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, ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop July 15-16, 2024, on “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.” Dr. Monica Bertagnolli, director of the NIH, will deliver the keynote presentation exploring how to identify high-priority healthcare issues that require the effort, time, and funding ...

In this Friday’s PCT Grand Rounds, Reto Auer of the University of Bern will present “Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under Regulatory and Epidemic Changes.” The Grand Rounds session will be held on Friday, June 21, 2024, at 1:00 pm eastern. Auer is an associate ...

Diana Burgess, a co–principal investigator of the NIH Pragmatic Trials Collaboratory’s RAMP trial, will present the results of the precursor LAMP trial as part of the Veterans Affairs (VA) Health Systems Research Cyberseminars series. The Learning to Apply Mindfulness to Pain (LAMP) trial is a multisite pragmatic clinical trial that compared 2 approaches for delivering mindfulness-based ...

In this Friday’s PCT Grand Rounds, Stefan James and Jonas Oldgren of Uppsala University will present “DAPA-MI – A Pragmatic Registry-Based Double-Blind RCT Trial Designed for Regulatory Evaluation.” The Grand Rounds session will be held on Friday, June 14, 2024, at 1:00 pm eastern. DAPA-MI (Dapagliflozin in Patients With MI) was a registry-based, placebo-controlled trial of dapagliflozin ...

Many older adults who participate in acupuncture research may have prior experience with acupuncture, according to an analysis of data from the BackInAction trial. The finding has implications for the design and conduct of future pragmatic clinical trials involving acupuncture. BackInAction, an NIH Collaboratory Trial, is testing strategies for the delivery of acupuncture to older patients ...

The NIH Pragmatic Trials Collaboratory Coordinating Center is pleased to announce that the BEST-ICU trial received approval to transition from the planning phase to the implementation phase of the study. Congratulations to the BEST-ICU principal investigators and study team for reaching this important milestone! BEST-ICU, an NIH Collaboratory Trial, is a pragmatic trial that aims to ...

In this Friday’s PCT Grand Rounds, Russell Rothman of Vanderbilt University Medical Center and Jason Block of Harvard Medical School will present “The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet for a Novel Cohort Study.” The Grand Rounds session will be held on Friday, June 7, 2024, at 1:00 pm eastern. Rothman is a professor ...

Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials.” The 1-day workshop, held on May 19 at the 45th annual Society for Clinical Trials meeting in Boston, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in ...

In this Friday’s PCT Grand Rounds, Shruti Gohil of the University of California, Irvine, will present “The INSPIRE Abdominal and Skin/Soft Tissue Infection Trials: Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients.” The Grand Rounds session will be held on Friday, May 31, 2024, at 1:00 pm eastern. Gohil is an assistant professor of ...

Leaders of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, on May 9 and 10 for the program’s 2024 Annual Steering Committee Meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research. All materials from the meeting are now available online. The NIH Pragmatic Trials Collaboratory added 9 new trials in ...

In a secondary analysis of data from the TSOS study pooled with data from 2 other comparative effectiveness trials, baseline patient clinical and demographic characteristics were associated with persistent symptoms of posttraumatic stress disorder (PTSD) and diminished treatment response. The report was published online ahead of print in Psychiatry. The TSOS study, an NIH Collaboratory Trial led by ...

In a new article, investigators from 2 pragmatic clinical trials of telehealth-delivered physical therapy share insights into the challenges they faced in implementing the study interventions, especially in historically underserved communities. The article was published last month in Frontiers in Pain Research. Telehealth delivery of nonpharmacologic pain management has expanded opportunities to overcome access barriers. However, telehealth ...

According to a report from the NIH Pragmatic Trials Collaboratory Coordinating Center, journal editors and peer reviewers were familiar with pragmatic clinical trials and their designs and analytic approaches, but they often asked for more information about intervention implementation. The report was published this week in the Living Textbook of Pragmatic Clinical Trials. The report’s authors invited ...

In this Friday’s PCT Grand Rounds, Ken Mahaffey of Stanford University and Nishant Shah and Neha Pagidipati of Duke University will present “CardioHealth Alliance: A Platform to Improve Care.” The Grand Rounds session will be held on Friday, May 17, 2024, at 1:00 pm eastern. Mahaffey is the associate dean for clinical research in the Stanford University ...

An ongoing funding opportunity from the National Institutes of Health (NIH) is supporting dissemination and implementation research in health. The purpose of the funding opportunity is “to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, ...

In this Friday’s PCT Grand Rounds, Gregory Tasian of the Children’s Hospital of Philadelphia will present “Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial.” The Grand Rounds session will be held on Friday, May 3, 2024, at 1:00 pm eastern. The Pediatric Kidney Stone (PKIDS) Care Improvement Network Trial is a patient-centered, pragmatic ...

In this Friday’s PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present “Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape.” The Grand Rounds session will be held on Friday, April 26, ...

In an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging ...

During the course of the years-long pragmatic clinical trials supported by the NIH Pragmatic Trials Collaboratory, many unanticipated challenges have occurred, some of which have had profound effects on usual care, trial implementation, data systems, and staff. These unanticipated changes threatened the ability of the trials to address the questions they were designed to answer. ...

In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The Grand Rounds session will be held on Friday, April 19, 2024, at 1:00 pm eastern. The YODA Project promotes open science, research transparency, and the sharing of clinical research ...

In this Friday’s PCT Grand Rounds, Corita Grudzen of the Memorial Sloan Kettering Cancer Center will present “Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments,” including the results of the PRIM-ER trial. The Grand Rounds session will be held on Friday, April 12, 2024, at 1:00 pm eastern. Grudzen is ...

A primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care, according to the ICD-Pieces study. The results of the study were published this week in the New England Journal of Medicine. ICD-Pieces, an NIH Collaboratory Trial, was ...

In this Friday’s PCT Grand Rounds, Erik van Zwet of Leiden University Medical Center will present “A New Look at P Values for Randomized Clinical Trials.” The Grand Rounds session will be held on Friday, April 5, 2024, at 1:00 pm eastern. Dr. van Zwet is an associate professor in the Department of Biomedical Data Sciences at ...

In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm ...

The Patient-Centered Outcomes Research Institute (PCORI) announced the release of its new Foundational Expectations for Partnerships in Research. The resource is an update of the 2014 PCORI Engagement Rubric. It builds on a growing body of evidence about engaging patients and other partners in patient-centered comparative effectiveness research. A webinar on April 4 will explore the ...

The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective ...

In this Friday’s PCT Grand Rounds, Warren Jones of Emory University will present “Early Diagnosis and Assessment of Autism via Objective Measurements of Social Visual Engagement.” The Grand Rounds session will be held on Friday, March 22, 2024, at 1:00 pm eastern. Jones is the director of research at the Marcus Autism Center and the Norman Nien ...

The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available. The program’s Design and Statistics Core ...

In this Friday’s PCT Grand Rounds, Edward Qian of Vanderbilt University will present “The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial.” The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern. The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury ...