American Lung Association Study Published as Editor’s Choice Article in Latest Edition of “Chest” Identifies Criteria to Screen for Chronic Sinonasal Disease

Study provides advancement in diagnosis of chronic sinonasal disease

WASHINGTON, D.C. (November 17, 2009)

Until recently, diagnosis of sinonasal disease was difficult and expensive, as an effective screening instrument did not exist.  A new study conducted by the American Lung Association's Asthma Clinical Research Centers (ACRC) has identified a simple, five-item questionnaire, based on the frequency of nasal symptoms, to accurately screen for this disease.

"For years physicians have relied on costly and inconvenient CT scans or endoscopy to diagnose sinonasal disease," said Norman H. Edelman, MD, American Lung Association Chief Medical Officer. "The ACRC's discovery of this simple, yet reliable, screening tool is a critical advancement in diagnosing this chronic disease in patients with sinus symptoms.  There is much less risk involved with this new screening tool that can now be used as the first step in diagnosing sinonasal disease. It is expected that the need for expensive CT scans and invasive endoscopy will be significantly reduced with the use of this tool."  

Patients participating in the American Lung Association's ACRC study were evaluated for chronic sinonasal disease using this five-item questionnaire, which proved more sensitive and specific when compared to the diagnosis of a panel of experts than sinus CT scans and nasal endoscopy.

The results of this study were published as the Editor's Choice Article in the November issue of Chest: The Cardiopulmonary and Critical Care Journal. NIH has also granted the American Lung Association's ACRC with additional funding to further study patients with sinonasal disease and asthma to test the efficacy of Nasonex with asthma management.

"This additional research is important because it will allow us to determine if treating sinonasal disease in patients with asthma also affects their asthma management," said Anne E. Dixon, MD, FCCP .  "This research, which begins this spring and will conclude in 2014, may provide a breakthrough in asthma management for the more than 23 million Americans with asthma."   

This study was supported by the American Lung Association, National Institutes of Health grant, and an unrestricted grant from Schering-Plough.

The ACRC Network is an American Lung Association sponsored research program that conducts large scale clinical trials with the mission of advancing the care and treatment of people with asthma. The network, with a central data coordinating center and 18 clinical centers located across the country, is the largest of its kind. By placing its clinical centers around the country, the ACRC Network is able to enroll large numbers of patients for clinical trials, thus ensuring relevant research findings can be interpreted with the highest level of scientific authority.


Abstract: Criteria To Screen for Chronic Sinonasal Disease

Background: Sinusitis and rhinitis are associated with uncontrolled asthma. There are no simple, validated tools to screen for these diseases. The objective of this study was to assess instruments to assist in the diagnosis of chronic sinonasal disease.

Objective: The study objective was to determine the most sensitive, specific, and reproducible instrument for use in the diagnosis of chronic sinonasal disease.

Methods:  Participants without acute sinonasal symptoms underwent an extensive evaluation. The results were submitted to an expert panel that used the Delphi method to achieve consensus. Using the consensus diagnosis of the panel, we determined the sensitivity and specificity of test procedures to diagnose chronic sinonasal disease. We determined the reproducibility of the most sensitive and specific instrument in a separate cohort.

Results:  Fifty-nine participants were evaluated, and the expert panel reached consensus for all (42 participants with chronic sinonasal disease, 17 participants without chronic sinonasal disease). A six-item questionnaire based on the frequency of nasal symptoms was the most sensitive tool used to diagnose sinonasal disease (minimum specificity, 0.90). Reproducibility testing in a separate cohort of 63 participants (41 chronic sinonasal disease with asthma, 22 chronic sinonasal disease without asthma) showed a concordance correlation coefficient of 0.91 (95% CI, 0.85 to 0.94) when this questionnaire was limited to five items (ie, excluding a question on smell). This five-item questionnaire had a sensitivity of 0.90 (95% CI, 0.77 to 0.97), a specificity of 0.94 (95% CI, 0.71 to 1.00), and an area under the receiver operating characteristic curve of 0.97 (95% CI, 0.93 to 1.0). Sinus CT scans and nasal endoscopy lacked sensitivity for use in the diagnosis of chronic sinonasal disease.

Conclusions: We have developed a sensitive, specific, and reproducible instrument to screen for chronic sinonasal disease. Validation studies of this five-item questionnaire are needed, including in patients with asthma.