Outcome assessments of the PAEPAD Study
Outcomes | Instruments/diagnostic criteria | Immediately post intervention | On discharge from OB ward | On disease flares | 3 months postnatal | 1 year postnatal | 2 years postnatal |
Primary outcomes | |||||||
Cumulative incidence of AD at 2 years | Hanifin and Rajka | ✕ | |||||
Secondary outcomes | |||||||
AD outcomes | |||||||
Time to first AD episode | Hanifin and Rajka | ✕ | |||||
Time to first topical corticosteroid exposure | ✕ | ||||||
Disease-related quality of life | IDQOL | ✕ | |||||
Disease severity | SCORAD, EASI and IGA | ✕ | |||||
Frequency of AD flares | |||||||
AD disease-free days | IGA | ||||||
Cumulative clinical visit duration | From the parents being seated within the consulting room to their exit thereafter | ✕ | |||||
Atopic march outcomes | |||||||
Asthma incidence | ✕ | ||||||
Recurrent wheeze incidence | ✕ | ||||||
Rhinitis incidence | ✕ | ||||||
Food sensitisation incidence | Allergen-specific IgE | ✕ | |||||
Obstetric outcomes | |||||||
Mode of birth | Eutocic/dystocic/C-section | ✕ | |||||
Pathological pregnancy | Gestational diabetes, pre-eclampsia, placenta previa, placental abruption, prelabor rupture of membranes, puerperal infection, postpartum haemorrhage | ✕ | |||||
Neonatal outcomes: | |||||||
Newborn’s weight | ✕ | ||||||
Admission in neonatal care unit (yes/no) | ✕ | ||||||
Apgar Score | ✕ | ||||||
Fetal growth retardation | ✕ | ||||||
Any morbidity of the newborn that results in hospitalisation in the first 3 months of life | ✕ | ||||||
Emollient usage | Total volume, brand, frequency | ✕ | ✕ | ✕ | |||
Bathing practice | Frequency, duration of bathing, bath temperature, cleanser usage, soap usage | ✕ | ✕ | ✕ | |||
Patient disease knowledge and attitude changes | Questionnaire currently under validation | ✕ | ✕ | ✕ | ✕ | ✕ |
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; IDQOL, Infantile Dermatitis Quality of Life; IGA, Investigator Global Assessment; OB, obstetrics; PAEPAD, Preventive Antenatal Educational Program on Allergic Diseases; SCORAD, SCORing of Atopic Dermatitis.