- October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New NIH Collaboratory Trials
The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative NIH Collaboratory Trials, which will extend the program’s mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.
Three of the new projects ...
- October 25, 2023: In This Friday’s PCT Grand Rounds, Krumholz Presents PaxLC Trial of Paxlovid for Long COVID
In this Friday’s PCT Grand Rounds, Harlan Krumholz of Yale University will present “Digital, Decentralized and Democratized: Lessons From the Yale PaxLC Trial.”
The Grand Rounds session will be held on Friday, October 27, 2023, at 1:00 pm eastern.
The PaxLC Trial is a decentralized study of Paxlovid in adult participants with long COVID. Krumholz, the principal ...
- October 18, 2023: In This Friday’s PCT Grand Rounds, Ending Hepatitis C in the United States
In this Friday’s PCT Grand Rounds, Rachael Fleurence of the NIH and Joshua Sharfstein of Johns Hopkins University will present “A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists.”
The Grand Rounds session will be held on Friday, October 20, 2023, at 1:00 pm eastern.
Fleurence is a ...
- October 12, 2023: GRACE Team Shares Lessons About Monitoring Signals of Suicidality in Pragmatic Clinical Trials
In a new article published this week in Contemporary Clinical Trials Communications, the GRACE DNIH Collaboratory Trial team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. The work builds on their experience conducting research involving patients with sickle cell disease and on previous work from the NIH ...
- October 11, 2023: In This Friday’s PCT Grand Rounds, Incorporating Social Determinants of Health Into PCORnet
In this Friday’s PCT Grand Rounds, Keith Marsolo of Duke University will present “Incorporating Social Determinants of Health Into PCORnet.”
The Grand Rounds session will be held on Friday, October 13, 2023, at 1:00 pm eastern.
Marsolo is an associate professor of population health sciences at Duke University and a cochair of the NIH Pragmatic Trials Collaboratory’s ...
- October 10, 2023: Ethics Consultation Documents Now Available for BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE
Ethics and regulatory onboarding documentation for the NIH Pragmatic Trials Collaboratory’s newest NIH Collaboratory Trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE studies.
The consultations took place by video conference and included representation from ...
- October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials ...
- October 5, 2023: GRACE Trial Featured on CBS News Chicago for Sickle Cell Awareness Month
The GRACE trial, an NIH Pragmatic Trials Collaboratory Trial, was featured in a segment on CBS News Chicago. Co–principal investigator Ardith Doorenbos was interviewed for the segment as part of the news program’s observance of Sickle Cell Awareness Month.
“Millions of people around the world with sickle cell disease really suffer from very serious chronic pain, ...
- October 4, 2023: Special Biostatistics Grand Rounds Series Begins Friday With Rigorous Methods for Hybrid Studies
In this Friday’s PCT Grand Rounds, David Murray of the NIH Office of Disease Prevention will kick off our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Hybrid Studies Should Not Sacrifice Rigorous Methods.” The session will be held on Friday, October 6, at 1:00 pm eastern and ...
- October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs
The Patient-Centered Outcomes Core has developed a new tool kit to provide resources to support the capture of patient-reported outcome (PRO) measures in diverse study populations. The tool kit is intended for research teams conducting pragmatic clinical trials, including those participating in the NIH Pragmatic Trials NIH Collaboratory Trials.
This tool kit contains 3 sections:
Brief background ...
- September 27, 2023: This Friday’s PCT Grand Rounds to Highlight PROTEUS Consortium
In this Friday’s PCT Grand Rounds, Claire Snyder of Johns Hopkins University and Norah Crossnohere and Anne Schuster, both of Ohio State University, will present “Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium.”
The Grand Rounds session will be held on Friday, September 29, 2023, at 1:00 pm eastern.
The PROTEUS Consortium ...
- September 20, 2023: This Friday’s PCT Grand Rounds Explores the Role of Community Health Workers in Early Childhood Well-Child Care
In this Friday’s PCT Grand Rounds, Tumaini Rucker Coker of the University of Washington and Seattle Children’s Hospital will present “Community Health Workers in Early Childhood Well-Child Care.”
The Grand Rounds session will be held on Friday, September 22, 2023, at 1:00 pm eastern.
Coker is the chief of general pediatrics and a professor of pediatrics at ...
- September 13, 2023: PCT Grand Rounds to Feature Real-World Trial of Food Choice Incentives for Lower-Income Adults
In this Friday’s PCT Grand Rounds, Pasquale Rummo of the NYU Grossman School of Medicine will present “Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings.”
The Grand Rounds session will be held on Friday, September 15, 2023, at 1:00 pm eastern.
Rummo is an associate professor ...
- September 11, 2023: IMPACT Collaboratory Accepting Applications for Annual Training Workshop
On January 24-25, 2024, the IMPACT Collaboratory will hold its fourth annual virtual Training Workshop entitled Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) Among People Living With Dementia (PLWD) and Their Care Partners.
The 1.5-day virtual workshop features all new material to build a foundation in practical aspects of designing and conducting embedded pragmatic ...
- September 8, 2023: DEVICE Pragmatic Trial of Emergency Airway Management to Be Featured in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Matthew Prekker of the University of Minnesota and Jonathan Casey of Vanderbilt University will present “The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management.”
The Grand Rounds session will be held on Friday, September 8, 2023, at 1:00 pm eastern.
Prekker is an associate professor of emergency medicine and ...
- September 5, 2023: NIH Pragmatic Trials Collaboratory Announces Grand Rounds Series on Design and Analysis of Pragmatic Clinical Trials
The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to share advances in the design and analysis of pragmatic clinical trials.
Join us on the first Friday of each month, October through January, to hear the latest best practices and explore emerging questions with experts from the program’s Biostatistics and Study Design Core.
Over ...
- August 31, 2023: FDA’s Robert Califf and Coauthors Assert More Is Needed to Achieve Learning Health Care
In an article published this month in the American Journal of Bioethics, FDA Commissioner Robert Califf and coauthors suggest that—despite the potential of embedded pragmatic research to generate information to improve clinical practice and public health policy—it is still relatively uncommon in US healthcare.
“Simply stated, what we are currently doing does not work, and in ...
- August 30, 2023: NIH Pragmatic Trials Collaboratory Welcomes New NIH Collaboratory Trial: I CAN DO Surgical ACP
We are excited to welcome I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) to our portfolio of innovative NIH Collaboratory Trials. This project is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute on Aging (NIA).
Despite advance care planning (ACP) being incorporated into ...
- August 23, 2023: PCT Grand Rounds to Highlight a Pragmatic Trial of an EHR Display of Real-Time PRO Data
In this Friday’s PCT Grand Rounds, Gabriela Schmajuk of the University of California, San Francisco, will present “Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges.”
The Grand Rounds session will be held on Friday, August 25, 2023, at 1:00 pm eastern.
Schmajuk is a professor of medicine at UCSF and the ...
- August 22, 2023: Distributed Research Network Shares Opportunities and Challenges for Pragmatic Research Embedded in Health Insurance Plans
In an article published this month in Clinical Trials, researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans.
“There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates ...
- August 17, 2023: American Journal of Bioethics Publishes Special Issue on Pragmatic Clinical Trials
When research and clinical care are deliberately integrated in an embedded pragmatic clinical trial, the nature and extent of investigators’ obligations to patient-subjects are blurred, as is the clinician’s duty to participate is such research. To address these questions, the American Journal of Bioethics (AJOB) recently published commentaries on 2 target articles in a special ...
- August 16, 2023: In This Friday’s PCT Grand Rounds, the Draft Revision of the ICH Good Clinical Practice Guideline
In this Friday’s PCT Grand Rounds, Martin Landray of the University of Oxford, Khair ElZarrad of the US Food and Drug Administration, and Adrian Hernandez of Duke University will present “Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6).”
The Grand Rounds session will be held on Friday, August 18, ...
- August 14, 2023: Program Leaders Reflect on Cross-Core Collaboration and Opportunities for the Future
In an interview during the program’s Annual Steering Committee Meeting, Drs. Kevin Weinfurt and Greg Simon reflected on cross-Core collaboration within the NIH Pragmatic Trials Collaboratory and opportunities for growth in the future.
More than a decade ago, when the NIH Pragmatic Trials Collaboratory got its start, the focus was on identifying and answering the big ...
- August 9, 2023: Joe Ali to Lead Seminar on Advancing Justice and Equity in Pragmatic Trials
On September 12, Joe Ali, a longtime member of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, will present “Advancing Justice and Equity in Pragmatic Clinical Trials.” The presentation is part of the Spotlight on Pain Management series of the VA HSR&D Cyberseminars.
Advance registration is required.
VA HSR&D Cyberseminars: Spotlight on Pain Management
“Advancing Justice and ...
- August 9, 2023: REMAP-CAP Trial Returns to PCT Grand Rounds This Friday
In this Friday’s PCT Grand Rounds, Patrick Lawler of the McGill University Health Centre will present “The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions.”
The Grand Rounds session will be held on Friday, August 11, 2023, at 1:00 pm eastern.
The REMAP-CAP trial (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia) has a novel ...
- August 8, 2023: Lessons on Intervention Delivery and Complexity Shared at the Annual Steering Committee Meeting
In an interview at this year’s NIH Pragmatic Trials Collaboratory Steering Committee annual meeting, Drs. Steven George, Vincent Mor, and Angelo Volandes discussed the complexity of intervention delivery in pragmatic clinical trials and the impact it can have on researchers’ ability to discern trial results.
“Without delving deeply into the way in which an intervention can ...
- August 7, 2023: Implementation Science Core Cochairs Discuss Implementation Challenges, Strategies in Pragmatic Trials
In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Implementation Science Core cochairs Hayden Bosworth and Devon Check reflected on the Core’s goals and factors for implementation success.
The Implementation Science Core, which launched in 2022, supports implementation-related research aims in pragmatic clinical trials to promote the uptake and sustainability of effective ...
- August 3, 2023: NCI’s David Chambers Discusses Role of Implementation Science in Pragmatic Research
This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured implementation science as one of the topics of focus. In an interview after his keynote presentation, Dr. David Chambers, deputy director for implementation science at the National Cancer Institute, shared his thoughts on opportunities for implementation science in the context of pragmatic ...
- August 2, 2023: Want to Play a Game? AI and Machine Learning in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University will present “AI & ML: Want to Play a Game?”
The Grand Rounds session will be held on Friday, August 4, 2023, at 1:00 pm eastern.
Perakslis is a professor in population health sciences and the chief research technology strategist in the Duke University School of ...
- August 1, 2023: NIH Collaboratory Expands LinkedIn Presence to Join Growing Community of Researchers
With the NIH Pragmatic Trials Collaboratory entering its second decade, we are expanding our presence on the LinkedIn social media platform to promote research that advances the design, conduct, and dissemination of pragmatic clinical trials.
If you are active on LinkedIn, we invite you to follow our page for the latest news about our innovative NIH ...
- July 31, 2023: NIH Announces Funding Opportunity for Pain Management Collaboratory Pragmatic Trials
The NIH this month published notice of a funding opportunity to support the next round of pragmatic clinical trials within the NIH-DoD-VA Pain Management Collaboratory (PMC).
Read the full notice of funding opportunity (RFA-AT-24-004).
The PMC was established in 2017 with an initial cohort of 11 pragmatic trials. The new funding opportunity leverages the experience, expertise, and ...
- July 27, 2023: NIH Collaboratory Hosts Onboarding Session for Newest NIH Collaboratory Trials
Leaders of the NIH Pragmatic Trials Collaboratory hosted an onboarding meeting for the program’s 3 newest NIH Collaboratory Trials. The projects joined the program under the UG3 cooperative agreement mechanism to support a 1-year planning phase in preparation for potential transition to a UH3 implementation phase.
Access the complete materials from the onboarding session.
During the session, ...
- July 26, 2023: In Friday’s PCT Grand Rounds, Carl Bergstrom to Share Tools to Fight Misinformation in Medicine
In this Friday’s PCT Grand Rounds, Professor Carl Bergstrom of the University of Washington will present “How Can Researchers Fight Misinformation About Medicine?”
The Grand Rounds session will be held on Friday, July 28, 2023, at 1:00 pm eastern.
Bergstrom is a professor of biology at the University of Washington. He writes frequently on the spread of ...
- July 24, 2023: Bioethics Research Project Explores Data Sharing and Respect for Trial Participants
At the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in May, Dr. Stephanie Morain discussed the results of a recent bioethics initiative to explore ethical considerations for data sharing in the context of pragmatic clinical trials. The project was supported by a supplemental grant award from the NIH through the NIH HEAL Initiative.
Morain and ...
- July 20, 2023: Latest Podcast Episode Features BeatPain Utah’s Julie Fritz
In a new episode of our Rethinking Clinical Trials podcast, Dr. Julie Fritz speaks with host Dr. Adrian Hernandez about partnering with community health centers in the BeatPain Utah study. Fritz and colleague Dr. Guilherme Del Fiol presented on their experiences during the June 16 session of Grand Rounds.
Listen to the latest podcast episode on ...
- July 19, 2023: IMPACt-LBP Study Team Will Share Early Lessons in This Friday’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Dr. Christine Goertz and Dr. Adam Goode of Duke University will present “Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons From IMPACt-LBP.”
The Grand Rounds session will be held on Friday, July 21, 2023, at 1:00 pm eastern.
IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Trials, ...
- July 18, 2023: NIH Collaboratory Researchers Highlight Ethical Obligation, Value of Sharing Trial Results With Participants
In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. Both also participated in a discussion session about the challenges and value of results dissemination. DeBar is a principal investigator of the BackInAction and PPACT ...
- July 17, 2023: NIH Pragmatic Trials Collaboratory Welcomes First Class of Fellows
The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators from underrepresented or minoritized groups with a scholarly interest in pragmatic clinical trials.
“We are very excited to welcome the 2 inaugural fellows to the NIH Pragmatic Trials Collaboratory Fellowship Program and give them the education and ...
- July 13, 2023: Adrian Hernandez Shares Insights Into Driving Change to Promote Data Sharing
At the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, we interviewed Dr. Adrian Hernandez about how to better promote data sharing. Hernandez is a co–principal investigator of the program’s Coordinating Center and the executive director of the Duke Clinical Research Institute.
“We have to change the incentive structure because we still have barriers for ...
- July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial
In this Friday’s PCT Grand Rounds, Christopher Granger and Neha Pagidipati of Duke University will present “Lessons From the COORDINATE-Diabetes Trial.”
The Grand Rounds session will be held on Friday, July 14, 2023, at 1:00 pm eastern.
The Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes (COORDINATE)–Diabetes was a cluster randomized trial assessing the effect ...
- July 12, 2023: Workshop Materials Now Available From ‘Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings’
Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings.“
The 2-day workshop, held in June at the 2023 AcademyHealth Annual Research Meeting in Seattle, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus ...
- July 11, 2023: Chat 4 Heart Health NIH Collaboratory Trial Joins the NIH Pragmatic Trials Collaboratory
The NIH Collaboratory is excited to announce the addition of LE8 Bot + BackUp (or Using Artificially Intelligent Text Messaging Technology to Improve American Heart Association’s Life’s Essential 8 Health Behaviors) to its portfolio of innovative NIH Collaboratory Trials.
The American Heart Association (AHA) identifies Life’s Essential 8 (LE8) lifestyle factors as eating better, being more ...
- July 10, 2023: EHR Core’s Keith Marsolo Shares Scientific Goals and Resources Needed For Data Sharing
In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, Keith Marsolo, PhD, Co-Chair of the Electronic Health Records Core, reflected on data sharing experiences from the program and factors affecting the meaningful re-use of data.
“The data sharing experiences from the NIH Pragmatic Trials Collaboratory Trials have been fairly limited. Most ...
- July 6, 2023: NIH Pragmatic Trials Collaboratory Welcomes 2 New NIH Collaboratory Trials: BEST-ICU and TAICHIKNEE
The NIH Pragmatic Trials Collaboratory is excited to add 2 new NIH Collaboratory Trials to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. BEST-ICU (or Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU) is supported by the National Heart, Lung, and Blood Institute (NHLBI). TAICHIKNEE ...
- July 5, 2023: This Week’s PCT Grand Rounds to Highlight IMPLEMENT-HF Study
In this Friday’s PCT Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study.”
The Grand Rounds session will be held on Friday, July 7, 2023, at 1:00 pm eastern.
Dr. Bhatt is an associate physician at the Kaiser Permanente San ...
- July 3, 2023: Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data
Pragmatic research is vulnerable to biases due to differences in data capture and access to care for different subsets of the population, which, if left unaddressed, can propagate inequities in health and the healthcare system.
In a new article published online ahead of print in JAMIA, the NIH Pragmatic Trials Collaboratory’s Trial teams reflect on the ...
- June 29, 2023: Grand Rounds Podcast with Dr. Joshua Denny on All of Us Research Program is Available
In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Joshua Denny continues his discussion about All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.
The full May 5 Grand Rounds webinar with Dr. Denny is also available.
- June 29, 2023: Workshop Materials and Videocast Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’
Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
Access the complete workshop ...
- June 29, 2023: Health Equity Core Leaders Share Insights From Annual Steering Committee Meeting
In an interview during the annual Steering Committee meeting, Drs. Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group, shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory.
One question discussed at the meeting was how to embed health equity in pragmatic clinical trials. Gonzalez-Guarda said that ...
- June 28, 2023: In This Week’s PCT Grand Rounds, What’s Left for Decentralized Clinical Trials?
In this Friday’s PCT Grand Rounds, Adrian Hernandez, Pamela Tenaerts, and Craig Lipset will present “Decentralized Trials – From Guidance to Reality & What’s Left.”
The Grand Rounds session will be held on Friday, June 30, 2023, at 1:00 pm eastern.
Dr. Hernandez is a professor of medicine and director of the Duke Clinical Research Institute at ...