Sore Throat Assessment Tool-10 for patients with acute pharyngo-tonsillitis.

INTRODUCTION: The aim of this study was to develop and validate a patient-based questionnaire for the assessment of sore throat symptoms. The questionnaire can be used to quantify the effects of different treatments in patients with acute pharyngo-tonsillitis (APT). METHODS: A 13-item questionnaire was constructed using a five-point Likert scale. Adult patients with APT consulting one of the participating general practitioners answered the survey. Healthy students served as controls. RESULTS: A total of 77 sore throat patients and 103 healthy controls were included. Ten items had moderate to high (> 0.25) inter-item correlations and high mean scores (> 3.0) among patients and were included in the final tool, the Sore Throat Assessment Tool (STAT)-10. The patients' mean STAT-10 score was 36.5 (95% confidence interval (CI): 34.8-38.2) at the time of inclusion compared with 10.4 (95% CI: 10.2-10.6) for controls (p < 0.001). Cronbach s alpha coefficient for the questionnaire was 0.87. The standard error of measurement was 2.99, the intraclass correlation 0.92 and the Spearman correlation test-retest reliability 0.87. The STAT-10 scores increased with Centor scores (p = 0.018). CONCLUSIONS: The reliability and validity of the STAT-10 were very high. The STAT-10 is the first validated tool for measuring the intensity and duration of symptoms from the perspective of sore throat patients and for quantifying and comparing different treatment modalities in APT patients. FUNDING: This study received funding from The Lundbeck Foundation (Grant #R185-2014-2482), Fonden for Laegevidenskabens Fremme, and Hans Skouby s Fond. TRIAL REGISTRATION: The study was approved by the Danish Data Protection Agency (2015-57-0002).