- March 14, 2024: IMPACT Collaboratory Announces New Statistical Tools for Pragmatic Trials
The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available.
The program’s Design and Statistics Core ...
- March 13, 2024: In This Friday’s PCT Grand Rounds, a Pragmatic Trial of Antibiotic Choice on Renal Outcomes
In this Friday’s PCT Grand Rounds, Edward Qian of Vanderbilt University will present “The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial.”
The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern.
The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury ...
- March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials
In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results ...
- March 6, 2024: In This Week’s PCT Grand Rounds, Public-Private Partnerships in Health AI
In this Friday’s PCT Grand Rounds, Michael Pencina of Duke University will present “Public-Private Partnerships in the Trustworthy Health AI Ecosystem.”
The Grand Rounds session will be held on Friday, March 8, 2024, at 1:00 pm eastern.
Pencina is a professor of biostatistics and bioinformatics and the vice dean for data science in the Duke University School ...
- March 5, 2024: Registration Opens for Pragmatic Trials Workshop at SCT 45th Annual Meeting
The NIH Pragmatic Trials Collaboratory will offer a preconference workshop at the 45th Annual Meeting of the Society for Clinical Trials in Boston. Registration for the workshop is now open.
The workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials ...
- February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.”
The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern.
Doyle is the Erwin H. Schell Professor ...
- February 27, 2024: HCSRN Announces Preconference Grant Writing Workshop, Extends Early-Bird Registration
The Health Care Systems Research Network (HCSRN) extended early-bird registration for its 2024 Annual Conference to February 29. The conference will be held from April 9 to 11 in Milwaukee, Wisconsin.
New this year, a preconference grant writing workshop will take place on Monday, April 8. The workshop will bring together experts throughout HCSRN to assist ...
- February 26, 2024: In PRIM-ER Qualitative Study, EM Talk Program Improved Serious Illness Conversation Skills
Communication skills training using the EM Talk model reached a high proportion of clinicians in participating emergency departments and improved their serious illness conversation skills, according to a qualitative study conducted as part of the PRIM-ER trial. The observed reach and effectiveness of the training program has the potential to improve use of these skills ...
- February 22, 2024: Updated Template Provides Guidance for Reporting of Pragmatic Trial Results
An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials.
The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems ...
- February 21, 2024: In This Week’s PCT Grand Rounds, Virtual Monitoring in Decentralized Clinical Trials
In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”
The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern.
Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice ...
- February 19, 2024: Virtual Monitoring in Decentralized Trials, in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”
The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern.
Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice ...
- February 14, 2024: In This Friday’s PCT Grand Rounds, Clinical Implications of the MINT Trial
In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.”
The Grand Rounds session will be held on Friday, February 16, 2024, at 1:00 pm eastern.
Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard ...
- February 13, 2024: New Chapter of Living Textbook Highlights Value of Patient Engagement and Provides Practical Strategies
The NIH Pragmatic Trials Collaboratory published a new chapter in its Living Textbook of Pragmatic Clinical Trials. The chapter, Patient Engagement, describes principles and strategies for effectively engaging patient partners.
Because patients can provide valuable insights and perspectives about clinical care for specific conditions, they are key partners for pragmatic clinical trials. The chapter highlights the value ...
- February 8, 2024: HCSRN Nears Early-Bird Registration Deadline, Announces Opening Plenary Speaker
The Health Care Systems Research Network (HCSRN) continued early-bird registration and announced the opening plenary speaker for its 2024 Annual Conference, which will be held from April 9 to 11 in Milwaukee, Wisconsin.
This year’s opening plenary session will feature keynote speaker David Kent, director of the Tufts Predictive Analytics and Comparative Effectiveness Center and a ...
- February 7, 2024: Pragmatic Recruitment of Underrepresented Groups, in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.”
The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern.
Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in ...
- February 6, 2024: Racial and Ethnic Minority Injury Survivors See Greater Improvements in PTSD Symptoms in the TSOS Study
Injury survivors from racial and ethnic minority groups experienced greater improvements than White injury survivors in their posttraumatic stress disorder (PTSD) symptoms after receiving a stepped collaborative care intervention. This was the finding of a secondary analysis of data from the Trauma Survivors Outcomes and Support (TSOS) study, an NIH Pragmatic Trials Collaboratory Trial led ...
- January 31, 2024: Improving the Public’s Understanding of the FDA, in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Susan Winckler of the Reagan-Udall Foundation for the FDA will present “Strategies for Improving Public Understanding of FDA and the Products It Regulates: Why Should We Care, and What Might We Do?”
The Grand Rounds session will be held on Friday, February 2, 2024, at 1:00 pm eastern.
Winckler is the ...
- January 29, 2024: IMPACT Collaboratory Announces Health Equity Certificate Program for Pragmatic Trials Researchers
The NIA IMPACT Collaboratory announced a new online certificate program designed to empower researchers at all levels in integrating health equity considerations into embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners.
Program Overview
This comprehensive training program, aligned with the IMPACT Collaboratory’s “Best Practices for Integrating Health Equity into ePCTs for ...
- January 25, 2024: Living Textbook Offers Pointers for Using an sIRB
The NIH Pragmatic Trials Collaboratory this week published a new chapter in its Living Textbook of Pragmatic Clinical Trials. Part of the Living Textbook’s new Ethics and Regulatory collection, the chapter discusses the logistics of using a single IRB (sIRB).
In 2016, the NIH issued a policy establishing the expectation that a “single IRB of record” ...
- January 24, 2024: In This Friday’s PCT Grand Rounds, Healthcare AI That’s Safe, Effective, and Equitable
In this Friday’s PCT Grand Rounds, Suresh Balu and Mark Sendak of Duke University will present “Advancing the Safe, Effective, and Equitable Use of AI in Healthcare.”
The Grand Rounds session will be held on Friday, January 26, 2024, at 1:00 pm eastern.
Balu is the director of the Duke Institute for Health Innovation (DIHI) and the ...
- January 23, 2024: Ethics Consultation Documents Now Available for RAMP Trial
Ethics and regulatory onboarding documentation is now available for RAMP, one of the NIH Pragmatic Trials Collaboratory’s newest pragmatic clinical trials. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the study.
The consultation took place by video conference and included representation from the study’s principal investigator ...
- January 22, 2024: Your Pragmatic Trial Has Ended. Now What?
What happens to a pragmatic trial intervention after the study ends?
In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s completed pragmatic clinical trials summarize the posttrial interpretation of their trials’ results and consider the factors that influenced the sustainment or de-implementation of the studies’ interventions.
The article was published ...
- January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?
In this Friday’s PCT Grand Rounds, Pamela Douglas of Duke University will present “Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials.”
The Grand Rounds session will be held on Friday, January 19, 2024, at 1:00 pm eastern.
Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past ...
- January 16, 2024: Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study
Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory’s newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study.
The consultations took place by video conference and included representation ...
- January 11, 2024: BeatPain Utah Study Team Uses Implementation Mapping Approach to Plan Hybrid Trial
In a new article from the NIH Pragmatic Trials Collaboratory, the BeatPain Utah study team describes the “implementation mapping” they used to plan for trial implementation. The comprehensive, systematic approach enabled the team to craft an implementation plan for a complex telehealth intervention and to identify outcomes for evaluating the success of the implementation strategies.
The ...
- January 10, 2024: In This Friday’s PCT Grand Rounds, a Lottery for Allocating Scarce COVID-19 Resources
In this Friday’s PCT Grand Rounds, Erin McCreary of the University of Pittsburgh will present “Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce COVID-19 Resources.”
The Grand Rounds session will be held on Friday, January 12, 2024, at 1:00 pm eastern.
McCreary is a clinical assistant professor of medicine at the University of Pittsburgh ...
- January 9, 2024: Ethics Consultation Documents Now Available for iPATH Trial
Ethics and regulatory onboarding documentation is now available for iPATH, one of the NIH Pragmatic Trials Collaboratory’s newest pragmatic clinical trials. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the study.
The consultation took place by video conference and included representation from the study’s principal investigator ...
- January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them.
The article was published this week in Contemporary Clinical Trials.
PRO measures reflect meaningful aspects ...
- January 3, 2024: Special Biostatistics Series Concludes With Missing Data in Cluster Randomized Trials
In this Friday’s PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with “Methods for Handling Missing Data in Cluster Randomized Trials.” The session will be held on Friday, January 5, at 1:00 pm eastern.
Wang is ...
- January 2, 2024: NINR Announces Funding Opportunity to Address Social Needs Through Healthcare-Community Partnerships
The National Institute of Nursing Research (NINR) has published a funding opportunity for research to develop and expand interventions and programs that leverage existing or create new healthcare-community partnerships to address unmet social needs among individuals and families and adverse social determinants of health within communities-especially in populations that experience health disparities.
Read the full announcement ...
- December 18, 2023: Ethics Consultation Documents Now Available for ARBOR-Telehealth and I CAN DO Surgical ACP
Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory’s newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the ARBOR-Telehealth and I CAN DO Surgical ACP studies.
The consultations took place by video conference and included representation from ...
- December 13, 2023: In This Week’s PCT Grand Rounds, a Path Forward for Diversifying Clinical Trials
In this Friday’s PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present “Diversifying Clinical Trials: A Path Forward.”
The Grand Rounds session will be held on Friday, December 15, 2023, at 1:00 pm eastern.
Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the ...
- December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the Distributed Research Network, and study designs and results from the NIH ...
- December 6, 2023: Jumpstarting Communication About Goals of Care, in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present “A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness.”
The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm ...
- December 5, 2023: Applications Open for HDRN Canada Pragmatic Trials Training Program
Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program.
This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors. Funding will be made available ...
- December 4, 2023: Latest Grand Rounds Podcast Features Harlan Krumholz and the Yale PaxLC Trial Research Team
In a new episode of our Rethinking Clinical Trials podcast, Dr. Harlan Krumholz and members of his research team speak with host Dr. Lesley Curtis about lessons from the digital, decentralized, and democratized Yale PaxLC Trial. Krumholz and team presented on their experiences during the October 27 session of Grand Rounds.
Listen and subscribe to the ...
- November 30, 2023: HCSRN Calls for Abstracts and Panel Presentations for 2024 Annual Conference
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2024 Annual Conference until December 11, 2023. This year’s meeting will be held in Milwaukee, Wisconsin, from April 9 to 11, 2024.
The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. ...
- November 29, 2023: NIH Offers Methods Webinar on Implementation Science With Insights From Behavioral Economics
The NIH Office of Disease Prevention will continue its Methods: Mind the Gap webinar series on Friday, December 8, with “Supercharging Implementation Science With Insights From Behavioral Economics.” Rinad Beidas, chair and Ralph Seal Paffenbarger Professor of Medical Social Sciences at the Feinberg School of Medicine at Northwestern University, will lead the webinar.
The Methods: Mind ...
- November 29, 2023: Special Biostatistics Series Continues With Guidelines for Stepped-Wedge Trials
In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern.
Hughes is a professor ...
- November 28, 2023: Workshop Summary Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’
The workshop summary is 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.
The workshop included 4 panels:
Panel ...
- November 27, 2023: NIH Announces Funding Opportunity for Implementation Studies of Substance Use Treatment and Prevention in Populations That Experience Health Disparities
The National Institutes of Health’s Office of Disease Prevention (ODP) issued a new funding opportunity to support implementation studies in treatment and prevention for alcohol, tobacco, and other drugs use and misuse in adult populations that experience health disparities.
ODP and participating NIH Institutes and Centers are inviting applications for research projects that test innovative approaches ...
- November 15, 2023: In This Friday’s PCT Grand Rounds, Results From the Nudge NIH Collaboratory Trial
In this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull of the University of Colorado will present “Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results From the Nudge Study.”
The Grand Rounds session will be held on Friday, November 17, 2023, at 1:00 pm eastern.
Nudge is an NIH Collaboratory ...
- November 13, 2023: New Chapter of Living Textbook Explores Ethical Considerations for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials
The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Ethics and Equity for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials,” describes key considerations and challenges with leveraging artificial intelligence and machine learning in pragmatic clinical trials.
The chapter provides guidance on responsible ...
- November 2, 2023: NIH Pragmatic Trials Collaboratory Launches New Online Training Resources
The NIH Pragmatic Trials Collaboratory has launched an enhanced training section of rethinkingclinicialtrials.org that includes a new series of video learning modules and reorganized and refreshed pragmatic clinical trials training resources.
The new training section features a series of 8 self-paced, guided video modules on topics that cover every phase of a pragmatic clinical trial. The ...
- November 1, 2023: Special Biostatistics Series Continues With Complex Clustering in Pragmatic Trials
In this Friday’s PCT Grand Rounds, Jonathan Moyer of the NIH Office of Disease Prevention will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “The Perils and Pitfalls of Complex Clustering in Pragmatic Trials.” The session will be held on Friday, November 3, at 1:00 pm ...
- 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 ...