training

Design and Analysis of Embedded Pragmatic Clinical Trials: NIH-Hosted Workshop (May 2019)

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May 2, 2019: This NIH-hosted workshop included panel discussions on the challenges in the design and analysis of ePCTs.

Workshop Summary

Agenda and Slides

Welcome and Introduction

Helene Langevin, MD
Richard Hodes, MD
Catherine Meyers, MD
Wendy Weber, ND, PhD, MPH

Keynote: Pragmatic Trials Involving Group Randomization or Delivery of Interventions to Groups: GRTs, IRGTs, and SW-GRTs

David Murray, PhD

Panel 1: Measurement and Data: Outcomes, Exposures, and Subgroups Based on EHR Data

Moderator: Rui Wang, PhD

Panel:

    • Pragmatic Trial of Video Education in Nursing Homes (PROVEN) (Vince Mor, PhD; Roee Gutman, PhD)
    • STrategies to Reduce Injuries and Develop confidence in Elders (STRIDE) (Nancy Latham, PhD, PT; Dave Ganz, MD, MPH; Peter Peduzzi, PhD)
    • Active Bathing to Eliminate (ABATE) Infection (Susan Huang, MD, MPH; Ken Kleinman, ScD)

Panel 2: To Cluster or Not to Cluster?

Moderator: Keith Goldfeld, DrPH

Panel:

    • Improving Chronic Disease Management with Pieces (ICD-Pieces™) (Miguel Vazquez, MD; Chul Ahn, PhD)
    • Collaborative Care for Chronic Pain in Primary Care (PPACT) (Lynn DeBar, PhD, MPH; William Vollmer, PhD)
    • Suicide Prevention Outreach Trial (SPOT) (Greg Simon, MD, MPH; Susan Shortreed, PhD)

Panel 3: Choosing a Parallel Group or Stepped-Wedge Design

Moderator: Fan Li, PhD

Panel:

    • Lumbar Imaging with Reporting of Epidemiology (LIRE) (Jerry Jarvik, MD, MPH; Patrick Heagerty, PhD)
    • Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED) (Ted Melnick, MD, MHS; Jim Dziura, MPH, PhD)
    • A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS]) (Doug Zatzick, MD; Patrick Heagerty, PhD)

Panel 4: Unique Complications

Moderator: Andrea Cook, PhD

Panel:

    • Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) (Myles Wolf, MD; Hrishikesh Chakraborty, DrPH)
    • Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) (Bev Green, MD, MPH; William Vollmer, PhD)
    • Time to Reduce Mortality in End-Stage Renal Disease (TiME) (Laura Dember, MD; J. Richard Landis, PhD; Jesse Hsu, PhD)

Summary and Concluding Remarks

ePCTs of Therapeutic A vs. B Interventions: NIH-Hosted Workshop (May 2018)

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May 16, 2018: This workshop explored challenges and strategies for planning and implementing ePCTs that compare two or more therapeutic medical regimens.

Workshop Summary

Agenda and Slides

Welcome and Introduction

David Shurtleff, PhD
Richard Hodes, MD
Catherine Meyers, MD
Wendy Weber, PhD, MPH

 

Panel 1: Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success

Moderator: Rich Platt, MD, MSc

Panel:

    • Steve Friedhoff, MD
    • Kenneth Sands, MD, MPH
    • Joseph Chin, MD

Panel 2: Examples in Action: Embedded A vs. B Trials

Moderator: Beverly Green, MD, MPH

Panel:

    • Ryan Ferguson, ScD, MPH
    • Susan Huang, MD, MPH
    • Michael Kappelman, MD, MPH

Panel 3: Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials

Moderator: Greg Simon, MD, MPH

Panel:

    • Scott Solomon, MD
    • Rachael Fleurence, PhD
    • Kourtney Davis, PhD, MSPH

Panel 4: Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials

Moderator: Adrian Hernandez, MD

Panel:

    • Jacqueline Corrigan-Curay, MD, JD
    • Owen Faris, PhD
    • Julie Kaneshiro, MA

Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator:

Moderator: David Wendler, PhD

Panel:

    • Barbara Bierer, MD
    • Spencer Hey, PhD
    • Judith Carrithers, JD, MPA

Summary and Concluding Remarks

Moderator: Cathy Meyers, MD

Panel:

    • Adrian Hernandez, MD
    • Rich Platt, MD, MSc
    • Beverly Green, MD, MPH
    • Greg Simon, MD, MPH
    • Dave Wendler, PhD

ePCT Training Workshop Course Materials (February 2018)

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February 20-21, 2018: This workshop provided training to mid- to senior-level investigators who are interested in conducting embedded pragmatic clinical trials (ePCTs). During the workshop, the NIH Collaboratory piloted the educational materials for investigators and collected feedback on the quality and appropriateness of the materials.

Agenda

Participant Guide

Agenda and Slides

Day 1: February 20

Welcome and Introduction

Gloria Coronado, PhD
Doug Zatzick, MD

Session 1: What Are Embedded Pragmatic Clinical Trials?

Lesley Curtis, PhD
Gloria Coronado, PhD
Doug Zatzick, MD

Session 2: Engaging All Stakeholders and Aligning With Healthcare System Partners

Leah Tuzzio, MPH

Session 3: Designing With Implementation in Mind

Doug Zatzick, MD

Session 4: Design and Analytic Considerations

Liz Turner, PhD

Session 5: Regulatory and Ethical Challenges of ePCTs

Kevin Weinfurt, PhD

Day 2: February 21

Session 6: Measuring Outcomes

Rachel Richesson, PhD, MPH
Lesley Curtis, PhD

Session 7: Pilot and Feasibility Testing

Wendy Weber, ND, PhD, MPH

Session 8: Dissemination

Doug Zatzick, MD

Session 9: ePCT Team Composition

Lesley Curtis, PhD

Session 10: Developing a Compelling Application

Marcel Salive, MD, MPH

Disseminating, Implementing, and Sustaining Evidence-Based Practices Into Clinical Care: NIH-Hosted Workshop (May 2017)

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May 24, 2017: This workshop identified best practices for the dissemination, implementation, and sustainability of ePCT findings. When conducted within integrated healthcare systems, ePCTs can leverage existing infrastructure to answer important clinical questions in a cost-effective manner.

Agenda and Slides

Welcome and Introduction

Josephine Briggs, MD
Richard Hodes, MD
Catherine Myers, MD
Wendy Weber, ND, PhD, MPH

Keynote: An Orientation to Dissemination, Implementation, Sustainability De-Implementation and the Science of Making Science Matter

David Chambers, DPhil

Panel 1: Setting the Stage for Dissemination and Implementation

Moderator: David Chambers, DPhil

Panel:

    • Susan Huang, MD, MPH
    • Doug Zatzick, MD
    • Gloria Coronado, PhD

Panel 2: Health System Engagement: Partnership, Relationships, and Transparency

Moderator: Eric Larson, MD, MPH

Panel:

    • Miguel Vazquez, MD
    • John Warner, MD
    • Lynn DeBar, PhD, MPH
    • Andrew Bertagnolli, PhD
    • Vincent Mor, PhD

Panel 3: Swimming with the Sharks - Translation of Pragmatic Trial Results

Moderator: Lesley Curtis, PhD
Presenter: Greg Simon, MD, MPH

Panel:

    • Susan Mullaney, MHA
    • Edward Septimus, MD
    • Matt Hough, MD

Panel 4: Designing for Sustainability

Moderator: Amy Kilbourne, PhD, MPH

Panel:

    • Laura Dember, MD
    • Jerry Jarvik, MD, MPH
    • Patrick Luetmer, MD
    • Greg Simon, MD, MPH

Panel 5: Stakeholder Reactions Panel Discussion

Moderator: Catherine Myers, MD

Panel:

    • John Warner, MD
    • Susan Mullaney, MHA
    • Amy Kilbourne, PhD, MPH

Summary and Concluding Remarks

Ethical and Regulatory Issues of Pragmatic Clinical Trials: NIH-Hosted Workshop (May 2016)

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May 10, 2016: This workshop focused on unique ethical and regulatory issues identified by the NIH Collaboratory Trials supported by the NIH Health Care Systems Research Collaboratory Program.

Agenda and Slides

Welcome and Introduction

Catherine Myers, MD
Wendy Weber, ND, PhD, MPH

Keynote: Addressing the Ethical and Regulatory Issues in Pragmatic Clinical Trials

Jeremy Sugarman, MD, MPH

Panel 1: Options for Altered Consent and the Importance of Minimal Risk Determination

Moderator: Kevin Weinfurt, PhD

Panel:

    • Laura Dember, MD
    • Gregory Simon, MD, MPH
    • John Lantos, MD
    • Emma Meagher, MD

Panel 2: Oversight of Pragmatic Clinical Trials: Institutional Review Boards and Data and Safety Monitoring Boards

Moderator: Adrian Hernandez, MD, MHS

Panel:

    • Douglas F. Zatzick, MD
    • P. Pearl O'Rourke, MD
    • Susan S. Ellenberg, PhD

Panel 3: Privacy Issues for Pragmatic Clinical Trials

Moderator: Valerie Bonham, JD

Panel:

    • Sarah M. Greene, MPH
    • Valery Gordon, PhD, MPH
    • Miguel Bazquez, MD

Panel 4: Vulnerable Populations

Moderator: David Wendler, PhD

Panel:

    • Susan S. Huang, MD
    • Mary Jane Welch, DNP, APRN, BC

Panel 5: Expert Panel Q&A

Moderator: Jeremy Sugarman, MD, MPH

    • Kevin Weinfurt, PhD
    • Adrian Hernandez, MD, MHS
    • Valerie Bonham, JD
    • David Wendler, PhD

Summary and Concluding Remarks