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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25926.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Examining the Use of Biomarkers in Establishing the Presence and Severity of Impairments PROCEEDINGS OF A WORKSHOP Megan Snair, Tracy Lustig, and Cyndi Trang, Rapporteurs Board on Health Care Services Health and Medicine Division PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS  500 Fifth Street, NW  Washington, DC 20001 This activity was supported by a contract between the National Academy of Sci- ences and the Social Security Administration. 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/10.17226/25926 Additional copies of this publication are 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 2020 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. 2020. Examining the use of biomarkers in establishing the presence and severity of impair- ments: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/25926. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institu- tion 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 char- ter 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 COPY—Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typi- cally include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s 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 opin- ions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY—Uncorrected Proofs

PLANNING COMMITTEE ON THE STATE OF THE SCIENCE OF THE USE OF BIOMARKERS TO ESTABLISH THE PRESENCE AND SEVERITY OF IMPAIRMENTS1 SARA ROSENBAUM (Chair), Harold and Jane Hirsh Professor, Health Law and Policy, Milken Institute School of Public Health, The George Washington University LINDA BRADY, Director, Division of Neuroscience and Basic Behavioral Science, National Institute of Mental Health, National Institutes of Health BETTY DIAMOND, Chief, Autoimmune Disease Center, Feinstein Institutes for Medical Research SARAH MORRIS, Chief, Adult Psychopathology and Psychosocial Intervention Development Branch; Program Officer, Schizophrenia Spectrum Disorders Program, National Institute of Mental Health, National Institutes of Health RALPH NITKIN, Deputy Director, National Center for Medical Rehabilitation Research; Director, Biological Sciences and Career Development Program, National Institute of Child Health and Human Development, National Institutes of Health PATRICIA OWENS, Consultant, Health and Disability Policy and Programs SARAH RUIZ, Associate Director, Office of Research Sciences, National Institute on Disability, Independent Living, and Rehabilitation Research IRA SHOULSON, Professor of Neurology, University of Rochester; Adjunct Professor of Neurology, Georgetown University ROBERT WALLACE, Irene Ensminger Stecher Professor, Cancer Research, The University of Iowa Health and Medicine Division Staff TRACY LUSTIG, Senior Program Officer CYNDI TRANG, Research Associate JOE GOODMAN, Senior Program Assistant SHARYL NASS, Senior Director, Board on Health Care Services 1  The National Academies of Sciences, Engineering, and Medicine’s 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 COPY—Uncorrected Proofs

PREPUBLICATION COPY—Uncorrected Proofs

Reviewers T his Proceedings of a Workshop was reviewed in draft form by indi- viduals chosen for their diverse perspectives and technical exper- tise. 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 proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following individuals for their review of this proceedings: TOM ARRISON, National Academies of Sciences, Engineering, and Medicine HOWARD H. GOLDMAN, University of Maryland School of Medicine LAUREN OLIVA, Biogen MARK RASENICK, University of Illinois College of Medicine Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by WALTER R. FRONTERA, University of Puerto Rico School of Medicine. He was responsible for vii PREPUBLICATION COPY—Uncorrected Proofs

viii REVIEWERS making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies. PREPUBLICATION COPY—Uncorrected Proofs

Contents ACRONYMS AND ABBREVIATIONS xi 1 INTRODUCTION 1 Background, 2 Organization of Proceedings, 2 2  UNDERSTANDING BIOMARKER USE AND ITS POTENTIAL FOR DETERMINING HEALTH AND FUNCTION 5 History and Definition of Biomarkers, 6 Relating Biomarkers to Health and Function, 9 Discussion, 13 3 STATE OF THE SCIENCE FOR SPECIFIC IMPAIRMENTS 17 Major Depression, 18 Post-Traumatic Stress Disorder, 21 Schizophrenia, 22 Chronic Pain and Fibromyalgia, 26 Arthritis, 28 Low Back Pain, 31 Discussion, 33 ix PREPUBLICATION COPY—Uncorrected Proofs

x CONTENTS 4 LEGAL AND ETHICAL IMPLICATIONS 37 Concerns for the Use of Biomarkers in Disability, 38 Potential Harms and Benefits, 39 Considerations for Decision Making in Defining Disability, 40 5 FINAL THOUGHTS 43 Examining Positive Findings and Potential Challenges, 44 Suggestions for the Use of Biomarkers in the Social Security Administration, 46 REFERENCES 47 APPENDIXES A Statement of Task 53 B Workshop Agenda 55 C Biographical Sketches of Workshop Speakers and Planning Committee Members 59 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations ACPA anti-citrullinated peptide antibody BEST Biomarkers, EndpointS, and other Tools glossary BIPEDS burden of disease, investigative, prognostic, efficacy of intervention, diagnostic, safety BMI body mass index CNS central nervous system COA clinical outcome assessment COU context of use EEG electroencephalogram FDA Food and Drug Administration FNIH Foundation for the National Institutes of Health GABA gamma aminobutyric acid GPS global positioning system HAQ health assessment questionnaire ICF International Classification of Functioning, Disability and Health xi PREPUBLICATION COPY—Uncorrected Proofs

xii ACRONYMS AND ABBREVIATIONS MRI magnetic resonance imaging MVP Million Veteran Program NIH National Institutes of Health OA osteoarthritis PET positron emission tomography PTSD post-traumatic stress disorder RA rheumatoid arthritis RANTES regulated on activation, normal T-cell expressed and secreted SSA Social Security Administration SSRI selective serotonin reuptake inhibitor WHO World Health Organization PREPUBLICATION COPY—Uncorrected Proofs

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As part of the overall disability determination process, the Social Security Administration uses a step-by-step approach to understand how severe an individual's condition is and whether it meets program criteria for disability. The use of various types of biomarkers has been suggested as a way to strengthen the amount and quality of objective evidence available to the review process.

At the request of the Social Security Administration, the National Academies of Sciences, Engineering, and Medicine's Board on Health Care Services organized a virtual workshop on July 21, 2020, titled The State of the Science of the Use of Biomarkers to Establish the Presence and Severity of Impairments. Workshop discussions focused on the current and potential uses for biomarkers; explored legal and ethical implications associated with biomarker use in clinical decision making; and considered the possible uses of nongenetic biomarkers as tools for the diagnosis or prognosis of the severity of specific physical and mental impairments. This publication summarizes the presentations and discussion of the workshop.

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