Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Digging Into Dilemmas of Pragmatic Clinical Trials.“ The 2-day workshop, hosted by the NIH, featured a keynote address by David Zaas, president of Atrium Health Wake Forest Baptist, gaps and opportunities for researchers in the US healthcare system. The first day of ...

In 2 recent studies, as part of the NOHARM trial, researchers explored the perspectives of patients and nurses on the implementation of a perioperative nonpharmacologic pain care education program. One study, published in JMIR Nursing, evaluated inpatient nurses’ perceptions of barriers and facilitators to implementing the Healing After Surgery initiative. Healing After Surgery is a program ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Laura Galuchie and Zak Smith will present “Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data.” The Grand Rounds session will be held on Friday, November 21, 2025, at 1:00 pm eastern. Galuchie is a senior director of global clinical development at Merck & Co, Inc. Smith ...

Patients with chronic low back pain and other chronic overlapping pain conditions, compared with patients with low back pain alone, experienced more severe pain symptoms and higher levels of anxiety, depression, and fatigue, according to an analysis from the OPTIMUM trial. The report was published in the October issue of the European Journal of Pain. Chronic low ...

The NIH Pragmatic Trials Collaboratory launched a new learning module video, Lessons Learned From Implementing a Pragmatic Trial Using EHR and Other Real-World Data. The video explores opportunities for turning routine clinical care recorded in the electronic health record (EHR) into real-world data for pragmatic trials. The video uses the experience of ICD-Pieces, an NIH Collaboratory ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Mark Siedner of Harvard Medical School will present “IMPACT-BP: A Community-Based Intervention for Sustainable Blood Pressure Control in Rural KwaZulu-Natal, South Africa.” The Grand Rounds session will be held on Friday, November 14, 2025, at 1:00 pm eastern. Siedner is a professor of medicine at Harvard Medical School and ...

We are excited to add 2 new NIH Collaboratory Trials to our portfolio of innovative pragmatic clinical trials embedded in healthcare systems. CARNATION and EquiP PC are supported by the National Institute of Neurological Disorders and Stroke through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component ...

Two of the newest NIH Collaboratory Trials have begun enrollment. Congratulations to the study teams from APA-SM and iPATH for reaching this important project milestone! APA-SM is enrolling patients in a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in South Carolina and Texas. The study will also include implementation outcomes, ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Daniel Pach and Stefanie Lysk will present “EMMA – A Remote, Decentralized Clinical Trial to Evaluate the Effectiveness of a Migraine App.” The Grand Rounds session will be held on Friday, November 7, 2025, at 1:00 pm eastern. Pach is a senior researcher at Charité – Universitätsmedizin Berlin with ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 18th Annual Conference on the Science of Dissemination and Implementation in Health in National Harbor, Maryland. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions,” will introduce concepts in the design, conduct, and implementation of ...

The NIA IMPACT Collaboratory announced a request for applications for its 2025 Demonstration Projects Grants Program. The program will fund up to 2 Demonstration Projects, each providing up to $800,000 in total direct costs over a 24-month period. The awards will support full-scale embedded pragmatic clinical trials. Projects must evaluate the effectiveness of nonpharmacological interventions embedded ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Peter Margolis, Sean C. Dowdy, and Sarah Greene will present “The LHS Shared Commitments — All Treats, No Tricks.” The Grand Rounds session will be held on Friday, October 31, 2025, at 1:00 pm eastern. Margolis is an adjunct professor of pediatrics at the Stanford University School of Medicine ...

The NIH Pragmatic Trials Collaboratory has expanded its social media presence to the Bluesky social media platform to promote research that advances the design, conduct,  dissemination, and implementation of pragmatic clinical trials. If you are active on Bluesky, we invite you to follow us for the latest news about our innovative NIH Collaboratory Trials, tools and resources from the Core ...

A new study snapshot and updated ethics and regulatory documentation are now available for the APA-SM study. A year into the project, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. New resources for APA-SM include: a study snapshot updated ethics and regulatory documentation APA-SM is testing a 4-week auricular ...

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel proposals for its 2026 Annual Conference until December 8, 2025. This year’s meeting will be held in Dallas from April 21 to 23, 2026. Information about conference registration, preconference workshops, and accommodations is also available. Early-bird registration is open through March 2. The them ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Renato Lopes of the Duke University Medical Center will present “Studying Neglected Diseases: Insights From the PARACHUTE-HF Trial.” The Grand Rounds session will be held on Friday, October 24, 2025, at 1:00 pm eastern. Lopes is a professor of medicine in the cardiology division at Duke University Medical Center ...

In a new episode of the Rethinking Clinical Trials Podcast, Emily O’Brien of Duke University expanded on key takeaways from her recent Grand Rounds presentation, “Avoiding the Fumble: Building on a Decade of Lessons from Pragmatic Clinical Trials.” Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. The Grand Rounds presentation ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on November 4 and 5, 2025, on “Digging Into Dilemmas of Pragmatic Clinical Trials.” David Zaas, president of Atrium Health Wake Forest Baptist, will deliver a keynote presentation describing the state of healthcare delivery in the United States and the constraints on healthcare systems that ...

A new article from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core offers a comprehensive scoping review of published empirical ethics research related to pragmatic clinical trials. These trials, which are designed to assess evidence-based interventions in real-world settings, present a variety of unique ethical and regulatory challenges. The article was published online ahead of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Charles Bailey of the University of Pennsylvania and Keith Marsolo of the Duke University School of Medicine will present “Making Effective Use of Data Infrastructure in PCORnet®.” The Grand Rounds session will be held on Friday, October 17, 2025, at 1:00 pm eastern. Bailey is an associate professor of ...

The NIH Pragmatic Trials Collaboratory this week published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, Decentralized Pragmatic Clinical Trials, covers activities of a pragmatic trial that can occur remotely—at a location separate from an investigator’s location—such as participant engagement, recruitment, consent, study interventions and procedures, collection of patient-reported outcomes, ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Julie Fritz of the University of Utah and Sebastian Tong of the University of Washington will present “Engaging Rural Communities in Pragmatic Clinical Trials: Leveraging the CARE for Health Initiative Hubs to Enhance Enrollment for BeatPain.” The Grand Rounds session will be held on Friday, October 10, 2025, ...

A new study snapshot and updated ethics and regulatory documentation are now available for the iPATH trial. Eighteen months into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. New resources for iPATH include: a study snapshot updated ethics and regulatory documentation iPATH, an NIH Collaboratory Trial led ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on November 4 and 5, 2025, on “Digging Into Dilemmas of Pragmatic Clinical Trials.” David Zaas, president of Atrium Health Wake Forest Baptist, will deliver a keynote presentation describing the state of healthcare delivery in the United States and the constraints on healthcare systems that ...

The study design paper for I CAN DO Surgical ACP has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! I CAN DO Surgical ACP, an NIH Collaboratory Trial, is testing a system-based approach to help older adults undergoing elective surgery engage in advance ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Elisabetta Tonet of the Azienda Ospedaliero–Universitaria di Ferrara will present “Multi-Domain Rehabilitation for Older Patients With Myocardial Infarction: The PIpELINe Trial.” The Grand Rounds session will be held on Friday, October 3, 2025, at 1:00 pm eastern. Tonet is a cardiology consultant in the Cardiology Unit of the Azienda ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 18th Annual Conference on the Science of Dissemination and Implementation in Health in National Harbor, Maryland. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions,” will introduce concepts in the design, conduct, and implementation of ...

Community health centers serving a higher percentage of unhoused patients and patients who are best served in a language other than English had lower rates of diabetes control, hypertension control, or both, according to an analysis from the iPATH research team. The findings can inform initiatives to improve care in community health centers. The report was ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 26, longtime leaders from the NIH Pragmatic Trials Collaboratory will present “Significance in Pragmatic Clinical Trials: P Values vs Decision-Maker Perspectives.” The Grand Rounds session will be held on Friday, September 26, 2025, at 1:00 pm eastern. Greg Simon is a senior investigator at the ...

In a new episode of the Rethinking Clinical Trials Podcast, Greg Simon and Lorella Palazzo discuss key takeaways from the new End-of-Trial Decision-Making chapter of the Living Textbook. Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. The chapter provides guidance on how to navigate the hiatus between the end of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Denise van Hout of University Medical Center Utrecht will present “Hurdles for the Delivery of Trials: Insights From the Randomized Embedded Multifactorial Adaptive Platform Trial on Community-Acquired Pneumonia (REMAP-CAP) in Europe.” The Grand Rounds session will be held on Friday, September 19, 2025, at 1:00 pm eastern. van Hout ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on November 4 and 5, 2025, on “Digging Into Dilemmas of Pragmatic Clinical Trials.” David Zaas, president of Atrium Health Wake Forest Baptist, will deliver a keynote presentation describing the state of healthcare delivery in the United States and the constraints on healthcare systems that ...

Older patients with chronic low back pain who receive acupuncture treatment have greater improvements in pain and disability compared with patients who receive usual care alone, according to the BackInAction trial. The results of the study were published online in JAMA Network Open. BackInAction, an NIH Collaboratory Trial, compared standard and enhanced courses of acupuncture with usual ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Natalia Morone, Carol Greco, and Kim Faurot will present “Initial Outcomes of the Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) Pragmatic Trial.” The Grand Rounds session will be held on Friday, September 12, 2025, at 1:00 pm eastern. OPTIMUM, an NIH Collaboratory Trial, is studying the addition ...

In a descriptive analysis of the study population in the BackInAction trial, researchers found that participants enrolled from federally qualified health centers (FQHCs) had higher than average clinical and social risks at baseline, potentially complicating intervention delivery for these patients while adding to the generalizability of the trial’s results. The report was published in Contemporary Clinical ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 26, longtime leaders from the NIH Pragmatic Trials Collaboratory will present “Significance in Pragmatic Clinical Trials: P Values vs Decision-Maker Perspectives.” The Grand Rounds session will be held on Friday, September 26, 2025, at 1:00 pm eastern. Greg Simon is a senior investigator at the ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Robert Califf of Duke University will present “The Non-Learning Health System.” The Grand Rounds session will be held on Friday, September 5, 2025, at 1:00 pm eastern. As a former US commissioner of food and drugs, Califf led the Food and Drug Administration from 2016 to 2017 and again ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 5, special guest Dr. Robert Califf will present “The Non-Learning Health System.” The Grand Rounds session will be held on Friday, September 5, 2025, at 1:00 pm eastern. As a former US commissioner of food and drugs, Califf led the Food and Drug Administration from ...

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, researchers discussed the obligations pragmatic trials researchers have to research participants, partnering healthcare systems, and each other after a trial is complete. Panelists for the session included moderators Pearl O’Rourke and Jeremy Sugarman, cochairs of the NIH Collaboratory’s Ethics and Regulatory Core; Stephanie Morain, also ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Emily O’Brien of Duke University will present “The PCORnet Playbook: Avoiding the Fumble in Pragmatic Trials.” The Grand Rounds session will be held on Friday, August 22, 2025, at 1:00 pm eastern. O’Brien is an associate professor in population health sciences at Duke University. She serves as cochair of ...

A new analysis from the INSPIRE research team found that automated prompts to improve judicious use of antibiotics for hospitalized patients led to sustained reductions in the use of extended-spectrum antibiotics. The findings were reported in a research letter in JAMA. INSPIRE, an NIH Collaboratory Trial, consisted of 2 cluster randomized trials that used personalized clinical decision ...

Does a higher or lower target for phosphate control offer the best balance of benefits and risks in patients receiving maintenance hemodialysis? This important question remains unanswered, after the HiLo research team reported on the challenges that led to early termination of their innovative pragmatic clinical trial. The article was published online ahead of print in ...

In a new episode of the Rethinking Clinical Trials Podcast, Pearl O’Rourke and Dave Wendler discuss their recent publication, “Disentangling Informing Participants From Obtaining Their Consent.” Listen and subscribe to the podcast on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. O’Rourke and Wendler noted that IRBs will often assume nothing needs to be communicated to participants in trials that ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Tim Walsh, Chris Weir, and Richard Parker of the University of Edinburgh will present “Dexmedetomidine or Clonidine-Based Sedation Compared With Propofol in Critically Ill Patients: The A2B Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, August 15, 2025, at 1:00 pm eastern. Walsh is professor ...

The NIH Pragmatic Trials Collaboratory Implementation Science Core, led by Devon Check and Hayden Bosworth, has developed a new chapter on implementation to assist study teams with the complex process of using and studying implementation strategies to help implement research findings into clinical care. The chapter includes sections on: Factors Influencing Implementation of PCT Results Incorporating Implementation ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Eden Evins of Harvard Medical School will present “Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, August 8, 2025, at 1:00 pm eastern. Evins is the Cox Family Professor of Psychiatry in the Field of Addiction Medicine and ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 5, special guest Dr. Robert Califf will present “The Non-Learning Health System.” The Grand Rounds session will be held on Friday, September 5, 2025, at 1:00 pm eastern. As a former US commissioner of food and drugs, Califf led the Food and Drug Administration from ...

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, ...

Pragmatic clinical trials are conducted as part of routine healthcare delivery and often compare an intervention to usual care. To do this, researchers must understand, monitor, and document standard care at participating research sites. At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Duke University’s Emily O’Brian asked a panel of trialists about the ...

In a new episode of the NIH Pragmatic Trials Collaboratory Podcast, Lesley Curtis and Keith Marsolo of the NIH Pragmatic Trials Collaboratory discuss the latest Living Textbook learning module, “Healthcare Data Interoperability and Standardization for Research.” Listen and subscribe to the podcast on SoundCloud or Apple Podcasts. Curtis and Marsolo developed the module to help researchers understand how healthcare data ...