- July 3, 2023: Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data
Pragmatic research is vulnerable to biases due to differences in data capture and access to care for different subsets of the population, which, if left unaddressed, can propagate inequities in health and the healthcare system.
In a new article published online ahead of print in JAMIA, the NIH Pragmatic Trials Collaboratory’s Trial teams reflect on the ...
- June 29, 2023: Grand Rounds Podcast with Dr. Joshua Denny on All of Us Research Program is Available
In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Joshua Denny continues his discussion about All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.
The full May 5 Grand Rounds webinar with Dr. Denny is also available.
- June 29, 2023: Workshop Materials and Videocast Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’
Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
Access the complete workshop ...
- June 29, 2023: Health Equity Core Leaders Share Insights From Annual Steering Committee Meeting
In an interview during the annual Steering Committee meeting, Drs. Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group, shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory.
One question discussed at the meeting was how to embed health equity in pragmatic clinical trials. Gonzalez-Guarda said that ...
- June 28, 2023: In This Week’s PCT Grand Rounds, What’s Left for Decentralized Clinical Trials?
In this Friday’s PCT Grand Rounds, Adrian Hernandez, Pamela Tenaerts, and Craig Lipset will present “Decentralized Trials – From Guidance to Reality & What’s Left.”
The Grand Rounds session will be held on Friday, June 30, 2023, at 1:00 pm eastern.
Dr. Hernandez is a professor of medicine and director of the Duke Clinical Research Institute at ...
- June 27, 2023: Reflections on Health Equity in the Pragmatic Trials Landscape From the Annual Steering Committee Meeting
A focus of the 2023 NIH Pragmatic Trials Collaboratory Annual Steering Committee Meeting was health equity in embedded pragmatic clinical trials (ePCTs). In an interview during the meeting, Drs. Anne Trontell and Ana Quiñones reflected on health equity in the ePCT landscape.
Trontell, who is the associate director for comparative clinical effectiveness research at the Patient-Centered ...
- June 26, 2023: NIMHD Director Discusses Ways Researchers Can Help Reduce Health Disparities
This year’s annual Steering Committee meeting for the NIH Pragmatic Trials Collaboratory featured health equity as a central topic of discussion. In an interview after his keynote presentation, Eliseo J. Pérez-Stable, MD, Director of the National Institute on Minority Health and Health Disparities (NIMHD), shared his thoughts on national priorities for reducing health disparities and ...
- June 22, 2023: EMBED Team Documents Rise in Fentanyl-Associated Overdose Deaths
Researchers from EMBED, an NIH Pragmatic Trials Collaboratory Trials, found a sharp rise in out-of-hospital overdose deaths in the early years of the COVID-19 pandemic, attributable largely to increasing involvement of fentanyl.
The findings were published online ahead of print this week in the New England Journal of Medicine.
EMBED was a cluster randomized trial across 21 ...
- June 22, 2023: Taunton Paine Discusses New NIH Data Sharing Policy at Annual Steering Committee Meeting
At the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in May, we interviewed Taunton Paine, director of the NIH Scientific Data Sharing Policy Division, about the NIH’s new Data Management & Sharing Policy, which took effect in 2023.
Under the new policy, all NIH-funded research requires a submission plan that describes how, where, and when ...
- June 21, 2023: Results of ICD-Pieces to Be Presented in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Miguel Vazquez of the University of Texas Southwestern Medical Center and George “Holt” Oliver of the Parkland Center for Clinical Innovation will present “Improving Delivery of Care for Chronic Kidney Disease, Diabetes, and Hypertension,” including results from the ICD-Pieces NIH Collaboratory Trial.
The Grand Rounds session will be held on ...
- June 15, 2023: Regulatory Considerations for Clinical Decision Support Software in Pragmatic Trials Explored at Annual Steering Committee Meeting
This year’s annual Steering Committee meeting for the NIH Pragmatic Trials Collaboratory featured 2 special guests from the US Food and Drug Administration’s Digital Health Center of Excellence—Matthew Diamond, MD, PhD, Chief Medical Officer, and Sonja Fulmer, PhD, Acting Deputy Director. They joined to share information on the FDA’s approach to clinical decision support (CDS) ...
- June 14, 2023: IMPACt-LBP and INSPIRE Have Updated Study Snapshots, Ethics and Regulatory Documentation
Updated study snapshots and ethics and regulatory documentation are now available for the IMPACt-LBP and INSPIRE trials, both NIH Pragmatic Trials Collaboratory Trials.
IMPACt-LBP transitioned from the planning phase to the implementation phase in August. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and ...
- June 14, 2023: BeatPain Utah Pragmatic Trial Featured in This Friday’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Julie Fritz and Guilherme Del Fiol of the University of Utah will present “BeatPain Utah Pragmatic Clinical Trial: Partnering With Community Health Centers Within a Socio-Technical Framework.”
The Grand Rounds session will be held on Friday, June 16, 2023, at 1:00 pm eastern.
BeatPain Utah, an NIH Collaboratory Trials, is studying ...
- June 13, 2023: Annual Steering Committee Meeting Gathers Program Leadership to Share Lessons, Tackle Latest Challenges
On May 16-17, 2023, over 100 members of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, for its annual Steering Committee meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research. In an interview with Wendy Weber, NIH Project Officer, and Lesley Curtis, co-principal investigator of the Coordinating Center, ...
- June 8, 2023: LTC Data Cooperative Releases Funding Opportunity for 2023 Real World Data Scholars Program
The Long-Term Care (LTC) Data Cooperative this week announced a request for applications for the newly established 2023 Real World Data Scholars Program. This program supports the development of advanced graduate students, postdoctoral fellows, and early-career faculty who are interested in developing their expertise and experience in working with electronic health record (EHR) data.
The program offers ...
- June 7, 2023: This Week’s PCT Grand Rounds Will Feature the DUPLICATE Initiative
In this Friday’s PCT Grand Rounds, Shirley Wang of Harvard Medical School will present “Emulating Randomized Clinical Trials With Non-randomized Real-World Evidence Studies: Results From the RCT DUPLICATE Initiative.” The Grand Rounds session will be held on Friday, June 9, 2023, at 1:00 pm eastern.
The DUPLICATE initiative is building an empirical evidence base for using ...
- June 6, 2023: INSPIRE NIH Collaboratory Trial Principal Investigators Share Update at Annual Steering Committee Meeting
In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in Bethesda, Maryland, Richard Platt, MD, MS (co-principal investigator) and Shruti Gohil, MD, MPH (lead investigator) of the INSPIRE NIH Collaboratory Trial shared the status of the trials, discussed recent lessons learned, described the impact they hope their trials will have on the ...
- May 31, 2023: NIH Pragmatic Trials Collaboratory Announces Virtual Workshop on Getting the Right Evidence to Decision-Makers Faster
Register today! The NIH Pragmatic Trials Collaboratory will host a virtual workshop June 20-21, 2023, to explore the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs).
The workshop, “Getting the Right Evidence to Decision-Makers Faster,” will kick off on Tuesday, June 20, at 11:00 ...
- May 31, 2023: PROACT Xa Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern.
PROACT Xa was a prospective, randomized clinical trial conducted to determine ...
- May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder
In a secondary analysis from the EMBED pragmatic clinical trial, Black patients with opioid use disorder were less likely than White patients to be initiated on buprenorphine in the emergency department.
The study’s findings were published recently in Academic Emergency Medicine.
EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 ...
- May 17, 2023: In This Week’s PCT Grand Rounds, Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture
In this Friday’s PCT Grand Rounds, Robert O’Toole of the University of Maryland will present “Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture.” The Grand Rounds session will be held on Friday, May 19, 2023, at 1:00 pm eastern.
Dr. O’Toole is the chief of Orthopaedics at the R. Adams Cowley Shock Trauma Center, head ...
- May 15, 2023: EMBED Offers Lessons for Intervention Adoption, Implementation, and Maintenance
Organizational culture, clinician training and support, the ability to link patients to ongoing treatment, and the ability to tailor implementation to each clinical site were key determinants of successful implementation of an intervention to promote buprenorphine initiation in emergency departments, according to a qualitative study conducted as part of the EMBED pragmatic clinical trial.
The study’s ...
- May 11, 2023: Article Outlines Key Stakeholder Insights Related to Participant Data Sharing in Pragmatic Trials
A new article from the NIH Pragmatic Trials Collaboratory outlines stakeholder insights and ethical considerations related to sharing deidentified, participant-level data in pragmatic clinical trials. While there are numerous arguments for and against data sharing in the context of pragmatic trials, the report aims to address the gap in documented stakeholder perspectives.
The article was published ...
- May 10, 2023: In This Week’s PCT Grand Rounds, a Pragmatic Trial of the COACH Blood Pressure Self-Management App
In this Friday’s PCT Grand Rounds, Richelle Koopman of the University of Missouri will present “Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension.” The Grand Rounds session will be held on Friday, May 12, 2023, at 1:00 pm eastern.
Dr. Koopman is professor and vice chair for ...
- May 8, 2023: Pragmatic Trials Workshop Offered at AcademyHealth Conference
The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5-day preconference workshop at the 2023 Annual Research Meeting in Seattle, Washington.
The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings,” will cover the essentials of embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary ...
- May 3, 2023: In This Friday’s PCT Grand Rounds, All of Us Brings Big Cohorts to Precision Medicine
In this Friday’s PCT Grand Rounds, Joshua Denny of the All of Us Research Program at NIH, will present “All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.” The Grand Rounds session will be held on Friday, May 5, 2023, at 1:00 pm eastern.
Dr. Denny is the chief executive ...
- April 27, 2023: New Chapter Describes Intervention Delivery and Complexity
The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Intervention Delivery and Complexity,” illustrates that—although an intervention may be simple—the actual delivery of the intervention may be complex due to factors such as new workflows, special training of frontline staff, and the number of components ...
- April 26, 2023: In This Week’s PCT Grand Rounds, a Cluster-Crossover Trial of Oxygen Saturation Targets
In this Friday’s PCT Grand Rounds, Matthew Semler of Vanderbilt University will present “Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-Crossover Trial.” The Grand Rounds session will be held on Friday, April 28, 2023, at 1:00 pm eastern.
Dr. Semler is an assistant professor of medicine and bioinformatics and the medical director ...
- April 24, 2023: Grand Rounds Podcast Returns, Featuring Drs. Russell Rothman and Erin Holve on Almost a Decade of Research in PCORnet
In the latest episode of the NIH Collaboratory Grand Rounds podcast, Drs. Russell Rothman, Erin Holve and Lesley Curtis continue their discussion about PCORnet – From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.
The full March 24 Grand Rounds webinar with Drs. Rothman and Holve is also available.
- April 24, 2023: Webinar Will Highlight Meaningful Engagement of Patients and Communities in NIH HEAL Initiative Studies
An upcoming webinar in the NIH HEAL Initiative’s HEAL Headliners series will highlight the experiences of 2 projects in meaningfully engaging patients and community partners throughout the research process to ensure that the findings have the greatest public health impact. The webinar will be held on Friday, May 5, 2023, at 2:00 pm eastern.
Rosemarie Martin ...
- April 20, 2023: Workshop on Essentials of Embedded Pragmatic Clinical Trials Offered at AcademyHealth 2023 Annual Research Meeting
The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5 day pre-conference workshop at the 2023 Annual Research Meeting in Seattle, Washington. The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials Workshop,” will provide an introduction to the investigative opportunities for embedded health systems ...
- April 19, 2023: MyTEMP Cluster Randomized Trial to Be Featured in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine & Dentistry will present “Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-Randomised Trial.” The Grand Rounds session will be held on Friday, April 21, 2023, at 1:00 pm eastern.
Dr. Garg is a professor ...
- April 12, 2023: This Week’s PCT Grand Rounds to Provide Updates on RECOVER Long COVID Initiative
In this Friday’s PCT Grand Rounds, Kanecia Zimmerman of Duke University will present “RECOVER in Action: Status of Clinical Trial Protocols.” The Grand Rounds session will be held on Friday, April 14, 2023, at 1:00 pm eastern.
Dr. Zimmerman is an associate professor of pediatrics in the Duke University School of Medicine. The Researching COVID to ...
- April 11, 2023: NCATS Issues Request for Information to Decrease Health Disparities via Decentralized Clinical Trials
The NIH National Center for Advancing Translational Sciences (NCATS) recently announced a new Request for Information (RFI) entitled, “Advancing Clinical and Translational Science Through Accelerating the Decentralization of Clinical Trials.” The goals of the RFI are to identify ways that decentralized clinical trials can help make trials more effective, efficient, and equitable. In particular, comments ...
- April 10, 2023: Li Receives New PCORI Award to Develop Causal Inference Methods for Stepped-Wedge Cluster Randomized Trials
Dr. Fan Li, a member of the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core since 2013, has received approval of a 3-year funding award from the Patient-Centered Outcomes Research Institute (PCORI) to develop causal inference methods for stepped-wedge cluster randomized trials—a design that has been increasingly adopted in pragmatic trials. Li is an ...
- April 6, 2023: New Chapter of Living Textbook Describes the Ethical Considerations of Sharing Data From Embedded Pragmatic Clinical Trials
The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “Ethical Considerations of Data Sharing in Pragmatic Clinical Trials,” describes human subjects research regulations that may impact sharing data from embedded pragmatic clinical trials (ePCTs) and the ethical considerations for respecting the interests of ...
- April 5, 2023: This Friday’s PCT Grand Rounds Highlights Applications of Behavioral and Implementation Science in Cardiovascular Medicine
In this Friday’s PCT Grand Rounds, Srinath Adusumalli of the University of Pennsylvania will present “A Nudge Towards Cardiovascular Health: Applications of Behavioral and Implementation Science in Cardiovascular Medicine.” The Grand Rounds session will be held on Friday, April 7, 2023, at 1:00 pm eastern.
Dr. Adusumalli is an adjunct assistant professor of medicine and an ...
- April 4, 2023: New Quick Start Guide Pulls Together Resources for ePCT Project Managers
The NIH Pragmatic Trials Collaboratory is pleased to announce the latest resource as part of its Quick Start Guide series. These Quick Start Guides are intended to support the successful conduct of embedded pragmatic clinical trials (ePCTs). The ePCT Quick Start Guide for Project Managers links to resources for project managers to support the conduct ...
- March 29, 2023: This Friday’s PCT Grand Rounds Features Novel Approach to Lowering Blood Pressure in QUARTET USA Trial
In this Friday’s PCT Grand Rounds, Jody Cioliono will present “Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension (QUARTET USA): Results From a Randomized Controlled Trial.” The Grand Rounds session will be held on Friday, March 31, 2023, at 1:00 pm eastern.
The QUARTET USA trial tested a novel approach to lowering blood pressure ...
- March 23, 2023: AJOB Calls for Peer Commentaries on Ethics in Pragmatic Trials
The American Journal of Bioethics (AJOB) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.
Unlike AJOB‘s typical Open Peer Commentaries, commentaries for the special issue may be ...
- March 22, 2023: A Decade of PCORnet Research in This Week’s PCT Grand Rounds
In this Friday’s PCT Grand Rounds, Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati will present “From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.” The Grand Rounds session will be held on Friday, March 24, 2023, at 1:00 pm eastern.
Holve is the chief research infrastructure officer for PCORI. ...
- March 16, 2023: Grand Rounds Podcast Returns, Featuring Dr. Michael Gibson on a New Paradigm in Conducting Virtual Clinical Trials
In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Michael Gibson and Dr. Adrian Hernandez continue their discussion about The Heartline Trial and a new paradigm for virtual clinical trials.
The full February 17 Grand Rounds webinar with Dr. Gibson is also available.
- March 15, 2023: In This Friday’s PCT Grand Rounds, PROs for Adverse Event Monitoring in Oncology
In this Friday’s PCT Grand Rounds, Ethan Basch of the University of North Carolina at Chapel Hill will present “Patient-Reported Outcomes for Symptom and Adverse Event Monitoring in Oncology.” The Grand Rounds session will be held on Friday, March 17, 2023, at 1:00 pm eastern.
Basch is the Richard M. Goldberg Distinguished Professor of Medical Oncology ...
- March 15, 2023: IMPACt-LBP Enrolls First Patient in Study of Collaborative Care for Low Back Pain
IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Trial, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone!
Co-led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care. In the ...
- March 8, 2023: Biostatistics Core Sponsors This Week’s PCT Grand Rounds on Estimands in Cluster Randomized Trials
In this Friday’s PCT Grand Rounds, Brennan Kahan of University College London will present “Estimands in Cluster-Randomized Trials: Choosing Analyses That Answer the Right Question.” This session is sponsored by the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core Working Group.
The Grand Rounds session will be held on Friday, March 10, 2023, at 1:00 ...
- March 7, 2023: Webinar on Causal Inference in Pragmatic Trials Coming to IMPACT Collaboratory
In the March 16 session of IMPACT Grand Rounds, the NIA IMPACT Collaboratory will host Dr. Eleanor Murray, who will present on the topic of causal inference in pragmatic trials.
From the announcement:
Join us for IMPACT Grand Rounds on Thursday, March 16 at 12pm ET with Dr. Murray who will be presenting on the “Causal Inference in Pragmatic Trials.”
Eleanor ...
- March 1, 2023: This Week’s PCT Grand Rounds Highlights Implementation Lessons From GGC4H
In this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H, an NIH Pragmatic Trials Collaboratory Trial.
The Grand Rounds session will be held on Friday, March ...
- February 28, 2023: SMDM Will Host Webinar on Equity in Medical Decision Making
The Society for Medical Decision Making (SMDM) will host a free, live webinar on Thursday, March 2, to discuss equity and patient engagement. The webinar, “Equity in Medical Decision Making: Perspectives from Patient Partners and SMDM Members,” was organized by the SMDM Patient Advisory Council.
From the announcement:
In this webinar we will discuss equity, what it ...
- February 24, 2023: NIDA Announces Substance Use Prevention Challenge Funding Opportunity
The National Institute on Drug Abuse (NIDA) invites primary care clinical and research teams to take part in a new Challenge competition funding opportunity, “Substance Use Prevention Services in Primary Care!” With this Challenge, NIDA is seeking better understanding of how primary care providers can implement substance use prevention interventions in their clinical settings.
The Challenge ...
- February 22, 2023: In This Week’s PCT Grand Rounds, an Inclusive, Real-World S2302 Pragmatica-Lung
In this Friday’s PCT Grand Rounds, Dr. Konstantin Dragnev and Dr. Karen Reckamp will present “S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials.”
The Grand Rounds session will be held on Friday, February 24, 2023, at 1:00 pm eastern.
S2302 Pragmatica-Lung is pragmatic clinical trial testing the effect of ramucirumab and ...