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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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. ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...