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

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

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

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

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.

September 22, 2022: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

AcademyHealth and NIH logosThe 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, and implementation of pragmatic clinical trials embedded in healthcare systems.

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 pragmatic clinical trials and share lessons from implementation science for increasing engagement of diverse participants

The theme of this year’s D&I conference is “(Re)Building Better Systems: Being Proactive, Nimble, and Responsive.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 11, 8:00 am-4:45 pm
Walter E. Washington Convention Center, Washington, DC

March 22, 2022: AHRQ Publishes Hospital Infection Prevention Toolkit Based on ABATE Infection Trial

ABATE Infection logoThe Agency for Healthcare Research and Quality (AHRQ) published a new Toolkit for Decolonization of Non-ICU Patients With Devices to help clinical teams implement a protocol to reduce bloodstream infections by approximately 30% in patients with specific medical devices.

The new toolkit is based on intervention materials successfully used in the ABATE Infection trial, one of the first NIH Collaboratory Trials of the NIH Pragmatic Trials Collaboratory. ABATE Infection was a large-scale pragmatic trial involving approximately 189,000 patients in the baseline period and 340,000 patients in the intervention period across 194 non–critical care units in 53 hospitals.

From the AHRQ announcement:

The free, customizable toolkit includes step-by-step instructions, handouts, and educational videos to show frontline teams how to apply a decolonization protocol for non-ICU patients who may be at greater risk of bloodstream infections because they have certain devices, such as central venous catheters. The decolonization protocol includes instructions on helping patients bathe with an antiseptic soap and applying a nasal antibiotic ointment to carriers of Methicillin-resistant Staphylococcus aureus (MRSA).

ABATE Infection was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Allergy and Infectious Diseases and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about ABATE Infection.

February 22, 2022: New Training Workshop on the Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials Now Available

The NIH Pragmatic Trials Collaboratory is pleased to announce a new training workshop now available on the ePCT Training Workshop webpage.

 

Logo for the NIA IMPACT Collaboratory

 

On December 13, 2021 The NIH Pragmatic Trials Collaboratory and the NIA IMPACT Collaboratory co-hosted a Pre-Conference Workshop “Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials” for Academy Health’s Annual Conference on the Science of Dissemination and Implementation in Health Conference (D&I).

This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), with a particular focus on the intersection between ePCTs and implementation research methods. The workshop provides an introduction to the investigative opportunities for embedded health systems research, along with strategies for integrating implementation research methods in the design and conduct of ePCTs with the goal of providing real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the NIH Health Care Systems Research Collaboratory and the NIA IMPACT ADRD Collaboratory support and illustrate the topics presented.

View the workshop slides and recordings.

Visit the ePCT Training Resources webpage for more resources, including self-study guides, handouts, and video modules.

December 8, 2021: NIH Collaboratory and IMPACT Collaboratory Offer Workshop on Dissemination and Implementation Research and Pragmatic Trials

Logo for AcademyHealthThe NIH Collaboratory is partnering with the IMPACT Collaboratory to offer a pre-conference workshop on December 13 at AcademyHealth’s 14th Annual Conference on the Science of Dissemination and Implementation in Health.

The workshop, Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials, will provide an introduction to investigative opportunities for pragmatic clinical trials embedded in healthcare systems, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy.

The workshop is being offered free to conference attendees but requires a separate registration. The workshop will provide strategies for integrating implementation research methods in the design and conduct of ePCTs. Speakers will share firsthand experiences and case studies from the NIH Collaboratory and the IMPACT Collaboratory.

The learning objectives of the workshop include:

  • To identify key areas of synergy between ePCTs and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing ePCTs within diverse healthcare systems, and to describe opportunities for integrating implementation research methods into ePCTs
  • To increase the capacity of health services researchers to address important clinical questions with ePCTs and implementation research methods

CONFERENCE DETAILS AND REGISTRATION
14th Annual Conference on the Science of Dissemination and Implementation in Health: Broadening Horizons for Impact: Incorporating Multisectoral Approaches into D&I Science
December 13, 2021

July 6, 2021: New Quick Start Guide Offers Advice for Partnering With Healthcare System Leaders

The NIH Collaboratory is pleased to share a new resource to help clinical investigators successfully partner with healthcare system leaders. The Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships provides advice from NIH Collaboratory and healthcare system leadership and serves as an annotated table of contents for the Living Textbook, pointing readers to essential content.Quick Start Guide for Partnerships

The Quick Start Guide is part of a series of tools intended to support the successful conduct of ePCTs within healthcare systems. The first guide in the series, the Quick Start Guide for Investigators, is designed for clinical investigators interested in learning how to conduct an ePCT. The NIH Collaboratory Coordinating Center is developing more Quick Start Guides for different audiences and use cases.

June 28, 2021: AcademyHealth Announces Abstract Deadline for Dissemination and Implementation Science Conference

Logo for AcademyHealthAcademyHealth is accepting abstracts for the 14th Annual Conference on the Science of Dissemination and Implementation in Health until July 27, 2021. This year’s meeting will be held virtually from December 14 to 16.

Read the complete call for abstracts.

The theme of this year’s virtual online meeting is “Broadening Horizons for Impact: Incorporating Multisectoral Approaches into D&I Science.” The annual conference is cohosted by the NIH and AcademyHealth with the goal of realizing “the full potential of evidence to optimize health and health care by bridging the gap between research, practice, and policy.”