Specialty: Primary Care, Disease: Skin/ Papulosquamous disorders, Inflammatory/ Certain disorders involving the immune mechanism Skin and Connective Tissue Diseases Psoriasis
Conditions
Interventions
1. Clinical Assessment including a physical examination and completion of questionnaires related to psoriasis and quality of life (QoL)
2. Participants in the standard care arm of the trial will be re
Sponsors
Royal United Hospitals Bath NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At all participating GP practices, patients will be eligible to take part in the trial if they meet the following criteria: 1. Males and females age 18-70 at time of recruitment 2. Their primary care record contains a Read Code for psoriasis at any time prior to their date of recruitment 3. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: Participant Exclusion Criteria: 1. A prior diagnosis of psoriatic complications relevant to the study 2. Inability to comply with the study follow-up schedule 3. Unsuitable to participate in the study as determined by the screening GP 4. Previously participated in the TUDOR trial (in the case of participants who may move between participating GP practices due to house move or other reasons)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical function, measured by the Health Assessment Questionnaire and Disability Index (HAQ-DI) score at 24 months. The primary outcome will be analysed using a fixed effects zero-inflated beta regression model adjusting for the stratification factors, HAQ-DI measured at baseline, other relevant baseline covariates, and treatment arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease activity for people diagnosed with psoriatic complications at 24 months post registration. Disease specific questionnaires will be analysed using multivariable fixed effects models, adjusting for the stratification factors and relevant baseline covariates. This will be based on data collected at 24 months post registration. 2. The diagnostic accuracy of an updated symptom questionnaire for identification of psoriatic disease. The diagnostic accuracy of the questionnaire will be assessed by estimating of the sensitivity and specificity, positive and negative predictive values, and AUCs of the questionnaires, against the gold standard for diagnosing psoriatic disease. Regression-based sensitivity analysis, incorporating the possibility of dependence in the outcomes will be utilised to explore the additional explanatory power of the updated questionnaire. This will be measured either at baseline or 24 months depending upon the arm of the study. 3. To compare the sensitivity and specificity of the updated symptom screening tool with the symptom questionnaire currently approved for use in standard care. The differences between the updated and the currently approved questionnaires in terms of their sensitivity and specificity, positive and negative predictive values, and AUCs will be assessed. Where participants have completed both questionnaires, adjusted McNemar's tests, which account for clustered data, will be used to compare sensitivity and specificity. To examine the optimal method for screening for psoriatic disease, diagnostic questionnaires and their different cut points will be compared using receiver operator characteristic (ROC) curve analysis. This will be measured either at baseline or 24 months depending upon the arm of the study. 4. The impact of psoriatic complications on health-related quality of life and work productivity. Quality of Life and Work Productivity questionnaires will be analysed using a mixed effects model, adjusting for the st | — |
Countries
England, United Kingdom
Contacts
Public ContactClaire Davies
Outcome results
None listed