enterprises in health and medicine,” said authors Rachael L. Fleurence, PhD, MSc, Office of the Director, National Institutes of Health, Bethesda, MD, USA, and Scott Ramsey, MD, PhD, Fred Hutchinson Cancer Center, Seattle, WA, USA. “As a source of real-world data (RWD), EHR-derived databases can provide unique depth and detail on patients’ health and their care. However, there are several important limitations and issues with these data sources that can impact their validity and relevance for health technology assessments (HTA). Accordingly, the purpose of this task force is to establish consensus on the principles for evaluating and reporting on the suitability of EHR data for HTA organizations.”

This ISPOR Good Practices Report developed a framework for assessing the suitability of EHR data. The Task Force created a tool—The SUITABILITY Checklist—to assist HTA groups determine the quality and fitness of purpose of these databases. The SUITABILITY Checklist focuses on 2 main elements. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness. Data fitness-for-purpose examines the accuracy and the suitability of data to answer the particular question at hand.

Furthermore, the report offers guidance to HTA agencies and policy makers for improving the suitability of EHR-derived data for decision making over time. Its recommendations include developing a common set of standards, fostering multistakeholder collaborations to identify best practices, disseminating exemplary case studies, and investing in the training of a workforce dedicated to this field.

“The size and scope of EHR-derived analysis datasets will only grow over time. ” noted Fleurence and Ramsey. “New sources of data such as patient-reported and self-measurement data (eg, from wearable sensors) will make their way into clinical practice and EHRs. In addition, new analytic methods that take advantage of machine learning and generative artificial intelligence will transform our ability to analyze these databases. In the end, health technology assessors will both benefit from and be challenged by EHR-derived data. The task force encourages HTA agencies to play an active role in this fast-evolving field.”

The Good Practices Report was accompanied by an editorial by Mark McClellan, MD, PhD, Duke-Margolis Institute for Health Policy, Duke University, Durham, North Carolina, USA; Marianne Hamilton Lopez, PhD, MPA, Duke-Margolis Institute for Health Policy, Washington, DC, USA; and Gregory Daniel, PhD, MPH, Vice President & Heald of Global Public Policy, Eli Lilly and Company, Washington, DC, USA. Their comments, “Perspectives on Improving Value Assessment With the ISPOR SUITABILITY Checklist,” also published in the June 2024 issue of Value in Health, emphasizes the growing importance and challenges of value assessment amidst rapid healthcare innovation, and the potential for real-world EHR data, with appropriate standards, to enhance this effort. “The ISPOR report calls for collaborations among HTA agencies and related regulatory agencies to develop and endorse a common set of standards specific to the use of EHRs in decision making,” said McClellan, “but such collaborations must include representatives more broadly from the patient, payer, provider, and product development communities. While there are different perspectives on how to best integrate RWD and evidence into payment and value-based care reforms, we can agree that it is imperative that we have systems in place to understand and measure value from a multistakeholder perspective; that the EHR data used in care delivery could be an important contributor to value assessment; and that many opportunities remain to improve its use in assessing value.” The editorial closes by noting that the opportunities for addressing ongoing access and affordability challenges are also improving, with further progress on electronic data standards, interoperability, and methods, including embedded, real-world clinical trials and fit-for-purpose observational analyses, for turning better RWD into badly needed evidence.

Further Reading:

• Acceptability of Using Real-World Data to Estimate Relative Treatment Effects in Health Technology Assessments: Barriers and Future Steps
• Data Governance for Real-World Data Management: A Proposal for a Checklist to Support Decision Making
• Enhancing Patient Centricity of Real-World Data Research: An Exploratory Analysis Using the Patient Experience Mapping Toolbox
• Structure and Content of a Taxonomy to Support the Use of Real-World Evidence by Health Technology Assessment Practitioners and Healthcare Decision Makers

About ISPOR’s Task Force on the Use of Electronic Health Records for Health Technology Assessment

The objective is to establish consensus on and provide emerging good practices for conducting, reporting, and evaluating data quality of EHRs for HTAs, including a data quality checklist for use of EHR-derived RWD. The task force will build on the frameworks and approaches under development across HTA agencies, as well as on the richer data quality standards literature that has been more focused on regulatory decision making.

This topic is of high interest in the health economics and outcomes research (HEOR) community and across geographies, given the inexorable increase of digital data across the globe. Currently, there are no fully developed frameworks for HTA use, including a lack of attention on resource use derived from RWD that informs costs and budget impact analyses. These data may need to be evaluated and assessed differently from clinical data informing effectiveness. The task force will explore this in detail and report recommendations for different types of uses, such as clinical effectiveness or resource use. The patient perspective in study design and outcome selection has been recognized as increasingly important and we will include a section on patient-centeredness in the final report. Click here to learn more.

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ABOUT ISPOR

ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE^®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.

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ABOUT VALUE IN HEALTH

Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2022 impact factor score is 4.5 and its 5-year impact factor score is 6.2. Value in Health is ranked 8th of 87 journals in health policy and services, 21st of 105 journals in healthcare sciences and services, and 69th of 380 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.

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