Psoriasis in children and young people Skin and Connective Tissue Diseases Psoriasis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Cases: 1. Children/young people (0 to <18 years of age) 2. Confirmed diagnosis of plaque psoriasis by a dermatologist 3. Active disease at the time of assessment 4. Able to consent Controls: 1. Children/young people (0 to <18 years of age) 2. Confirmed diagnosis of a scaly inflammatory rash (excluding psoriasis and indeterminate psoriasis) by a dermatologist 3. Active disease at the time of assessment 4. Able to consent Indeterminate psoriasis: 1. Children/young people (0 to <18 years of age) 2. Diagnosis of indeterminate or possible psoriasis by a dermatologist 3. Active disease at the time of assessment 4. Able to consent and willing to receive a follow-up questionnaire after 24 months
Exclusion criteria
Exclusion criteria: 1. Children/young people with pustular psoriasis 2. Children/young people with erythrodermic psoriasis 3. Children/young people without a dermatologist’s diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consensus agreed diagnostic criteria vs reference standard (dermatologist’s diagnosis). The presence or absence (binary) of each of the diagnostic criterion will be assessed by study investigators trained to undertake the diagnostic criteria assessment and blinded to the diagnosis of the participant. The threshold for diagnosis according to the consensus agreed diagnostic criteria has been determined through the consensus study. The diagnostic accuracy of the consensus agreed diagnostic criteria will be assessed using sensitivity and specificity. The best predictive diagnostic criteria will be developed using multivariate analysis and the decision to include individual criteria in the model will be based on the likelihood ratio. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The diagnostic performance of the consensus agreed diagnostic criteria and the best predictive criteria for plaque psoriasis (measured as per the primary objective); these criteria will be graphically presented and compared on Receiver Operator Characteristic (ROC) curves 2. The inter-observer variability in the diagnostic criteria assessment; two study investigators will independently undertake the diagnostic criteria assessment. The variability between the investigators will be assessed using the Kappa statistic 3. The variability in the reference standard for psoriasis; a sample of clinical images of participants with psoriasis (taken as part of routine practice) will be anonymised and circulated amongst clinical principal investigators. The variability in principal investigators’ opinions on the diagnosis of psoriasis will be assessed using the Kappa statistic 4. The performance of the best predictive diagnostic criteria in identifying children/young people with psoriasis currently diagnosed with indeterminate disease (nested sub-study); a questionnaire will be sent 24 months after the end of the study asking about their current skin disease. The best predictive criteria vs participant reported diagnosis from the questionnaire. The performance of the best predictive criteria will be assessed using sensitivity and specificity | — |
Countries
England, United Kingdom