Table 1

Study measures and timing

ActivityPrior 3 years*Screening/ enrolment visitFollow-up
Year 1Year 2Year 3Year 4Year 5
Month 0Month 6Month 12Month 18Month 24Month 30Month 36Month 42Month 48Month 54Month 60
Informed consentX
Demographics and background formsX
Biologic sample collectionX
Patient reported outcome surveys†XPatient-reported outcomes will be completed every 3 months
Investigator global assessment†XTo be collected at all standard of care visits
Medical records submission*XXXXXXXXXXXX
  • For paediatrics, these include: UKWPC,12 26 POEM-Paediatric/Proxy,27 PROMIS-Itch Severity, NRS-Pain, NRS-Sleep, PROMIS-Paediatric Anxiety, PROMIS-Paediatric Depression, Children’s Dermatology Life Quality Index (CDLQI)28 and PO-SCORAD; these are all completed every 3 months except for UKWPC (one time) and POEM-Paediatric/Proxy, CDLQI and PO-SCORAD (every 6 months).

  • *Three years of historical records will be submitted following the screening/enrolment visit. During the follow-up period, medical records will be submitted every 6 months for up to 5 years. The first submission during the follow-up period will be 6 months following the screening/enrolment visit. Additional interim medical records submissions may be requested.

  • †UK Working Party diagnostic criteria (UKWPC),12 26 Patient-Oriented Eczema Measure (POEM),29 Patient-Reported Outcomes Measurement Information System (PROMIS)-Itch Severity,30 Numerical Rating Scale for Pain (NRS-Pain),31 NRS-Sleep,32 33 PROMIS-General, PROMIS-Mood and Sleep, PROMIS-Activity and Clothing, PROMIS-Scratching Behaviour, PROMIS-Anxiety, PROMIS-Depression, PROMIS-Itch Triggers, PROMIS-Itch Quality,34 Dermatology Life Quality Index (DLQI),35 Patient-Oriented-SCORing Atopic Dermatitis (PO-SCORAD)36 37 and the Work Productivity and Activity Impairment (WPAI).38 These are all completed every 3 months except for UKWPC, PROMIS-Itch Triggers and PROMIS-Itch Quality (one time), and DLQI and WPAI (every 6 months).

  • ‡Validated Investigator Global Assessment (vIGA) ±body surface area assessment will be obtained at baseline and all follow-up visits.