2022

Ethical & Regulatory Dimensions of Pragmatic Clinical Trials: Special Grand Rounds Series (September 2022-February 2023)

Posted on by Lauren Stewart

In 2022-2023, the NIH Pragmatic Trials Collaboratory used its popular PCT Grand Rounds platform to host a special workshop series to examine ethical and regulatory challenges in pragmatic clinical trials. The series included moderated panel discussions, in which the NIH Collaboratory's Ethics and Regulatory Core brought together bioethicists, investigators, and regulatory experts to share lessons learned, discuss empirical findings, and explore remaining uncertainties.

Grand Rounds Sessions

September 9, 2022, 1:00 pm ET: Keynote: Building an Academic Learning Health System: Why Is It So Hard?

Speaker: Steven Joffe, MD, MPH
Moderator: Stephanie Morain, PhD, MPH

October 14, 2022, 1:00 pm ET: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials 

Speakers: Joseph Ali, JD; Leslie J. Crofford, MD; Tanya Matthews, PhD
Moderator: Stephanie Morain, PhD, MPH

November 11, 2022, 1:00 pm ET: Data Sharing and Pragmatic Clinical Trials: Law and Ethics Amidst a Changing Policy Landscape 

Speakers: Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics
Moderator: P. Pearl O’Rourke, MD

December 9, 2022, 1:00 pm ET: The Stepped-Wedge Cluster Randomized Trial: Friend or Foe?

Speakers: David Magnus, PhD; Monica Taljaard, PhD
Moderator: Stephanie Morain, PhD, MPH

January 13, 2023, 1:00 pm ET: Ethical Considerations When Vulnerable Populations Are Subjects in Pragmatic Trials

Speaker: Emily A. Largent, JD, PhD, RN
Moderator: Stephanie Morain, PhD, MPH

February 10, 2023, 1:00 pm ET: Informing and Consenting: What Are the Goals?

Speakers: P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD
Moderator: Stephanie Morain, PhD, MPH

 

Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations: AcademyHealth Conference on the Science of Dissemination and Implementation in Health (December 2022)

Posted on by Lauren Stewart

December 11, 2022: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 15th AcademyHealth Annual Conference on the Science of Dissemination and Implementation in Health. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Agenda

Speaker Biographies

Program Overview

Participant Guide

Agenda and Slides

Morning Sessions

Welcome and Introduction

Wendy Weber, ND, PhD, MPH

Session 1: What are Embedded Pragmatic Clinical Trials (ePCTs)?
Wendy Weber, ND, PhD, MPH

Session 2: Engaging Stakeholders & Aligning with Health System Partners
Emily O’Brien, PhD

Session 3: Objectives and Trial Design: An Overview of Hybrid Designs
Emily O’Brien, PhD

Session 4: Measuring Outcomes
Emily O’Brien, PhD

Session 5: ePCT Design
David Murray, PhD

Session 6: ePCT Analysis
David Murray, PhD

Session 7:  ePCTs in Context: Panel Discussion with NIH Collaboratory Trial PIs
Moderator:  Emily O’Brien, PhD

*This session includes the Case Study Presentations.

 

Afternoon Sessions

Session 8: Pilot & Feasibility Testing
Wendy Weber, ND, PhD, MPH

Session 9: Ethical & Regulatory Oversight Considerations
Stephanie Morain, PhD, MPH

Session 10: ePCTs in Context: Panel Discussion with NIH Collaboratory Trial PIs
Moderator: Wendy Weber, ND, PhD, MPH

*This session includes the Case Study Presentations.

Session 11: Assembling an ePCT Team & Writing a Grant Application
Beda Jean-Francois, PhD

Session 12: Next Steps
Wendy Weber, ND, PhD, MPH

 

Case Studies

Examples from NIH Collaboratory Trials: 

Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade: NIH-Hosted Workshop (June 2022)

Posted on by Gina Uhlenbrauck

June 15-16, 2022: This workshop is an opportunity to glean the most salient lessons learned from an experienced group of pragmatic trial investigators who will openly share the challenges they have encountered, solutions they have developed, and thoughts for the future. 

Workshop Agenda

Workshop Summary

Workshop Description

Videocast Recording: Day 1

Videocast Recording: Day 2

Agenda and Slides

Day 1: June 15, 2022

Welcome and Introduction

Wendy Weber, ND, PhD, MPH
Helene Langevin, MD

Keynote: Pragmatic Clinical Trials: The Role of Nursing Science

Shannon N. Zenk, PhD, MPH, RN, FAAN

Session 1: Can We Squeeze More Value Out of Electronic Health Records?

Moderator: Keith Marsolo, PhD

Panel:

  • ICD-Pieces™: Improving Chronic Disease Management with Pieces (Miguel Vazquez, MD)
  • LIRE: Lumbar Imaging with Reporting of Epidemiology (Jeffrey (Jerry) Jarvik, MD, MPH)
  • NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management (Andrea Cheville, MD)
  • SPOT: Suicide Prevention Outreach Trial (Greg Simon, MD, MPH)

Session 2: Should We Be Considering a Different Study Design?

Moderator: Patrick Heagerty, PhD

Panel:

Summary and Concluding Remarks

Lesley Curtis, PhD
Wendy Weber, ND, PhD, MPH
Keith Marsolo, PhD
Patrick Heagerty, PhD

Day 2: June 16, 2022

Welcome and Introduction

Wendy Weber, ND, PhD, MPH
Helene Langevin, MD

Session 3: What Is the Most Effective Use of the 1-Year Planning Phase?

Moderator: Wendy Weber, ND, PhD, MPH

Panel:

Session 4: How Do We Implement Interventions in Complex Health Care Systems?

Moderator: Steven George, PT, PhD

Panel:

  • STOP CRC: Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (Gloria Coronado, PhD)
  • ICD-Pieces™: Improving Chronic Disease Management with Pieces (Miguel Vazquez, MD)
  • GGC4H: Guiding Good Choices for Health: Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems (Margaret Kuklinski, PhD)
  • GRACE: Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (Miriam Ezenwa, PhD, MSN, BSN, RN, FAAN)

Summary and Concluding Remarks

Lesley Curtis, PhD
Wendy Weber, ND, PhD, MPH
Steven George, PT, PhD

 

Essentials of Embedded Pragmatic Clinical Trials Workshop: Health Care Systems Research Network Annual Conference (April 2022)

Posted on by terren.green@duke.edu

April 11, 2022: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. This training workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provided firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Workshop Summary & Additional Resources

Agenda and Slides

Welcome and Introduction

Kevin Weinfurt, PhD

Session 1: What Are Embedded PCTs (ePCTs)?
Kevin Weinfurt, PhD

Session 2: Objectives and Trial Design: An Overview of Hybrid Design
Devon Check, PhD

Session 3: Measuring Outcomes
Devon Check, PhD

Session 4: ePCT Experimental Design & Analysis
Patrick Heagerty, PhD

 

Agenda and Slides

Session 5: Pilot & Feasibility Testing
Miguel Vazquez, MD

Session 6: Ethical & Regulatory Oversight Considerations
Kevin Weinfurt, PhD

Session 7: Writing a Compelling Grant Application
Michael Ho, MD, PhD

Session 8: ePCTs in Context: Panel Discussion
Moderator: Kevin Weinfurt, PhD

*This presentation contains case studies.

Session 9: Next Steps
Kevin Weinfurt, PhD

 

Case Studies

Examples from NIH Collaboratory Trials: