Study measures and timing
| Activity | Prior 3 years* | Screening/ enrolment visit | Follow-up | |||||||||
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | ||||||||
| Month 0 | Month 6 | Month 12 | Month 18 | Month 24 | Month 30 | Month 36 | Month 42 | Month 48 | Month 54 | Month 60 | ||
| Informed consent | X | |||||||||||
| Inclusion/exclusion | X | |||||||||||
| Demographics and background forms | X | |||||||||||
| Biologic sample collection | X | |||||||||||
| Patient reported outcome surveys† | X | Patient-reported outcomes will be completed every 3 months | ||||||||||
| Investigator global assessment† | X | To be collected at all standard of care visits | ||||||||||
| Medical records submission* | X | X | X | X | X | X | X | X | X | X | X | X |
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.