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

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

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