Domains | Domain items |
---|---|
Demographics | Social history |
Marital history | |
Past AE treatments | Previous topical treatments for AE |
Previous day hospital care treatments for AE | |
Previous hospitalisation for AE | |
Previous structured education programme for AE | |
Current AE treatments | Topical treatments |
Allergy test results | Delayed contact hypersensitivity patch test |
Atopy patch test | |
Double-blind, placebo-controlled food challenge | |
Skin-prick testing to foods or aeroallergens | |
Chronic (inflammatory) comorbidities | Inflammatory bowel disease |
Rheumatoid arthritis | |
Diabetes mellitus | |
Smoking/alcohol/recreational drug history | Smoking history |
Alcohol intake | |
Recreational drug history (soft drugs) | |
Current concomitant medication (i.e. other than specific AE medication | Antihistamines, oral or topical |
Topical antibiotics | |
Oral antibiotics | |
Allergic rhinoconjunctivitis medication | |
Asthma medication | |
Baseline physical examination | Fitzpatrick skin type |
Weight and height for BMI calculation | |
Blood pressure | |
Body temperature | |
Chest (lung) auscultation | |
Heart auscultation | |
Lymph node palpation (axillary and inguinal) | |
Skin examination | |
Baseline physician and patient reported domains | Physician-assessed clinical signs, e.g. EASI or SCORAD score |
Investigator/physician global assessment, e.g. IGA | |
Patient-reported symptoms, e.g. POEM, itch or sleep score | |
Patient global assessment, e.g. PGA | |
Generic quality of life score | |
Dermatology-specific quality of life score | |
AE-specific quality of life score | |
Patient-reported satisfaction with AE care received | |
Baseline investigations and assessments | Blood testing for past/current tuberculosis |
Chest radiograph | |
Hepatitis B status | |
Hepatitis C status | |
Human immunodeficiency virus (HIV) status | |
Varicella zoster virus (VZV) immune status | |
Pregnancy | |
Monitoring P3NP in case of methotrexate use in adults | |
Evaluating TPMT level prior to azathioprine use | |
Collection of medical photographs to monitor disease extent | |
Baseline biorepository samples | Collection of blood for biomarkers, e.g. TARC |
Collection of DNA (blood or saliva) for filaggrin analysis | |
Collection of biomaterials, e.g. DNA, PBMC or skin biopsy, for a biorepository | |
Baseline management | Reasons for choosing specific treatment (systemic or phototherapy) |
Routine recording of relative contraindication(s) for selected treatment | |
Follow-up general questions | Minimum follow-up frequency for registry data entry, once stable therapeutic dose has been reached: |
 A. 2 months | |
 B. 3 months | |
 C. 4 months | |
 D. 5 months | |
 E. 6 months | |
Minimum follow-up frequency for registry data entry, after stopping photo- or systematic therapy: | |
 A. 3 months | |
 B. 6 months | |
 C. Annually | |
 D. No follow-up | |
Follow-up physical examination | Weight and height for BMI calculation |
Blood pressure | |
Body temperature | |
Chest (lung) auscultation | |
Heart auscultation | |
Lymph node palpation (axillary and inguinal) | |
Skin examination | |
Follow-up physician- and patient-reported domains | Physician-assessed clinical signs, e.g. EASI or SCORAD score |
Investigator/physician global assessment, e.g. IGA | |
Patient-reported symptoms, e.g. POEM, itch or sleep score | |
Patient global assessment, e.g. PGA | |
Generic quality of life score | |
Dermatology-specific quality of life score | |
AE-specific quality of life score | |
Reporting of disease control, e.g. flares, fully controlled weeks, by physician | |
Reporting of disease control, e.g. flares, fully controlled weeks, by patient | |
Adherence to treatment between appointments | |
Patient-reported satisfaction with AE care received | |
Follow-up investigations and assessments | Minimum frequency of safety investigations: |
 A. 6 weeks | |
 B. 8 weeks | |
 C. 10 weeks | |
 D. 12 weeks | |
 E. 14 weeks | |
 F. 16 weeks | |
Collection of medical photographs to monitor disease extent | |
Follow-up biorepository samples | Collection of blood for biomarkers, e.g. TARC |
Collection of biomaterials, e.g. DNA, PBMC or skin biopsy, for a biorepository |