The Johns Hopkins Berman Institute of Bioethics is accepting applications for its 2023-2024 Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, ...

The NIH Pragmatic Trials Collaboratory has developed an online tool to evaluate the complexity of delivery of a trial intervention. To develop the tool, principal investigators of embedded pragmatic clinical trials (ePCTs) shared critical drivers of complexity that affected their ability to implement an intervention and discern treatment effects. An article describing the tool and its ...

In this Friday’s PCT Grand Rounds, Professor Luregn Schlapbach of the University Children’s Hospital Zurich will present “Pragmatic Trials for Children With Congenital Heart Disease: Insights From the NITRIC Trial.” The Grand Rounds session will be held on Friday, February 3, 2023, at 1:00 pm eastern. Schlapbach is head of intensive care and neonatology at the University ...

In an article published today in the Annals of Internal Medicine, leaders of the NIH Pragmatic Trials Collaboratory suggest that data sharing is not rising to its potential, and that more guidance is needed to prevent data sharing from becoming a “box-checking exercise.” “NIH should consider guidance to help investigators and NIH institutional centers understand what ...

The NIA IMPACT Collaboratory is seeking letters of intent from interested applicants for Cycle 5A of its Pilot Grants Program. The 1-year pilot grant awards will fund up to $175,000 in direct costs for pilot studies that aim to generate preliminary data for full-scale embedded pragmatic clinical trials of nonpharmacologic interventions in healthcare systems for persons ...

The NIH Pragmatic Trials Collaboratory began 2023 with 2 new Core Working Groups focused on health equity and implementation science. The membership of both Cores draws from across the program to support the design and implementation of the NIH Collaboratory Trials. “By launching these 2 new Core Working Groups, the NIH Pragmatic Trials Collaboratory is reaffirming ...

In this Friday’s PCT Grand Rounds, Dr. Derek Russell of the University of Alabama at Birmingham and Dr. Matthew Semler of Vanderbilt University will present “The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure.” The Grand Rounds session will be held on Friday, January 27, 2023, at 1:00 pm eastern. Russell ...

The INSPIRE NIH Collaboratory Trial went live this month, with a new order entry screen being activated in the electronic health record at 51 hospital sites randomized to the intervention. Congratulations to lead investigator Dr. Shruti Gohil, co–principal investigators Dr. Susan Huang and Dr. Richard Platt, and the INSPIRE team! INSPIRE is studying the effectiveness of a personalized ...

In this Friday’s PCT Grand Rounds, Mikhail Kosiborod of the University of Missouri-Kansas City will present “Collaborative Pragmatic Trials in Action: EVOLVE-MI.” The Grand Rounds session will be held on Friday, January 20, 2023, at 1:00 pm eastern. Kosiborod is a cardiologist, the vice president of research at Saint Luke’s Health System, and a professor of medicine ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Emily Largent will present “Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials.” The Grand Rounds session will be held on Friday, January 13, 2023, at 1:00 pm eastern. Dr. Largent is the Emanuel ...

In this Friday’s COVID-19 Grand Rounds, Dr. Carolyn Bramante and Dr. Thomas Murray of the University of Minnesota will present “Outpatient Treatment of COVID-19 With Metformin, Ivermectin, or Fluvoxamine: 10-Month Follow-up and Effects on Developing Long COVID.” The Grand Rounds session will be held on Friday, January 6, at 1:00 pm eastern. Join the online meeting. The ...

The Health Care Systems Research Network (HCSRN) extended the early-bird registration deadline for its 2023 annual conference in Denver, Colorado, to January 9. The discounted registration rate will apply through this date. The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials.” The workshop ...

In this Friday’s PCT Grand Rounds, Alex Spyropoulos and Jeffrey Solomon of the Feinstein Institutes for Medical Research will present “The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients.” The Grand Rounds session will be held on Friday, December 16, 2022, at 1:00 pm eastern. Spyropoulos is a professor of medicine ...

Investigators from the NIH Pragmatic Trials Collaboratory in 2022 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the Distributed Research Network, and study designs and results from the NIH Collaboratory Trials. This year, the NIH ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Monica Taljaard and David Magnus will present “The Stepped Wedge Cluster Randomized Trial: Friend or Foe?” The Grand Rounds session will be held on Friday, December 9, 2022, at 1:00 pm eastern. Taljaard is a ...

In this Friday’s PCT Grand Rounds, Dr. Michael Felker of Duke University will present “A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern. Felker is a professor of medicine in the Duke University ...

The NIH Pragmatic Trials Collaboratory is excited to welcome the INSPIRE NIH Collaboratory Trial to its portfolio of innovative, large-scale pragmatic clinical trials embedded in healthcare systems. INSPIRE (or Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) will implement the INSPIRE-ASP Trials for Abdominal and Skin and Soft Tissue Infections. These 2 cluster ...

A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). The findings highlight the need for better integration of patient-reported health data into pragmatic research studies. Results of the study were published in JAMA Cardiology. Patient-reported health data ...

The Health Care Systems Research Network (HCSRN) opened registration and announced the opening plenary speaker for its 2023 annual conference in Denver, Colorado. This year’s opening plenary session will feature keynote speaker Dr. Abdul Shaikh, population health analytics leader for the worldwide public sector at Amazon Web Services (AWS). New and emerging approaches to using AI/ML, ...

In this Friday’s PCT Grand Rounds, Dr. Padmanabhan Ramnarayan of Imperial College London will present “The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support in Children.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern. Ramnarayan is a reader in pediatric critical care at Imperial College London. FIRST-ABC is a ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Stephanie Morain and Kayte Spector-Bagdady will present “Data Sharing and Pragmatic Clinical Trials: Law and Ethics Amidst a Changing Policy Landscape.” The Grand Rounds session will be held on Friday, November 11, 2022, at ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, ...

In this Friday’s PCT Grand Rounds, Dr. Amit Goyal of the Cleveland Clinic will present “The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development.” The Grand Rounds session will be held on Friday, November 4, 2022, at 1:00 pm eastern. Goyal is a fellow in interventional/structural cardiology at the Cleveland Clinic and a cofounder ...

The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop at the 2023 Health Care Systems Research Network (HSCRN) Annual Conference in Denver, Colorado. This year’s conference theme is “Leveraging the Power of the Network in Rapidly Changing Times.” The NIH Collaboratory workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials,” will ...

In this Friday’s PCT Grand Rounds, Emily O’Brien of Duke University and Russell Rothman of Vanderbilt University will present “The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance.” The Grand Rounds session will be held on Friday, October 28, 2022, at 1:00 ...

The NIH Pragmatic Trials Collaboratory is pleased to announce the addition of 2 new Core Working Groups that will be focused on implementation science and health equity. The Implementation Science Core will provide technical support and pragmatic trial expertise for NIH Collaboratory Trials with a specific focus on innovative dissemination and implementation science approaches. The Core ...

Abstract submissions and panel presentation submissions for the Health Care Systems Research Network (HCSRN) 2023 Annual Conference are due this Friday, October 21. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. The HCSRN’s ...

In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University and Andrea Downing of The Light Collective will present “Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat.” The Grand Rounds session will be held on Friday, October 21, 2022, at 1:00 pm eastern. A professor of population health sciences ...

The NIH Pragmatic Trials Collaboratory announced the addition of a new collection in the Living Textbook of Pragmatic Clinical Trials focused on ethical and regulatory aspects of pragmatic trials. “The Living Textbook is a dynamic, evolving collection of knowledge gained from 10 years of conducting pragmatic clinical trials within the NIH Collaboratory,” said Dr. Kevin Weinfurt, ...

Rachel Richesson, cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core, will present this week at IMPACT Collaboratory Grand Rounds. The virtual session, “Developing Standards and Quality Metrics for Clinical Phenotyping Using EHR Data in Pragmatic Clinical Trials,” will be held on Thursday, October 20, 2022, at 12:00 pm eastern. Richesson is a professor ...

The National Institute of Nursing Research (NINR) will host a webinar for its recent request for applications, “RFA-NR-23-001, HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3 Clinical Trial Required).” The webinar will describe key features of the funding opportunity, review the interests of participating Institutes and Centers, and address questions from ...

This Friday’s PCT Grand Rounds will feature the next installment of our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Joe Ali, Tanya Matthews, and Leslie Crofford will present “Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, October ...

The Agency for Healthcare Research and Quality (AHRQ) announced a new competition to explore the feasibility, resources, and infrastructure needed to integrate real-world healthcare system data into the agency’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000. Learn more about AHRQ’s Challenge on Integrating Healthcare System Data With ...

The Health Care Systems Research Network (HCSRN) has extended to October 21 the deadline for abstract submissions and panel presentation submissions for its 2023 Annual Conference. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery ...

In this Friday’s PCT Grand Rounds, Dr. Melanie Meersch-Dini of University Hospital Münster (Germany) will present “Impact of Handovers of Anesthesia Care on Morbidity and Mortality.” The Grand Rounds session will be held on Friday, October 7, 2022, at 1:00 pm eastern. Dr. Meersch-Dini will discuss the results of the HandiCAP trial (Impact of Handover of ...

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. The ...

In this Friday’s PCT Grand Rounds, Marianne Chase of Massachusetts General Hospital and Dr. Jörg Goldhahn of ETH Zurich will present “CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials.” The Grand Rounds session will be held on Friday, September 30, 2022, at 1:00 pm eastern. Chase is senior director for clinical ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, ...

In this Friday’s PCT Grand Rounds, Dr. Margaret McConnell of the Harvard T.H. Chan School of Public Health will present “Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population.” The Grand Rounds session will be held on Friday, September 23, 2022, at 1:00 pm eastern. Dr. McConnell is an ...

The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2023-2024 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical ...

In this Friday’s PCT Grand Rounds, Dr. Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The Grand Rounds session will be held on Friday, September 16, 2022, at 1:00 pm eastern. Dr. Biering-Sørensen is professor and head of the Center for Translational Cardiology and ...

The deadline to submit letters of intent for the NIA IMPACT NIH Collaboratory Trials Program has been extended to September 30, 2022. This summer, the IMPACT Collaboratory announced a request for applications for its NIH Collaboratory Trials Program.  This funding mechanism supports large-scale pragmatic clinical trials embedded in healthcare systems to test the effectiveness of nonpharmacological ...

In this Friday’s PCT Grand Rounds, Dr. Steve Joffe will kick off our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials, with a keynote presentation, “Building an Academic Learning Health System: Why Is It So Hard?” The Grand Rounds session will be held on Friday, September 9, 2022, at 1:00 pm ...

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. This year’s meeting will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. ...

A new section of the NIH Pragmatic Trials Collaboratory’s Living Textbook of Pragmatic Clinical Trials discusses challenges associated with Evaluating Fitness for Use of real-world data for trials. The section uses a case study from the Harmony Outcomes EHR Ancillary Study (eHARMONY) to describe lessons learned and to provide recommendations for studies considering incorporating real-word data as ...

The US Food and Drug Administration (FDA) will host a webinar on September 9 for industry, patient groups, and other interested stakeholders to discuss and answer questions about the draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The draft guidance, known as “Guidance 3,” is the third of 4 methodological guidance ...

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems. With this new Grand Rounds series, ...

In this Friday’s PCT Grand Rounds, Dr. Areef Ishani of the University of Minnesota will present “The Diuretic Comparison Project: A Large Pragmatic Clinical Trial.” The Grand Rounds session will be held on Friday, August 26, 2022, at 1:00 pm eastern. The Diuretic Comparison Project is a large, national “point-of-care clinical trial” comparing the effects of ...

The NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP NIH Collaboratory Trial received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in ...

The NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, announced its intent to publish a new funding opportunity for cooperative research that will accelerate implementation of nonopioid interventions for chronic pain management in rural and remote populations. The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and ...