In this Friday’s Rethinking Clinical Trials Grand Rounds, Kenneth Kehl of the Dana-Farber Cancer Institute will present “Clinical Trial Notifications Triggered by Artificial Intelligence–Detected Cancer Progression.” The Grand Rounds session will be held on Friday, August 1, 2025, at 1:00 pm eastern. Kehl is a physician and associate director of research at the Dana-Farber Cancer Institute and ...

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Angelo Volandes, co–principal investigator (PI) of the ACP PEACE trial, led a panel of investigators who shared key challenges and lessons learned from their recently launched trials. The panelists included Stephanie Fitzpatrick, PI of the MOMs Chat & Care Study, Elizabeth Wick, co-PI of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Jon Tilburt of the Mayo Clinic in Arizona and Andrea Cheville of the Mayo Clinic in Minnesota will present “Initial Outcomes of the NOHARM Pragmatic Trial.” The Grand Rounds session will be held on Friday, July 25, 2025, at 1:00 pm eastern. NOHARM, an NIH Collaboratory Trial, is testing ...

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, a team of experts shared key decisions about whether or not to integrate digital tools into the electronic health record (EHR). The panel, moderated by Steve George of the NIH Collaboratory Coordinating Center, explained that the decision hinges on 4 critical factors: complexity, institutional ...

The Health Care Systems Research Network (HCSRN) will hold its 2026 Annual Conference from April 21 to 23, 2026, in Dallas, Texas. HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of ...

Features of the external environment during online medical group visits and interacting with the technology itself emerged as key themes in interviews with patients participating in the OPTIMUM trial. The findings were published online in Global Advances in Integrative Medicine and Health. OPTIMUM, an NIH Collaboratory Trial led by Natalia Morone of Boston University and Boston Medical Center, is ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Adrian Hernandez and Rebecca Sullenger of Duke University will present “State of Clinical Trials: An Analysis of ClinicalTrials.gov.” They will be joined by a discussion panel that will include Sara Bristol Calvert of the Clinical Trials Transformation Initiative (CTTI) and Karen Chiswell and Christopher J. Lindsell of Duke ...

Engaging with community partners can enrich and inform research through the lifespan of a trial. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Cherise Harrington, cochair of the program’s Community Health Improvement Core, led a discussion about building relationships with communities in pragmatic research. The panelists included Jennifer Kawi, principal ...

The P value is a statistic frequently used in biomedical research for the presentation of study findings. It represents a dichotomous decision about whether a finding is “statistically significant” based on a predetermined level, typically  < .05. Although the peer-reviewed journals in which researchers aspire to publish their work are anchored to P values, the information used ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Tyler Cope and Trevor Lentz of the Duke Clinical Research Institute will present “Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights From the AIM-back Trial.” The live webinar will be held on Friday, July 11, 2025, at 1:00 pm eastern. Cope is a clinical research ...

In an analysis of data on seriously ill older adults from emergency departments that participated in the PRIM-ER trial, poor prognosis was associated with fewer healthy days at home. However, a cancer diagnosis was associated with more healthy days at home. The analysis was published online this month in BMC Geriatrics. PRIM-ER, an NIH Collaboratory Trial, was ...

PTJ: Physical Therapy & Rehabilitation Journal (PTJ) is soliciting manuscript proposals for a special issue on embedded clinical research relevant to physical therapy and rehabilitation science. Proposals are due no later than September 1, 2025, and the special issue is scheduled for publication in 2026. From the announcement: Embedded Clinical Research: Pragmatic Trials, Big Data, and Beyond Traditionally, ...

Trust in their clinicians, positive interactions with study staff, and opportunities for social connection can improve recruitment, retention, and engagement with research participants, according to focus groups of participants in the OPTIMUM trial. These factors can be especially important for first-time research participants and for groups that are historically underrepresented in clinical trials. The article was published ...

Although the need for pragmatic research in primary care settings is great, conduct of pragmatic clinical trials in these settings remains nascent. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Wendy Weber of the National Center for Complementary and Integrative Health (NCCIH) led a discussion about how to expand ...

A key feature of the NIH Pragmatic Trials Collaboratory is its culture of learning and knowledge sharing among investigators who are planning and conducting pragmatic clinical trials. In a session at the program’s 2025 Annual Steering Committee Meeting, a panel of investigators discussed their recently completed NIH Collaboratory Trials and their thoughts about future directions ...

In a new episode of the NIH Pragmatic Trials Collaboratory Podcast, Rich Platt, Hayden Bosworth, and Greg Simon of the NIH Pragmatic Trials Collaboratory discuss their JAMA Viewpoint, “Making Pragmatic Clinical Trials More Pragmatic.” Listen and subscribe to the podcast on SoundCloud or Apple Podcasts. In the Viewpoint, the authors propose solutions to the discordance between the results of pragmatic trials ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Amrita Mukhopadhyay of the NYU Grossman School of Medicine will present “The BETTER CARE-HF Study: A Pragmatic Cluster Randomized Trial to Improve Heart Failure Care.” The live webinar will be held on Friday, June 27, 2025, at 1:00 pm eastern. Mukhopadhyay is the Eugene Braunwald, MD, Assistant Professor of ...

The study design paper for ARBOR-Telehealth has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! The ARBOR-Telehealth study is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. ...

A new section of the Living Textbook of Pragmatic Clinical Trials describes considerations for choosing patient-reported outcome measures in pragmatic clinical trials. “Where possible, investigators are encouraged to use measures with adequate support for validity that are in the public domain,” the authors wrote. The authors provide a set of questions to guide investigators in choosing appropriate ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Scott Garrison of the University of Alberta will present “The BedMed and BedMed-Frail Randomized Trials.” The trials compared bedtime vs morning administration of antihypertensive medications. The live webinar will be held on Friday, June 20, 2025, at 1:00 pm eastern. Garrison is a professor of family medicine at the ...

The NIH Pragmatic Trials Collaboratory held its 2025 Annual Steering Committee Meeting in Bethesda, Maryland, on May 28 and 29. The program’s leadership discussed evolving approaches to pragmatic clinical trials and considered the latest developments in the landscape of pragmatic research. All materials from the meeting are now available online. The NIH Pragmatic Trials Collaboratory added 3 ...

A new chapter of the Living Textbook of Pragmatic Clinical Trials describes regulatory requirements for informed consent, waivers and alterations of consent, mechanisms for notification, and research participants’ perspectives on a variety of approaches to consent and notification—all with a focus on special considerations for pragmatic clinical trials. For a variety of reasons, the  application of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Stephanie Morain, Nancy Kass, and Ruth Faden will present “Fit for Purpose: Improving the Ethical Oversight of Pragmatic Clinical Trials.” The live webinar will be held on Friday, June 13, 2025, at 1:00 pm eastern. Morain is an associate professor of health policy and management in the Bloomberg School ...

The Health Care Systems Research Network (HCSRN) will hold its 2026 Annual Conference from April 21 to 23, 2026, in Dallas, Texas. HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Jonathan Casey of Vanderbilt University Medical Center will present “The REDCap Advanced Randomization Module: A Trial Innovation Network Project to Support the Needs of Modern Trials.” The live webinar will be held on Friday, June 7, 2025, at 1:00 pm eastern. Casey is an assistant professor of medicine, a ...

In an evaluation conducted alongside the GGC4H trial, researchers assessed the intervention fidelity of a version of the Guiding Good Choices parenting program that was adapted for online delivery. They found that virtual delivery of the intervention was feasible but that retention of participants was a challenge. The report was published in the Journal of Community ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial.” The Grand Rounds session will be held on Friday, May 30, 2025, at 1:00 pm eastern. Bhatt is a cardiologist at the ...

The NIH Pragmatic Trials Collaboratory has launched a new learning module, Healthcare Data Interoperability and Standardization for Research, exploring the complexities of collecting, storing, and transforming healthcare data in the electronic health record to achieve optimal patient and research outcomes. The learning module, which was developed by members of the NIH Collaboratory’s Electronic Health Records Core ...

In a new episode of our Rethinking Clinical Trials Podcast, Drs. Angelo Volandes and James Tulsky speak with host Dr. Adrian Hernandez about the results of the ACP PEACE study. Listen and subscribe to the podcast on SoundCloud or Apple Podcasts. ACP PEACE, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized trial testing the delivery of a video decision ...

Pragmatic clinical trials embedded in healthcare systems rely on partnerships between investigators and healthcare system leaders to conduct research. As the end of a pragmatic trial approaches, research teams and their partners often face uncertainties around this undefined phase when researchers are waiting on results. End-of-trial decision-making, including whether to sustain an intervention, has implications ...

A video decision aid for older patients with advanced cancer, coupled with communication skills training for clinicians, led to higher rates of documented advance care planning in oncology clinics, according to the ACP PEACE study. The results of the study were published in the May issue of JAMA Network Open. Many older adults with advanced cancer do ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Jeffrey Spaeder and Adrian Hernandez will present “Pivoting Clinical Trials Into a New and Evolving World.” The Grand Rounds session will be held on Friday, May 16, 2025, at 1:00 pm eastern. Spaeder is the chief medical and scientific officer at IQVIA. Hernandez, who serves as co–principal investigator of ...

In this Friday’s PCT Grand Rounds, Andrea Cook, Lynn DeBar, and Patricia Herman will present “A Policy-Relevant Pragmatic Trial on Acupuncture Effectiveness for Low Back Pain in Older Adults: Clinical and Cost Outcomes and Lessons Learned.” The Grand Rounds session will be held on Friday, May 9, 2025, at 1:00 pm eastern. The speakers will present the ...

The Nudge Unit at Penn Medicine opened registration and abstract submissions for the 2025 Nudges in Health Care Symposium. The event is “focused on exploring the application of behavioral economics principles and nudges in healthcare settings.” The Nudge Unit is supported by Center for Health Care Transformation and Innovation and the Penn Center for Health Incentives ...

In this Friday’s PCT Grand Rounds, Roland RJ van Kimmenade will present “Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake: The FRESH-UP Study.” The Grand Rounds session will be held on Friday, May 2, 2025, at 1:00 pm eastern. Van Kimmenade is a cardiologist at Radboud University Medical Center in Nijmegen, Netherlands. Join the online meeting.

In this Friday’s PCT Grand Rounds, Ming Tai-Seale of the University of California, San Diego, will present “Automated Response Technology Integrated Into EMR and Physician-Patient Communication.” The Grand Rounds session will be held on Friday, April 25, 2025, at 1:00 pm eastern. Tai-Seale is professor and vice chair of research in the Department of Family Medicine at ...

Even in minimal-risk studies that do not use the standard consent process, there may be value in informing participants about the research. Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory. The open-access article was ...

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory’s newest studies is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the LungSMART trial and the STEP-2 trial. The consultations took place by video conference and included representation from the study ...

Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. The work, which was supported by the NIH Pragmatic Trials Collaboratory’s Distributed Research Network and by a grant from the National Institute on Aging, was published this week in Alzheimer’s & Dementia: ...

In this Friday’s PCT Grand Rounds, Sanjit Jolly of McMaster University will present “Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial.” The Grand Rounds session will be held on Friday, April 18, 2025, at 1:00 pm eastern. Jolly is an interventional cardiologist at Hamilton Health Sciences and the Stuart ...

The TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone! TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis. The practice of tai ...

A program that used automated prompts to deliver patient-specific risk information to clinicians led to significant reductions in the use of extended-spectrum antibiotics for hospitalized patients, according to the INSPIRE trials. The results of the trials were published online ahead of print in JAMA Internal Medicine and JAMA Surgery. INSPIRE, an NIH Collaboratory Trial, consists of 2 ...

In this Friday’s PCT Grand Rounds, Jeremy Shefner of the Barrow Neurological Institute will present “A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial.” The Grand Rounds session will be held on Friday, April 11, 2025, at 1:00 pm eastern. Shefner is a professor of neurology at the Barrow Neurological ...

The study design paper for IMPACt-LBP has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! IMPACt-LBP is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain. The study team is seeking to determine if ...

In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern. Heerman is an associate professor of internal medicine and pediatrics, the William K. ...

In this Friday’s PCT Grand Rounds, Matthew Engelhard and Anivarya Kumar of Duke University will present “A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management.” The Grand Rounds session will be held on Friday, March 28, 2025, at 1:00 pm eastern. Engelhard is an assistant professor ...

Researchers from iPATH, an NIH Collaboratory Trial, described key considerations for integrating artificial intelligence tools into analyses of qualitative data. The report was posted this month on the AcademyHealth Blog. The iPATH trial, led by principal investigator Sara Singer at Stanford University, will test the implementation of a practice transformation strategy for type 2 diabetes in federally ...

In this Friday’s PCT Grand Rounds, Alexander J. “AJ” Blood of Harvard Medical School and Brigham and Women’s Hospital will present “Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care.” The Grand Rounds session will be held on Friday, March 21, 2025, at 1:00 pm eastern. Blood is an instructor of medicine ...

In a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in non–intensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections. The study results were published this month in JAMA Network Open. ABATE Infection, an NIH Collaboratory Trial, was a cluster ...

In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND. Join the online meeting.