New study snapshots and updated ethics and regulatory documentation are now available for the LungSMART and STEP-2 trials. One year into the studies, and after receiving approval to transition to the implementation phase, the research teams reviewed and updated the minutes of their initial consultations with the Ethics and Regulatory Core. LungSMART and STEP-2 are the ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Andrea Cheville and Jon Tilburt will present the main outcomes of the NOHARM trial, “Boosting Peri-Operative Pain Care: Mixed Results (and Myriad Implications) From the NOHARM Pragmatic Trial.” Congratulations to Drs. Cheville and Tilburt and the entire NOHARM study team! The Grand Rounds session will be held on ...

The study design paper for TAICHIKNEE has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! TAICHIKNEE is comparing the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis. The practice of tai chi integrates physical, ...

The NIH Pragmatic Trials Collaboratory published the second installment of its special 4-part educational podcast series covering facets of pragmatic trial design that are essential to the success of embedded research. Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. Where Episode 1 of the series set the stage with ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Margaret Kuklinski and Stacy Sterling will present their main outcomes in “A Pragmatic Trial of Family-Focused Prevention in Pediatric Primary Care: Successes, Challenges, and Lessons Learned – Guiding Good Choices for Health (GGC4H).” Congratulations to Drs. Kuklinski, Sterling, and the entire GGC4H study team! The Grand Rounds session ...

In a study that used large language models (LLMs) to adjudicate documented goal-concordant care from longitudinal electronic health record (EHR) data, LLM-based ratings and rationales were broadly consistent with human adjudication. The study suggests that LLM-based tools show promise as complementary adjudicators of such records in research that would otherwise rely on labor-intensive manual chart ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Daniel Yazdi of UpDoc and Cedars-Sinai will present “Agentic AI in Cardiovascular Care Delivery: UpDoc’s Approach to ARPA-H ADVOCATE.” The Grand Rounds session will be held on Friday, October 23, 2026, at 1:00 pm eastern. Yazdi is the Clinical Product Lead at UpDoc and a cardiologist at Cedars-Sinai. Join the ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 19th Annual Conference on the Science of Dissemination and Implementation in Health in National Harbor, Maryland. The workshop, “Introduction to Dissemination and Implementation in Pragmatic Trials: Tools and Strategies for Enhancing Public Health Impact,” will provide an introduction to concepts in the design, conduct, ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Adrian Hernandez of Duke University will present “Catalyzing Change: How First-in-Patient Trials Can Fix US Clinical Trials.” The Grand Rounds session will be held on Friday, October 16, 2026, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute and a vice dean at ...

Among participants in the GRACE trial with sickle cell disease, depressive symptoms were associated with worse pain outcomes both directly and indirectly through pain catastrophizing. The study is the first to observe the mediating role of catastrophizing between depression and pain outcomes in adults with sickle cell disease and chronic pain. The report was published online ...

In medically underserved communities, patients’ prior experience with virtual doctor visits influenced their willingness to participate in a telehealth-delivered mindfulness program for chronic low back pain. The analysis from the OPTIMUM trial was published online in JMIR mHealth and uHealth. OPTIMUM, an NIH Collaboratory Trial, studied the addition of mindfulness-based group telehealth visits to usual care for ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Christoph Hornik and Moulik Shah will present “An End-to-End Agentic AI Platform to Automate Clinical Trials: A Proof-of-Concept and Evaluation Study.” The Grand Rounds session will be held on Friday, October 9, 2026, at 1:00 pm eastern. Hornik is a professor of pediatrics at Duke University and a member ...

A strategy of engagement with rural partners in the APA-SM trial led to codesign of a feasible, culturally relevant study intervention for use in rural settings. The results were published online in Frontiers in Pain Research. APA-SM, an NIH Collaboratory Trial, is testing a 4-week auricular point acupressure telehealth intervention for self-management of chronic pain in rural ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Alicia Heapy and Diana Higgins will present “Self-Directed Versus Clinician-Delivered Cognitive Behavioral Therapy for Chronic Pain: Results From the COPES ExTRA Pragmatic Trial.” The Grand Rounds session will be held on Friday, October 2, 2026, at 1:00 pm eastern. Heapy is an associate professor in the Department of Psychiatry ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 19th Annual Conference on the Science of Dissemination and Implementation in Health in National Harbor, Maryland. The workshop, “Introduction to Dissemination and Implementation in Pragmatic Trials: Tools and Strategies for Enhancing Public Health Impact,” will provide an introduction to concepts in the design, conduct, ...

In the NOHARM trial, a strategy to promote nondrug pain management after surgery reduced exposure to opioids without worsening pain interference, physical function, and other patient-reported outcomes. “Electronic health record (EHR)–enabled strategies that emphasize patient-centered decision-making and education may reduce opioid exposure while maintaining patient-centered outcomes, reinforcing the ongoing need for patient education to address opioid-related ...

Materials and video recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Endpoint Strategy in Pragmatic Trials: From Big Questions to Meaningful Outcomes.“ The workshop shared evidence and best practices in thoughtfully selecting endpoints and interpreting treatment effects in pragmatic clinical trials embedded in healthcare systems to best inform decision-making. The first day of ...

In September 2026, the NIH Pragmatic Trials Collaboratory published the first installment of a special 4-part educational podcast series covering facets of pragmatic trial design that are essential to the success of embedded research. Episodes are published monthly and will draw on expertise and experience from the NIH Collaboratory trials: Designing Fit-for-Purpose ePCTs (Wendy Weber, ND, ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Corey Bills of the University of Colorado will present “Research During Active War in Ukraine: Experiences From the PACT-ARROW Study.” PACT-ARROW (Prevention and Treatment Clinical Trials for Antimicrobial Resistance Research to Improve Outcomes of Traumatic Wounds in Ukraine) is using a master protocol as a platform for evaluating ...

The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, has announced a request for applications for its 2027 Health Care Systems Scholars Program. From the announcement: The IMPACT Collaboratory will fund up to two Health Care System Scholar Awards. Each award will provide up ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Erika Rangel of Harvard Medical School and Mass General Brigham will present “The 4th Trimester Initiative: A Randomized Controlled Trial of Support for Childbearing Medical Trainees.” The Grand Rounds session will be held on Friday, September 18, 2026, at 1:00 pm eastern. Rangel is an associate professor of surgery ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Ryan Zarychanski of the University of Manitoba will present “Embedded Trials in a Learning Health System: A Hospital Policy of Tranexamic Acid to Reduce Transfusion in Major Noncardiac Surgery.” The Grand Rounds session will be held on Friday, September 11, 2026, at 1:00 pm eastern. Zarychanski is a professor ...

The NIH Collaboratory Living Textbook offers a variety of training resources intended for researchers, research team members, clinicians, healthcare system leaders and staff, and others involved in pragmatic clinical trial (PCT) research. These resources cover foundational information preparing learners to engage meaningfully with PCT research. A Learning Modules section provides a series of self-paced videos featuring ...

Text message reminders to support cardiovascular medication adherence can be a low-cost tool for healthcare systems, according to a recent analysis from the Nudge study. The report was published online in the American Journal of Managed Care. The Nudge study, an NIH Collaboratory Trial led by Michael Ho of Kaiser Permanente Colorado and Sheana Bull of the ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on September 8 and 9, 2026, on “Endpoint Strategy in Pragmatic Trials: From Big Questions to Meaningful Outcomes.” The workshop will share evidence and best practices in thoughtfully selecting endpoints and interpreting treatment effects in pragmatic clinical trials embedded in healthcare systems to best inform ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Haider Warraich of ARPA-H will present “Evaluating Clinical Agentic AI.” The Grand Rounds session will be held on Friday, August 28, 2026, at 1:00 pm eastern. Warraich is a program manager at ARPA-H (Advanced Research Projects Agency for Health). Join the online meeting Add to your calendar: Google iCal Outlook Or join the Grand Rounds ...

A new article from the NOHARM team describes the strategies the team identified for supporting posttrial sustainment of the study intervention. Their experience highlights the importance of planning for sustainment and offers lessons for designers of future pragmatic clinical trials. The article was published online in Learning Health Systems. NOHARM, an NIH Collaboratory Trial led by Andrea ...

Using the interactive text messaging intervention from the LungSMART trial as a case study, researchers demonstrated the application of a proposed framework for assessing the fit of custom large language models (LLMs) in public health interventions. The report was published online in the Journal of Medical Internet Research. Integration of custom LLMs into health chatbots and other ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Eric Karl Oermann of New York University will present “Off-Label Intelligence: Books, Language Models, and AI as a Medical Device.” The Grand Rounds session will be held on Friday, August 21, 2026, at 1:00 pm eastern. Oermann is an associate professor of neurosurgery, radiology, and data science at New ...

In a new episode of the NIH Pragmatic Trials Collaboratory Podcast, Alison Huang and Derek Angus expanded on key insights from their recent Grand Rounds presentation in which they introduced the mission and structure of JAMA+ Trials. Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. A high ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on September 8 and 9, 2026, on “Endpoint Strategy in Pragmatic Trials: From Big Questions to Meaningful Outcomes.” The workshop will share evidence and best practices in thoughtfully selecting endpoints and interpreting treatment effects in pragmatic clinical trials embedded in healthcare systems to best inform ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Christopher Lindsell, Lloyd Michener, Justin Moore, Boris Volkov, and Reuben Adatorwovor will present “Designing for Impact: Introducing Translational Design Studies.” The Grand Rounds session will be held on Friday, August 14, 2026, at 1:00 pm eastern. Lindsell is vice dean for data science and AI at the Duke University ...

STEP-2, an NIH Collaboratory Trial, will evaluate the comparative effectiveness and cost-effectiveness of in-clinic vs mailed distribution of human papillomavirus (HPV) self-sampling kits to improve cervical cancer screening rates among patients receiving care in community health centers. This summer, after our 2026 Annual Steering Committee Meeting, we spoke with co-principal investigators Rachel Winer, Amanda Petrik, and ...

Members of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core Working Group recorded the experiences of pragmatic trial investigators in using computable phenotypes in their studies. The article was published online in JAMIA Open. Using real-world data for research poses many challenges, including variations in data documentation practices. Researchers use computable phenotypes—data queries that use ...

In a secondary analysis of data from the INSPIRE trials, an antibiotic stewardship program that included automated prompts to deliver patient-specific risk information to clinicians led to significant reductions in the use of extended-spectrum antibiotics in patients with cancer who were hospitalized with infection. The analysis extends the findings of INSPIRE to a population of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Sreek Vemulapalli and Ricardo Henao will present “ADAPT-CEC: AI for Clinical Event Adjudication and Implications for Clinical Trials.” The Grand Rounds session will be held on Friday, August 7, 2026, at 1:00 pm eastern. Vemulapalli is an associate professor of medicine and the director of cardiovascular imaging at Duke ...

In a qualitative study, the APA-SM team gained insights from research partners in rural areas to inform refinements of the trial’s smartphone-based intervention for self-management of chronic musculoskeletal pain. The results of the qualitative study were published online in Health Services Insights. APA-SM, an NIH Collaboratory Trial, is testing a 4-week auricular point acupressure telehealth intervention for ...

In a new episode of the Rethinking Clinical Trials Podcast, Christine Goertz and Steven George of Duke University discussed slow recruitment mitigation strategies, one of the small group discussion topics at the NIH Pragmatic Trial Collaboratory’s 2026 Annual Steering Committee Meeting. Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Steven T. George and S. Nicole Hastings will present “Sequenced Care Pathway Versus Pain Navigator Pathway for Veterans With Low Back Pain: Results and Reflections From the AIM-Back Cluster Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, July 31, 2026, at 1:00 pm eastern. George ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on September 8 and 9, 2026, on “Endpoint Strategy in Pragmatic Trials: From Big Questions to Meaningful Outcomes.” The workshop will share evidence and best practices in thoughtfully selecting endpoints and interpreting treatment effects in pragmatic clinical trials embedded in healthcare systems to best inform ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Rachel Greenberg and Danny Benjamin will present “The Pediatric Trials Network: Innovating to Make Drugs Safe and Effective for Children.” The Grand Rounds session will be held on Friday, July 24, 2026, at 1:00 pm eastern. Greenberg is a professor of pediatrics at Duke University and an MPI of ...

Having patients and other research partners at the table during the planning of dissemination strategies is key to sustaining effective interventions and driving practice change. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with Hayden Bosworth and Cherise Harrington about the value of planning for and following through on dissemination in pragmatic ...

The NIH Pragmatic Trials Collaboratory has added a new section to the Living Textbook in the Building Partnerships and Teams to Ensure a Successful Trial chapter. The new section, Partnering With Underresourced Clinics to Conduct PCTs, focuses on partnering with federally qualified health centers (FQHCs) and other underresourced clinics to conduct pragmatic clinical trials. FQHCs and ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Ary Serpa Neto of Monash University and Austin Health will present “Sodium Bicarbonate for Metabolic Acidosis in the Intensive Care Unit (The SODa-BIC Trial).” The Grand Rounds session will be held on Friday, July 17, 2026, at 1:00 pm eastern. Serpa Neto is the Co-deputy Director of the Australian ...

Three studies from the first cohort of NIH Collaboratory Trials in pain management supported through the NIH HEAL Initiative are nearing completion. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we asked investigators Natalia Morone, Andrea Cheville, and Ardith Doorenbos to reflect on their experiences in the program and to share lessons for other ...

EquiP PC, an NIH Collaboratory Trial, will test an adapted behavioral health integration toolkit to improve chronic pain care. The trial will assess reduced pain interference, improved integrated behavioral health, and implementation success with the goal of expanding access to high-quality, team-based chronic pain care in primary care settings. At the NIH Collaboratory’s 2026 Annual Steering ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Fran Balamuth of the University of Pennsylvania and Scott Weiss of Thomas Jefferson University will present “A Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis.” The Grand Rounds session will be held on Friday, July 10, 2026, at 1:00 pm eastern. Balamuth is a professor of ...

The increasing presence of AI in healthcare settings and the use of AI tools in clinical trials raise questions about how these tools can be rigorously evaluated to generate the best evidence base for their potential benefits and harms. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with Jeremy Sugarman and Adrian ...

The NIH Office of Disease Prevention will continue its Methods: Mind the Gap webinar series on July 29 with “From Working Models to Reliable Evidence: Robust and Efficient Analysis of Cluster-Randomized Trials.” Dr. Bingkai Wang of the University of Michigan School of Public Health will lead the session. From the announcement: Cluster-randomized trials are essential for evaluating ...

Participation in telehealth-delivered, mindfulness-based group medical visits led to significant improvements in pain intensity and pain interference among patients with chronic low back pain in the OPTIMUM pragmatic trial. The results of the trial were published online ahead of print in JAMA Internal Medicine. OPTIMUM, an NIH Collaboratory Trial, studied the addition of mindfulness-based group telehealth visits ...