Validation and Reliability of the Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Internal Consistency of the Turkish Version of the P-DrHy-Q
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Internal Consistency of the Turkish Version of the P-DrHy-Q
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Hilal Gungor
Medical Doctor, Pediatric Immunology and Allergy
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization