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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
28 events found.

Events

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  • August 2018

  • Fri 17

    Grand Rounds August 17: The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet NIH Collaboratory Trial

    August 17, 2018 @ 1:00 pm - 2:00 pm

    Speakers: David Arterburn, MD, MPH Kaiser Permanente Washington Kathleen McTigue, MD, MPH University of Pittsburgh Medical Center Neely Williams, Mdiv Patient Collaborator, Mid-South CDRN Laura Rasmussen-Torvik, PhD Northwestern Medicine Topic: The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet NIH Collaboratory Trial Date: Friday, August 17, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether […]

  • Fri 24

    Grand Rounds August 24: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research

    August 24, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Mark Huffman, MD, MPH Associate Professor of Preventive Medicine and Medicine-Cardiology Northwestern University Feinberg School of Medicine Topic: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research Date: Friday, August 24, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich […]

  • September 2018

  • Fri 7

    Grand Rounds September 7: NIH Collaboratory: Research Transformation in Progress

    September 7, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University School of Medicine Kevin Weinfurt, PhD Professor and Vice Chair for Research Department of […]

  • Fri 14

    Grand Rounds September 14: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

    September 14, 2018 @ 1:00 pm - 2:00 pm

    Speakers: John Hubbard, Ph.D., FCP Strategic Advisory Board, Genstar Capital Barry Peterson, Ph.D Independent Consultant Cheryl A. Grandinetti, Pharm.D. Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance […]

  • Fri 21

    Grand Rounds September 21: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm

    September 21, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey R. Botkin, M.D., M.P.H. Associate Vice President for Research Professor of Pediatrics University of Utah School of Medicine Consuelo H. Wilkins, M.D., MSCI Associate Professor of Medicine Vanderbilt […]

  • Fri 28

    Grand Rounds September 28: Assessing and reducing risk of re-identification when sharing sensitive research datasets

    September 28, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Gregory Simon MD, MPH Investigator Kaiser Permanente Washington Health Research Institute Deven McGraw, JD, MPH, LLM General Counsel & Chief Regulatory Officer Ciitizen (former HIPAA Deputy Director, HHS Office […]

  • October 2018

  • Fri 5

    Grand Rounds October 5: Testing New Atrial Fibrillation Screening Methods at Scale

    October 5, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Mintu Turakhia MD, MAS Associate Professor of Medicine. Stanford University Executive Director, Stanford Center for Digital Health Director of Cardiac Electrophysiology, VA Palo Alto Healthcare System Marco Perez MD […]

  • Fri 12

    Grand Rounds October 12: MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and Patients

    October 12, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Renee Mitchell, MT(ASCP), CLS(NCA) Regulatory Affairs Boston Scientific Corporation, Inc. Terrie Reed, MSIE Senior Advisor for UDI Adoption US Food and Drug Administration (FDA) Roseann White, MA Director of […]

  • Fri 19

    Grand Rounds October 19: A New Path Forward for Using Decentralized Clinical Trials

    October 19, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Annemarie Forrest Clinical Trials Transformation Initiative (CTTI) Penny Randall, MD, MBA VP and Global Therapeutic Head, CNS, IQVIA Jeffry Florian, PhD Clinical Analyst, Office of New Drugs, FDA CDER […]

  • Fri 26

    Grand Rounds October 26: Making Measurements Meaningful

    October 26, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Brian J. Zikmund-Fisher, Ph.D. Associate Professor of Health Behavior and Health Education University of Michigan Associate Director of the UM Center for Bioethics and Social Sciences in Medicine Topic: […]

  • November 2018

  • Fri 2

    Grand Rounds November 2: EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

    November 2, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Ted Melnick, MD, MHS Assistant Professor of Emergency Medicine Program Director, ACGME Clinical Informatics Fellowship Yale School of Medicine Gail D’Onofrio, MD Professor and Chair of Emergency Medicine, Yale […]

  • Tue 6

    DCRI Research Forum: Dr. Jeffrey Jarvik on Lumbar Imaging with Reporting of Epidemiology (LIRE)

    November 6, 2018 @ 12:00 pm - 1:00 pm

    DCRI Research Forum  Dr. Jeffrey Jarvik on Lumbar Imaging with Reporting of Epidemiology (LIRE)  12:00 pm | Eastern Daylight Time (New York, GMT-04:00) | 1 hr. Meeting number (access code): 732 […]

  • Fri 9

    Grand Rounds November 9: Data Linkage Within, Across, and Beyond PCORnet

    November 9, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Thomas W. Carton, PhD, MS Chief Data Officer, Louisiana Public Health Institute PI, REACHnet Keith Marsolo, PhD Instructor Department of Population Health Sciences Duke University School of Medicine Topic: […]

  • Fri 16

    Grand Rounds November 16: Primary Palliative Care for Emergency Medicine (PRIM-ER)

    November 16, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Corita R. Grudzen, MD, MSHS, FACEP Vice Chair for Research Associate Professor of Emergency Medicine and Population Health Ronald O. Perelman Department of Emergency Medicine NYU School of Medicine […]

  • Fri 23

    Grand Rounds November 23rd: No Presentation (Week of Thanksgiving)

    November 23, 2018 @ 1:00 pm - 2:00 pm

    Grand Rounds July 6th: No Presentation (In observance of the Thanksgiving holiday) We hope to see you next week.

  • Fri 30

    Grand Rounds November 30: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome?

    November 30, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Gregory E Simon MD MPH Senior Investigator, Kaiser Permanente Washington Health Research Institute Susan M. Shortreed, PhD Associate Investigator Biostatistics Unit, Kaiser Permanente Washington Health Research Institute Topic: Validating […]

  • December 2018

  • Fri 7

    Grand Rounds December 7: Cluster randomized trials in health care delivery systems: lessons from STIC2IT

    December 7, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Niteesh K. Choudhry, MD, PhD Professor, Harvard Medical School Executive Director, Center for Healthcare Delivery Sciences, Brigham and Women’s Hospital Topic: Cluster randomized trials in health care delivery systems: […]

  • Fri 14

    Grand Rounds December 14: Guiding Good Choices for Health (GGC4H): Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems

    December 14, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Richard F. Catalano, PhD, MPI GGC4H Co-Founder, Social Development Research Group Professor, School of Social Work University of Washington Margaret Kuklinski, PhD, MPI GGC4H Research Scientist Social Development Research […]

  • Fri 21

    Grand Rounds December 21: No Presentation (Week before Christmas Holiday)

    December 21, 2018 @ 1:00 pm - 2:00 pm

    Grand Rounds December 21: No Presentation (In observance of Christmas holiday)  

  • Fri 28

    Grand Rounds December 28: No Presentation (New Year’s Holiday)

    December 28, 2018 @ 1:00 pm - 2:00 pm

    Grand Rounds December 28th: No Presentation (In observance of New Year's holiday) We hope to see you next week.

  • January 2019

  • Fri 4

    Grand Rounds January 4: TRANSFORMing Research for Patients With Heart Failure

    January 4, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Robert J. Mentz, MD Associate Professor of Medicine Duke University School of Medicine Kevin J. Anstrom, PhD Professor of Biostatistics and Bioinformatics Director of Biostatistics, Duke Clinical Research Institute […]

  • Fri 11

    Grand Rounds January 11: Nudge: Text Messaging at Scale in Diverse Health Systems to Support Adherence to Cardiac Medication

    January 11, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Sheana Bull, PhD, MPH Professor, Colorado School of Public Health Director, mHealth Impact Lab Michael Ho, MD, PhD Professor of Medicine, University of Colorado School of Medicine & Staff […]

  • Fri 18

    Grand Rounds January 18: Pragmatic Trials in End-stage Renal Disease (ESRD): HiLo

    January 18, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Myles Wolf, MD, MMSc Charles Johnson, MD Professor of Medicine Chief, Duke Nephrology Duke University School of Medicine Topic: Pragmatic Trials in end-stage renal disease(ESRD): HiLo Date: Friday, January 18, […]

  • Fri 25

    Grand Rounds January 25: A Learning Health System Story: Perinatal Outcomes Associated with a Major Change in Gestational Diabetes Screening

    January 25, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Sascha Dublin, MD PhD Senior Investigator Kaiser Permanente Washington Health Research Institute Gaia Pocobelli, PhD Research Associate Kaiser Permanente Washington Health Research Institute Topic: A Learning Health System Story: […]

  • February 2019

  • Fri 1

    Grand Rounds February 1: Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial

    February 1, 2019 @ 1:00 pm - 2:00 pm

    Speakers: James Tulsky, MD Chair, Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute Professor of Medicine, Harvard Medical School Chief, Division of Palliative Medicine, Brigham and Women’s Hospital […]

  • Fri 8

    Grand Rounds February 8: Paramedic Airway Management in Out-of-Hospital Cardiac Arrest – The Pragmatic Airway Resuscitation Trial (PART)

    February 8, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Henry E. Wang, MD, MS Professor and Vice Chair for Research Department of Emergency Medicine University of Texas Health Science Center at Houston Topic: Paramedic Airway Management in Out-of-Hospital […]

  • Fri 15

    Grand Rounds February 15: Improving Qualification of Investigators: Recommendations from the Clinical Trials Transformation Initiative

    February 15, 2019 @ 1:00 pm - 2:00 pm

    Speakers: Christine M. Hildebrand, PA-C Physician Assistant Sub Investigator Clinical Operations Lead Amici Clinical Research Janette Panhuis Chief Operating Officer, Population Health Research Institute David Braley Research Institute Topic: Improving […]

  • Fri 22

    Grand Rounds February 22: Going from a Learning Health System to Learning Health Units: Opportunities and Challenges

    February 22, 2019 @ 1:00 pm - 2:00 pm

    Speaker: Adrian F. Hernandez, MD MHS Vice Dean for Clinical Research Duke University School of Medicine Topic: Going from a Learning Health System to Learning Health Units: Opportunities and Challenges […]

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