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Living Textbook of
Pragmatic Clinical Trials

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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures
20 events found.

Grand Rounds Archives

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  2. Grand Rounds Archives

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  • July 2017

  • Fri 7

    July 7 Grand Rounds: Ethics and the Precision Medicine Initiative: Reflections from Working on the CentralPMI IRB (Nancy Kass, ScD)

    Featured July 7, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Nancy Kass, ScD Phoebe R. Berman Professor of Bioethics and Public Health Johns Hopkins Berman Institute of Bioethics Johns Hopkins Bloomberg School of Public Health Topic: Ethics and the Precision […]

  • Fri 28

    Grand Rounds: July 28: The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges (Galia Siegel, PhD; Anna Ordonez, MD, MAS; Scott Kim, MD, PhD; Kate Comtois, PhD, MPH)

    Featured July 28, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speakers: Galia Siegel, PhD Clinical Trials Program Coordinator Clinical Trials Operations and Biostatistics Branch Office of Clinical Research National Institute of Mental Health, NIH Anna E. Ordóñez, MD, MAS Deputy […]

  • August 2017

  • Fri 11

    Grand Rounds: August 11: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience (Gordon Bernard, MD)

    Featured August 11, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Gordon R. Bernard, MD Melinda Owen Bass Professor of Medicine Executive Vice President for Research Director, Vanderbilt Institute for Clinical and Translational Research Vanderbilt University Medical Center Topic: Embedding Clinical […]

  • Fri 18

    Grand Rounds: August 18: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes (Charlene Wong, MD)

    Featured August 18, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Charlene Wong, MD Assistant Professor Department of Pediatrics Duke Clinical Research Institute Margolis Center for Health Policy Duke University Topic: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental […]

  • Fri 25

    Grand Rounds August 25: Update and Thoughts from the Phenotypes, Data Standards, and Data Quality Core of the NIH HCS Research Collaboratory (Rachel Richesson, PhD, MPH)

    Featured August 25, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachel Richesson, PhD, MPH Associate Professor Duke University School of Nursing Topic: Update and Thoughts from the Phenotypes, Data Standards, and Data Quality Core of the NIH HCS Research Collaboratory Date: Friday, August 25, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) […]

  • September 2017

  • Fri 8

    Grand Rounds September 8: Leveraging Informatics in Pragmatic Research: Initial Experience in PCORnet (Russell Rothman, MD, MPP)

    Featured September 8, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Russell Rothman, MD, MPP Professor, Internal Medicine, Pediatrics, & Health Policy Vice President for Population Health Research Director, Center for Health Services Research Vanderbilt University Medical Center Topic: Leveraging Informatics in Pragmatic Research: Initial Experience in PCORnet Date: Friday, September 8, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate […]

  • Fri 15

    Grand Rounds September 15, 2017: Who to Include in a Pragmatic Trial? It Depends (Greg Simon, MD; Laura Dember, MD)

    Featured September 15, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Laura Dember, MD Professor of Medicine University of Pennsylvania Perelman School of Medicine Topic: Who to Include […]

  • Fri 22

    Grand Rounds September 22: Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST) (Rachael Fleurence, PhD)

    Featured September 22, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachael Fleurence, PhD Executive Director NEST Coordinating Center Medical Device Innovation Consortium (MDIC) Topic: Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST) […]

  • Fri 29

    Grand Rounds September 29: Preprints: What, Why Not and How (Harlan M. Krumholz, MD)

    Featured September 29, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Harlan M. Krumholz, MD Harold H. Hines, Jr. Professor of Medicine Yale University School of Medicine Director, Center for Outcomes Research and Evaluation Yale-New Haven Health System Founder, Hugo […]

  • October 2017

  • Fri 6

    Grand Rounds October 6: Health Is More Than Healthcare (Karen B. DeSalvo, MD, MPH, MSc)

    Featured October 6, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Karen DeSalvo, MD, MPH, MSc Former US HSS Acting Assistant Secretary for Health, National Coordinator for Health Information Technology Topic: Health Is More Than Healthcare Date: Friday, October 6, […]

  • Fri 13

    Grand Rounds October 13: Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records (Claire Snyder, PhD; Albert Wu, MD, MPH)

    Featured October 13, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Claire Snyder, PhD Professor of Medicine, Oncology, and Health Policy & Management Johns Hopkins Schools of Medicine and Public Health Albert W. Wu, MD, MPH, FACP Professor and Director […]

  • Fri 20

    Grand Rounds October 20: Automated Public Health Surveillance Using Electronic Health Record Data (Michael Klompas MD, MPH, FIDSA, FSHEA)

    Featured October 20, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Michael Klompas, MD, MPH, FIDSA, FSHEA Associate Professor Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA Topic: Automated Public Health Surveillance Using Electronic […]

  • November 2017

  • Fri 10

    Grand Rounds November 10: No Presentation (Veterans Day Holiday Weekend)

    November 10, 2017
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    There will be no Grand Rounds presentation November 10, 2017 in observance of Veterans Day.  We hope to see you next week for "ICD-Pieces:  From Planning to Performance" by Miguel […]

  • Fri 17

    Grand Rounds November 17: ICD-Pieces: From Planning to Performance (Miguel A. Vazquez, MD; George Oliver, MD)

    Featured November 17, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Miguel A. Vazquez, MD Professor of Medicine Clinical Chief Nephrology Division UT Southwestern Medical Center George Oliver, MD Vice President Clinical Informatics Parkland Center for Clinical Innovation Topic: ICD-Pieces:  […]

  • December 2017

  • Fri 8

    Grand Rounds December 8, 2017: Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH; Jeremy Sugarman, MD, MPH, MA; Susan Ellenberg, PhD)

    Featured December 8, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine Johns Hopkins Berman Institute of Bioethics Susan S. Ellenberg, PhD Professor of Biostatistics Professor of Medical Ethics and Health Policy Department of Biostatistics, Epidemiology and Informatics, Perelman School of […]

  • Fri 15

    Grand Rounds December 15: Does Machine Learning Have a Place in a Learning Health System? (Michael Pencina, PhD)

    Featured December 15, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Michael Pencina, PhD Professor of Biostatistics and Bioinformatics, Duke University Director of Biostatistics Duke Clinical Research Institute Topic: Does machine learning have a place in a learning health system Date: Friday, December 15, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich […]

  • January 2018

  • Fri 5

    Grand Rounds January 5: IMPACT-AFib: An 80,000 person Randomized Trial Using the Sentinel Initiative Platform (Noelle M. Cocoros, DSc, MPH; Christopher B. Granger, MD, FACC, FAHA; Richard Platt MD, MS; Sean Pokorney, MD)

    Featured January 5, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Noelle M. Cocoros, DSc, MPH Epidemiologist, Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Christopher B. Granger, MD, FACC, FAHA Professor of Medicine, Duke University Director, Cardiac Care Unit Duke University Medical Center Richard Platt, MD, MS Professor and Chair, Department of Population Medicine Harvard Medical School and Harvard […]

  • Fri 12

    Grand Rounds January 12: Behavioral Economic Principles to Understand and Change Clinician Behavior (Jeffrey A. Linder, MD, MPH, FACP)

    Featured January 12, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Jeffrey A. Linder, MD, MPH, FACP Chief, Division of General Internal Medicine and Geriatrics Michael A. Gertz Professor of Medicine Northwestern University Feinberg School of Medicine Topic: Behavioral Economic Principles to Understand and Change Clinician Behavior Date: Friday, January 12, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players […]

  • Fri 26

    Grand Rounds January 26: The Lumbar Imaging with Reporting of Epidemiology (LIRE) Trial: Subsequent Cross-Sectional Imaging Through 90 Days- Preliminary Results (Jeffrey Jarvik, MD, MPH; Patrick Heagerty, PhD)

    Featured January 26, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Jeffrey (Jerry) G. Jarvik MD MPH Professor, Radiology, Neurological Surgery and Health Services Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine Co-Director, Comparative Effectiveness, Cost and Outcomes Research Center Director, UW CLEAR Center for Musculoskeletal Disorders University of Washington Patrick J. Heagerty PhD Gilbert S. Omenn Endowed Chair in Biostatistics Professor and Chair, Department of Biostatistics University […]

  • February 2018

  • Fri 16

    Grand Rounds February 16: Considerations for the Return of Genomic Results (Heidi Rehm, PhD, FACMG; W. Andrew Faucett, MS, LGC)

    Featured February 16, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Heidi Rehm, PhD, FACMG Associate Professor of Pathology Brigham & Women's Hospital and Harvard Medical School W. Andrew (Andy) Faucett, MS, LGC Professor Director of Policy and Education Office of the Chief Scientific Officer Geisinger Topic: Considerations for the Return of Genomic Results Date: Friday, February 16, 2018, 1:00-2:00 p.m. ET Meeting Info: To […]

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