Chronic Rhinosinusitis (Diagnosis) Clinical Trial
Official title:
Development and Validation of a Descriptive and Clinically Relevant Postoperative Endoscopic Sinus Scoring System
Several endoscopic scores have been developed to assess Chronic Rhinosinusitis severity like the Modified Lund-Kennedy (MLK). This is a simple score only based on endoscopic signs. We proposed a more descriptive Alsaleh-Javer Endoscopic Sinus Score (AJESS) system which assesses all sinuses and nasal passages based on participant's severity of symptoms too. This would be a more reliable and clinically valid CRS endoscopic score. We aim to study thE AJESS system in 100 participants with stable CRS and 30 participants CRS who are experiencing an exacerbation (worsening of CRS).
Chronic rhinosinusitis (CRS) is a prevalent inflammatory disorder of the nasal passages and
sinuses associated with detrimental effects on quality of life and productivity as well as
billions of dollars in healthcare expenses and lost productivity each year. Numerous
endoscopic scoring systems have been developed to assess CRS disease severity such as the
popular Modified Lund-Kennedy (MLK) score which assesses sinus cavities only based on 3
criteria (polyps, edema, and discharge) with small 0-2 integer scales. Yet, such systems at
best have reported good to moderate reliabilities and weak to no correlation with
patient-reported outcome measures (PROMs) which should motivate further research to develop a
more reliable and clinically valid CRS endoscopic scoring system, especially one which can
better align the observed endoscopic signs of disease with the severity of symptoms reported
by patients. In this study we propose a more descriptive Alsaleh-Javer Endoscopic Sinus Score
(AJESS) system which assesses all sinuses and nasal passages with a numerical score of
inflammation severity, alphabetical score for presence of CRS features, and an aggregated
numerical score of overall disease severity. Our mixed-methods clinical study of 100 stable
post-operative CRS patients and 30 post-operative CRS patients experiencing an exacerbation
who are visiting St. Paul's Sinus Centre will gather both cross-sectional (1 visit, CRS
stable) and prospective (2 follow-up visits approximately 2-4 weeks apart each, CRS flares)
clinical data including two PROMs (SNOT-22, VAS) and an objective olfactory sensation test
(Sniffin' Sticks TDI Score) to assess AJESS and MLK scores in terms of inter-rater
reliability, test-retest reliability, correlation with clinical data, and responsiveness to
changes in clinical data. Pending validation and head-to-head analysis with the MLK score,
the AJESS system may be a more reliable and valid endoscopic scoring system for clinical
practice and outcomes research in CRS.
Study goals and objectives
1. Assess the test-retest and inter-rater reliability of the AJESS and MLK scores.
2. Assess the correlation of AJESS and MLK scores with cross-sectional PROMs (SNOT-22, VAS)
and Sniffin' Sticks TDI Score
3. Assess the reactivity of AJESS and MLK scores with prospective PROMs (SNOT-22, VAS) in
patients experiencing CRS exacerbations
Research design
Participants visiting St. Paul's Sinus Centre who meet inclusion criteria and no exclusion
criteria who are stable (N=100) and who are experiencing an exacerbation (N=30) will be
approached at random and consented to the study. Encounters are expected to be 30 minutes
each and participants experiencing a CRS or AFRS exacerbation will be expected to present for
follow-up after 3 weeks (+/- 1 week) intervals for a second and a third encounter until their
exacerbation are settled. The first encounter will collect relevant clinical data, endoscopic
photos of 10 anatomic sites, patient-reported outcomes measures (PROMs, eg.SNOT-22, VAS) and
olfactory sense test results (Sniffin' Sticks TDI score). Subsequent visits for exacerbated
participants will collect the same endoscopic photos, PROMs and olfactory sense test results.
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