Data Sharing and Embedded Research
Authors: Gregory E. Simon, Gloria Coronado, Lynn L. DeBar, Laura M. Dember, Beverly B. Green, Susan S. Huang, Jeffrey G. Jarvik, Vincent Mor, Joakim Ramsberg, Edward J. Septimus, Karen L. Staman, Miguel A. Vazquez, William M. Vollmer, Douglas Zatzick, Adrian F. Hernandez, Richard Platt
Journal: Annals of Internal Medicine (2017)

Ideas and Opinions7 November 2017Data Sharing and Embedded ResearchGregory E. Simon, MD, MPH, Gloria Coronado, PhD, Lynn L. DeBar, PhD, MPH, Laura M. Dember, MD, Beverly B. Green, MD, MPH, Susan S. Huang, MD, MPH, Jeffrey G. Jarvik, MD, MPH, Vincent Mor, PhD, Joakim Ramsberg, PhD, Edward J. Septimus, MD, Karen L. Staman, MS, Miguel A. Vazquez, MD, William M. Vollmer, PhD, Douglas Zatzick, MD, Adrian F. Hernandez, MD, MHS, and Richard Platt, MD, MSGregory E. Simon, MD, MPHFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Gloria Coronado, PhDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Lynn L. DeBar, PhD, MPHFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Laura M. Dember, MDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Beverly B. Green, MD, MPHFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Susan S. Huang, MD, MPHFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Jeffrey G. Jarvik, MD, MPHFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Vincent Mor, PhDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Joakim Ramsberg, PhDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Edward J. Septimus, MDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Karen L. Staman, MSFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Miguel A. Vazquez, MDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, William M. Vollmer, PhDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Douglas Zatzick, MDFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, Adrian F. Hernandez, MD, MHSFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this author, and Richard Platt, MD, MSFrom Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-0863 Annals Author Insight Video - Gregory E. Simon, MD, MPH In this video, Gregory E. Simon, MD, MPH, offers additional insight into the article, "Data Sharing and Embedded Research." SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Sharing of data from clinical trials has the potential to increase transparency and reproducibility in medical research, enable secondary analyses, decrease selective reporting, and accelerate translation of high-quality evidence into clinical care (1–3). Several solutions have been proposed to encourage the sharing of analyzable research data sets (4–8); however, the conceptual framework is rooted in explanatory clinical trials, which typically obtain explicit informed consent from participants and collect research-specific data focused on a narrow range of outcomes. Pragmatic research embedded in health systems often involves different data sources and data collection methods: It often involves a waiver of patient consent; ...References1. Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Pr; 2015. Google Scholar2. Warren E. Strengthening research through data sharing. N Engl J Med. 2016;375:401-3. [PMID: 27518656] doi:10.1056/NEJMp1607282 CrossrefMedlineGoogle Scholar3. Krumholz HM, Terry SF, Waldstreicher J. Data acquisition, curation, and use for a continuously learning health system. JAMA. 2016;316:1669-70. [PMID: 27668668] doi:10.1001/jama.2016.12537 CrossrefMedlineGoogle Scholar4. Taichman DB, Backus J, Baethge C, et al. Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med. 2016;164:505-6. [PMID: 26792258]. doi:10.7326/M15-2928 LinkGoogle Scholar5. Krumholz HM, Ross JS, Gross CP, et al. A historic moment for open science: the Yale University Open Data Access project and medtronic [Editorial]. Ann Intern Med. 2013;158:910-1. [PMID: 23778908]. doi:10.7326/0003-4819-158-12-201306180-00009 LinkGoogle Scholar6. Patel MR, Armstrong PW, Bhatt DL, et al; Academic Research Organization Consortium for Continuing Evaluation of Scientific Studies—Cardiovascular (ACCESS CV). Sharing data from cardiovascular clinical trials—a proposal. N Engl J Med. 2016;375:407-9. [PMID: 27518659] doi:10.1056/NEJMp1605260 CrossrefMedlineGoogle Scholar7. Pencina MJ, Louzao DM, McCourt BJ, et al. Supporting open access to clinical trial data for researchers: the Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative. Am Heart J. 2016;172:64-9. [PMID: 26856217] doi:10.1016/j.ahj.2015.11.002 CrossrefMedlineGoogle Scholar8. OPTUM Labs. 2017. Accessed at www.optumlabs.com on 17 May 2017. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Kaiser Permanente Washington Health Research Institute, University of Washington, and University of Washington School of Medicine, Seattle, Washington; Kaiser Permanente Center for Health Research, Portland, Oregon; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; University of California, Irvine School of Medicine, Orange, California; Brown University, Providence, Rhode Island;Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts; Hospital Corporation of America, Nashville, Tennessee; Texas A&M College of Medicine, Houston, Texas; CHB Wordsmith, Raleigh, North Carolina; University of Texas Southwestern Medical Center, Dallas, Texas; and Duke University School of Medicine, Durham, North Carolina.Disclaimer: The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the NIH, the U.S. Department of Health and Human Services, or any of its agencies.Grant Support: By a cooperative agreement (U54 AT007748) from the NIH Common Fund for the Coordinating Center of the NIH Health Care Systems Research Collaboratory and by the following NIH grants for the pragmatic trial demonstration projects: UH2 AT007797, UH3 DK102384 (TiME), UH2 MH106338-02, UH3 MH106338-02 (TSOS), UH3 AT007769 (ABATE), UH3 NS088731-02, UH3 AT007788-02 (PPACT), UH2 DK104655-02, UH3 DK104655-02 (ICD-Pieces), UH2 AT007766-01, UH3 AR066795 (LIRE), UH2 AG049619-02, UH3 AG049619-02 (PROVEN), UH3 AT007782-02, UH3 CA188640-02 (STOP CRC), and UH2 AT007755-01 (SPOT).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0863.Corresponding Author: Gregory Simon, MD, MPH, Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, #1600, Seattle, WA 98101; e-mail, simon.[email protected]org.Current Author Addresses: Drs. Simon and Green: Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, #1600, Seattle, WA 98101.Drs. Coronado, DeBar, and Vollmer: Kaiser Permanente Center for Health Research, 3800 North Interstate Avenue, Portland, OR 97227.Dr. Dember: Perelman School of Medicine, Blockley Hall, Office 920, 423 Guardian Drive, Philadelphia, PA 19104.Dr. Huang: University of California, Irvine School of Medicine, 101 The City Drive South, City Tower, Suite 400, Mail Code 4081, Orange, CA 92868.Drs. Jarvik and Zatzick: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Box 359728, 325 Ninth Avenue, Seattle, WA 98104.Dr. Mor: Brown University, Department of Community Health, Box G-S121-2, Providence, RI 02912.Drs. Ramsberg and Platt: Harvard Pilgrim Health Care Institute and Harvard Medical School, Department of Population Medicine, 401 Park Drive, Suite 401 East, Boston, MA 02215.Dr. Septimus: Texas A&M College of Medicine, 6431 Fannin Street, MSE R.234, Houston, TX 77030.Ms. Staman: CHB Wordsmith, Inc., 22 Bagwell Avenue, Raleigh, NC 27607.Dr. Vazquez: University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390.Dr. Hernandez: Duke University School of Medicine, 3116 North Duke Street, Durham, NC 27704.Author Contributions: Conception and design: G.E. Simon, L.L. DeBar, L.M. Dember, B.B. Green, V. Mor, E.J. Septimus, K.L. Staman, W.M. Vollmer, A.F. Hernandez, R. Platt.Analysis and interpretation of the data: G.E. Simon, L.L. DeBar, L.M. Dember, B.B. Green, E.J. Septimus, M.A. Vazquez, A.F. Hernandez, R. Platt.Drafting of the article: G.E. Simon, L.L. DeBar, J. Ramsberg, E.J. Septimus, K.L. Staman, M.A. Vazquez, R. Platt.Critical revision for important intellectual content: G.E. Simon, G. Coronado, L.L. DeBar, L.M. Dember, B.B. Green, S.S. Huang, J.G. Jarvik, V. Mor, E.J. Septimus, K.L. Staman, M.A. Vazquez, W.M. Vollmer, A.F. Hernandez, R. Platt.Final approval of the article: G.E. Simon, G. Coronado, L.L. DeBar, L.M. Dember, B.B. Green, S.S. Huang, J.G. Jarvik, V. Mor, J. Ramsberg, E.J. Septimus, K.L. Staman, M.A. Vazquez, W.M. Vollmer, D. Zatzick, A.F. Hernandez, R. Platt.Provision of study materials or patients: J.G. Jarvik, E.J. Septimus, D. Zatzick.Obtaining of funding: L.M. Dember, B.B. Green, J.G. Jarvik, A.F. Hernandez.Administrative, technical, or logistic support: K.L. Staman, A.F. Hernandez.Collection and assembly of data: L.M. Dember, J.G. Jarvik, E.J. Septimus, A.F. Hernandez.This article was published at Annals.org on 3 October 2017. PreviousarticleNextarticle Advertisement Annals Author Insight Video - Gregory E. Simon, MD, MPH In this video, Gregory E. Simon, MD, MPH, offers additional insight into the article, "Data Sharing and Embedded Research." FiguresReferencesRelatedDetails Metrics Cited byEthical issues in biomedical research using electronic health records: a systematic reviewReal‐world evidence to support regulatory decision making: New or expanded medical product indicationsBalancing professional obligations and risks to providers in learning healthcare systemsWhen Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?Data Access CommitteesAnalysis of data dictionary formats of HIV clinical trialsUsing Healthcare Data in Embedded Pragmatic Clinical Trials among People Living with Dementia and Their Caregivers: State of the ArtA framework to build similarity-based cohorts for personalized treatment advice – a standardized, but flexible workflow with the R package SimBaCoPrivacy-protecting multivariable-adjusted distributed regression analysis for multi-center pediatric studyAnalytic and Data Sharing Options in Real‐World Multidatabase Studies of Comparative Effectiveness and Safety of Medical ProductsPrinciples and procedures for data and safety monitoring in pragmatic clinical trialsThe TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration 7 November 2017Volume 167, Issue 9Page: 668-670KeywordsArchivesClinical trialsDisclosureElectronic medical recordsHealth careHealth care facilitiesHealth care providersHealth information technologyInformation storage and retrievalPrevention, policy, and public health ePublished: 3 October 2017 Issue Published: 7 November 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...