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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
10 events found.

Events

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  • March 2023

  • Fri 24

    Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

    March 24, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Erin Holve, PhD, MPH, MPP Chief Research Infrastructure Officer, Patient-Centered Outcomes Research Institute (PCORI) Russell Rothman. MD, MPP Director Institute for Medicine and Public Health and Senior Vice President, Population and Public Health, Vanderbilt University Medical Center Schuyler Jones, MD, Associate Professor, Duke Clinical Research Institute and Population Health Sciences, Duke University School of […]

  • Fri 31

    Grand Rounds March 31, 2023: Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA): Results From A Randomized Controlled Trial (Jody D. Ciolino, PhD)

    March 31, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Jody D. Ciolino, PhD Associate Professor Director, Master of Science in Biostatistics Department of Preventive Medicine – Biostatistics Biostatistics Collaboration Center (BCC) / Northwestern University Data Analysis and Coordinating Center (NUDACC) Northwestern University Feinberg School of Medicine Topic: Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA): Results From A Randomized […]

  • April 2023

  • Fri 7

    Grand Rounds April 7, 2023: A Nudge Towards Cardiovascular Health: Incorporating Insights from Behavioral Science to Improve Cardiovascular Care Delivery (Srinath Adusumalli, MD, MSHP, MBMI, FACC)

    April 7, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Srinath Adusumalli, MD, MSHP, MBMI, FACC Adjunct Assistant Professor of Medicine Adjunct Professor of Healthcare Management Perelman School of Medicine and The Wharton School University of Pennsylvania Senior Medical Director, Enterprise Virtual Care and Retail Health CVS Health Topic: A Nudge Towards Cardiovascular Health: Incorporating Insights from Behavioral Science to Improve Cardiovascular Care Delivery […]

  • Fri 14

    Grand Rounds April 14, 2023: RECOVER in Action: Status of Clinical Trial Protocols (Kanecia Zimmerman, MD, PhD, MPH)

    April 14, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Kanecia Zimmerman, MD, PhD, MPH Associate Professor of Pediatrics Duke Clinical Research Institute Duke University School of Medicine Topic: RECOVER in Action: Status of Clinical Trial Protocols Date: Friday, April 14, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 5365 9804 Passcode: 12345 […]

  • Fri 21

    Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD, MSc)

    April 21, 2023 @ 1:00 pm - 2:00 pm

    Speakers: Amit Garg, MD, MA (Education) FRCPC, FACP, PhD Associate Dean, Clinical Research, Schulich School of Medicine and Dentistry Past President, Canadian Society of Nephrology Lead, Institute for Clinical Evaluative Sciences Kidney, Dialysis and Transplantation Provincial Program Director, Institute for Clinical Evaluative Sciences (ICES) Western Facility Nephrologist, London Health Sciences Centre Professor, Medicine, Epidemiology & […]

  • Fri 28

    Grand Rounds April 28, 2023: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial (Matthew W. Semler, MD, MSc)

    April 28, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Matthew W. Semler, M.D., M.Sc. Assistant Professor of Medicine and Biomedical Informatics Medical Director, VICTR Center for Learning Healthcare Vanderbilt University Medical Center Topic: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial Date: Friday, April 28, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting […]

  • May 2023

  • Fri 5

    Grand Rounds May 5, 2023: All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine (Joshua C. Denny, MD, MS)

    May 5, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Joshua C. Denny, MD, MS CEO, All of Us Research Program National Institutes of Health Bethesda, MD Topic: All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine Date: Friday, May 5, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting […]

  • Fri 12

    Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. Koopman, MD, MS)

    May 12, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Richelle J. Koopman, MD, MS Professor and Vice Chair for Research and Faculty Affairs Jack M. and Winifred S. Colwill Endowed Professor Department of Family and Community Medicine University of Missouri Topic: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension Date: Friday, May 12, […]

  • Fri 19

    Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

    May 19, 2023 @ 1:00 pm - 2:00 pm

    Speaker: Robert O’Toole, MD Chief of Orthopaedics, R Adams Cowley Shock Trauma Center Head, Division of Orthopaedic Trauma Department of Orthopaedics Director, Clinical Research, Department of Orthopaedics University of Maryland School of Medicine Topic: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture Date: Friday, May 19, 2023, 1:00-2:00 p.m. ET To join the online […]

  • June 2023

  • Fri 2

    Grand Rounds June 2, 2023: PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

    June 2, 2023 @ 1:00 pm - 2:00 pm

    Speaker: John Alexander, MD, MHS Professor of Medicine/Cardiology DCRI/Duke University Topic: PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial Date: Friday, June 2, 2023, 1:00-2:00 p.m. ET To join the online meeting: Click the Zoom Meeting link below: https://duke.zoom.us/j/96153659804?pwd=VmNJVDE5VmtFbUFHY0lZeTM1K0Y5QT09 Meeting ID: 961 5365 9804 Passcode: 12345 One […]

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