Psoriasis
Conditions
Keywords
psoriasis, adolescents, quality of life, PRO (patient-reported outcome), validation
Brief summary
This study aims to develop and provide preliminary reliability and validity of a questionnaire to measure Health-related Quality of Life (HRQOL) in adolescents with psoriasis. To the best of our knowledge, this will be the first psoriasis-specific HRQOL instrument for use in adolescent patients. Data will be collected from a Danish population of adolescents with psoriasis (12-17 years), as well as from parents of adolescents with psoriasis, and a group of adolescents without psoriasis.
Detailed description
The present study will examine the psychometric properties of a preliminary 41-item version of the PsoTeenQOL. The preliminary PsoTeenQOL has been developed based on qualitative interviews of adolescents (12-17 years) with psoriasis, their parents, and health professionals working within the field, as well as literature reviews and existing questionnaires. Face and content validity has been established through subsequent cognitive interviews with the target group. Exploratory factor analysis (EFA) and analysis of differential item functioning (DIF) will be used to further refine the PsoTeenQOL questionnaire by selecting the most appropriate items. In addition, indicators of reliability (internal consistency; test-retest reliability), validity (construct validity, criterion validity; discriminant validity), and responsiveness will be evaluated.
Interventions
OTHERNo intervention
Completion of surveys
Sponsors
Herlev and Gentofte Hospital
LEO Pharma
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Inclusion criteria
* Either a) Subjects with psoriasis, b) Parents of adolescents 12-17 years with psoriasis, or c) Subjects without psoriasis * Ability to read Danish and complete electronic survey
Exclusion criteria
* Inability to read Danish and complete electronic survey
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examine the psychometric properties of the PsoTeenQOL | Baseline and up to 3 months after first completion of questionnaire package | Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indicators of validity | Baseline | Correlations and comparisons between PsoTeenQOL and similar non-psoriasis-specific instruments (Children's Dermatology Life Quality Index (CDLQI); Pediatric Quality of Life Inventory (PedsQL); WHO-5, proxy- and non-psoriasis control version of the PsoTeenQOL) as well as measures of disease severity (Self-assessed Simplified Psoriasis Index (saSPI), and Psoriasis Area Severity Index (PASI)). |
| Indicators of reliability | Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline | Internal consistencies (Cronbach's alpha), test-retest reliability and responsiveness of the PsoTeenQOL (change scores on the PsoTeenQOL as compared to the CDLQI and disease severity indicators) |
Countries
Denmark
Outcome results
None listed