The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials. Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in ...

In an article published online this week, leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities. The electronic health record and other digital modes ...

Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems. “Teams need to be aware of—and perhaps proactively investigate—possible changes ...

In a JAMA Viewpoint published online this week, coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices. In a decentralized clinical trial, some or all of the trial-related activities take ...

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA. Authors Caleigh Propes, Kayla Mehl, and Stephanie Morain ...

In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif ...

Greg Simon, a longtime member of the Coordinating Center leadership team for the NIH Pragmatic Trials Collaboratory, was selected by the Health Care Systems Research Network (HCSRN) Governing Board of Directors to receive the organization’s inaugural Founders’ Award. The new award recognizes individuals who best exemplify the spirit of the HCSRN’s early founders in their ...

The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominations for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. The committee will include: health professionals and scientists who are leaders in the field of pain research patients with pain-related conditions, patient-advocates, and community organizations for individuals ...

To build upon the progress of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH is holding workshops to gather input to inform strategic research priorities and advance the mission of HEAL pain research. The workshops will be held over the next few months (ET), as follows: Non-Addictive Pain Therapeutics Development November 15 @ 10:00 ...

In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern. Delgado is an associate professor of emergency medicine and epidemiology at ...

On November 18, 2024 at 2 pm eastern, the Duke Margolis Institute for Health Policy and Duke Health will co-host “From Principles to Practice: Exploring AI Governance in Health Systems.” In this public webinar, Duke-Margolis and Duke Health will discuss their newly released white paper on how health systems are navigating the role of AI ...

In this Friday’s PCT Grand Rounds, Sumit Agarwal of the University of Michigan will present “The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support.” The Grand Rounds session will be held on Friday, November 8, 2024, at 1:00 pm eastern. Agarwal is an assistant professor of internal medicine ...

A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study, an NIH Collaboratory Trial, is testing the ...

The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH. The updated chapter now includes information about how to develop a ...

In this Friday’s PCT Grand Rounds, Thomas Carton of the Louisiana Public Health Institute and Anitha John of George Washington University and the Children’s National Hospital will present “Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study.” The Grand Rounds session will be held on Friday, November 1, 2024, at 1:00 pm ...

Research-identifiable Medicare data can come from traditional fee-for-service Medicare claims or from Medicare Advantage claims. A new contribution to the Living Textbook of Pragmatic Clinical Trials published this month, Use of Medicare Data in PCTs, describes the important differences between these data. At the healthcare system level, differences in incentives for documenting diagnoses can affect the ...

The NIH Pragmatic Trials Collaboratory is pleased to welcome APA-SM (Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations) to its portfolio of innovative NIH Collaboratory Trials. The new project is supported by an award from the National Institute of Neurological Disorders and Stroke, with administrative oversight from the National Center for Complementary ...

In this Friday’s PCT Grand Rounds, Nicholas Bloom of Stanford University will present “Hybrid Working From Home Improves Retention Without Damaging Performance.” The Grand Rounds session will be held on Friday, October 25, 2024, at 1:00 pm eastern. Bloom is the William D. Eberle Professor of Economics at Stanford University, a senior fellow of the Stanford Institute ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical ...

Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute. BEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, ...

In a pilot study for the GGC4H trial, researchers found that a virtual version of the Guiando Buenas Decisiones program delivered in the context of pediatric primary care was feasible, acceptable, and appealing to pediatricians and parents. The program is a Spanish-language version of the Guiding Good Choices intervention being implemented in the GGC4H trial. The ...

In this Friday’s PCT Grand Rounds, Alexander Fanaroff of the University of Pennsylvania will present “Rigorous Testing of Behavior Change Interventions: Lessons From the BE ACTIVE Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, October 18, 2024, at 1:00 pm eastern. Fanaroff is an assistant professor of medicine at the University of Pennsylvania. Join ...

A new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials. Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of ...

In this Friday’s PCT Grand Rounds, Shawn Aaron of the University of Ottawa will present “Early Diagnosis and Treatment of Asthma and COPD.” The Grand Rounds session will be held on Friday, October 11, 2024, at 1:00 pm eastern. Aaron is a professor of medicine at the University of Ottawa and the director of the Canadian Respiratory ...

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel proposals for its 2025 Annual Conference until December 9, 2024. This year’s meeting will be held in St. Louis, Missouri, from April 8 to 10, 2025. Information about conference registration, preconference workshops, and accommodations is also available. Early-bird registration is open through February ...

In a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work. Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare ...

In this Friday’s PCT Grand Rounds, Tyler Winkelman of Hennepin Healthcare and the Hennepin Healthcare Research Institute, and David Johnson of Hennepin County, will present “Health Trends Across Communities – A Novel Health System-Public Health Data Partnership.” The Grand Rounds session will be held on Friday, October 4, 2024, at 1:00 pm eastern. Winkelman is the division ...

The NIH Communities Advancing Research Equity for Health™, or CARE for Health™, program announced 3 inaugural hubs for its primary care–focused clinical research network. These awards are part of a pilot project to test the feasibility of a research network that expands research opportunities to primary care settings. NIH envisions this approach will accelerate research ...

In this Friday’s PCT Grand Rounds, Tom Lietman of the University of California, San Francisco, will present “Azithromycin for Childhood Mortality: Randomizing Entire Countries.” The Grand Rounds session will be held on Friday, September 27, 2024, at 1:00 pm eastern. Lietman is the Ruth Lee and Phillips Thygeson Distinguished Professor in the Department of Ophthalmology and the ...

In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be ...

In this Friday’s PCT Grand Rounds, John Fortney of the University of Washington will present “Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.” The Grand Rounds session will be held on Friday, September 20, 2024, at 1:00 pm eastern. Fortney is a professor of psychiatry and behavioral sciences in the University of Washington School of ...

Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system ...

To avoid inflation in the rate of type 1 error, or false positives, in individually randomized group treatment (IRGT) trials, researchers should choose an analytic model that accounts for the correlations in outcome measures that arise when study participants receive an intervention from the same source, according to a report from the NIH Pragmatic Trials ...

In this Friday’s PCT Grand Rounds, Saul Faust of the University of Southampton will present “The HARMONIE Trial: Reimagining How to Design and Deliver Contract Commercial Clinical Trials.” The Grand Rounds session will be held on Friday, September 13, 2024, at 1:00 pm eastern. The HARMONIE trial was a pragmatic trial of the effect of nirsevimab on ...

In this Friday’s PCT Grand Rounds, Ardith Doorenbos of the University of Illinois, Chicago, and Diane Flynn of Madigan Army Medical Center will present “Conventional, Complementary, and Integrative Pain Therapies in a Military Population With Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design.” The Grand Rounds session will be held on Friday, ...

The National Center for Complementary and Integrative Health (NCCIH), with support from the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, published a notice of funding opportunity for pragmatic clinical trials within the infrastructure of the NIH-DOD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-011). The PMC was established in 2017 with ...

The Johns Hopkins Berman Institute of Bioethics is accepting applications for its Postdoctoral Fellowship in Clinical Research Ethics and Regulation. Fellows in the program work closely with the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in Clinical Research Ethics and ...

A virtual, asynchronous learning program that offers open-access modules to anyone interested in learning about the complex art of pragmatic clinical trial design and implementation is now available. Every week, a new open-access module features essential resources and leading Canadian trialists discussing a key component of clinical trials. The 2-year, pan-Canadian program—HDRN Canada Pragmatic Trials Training Program—follows ...

The Pain Management Collaboratory (PMC) will sponsor a series of presentations as part of the VA Spotlight on Pain Management (SoPM) Cyberseminar series, highlighting the accomplishments and future initiatives of the PMC. These webinars will feature early findings, lessons learned, and future directions for research based on the activities of PMC Pragmatic Clinical Trials. The series ...

The iPATH trial, one of the newest additions to our portfolio of NIH Collaboratory Trials, is testing the implementation of a practice transformation strategy for patients with type 2 diabetes in federally qualified health centers (FQHCs) in California, Massachusetts, Ohio, and Puerto Rico. We asked the principal investigator for iPATH, Sara Singer of Stanford University, to ...

In this Friday’s PCT Grand Rounds, David Bekelman and Lyndsay DeGroot of the University of Colorado will present “Improving Quality of Life in COPD and Heart Failure: Unpacking a Successful Multicomponent Virtual Team Intervention.” The Grand Rounds session will be held on Friday, August 23, 2024, at 1:00 pm eastern. Bekelman is a professor of medicine and ...

The NIH Pragmatic Trials Collaboratory has launched a new interactive learning path that provides essential knowledge to research teams on how to choose the most appropriate study design for a pragmatic clinical trial. The learning path is a series of self-paced training modules that include expert videos, reference materials, and knowledge checkpoints. Its content covers key ...

Leaders of 2 of the NIH Pragmatic Trials Collaboratory’s long-standing Core Working Groups recently shared updates from their work with the newest cohort of NIH Collaboratory Trials. We spoke with them during the NIH Collaboratory’s 2024 Annual Steering Committee Meeting in May. Over the last year, the Ethics and Regulatory Core engaged in a formal onboarding ...

The Chronic Pain and Fatigue Research Center at the University of Michigan is requesting applications for the HEAL National K12 Clinical Pain Career Development Award (HEAL K12). The HEAL K12 is a mentored career development program designed to provide protected time for clinicians and scientists to focus on training in and conducting clinical pain research. The award ...

In this Friday’s PCT Grand Rounds, Runar Solberg of the Norwegian Institute of Public Health will present “Methodological Insights and Lessons Learned From Conducting a Pragmatic Randomized Trial on Surgical Face Masks.” The Grand Rounds session will be held on Friday, August 16, 2024, at 1:00 pm eastern. Solberg is a research scientist in the Centre for ...

At the NIH Pragmatic Clinical Trials Collaboratory’s 2024 Annual Steering Committee Meeting, leaders of the Electronic Health Records (EHR) Core and the Patient-Centered Outcomes (PCO) Core discussed challenges and lessons learned in the NIH Collaboratory Trials. EHR cochairs Keith Marsolo and Rachel Richesson shared challenges related to EHR usage, including EHRs switching midtrial, unanticipated changes to ...

Few of the 20 million older adults who undergo elective surgical procedures in the United States each year engage in advance care planning. I CAN DO Surgical ACP, an NIH Collaboratory Trial, aims to address this missed opportunity to align older patients’ preferences with their surgical decisions and improve patient-clinician communications. We spoke with co–principal investigator ...

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. Califf and Bertagnolli spoke about the role the NIH Collaboratory can play in promoting scientifically rigorous, pragmatic clinical research that ...

In this Friday’s PCT Grand Rounds, Greg Simon and Susan Shortreed of the Kaiser Permanente Washington Health Research Institute (KPWHRI) will present “Does Starting Buprenorphine Prevent Suicidal Behavior? What Trial Should We Emulate?” The Grand Rounds session will be held on Friday, August 9, 2024, at 1:00 pm eastern. Simon is a senior investigator at KPWHRI and ...

Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.“ The 2-day workshop, hosted by the NIH, featured a keynote address by NIH Director Monica Bertagnolli exploring how to identify high-priority healthcare issues that require ...