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 ...

During the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Greg Simon and Steve George sat down to discuss challenges and lessons learned from NIH Collaboratory Trials on healthcare system and patient engagement. Simon said it is key for embedded pragmatic clinical trials to build long-term relationships with healthcare systems, starting with finding ...

In this Friday’s PCT Grand Rounds, Adrian Hernandez of Duke University will present “Precision Health to Population Health: Opportunities and Challenges for Gene Editing Therapies.” The Grand Rounds session will be held on Friday, August 2, 2024, at 1:00 pm eastern. Hernandez is a professor of medicine and vice dean in the Duke University School of Medicine ...

The Health Care Systems Research Network (HCSRN) will hold its 2025 Annual Conference from April 8 to 10, 2025, in St. Louis, Missouri. 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 ...

Among the newest NIH Collaboratory Trials is a study of an intervention to reduce rates of severe maternal morbidity, a health crisis in the United States that disproportionately affects Black patients. We spoke with principal investigator Stephanie Fitzpatrick about the MOMs Chat & Care Study at the NIH Collaboratory’s 2024 Annual Steering Committee Meeting. “In the United ...

The NIH HEAL Initiative issued a request for information seeking feedback on the initiative’s future strategic research priorities to address opioid use disorder, overdose, and pain. The NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, invites you to submit feedback to shape strategic research priorities that will guide the initiative’s future efforts to find ...

In this Friday’s PCT Grand Rounds, Gregg Fonarow of the University of California, Los Angeles, will present “Interventions for Optimization of Guideline-Directed Medical Therapy.” The Grand Rounds session will be held on Friday, July 26, 2024, at 1:00 pm eastern. Fonarow is the Eliot Corday Professor of Cardiovascular Medicine and Science at UCLA, director of the Ahmanson-UCLA ...

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes, authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent ...

In a new episode of our Rethinking Clinical Trials podcast, Drs. Pearl O’Rourke and Stephanie Morain speak with host Dr. Adrian Hernandez about waiver or alteration of informed consent for minimal risk clinical investigations. O’Rourke presented on the topic during the February 10 session of RCT Grand Rounds. Listen and subscribe to the podcast on SoundCloud ...

In this Friday’s PCT Grand Rounds, Brendan Everett and Deborah Wexler of Harvard Medical School will present “Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial.” The Grand Rounds session will be held on Friday, July 19, 2024, at 1:00 pm eastern. The PRECIDENTD study (Prevention of Cardiovascular and Diabetic Kidney Disease in Type 2 Diabetes) is comparing ...

A recent report from the Assistant Secretary for Planning and Evaluation in the US Department of Health and Human Services outlines 36 projects funded by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF). OS-PCORTF was created to build national data capacity and infrastructure and leverage existing clinical data and federal data for patient-centered ...

The NIH Pragmatic Trials Collaboratory Coordinating Center is pleased to announce that the Chat 4 Heart Health trial received approval to transition from the planning phase to the implementation phase of the study. Congratulations to Michael Ho and Sheana Bull, the Chat 4 Heart Health principal investigators, and their study team for reaching this important ...

In an interview during the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting, Tracy Wang of the Patient-Centered Outcomes Research Institute (PCORI) discussed challenges of conducting A vs B pragmatic clinical trials of approved drugs in routine clinical practice. Wang joined Adrian Hernandez, co–principal investigator of the NIH Collaboratory Coordinating Center, and Pearl O’Rourke, ...

In this Friday’s PCT Grand Rounds, Miguel Hernán of Harvard University will present “Causal Estimands: Should We Ask Different Causal Questions in Randomized Trials and in the Observational Studies That Emulate Them?” The Grand Rounds session will be held on Friday, July 12, 2024, at 1:00 pm eastern. Hernán is the Kolokotrones Professor of Biostatistics and Epidemiology ...

The NIH HEAL Initiative issued a request for information seeking feedback on the initiative’s future strategic research priorities to address opioid use disorder, overdose, and pain. The NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, invites you to submit feedback to shape strategic research priorities that will guide the initiative’s future efforts to find ...

During the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, 2 of the program’s research fellows described their research and discussed the value of the fellowship experience. Lindsay Ballengee, a physical therapist and doctoral student in population health sciences at Duke University, said her fellowship research builds on previous NIH Collaboratory work on ...

In a new episode of our Rethinking Clinical Trials podcast, Drs. Michael Pencina and Brian Anderson of the Coalition for Health AI speak with host Dr. Adrian Hernandez about public-private partnerships in a trustworthy health AI ecosystem. Pencina and Anderson presented on their experiences during the March 8 session of PCT Grand Rounds. Listen and subscribe ...

Three of the newest NIH Collaboratory Trials are supported through the NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, reflecting a special emphasis on developing strategies for the management of chronic pain in rural and remote populations. “There are many known disparities between urban and rural populations,” said Karen Kehl, a program director at ...

In this Friday’s PCT Grand Rounds, Fatima Mirza of the Warren Alpert Medical School of Brown University will present “Using ChatGPT to Facilitate Truly Informed Medical Consent.” The Grand Rounds session will be held on Friday, June 28, 2024, at 1:00 pm eastern. Mirza is chief resident in the Department of Dermatology at the Warren Alpert Medical ...

Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, last month for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research. The program added 9 new trials in the past year. The Annual Steering Committee Meeting provided a collaborative space for new ...

In an analysis of behavioral health data from the GGC4H study, researchers observed a significant increase in the rate of depression among early adolescents during the first year of the COVID-19 pandemic in the United States. The results extend findings on adolescent mental health during the pandemic to younger adolescents, a relatively understudied population. The report ...

NIH Pragmatic Trials Collaboratory Health Equity Core cochairs Rosa Gonzalez-Guarda and Cherise Harrington recently discussed the Core’s work supporting the NIH Collaboratory Trials to address issues related to health equity. Gonzalez-Guarda and Harrington sat down together during the NIH Collaboratory’s 2024 Annual Steering Committee Meeting in May and reflected on the past year. Throughout the last year, ...