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Cognitive Rehabilitation Therapy for Traumatic Brain Injury Model Study Protocols and Frameworks to Advance the State of the Science Wo rk sho p Summar y Karin Matchett, Rapporteur Board on the Health of Select Populations

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THE NATIONAL ACADEMIES PRESS  500 Fifth Street, NW  Washington, DC 20001 NOTICE: The workshop that is the subject of this workshop summary was ap- proved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This activity was supported by Contract No. HHSP23320042509XI/ HHSP23337029T/0002 between the National Academy of Sciences and the U.S. Department of Health and Human Services. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity. International Standard Book Number-13:  978-0-309-26786-1 International Standard Book Number-10:  0-309-26786-2 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. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2013 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent ad- opted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2013. Cognitive rehabilitation therapy for traumatic brain injury: Model study protocols and frameworks to ad- vance the state of the science: Workshop summary. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and techni- cal matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sci- ences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congres- sional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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PLANNING COMMITTEE ON COGNITIVE REHABILITATION THERAPY FOR TRAUMATIC BRAIN INJURY: MODEL STUDY PROTOCOLS AND FRAMEWORKS TO ADVANCE THE STATE OF THE SCIENCE1 IRA SHOULSON (Chair), Professor of Neurology, Pharmacology and Human Science, and Director of the Program for Regulatory Science and Medicine, Georgetown University, Washington, DC RICHARD KEEFE, Professor of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC MARY R. T. KENNEDY, Associate Professor, Department of Speech- Language-Hearing Science, University of Minnesota, Minneapolis HILAIRE THOMPSON, Assistant Professor in the School of Nursing, University of Washington, Seattle JOHN WHYTE, Director, Moss Rehabilitation Research Institute, Elkins Park, PA Consultant BARBARA G. VICKREY, Professor and Vice Chair, Department of Neurology, University of California, Los Angeles IOM Staff REBECCA KOEHLER, Program Officer MARYJO M. OSTER, Program Officer JON Q. SANDERS, Program Associate ANDREA COHEN, Financial Associate FREDERICK (RICK) ERDTMANN, Director, Board on the Health of Select Populations 1  Institute of Medicine 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 rapporteur and the institution. v

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Reviewers This workshop summary has been reviewed in draft form by individu- als chosen for their diverse perspectives and technical expertise, in accor- dance with procedures approved by the National Research Council’s Report Review Committee. 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: Alison Cernich, Defense Centers of Excellence Wayne A. Gordon, Mount Sinai School of Medicine Mary V. Radomski, Sister Kenny Research Center Rodney Vanderploeg, James A. Haley VA Hospital 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 Jack C. Ebeler, Health Policy Alternatives, Inc. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this workshop summary was carried out in ac- cordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteur and the institution. vii

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Acknowledgments Many individuals were responsible for the planning of the workshop and the production of this summary. We wish to additionally thank Charles Drebing for his assistance and expertise. ix

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Contents 1 INTRODUCTION 1 Objectives of the Workshop, 2 Organization of This Summary, 3 2 OVERVIEW OF THE INSTITUTE OF MEDICINE REPORT (OCTOBER 2011) 5 The Committee’s Approach, 6 Analysis of the 90 Studies, 8 Example of the Committee’s Process, 9 Overall Findings from the Analysis of the Literature, 10 The Limitations of the Current Literature on CRT for TBI, 10 The Committee’s Conclusions, 11 3 THE TRANSLATIONAL PIPELINE AND CLASSIFICATION SCHEMES FOR CRT INTERVENTIONS 13 The Translational Pipeline, 13 Guidelines for Creating Meaningful Descriptions of CRT Interventions, 22 4 KEY THEMES 27 The Translational Pipeline and Research Design, 28 Severity Levels of TBI: Discussion of Mild Injury, 30 Components of Research Studies and Their Characteristics at Different Points in the Maturational Process, 32 xi

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xii CONTENTS Databases, 38 Who Owns This Process Going Forward?, 39 Closing Remarks, 42 REFERENCES 45 APPENDIXES A  ecommendations of the IOM Report Cognitive Rehabilitation R Therapy for Traumatic Brain Injury: Evaluating the Evidence 47 B Workshop Agenda 51 C Biosketches of the Workshop Speakers and Moderators 55