Two new PCORnet® Studies are leveraging the PCORnet infrastructure to conduct patient-centered comparative clinical effectiveness research, aiming to fill critical gaps in clinical care knowledge in previously hard-to-study areas.

The first new PCORnet® Study, Rationale and Design of the Tube Size Randomized Trial during Emergency Tracheal Intubation (BREATHE), will be the first PCORnet® Study looking at the ER intubation process. Each year, 1.5 million people are intubated in the ER and while most survive, around 50 percent suffer vocal cord injuries. The BREATHE Study will compare the effect of using a smaller endotracheal tube versus using a larger endotracheal tube during ER and ICU intubations. It will compare outcomes that patients care about including time off a breathing machine, and breathing and speaking ability. The study will use patient-preferred communication methods like phone, text, or email to collect data.

This study, scheduled to begin enrollment this month, will be led by Principal Investigator Jonathan Casey, MD, MSCI, assistant professor of medicine at Vanderbilt University Medical Center and lead partner in the PCORnet Science, Technology, and Research (STAR) Clinical Research Network. Aligned with the patient-centered approach of PCORnet, patient and community engagement efforts were central to the design of the study. Patients reviewed study questions and researchers used the gathered insights from community engagement studios as well as surveys of patients and clinicians across the STAR network to shape the study.

This comparative clinical effectiveness research study will help doctors understand if using a smaller breathing tube prevents long-term problems with breathing, speaking, and swallowing, and how different breathing tube sizes may affect a patient’s recovery.

The second new PCORnet® Study, Comparative Effectiveness of Emerging Medications in Children with Inflammatory Bowel Disease (COMPARE), will compare the most commonly prescribed new treatments for children with pediatric inflammatory bowel diseases (PIBD). For up to half of youth with moderate to severe PIBD, anti-TNF therapies don’t work. Although new treatments for inflammatory bowel disease are available, they are often used off-label to treat PIBD because the medications have only been approved for use in adults.

The study team, led by Principal Investigator Michael Kappelman, MD, MPH, professor of pediatrics and epidemiology at the University of North Carolina School of Medicine, used the PCORnet® Common Data Model to identify potential participants for this observational study – children with Crohn’s disease or ulcerative colitis who were treated with standard anti-TNF therapies – at 30 sites participating in PCORnet. The study team also hosted community engagement studios and a listening session with former pediatric patients and parents of current patients to learn what is most important to patients and to get their input on the design of the study.

The COMPARE Study will fill a gap in clinical treatment knowledge for children with PIBD by studying the effectiveness, safety, and differences in how well the treatments work across groups of young participants. Results from this study will help patients, their caregivers, and doctors better understand new treatments options and improve care for children with PIBD.

Get an overview of PCORnet and learn more about both studies on the PCORnet Studies webpage.

Ready to learn how the infrastructure of PCORnet can support your next patient-centered study? Contact the PCORnet® Front Door to start the conversation.