Week | Study period | Closeout | ||||||||
Enrolment | Allocation | Postallocation | V1 | |||||||
V0 | Follow-up questionnaires | |||||||||
0 | 4 | 8 | 12 | 16 | 20 | 24 | 24 | |||
Parent-completed | ||||||||||
Screening questionnaire | ● | |||||||||
Demographics and medical history | ● | |||||||||
POEM | ● | ● | ● | ● | ● | ● | ● | ● | ||
Other eczema symptoms† | ● | ● | ● | ● | ● | ● | ● | |||
Other possible symptoms of food allergy | ● | ● | ||||||||
Diet of child (and breastfeeding mother) | ● | ● | ● | ● | ● | ● | ||||
Health service utilisation | ● | ● | ● | ● | ● | ● | ||||
Out-of-pocket expenses/time off work | ● | ● | ● | ● | ● | ● | ||||
ADQoL | ● | ● | ● | |||||||
CHU-9D | ● | ● | ● | |||||||
IDQoL | ● | ● | ● | |||||||
Parental anxiety (GAD-7) | ● | ● | ||||||||
Exit questionnaire | ● | |||||||||
Researcher-administered | ||||||||||
UK diagnostic criteria for atopic dermatitis | ● | |||||||||
Other possible symptoms of food allergy | ● | |||||||||
Diet of child (and breastfeeding mother) | ● | |||||||||
EASI | ● | ● | ||||||||
Structured allergy history | ○ | |||||||||
Skin prick test (SPT) | ○ | |||||||||
Oral food challenge (OFC) | * | |||||||||
Home dietary trial | * | |||||||||
EMR notes review | ● |
V0=baseline visit; V1=follow-up visit at 24 weeks.
●All participants; ○ Only participants in intervention group.
* only participants in intervention group with equivocal structured allergy history/SPT results.
† bother score, itch intensity, parent global assessment .
ADQoL, Atopic Dermatitis Quality of Life; CHU-9D, Children’s Health Utility 9D; EASI, Eczema Area Severity Index; EMR, electronic medical records; GAD-7, Generalised Anxiety Disorder 7; IDQoL, Infant Dermatitis Quality of Life; POEM, Patient Oriented Eczema Measure .