Major Symptom Score Utility Index for Patients with Acute Rhinosinusitis

Abstract

Background Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility Index (MSSUI). Methods Adult patients with acute rhinosinusitis were recruited for this longitudinal observational study through primary care and specialist physician offices. One hundred ninety patients participated in a preference elicitation exercise for MSS health states. Resulting preference data were used to generate a utility scoring algorithm for the MSS. Participants completed the MSS and 20-Question Sino-Nasal Outcome Test (SNOT-20) at baseline and completed the MSS twice daily for 15 days via daily diary. On days 7 and 15, participants completed the MSS, SNOT-20, and Overall Treatment Effect scale and were evaluated by physicians via the Physician Global Improvement Scale (PGIS). Results At baseline, the mean ± SD. MSSUI score was 0.51 ± 0.17 and was negatively correlated with SNOT-20 scores (r = -0.58; p < 0.001). Days 2–8 average MSSUI scores were negatively correlated with day 7 SNOT-20 (r = -0.46; p < 0.001) and PGIS (r = -0.22; p < 0.001) scores; whereas days 9-15 average MSSUI scores were inversely related to day 15 SNOT-20 (r = -0.40; p < 0.001) and PGIS (r = -0.32, p < 0.001) scores. Mean MSSUI scores improved from baseline with effect sizes at days 7 and 15 of 0.82 and 1.20, respectively. Conclusion The MSSUI represents an acceptable and psychometrically sound patient-reported end point for clinical trials comparing treatments for acute rhinosinusitis.