The PsoTeenQOL - Preliminary Reliability and Validity

The PsoTeenQOL - Preliminary Reliability and Validity of a Health-related Quality of Life Questionnaire for Adolescents With Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

To achieve maximum variation in participant demographic and clinical characteristics, eligible participants with psoriasis plus their parents will be identified through several sites; a) the Danish Psoriasis Association, b) the National Danish Birth Cohort, and c) all five tertiary hospital clinics in Denmark. All adolescents without psoriasis will be recruited from the National Danish Birth Cohort.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescents with psoriasis; No assigned intervention: completion of PsoTeenQOL and other instruments for assessment of psychometric properties and further refinement of the PsoTeenQOL.	Other: No intervention; Completion of surveys
Parents of adolescents with psoriasis; No assigned intervention: completion of proxy-version of the PsoTeenQOL for validation purposes	Other: No intervention; Completion of surveys
Adolescents without psoriasis; No assigned intervention: completion of non-psoriasis control-version of the PsoTeenQOL for validation purposes	Other: No intervention; Completion of surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine the psychometric properties of the PsoTeenQOL	Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument	Baseline and up to 3 months after first completion of questionnaire package

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indicators of validity	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)).	Baseline
Indicators of reliability	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)	Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: LEO Pharma; Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Hilde Randa, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: psoriasis, adolescents, quality of life, PRO (patient-reported outcome), validation
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: HRQOL hos unge med psoriasis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO