d="abspara0015">We collected information from 186 patients with EoE in Switzerland and the United States (69.4% male; median age, 43 y) via surveys (n = 135), focus groups (n = 27), and semistructured interviews (n = 24). Items were generated for the instruments to assess biologic activity based on physician input. Linear regression was used to quantify the extent to which variations in patient-reported disease characteristics could account for variations in patient assessment of EoE severity. The PRO instrument was used prospectively in 153 adult patients with EoE (72.5% male; median age, 38 y), and validated in an independent group of 120 patients with EoE (60.8% male; median age, 40.5 y).
d="abspara0020">Seven PRO factors that are used to assess characteristics of dysphagia, behavioral adaptations to living with dysphagia, and pain while swallowing accounted for 67% of the variation in patient assessment of disease severity. Based on statistical consideration and patient input, a 7-day recall period was selected. Highly active EoE, based on endoscopic and histologic findings, was associated with an increase in patient-assessed disease severity. In the validation study, the mean difference between patient assessment of EoE severity (range, 0–10) and PRO score (range, 0–8.52) was 0.15.
d="abspara0025">We developed and validated an EoE scoring system based on 7 PRO items that assess symptoms over a 7-day recall period. d="intref0010" class="interref" data-locatorType="url" data-locatorKey="http://Clinicaltrials.gov">Clinicaltrials.gov number: d="intref0015" class="interref" data-locatorType="ctgov" data-locatorKey="NCT00939263">NCT00939263.