A workshop focused on the inclusion of diverse participants in pragmatic clinical trials with insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators
training
Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)
In 2021, NIH Collaboratory Grand Rounds held a special workshop series to provide insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators. The Grand Rounds series included moderated panel discussions, case examples from the NIH Collaboratory Trials, and culminated with a podcast discussion from a panel of experts.
Agenda and Slides
Session 1: May 14, 2021: Keynote: Diverse Representation Among Clinical Trial Participants: Why it is Important and How Can We Improve
Moderator: Kanecia Zimmerman, MD
Speaker: Clyde W. Yancy, MD, MSc
Session 2: June 4, 2021: Planning for Diversity: Stakeholder Engagement and Site Selection to Maximize Diversity
Moderator: Wendy Weber, ND, PhD, MPH
Speakers: Julie Fritz, PhD, PT; David Wetter, PhD, MS; Gloria Coronado, PhD; Amanda Petrik, MS
Session 3: June 25, 2021: Meeting Participants Where They Are: Outreach, Trust, and Consent to Maximize Diversity
Moderator: Emily O'Brien, PhD
Speakers: Jonathan Jackson, PhD; Judith Schlaeger, PhD, CNM, Lac, FAAN; Stacy Sterling, DrPH, MSW, MPH
Session 4: July 16, 2021: Maximizing Diversity in PCTs: What Can We Learn From Implementation Trials
Moderator: David Chambers, DPhil
Speakers: Amanda Midboe, PhD; Anne Trontell, MD, MPS
Session 5: July 30, 2021: Diversity in the PCT Ecosystem: How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?
Moderator: Lesley Curtis, PhD
Speakers: Marie Bernard, MD; George Mensah, MD; Natalia Morone, MD
Session 6: August 2, 2021: Podcast: Summary Expert Panel Discussion
Moderator: Robin Boineau, MD, MA
Speakers: Kanecia Zimmerman, MD; Wendy Weber, ND, PhD, MPH; Emily O'Brien, PhD; David Chambers, DPhil; Lesley Curtis, PhD
ePCT Workshop: Health Care Systems Research Network (Virtual, May 2021)
This virtual workshop introduced concepts in the design, conduct, and implementation of ePCTs, with a particular focus on methods relevant to health services researchers. The workshop provided a greater understanding of the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the Collaboratory Demonstration Projects illustrated the topics presented.
Agenda and Slides
Day 1: May 11
Session 1: What Are Embedded PCTs (ePCTs)?
Wendy Weber, ND, PhD, MPH
Session 2: Measuring Outcomes
Emily O'Brien, PhD
Session 3: ePCT Design & Analysis
Patrick Heagerty, PhD
Day 2: May 12
Session 1: Pilot & Feasibility Testing
Wendy Weber, ND, PhD, MPH
Session 2: Ethical & Regulatory Oversight Considerations
Stephanie Morain, PhD, MPH
Session 3: Writing a Compelling Grant Application
Marcel Salive, MD, MPH
Session 4: ICD-Pieces Case Study
Miguel Vazquez, MD
Session 5: LIRE Case Study
Jeffrey (Jerry) G. Jarvik, MD, MPH
Session 6: OPTIMUM Case Study
Natalia Morone, MD
ePCT Workshop: Health Care Systems Research Network
ePCT Workshop: Health Care Systems Research Network (Virtual, May 2021)
A workshop on the essentials of embedded PCTs (ePCTs) with a focus on methods relevant to health services researchers
EHR Workshop Video Modules
EHR Video Modules
This selection of short educational videos is drawn from our 2020 EHR Workshop Grand Rounds Series, “Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials.” The series highlighted advances in digital health, new approaches and evolving standards for electronic health records (EHRs), and implications for researchers conducting pragmatic trials.
Advances at the Intersection of Digital Health, EHRs, and PCTs: NIH-Hosted Workshop (May-July 2020)
May-July 2020: In 2020, NIH Collaboratory Grand Rounds held a special workshop series to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials. The series highlighted advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. The Grand Rounds series included moderated panel discussions that focused on the use of digital technologies in pragmatic clinical trials, case examples from the NIH Collaboratory Trials, and recent initiatives from the Office of the National Coordinator for Health Information Technology to reshape standards and drive the evolution of EHRs in healthcare and research. The series culminated with a podcast discussion from a panel of experts.
Agenda and Slides
Session 1: May 1, 2020: Keynote: Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?
Speaker: Robert Califf, MD, MACC
Session 2: May 8, 2020: Real World Evidence: Contemporary Experience and Future Directions
Speakers: Jacqueline Corrigan-Curay, JD, MD; Joshua C. Denny, MD, MS, FACMI
Moderator: Patrick J. Heagerty, PhD
Session 3: May 29, 2020: Experiences From the Collaboratory PCTs
Speakers: Jeffrey [Jerry] G. Jarvik, MD, MPH; Lynn DeBar, PhD; Doug Zatzick, MD; Vince Mor, PhD
Moderator: Wendy Weber, ND, PhD, MPH
Session 4: June 26, 2020: Keys to Success in the Evolving EHRs Environment
Speakers: Teresa Zayas-Cabán, PhD; George [Holt] Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH
Moderator: Keith Marsolo, PhD
Session 5: July 8, 2020: Podcast: Summary Expert Panel Discussion
Speakers: Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH
Moderator: Lesley H. Curtis, PhD
EHR Video Modules
Watch our selection of short educational videos drawn from this 2020 EHR Workshop Grand Rounds Series. The series highlighted advances in digital health, new approaches and evolving standards for electronic health records (EHRs), and implications for researchers conducting pragmatic trials.
Quick Start Guides
Quick Start Guides
Sign up to receive the The NIH Collaboratory Quick Start Guides. These guides are designed for clinical investigators interested in learning how to conduct embedded pragmatic clinical trials (ePCTs) and successfully partner with health care systems leaders.
Living Textbook Video Modules
Living Textbook Video Modules
Short educational videos drawn from our 2020 Living Textbook Grand Rounds Series. The series focused on the Living Textbook and featured expert speakers guiding the audience through the life cycle of an embedded pragmatic clinical trial—from idea to funding to implementation.
Intraclass Correlation Coefficient Cheat Sheet
Intraclass Correlation Coefficient Cheat Sheet
An introductory description of the intraclass correlation coefficient, a descriptive statistic that is important for the design and analysis of cluster-randomized trials
ePCT Seminar: American Society of Nephrology (November 2019)
November 8, 2019: This seminar, offered by the NIH Collaboratory in partnership with the American Society of Nephrology, was held in Washington, D.C. during ASN Kidney Week. The seminar sessions provided an introduction to concepts in the design of embedded pragmatic clinical trials (ePCTs), with a focus on interventions that are relevant to the nephrology research community. All presentations are downloadable in PDF format.
Agenda and Slides
Embedded Pragmatic Clinical Trials: Accelerating Evidence Generation in Nephrology
Welcome and Introduction
Catherine M. Meyers, MD
Susan R. Mendley, MD
Session 1: Opportunities for Embedded Pragmatic Clinical Trials in Nephrology
Laura Dember, MD
Session 2: Design and Analysis: Strategies for Embedded Pragmatic Clinical Trials
Qilu Yu, PhD
Session 3: Engaging Stakeholders and Aligning with Health System Partners
Miguel Vazquez, MD
Session 4: Designing for Post-Trial Implementation
Wynne Norton, PhD