Allergy and Immunology, Caregivers, Drug Hypersensitivity, Quality of Life (QOL)
Conditions
Brief summary
This study aims to evaluate the psychometric properties of the Turkish version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q), a disease-specific instrument assessing the health-related quality of life (HRQoL) in caregivers of children with suspected or confirmed drug hypersensitivity reactions. The P-DrHy-Q is designed to capture the psychosocial burden experienced by caregivers and includes two main domains: Mental Health and Social Activity. This study involves a forward-backward translation process, cultural adaptation, internal consistency analysis, and test-retest reliability assessment in a Turkish caregiver population.
Interventions
Participants will complete the Turkish-translated version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q), which includes 12 items assessing psychosocial burden in two domains: mental health and social activity. A subgroup of participants (n ≈ 20) will complete the same questionnaire again after 14 days to assess test-retest reliability
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥ 18 years * Primary caregiver of a child under the age of 18 * Child must have a documented history of drug hypersensitivity * Fluent in written and spoken Turkish * Willingness to participate and provide written informed consent * Availability to complete both baseline and follow-up questionnaire within the designated time frame
Exclusion criteria
* Caregivers with diagnosed psychiatric or cognitive disorders * Inability to read or write in Turkish * Child currently experiencing an acute drug hypersensitivity reaction * Previous participation in the pilot testing phase of this validation study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internal Consistency of the Turkish Version of the P-DrHy-Q | Within 30 days from initial questionnaire administration | The internal consistency of the Turkish translation of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q) will be assessed. This analysis will evaluate the degree to which all items on the scale measure the same underlying construct (psychosocial burden in caregivers of children with drug hypersensitivity). Cronbach's alpha coefficient will be calculated for the total scale and its subscales (mental health and social activity).α ≥ 0.70 = Acceptable |
| Test-Retest Reliability of the Turkish P-DrHy-Q | From Day 1 to Day 15 (14-day interval between two administrations) | This outcome assesses the stability of the Turkish version of the P-DrHy-Q over time in the absence of clinical change. Test-retest reliability ensures that the questionnaire produces consistent results when administered under similar conditions.A subset of 20 caregivers will complete the P-DrHy-Q a second time after 3 days. The Pearson correlation coefficient will be used to compare scores from the first and second administrations.r ≥ 0.70 = Good-Acceptable |
Countries
Turkey (Türkiye)