Background and Aims: The international EEsAI study group
aims to develop, validate and evaluate the first pediatric EoE
activity index (ped-EEsAI). We report on results of phase 1,
which aims to generate candidate items.
Methods: This study involves 3 phases: (1) item generation, (2) index derivation and
testing on a first patient cohort, and (3) validation in a second
cohort. In phase 1, item generation, weighting and reduction are
achieved through a Delphi process with an international EoE
expert group. The experts proposed and ranked candidate
items on a 7-point Likert scale (0 = no, 6 = perfect relationship
with EoE activity).
Results: 23 international EoE experts proposed and ranked 39 items (20 clinical, 6 endoscopic, 8
histologic, 5 laboratory items). Rank order for clinical items:
dysphagia related to food consistencies (median 5, range 2-6),
severity of dysphagia (5, 3-6), frequency of dysphagia episodes
(5, 3-6), regurgitation and vomiting (4, 2-5), response to dietary
restrictions (4, 1-6); endoscopic items: whitish exudates (5, 3-6),
furrowing (4, 3-6), corrugated rings (4, 2-6), linear shearing (4,
2-6), strictures (3, 2-6); histologic items: intraepithelial
eosinophil count (5, 4-6), lamina propria fibrosis (3, 2-6), basal
layer enlargement (3, 1-5); laboratory items: % blood
eosinophils (3, 0-5).
Conclusions: These items will now be
reduced in further Delphi rounds, tested on a cohort of 100
pediatric EoE patients and validated in a second independent
cohort, resulting in a robust, broadly accepted disease activity
index for use in clinical trials and daily care.