dissemination

February 9, 2026: New NIH Collaboratory Resource Highlights Dissemination Opportunities for Pragmatic Trials

Posted on by Damon Seils

The NIH Pragmatic Trials Collaboratory published a new handout describing the variety of dissemination opportunities for pragmatic clinical trials to help investigators plan for broad dissemination.

Pragmatic clinical trials embedded in healthcare systems are designed to answer pressing questions of interest to healthcare system leaders, patients, and frontline clinicians. The results of pragmatic trials can also inform regulators, policymakers, payers, and others. Disseminating findings widely is paramount for these trials to have real-world impact.

The new handout, which was developed by the NIH Collaboratory Coordinating Center with input from investigators for several of the NIH Collaboratory Trials, offers examples of strategies for broad dissemination of trial results beyond academic publications.

View the handout: Dissemination Opportunities for Pragmatic Trials

January 27, 2026: Workshop Materials Available From ‘Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions’

Posted on by Damon Seils

Logo for the 18th Annual Conference on the Science of Dissemination and Implementation in HealthComplete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions.”

The full-day workshop, held on December 14 at AcademyHealth’s 18th Annual Conference on the Science of Dissemination and Implementation in Health, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers. Presenters shared firsthand experiences and case studies from the NIH Collaboratory Trials. The learning objectives of the workshop included:

  • To identify areas of synergy between embedded pragmatic clinical trials and implementation research
  • To introduce participants to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded in diverse healthcare systems, and describe opportunities for integrating implementation research methods into these trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials, and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

Access the complete workshop materials, including slides, speaker biographies, and the full participant guide.

December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Posted on by Damon Seils

Cover image of the journal Clinical TrialsIn a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation.

The article was published online ahead of print in Clinical Trials.

There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants. However, this practice has not been examined in the context of pragmatic clinical trials, which have special features that may complicate the ethics and logistics of sharing aggregate results.

The report’s authors summarize the ethical arguments for sharing aggregate results and describe the features of pragmatic trials that may raise logistical and other barriers to disclosure. They also discuss the important role healthcare system partners play in sharing results from pragmatic trials.

The authors offer the following recommendations:

  • Sharing aggregate results with research participants should be the default, and decisions not to share should be justified
  • Planning for sharing aggregate results should begin early in the planning of the trial
  • The healthcare care systems in which the trial is embedded should be key partners in decisions about what and how to share
  • Proactive sharing of results from a pragmatic trial that was conducted under a waiver or alteration of consent, including an explanation for why consent was not obtained in the study, can promote trust in the investigators and their healthcare system partners

Read the full report.

The article was coauthored by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, including Stephanie Morain, Abigail Brickler, Joseph Ali, Caleigh Propes, and Kayla Mehl of Johns Hopkins University; Pearl O’Rourke, formerly of Partners HealthCare; Kayte Spector-Bagdady of the University of Michigan; Benjamin Wilfond of the Seattle Children’s Hospital; Vasiliki Rahimzadeh of the Baylor College of Medicine; and David Wendler of the NIH Clinical Center.

October 22, 2024: Registration Opens for Pragmatic Trials Workshop at AcademyHealth–NIH Dissemination & Implementation Conference

Posted on by Damon Seils

AcademyHealth D&I Conference logoThe NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

The theme of this year’s D&I conference is “Moving Fast and Slow: Optimizing the Pace of Implementation.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 8, 10:00 am-6:00 pm
Crystal Gateway Marriott, Arlington, Virginia

May 16, 2024: Journal Peer Reviewers Are Familiar With Pragmatic Trials, Want More on Implementation

Posted on by Damon Seils

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 the principal investigators of the first several completed NIH Collaboratory Trials to confidentially share the journal peer reviews of manuscripts reporting the trials’ main outcomes. They independently reviewed the peer reviews of the manuscripts to note common questions and themes.

“We did not generally observe that reviewers were unfamiliar with pragmatic clinical trials or had difficulty understanding the design and analytic approaches of the studies,” the authors reported. Instead, they found that the reviewers in many cases requested more information about implementation outcomes, implementation strategies, and intervention content.

Although many of the NIH Collaboratory Trial teams have published separate implementation-focused papers, the report suggests that reviewers may want or expect some of this information to be included with the report of primary study outcomes to aid in the interpretation of results.

Read the full report.

May 13, 2024: Ongoing Funding Opportunity Supports Studies of Implementation and Sustainability of Interventions

Posted on by Damon Seils

NIH logoAn 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, and policies.”

Posttrial sustainment and deimplementation of study interventions has been a focus of the NIH Collaboratory’s Implementation Science Core. In a recent article, investigators from 6 of the program’s completed pragmatic clinical trials summarized the posttrial interpretation of their trials’ results and considered the factors that influenced the sustainment or deimplementation of the studies’ interventions.

The article was published early this year in the Journal of General Internal Medicine.

Three lessons emerged from the review:

  • Ineffective interventions may be sustained if they have other measured or perceived benefits.
  • Effective interventions may not be sustained if they require significant resources.
  • Alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions.

Read about the NIH funding opportunity for research that supports the dissemination and implementation of evidence-based interventions.

February 22, 2024: Updated Template Provides Guidance for Reporting of Pragmatic Trial Results

Posted on by Damon Seils

An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials.

The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems in the conduct of pragmatic trials, and special ethical and regulatory considerations.

Download the template.

The updated template is organized by the recommended reporting elements presented in the CONSORT checklist and draws on recent experiences and lessons learned from the NIH Collaboratory Trials. Appendices include links to CONSORT and its relevant extensions, the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tools and resources, and examples of figures to include in pragmatic trial reports.

October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

Posted on by Damon Seils

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

The theme of this year’s D&I conference is “Raising Expectations for D&I Science: Challenges and Opportunities.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 10, 10:00 am-6:00 pm
Gateway Marriott, Arlington, Virginia

July 18, 2023: NIH Collaboratory Researchers Highlight Ethical Obligation, Value of Sharing Trial Results With Participants

Posted on by Hannah Webster
Headshots of Dr. Lynn DeBar and Dr. Natalia Morone
Dr. Lynn DeBar and Dr. Natalia Morone

In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. Both also participated in a discussion session about the challenges and value of results dissemination. DeBar is a principal investigator of the BackInAction and PPACT NIH Collaboratory Trials, and Morone is the principal investigator of the OPTIMUM NIH Collaboratory Trial.

They described sharing results as important now more than ever. Dissemination can be a feasible and respectful way to keep patients involved in the study. It can also combat misinformation and promote trust.

An Ethical Obligation

DeBar and Morone said they are often surprised by the number of research participants, particularly older patients, who participate in trials based on altruism or with the goal of contributing to advancing science.

“We have done focus groups about why people participate in research, and many times it is the altruism,” Morone said. “People want to help others, and they very specifically said they want to know what’s going on with the study.”

In this case, there may especially be a moral obligation to share results with patients.

“I think it’s an obligation because they were generous in giving us their time, but also, they requested it,” DeBar said. “I think we have that responsibility.”

Engaging With Community Advisory Boards

Both researchers highlighted how valuable community stakeholder insight is in how to best communicate results with patients. Community advisory boards can provide a wealth of information.

“Having materials vetted by folks that represent your population is really valuable,” Morone said. “As a physician, I will start using medical language with my patients, and as a researcher, I may use research language. It’s just so automatic.”

That’s why removing jargon and making results accessible is so important, and community experts can provide that necessary insight, Morone explained. Stakeholder perspectives may also change over time, so research teams should be flexible.

Morone recalled an instance when community advisory board representatives requested testimonials from participants on the research project’s website.

“When you have someone with lived experienced sharing the results, it just carries a weight that I do not [as a researcher],” Morone said.

DeBar highlighted that results can and can be presented in creative and engaging ways. Lay summaries, videos, and graphics can help complicated research results be more accessible.

Communicating Results Over Time

Especially in the context of pragmatic trials, and when trials take place over many years, teams should not wait until the end of the study to share information, they said.

“If they are informed, participants can be better partners,” DeBar explained.

Sharing results over the course of the study can be a mechanism for engaging participants. Even if individual data can’t be shared, aggregate data provides insight.

“We aren’t waiting to the end of the study. We are updating our website, and we send them newsletters with information because they ask us for it,” Morone said.

She noted that when patients are engaged and treated as partners in research, they will often be part of the dissemination efforts.

DeBar highlighted that sharing anecdotes, when they align with data, can be a powerful way to communicate results with participant partners.

“I like the phrase fact-congruent stories,” she said. “Those are the things that are really compelling to people. You definitely need the results of the study, but if it can be packaged in ways that really bring that to life, it makes a big difference.”

May 11, 2023: Article Outlines Key Stakeholder Insights Related to Participant Data Sharing in Pragmatic Trials

Posted on by Hannah Webster

Headshot of Dr. Stepanie Morain

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 this month in Learning Health Systems.

The authors, including members of the NIH Collaboratory’s Ethics and Regulatory Core, recruited stakeholders who represented a range of experiences. They then conducted 40 semistructured interviews focused on ethical considerations. The team identified 5 overarching themes after analyzing the interviews: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing data; and (5) diverse views about the likely benefits resulting from sharing data.

A key insight was that a “one size fits all” model for promoting broader sharing of data from pragmatic trials is not feasible, and policies must be sensitive to the unique challenges that pragmatic trials present, such as variation among trials.

“Our data indicate unresolved tensions in how to fulfill this expectation for [pragmatic clinical trials],” the authors wrote. “Future work could inform efforts to tailor data-sharing policy and practice to reflect these and other challenges, including sharing experiences from trials that have successfully navigated these tensions.”

Lead author Stephanie Morain and co-authors Juli Bollinger, Kevin Weinfurt, and Jeremy Sugarman are members of the NIH Collaboratory’s Ethics and Regulatory Core. This work was supported within the NIH Pragmatic Trials Collaboratory by a supplemental grant award from the National Center for Complementary and Integrative Health.

Read the full report.