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The development and validation of an instrument to assess acute sinus disease in children
J M Garbutt1, E F Gellman, B Littenberg
1Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Insights
A new Sinus Symptom Score (S5) reliably quantifies acute sinusitis burden in children. This validated tool aids clinical trials by assessing treatment effects and patient eligibility without physician evaluation.
Area of Science:
- Pediatric Medicine
- Clinical Research Methodology
- Health Outcomes Measurement
Background:
- Acute sinusitis is a common pediatric illness.
- Quantifying disease burden in children is crucial for clinical trials.
- Existing instruments may lack reliability or responsiveness.
Purpose of the Study:
- To develop and validate a reliable and responsive instrument to measure acute sinusitis disease burden in children.
- To create a tool for use in clinical trials to assess treatment efficacy and patient eligibility.
Main Methods:
- Cross-sectional survey of 1611 pediatric patients to identify key sinusitis symptoms.
- Logistic regression used to determine symptoms predicting clinical sinusitis diagnosis.
- Prospective cohort study of 41 children with sinusitis to assess S5 reliability and responsiveness.
Main Results:
- The Sinus Symptom Score (S5) includes nasal obstruction, cough, headache, and colored nasal discharge.
- S5 demonstrated excellent intra-subject reliability (ICC = 0.94) at 12 hours.
- S5 was responsive to clinical improvement in children over 14 days (p = 0.0062).
Conclusions:
- The S5 is a standardized, reliable, and responsive measure for acute sinusitis in children.
- The S5 can be administered easily by parents, aiding clinical trial efficiency.
- This score facilitates study eligibility determination and treatment effect assessment without physician evaluation.
Abstract:
Our goal was to produce a reliable, responsive instrument to quantify disease burden in children with acute sinusitis for use in clinical trials. In a cross sectional survey of 1611 community pediatric patients, parents rated the burden attributable to 13 sinus symptoms. Using logistic regression, we identified five symptoms that predicted the clinical diagnosis of sinusitis. The S5 is the average symptom score for nasal obstruction, daytime and nighttime coughing, headache and colored nasal discharge (range 0-3). The S5 was high in children with acute sinusitis (mean = 1.54, SD = 0.77, N = 93), and low in well children (mean = 0.42, SD = 0.56, N = 1019). We assessed reliability and responsiveness of S5 in a prospective cohort study of 41 children with sinusitis. Parents completed a questionnaire at the office visit, at 12 h and 3, 7, 10 and 14 days. Intra-subject reliability at 12 h was excellent (ICC = 0.94). The S5 score was responsive in 24 patients followed for 14 days who improved (mean change = 1.52, SD = 0.12, p = 0.0062). The S5 score is standardized, reliable, responsive, easily obtained, and can be used to determine study eligibility and assess treatment effects without a physician's evaluation.