Grand Rounds: Pediatric IBD, Hypertension Texting, and Pediatric Trials Network

Recent sessions of the Rethinking Clinical Trials Grand Rounds series covered the COMPARE-Pediatric IBD study, a hypertension self-management intervention for Black Veterans, and the upcoming Pediatric Trials Network presentation.

Michael D. Kappelman, professor of pediatric gastroenterology at the University of North Carolina at Chapel Hill, presented the COMPARE-Pediatric IBD study in the February 13, 2026 Grand Rounds. Inflammatory Bowel Disease (IBD) is a chronic gastrointestinal condition affecting roughly 100,000 youth in the United States, with a profound impact on nutrition, growth, physical, and psychosocial development. Anti-TNF biologics are the only FDA-approved advanced therapies for children, and approximately 30% of patients experience treatment failure within 2 years. COMPARE-Pediatrics IBD, a PCORnet® study, includes 2 parallel multi-center, prospective cohort studies and retrospective cohort studies. The former, developed with multi-stakeholder input, will compare the effectiveness of emerging therapies in children with IBD; the latter will characterize the safety of these treatments and explore the heterogeneity of treatment effects across subgroups. The study is utilizing PCORnet’s infrastructure, including Prep-to-Research Queries and the PCORnet Common Data Model (CDM). The study team opted not to conduct a randomized pragmatic trial because they anticipated that desperate families would be reluctant to “roll the dice” with randomization and because insurance coverage for expensive off-label medications often dictates which therapy a patient can receive. Kappelman noted that while the CDM is effective for structured data, it cannot yet capture nuanced interpretations, such as specific MRI findings, which require more advanced AI or manual review.

On March 27, 2026, Sarah L. Cutrona, acting director of the Center for Health Optimization and Implementation Research at VA Bedford Healthcare System and professor at UMass Chan Medical School, presented a randomized clinical trial on text messaging and video stories to support hypertension self-management in Black Veterans. This study sought to improve HTN control and self-management among about 600 Black Veterans by supplementing a preexisting video story intervention with longitudinal texting support. Those in the intervention arm watched 5 video stories featuring other Black Veterans, chose their preferred storyteller, and received educational and interactive messages aligned with that storyteller. Those in the control arm received only interactive messages. While participants in both arms saw marginal improvements in systolic and diastolic blood pressure (BP), there was no significant difference in the BP change between the arms. The intervention saw high treatment fidelity (92%) and sustained engagement, with over 55% of participants responding to texts through the end of the 6-month period. Researchers concluded that the interactive text messages, which were present in both arms, were an effective way to maintain engagement in a multi-month study and may serve as a useful strategy for future longitudinal interventions supporting Black Veterans. The control group was intentionally kept active to isolate the specific impact of storytelling, and the intervention was shaped by direct feedback from veteran consultants.

In the upcoming Grand Rounds on Friday, July 24, 2026, at 1:00 pm eastern, Rachel Greenberg and Danny Benjamin will present “The Pediatric Trials Network: Innovating to Make Drugs Safe and Effective for Children.” Greenberg is a professor of pediatrics at Duke University and an MPI of the Pediatric Trials Network. Benjamin is the Kiser-Arena Distinguished Professor of Pediatrics at Duke University, deputy executive director of the Duke Clinical Research Institute, and lead PI of the Pediatric Trials Network.