news 2023

December 18, 2023: Ethics Consultation Documents Now Available for ARBOR-Telehealth and I CAN DO Surgical ACP

Posted on by Damon Seils

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the ARBOR-Telehealth and I CAN DO Surgical ACP studies.

The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel. Both projects are in their planning phase.

ARBOR-Telehealth will evaluate the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. A secondary aim of the study is to compare the effectiveness of the study's risk-stratification approach.

I CAN DO Surgical ACP will identify a system-based approach to help older adults undergoing elective surgery engage in advance care planning. The project will leverage the existing electronic health record and patient portal, PREPARE for Your Care materials to assist patients with completion of advance care planning, virtual healthcare navigators, and electronic nudges. Another goal of the study is to understand digital engagement, language, and social drivers of health that drive engagement in the intervention.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

December 13, 2023: In This Week’s PCT Grand Rounds, a Path Forward for Diversifying Clinical Trials

Posted on by Damon Seils

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward."

The Grand Rounds session will be held on Friday, December 15, 2023, at 1:00 pm eastern.

Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute at the Mount Sinai School of Medicine.

Join the online meeting.

December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A collage of journal cover images.Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of 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 Collaboratory contributed nearly 30 articles to the peer-reviewed literature, including the study design papers for the GRACE and BackInAction trials.

The total number of published articles from the NIH Collaboratory surpassed 300 this year. Learn more about the program's publications.

Coordinating Center

Cross-Core Collaboration

Distributed Research Network

Biostatistics and Study Design Core

Ethics and Regulatory Core

ACP PEACE

BackInAction

EMBED

GRACE

LIRE

Nudge

OPTIMUM

PRIM-ER

STOP CRC

December 6, 2023: Jumpstarting Communication About Goals of Care, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Drs. Ruth Engelberg, Erin Kross, and Robert LeeIn this Friday's PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present "A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness."

The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm eastern.

Engelberg is a research professor of medicine, Kross is an associate professor of medicine, and Lee is an assistant professor of medicine in pulmonary, critical care, and sleep medicine at the University of Washington.

Join the online meeting.

December 5, 2023: Applications Open for HDRN Canada Pragmatic Trials Training Program

Posted on by Damon Seils

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program.

This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors. Funding will be made available to successful applicants across all 3 streams to facilitate their engagement in the program.

Access the application forms.

Applications will be accepted until Friday, December 22, 2023. The program will commence on April 15, 2024.

There will be an emphasis on experiential learning for future trial leaders and postdoctoral fellows in the program through the development of a pragmatic trial protocol. Moreover, the program is aiming for highly qualified personnel employed by HDRN Canada member organizations to be involved, when possible, in a project-based learning experience. These projects will further HDRN Canada’s ability to support pragmatic trials research in the long term. (Note, however, that the highly qualified personnel stream is not restricted to applicants from HDRN Canada.)

December 4, 2023: Latest Grand Rounds Podcast Features Harlan Krumholz and the Yale PaxLC Trial Research Team

Posted on by Elizabeth Mccamic

In a new episode of our Rethinking Clinical Trials podcast, Dr. Harlan Krumholz and members of his research team speak with host Dr. Lesley Curtis about lessons from the digital, decentralized, and democratized Yale PaxLC Trial. Krumholz and team presented on their experiences during the October 27 session of Grand Rounds.

Listen and subscribe to the podcast on SoundCloud or Apple Podcasts, and view the full October 27 Grand Rounds webinar.

November 30, 2023: HCSRN Calls for Abstracts and Panel Presentations for 2024 Annual Conference

Posted on by Damon Seils

HCSRN Milwaukee 2024 logoThe Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2024 Annual Conference until December 11, 2023. This year’s meeting will be held in Milwaukee, Wisconsin, from April 9 to 11, 2024.

The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. The HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of learning healthcare systems. Learn more about the HCSRN.

This year, the HCSRN is celebrating its 30th anniversary. From its founding in 1994, the HCSRN has hosted an annual conference geared toward bringing together a diverse group of researchers, study managers, clinicians, funding agency personnel, and patient-partners to promote collaboration and share findings about research in real-world care delivery settings. Early-bird registration is open until February 18.

November 29, 2023: NIH Offers Methods Webinar on Implementation Science With Insights From Behavioral Economics

Posted on by Damon Seils

The NIH Office of Disease Prevention will continue its Methods: Mind the Gap webinar series on Friday, December 8, with "Supercharging Implementation Science With Insights From Behavioral Economics." Rinad Beidas, chair and Ralph Seal Paffenbarger Professor of Medical Social Sciences at the Feinberg School of Medicine at Northwestern University, will lead the webinar.

The Methods: Mind the Gap series explores research design, measurement, intervention, data analysis, and other methods of interest in prevention science. The December 8 session will describe efforts to use tools from implementation science and behavioral economics to improve implementation of evidence-based practices.

Register in advance to join the online presentation. Registration is required.

November 29, 2023: Special Biostatistics Series Continues With Guidelines for Stepped-Wedge Trials

Posted on by Damon Seils

In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern.

Hughes is a professor emeritus of biostatistics at the University of Washington. This session’s moderator, Patrick Heagerty, is a professor of biostatistics at the University of Washington and a cochair of the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core.

Join the online meeting.

This special Grand Rounds series will include additional moderated webinar discussions that bring together biostatisticians, clinical trials methodologists, and investigators to discuss challenges and share lessons learned in the design, implementation, and analysis of pragmatic trials. Download the series flyer and see the full schedule below.

All sessions are free and open to the public; no registration is required.

November 28, 2023: Workshop Summary Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Posted on by Karen Staman

The workshop summary is 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.

The workshop included 4 panels:

  • Panel 1: How Have Health Systems Made Decisions Based on Evidence Collected in PCTs?

    • Panelists: Devon Check, Vincent Mor, Lynn DeBar, Kathryn Glassberg, Douglas Zatzick, Eileen Bulger, Susan Huang, Kenneth Sands, Edward Septimus; Moderator: Gregory Simon

  • Panel 2: How Do We Generate the Right Evidence to Support Decision-Makers?

    • Panelists: Kenneth Sands, Eileen Bulger, Edward Septimus, Amy Kilbourne, Rosa Gonzalez-Guarda, Patrick Heagerty; Moderator: Hayden Bosworth

  • Panel 3: Learning Faster

    • Panelists: Gloria Coronado, Natalia Morone, Corita Grudzen, Kevin Chan, Pearl O’Rourke, Cheryl Boyce, Andrea Cook; Moderator: Kevin Weinfurt

  • Panel 4: Potential Structures and Incentives for Faster Learning

    • Panelists: David Chambers, Wynne Norton, Tisha Wiley, Kenneth Sands, Edward Septimus, Gloria Coronado, Natalia Morone, Corita Grudzen; Moderator: Richard Platt

Access the complete workshop materials, including slides and videocast recordings, as well as the keynote presentation by Andrew Bindman, executive vice president and chief medical officer for Kaiser Permanente.