June 11, 2026: Harnessing Qualitative Methods in Pragmatic Trials: An Interview With Emily O’Brien and David Chambers

Qualitative methods can bring additional dimensions to pragmatic research to help study teams better understand participants’ experiences, improve recruitment and retention, and contextualize study results. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with Emily O’Brien and David Chambers about the ways researchers can use qualitative methods to enhance pragmatic trials.

“It’s been really fun to see all the different ways the investigators [for the NIH Collaboratory Trials] have incorporated qualitative methods to complement the other kinds of methods they use in their studies,” said O’Brien, an associate professor of population health sciences at Duke University and cochair of the NIH Collaboratory’s Patient Centered Outcomes Core.

O’Brien highlighted the experience of the MOMs Chat & Care Study, in which the research team used narrative interviews, a method of qualitative data collection that asks participants to produce in-depth stories to describe their experiences.

“This is going to be really helpful in contextualizing the results and trying to understand better which populations the intervention works well for and, if they can improve the intervention in the future, what that might look like,” O’Brien said.

Go to the full video.

“One of the main challenges in integrating qualitative data into pragmatic clinical trials is that there are so many ways you can use qualitative data,” said Chambers. Chambers is deputy director for implementation science at the National Cancer Institute.

“You can use it to refine an intervention, to understand the results better, to improve your recruitment strategies,” he said, “so it’s really about prioritization and trying to figure out how to identify the highest-value opportunities to collect those data and make sure the study is informed by whatever you’re finding from the qualitative data.”

Go to the full interview.

In the coming weeks, we will share more highlights from the 2026 Annual Steering Committee Meeting. Access the complete meeting materials.

Video still from an interview with Dr. Emily O'Brien and Dr. David Chambers
Dr. Emily O’Brien and Dr. David Chambers

 

April 2026 Annual Steering Committee Meeting

April 13-14, 2026 | Bethesda, MD

Main Purpose

Day 1: Address challenges and share lessons from new, in-progress, and completed NIH Collaboratory Trials to promote meaningful evidence generation; learn about new methodologies and areas of focus for embedded pragmatic clinical trials (ePCTs); and have rich discussions on topics including qualitative research and in-depth feasibility assessment.

Day 2: Address challenges and share lessons from new, in-progress, and completed NIH Collaboratory Trials; discuss strategies for boosting the efficiency, relevancy, and impact of ePCTs, including approaches for interpretation and dissemination of findings and innovative, responsible use of artificial intelligence tools.

Photo of a large conference room

Agenda and Slides

Day 1: Monday, April 13, 2026

Welcome and Opening Remarks

David Shurtleff, PhD; Richard Hodes, MD; Wendy Weber, ND, PhD, MPH; Beda Jean-Francois, PhD; Lesley Curtis, PhD

Charting the Course for Pragmatic Research: Pain Care and Beyond

Explore what’s on the horizon for the ePCT ecosystem (NIH Collaboratory and beyond); Discuss priority evidence needs that may be addressed through ePCTs; Identify the methods and knowledge required for the next generation of ePCTs, including existing gaps

Moderator: Rob Califf, MD

Presenters: Kevin Weinfurt, PhD; David Shurtleff, PhD

Panel:

Campfire Session: EquiP PC

Describe challenges and ongoing issues; Hear advice from other investigators

Kari Stephens, PhD

Discovery in Disguise: Lessons From “Neutral” ePCTs

Discuss techniques for designing ePCTs that provide reliable, actionable evidence; Share statistical approaches and considerations based on ePCTs with nonsignificant effects on their primary outcomes; Examine what is gained from ePCTs that do not meet their primary outcome

Moderator: Josie Briggs, MD

Panel:

Harnessing Qualitative Research in ePCTs

Describe opportunities for qualitative methods to enhance ePCTs (eg, refining workflows, preparing for implementation); Share successful qualitative research methods employed by NIH Collaboratory Trials; Discuss ways to navigate challenges of qualitative research in ePCTs, such as timing, resources, and how to share qualitative data

Moderator: Emily O'Brien, PhD

Presenter: David Chambers, DPhil

Panel:

  • Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
  • Melissa Basile, PhD
  • Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
  • Richard Skolasky, ScD

Lightning Talks: Sharing Lessons and Top-Level Results

Describe top-level results, lessons learned, and future plans; 3 minutes per trial followed by 15 minutes of open discussion with attendees

Andrea Cheville, MD, MSCE; Ardith Doorenbos, PhD, RN, FAAN; Natalia Morone, MD, MS; Kathleen Sluka, PT, PhD

More Than Kicking the Tires: Assessing Feasibility in the Planning Phase

Discuss how assessing feasibility is not only about meeting milestones; Share examples of how ePCT researchers can discover and tackle difficult challenges in the planning phase; Explore benefits and challenges of an in-depth feasibility assessment in ePCTs

Moderator: Angelo Volandes, MD, MPH

Panel:

  • Karen Kehl, PhD, RN, FPCN
  • Amanda Petrik, PhD
  • Sebastian Tong, MD, MPH
  • Chenchen Wang, MD, MSc

Closing Remarks

David Shurtleff, PhD; Richard Hodes, MD; Wendy Weber, ND, PhD, MPH; Beda Jean-Francois, PhD; Lesley Curtis, PhD

Day 2: Tuesday, April 14, 2026

Opening Remarks

David Shurtleff, PhD; Richard Hodes, MD; Wendy Weber, ND, PhD, MPH; Beda Jean-Francois, PhD; Lesley Curtis, PhD

Campfire Session: CARNATION

Describe challenges and ongoing issues; Hear advice from other investigators

Lynn DeBar, PhD, MPH; Rachel Gold, PhD, MPH; Nicole Cook, PhD, MPA

Networking

Consult with Core chairs and colleagues on issues your trial is facing; Engage in small group discussion

Slow Recruitment: Strategies for Prevention and Mitigation

  • Steven George, PT, PhD, FAPTA
  • Christine Goertz, DC, PhD

Data Sharing and Repositories for HEAL/PRISM Trials: Best Practices, HEAL CDE Framework, etc.

  • Andrea Cheville, MD, MSCE
  • Keith Marsolo, PhD

Use of Digital Tools: Practical, Regulatory, and Ethical Issues

  • Joseph Ali, JD

Dissemination Done Better: Practical Tips for ePCT Researchers

Describe how to collaborate with partners in interpreting findings prior to dissemination; Share successful dissemination strategies from NIH Collaboratory Trials that have helped promote changes in care; Explore approaches for dissemination of findings beyond the publication of results in an academic journal

Moderator: Hayden Bosworth, PhD

Panel:

ePCTs in the AI Revolution: Balancing Innovation With Responsibility

Share new and emerging AI capabilities with the potential to transform ePCTs; Discuss ethical considerations associated with AI use in research, such as when a human should be in the loop; Describe challenges and areas of uncertainty for ePCTs in the era of AI

Moderator: Adrian Hernandez, MD, MHS

Presenter: Emily O'Brien, PhD

Panel:

  • Guilherme Del Fiol, MD, PhD
  • Michael Ho, MD, PhD
  • Keith Marsolo, PhD
  • Jeremy Sugarman, MD, MPH, MA
  • Angelo Volandes, MD, MPH

Closing Remarks

David Shurtleff, PhD; Richard Hodes, MD; Wendy Weber, ND, PhD, MPH; Beda Jean-Francois, PhD; Lesley Curtis, PhD

 

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Grand Rounds January 9, 2026: Pragmatic Care Embedded Randomization: Insights From the KP-VACCINATE Megatrial (Ankeet S. Bhatt, MD, MBA, ScM)

Speaker

Ankeet S. Bhatt, MD, MBA, ScM
Cardiologist, Kaiser Permanente San Francisco Medical Center
Research Scientist, Kaiser Permanente Northern California Division of Research
Assistant Professor, Kaiser Permanente Bernard J. Tyson School of Medicine
Adjunct Professor, Stanford University School of Medicine

Keywords

Vaccination; Learning Health System; Implementation Science; Nudges; Influenza; Cardiovascular

Key Points

  • Every year, influenza leads to over 500,000 deaths and 3-5 million severe cases globally. It increases the risk of cardiovascular (CV) events like myocardial infarction and heart failure. Though health guidelines strongly recommend annual influenza vaccination, rates remain suboptimal globally and persistent inequities exist. There’s an urgent need for novel, effective, and scalable strategies to improve influenza vaccination rates.
  • The KP-VACCINATE trial is one of the largest ever conducted, randomizing over 3.6 million patients in under 30 days. It included several pragmatic elements, such as coordination with existing vaccine promotion efforts; randomization performed by operational health system teams; and endpoint capture fully embedded in the electronic health record.
  • The study team assessed the effect of a cardiovascular-focused nudge communication on influenza vaccination rates and found that there was no effect. Despite the negative results, the trial establishes that pragmatic and rapid randomization of communication strategies is operationally feasible at scale with routine healthcare workflows in the US.

Discussion Themes

The study team targeted a larger-than-usual population in order to 1) demonstrate the feasibility of randomization within a large-scale health system, and 2) be well-powered for subgroup analyses that could help tailor future interventions.

Dr. Bhatt viewed the negative result as an illustration of the importance of design and context for interventions based in behavioral science, rather than an indication that nudges are ineffective.

Future directions may include involvement of the broader care team, with primary care providers and specialty providers playing a potentially critical role in nudging patients towards vaccine uptake.

Digging Into Dilemmas of Pragmatic Clinical Trials: NIH-Hosted Workshop (November 2025)

November 4-5, 2025: This 2-day workshop focused on the perspectives of providers, healthcare systems, regulators, and payers that can inform better approaches to research embedded in healthcare delivery. A series of panels discussed considerations for research in healthcare systems across a variety of communities; platform trials as an emerging method; implications of pragmatic trials with null findings for future pragmatic research; and the role of pragmatic trials in comparative effectiveness research of artificial intelligence algorithms.

Agenda, Slides, and Recordings

Day 1: November 4

Welcome and Introduction

Wendy Weber, ND, PhD, MPH*
Helene Langevin, MD*
Presented by: Lesley Curtis, PhD

Keynote: Landscape of Healthcare in America: Gaps and Opportunities (That Researchers Need to Hear)

David Zaas, MD, MBA

Session 1: Understanding Needs and Priorities of Health Systems Across Communities

Moderator: Cherise Harrington, PhD, MPH

Panel:

  • Aimee Eden, PhD, MPH*
  • Rachel Gold, PhD, MPH
  • Caleb Holtzer, MD, MPH
  • Ann Sheehy, MD, MS*
  • Sebastian Tong, MD, MPH

Session 2: Realizing the Potential of Platform Trials

Moderator: Adrian Hernandez, MD, MHS

Panel:

  • Marianne Kearney Chase
  • Martin Landray, MB ChB, PhD
  • Gregory Levin, PhD
  • Christopher Lindsell, PhD
  • Bijoy Menon, MBBS, MD, DM, MSc

Summary and Concluding Remarks

Lesley Curtis, PhD
Cherise Harrington, PhD, MPH
Adrian Hernandez, MD, MHS
Wendy Weber, ND, PhD, MPH*

Day 2: November 5

Welcome and Introduction

Wendy Weber, ND, PhD, MPH*
Helene Langevin, MD*
Presented by: Kevin Weinfurt, PhD

Session 3: What Do We Learn From Null Pragmatic Trials?

Presenter: Kevin Weinfurt, PhD

Moderator: Josephine Briggs, MD

Panel:

  • Corita Grudzen, MD, MSHS
  • Michael Ho, MD, PhD
  • Vincent Mor, PhD
  • Miguel Vazquez, MD

Session 4: What Is the Role of ePCTs in the Age of Artificial Intelligence?

Moderator: Emily O'Brien, PhD

Panel:

  • Adrian Hernandez, MD, MHS
  • Michael Ho, MD, PhD
  • Rohan Khera, MD, MS
  • Edward Melnick, MD, MHS
  • Jeremy Sugarman, MD, MPH, MA
  • Kenneth Wiley, PhD*


Summary and Concluding Remarks

Josephine Briggs, MD
Lesley Curtis, PhD
Emily O'Brien, PhD
Wendy Weber, ND, PhD, MPH*
Kevin Weinfurt, PhD

*Participated in workshop planning but unable to attend the live event due to the federal government shutdown.

September 8, 2025: P Values vs Decision-Maker Perspectives, in a Special Grand Rounds Session on September 26

In a special session of Rethinking Clinical Trials Grand Rounds on September 26, longtime leaders from the NIH Pragmatic Trials Collaboratory will present “Significance in Pragmatic Clinical Trials: P Values vs Decision-Maker Perspectives.”

The Grand Rounds session will be held on Friday, September 26, 2025, at 1:00 pm eastern.

Greg Simon is a senior investigator at the Kaiser Permanente Washington Health Research Institute, a member of the NIH Collaboratory leadership team, and a cochair of the NIH Collaboratory’s Health Care Systems Interactions Core. Susan Huang is a Chancellor’s Professor in the Division of Infectious Diseases at the UC Irvine School of Medicine and the medical director of epidemiology and infection prevention at UCI Health. She was the principal investigator for ABATE Infection, an NIH Collaboratory Trial. Liz Turner is an associate professor of biostatistics and bioinformatics and global health at Duke University and a cochair of the NIH Collaboratory’s Biostatistics and Study Design Core.

Join the online meeting.

 

August 11, 2025: New Living Textbook Chapter Explores Implementation in Pragmatic Clinical Trials

The NIH Pragmatic Trials Collaboratory Implementation Science Core, led by Devon Check and Hayden Bosworth, has developed a new chapter on implementation to assist study teams with the complex process of using and studying implementation strategies to help implement research findings into clinical care. The chapter includes sections on:

Case studies are used to illustrate how pragmatic clinical trials embedded in healthcare systems use implementation frameworks, including examples from RAMP, BEST-ICU, STOP CRC, TSOS, ABATE, STEP-2, and GRACE.

For more, see our collection of chapters on Dissemination and Implementation, which includes chapters on Dissemination to Different Stakeholders, Data Sharing and Embedded Research, and End-of-Trial Decision-Making.

June 23, 2025: How to Choose Patient-Reported Outcome Measures in Pragmatic Clinical Trials?

Living Textbook iconA new section of the Living Textbook of Pragmatic Clinical Trials describes considerations for choosing patient-reported outcome measures in pragmatic clinical trials.

“Where possible, investigators are encouraged to use measures with adequate support for validity that are in the public domain,” the authors wrote.

The authors provide a set of questions to guide investigators in choosing appropriate measures. For example, investigators may want to understand whether the patient-reported outcome is in electronic health records, is in the public domain, and is valid for the use case in question.

The considerations were developed by members of the NIH Pragmatic Trials Collaboratory’s Patient-Centered Outcomes Core in collaboration with the Health Care Systems Interactions Core, the Electronic Health Records Core, and colleagues at the NIH.

Grand Rounds March 28, 2025: A Cross-Sectional Study of GPT-4–Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management (Anivarya Kumar, BA; Matthew Engelhard, MD, PhD)

Speakers

Anivarya Kumar, BA
Fourth-Year Medical Student
Duke University School of Medicine

Matthew Engelhard, MD, PhD
Assistant Professor, Department of Biostatistics & Bioinformatics
Duke University School of Medicine

Keywords

Health Literacy; Large Language Models; Artificial Intelligence; Electronic Health Records

Key Points

  • Limited health literacy (HL) has tangible effects on morbidity and mortality: it’s associated with higher rates of hospital admissions and readmissions; medication nonadherence; healthcare costs; and all-cause mortality. 9 in 10 adults have limited HL, and rates are 2 – 3 times lower in marginalized populations.
  • 71% of patients report accessing their electronic health records (EHRs) to read documentation from their clinical visits, particularly the discharge summary notes (DSNs). But clinical notes have low levels of readability, hindering patients’ ability to engage in shared decision-making.
  • The research team looked at whether a Generative-Pre-trained-Transformer-4 (GPT-4)-based plain language translation of DSNs could improve patient comprehension of disease course and management.
  • 533 patients, recruited from a pool of EHR users, were randomly assigned 4 DSNs to assess. After reading the DSNs – 2 translated into more accessible language, 2 untranslated – patients answered questions assessing their objective comprehension, subjective comprehension, confidence, and time spent on each DSN.
  • Compared to the untranslated DSNs, objective understanding of the translated DSNs increased by 6.1%; subjective understanding increased 18%; confidence increased 45%; and average time spent with the DSNs decreased 51%.
  • The research team concluded that GPT translation of DSNs significantly improved patient comprehension of disease course and management and optimized time spent reading them. The effect was significantly greater in marginalized populations with historically low health literacy, reducing the gap in comprehension scores between patient populations.
  • Limitations included the use of standardized DSNs as opposed to real-world DSNs; the use of MyChart when enrolling patients, leading to a participant group with a higher baseline HL; and the modest number of Hispanic patients enrolled in the study.
  • Race is a significant and independent factor for HL. Preliminary data suggests that GPT translation can help close this gap. The research team identified this as an area for further study.

Discussion Themes

While discharge instructions alone can be great for providing patients with action items, they lack some of the context that DSNs can provide, lending the patient a more complete understanding of their condition.

The advantages of providing pre-generated materials, as opposed to pointing patients to an large language model (LLM) like Chat GPT for a more interactive explanation of their condition, include the potential for screening by a healthcare professional and less of a burden on the patient.

The study team ended up favoring “semantically-focused” translations over translations that focused solely on simplifying the language or avoiding jargon. When the LLM was asked to focus on semantics, it was more likely to define concepts and their implications.

Health literacy and reading level are not necessarily on par, and patient-centric or accessible language/LLMs are very important to consider. This may require further investigation, e.g. through qualitative interviews.

Grand Rounds January 10, 2025: FM-TIPS Community Engagement Methods for Recruitment (Dana Dailey PT, PhD; Heather Schacht Reisinger, PhD)

Speakers

Dana Dailey PT, PhD
Assistant Research Scientist
Physical Therapy and Rehabilitation Science
University of Iowa
Associate Professor, Physical Therapy Department
St. Ambrose University

Heather Schacht Reisinger, PhD
Director, Implementation Science Center
Associate Director for Engagement, Integration, and Implementation
Institute for Clinical and Translational Science
Professor, Division of General Internal Medicine at the University of Iowa

Keywords

Community-Engaged Research; Recruitment

Key Points

  • The Fibromyalgia TENS in Physical Therapy (FM-TIPS) study sought to test the feasibility and effectiveness of adding Transcutaneous Electrical Nerve Stimulation (TENS) to standard physical therapy (PT) care in a real-world PT setting. Their primary outcome was the change in movement pain, from baseline to 50 days.
  • By February 2022, the team had activated 25 active PT clinics across seven Midwestern states. In February 2023, the team received a diversity supplement for community engagement and brought on a Community Engagement Coordinator.
  • After developing a community engagement process and implementing six community engagement strategies, inquiries about the study increased significantly, screening rates held steady, and enrollment rates increased. These effects were more pronounced in targeted clinics.
  • Engagement with the clinics, clinicians, and community had a significant impact on the pragmatic trial. Dr. Dailey noted that clinicians felt more supported and seen as a part of both the clinic and the community. Conversations with participants were also fruitful, helping the researchers understand how participants were feeling when they weren’t in therapy.
  • Clinical research in community physical therapy clinics is not common, and there was a steep learning curve for many of the physical therapists involved. Community support helped them navigate screening and enrollment.
  • The study team developed individualized clinic plans through inquiry of clinicians and clinics. This feedback helped them identify organizations to collaborate with, local events, etc.
  • Process building, including implementation and complete documentation of outcome measures, was important to site evaluation. As a result of these activities, the research team was able to carry lessons over into low-enrolling clinics, adapt, and make productive changes.

Discussion Themes

When researchers think about pragmatic trials involving clinics, Dr. Reisinger noted, it becomes difficult to delineate the concepts of “community members” and “participants.” For example, it’s important to also think about clinicians also as community members who are living and working in those spaces, and who have a deep knowledge of and commitment to their community. All of that knowledge will be important to decision-making.

Intensive and responsive community engagement was made possible for this pragmatic trial by the diversity supplement, which enabled the team to hire two full-time community engagement coordinators. At the rate they were going before they implemented community engagement, the study team would not have hit their enrollment target; in the end, they exceeded it.

Researcher teams should always be adaptive and flexible when doing community engagement, even when it comes to documentation.