Essential Elements for Sharing a Data Package (NIH HEAL Initiative)
2025-03-20 13:00 - 14:00 (America/New_York)
Essential Elements for Sharing a Data Package
NIH HEAL Initiative Data Stewardship Group
March 20, 2025; 1:00-2:00 pm ET

The HEAL Data Stewardship Group is excited to announce the next Fresh FAIR Webinar! Please join us on Thursday, March 20 from 1:00-2:00 p.m. Eastern Time for Essential Elements for Sharing a Data Package.
Description: Effective data packaging is essential for ensuring that research data remains structured, discoverable, and reusable in alignment with the NIH HEAL Initiative’s goals. This webinar will explore best practices for data packaging across various stages of the research lifecycle, emphasizing the importance of meeting repository requirements and adhering to FAIR data principles.
Sarah Myer, MPH, a HEAL Steward, will highlight the significance of well-structured data within the NIH HEAL Initiative, explaining how data advances research within the biopsychosocial model of pain and addiction, supporting interdisciplinary collaboration and secondary reuse. Attendees will gain insights into the role of metadata in the HEAL Data Ecosystem (HDE) and its impact on data discoverability and secondary use underscoring the value of data packaging components for reusability.
Brienna Larrick, Ph.D., PMP, from the HEAL Platform, will outline the key components of a well-organized data package. The session will explain the common types of files included in a data package by providing an overview distinguishing between processed and raw data files, recommending preferred formats (e.g., CSV, TSV, JSON) for various data types, and demonstrating examples for mapping variables to ontologies and semantic standards such as Common Data Elements (CDEs).
To illustrate these concepts, the webinar will feature HEAL-specific examples of study teams that have successfully packaged and submitted datasets to repositories to illustrate effective approaches to data organization, metadata creation, and adherence to repository requirements.
Attendees will also have access to key resources, including Data Curation Costs for Submitting, the ICPSR Guide to Social Science Data Preparation and Archiving (6th ed.), and the NIH Pragmatic Trials Collaboratory Living Notebook.
A live Q&A session will follow, enabling participants to engage with experts and address specific challenges related to data packaging and submission. The webinar will conclude with a call to action, encouraging researchers to submit their datasets to HEAL repositories using best practices that enhance data accessibility and long-term usability.
Register now!

Grand Rounds March 21, 2025: Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care (Alexander J. “AJ” Blood, MD, MSc)
2025-03-21 13:00 - 14:00 (America/New_York)
Speaker:
Alexander J. “AJ” Blood, MD, MSc
Associate Director, Accelerator for Clinical Transformation Research Group
Instructor of Medicine at Harvard Medical School
Cardiologist and Intensivist
Brigham and Women’s Hospital
Title: Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care
Date: Friday, March 21, 2025, 1:00-2:00 p.m. ET
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Grand Rounds March 28, 2025: A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management (Matthew Engelhard, MD, PhD; Anivarya Kumar, BA)
2025-03-28 13:00 - 14:00 (America/New_York)
Speakers:
Matthew Engelhard, MD, PhD
Assistant Professor, Department of Biostatistics & Bioinformatics
Duke University School of Medicine
Anivarya Kumar, BA
Fourth-Year Medical Student
Duke University School of Medicine
Title: A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management
Date: Friday, March 28, 2025, 1:00-2:00 p.m. ET
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Grand Rounds April 4, 2025: A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial (Bill Heerman, MD, MPH)
2025-04-04 13:00 - 14:00 (America/New_York)
Speaker:
Bill Heerman, MD, MPH
Associate Professor of Internal Medicine and Pediatrics
William K. Warren Foundation Chair in Medicine
Chief, Division of Academic General Pediatrics
Vanderbilt University Medical Center
Title: A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial
Date: Friday, April 4, 2025, 1:00-2:00 p.m. ET
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Grand Rounds April 11, 2025: A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial (Jeremy M. Shefner, MD, PhD)
2025-04-11 13:00 - 14:00 (America/New_York)
Speaker:
Jeremy M. Shefner, MD, PhD
Professor of Neurology
Barrow Neurological Institute
Title: A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial
Date: Friday, April 11, 2025, 1:00-2:00 p.m. ET
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Grand Rounds April 18, 2025: Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial (Sanjit S. Jolly, MD, MSc, FRCPC)
2025-04-18 13:00 - 14:00 (America/New_York)
Speaker:
Sanjit S. Jolly, MD, MSc, FRCPC
Interventional Cardiologist, Hamilton Health Sciences
Stuart Connolly Chair in Cardiology
Professor of Medicine, McMaster University
Title: Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial
Date: Friday, April 18, 2025, 1:00-2:00 p.m. ET
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Grand Rounds April 25, 2025: Automated Response Technology Integrated into EMR and Physician-Patient Communication (Ming Tai-Seale, PhD, MPH)
2025-04-25 13:00 - 14:00 (America/New_York)
Speaker:
Ming Tai-Seale, PhD, MPH
Professor
Departments of Family Medicine and Medicine (Bioinformatics)
University of California San Diego School of Medicine
Director of UC San Diego Learning Health Systems Science Center
Title: Automated Response Technology Integrated into EMR and
Physician-Patient Communication

Date: Friday, April 25, 2025, 1:00-2:00 p.m. ET
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Grand Rounds May 2, 2025: Fluid REStriction in Heart failure versus liberal fluid UPtake: The FRESH-UP Study (Roland RJ van Kimmenade, MD, PhD)
2025-05-02 13:00 - 14:00 (America/New_York)
Speaker:
Roland RJ van Kimmenade, MD, PhD
Cardiologist, Radboud University Medical Center
Nijmegen, the Netherlands
Title: Fluid REStriction in Heart failure versus liberal fluid UPtake: The FRESH-UP Study

Date: Friday, May 2, 2025, 1:00-2:00 p.m. ET
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What Does it Mean to Implement PROMs in Clinical Practice? (ISOQOL)
2025-05-06 09:00 - 12:00 (America/Chicago)
Register today to attend the ISOQOL 1st Virtual Symposium, an event focused on challenges that healthcare providers (HCPs) encounter in the integration of patient-reported outcome measures (PROMs) into routine practice. Scheduled for three half-days from 6-8 May 2025, this virtual event will consist of panel discussions, presentations, an interactive online activity, real world case studies, and live attendee engagement and interaction with the speakers.
Session Highlight
Session 1: What Does it Mean to Implement PROMs in Clinical Practice?
Although the use of PROMs in practice is increasing, sometimes HCPs face barriers when trying to use PROMs across various clinical settings and inter-professional teams. Implementing PROMs on a wide scale poses significant challenges, as it requires engaging providers and changing their clinical practice (e.g., workflow and roles). This first session provides an overview of Implementation Science (IS) frameworks to guide the workshop and illustrate the intersection between the “user” and “implementation process” domains. Also, we will review key terms/nomenclature and discuss the underlying assumptions that frame this symposium. Finally, examples of the various ways in which PROMs can be adopted in clinical practice (e.g., screening, assessment, monitoring, planning, and evaluating care/treatment) will be discussed.
More information: https://mailchi.mp/isoqol/implement-proms-in-clinical-practice-like-a-pro

Grand Rounds May 9, 2025: A Policy-Relevant Pragmatic Trial on Acupuncture Effectiveness for Low Back Pain in Older Adults: Clinical and Cost Outcomes and Lessons Learned (Andrea J. Cook, PhD; Lynn L. DeBar, PhD, MD; Patricia M. Herman, PhD, ND)
2025-05-09 13:00 - 14:00 (America/New_York)
Speakers:
Andrea J. Cook, PhD
Kaiser Permanente Washington Health Research Institute
Lynn L. DeBar, PhD, MPH
Kaiser Permanente Center for Health Research
Patricia M. Herman, PhD, ND
RAND
Title: A Policy-Relevant Pragmatic Trial on Acupuncture Effectiveness for Low Back Pain in Older Adults: Clinical and Cost Outcomes and Lessons Learned

Date: Friday, May 9, 2025, 1:00-2:00 p.m. ET
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Grand Rounds May 16, 2025: Pivoting Clinical Trials Into a New and Evolving World (Jeffrey A. Spaeder, MD; Adrian F. Hernandez, MD, MHS)
2025-05-16 13:00 - 14:00 (America/New_York)
Speakers:
Jeffrey A. Spaeder, MD
Chief Medical and Scientific Officer
Senior Vice President
IQVIA
Adrian F. Hernandez, MD, MHS
Executive Director
Duke Clinical Research Institute
Vice Dean
Duke University School of Medicine
Title: Pivoting Clinical Trials Into a New and Evolving World
Date: Friday, May 16, 2025, 1:00-2:00 pm ET
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Webinar ID: 940 4143 3493
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Grand Rounds May 30, 2025: Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial (Ankeet S. Bhatt, MD, MBA, ScM)
2025-05-30 13:00 - 14:00 (America/New_York)
Speaker:
Ankeet S. Bhatt, MD, MBA, ScM
Cardiologist, Kaiser Permanente San Francisco Medical Center
Research Scientist, Kaiser Permanente Northern California
Division of Research
Adjunct Professor, Stanford University School of Medicine
Title: Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial

Date: Friday, May 30, 2025, 1:00-2:00 p.m. ET
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Grand Rounds June 6, 2025: The REDCap Advanced Randomization Module: A Trial Innovation Network Project to Support the Needs of Modern Trials (Jonathan D. Casey, MD, MSc)
2025-06-06 13:00 - 14:00 (America/New_York)
Speaker:
Jonathan D. Casey, MD, MSc
Assistant Professor
Co-PI, Vanderbilt Trial Innovation Center
Director, Coordinating Center, Pragmatic Critical Care Research Group
Title: The REDCap Advanced Randomization Module: A Trial Innovation Network Project to Support the Needs of Modern Trials

Date: Friday, June 6, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 939 9972 0498
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Grand Rounds June 13, 2025: Fit for Purpose: Improving the Ethical Oversight of Pragmatic Clinical Trials (Stephanie Morain, PhD, MPH; Nancy Kass, ScD; Ruth Faden, PhD, MPH)
2025-06-13 13:00 - 14:00 (America/New_York)
Speakers:
Stephanie Morain, PhD, MPH
Associate Professor, Berman Institute of Bioethics & Department of Health Policy & Management
Johns Hopkins University
Nancy Kass, ScD
Phoebe Berman Professor of Bioethics & Public Health
Berman Institute of Bioethics & Department of Health Policy & Management
Johns Hopkins University
Ruth Faden, PhD, MPH
Philip Franklin Wagley Professor of Biomedical Ethics
Berman Institute of Bioethics & Department of Health Policy & Management
Johns Hopkins University
Title: Fit for Purpose: Improving the Ethical Oversight of Pragmatic Clinical Trials

Date: Friday, June 13, 2025, 1:00-2:00 p.m. ET
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Grand Rounds June 20, 2025: The BedMed Trials: Does the Timing of Blood Pressure Medication Matter? (Scott Garrison MD, PhD, CCFP)
2025-06-20 13:00 - 14:00 (America/New_York)
Speaker:
Scott Garrison MD, PhD, CCFP
Professor, University of Alberta, Department of Family Medicine
Director, Pragmatic Trials Collaborative
Title: The BedMed Trials: Does the Timing of Blood Pressure Medication Matter?

Date: Friday, June 20, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 932 4373 3883
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Grand Rounds June 27, 2025: The BETTER CARE-HF Study: A Pragmatic Cluster Randomized Trial to Improve Heart Failure Care (Amrita Mukhopadhyay, MD, MS)
2025-06-27 13:00 - 14:00 (America/New_York)
Speaker:
Amrita Mukhopadhyay, MD, MS
Eugene Braunwald, MD Assistant Professor of Cardiology
The Leon H. Charney Division of Cardiology Department of Medicine
Division of Healthcare Delivery Science Department of Population Health
NYU School of Medicine
NYU Langone Health
Title: The BETTER CARE-HF Study: A Pragmatic Cluster Randomized Trial to Improve Heart Failure Care

Date: Friday, June 27, 2025, 1:00-2:00 p.m. ET
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Grand Rounds July 11, 2025: Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights From the AIM-Back Trial (Tyler Cope, PT, DPT, ATC; Trevor Lentz, PT, PhD, MPH)
2025-07-11 13:00 - 14:00 (America/New_York)
Speakers:
Tyler Cope, PT, DPT, ATC
Duke Clinical Research Institute
Department of Population Health Sciences,
Duke University School of Medicine
Trevor Lentz, PT, PhD, MPH
Associate Professor
Department of Orthopaedic Surgery,
Duke University School of Medicine
Duke Clinical Research Institute
Title: Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights From the AIM-Back Trial
Date: Friday, July 11, 2025, 1:00-2:00 pm ET
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Grand Rounds July 18, 2025: State of Clinical Trials: An Analysis of ClinicalTrials.gov (Adrian F. Hernandez, MD, MHS; Rebecca D. Sullenger, MPH; Sara Bristol Calvert, PharmD; Karen Chiswell, PhD; Christopher J. Lindsell, PhD)
2025-07-18 13:00 - 14:00 (America/New_York)
Speakers:
Adrian F. Hernandez, MD, MHS
Executive Director
Duke Clinical Research Institute
Rebecca D. Sullenger, MPH
Duke University School of Medicine
MD Student | Class of 2026
Panelists:
Sara Bristol Calvert, PharmD
Director of Projects
Clinical Trials Transformation Initiative
Karen Chiswell, PhD
Statistical Scientist
Duke Clinical Research Institute
Christopher J. Lindsell, PhD
Director, Data Science and Biostatistics
Duke Clinical Research Institute
Title: State of Clinical Trials: An Analysis of ClinicalTrials.gov
Date: Friday, July 18, 2025, 1:00-2:00 pm ET
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Webinar ID: 925 5714 2217
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Grand Rounds July 25, 2025: Initial Outcomes of the NOHARM Pragmatic Trial (Jon Tilburt, MD; Andrea Cheville, MD)
2025-07-25 13:00 - 14:00 (America/New_York)
Speakers:
Jon Tilburt, MD
Professor of Medicine
Mayo Clinic in Arizona
Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic in Minnesota
Title: Initial Outcomes of the NOHARM Pragmatic Trial
Date: Friday, July 25, 2025, 1:00-2:00 pm ET
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Grand Rounds August 1, 2025: Clinical Trial Notifications Triggered by Artificial Intelligence–Detected Cancer Progression (Kenneth L. Kehl, MD, MPH)
2025-08-01 13:00 - 14:00 (America/New_York)
Speaker:
Kenneth L. Kehl, MD, MPH
Assistant Professor of Medicine and Physician
Dana-Farber Cancer Institute
Title: Clinical Trial Notifications Triggered by Artificial Intelligence–Detected Cancer Progression

Date: Friday, August 1, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 937 6357 0190
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Grand Rounds August 8, 2025: Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial (A. Eden Evins, MD, MPH)
2025-08-08 13:00 - 14:00 (America/New_York)
Speaker:
A. Eden Evins, MD, MPH
Cox Family Professor of Psychiatry, Harvard Medical School
Founding Director, MGH Center for Addiction Medicine
Director for Faculty Development, Mass General Hospital Department of Psychiatry
Title:Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial

Date: Friday, August 8, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 949 6995 8131
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Grand Rounds August 15, 2025: Dexmedetomidine or Clonidine-Based Sedation Compared With Propofol in Critically Ill Patients: The A2B Randomized Clinical Trial (Tim Walsh, MD, FFICM; Chris Weir, PhD; Richard Parker, MSc)
2025-08-15 13:00 - 14:00 (America/New_York)
Speakers:
Tim Walsh, MD, FFICM
Chair of Critical Care, Professor
Usher Institute
University of Edinburgh
Chris Weir, PhD
Chair of Medical Statistics, Professor
Edinburgh Clinical Trials Unit, Usher Institute
University of Edinburgh
Richard Parker, MSc
Research Fellow
Edinburgh Clinical Trials Unit, Usher Institute
University of Edinburgh
Title: Dexmedetomidine or Clonidine-Based Sedation Compared With Propofol in Critically Ill Patients: The A2B Randomized Clinical Trial

Date: Friday, August 15, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 925 3084 0134
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Grand Rounds August 22, 2025: The PCORnet Playbook: Avoiding the Fumble in Pragmatic Trials (Emily O'Brien, PhD, FAHA)
2025-08-22 13:00 - 14:00 (America/New_York)
Speaker:
Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences
Title: The PCORnet Playbook: Avoiding the Fumble in Pragmatic Trials

Date: Friday, August 22, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 972 9822 1531
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Grand Rounds September 5, 2025: The Non-Learning Health System (Robert Califf, MD)
2025-09-05 13:00 - 14:00 (America/New_York)
Speaker:
Robert Califf, MD
Instructor in Medicine
Duke University Medical Center
Former Commissioner of Food and Drugs
Title: The Non-Learning Health System

Date: Friday, September 5, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 972 9798 4183
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Grand Rounds September 12, 2025: Initial Outcomes of the Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) Pragmatic Trial (Natalia E. Morone, MD, MS; Carol M. Greco, PhD; Kim Faurot, PhD)
2025-09-12 13:00 - 14:00 (America/New_York)
Speakers:
Natalia E. Morone, MD, MS
Boston Medical Center/Boston University
Carol M. Greco, PhD
University of Pittsburgh
Kim Faurot, PhD
University of North Carolina at Chapel Hill
Title: Initial Outcomes of the Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) Pragmatic Trial

Date: Friday, September 12, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 942 9187 8697
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Grand Rounds September 19, 2025: Hurdles for the Delivery of Trials: Insights From the Randomized Embedded Multifactorial Adaptive Platform Trial on Community-Acquired Pneumonia (REMAP-CAP) in Europe (Denise van Hout, MD, PhD)
2025-09-19 13:00 - 14:00 (America/New_York)
Speaker:
Denise van Hout, MD, PhD
Postdoctoral Researcher
Julius Center for Health Sciences and Primary Care
University Medical Center Utrecht, the Netherlands
Title: Hurdles for the Delivery of Trials: Insights From the Randomized Embedded Multifactorial Adaptive Platform Trial on Community-Acquired Pneumonia (REMAP-CAP) in Europe

Date: Friday, September 19, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 914 3049 1297
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Grand Rounds September 26, 2025: Significance in ePCTs: P Values vs Decision-Maker Perspectives (Gregory E. Simon, MD, MPH; Susan Huang, MD, MPH; Elizabeth Turner, PhD)
2025-09-26 13:00 - 14:00 (America/New_York)
Speakers:
Gregory E. Simon, MD, MPH
Kaiser Permanente Washington Health Research Institute
Susan Huang, MD, MPH
University of California Irvine
Elizabeth Turner, PhD
Duke University
Title: Significance in Pragmatic Clinical Trials: P Values vs Decision-Maker Perspectives

Date: Friday, September 26, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 970 6498 4108
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Grand Rounds October 3, 2025: Multi-Domain Rehabilitation for Older Patients With Myocardial Infarction: The PIpELINe Trial (Elisabetta Tonet, MD)
2025-10-03 13:00 - 14:00 (America/New_York)
Speaker:
Elisabetta Tonet, MD
Cardiology Consultant
Cardiology Unit
Azienda Ospedaliero–Universitaria di Ferrara, Italy
Title: Multi-Domain Rehabilitation for Older Patients With Myocardial Infarction: The PIpELINe Trial

Date: Friday, October 3, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 913 1236 6543
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Grand Rounds October 10, 2025: Engaging Rural Communities in Pragmatic Clinical Trials: Leveraging the CARE for Health Initiative Hubs to Enhance Enrollment for BeatPain (Julie M. Fritz, PhD, PT, FAPTA; Sebastian Tong, MD, MPH)
2025-10-10 13:00 - 14:00 (America/New_York)
Speakers:
Julie M. Fritz, PhD, PT, FAPTA
Distinguished Professor
Department of Physical Therapy & Athletic Training University of Utah
Sebastian Tong, MD, MPH
Associate Professor
University of Washington
Title: Engaging Rural Communities in Pragmatic Clinical Trials: Leveraging the CARE for Health Initiative Hubs to Enhance Enrollment for BeatPain
Date: Friday, October 10, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 935 1761 8705
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Grand Rounds October 17, 2025: Making Effective Use of Data Infrastructure in PCORnet® (Charles Bailey, MD, PhD; Keith Marsolo, PhD)
2025-10-17 13:00 - 14:00 (America/New_York)
Speakers:
Charles Bailey, MD, PhD
Department of Pediatrics
Perelman School of Medicine
University of Pennsylvania
Biomedical and Health Informatics
Children’s Hospital of Philadelphia
Keith Marsolo, PhD
Associate Professor
Department of Population Health Sciences
Duke Clinical Research Institute
Duke University School of Medicine
Title: Making Effective Use of Data Infrastructure in PCORnet®
Date: Friday, October 17, 2025, 1:00-2:00 p.m. ET
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Webinar ID: 919 8892 0138
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