MedStar Health and Georgetown University Researchers Lead Largest Clinical Trial of Its Kind on Acute Rhinosinusitis, Examining Treatments and Innovative Data Collection Modalities

WASHINGTON – The Patient-Centered Outcomes Research Institute (PCORI) has awarded a research team led by Dan Merenstein, MD, professor of family medicine at Georgetown’s School of Medicine and professor of human science at the School of Health and Nawar M. Shara, PhD, director of Center of Biostatistics, Informatics and Data Science (CBIDS) at the MedStar Health Research Institute, a $23.6 million research grant to study treatments for acute rhinosinusitis.

Acute rhinosinusitis involves inflammation of the nose and sinus passages, most often caused by a viral or bacterial infection. Symptoms often include congestion, headaches, sinus pressure, facial pain, and a green/yellow nasal discharge. Together, the investigators will recruit more than 3,700 people diagnosed with acute rhinosinusitis to the largest clinical trial of its kind to study various treatment approaches. The randomized clinical trial will compare outcomes among treatments with antibiotics, nasal sprays such as intranasal corticosteroids (INCS), over-the-counter supportive treatment, or saline nasal irrigation (SNI). Some arms of the study will include a placebo.

“Acute rhinosinusitis leaves people feeling miserable and desperate for relief, and their care providers eager to help,” says Dr. Merenstein, professor and director of research programs for Georgetown’s Department of Family Medicine. “Unfortunately, in the absence of clinically proven treatments, providers often prescribe antibiotics. We want to know if there’s a better way to treat patients and alleviate symptoms quicker.”

In addition to exploring how to best improve treatment outcomes for patients, this study will also utilize several methods to collect data from participants, including voice-enabled devices like Amazon’s Alexa EchoDot, in the hopes of facilitating and improving data collection accuracy with this technology.

“Given the scale of this study, we have the opportunity to learn more about how smart devices can help improve care, starting with how patients share information about their health with providers,” said Dr. Shara, co-investigator for the study. “Using technology to strengthen the relationship between patient and provider is an exciting proposition but we should be rigorous in our pursuit to understand potential useability challenges,” In recent years, Dr. Shara has led two other clinical trials where voice assistants were used for data collection and has specifically focused on recruiting participants from lower-resourced communities where technology access may have historically been low.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions.

The study was selected for funding through a PCORI initiative to support large-scale, high-impact comparative effectiveness research trials in a multi-phase format allowing for testing and refinement of the study approach. The study will involve an initial feasibility phase to maximize the likelihood of full trial success. The study was selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals.

The research collaboration also involves investigators from the University of Washington, UCLA, Virginia Commonwealth University, Penn State, and the University of Wisconsin.

###

This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.