Rhinosinusitis: establishing definitions for clinical research and patient care

Abstract

Background: There is a need for more research on all forms of rhinosinusitis. Progress in this area has been hampered by a lack of consensus definitions and the limited number of published clinical trials.

Objectives: To develop consensus definitions for rhinosinusitis and outline strategies useful in clinical trials.

Methods: Five national societies, The American Academy of Allergy, Asthma and Immunology; The American Academy of Otolaryngic Allergy; The American Academy of Otolaryngology Head and Neck Surgery; The American College of Allergy, Asthma and Immunology; and the American Rhinologic Society formed an expert panel from multiple disciplines. Over two days, the panel developed definitions for rhinosinusitis and outlined strategies for design of clinical trials.

Results: Committee members agreed to adopt the term “rhinosinusitis” and reached consensus on definitions and strategies for clinical research on acute presumed bacterial rhinosinusitis, chronic rhinosinusitis without polyposis, chronic rhinosinusitis with polyposis, and classic allergic fungal rhinosinusitis. Symptom and objective criteria, measures for monitoring research progress, and use of symptom scoring tools, quality-of-life instruments, radiologic studies, and rhinoscopic assessment were outlined for each condition.

Conclusion: The recommendations from this conference should improve accuracy of clinical diagnosis and serve as a starting point for design of rhinosinusitis clinical trials.

Fig 1

Sinus CT scan of a patient with viral rhinosinusitis showing abnormalities of the maxillary and ethmoid sinuses. Reprinted with permission Arch Otolaryngol Head Neck Surg 1994;120:144. Copyrighted © 1994, American Medical Association. All Rights reserved.

Fig 2

Coronal CT scan of the maxillary sinus of an adult with a common cold. A, Fourth day of illness, showing multiple bubbles in the sinus cavity (white arrows), occlusion of the infundibulum (black arrowhead), and homogeneous abnormality along the medial wall and floor of the sinus cavity (black arrow). B, Seventh day of illness, showing occlusion of the infundibulum (black arrowhead) and homogenous abnormality of the lower two thirds of the sinus cavity (black arrow). Few bubbles are still present in this material, but most of those present earlier have burst (white arrow). Reprinted with permission from Gwaltney JM, Jr, Hendley JO, Phillips CD, et al. Nose blowing propels nasal fluid into the paranasal sinuses. Clin Infect Dis 2000;30(2):387-92. Published by The University of Chicago Press. © 2000 by the Infectious Diseases Society of America.

Fig 3

Intranasal pressure time histories for a representative nose blow, coughing bout, and sneeze shown on the same scale for comparison (dashed line, nose blow; solid line, coughing bout; dotted line, sneeze). Reprinted with permission from Gwaltney JM, Jr, Hendley JO, Phillips CD, et al. Nose blowing propels nasal fluid into the paranasal sinuses. Clin Infect Dis 2000;30(2):387-92. Published by The University of Chicago Press. © 2000 by the Infectious Diseases Society of America.

Fig 4

Sinus CT scan of an adult after instillation of contrast medium into the nasopharynx, followed by nose blowing. A, Contrast in an anterior ethmoid sinus cell (short arrow) and in the floor of the nasal cavities (long arrow). B, Contrast in the infundibulum bilaterally (short arrows) and in the maxillary sinus outlining a bubble (long arrows). C, Contrast in the posterior ethmoid sinus (arrow). D, Contrast in the sphenoid sinus outlining a bubble (arrow). Reprinted with permission from Gwaltney JM, Jr, Hendley JO, Phillips CD, et al. Nose blowing propels nasal fluid into the paranasal sinuses. Clin Infect Dis 2000;30(2):387-92. Published by The University of Chicago Press. © 2000 by the Infectious Diseases Society of America.

Fig 5

Soft tissue algorithm CT scan showing findings typical of AFRS. Note the heterogeneous appearance within involved paranasal sinuses.

Fig 6

Sinus pressure thresholds (mean ± 95% CI) decreased from the healthy control (non–chronic fatigue syndrome/no rhinosinusitis) to chronic fatigue syndrome/CRS group. Significant differences were found from non–chronic fatigue syndrome/no rhinosinusitis (^∗P < .05, ^∗∗P < .001, ^∗∗∗P < .00001, and ^∗∗∗∗P < .0000001), chronic fatigue syndrome/CRS (#P < .01, ##P < .0001), and chronic fatigue syndrome/no rhinosinusitis (@.07 < P < .05, @@P < .02). Sinus thresholds were significantly reduced in both subjects with chronic fatigue syndrome and subjects without chronic fatigue syndrome with acute rhinosinusitis and CRS compared with the non–chronic fatigue syndrome/no rhinosinusitis control group. CFS, Chronic fatigue syndrome; sinusitis, rhinosinusitis.

Fig 7

Two distinct histologic subsets of CRS. Glandular hypertrophy-hyperplasia is noted in May class III, with an increase in the percentage of the mucosal area occupied by mucous glands. In contrast, visually observed and histologic polypoid degeneration occurs in an exclusive and nonoverlapping group. Massive polyposis is found in pansinusitis (May class IV).

Fig 8

Proposed subclassification of CRS.

Table XII

Individual rhinosinusitis symptoms: severity scoring assessment

Table XIII

Global assessment of rhinosinusitis symptom severity

Table XIV

Quality of life assessment for rhinosinusitis severity

Table XV

Effect of current and past treatment assessments