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THE LEARNING HEALTH SYSTEM SERIES ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE LEARNING WHA WORKS T Infrastructure Required for Comparative Effectiveness Research Workshop Summary LeighAnne Olsen, Claudia Grossmann, and J. Michael McGinnis

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. This project was supported by the Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Founda- tion, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, sanofi-aventis, and Stryker. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-12068-5 International Standard Book Number-10: 0-309-12068-3 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www. nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2011 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 adopted 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). 2011. Learning What Works: Infra- structure Required for Comparative Effectiveness Research: 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 Acad- emy has a mandate that requires it to advise the federal government on scientific and technical 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 engineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional 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 Coun- cil 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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ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE* Denis A. Cortese (Chair), Emeritus President and Chief Executive Officer, Mayo Clinic; Foundation Professor, ASU Donald Berwick, Administrator, Centers for Medicare & Medicaid Services (ex officio) David Blumenthal, National Coordinator, Office of the National Coordinator for Health IT (ex officio) Bruce G. Bodaken, Chairman, President, and Chief Executive Officer, Blue Shield of California David R. Brennan, Chief Executive Officer, AstraZeneca PLC Paul Chew, Chief Science Officer and CMO, sanofi-aventis U.S., Inc. Carolyn M. Clancy, Director, Agency for Healthcare Research and Quality (ex officio) Michael J. Critelli, Former Executive Chairman, Pitney Bowes, Inc. Helen Darling, President, National Business Group on Health Thomas R. Frieden, Director, Centers for Disease Control and Prevention (designee: Chesley Richards) (ex officio) Gary L. Gottlieb, President and CEO, Partners HealthCare System James A. Guest, President, Consumers Union George C. Halvorson, Chairman and Chief Executive Officer, Kaiser Permanente Margaret A. Hamburg, Commissioner, Food and Drug Administration (ex officio) Carmen Hooker Odom, President, Milbank Memorial Fund Board Ardis Hoven, Board Chair, American Medical Association Brent James, Chief Quality Officer and Executive Director, Institute for Health Care Delivery Research, Intermountain Healthcare Michael M. E. Johns, Chancellor, Emory University Craig Jones, Director, Vermont Blueprint for Health Cato T. Laurencin, Vice President for Health Affairs, Dean of the School of Medicine, University of Connecticut Stephen P. MacMillan, President and Chief Executive Officer, Stryker Mark B. McClellan, Director, Engelberg Center for Healthcare Reform, The Brookings Institution Sheri S. McCoy, Worldwide Chairman, Johnson & Johnson Pharmaceuticals Group Elizabeth G. Nabel, President, Brigham and Women’s Hospital *Formerly the Roundtable on Evidence-Based Medicine. Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. v

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Mary D. Naylor, Professor and Director of Center for Transitions in Health, University of Pennsylvania Peter Neupert, Corporate Vice President, Health Solutions Group, Microsoft Corporation William D. Novelli, Former CEO, AARP; Professor, Georgetown University Jonathan B. Perlin, Chief Medical Officer and President, Clinical Services, HCA, Inc. Robert A. Petzel, Under Secretary, Veterans Health Administration (ex officio) Richard Platt, Professor and Chair, Harvard Medical School and Harvard Pilgrim Health Care John C. Rother, Group Executive Officer, AARP John W. Rowe, Professor, Mailman School of Public Health, Columbia University Susan Shurin, Acting Director, National Heart, Lung, and Blood Institute (ex officio) Mark D. Smith, President and CEO, California HealthCare Foundation George P. Taylor, Assistant Secretary for Health Affairs (Acting), Department of Defense (designee: Michael Dinneen) (ex officio) Reed D. Tuckson, Executive VP and Chief of Medical Affairs, UnitedHealth Group Frances M. Visco, President, National Breast Cancer Coalition Workshop Planning Committee John W. Rowe (Chair), Mailman School of Public Health, Columbia University Stuart H. Altman, Brandeis University Kathleen A. Buto, Johnson & Johnson Carolyn M. Clancy, Agency for Healthcare Research and Quality W. David Helms, AcademyHealth Mark B. McClellan, Brookings Institution Peter R. Orszag, Congressional Budget Office Roundtable Staff Christie Bell, Financial Associate Patrick Burke, Financial Associate (until December 2009) Andrea Cohen, Financial Associate (until December 2008) Claudia Grossmann, Program Officer Kiran Gupta, Research Assistant (until May 2009) Katie Jakubs, National Institutes of Health detailee J. Michael McGinnis, Senior Scholar and Executive Director vi

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LeighAnne Olsen, Program Officer Daniel O’Neill, Research Associate (until December 2008) Stephen Pelletier, Consultant Brian Powers, Senior Program Assistant Valerie Rohrbach, Program Assistant Julia Sanders, Program Assistant Robert Saunders, Program Officer Ruth Strommen, Intern Leigh Stuckhardt, Program Associate Kate Vasconi, Senior Program Assistant (until January 2011) Pierre Yong, Program Officer (until May 2010) Catherine Zweig, Senior Program Assistant (until June 2010) vii

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance 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 report as sound as possible and to ensure that the report 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 report: Barbara Alving, National Institutes of Health Meryl Bloomrosen, American Medical Informatics Association Jean Paul Gagnon, sanofi-aventis Larry A. Green, University of Colorado at Denver Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Sam- uel Nussbaum, Wellpoint, Inc. Appointed by the National Research Council and the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. ix

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Institute of Medicine Roundtable on Value & Science-Driven Health Care1 Charter and Vision Statement The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effec- tiveness is generated and used to improve health and health care. Participants have set a goal that, by the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. Roundtable members will work with their colleagues to identify the issues not being adequately addressed, the nature of the barriers and possible solutions, and the priorities for action, and will marshal the resources of the sectors represented on the Roundtable to work for sustained public–private cooperation for change. ****************************************** The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effec- tiveness is generated and used to improve health and health care. We seek the development of a learning health system that is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care, and to ensure innovation, quality, safety, and value in health care. Vision: Our vision is for a healthcare system that draws on the best evi- dence to provide the care most appropriate to each patient, emphasizes preven- tion and health promotion, delivers the most value, adds to learning throughout the delivery of care, and leads to improvements in the nation’s health. Goal: By the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. We feel that this presents a tangible focus for progress toward our vision, that Americans ought to expect at least this level of perfor- mance, that it should be feasible with existing resources and emerging tools, and that measures can be developed to track and stimulate progress. Context: As unprecedented developments in the diagnosis, treatment, and long-term management of disease bring Americans closer than ever to the promise of personalized health care, we are faced with similarly unprecedented challenges to identify and deliver the care most appropriate for individual needs and conditions. Care that is important is often not delivered. Care that is delivered is often not important. In part, this is due to our failure to apply the evidence we have about the medical care that is most effective—a failure related to shortfalls in provider knowledge and accountability, inadequate care coordination and support, lack of insurance, poorly aligned payment incen- 1 Formerly the Roundtable on Evidence-Based Medicine. xi

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xx CONTENTS Knowledge Synthesis and Translation That Need to Be Applied, 115 Richard A. Justman Methods That Need to Be Developed, 123 Eugene H. Blackstone, Douglas B. Lenat, and Hemant Ishwaran Coordination and Technical Assistance That Need to Be Supported, 144 Jean R. Slutsky 3 The Information Networks Required 153 Introduction, 153 Electronic Health Records: Needs, Status, and Costs for U.S. Healthcare Delivery Organizations, 155 Robert H. Miller Data and Information Hub Requirements, 163 Carol C. Diamond Integrative Vehicles Required for Evidence Review and Dissemination, 172 Lorne A. Becker 4 The Talent Required 191 Introduction, 191 Comparative Effectiveness Workforce— Framework and Assessment, 192 William R. Hersh, Timothy S. Carey, Thomas Ricketts, Mark Helfand, Nicole Floyd, Richard N. Shiffman, and David H. Hickam Toward an Integrated Enterprise—The Ontario, Canada, Case, 221 Danielle Whicher, Kalipso Chalkidou, Irfan Dhalla, Leslie Levin, and Sean R. Tunis 5 Implementation Priorities 241 Introduction, 241 Information Technology Platform Requirements, 242 Mark E. Frisse Data Resource Development and Analysis Improvement, 248 T. Bruce Ferguson, Jr., and Ansar Hassan Practical Challenges and Infrastructure Priorities for Comparative Effectiveness Research, 266 Daniel E. Ford Transforming Health Professions Education, 272 Benjamin K. Chu

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xxi CONTENTS Building the Training Capacity for a Health Research Workforce of the Future, 280 Steven A. Wartman and Claire Pomeroy Public–Private Partnerships, 293 Carmella A. Bocchino, Rachel E. Behrman, and William Z. Potter 6 Moving Forward 315 Introduction, 315 The Roadmap—Policies, Priorities, Strategies, and Sequencing, 316 Common Themes in Workshop Discussions, 318 Key Factors and Needs, 323 Quick Hits—Things That Can Be Done Now, 325 Appendixes* A Learning What Works Best: The Nation’s Need for Evidence on Comparative Effectiveness in Health Care 333 B Comparative Effectiveness Studies Inventory Project 439 C Comparative Effectiveness Research Priorities: IOM Recommendations (2009) 469 D Comparative Effectiveness Research Priorities: FCCCER Recommendations (2009) 511 E Affordable Care Act (ACA) (2010) Provisions for the Patient-Centered Outcomes Research Institute (PCORI) 519 F Workshop Agenda 541 G Biographical Sketches of Workshop Participants 549 H Workshop Attendee List 569 *Appendixes A-E are not printed in this book. They are available online at http://www.nap. edu/catalog.php?record_id=12214.

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Abbreviations and Acronyms AAAS American Association for the Advancement of Science AAP American Academy of Pediatrics AASHTO American Association of State Highway and Transportation Officials ACA Affordable Care Act (2010) ACC American College of Cardiology ACOG American Congress of Obstetricians and Gynecologists ADHD attention deficit hyperactivity disorder ADNI Alzheimer’s Disease Neuroimaging Initiative AF atrial fibrillation AHA American Heart Association or American Hospital Association AHC academic health center AHIP America’s Health Insurance Plans AHRQ Agency for Healthcare Research and Quality AIDS acquired immunodeficiency syndrome ALS amyotrophic lateral sclerosis AMA American Medical Association AMCP Academy of Managed Care Pharmacy AMD age-related macular degeneration AMI acute myocardial infarction AQA Ambulatory Care Quality Alliance ARRA American Recovery and Reinvestment Act ASC active surveillance culturing xxiii

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xxiv ABBREVIATIONS AND ACRONYMS BC Biomarkers Consortium BMI biomedical informatics BMS bare-metal stent CABG coronary artery bypass graft CADTH Canadian Agency for Drugs and Technologies in Health CARE ICDJ Querying Author about Definition CATIE Clinical Antipsychotic Trials in Intervention Effectiveness CCN Cardiac Care Network (Ontario) CCR Center for Cancer Research CDC Centers for Disease Control and Prevention CDMS chronic disease management system CDR Common Drug Review (Canada) CDRH Center for Devices and Radiological Health CDSR Cochrane Database of Systematic Reviews CE comparative effectiveness CEAP Committee for Assessment of Diagnostic and Therapeutic Procedures (France) CED coverage with evidence development CENTRAL Cochrane Central Register of Controlled Trials CEPP Committee for Assessment of Devices and Health Technologies (France) CER comparative effectiveness research CEVG Cochrane Eyes and Vision Group CHD coronary heart disease CI confidence interval CIHR Canadian Institutes of Health Research CIS clinical information system CMS Centers for Medicare & Medicaid Services CMTP Center for Medical Technology Policy CNS central nervous system COE Center for Outcomes and Evidence COMPUS Canadian Optimal Medication Prescribing and Utilization Service COPD chronic obstructive pulmonary disease COPR Council of Public Representatives COX cyclo oxygenase CPI Critical Path Initiative CPOE computerized physician order entry CPR computer-based patient record CPSC Consumer Product Safety Commission CRG Cochrane HIV/AIDS review group CRN Cancer Research Network

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xxv ABBREVIATIONS AND ACRONYMS CS computer science CT computed tomography CTSA Clinical and Translational Science Awards CTSC Clinical and Translational Science Center DAG directed acyclic graph DBS deep brain stimulation DCRI Duke Clinical Research Institute DEcIDE Developing Evidence to Inform Decisions about Effectiveness DERP Drug Effectiveness Review Project DES drug-eluting stent DHS Department of Homeland Security DNA deoxyribonucleic acid DOD Department of Defense DOE Department of Energy DSM Diagnostic and Statistical Manual of Mental Disorders EBM evidence-based medicine EC executive committee ECG electrocardiogram EHR electronic health record EMEA European Medicines Agency EMR electronic medical record EPC evidence-based practice center EUnetHTA European Network for Health Technology Assessment FDA Food and Drug Administration FDAAA FDA Amendments Act of 2007 FFRDC federally funded research and development center FNIH Foundation for the National Institutes of Health FOMC Federal Open Market Committee FTC Federal Trade Commission FTE full-time equivalent FY fiscal year G-BA Federal Joint Committee (Germany) GBS Guillain-Barré Syndrome GCGH Grand Challenges in Global Health GERD gastroesophageal reflux disease GIN Guidelines International Network GKS gamma knife surgery GPRD General Practices Research Data (United Kingdom)

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xxvi ABBREVIATIONS AND ACRONYMS GRADE Grading of Recommendations Assessment, Development, and Evaluation Working Group HAI hospital acquired infection HAS Haute Autorité de Santé (France) HCDS health care delivery system HECS highly effective clinical services HEI Health Effects Institute HER2 human epidermal growth factor receptor 2 HHS Department of Health and Human Services HIMSS Health Information Management Systems Society HIPAA Health Insurance Portability and Accountability Act HIT health information technology HIV human immunodeficiency virus HMO health maintenance organization HMORN HMO Research Network HQA Hospital Quality Alliance HR hazard ratio HRT hormone-replacement therapy HSI Homeland Security Institute HSR health services research HSRProj Health Services Research Projects in Progress HTA health technology assessment HVI Heart and Vascular Institute IC institute and center ICD implantable cardiac defibrillator ICER Institute for Clinical and Economic Review ICES Institute for Clinical Evaluative Sciences IDA Institute for Defense Analyses IH international health ILI influenza-like-illness INHATA International Network of Agencies for Health Technology Assessment IOM Institute of Medicine IQWiG Institute for Quality and Efficiency (Germany) IRB institutional review board ISO independent scientific organization IT information technology JHU Johns Hopkins University

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xxvii ABBREVIATIONS AND ACRONYMS LLNL Lawrence Livermore National Laboratory LVEF left ventricular ejection fraction MAS Medical Advisory Secretariat MCV meningococcal conjugate vaccine MEDCAC Medicare Evidence Development and Coverage Advisory Committee MedPAC Medicare Payment Advisory Commission MI myocardial infarction MIS management information systems MIT Massachusetts Institute of Technology MMA Medicare Prescription Drug, Improvement, and Modernization Act MOHLTC Ministry of Health and Long-Term Care (Ontario) MRI magnetic resonance imaging MRSA methicillin-resistant Staphylococcus aureus MSAC Medical Services Advisory Committee (Australia) NAE National Academy of Engineering NANSAID non-aspirin, non-steroidal anti-inflammatory drug NAS National Academy of Sciences NC2D National Consortium of Clinical Databases NCCN National Cancer Care Network NCHRP National Cooperative Highway Research Program NCHS National Center for Health Statistics NCI National Cancer Institute NDAI National Data Aggregation Initiative NGO nongovernmental organization NHLBI National Heart, Lung, and Blood Institute NHS National Health Service (United Kingdom) NICE National Institute for Health and Clinical Excellence (United Kingdom) NIH National Institutes of Health NMCES National Medical Care Expenditure Survey NNSA National Nuclear Security Administration NRC National Research Council NRT nicotine replacement therapy NSAID non-steroidal anti-inflammatory drug NSF National Science Foundation NYHA New York Heart Association NYU New York University

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xxviii ABBREVIATIONS AND ACRONYMS OAI Osteoarthritis Initiative ODE-I Office of Drug Evaluation I OFPP Office of Federal Procurement Policy OHSU Oregon Health and Science University OHTAC Ontario Health Technology Assessment Committee OS Office of the Secretary OSD Office of the Secretary of Defense OSTP Office of Science and Technology Policy OTA Office of Technology Assessment OTC over-the-counter PACS Picture Archiving and Communication System PATH Program for the Assessment of Technology in Health PBAC Pharmaceutical Benefits Advisory Committee (Australia) PCI percutaneous coronary intervention PCORI Patient-Centered Outcomes Research Institute PCR polymerase chain reaction PDUFA Prescription Drug Use Fee Act PET positron emission tomography POC point of care PPP public–private partnership PSA prostate-specific antigen PSAC Priority Setting Advisory Committee PTSD post-traumatic stress disorder QI quality improvement QIO quality improvement organization R&D research and development RCT randomized controlled trial or randomized clinical trial RNI radionuclide imaging RWJF Robert Wood Johnson Foundation S&T science and technology SBU Swedish Council on Technology Assessment in Health Care SEER Surveillance, Epidemiology and End Results SES socioeconomic status SHRPII Strategic Highway Research Programs II SNOMED Systematized Nomenclature of Medicine SPARQL SPARQL Protocol and RDF Query Language SSNDI Social Security National Death Index SSRI selective serotonin reuptake inhibitor STEMI ST-segment elevation myocardial infarction

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xxix ABBREVIATIONS AND ACRONYMS STPI Science and Technology Policy Institute STS Society of Thoracic Surgeons SUNY State University of New York TAB Technology Assessment Board TAPP transabdominal pre-peritoneal TCA tricyclic antidepressant TEC Technology Evaluation Center TEP totally extraperitoneal TGA Therapeutic Goods Administration (Australia) THETA Toronto Health Economics and Technology Assessment Collaboration tPA tissue plasminogen activator TRB Transportation Research Board UAB University of Alabama at Birmingham UC University of California UMLS unified medical language system UNC University of North Carolina URI upper respiratory infection USPSTF U.S. Preventive Services Task Force USQA U.S. Quality Algorithms USRDS U.S. Renal Data System VA Department of Veterans Affairs VATAP VA Technology Assessment Program VBID value-based insurance design VHA Veterans Health Administration VSD Vaccine Safety Datalink WHO World Health Organization

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