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Innovation in Electronic Health Records for Oncology Care, Research, and Surveillance Erin Balogh, Frances Amankwah, Theresa Wizemann, and Sharyl Nass, Rapporteurs National Cancer Policy Forum Board on Health Care Services Health and Medicine Division Computer Science and Telecommunications Board Division on Engineering and Physical Sciences Proceedings of a Workshop PREPUBLICATION COPYâUncorrected Proofs
THE NATIONAL ACADEMIES PRESSâ 500 Fifth Street, NWâ Washington, DC 20001 This activity was supported by Contract No. 200-2011-38807 (Task Order No. 75D30120F00089) and Contract No. HHSN263201800029I (Task Order No. HHSN26300008) with the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Community Cancer Centers, Bristol Myers Squibb, Cancer Support Community, Flatiron Health, Merck & Co., Inc., National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Partners in Health, Pfizer Inc., Sanofi, and Society for Immunotherapy of Cancer. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/26720 This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2022 by the National Academy of Sciences. National Academies of Sciences, Engineering, and Medicine and National Academies Press and the graphical logos for each are all trademarks of the National Academies of Sciences. All rights reserved. Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Innovation in electronic health records for oncology care, research, and surveillance: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26720. PREPUBLICATION COPYâUncorrected Proofs
The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPYâUncorrected Proofs
Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the studyâs statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committeeâs deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. Rapid Expert Consultations published by the National Academies of Sciences, Engineering, and Medicine are authored by subject-matter experts on narrowly focused topics that can be supported by a body of evidence. The discussions contained in rapid expert consultations are considered those of the authors and do not contain policy recommendations. Rapid expert consultations are reviewed by the institution before release. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPYâUncorrected Proofs
PLANNING COMMITTEE1 MIA LEVY (Co-Chair), Chief Medical Officer, Foundation Medicine, Inc. LAWRENCE N. SHULMAN (Co-Chair), Professor of Medicine, Deputy Director for Clinical Services, and Director of the Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network NICOLE F. DOWLING, Associate Director for Science, Division of Cancer Prevention and Control, National Center for Chronic Disease Control and Prevention, Centers for Disease Control and Prevention MIMI HUIZINGA, Senior Vice President and Head of Medical Affairs, ImmunoGen, Inc. BRADLEY MALIN, Accenture Professor of Biomedical Informatics, Biostatistics, and Computer Science and Vice Chair for Research Affairs, Department of Biomedical Informatics, Vanderbilt University Medical Center ALEXANDER MELAMED, Assistant Professor, Department of Obstetrics and Gynecology, Columbia University Medical Center, New York Presbyterian Hospital NEAL MEROPOL, Vice President, Research Oncology, Flatiron Health; and Adjunct Professor, Case Comprehensive Cancer Center ETTA D. PISANO, Senior Director for Research Development, Center for Research and Innovation, American College of Radiology; and Vice Chair for Research, Department of Radiology, Beth Israel Deaconess Medical Center JULIE SCHNEIDER, Associate Director, Research Strategy and Partnership, Oncology Center of Excellence, Food and Drug Administration ROBERT A. WINN, Director, Massey Cancer Center; Senior Associate Dean for Cancer Innovation, Professor of Pulmonary Disease and Critical Care Medicine, and Lipman Chair in Oncology, School of Medicine, Virginia Commonwealth University; and President-Elect, Association of American Cancer Institutes 1 The National Academies of Sciences, Engineering, and Medicineâs planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speak- ers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution. v PREPUBLICATION COPYâUncorrected Proofs
ROBIN YABROFF, Scientific Vice President, Health Services Research, American Cancer Society Project Staff FRANCIS AMANKWAH, Program Officer RACHEL AUSTIN, Senior Program Assistant (until June 2022) LORI BENJAMIN BRENIG, Research Associate ANNALEE GONZALES, Administrative Assistant (until May 2022) ARZOO TAYYEB, Finance Business Partner ERIN BALOGH, Co-Director, National Cancer Policy Forum SHARYL J. NASS, Co-Director, National Cancer Policy Forum; and Senior Director, Board on Health Care Services vi PREPUBLICATION COPYâUncorrected Proofs
NATIONAL CANCER POLICY FORUM1 EDWARD J. BENZ, JR. (Chair), President and Chief Executive Officer, Emeritus, Dana-Farber Cancer Institute; and Richard and Susan Smith Distinguished Professor of Medicine, Genetics and Pediatrics, Harvard Medical School PETER C. ADAMSON, Global Head, Oncology Development and Pediatric Innovation, Sanofi GARNET L. ANDERSON, Senior Vice President and Director, Public Health Sciences Division, Fred Hutchinson Cancer Center; Affiliate Professor, Department of Biostatistics, University of Washington; and Principal Investigator, Womenâs Health Initiative Clinical Coordinating Center KAREN BASEN-ENGQUIST, Annie Laurie Howard Research Distinguished Professor, Director of the Center for Energy Balance in Cancer Prevention and Survivorship, and Professor of Behavioral Science, The University of Texas MD Anderson Cancer Center SMITA BHATIA, Director of the Institute for Cancer Outcomes and Survivorship, Gay and Bew White Endowed Chair in Pediatric Oncology, and Professor and Vice Chair of Outcomes for Pediatrics, Department of Pediatrics, School of Medicine, Institute for Cancer Outcomes and Survivorship, The University of Alabama at Birmingham CHRIS BOSHOFF, Chief Development Officer, Global Product Development, Oncology and Rare Disease, Pfizer Inc. CATHY J. BRADLEY, David F. and Margaret Turley Grohne Endowed Chair for Cancer Prevention and Control Research, Professor and Associate Dean for Research, Colorado School of Public Health; and Bunn Chair of Cancer Research and Deputy Director, University of Colorado Comprehensive Cancer Center OTIS W. BRAWLEY, Bloomberg Distinguished Professor, Department of Epidemiology and Oncology, Bloomberg School of Public Health and Department of Oncology, School of Medicine, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University 1 The National Academies of Sciences, Engineering, and Medicineâs forums and round- tables do not issue, review, or approve individual documents. The responsibility for the pub- lished Proceedings of a Workshop rests with the workshop rapporteurs and the institution. vii PREPUBLICATION COPYâUncorrected Proofs
ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network CHRISTINA CHAPMAN, Assistant Professor of Radiation Oncology, Baylor College of Medicine GWEN DARIEN, Executive Vice President, Patient Advocacy and Engagement, National Patient Advocate Foundation NANCY E. DAVIDSON, Executive Vice President for Clinical Affairs, Senior Vice President, and Professor, Clinical Research Division, Fred Hutchinson Cancer Center; Professor and Head, Division of Medical Oncology, Department of Medicine, University of Washington; and Raisbeck Endowed Chair for Collaborative Cancer Research JAMES H. DOROSHOW, Director, Division of Cancer Treatment and Diagnosis, Deputy Director for Clinical and Translational Research, and Head of the Oxidative Signaling and Molecular Therapeutics Group, National Cancer Institute of the National Institutes of Health NICOLE F. DOWLING, Associate Director for Science, Division of Cancer Prevention and Control, National Center for Chronic Disease Control and Prevention, Centers for Disease Control and Prevention SCOT W. EBBINGHAUS, Vice President and Therapeutic Area Head, Oncology Clinical Research, Merck Research Laboratories KOJO S. J. ELENITOBA-JOHNSON, Inaugural Chair of the Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center STANTON L. GERSON, Dean and Senior Vice President, Medical Affairs, Case Western Reserve University School of Medicine; Acting Director, Case Comprehensive Cancer Center; Asa & Patricia ShiverickâJane B. Shiverick (Tripp) Professor of Hematological Oncology; and Distinguished University Professor and Director, National Center for Regenerative Medicine, Case Western Reserve University JULIE R. GRALOW, Chief Medical Officer and Executive Vice Present, American Society of Clinical Oncology ROY S. HERBST, Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, and Associate Director for Translational Research, Yale Comprehensive Cancer Center and Yale School of Medicine HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center viii PREPUBLICATION COPYâUncorrected Proofs
CHANITA HUGHES-HALBERT, Vice Chair for Research, Professor in the Department of Preventive Medicine, and Associate Director for Cancer Equity, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California ROY A. JENSEN, Professor of Pathology and Laboratory Medicine, William R. Jewell, MD Distinguished Masonic Professor of Cancer Research, and Director, The University of Kansas Cancer Center; Director, Kansas Masonic Cancer Research Institute; and Past President, Association of American Cancer Institutes RANDY A. JONES, Professor and Associate Dean for Partner Development and Engagement, University of Virginia School of Nursing; and Assistant Director, Community Outreach and Engagement, Emily Couric Clinical Cancer Center, University of Virginia BETH Y. KARLAN, Vice Chair, Womenâs Health Research; Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine; and Director, Cancer Population Genetics, Jonsson Comprehensive Cancer Center, University of California, Los Angeles SAMIR N. KHLEIF, Director, Jeannie and Tony Loop Immuno- Oncology Lab; Biomedical Scholar and Professor of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center; and Member, Society for Immunotherapy of Cancer MIA LEVY, Chief Medical Officer, Foundation Medicine, Inc. SCOTT M. LIPPMAN, Director, Moores Cancer Center; and Distinguished Professor of Medicine, Senior Associate Dean, Associate Vice Chancellor for Cancer Research and Care, and Chugai Pharmaceutical Chair in Cancer, University of California, San Diego LARISSA NEKHLYUDOV, Professor of Medicine, Harvard Medical School; Internist, Brigham and Womenâs Hospital; and Clinical Director, Internal Medicine for Cancer Survivors, Dana-Farber Cancer Institute RANDALL A. OYER, Clinical Professor of Medicine, Perelman School of Medicine; Executive Medical Director, Ann B. Barshinger Cancer Institute, Penn Medicine Lancaster General Health; and Past President, Association of Community Cancer Centers CLEO A. RYALS, Head of Health Equity and Health Disparities Research, Flatiron Health RICHARD L. SCHILSKY, Principal Investigator, ASCO TAPUR Study; and Professor Emeritus, University of Chicago ix PREPUBLICATION COPYâUncorrected Proofs
JULIE SCHNEIDER, Associate Director, Research Strategy and Partnership, Oncology Center of Excellence, Food and Drug Administration SUSAN M. SCHNEIDER, Associate Professor Emerita, School of Nursing, Duke University LAWRENCE N. SHULMAN, Professor of Medicine, Deputy Director for Clinical Services, and Director, Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania HEIDI SMITH, Vice President, Center of Operations and Research Excellence, U.S. Clinical Development and Medical Affairs, Oncology, Novartis Pharmaceuticals LARA STRAWBRIDGE, Director, Division of Ambulatory Payment Models, Patient Care Models Group, Center for Medicare and Medicaid Innovation, Centers for Medicare and Medicaid Services GEORGE J. WEINER, Director of the Holden Comprehensive Cancer Center at The University of Iowa, C. E. Block Chair of Cancer Research, and Professor of Internal Medicine and Pharmaceutical Science, University of Iowa ROBERT A. WINN, Director, Massey Cancer Center; Senior Associate Dean for Cancer Innovation, Professor of Pulmonary Disease and Critical Care Medicine, and Lipman Chair in Oncology, School of Medicine, Virginia Commonwealth University; and President-Elect, Association of American Cancer Institutes ROBIN YABROFF, Scientific Vice President, Health Services Research, American Cancer Society National Cancer Policy Forum Staff FRANCIS AMANKWAH, Program Officer LORI BENJAMIN BRENIG, Research Associate TORRIE BROWN, Program Coordinator (from August 2022) CHIDINMA CHUKWURAH, Senior Program Assistant (from August 2022) JACARI JENNINGS, Senior Program Assistant (from July 2022) ARZOO TAYYEB, Finance Business Partner ERIN BALOGH, Co-Director, National Cancer Policy Forum SHARYL J. NASS, Co-Director, National Cancer Policy Forum; and Senior Director, Board on Health Care Services x PREPUBLICATION COPYâUncorrected Proofs
Reviewers This Proceedings of a Workshop was reviewed in draft form by individu- als chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsive- ness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: ETHAN M. BASCH, University of North Carolina TUFIA C. HADDAD, Mayo Clinic MATTHEW B. WEINGER, Vanderbilt University Medical Center Although the reviewers listed above provided many constructive com- ments and suggestions, they were not asked to endorse the conclusions or rec- ommendations of this report nor did they see the final draft before its release. The review of this report was overseen by DANIEL R. MASYS, University of Washington. He was responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully con- sidered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies. xi PREPUBLICATION COPYâUncorrected Proofs
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Acknowledgments Support from the many annual sponsors of the National Academies of Sciences, Engineering, and Medicineâs National Cancer Policy Forum is crucial to the work of the forum. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Non-federal sponsors include the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Asso- ciation of Community Cancer Centers, Bristol Myers Squibb, Cancer Support Community, Flatiron Health, Merck & Co., Inc., National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Partners in Health, Pfizer Inc., Sanofi, and Society for Immunotherapy of Cancer. The forum wishes to express its gratitude to the expert speakers whose presentations and discussions helped inform efforts to improve the develop- ment and use of electronic health records for oncology care, research, and surveillance. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. xiii PREPUBLICATION COPYâUncorrected Proofs
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Contents ACRONYMS AND ABBREVIATIONS xix PROCEEDINGS OF A WORKSHOP 1 WORKSHOP OVERVIEW 1 OVERVIEW OF THE USE OF EHRs IN ONCOLOGY CARE, RESEARCH, AND SURVEILLANCE 8 The EHR in Clinical Oncology Practice, 9 The EHR and the Patientâs Relationship with Health Care Providers, 11 The EHR in Quality Improvement and Research, 15 IMPROVING THE PATIENT-FACING ASPECTS OF EHRs 17 Todayâs Patient Portal, 17 The EHR as a Tool for PatientâClinician Communication, 18 Integrating Patient-Reported Outcomes into Oncology EHR Systems, 20 Sharing of Patient Data within and among EHR Systems, 22 Using the EHR to Nudge Evidence-Based Cancer Care, 23 Next-Generation EHRs, 24 OPTIMIZING THE FUNCTIONALITY AND USABILITY OF EHRs IN ONCOLOGY CARE 27 Critical Decision Support, 28 xv PREPUBLICATION COPYâUncorrected Proofs
xvi CONTENTS Applying a Human-Centered Design Approach to Improving EHR Systems, 32 Integration and Interoperability to Improve EHR Functionality and Support a Learning Health Care System, 37 IMPROVING EHR DATA COLLECTION TO SUPPORT CLINICAL CARE, QUALITY AND VALUE, AND RESEARCH 38 Improving Data Collection and Display to Support Clinical Decision Making, 38 Opportunities to Improve the Usability of EHRs for Research Purposes, 41 Opportunities to Improve EHR Data Collection to Support High-Quality Care and Value, 42 Suggestions to Improve Data Collection and Promote Data Sharing, 42 FEDERAL AGENCIES AS PARTNERS IN DRIVING EHR INNOVATION 43 OSTP: The Role of Science and Technology Policy in Advancing EHRs, 43 The NCI: Using EHR Data for Cancer Surveillance, 44 The CDC: Leveraging EHRs for Public Health Planning and Research, 46 The FDA: Using EHR Data to Generate Evidence for Oncology Product Development, 48 ONC: Advancing Interoperability and Innovation in Health IT, 49 CMS: Enabling EHRs to Better Support Health Care Data Exchange, 50 Addressing the Challenges of Integrating SDOH Data in the EHR, 51 Coordinating EHR-Related Efforts across Federal Agencies and with Partners, 52 REFLECTIONS 53 REFERENCES 54 APPENDIX A STATEMENT OF TASK 59 APPENDIX B WORKSHOP AGENDA 61 PREPUBLICATION COPYâUncorrected Proofs
Boxes, Figures, and Table BOXES 1 Observations on the Current Capabilities and Use of EHRs in Cancer Care: Highlights of Points Made by Individual Workshop Participants, 2 2 Suggestions from Individual Workshop Participants to Advance the Development, Implementation, and Use of EHRs in Oncology Care, Research, and Surveillance, 5 FIGURES 1 Average number of secure patient portal messages per month for the hematologyâoncology clinicians at the University of Pennsylvania. The number of messages increased substantially after the onset of the COVID-19 pandemic, 11 2 EHRs in prospective clinical research, 16 3 Integrating patient self-reporting of symptoms into the EHR workflow, 20 4 Spectrum of nudge interventions for clinicians and patients, 24 5 Human-centered approach to EHR design, 32 6 Systems Engineering for Patient Safety (SEIPS) 3.0 model of the patient care, 35 7 Flow of data to the CDC National Program of Cancer Registries, 46 TABLE 1 Framework for a Patientâs Health Care Responsibilities and Challenges and Their Impact on Daily Life, 34 xvii PREPUBLICATION COPYâUncorrected Proofs
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Acronyms and Abbreviations AI artificial intelligence AMIA American Medical Informatics Association APHL AIMS Association of Public Health Laboratories Informatics Messaging Services API application programming interface APM alternative payment models ASCO American Society of Clinical Oncology CAP College of American Pathologists CDC Centers for Disease Control and Prevention CEHRT certified EHR technology CMMI Center for Medicare and Medicaid Innovation CMS Centers for Medicare & Medicaid Services CPT current procedural technology CRISS Center for Research and Innovation in System Safety CTAC Clinical and Translational Research Advisory Committee DoD U.S. Department of Defense DOE U.S. Department of Energy EHR electronic health record ePRO electronic patient-reported outcome xix PREPUBLICATION COPYâUncorrected Proofs
xx ACRONYMS AND ABBREVIATIONS FDA U.S. Food and Drug Administration FHIR Fast Healthcare Interoperability Resources HIE health information exchange HIPAA Health Insurance Portability and Accountability Act of 1996 HITECH Health Information Technology for Economic and Clinical Health Act HL7 Health Level 7 ICD International Classification of Disease KP Kaiser Permanente mCODE minimal Common Oncology Data Elements MIPS Merit-Based Incentive Payment System ML machine learning MUSC Medical University of South Carolina NCI National Cancer Institute NIH National Institutes of Health NLP natural language processing OHDSI Observational Health Data Sciences and Informatics ONC Office of the National Coordinator for Health Information Technology OSTP Office of Science and Technology Policy PCOR Patient Centered Outcomes Research PRO patient-reported outcome QI quality improvement SDOH social determinants of health SEER Surveillance, Epidemiology, and End Results SEIPS Systems Engineering Initiative for Patient Safety SIC serious-illness conversation TEFCA Trusted Exchange Framework Common Agreement USCDI United States Core Data for Interoperability PREPUBLICATION COPYâUncorrected Proofs
