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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×

APPLYING AN IMPLEMENTATION SCIENCE APPROACH TO GENOMIC MEDICINE

WORKSHOP SUMMARY

Siobhan Addie, Steve Olson, and Sarah H. Beachy, Rapporteurs

Roundtable on Translating Genomic-Based Research for Health

Board on Health Sciences Policy

Health and Medicine Division

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Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×

THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001

This project was supported by contracts between the National Academy of Sciences and the American Academy of Nursing (unnumbered contract); American College of Medical Genetics and Genomics (unnumbered contract); American Heart Association (unnumbered contract); American Medical Association (unnumbered contract); American Society of Human Genetics (unnumbered contract); Association for Molecular Pathology (unnumbered contract); Biogen (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); Centers for Disease Control and Prevention (Contract No.200-2011-38807, Order No. 0039); College of American Pathologists (unnumbered contract); Department of Veterans Affairs (Contract No. VA240-14-C-0037); Eli Lilly and Company (unnumbered contract); Health Resources and Services Administration (Contract No. HHSH250200976014I, Order No. HHSH25034017T and HHSH250201500001I, Order No. HHSH25034003T); International Society for Cardiovascular Translational Research (unnumbered contract); Janssen Research & Development, LLC (unnumbered contract); Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (unnumbered contract); Merck & Co., Inc. (Contract No. CMO-140505-000393 and Contract No. CMO-150107-000659); National Cancer Institute (Contract No. HHSN263201200074I, Order Nos. HHSN26300005/0002 and HHSN26300066); National Human Genome Research Institute (Contract No. HHSN263201200074I, Order Nos. HHSN26300005/0002 and HHSN26300066); National Institute of Mental Health (Contract No. HHSN263201200074I, Order Nos. HHSN26300005/0002 and HHSN26300066); National Institute of Nursing Research (Contract No. HHSN263201200074I, Order Nos. HHSN26300005/0002 and HHSN26300066); National Institute on Aging (Contract No. HHSN263201200074I, Order Nos. HHSN26300005/0002 and HHSN26300066); National Society of Genetic Counselors (unnumbered contract); Northrop Grumman Health IT (unnumbered contract); and PhRMA (unnumbered contract). 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: 978-0-309-43776-9
International Standard Book Number-10: 0-309-43776-8
Digital Object Identifier: 10.17226/23403

Additional copies of this report are available for sale 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 2016 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. Applying an implementation science approach to genomic medicine: Workshop summary. Washington, DC: The National Academies Press. doi: 107226/23403.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×
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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. Ralph J. Cicerone 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. C. D. Mote, Jr., 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 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.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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PLANNING COMMITTEE1

W. GREGORY FEERO (Co-Chair), Associate Editor, Journal of the American Medical Association

DEBRA LEONARD (Co-Chair), Representative of the College of American Pathologists; Professor and Chair of Pathology and Laboratory Medicine, University of Vermont Medical Center

BRUCE BLUMBERG, Institutional Director of Graduate Medical Education, Kaiser Permanente

VENCE L. BONHAM, Senior Advisor to the Director on Genomics and Health Disparities; Associate Investigator, Social and Behavioral Research Branch, National Human Genome Research Institute

DAVID A. CHAMBERS, Deputy Director for Implementation Science, Division of Cancer Control and Population Sciences, National Cancer Institute

MICHAEL J. DOUGHERTY, Director of Education, American Society of Human Genetics

BRIAN S. MITTMAN, Senior Scientist, Veterans Affairs Greater Los Angeles Healthcare System; Senior Research Scientist, Kaiser Permanente

VICTORIA M. PRATT, Representative of the Association for Molecular Pathology; Associate Professor of Clinical, Medical, and Molecular Genetics; Director, Pharmacogenomics Laboratory, Department of Medical and Molecular Genetics, Indiana University School of Medicine

SAM SHEKAR, Chief Medical Officer, Health Information Technology Program, Northrop Grumman Information Systems

KATHERINE JOHANSEN TABER, Director, Personalized Medicine, American Medical Association

CATHERINE A. WICKLUND, Past President, National Society of Genetic Counselors; Director, Graduate Program in Genetic Counseling; Associate Professor, Department of Obstetrics and Gynecology, Northwestern University

JANET K. WILLIAMS, Representative of the American Academy of Nursing; Professor of Nursing, University of Iowa

___________________

1The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×

Roundtable Staff

SARAH H. BEACHY, Project Director (from July 2015)

ADAM C. BERGER, Project Director (until July 2015)

MEREDITH HACKMANN, Senior Program Assistant

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×

ROUNDTABLE ON TRANSLATING GENOMIC-BASED RESEARCH FOR HEALTH1

GEOFFREY GINSBURG (Co-Chair), Director, Center for Applied Genomics and Precision Medicine, Duke University, Durham, NC

SHARON TERRY (Co-Chair), President and Chief Executive Officer, Genetic Alliance, Washington, DC

NAOMI ARONSON, Executive Director, Technology Evaluation Center, Blue Cross and Blue Shield Association, Chicago, IL

EUAN ANGUS ASHLEY (until October 2015), Representative of the American Heart Association; Director, Center for Inherited Cardiovascular Disease, Stanford University School of Medicine, Palo Alto, CA

PAUL R. BILLINGS (until August 2015), former Chief Medical Officer, Life Technologies, Carlsbad, CA

REBECCA BLANCHARD (from February 2016), Executive Director, Genetics and Pharmacogenomics; Head, Clinical Pharmacogenomics, Merck and Co., Inc., West Point, PA

BRUCE BLUMBERG, Institutional Director of Graduate Medical Education, Northern California Kaiser Permanente, The Permanente Medical Group, Oakland, CA

PHILIP J. BROOKS (until September 2015), Health Scientist Administrator, Office of Rare Diseases Research, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD

JOHN CARULLI, Director, Translational Genomics, Biogen Idec, Cambridge, MA

ANN CASHION, Scientific Director, National Institute of Nursing Research, National Institutes of Health, Bethesda, MD

ROBERT B. DARNELL, President and Scientific Director, New York Genome Center; Investigator, Howard Hughes Medical Institute; Heilbrunn Cancer Professor and Senior Physician, Head, Laboratory of Molecular Neuro-Oncology, The Rockefeller University, New York, NY

MICHAEL J. DOUGHERTY, Director of Education, American Society of Human Genetics, Bethesda, MD

___________________

1The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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W. GREGORY FEERO, Contributing Editor, Journal of the American Medical Association, Chicago, IL

ANDREW N. FREEDMAN, Branch Chief, Clinical and Translational Epidemiology Branch, Epidemiology and Genetics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD

JENNIFER L. HALL, Representative of the International Society for Cardiovascular Translational Research; Associate Professor of Medicine, University of Minnesota, Minneapolis

RICHARD J. HODES, Director, National Institute on Aging, Bethesda, MD

MUIN KHOURY, Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA

GABRIELA LAVEZZARI, Assistant Vice President, Scientific Affairs, PhRMA, Washington, DC

THOMAS LEHNER, Director, Office of Genomics Research Coordination, National Institute of Mental Health, Bethesda, MD

DEBRA LEONARD, Representative of the College of American Pathologists; Professor and Chair of Pathology, University of Vermont College of Medicine; Physician Leader of Pathology and Laboratory Medicine, Fletcher Allen Health Care, University of Vermont College of Medicine, University of Vermont, Burlington

ELIZABETH MANSFIELD, Deputy Office Director for Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD

JENNIFER MOSER, Health Science Specialist, Genomic Medicine Program, Office of Research and Development, Department of Veterans Affairs, Washington, DC

LAURA K. NISENBAUM, Research Fellow, Tailored Therapeutics, Eli Lilly and Company, Indianapolis, IN

ROBERT M. PLENGE (until February 2016), Vice President, Merck Research Laboratories; Head, Genetics and Pharmacogenomics, Merck Research Laboratories, Boston, MA

VICTORIA M. PRATT, Representative of the Association for Molecular Pathology; Associate Professor of Clinical Medical and Molecular Genetics and Director, Pharmacogenomics Diagnostic Laboratory, Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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RONALD PRZYGODZKI (until August 2015), Associate Director for Genomic Medicine and Acting Director of Biomedical Laboratory Research and Development, Department of Veterans Affairs, Washington, DC

MARY V. RELLING, Member and Chair, Department of Pharmaceutical Sciences, St. Jude Children’s Research Hospital, Memphis, TN

NADEEM SARWAR, Vice President and Global Head, Genetics and Human Biology; Chief Clinical Officer, Product Creation Headquarters, Eisai Inc., Cambridge, MA

JOAN A. SCOTT, Chief, Genetic Services Branch, Division of Services for Children with Special Health Needs, Maternal and Child Health Bureau, Rockville, MD

SAM SHEKAR, Chief Medical Officer, Health Information Technology Program, Northrop Grumman Information Systems, McLean, VA

KATHERINE JOHANSEN TABER, Director, Personalized Medicine, American Medical Association, Chicago, IL

DAVID VEENSTRA, Professor, Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle

MICHAEL S. WATSON, Executive Director, American College of Medical Genetics and Genomics, Bethesda, MD

DANIEL WATTENDORF, Deputy Chief, Medical Innovations, Department of the Air Force; Program Manager, Defense Advanced Research Projects Agency/Defense Sciences Office, Arlington, VA

CATHERINE A. WICKLUND, Past President, National Society of Genetic Counselors; Director, Graduate Program in Genetic Counseling; Associate Professor, Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL

ROBERT WILDIN, Chief, Genomic Healthcare Branch, National Human Genome Research Institute, Bethesda, MD

JANET K. WILLIAMS, Representative of the American Academy of Nursing; Professor of Nursing, University of Iowa, College of Nursing, Chair of Behavioral and Social Science, Iowa City

Roundtable Staff

SARAH H. BEACHY, Project Director (from July 2015)

ADAM C. BERGER, Project Director (until July 2015)

SIOBHAN ADDIE, Associate Program Officer (from February 2016)

MEREDITH HACKMANN, Senior Program Assistant

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×

Board on Health Sciences Policy Staff

ANDREW M. POPE, Director

HILARY BRAGG, Program Coordinator

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
×

Reviewers

This workshop summary has been reviewed in draft form by individuals 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 institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

VENCE L. BONHAM, JR., National Human Genome Research Institute

LAURENCE MEYER, Salt Lake City Veterans Administration Medical Center

JANE PERLMUTTER, Gemini Group

ENOLA PROCTOR, Washington University in St. Louis

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by MELVIN WORTH. He was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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Acknowledgments

The support of the sponsors of the Roundtable on Translating Genomic-Based Research for Health was crucial to the planning and conduct of the workshop Applying an Implementation Science Approach to Genomic Medicine and for the development of the workshop summary report. Federal sponsors are the Centers for Disease Control and Prevention; Department of Veterans Affairs; Health Resources and Services Administration; National Cancer Institute; National Human Genome Research Institute; National Institute of Mental Health; National Institute of Nursing Research; and National Institute on Aging. Nonfederal sponsorship was provided by the American Academy of Nursing; American College of Medical Genetics and Genomics; American Heart Association; American Medical Association; American Society of Human Genetics; Association for Molecular Pathology; Biogen; Blue Cross and Blue Shield Association; College of American Pathologists; Eli Lilly and Company; International Society for Cardiovascular Translational Research; Janssen Research & Development, LLC; Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation; Merck & Co., Inc.; National Society of Genetic Counselors; Northrop Grumman Health IT; and PhRMA.

The Roundtable wishes to express its gratitude to the expert speakers who explored how to use principles from the field of implementation science to navigate the challenges, opportunities, and best practices to incorporating genomic technologies in the health care system. The Roundtable also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. The project director would like to thank project staff who worked diligently to develop both the workshop and the resulting summary.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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Abbreviations and Acronyms

ACMG American College of Medical Genetics and Genomics
ASCO American Society of Clinical Oncology
CDC Centers for Disease Control and Prevention
cffDNA cell-free fetal DNA
CFIR Consolidated Framework for Implementation Research
CPTP Canadian Partnership for Tomorrow Project
EBP evidence-based practice
EGAPP Evaluation of Genomic Applications in Practice and Prevention
EHR electronic health record
FDA U.S. Food and Drug Administration
GWAS genome-wide association study
IGNITE Implementing Genomics in Practice
MDHHS Michigan Department of Health and Human Services
MODY maturity-onset diabetes of the young
NHANES National Health and Nutrition Examination Survey
NHGRI National Human Genome Research Institute
NIH National Institutes of Health
PEER Platform for Engaging Everyone Responsibly
PMI Precision Medicine Initiative
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. Applying an Implementation Science Approach to Genomic Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23403.
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RCT randomized controlled trial
TAPUR Targeted Agent and Profiling Utilization Registry
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Although it is becoming increasingly more common for clinicians to use genomic data in their practices for disease prevention, diagnosis, and treatment, the process of integrating genomic data into the practice of medicine has been a slow and challenging one. Some of the major barriers impeding the incorporation of new genomic technology into clinical practice are: the difficulty of changing routine medical practices to account for the use of genetic testing, the limited knowledge of patients and providers about genomic medicine, assessing sufficient evidence to support the use of genetic tests, privacy and data security issues, and uncertainty about reimbursement.

The field of implementation science may be able to provide insights concerning efficient ways to incorporate genomic applications into routine clinical practice. The focus of implementation science studies is to identify integration bottlenecks and optimal approaches for a given setting and ultimately to promote the up-take of research findings. To explore the potential of implementation science to improve the integration of genomics into medicine, the National Academies of Sciences, Engineering, and Medicine held a workshop in Washington, DC, in November 2015. Participants explored the challenges and opportunities of integrating genomic advances into the clinic through the lens of implementation science. This report summarizes the presentations and discussions from the workshop.

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