Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization74 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Drug Hypersensitivity Quality of Life (QOL)Caregivers Allergy and Immunology

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Internal Consistency of the Turkish Version of the P-DrHy-Q

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

Time frame: Within 30 days from initial questionnaire administration

Test-Retest Reliability of the Turkish P-DrHy-Q

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

Time frame: From Day 1 to Day 15 (14-day interval between two administrations)