Repeatability of Total Nasal Symptom Scores (TNSS) in Allergic Rhinitis Individuals Using an Electronic Diary during Environmental Exposure Chamber (EEC) Visits

Abstract

The severity of allergic rhinitis is typically measured by TSS, scored on a Likert scale (0-3). However, VAS are increasingly being used in clinical trials. In the present study, we evaluated the correlation between an overall allergy symptoms VAS (0-100 mm) and TSS of allergic rhinitis subjects in the EEC over separate visits. METHODS: A total of 78 subjects with allergic rhinitis were exposed to ragweed allergen in the EEC and subsequently every 13 (+5) days thereafter for a total of 3 visits. During the EEC visits, subjects recorded their individual nasal and ocular symptoms to achieve a TSS as well as their overall allergy symptoms on a VAS using an electronic diary (ePDAT Ò) prior to EEC entry and every 30 minutes over a 2 hour period. RESULTS: Both TSS and VAS increased and peaked over time showing similar trends between all 3 visits. The average TSS and VAS showed a highly positive correlation at all 3 visits (Visit 1: r 5 0.7765, Visit 2: r 5 0.6433, Visit 3: r 5 0.7316, all p-values < 0.0001). When the correlation between TSS and VAS scores were analyzed over time, once again, high correlations were seen (Visit 1: r 5 0.9948, Visit 2: r 5 0.9873, Visit 3: r 5 0.9863, all p-values < 0.0001). CONCLUSIONS: These findings suggest that VAS can also be used as an alternative to total scores of individual nasal and ocular symptom scores symptoms correlating with disease severity and detecting symptom variation in allergic rhinitis individuals.

Systematic review of measures of disease severity in rhinitis

“…8 Unfortunately, there is still poor consensus in regard to how well PROMs correspond with physiologic measurements, such as peak nasal inspiratory flow (PNIF) and nasal airflow. 9,10 The goal of this study is to determine if measures of disease burden, specifically PROMs and clinical physiologic measures, vary based upon historical and more recent classification of rhinitis, as well as factors associated with these measures to better understand the impact of rhinitis upon our patients. This information will be useful as baseline data for future clinical studies examining treatment outcomes in rhinitis.…”