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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Health
Literacy in
Clinical
Research

Practice and Impact

PROCEEDINGS OF A WORKSHOP

Alexis Wojtowicz and Melissa G. French, Rapporteurs

Roundtable on Health Literacy

Board on Population Health and Public Health Practice

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. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

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

This activity was supported by contracts between the National Academy of Sciences and AbbVie Inc.; California Dental Association; East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Media; Health Literacy Partners; Health Resources and Services Administration (HHSH25034011T); Merck Sharp & Dohme Corp.; National Library of Medicine; Northwell Health; Office of Disease Prevention and Health Promotion (HHSP23337043); Pfizer Inc.; and UnitedHealth Group. 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: 978-0-309-49969-9
International Standard Book Number-10: 0-309-49969-0
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Health literacy in clinical research: Practice and impact: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/25616.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

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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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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.

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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. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

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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.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

PLANNING COMMITTEE ON HEALTH LITERACY IN CLINICAL TRIALS: PRACTICE AND IMPACT1

ANNLOUISE R. ASSAF, Patient Health Activation Expert and Global Medical Impact Assessment Senior Director, Pfizer Worldwide Medical and Safety; Professor (Adjunct), Brown University School of Public Health

BARBARA E. BIERER, Professor of Medicine and Faculty Director, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

TERRY C. DAVIS, Professor of Medicine and Pediatrics, Louisiana State University Health Sciences Center–Shreveport

LAUREN McCORMACK, Vice President, Public Health Research Division, RTI International

LAURIE MYERS, Global Health Literacy Director, Merck Sharp & Dohme Corp.

CATINA O’LEARY, President and Chief Executive Officer, Health Literacy Media

PHYLLIS J. PETTIT NASSI, Associate Director, Research and Science, Special Populations, American Indian Program, University of Utah Huntsman Cancer Institute

PATTY SPEARS, Research Patient Advocate, University of North Carolina Lineberger Comprehensive Cancer Center

CONSUELO H. WILKINS, Vice President for Health Equity, Vanderbilt University Medical Center

___________________

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. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

ROUNDTABLE ON HEALTH LITERACY1

LAWRENCE G. SMITH (Chair), Dean, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell; Executive Vice President and Physician-in-Chief, Northwell Health

ANNLOUISE R. ASSAF, Patient Health Activation Expert and Global Medical Impact Assessment Senior Director, Pfizer Worldwide Medical and Safety; Professor (Adjunct), Brown University School of Public Health

SUZANNE BAKKEN, Alumni Professor of Nursing and Professor of Biomedical Informatics, Columbia University

GEMIRALD DAUS, Public Health Analyst, Office of Health Equity, Health Resources and Services Administration

TERRY C. DAVIS, Professor of Medicine and Pediatrics, Louisiana State University Health Sciences Center–Shreveport

JENNIFER DILLAHA, Medical Director for Immunizations, Medical Advisor, Health Literacy and Communication, Arkansas Department of Health

JAMES DUHIG, Head, Risk Communication and Behavioral Systems, Office of Patient Safety, AbbVie Inc.

ALICIA FERNÁNDEZ, Professor of Medicine, Director, UCSF Latinx Center of Excellence, University of California, San Francisco, Zuckerberg San Francisco General Hospital

LISA FITZPATRICK, Senior Medical Director, DC Department of Health Care Finance, and Professorial Lecturer, The George Washington Milken Institute of Public Health

LORI K. HALL, Director of Health Literacy, Global Medical Strategy and Operations, Eli Lilly and Company

LINDA HARRIS, Director, Division of Health Communication and eHealth Team, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services

NICOLE HOLLAND, Assistant Professor and Director of Health Communication, Education, and Promotion, Tufts University School of Dental Medicine

ELLEN MARKMAN, Lewis M. Terman Professor of Psychology, Stanford University

JOHANNA MARTINEZ, Graduate Medical Education Director of Diversity and Health Equity, Northwell Health

___________________

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

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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MICHAEL McKEE, Associate Professor of Family Medicine, Director of MDisability, University of Michigan Medical School

LAURIE MYERS, Global Health Literacy Director, Merck Sharp & Dohme Corp.

CATINA O’LEARY, President and Chief Executive Officer, Health Literacy Media

MICHAEL PAASCHE-ORLOW, Professor of Medicine, Boston University School of Medicine

TERRI ANN PARNELL, Principal and Founder, Health Literacy Partners

LINDSEY A. ROBINSON, Diplomate, ABPD, California Dental Association

STEVEN RUSH, Director, Health Literacy Innovations, UnitedHealth Group

OLAYINKA SHIYANBOLA, Assistant Professor, Division of Social and Administrative Sciences, University of Wisconsin–Madison School of Pharmacy

VANESSA SIMONDS, Assistant Professor, Community Health, Montana State University

CHRISTOPHER R. TRUDEAU, Associate Professor of Medical Humanities, University of Arkansas for Medical Sciences; Associate Professor of Law, Bowen School of Law, University of Arkansas at Little Rock

EARNESTINE WILLIS, Kellner Professor in Pediatrics, Medical College of Wisconsin

AMANDA J. WILSON, Head, Engagement and Training, National Library of Medicine

MICHAEL S. WOLF, Professor, Medicine and Learning Sciences, Associate Division Chief, Research Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University

WINSTON F. WONG, Medical Director, Disparities Improvement and Quality Initiatives, Kaiser Permanente

Health and Medicine Division Staff

MELISSA G. FRENCH, Senior Program Officer (until January 2020)

ALEXIS WOJTOWICZ, Research Associate

ANNA W. MARTIN, Administrative Assistant

ROSE MARIE MARTINEZ, Senior Board Director, Board on Population Health and Public Health Practice

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

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:

CONNIE CITRO, Division of Behavioral and Social Sciences and Education, The National Academies of Sciences, Engineering, and Medicine

SYLVIA BAEDORF KASSIS, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

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 DEBORAH E. POWELL, University of Minnesota Medical School. She was responsible for 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. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

Acknowledgments

The sponsors of the Roundtable on Health Literacy made it possible to plan and conduct the workshop Health Literacy in Clinical Trials: Practice and Impact, which this proceedings summarizes. Federal sponsors from the U.S. Department of Health and Human Services are the Health Resources and Services Administration; National Library of Medicine; and Office of Disease Prevention and Health Promotion. Nonfederal sponsorship was provided by AbbVie Inc.; California Dental Association; East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Media; Health Literacy Partners; Merck Sharp & Dohme Corp.; Northwell Health; Pfizer Inc.; and UnitedHealth Group.

The workshop presentations were interesting and stimulated much discussion, and the Roundtable on Health Literacy would like to thank each of the speakers and moderators for their time and effort. Speakers and moderators were Emma Andrews, Connie Arnold, Annlouise R. Assaf, Barbara E. Bierer, Ebony Boulware, Deborah Collyar, Terry C. Davis, Lauren McCormack, Monika Mitra, Catina O’Leary, Phyllis J. Pettit Nassi, Saira Z. Sheikh, Lawrence G. Smith, Patty Spears, Jovonni R. Spinner, Alicia Staley, Christopher R. Trudeau, Consuelo H. Wilkins, and Rebecca J. Williams.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×
Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Acronyms and Abbreviations

AE adverse event
AI/AN American Indian/Alaska Native
CARE Committee on Advocacy, Research Communication, Ethics, and Disparities
CEO chief executive officer
CRC colorectal cancer
CTSA Clinical Translational Science Awards (NIH)
CTTI Clinical Trials Transformation Initiative
CV curriculum vitae
eIC electronic informed consent
EMA European Medicines Agency
EU European Union
FDA U.S. Food and Drug Administration
FIT fecal immunochemical test
FOBT fecal occult blood test
FQHC federally qualified health center
GDPR General Data Protection Regulation (European Union)
HIPAA Health Insurance Portability and Accountability Act
HLM Health Literacy Media
Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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IRB Institutional Review Board
LSU Louisiana State University
MIMICT Materials to Increase Minority Involvement in Clinical Trials
MRCT Center Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
NIH National Institutes of Health
NLM National Library of Medicine
OMHHE Office of Minority Health and Health Equity
PAIR Patient Advocates in Research
PALS Patient Advocates for Lupus Studies
PCP primary care physician or primary care provider
PRO patient-reported outcome
PSA public service announcement
PURPLE Programs to Address Unmet Needs and Promote Representation of All Participants in Lupus Clinical Trials Using Mobile Technology for Engagement
PWD people with disabilities
RA research assistant
REMS risk evaluation and mitigation strategies
RIC Recruitment Innovation Center
SACHRP Secretary’s Advisory Committee on Human Research Protections
UNC University of North Carolina
WHI Women’s Health Initiative
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Because of the individualized nature of drug and therapeutic treatments, clinical trials require participants who represent the diversity of the patient base. If early trials do not have a broad patient base, it can be difficult to know who may or may not benefit from or respond to a treatment later. In addition to diversity in recruitment, informed consent during participation is also crucial. If participants do not fully understand what they are signing up for, they may become confused, mistrustful, or drop out of a trial altogether, confusing investigators and possibly affecting the generalizability of a study.

To explore the incorporation of health literacy practices into clinical trials, the Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop presentations and discussion centered around issues related to the challenges or barriers for diverse populations' participation in clinical trials, best practices for clinical trial sites and researchers incorporating health literacy practices, and effective health literacy strategies for clear communication with participants. This publication summarizes the presentation and discussion of the workshop.

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