National Academies Press: OpenBook

Closing Evidence Gaps in Clinical Prevention (2021)

Chapter: Front Matter

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
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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.

Alexis Wojtowicz, Kathleen Stratton, and Tracy A. Lieu, Editors Committee on Addressing Evidence Gaps in Clinical Prevention Recommendations Board on Population Health and Public Health Practice Health and Medicine Division A Consensus Study Report of PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, NW   Washington, DC 20001 This activity was supported with federal funds from the Agency for Healthcare Research and Quality and the National Institutes of Health, U.S. Department of Health and Human Services, Contract/Task Order No. HHSN263201800029I/75N 98020F00005. 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/10.17226/26351 Library of Congress Catalog Number: 2021951344 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 2021 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. 2021. Closing evidence gaps in clinical prevention. Washington, DC: The National Academies Press. https://doi.org/10.17226/26351. 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 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 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 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. PREPUBLICATION COPY—Uncorrected Proofs

COMMITTEE ON ADDRESSING EVIDENCE GAPS IN CLINICAL PREVENTION RECOMMENDATIONS TRACY A. LIEU (Chair), Director of the Division of Research, Kaiser Permanente Northern California CATHY J. BRADLEY, Professor and Associate Dean for Research, Colorado School of Public Health; Deputy Director, University of Colorado Cancer Center THEODORE G. GANIATS, Professor Emeritus, Department of Family Medicine and Public Health, University of California, San Diego, School of Medicine KENG-YEN HUANG, Associate Professor, Departments of Population Health and Child & Adolescent Psychiatry, New York University Grossman School of Medicine PREETI GOKAL KOCHAR, Technical Information Specialist, National Library of Medicine, National Institutes of Health ANN E. KURTH, Dean and Linda Koch Lorimer Professor of Nursing, Yale School of Nursing; Professor of Epidemiology of Microbial Diseases, Yale School of Public Health TIANJING LI, Associate Professor, Department of Ophthalmology, University of Colorado School of Medicine K. M. VENKAT NARAYAN, Director, Emory Global Diabetes Research Center; Ruth and O.C. Hubert Chair of Global Health and Professor of Epidemiology, Rollins School of Public Health; Professor of Medicine, Emory University School of Medicine WANDA K. NICHOLSON, Professor, Department of General Obstetrics & Gynecology and Director, Diabetes and Obesity Core Center for Women’s Health Research, University of North Carolina School of Medicine ELIZABETH O. OFILI, Professor of Medicine, Morehouse School of Medicine; Chief Medical Officer, Morehouse Choice Accountable Care Organization NICOLAAS P. PRONK, President and Chief Science Officer, HealthPartners Institute ROBERT B. WALLACE, Irene Ensminger Stecher Professor Emeritus of Epidemiology and Internal Medicine, University of Iowa College of Public Health v PREPUBLICATION COPY—Uncorrected Proofs

Study Staff KATHLEEN R. STRATTON, Study Director ALEXIS WOJTOWICZ, Associate Program Officer AYSHIA COLETRANE, Senior Program Assistant REBECCA MORGAN, Senior Librarian MISRAK DABI, Finance Business Partner ROSE MARIE MARTINEZ, Senior Board Director Science Writer ROBERT POOL vi PREPUBLICATION COPY—Uncorrected Proofs

Reviewers This Consensus Study Report was reviewed in draft form by indi- viduals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical com- ments 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 responsiveness 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: SARABETH BRODER-FINGERT, University of Massachusetts ROGER CHOU, Oregon Health & Science University LAWRENCE S. B. GOLDSTEIN, University of California, San Diego DAVID GROSSMAN, Kaiser Permanente RICHARD M. HOFFMAN, University of Iowa RANDY A. JONES, University of Virginia ALEX KRIST, Virginia Commonwealth University DONALD R. MATTISON, University of South Carolina MARIA MORA PINZON, Wisconsin Alzheimer’s Institute HEIDI D. NELSON, Oregon Health & Science University JOHN E. NIEDERHUBER, Johns Hopkins University vii PREPUBLICATION COPY—Uncorrected Proofs

viii REVIEWERS DOUG K. OWENS, Stanford University JOE SELBY, Patient-Centered Outcomes Research Institute (retired) STEPHANIE ZAZA, Centers for Disease Control and Prevention (retired) Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the report nor did they see the final draft before its release. The review of this report was overseen by BOBBIE BERKOWITZ, Columbia University, and JACK EBELER, Health Policy Alternatives, Inc. They were respon- sible for making certain that an independent examination of this report 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 authoring committee and the National Academies. PREPUBLICATION COPY—Uncorrected Proofs

Preface Preventing suffering and loss of life through early identification and treatment of individuals at risk is a central purpose of clinical care. For decades, primary care clinicians and others have relied on recommen- dations of the U.S. Preventive Services Task Force (USPSTF) in these efforts. The USPSTF’s careful reliance on evidence from rigorous studies to inform its statements has often highlighted topics and questions for which the evidence is insufficient to make a definitive recommendation. In an ideal world, when an insufficient evidence statement is rendered, research sponsors and researchers should quickly initiate high-quality studies needed to fill the most important evidence gaps. However, in some cases the lack of a widely agreed-on framework for describing and categorizing such evidence gaps has hampered efficient communication and progress. The present study focused on developing a taxonomy to characterize evidence gaps in clinical prevention, and identifying research strategies and funding approaches to enable sponsors and researchers to more effec- tively fill these gaps. This work was sponsored by leaders in the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ), which supports the USPSTF. We are grateful to David Murray and Carrie Klabunde of the Office of Disease Prevention, NIH, and to Arlene Bierman and Amanda Borsky of the Center for Evidence and Practice Improvement, AHRQ, for their guidance and support. We also wish to acknowledge the important contributions of Susan Curry, who was instrumental in launching this effort. ix PREPUBLICATION COPY—Uncorrected Proofs

x PREFACE Our study committee approached this task with a sense of significance and optimism, and demonstrated intellectual generosity and gracious- ness throughout this multidisciplinary process. The committee and the Health and Medicine Division’s (HMD’s) staff of the National Academies developed this report and the taxonomy in an iterative manner, based on reviews of existing USPSTF recommendation statements and public meetings with experts from NIH, AHRQ, and other key organizations that sponsor research or support guideline committees, USPSTF members, and the research community. During this process we were particularly attuned to the fact that both the USPSTF and research sponsors must bal- ance competing priorities among the many evidence gaps that could be addressed. As a former member of the USPSTF, the past chair of an NIH grant review committee, and a leader of a research department in a health care delivery system, I greatly appreciated the ability of our committee members and expert key informants to think pragmatically about how to facilitate communication and collaboration by the multiple stakeholders needed to successfully address evidence gaps. We appreciate the education offered us by the speakers at our public meetings, including the following: • David Atkins, M.D., M.P.H., Director, Health Services Research & Development, U.S. Department of Veterans Affairs • Arlene Bierman, M.D., M.S., Director, Center for Evidence and Practice Improvement, AHRQ • Amanda Borsky, Dr.P.H., M.P.P., Program Manager, USPSTF, AHRQ • Sarabeth Broder-Fingert, M.D., M.P.H., Associate Professor of Pedi- atrics, Boston University School of Medicine; Co-Director, Innova- tion in Autism Disparities, Inclusion, Outreach, and Transition Services Lab, Boston University • Ned Calonge, M.D., M.P.H., President and Chief Executive Officer, Colorado Trust; Associate Professor of Family Medicine, Colorado School of Medicine, and Associate Professor of Epidemiology, Colo- rado School of Public Health, University of Colorado Denver • Doug Corley, M.D., Ph.D., Lead Investigator, National Cancer Institute (NCI) Population-based Research to Optimize the Screening Process Consortium; Research Scientist, Kaiser Perman- ente Northern California Division of Research • Susan Curry, Ph.D., Senior Advisor for Preventive Services, NIH; Dean Emerita and Distinguished Professor of Health Management and Policy, University of Iowa PREPUBLICATION COPY—Uncorrected Proofs

PREFACE xi • Paul Doria-Rose, Ph.D., D.V.M., Chief, Healthcare Assessment Research Branch, Health Delivery Research Program, Division of Cancer Control & Population Sciences, NCI • Chyke Doubeni, M.D., M.P.H., Member, USPSTF; Director, Mayo Clinic Center for Health Equity and Community Engagement Research • Carrie Klabunde, Ph.D., Senior Advisor for Disease Prevention, Office of Disease Prevention, NIH • Alex Krist, M.D., M.P.H., Immediate Past Chair, USPSTF; Professor of Family Medicine and Population Health, Virginia Commonwealth University • Amy Lansky, Ph.D., M.P.H., Director, Centers for Disease Control and Prevention Community Guide • Michael Lauer, M.D., Deputy Director, Extramural Research, NIH • Alan Leshner, Ph.D., Chief Executive Officer Emeritus, American Association for the Advancement of Science; Executive Publisher, Science; Former Director, National Institute on Drug Abuse, NIH; Former Deputy Director and Acting Director, National Institute of Mental Health (NIMH), NIH • Carol Mangione, M.D., M.S.P.H., FACP, Vice-Chair, USPSTF; Chief, Division of General Medicine & Health Services Research, University of California, Los Angeles (UCLA); Barbara A. Levey & Gerald S. Levey Professor of Medicine and Public Health, UCLA • David Murray, Ph.D., Associate Director for Prevention and Direc- tor, Office of Disease Prevention, NIH • Karen Robinson, Ph.D., M.Sc., Director, Evidence-based Practice Center, Johns Hopkins University • Michael Silverstein, M.D., M.P.H., Member, USPSTF; Professor of Pediatrics, Director, Division of General Academic Pediatrics, and Vice Chair, Research for the Department of Pediatrics, Boston University School of Medicine • Harold (Hal) Sox, M.D., Director, Peer Review, Patient-Centered Outcomes Research Institute • Ann Wagner, Ph.D., National Autism Coordinator, Office of NIMH Director, NIMH, NIH We are also grateful to Caitlin Phelps (American College of Obste- tricians and Gynecologists), Joe Selby, Steve Teutsch, and Gregory Traversy (Public Health Agency of Canada) for helpful observations and suggestions. The committee’s work would not have been possible without the insightful leadership of our study director Kathleen Stratton and the thoughtful and analytic contributions of Associate Program Officer Alexis PREPUBLICATION COPY—Uncorrected Proofs

xii PREFACE Wojtowicz. We benefited from the excellent organizational skills of Ayshia Coletrane and the lucid writing assistance of Robert Pool as we crafted this report. We extend thanks to Rose Marie Martinez for her farsighted guidance and to the National Academies’ Research Center staff and many other staff members within HMD and the National Academies for their support. The committee hopes this study will facilitate a common understand- ing of the key concepts related to evidence gaps in clinical prevention, support thoughtful discussion of priorities among multiple stakeholders, and lead to research that enhances clinical prevention in the years ahead. Tracy A. Lieu, Chair Committee on Addressing Evidence Gaps in Clinical Prevention Recommendations PREPUBLICATION COPY—Uncorrected Proofs

Contents ACRONYMS AND ABBREVIATIONS xvii SUMMARY 1 1 INTRODUCTION 19 Statement of Task, 20 Committee Process, 22 Organization of the Report, 23 References, 23 2 CLINICAL PRACTICE GUIDELINES AND THE U.S. PREVENTIVE SERVICES TASK FORCE 25 What Are Clinical Practice Guidelines?, 25 U.S. Preventive Services Task Force, 28 How Other Clinical Practice Guideline Developers Address Evidence Gaps, 37 References, 38 3 CLINICAL PREVENTION RESEARCH ENTERPRISE 43 National Institutes of Health, 43 Other Clinical Prevention Research Funders, 55 Researchers, 60 References, 60 xiii PREPUBLICATION COPY—Uncorrected Proofs

xiv CONTENTS 4 TAXONOMY AND WORKFLOW 65 Committee’s Approach, 68 Workflow, 73 Taxonomy for Classifying Evidence Gaps, 76 Taxonomy for Developing the Research Agenda, 94 Examples of Applying the Taxonomy to I Statements, 102 References, 109 5 RECOMMENDATIONS 113 Using the Taxonomy, 113 Fostering Clinical Prevention Research, 122 Advancing the Work of the U.S. Preventive Services Task Force, 124 References, 130 APPENDIXES A Topics with I Statements from the U.S. Preventive Services Task Force 133 B Research Methods 145 C Public Meeting Agendas 165 D Committee Member and Staff Biographies 169 E U.S. Preventive Services Task Force’s Reports to Congress 177 F U.S. Preventive Services Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021 183 PREPUBLICATION COPY—Uncorrected Proofs

Boxes, Figures, and Tables BOXES 1-1 Statement of Task, 21 3-1 Setting Research Priorities, 44 3-2 National Institutes of Health Strategic Plan for Fiscal Years 2021–2025, 45 4-1 Clinical Prevention Evidence Gaps Taxonomy Terms, 77 4-2 Evidence Gaps Identified by the U.S. Preventive Services Task Force for the Cognitive Impairment Screening Recommendation, 104 FIGURES S-1 A generic version of the analytic framework used by the U.S. Preventive Services Task Force, 5 S-2 Workflow for using the evidence gaps taxonomy, 7 S-3 The committee’s vision for the report and taxonomy’s role in improving clinical research by addressing evidence gaps, 15 2-1 U.S. Preventive Services Task Force recommendations development process: a graphic overview, 30 2-2 The relationship between the U.S. Preventive Services Task Force and the Community Preventive Services Task Force, 36 xv PREPUBLICATION COPY—Uncorrected Proofs

xvi BOXES, FIGURES, AND TABLES 3-1 2020 I statement survey summary, 53 4-1 Generic analytic framework for screenings, 71 4-2 Generic analytic framework for behavioral interventions, 71 4-3 Analytic framework for screenings and interventions to prevent dental caries in children younger than age 5, 72 4-4 Analytic framework for preventing HIV infection with PrEP, 72 4-5 The workflow for identifying evidence gaps in clinical prevention with the taxonomy, 74 4-6 The workflow with foundational evidence gaps facet, 79 4-7 The workflow with analytic framework evidence gaps facet, 83 4-8 The workflow with dissemination and implementation evidence gaps facet, 89 4-9 The workflow with prioritization criteria facet, 95 4-10 The workflow with study specifications facet, 100 5-1 The committee vision for improving clinical prevention research, 129 TABLES 2-1 Matrix of Assessing Certainty and Magnitude of Net Benefit Used by the U.S. Preventive Services Task Force, 31 2-2 Types of Evidence Gaps That May Lead to an I Statement for a Topic, 34 3-1 Frequently Used Funding Mechanisms at the National Institutes of Health, 46 3-2 Comparison of Grants and Contracts, 48 3-3 National Institutes of Health Activity Related to I Statements, 54 4-1 Foundational Evidence Gaps in the Cognitive Impairment Recommendation, 104 4-2 Analytic Framework Gaps in the Cognitive Impairment Recommendation, 105 4-3 Dissemination and Implementation Evidence Gaps in the Cognitive Impairment Recommendation, 106 4-4 Foundational Evidence Gaps in the Atrial Fibrillation Recommendation, 107 4-5 Analytic Framework Evidence Gaps in the Atrial Fibrillation Recommendation, 108 4-6 Dissemination and Implementation Evidence Gaps in the Atrial Fibrillation Recommendation, 109 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations AAA abdominal aortic aneurysm ACA Patient Protection and Affordable Care Act ACE angiotensin-converting enzyme AHCPR Agency for Healthcare Policy and Research AHRQ Agency for Healthcare Research and Quality ASD autism spectrum disorder CDC Centers for Disease Control and Prevention CDMRP Congressionally Directed Medical Research Program CISNET Cancer Intervention and Surveillance Modeling Network CPG clinical practice guideline CPSTF Community Preventive Services Task Force CT computed tomography CTFPHE Canadian Task Force on the Public Health Examination CTSA Clinical and Translational Science Awards D&I dissemination and implementation DOD U.S. Department of Defense ECG electrocardiography EPC Evidence-based Practice Center xvii PREPUBLICATION COPY—Uncorrected Proofs

xviii ACRONYMS AND ABBREVIATIONS FIT fecal immunochemical testing FOA funding opportunity announcement FY fiscal year HHS U.S. Department of Health and Human Services HMD Health and Medicine Division HRSA Health Resources and Services Administration IC institutes and centers MCI mild cognitive impairment NCI National Cancer Institute NHLBI National Heart, Lung, and Blood Institute NIH National Institutes of Health NIMH National Institute of Mental Health NOSI notice of special interest ODP Office of Disease Prevention PA program announcement PCORI Patient-Centered Outcomes Research Institute PICO population, intervention, comparison, outcomes PICOTS population, intervention, comparison, outcome, timing, setting PRC Prevention Research Center PrEP preexposure prophylaxis PROSPR Population-based Research to Optimize the Screening Process RCT randomized controlled trial RFA request for application RFP request for proposal SBIR Small Business Innovation Research SBTT Small Business Technology Transfer SPRINT Systolic Blood Pressure Intervention Trial SVS Society for Vascular Surgery UCLA University of California, Los Angeles USPSTF U.S. Preventive Services Task Force VA U.S. Department of Veterans Affairs PREPUBLICATION COPY—Uncorrected Proofs

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Closing Evidence Gaps in Clinical Prevention, a new consensus study report from the National Academies of Sciences, Engineering, and Medicine's Board on Population Health and Public Health Practice, evaluates evidence gaps in clinical prevention recommendations described by the United States Preventive Services Task Force and other clinical practice guideline developers and presents a taxonomy of these evidence gaps for future use. This report aims to improve the coordination of efforts to describe and communicate priority evidence gaps among funders and researchers. It also proposes new opportunities for collaboration among researchers, funders, and guideline developers to accelerate research that could close evidence gaps.

The authoring committee has also developed an interactive graphic that can be used as a workflow diagram for implementing the taxonomy. This workflow walks users through reviewing evidence, characterizing evidence gaps using relevant taxonomies, and developing a research agenda. Click here to view and engage with the interactive graphic.

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