Multispecialty Consortium Introduces Rhinosinusitis Clinical Trial Guidelines.

The first he described was the model for short-term therapeutic intervention for acute disease. In these settings, researchers would be utilizing a treatment algorithm that would be intended to shorten the duration of disease in people with acute rhinosinusitis. Antibiotics may may represent one intervention; symptom-relieving medications would represent another, Dr. Marple said. The point of this is to study the impact of a specific intervention upon a specific disease as measured by an objective outcome such as time to resolution of symptoms or differential improvement of CT findings.

The other three protocol designs are prevention of disease recurrence for chronic rhinosinusitis and short-term and long-term treatments for chronic disease.

These protocols were designed from a standpoint of guiding research, Dr. Marple said. The dilemma that we have in rhinosinusitis is one of a mosaic of treatments applied based on anecdotal evidence. No standardized, evidence-based algorithms exist. With this document, we’re trying to accelerate this process. At present, we have no clear understanding of the disease process that underlies chronic rhinosinusitis. We have no standardized treatment algorithms to apply to the disease process. The hope is that, as we collectively start producing more information, clinicians will be provided with treatments that have proven benefits.

Dr. Marple pointed out the irony of the need for such basic information for such a common disease. We’re still rather embryonic in our understanding of this disease process, he said. We all have an understanding of what chronic rhinosinusitis represents to our patients, but we’ve only had a standardized definition of the disease for the last four or five years. At present, there are a number of theories that attempt to explain the pathophysiology. Ideally, as data supporting some of these theories become more convincing, we would like a knowledge base to develop that would direct study of interventions that could improve outcomes for chronic rhinosinusitis in a consistent way. There’s so much to learn about this disease and the interventions that impact this disease.

Applying Scientific Rigor to Antibiotics

Eli O. Meltzer, MD

An example of an intervention method that could benefit from scientific rigor is the use of antibiotics, Dr. Marple said. This is the most common form of treatment for rhinosinusitis, but we have very little data to support that practice, he said. If you step back and look at the definition of rhinosinusitis, it is important to note that it’s an inflammatory disease process, so antibiotics may or may not have a role.