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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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Examining the Use
of Biomarkers in
Establishing the
Presence and Severity
of Impairments

PROCEEDINGS OF A WORKSHOP

Megan Snair, Tracy A. Lustig, and Cyndi Trang, Rapporteurs

Board on Health Care Services

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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.
×

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

This activity was supported by a contract between the National Academy of Sciences 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: 978-0-309-68263-3
International Standard Book Number-10: 0-309-68263-0
Digital Object Identifier: https://doi.org/10.17226/25926

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Suggested citation: 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. https://doi.org/10.17226/25926.

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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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.

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Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

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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Image

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 typically 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 opinions 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.

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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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 S. 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 E. 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 M. 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 B. WALLACE, Irene Ensminger Stecher Professor, Cancer Research, The University of Iowa

Health and Medicine Division Staff

TRACY A. 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 speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

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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Reviewers

This Proceedings of a Workshop was 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 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:

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

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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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.

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.
×
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.
×

Acronyms and Abbreviations

ACPA anti-citrullinated peptide antibody
BEST Biomarkers, EndpointS, and other Tools glossary
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
MRI magnetic resonance imaging
MVP Million Veteran Program
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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NIH National Institutes of Health
OA osteoarthritis
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
VA Department of Veterans Affairs
WHO World Health Organization
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 R7
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.
×
Page R8
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.
×
Page R9
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.
×
Page R11
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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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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