Development and validation of the parent-reported Drug Hypersensitivity Quality of Life Questionnaire

Summary: Background. Drug hypersensitivity in children impacts the quality of life of the patients and their caregivers. Measurements of the quality of life in children are different from adults, because children cannot answer the questions. This research aimed to develop and validate the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q). Methods. The 21-item scale was initially generated by researchers. Then, 3 experts were asked for their opinion about the scale. After adjusting the contents and language, the scale was answered by 97 caregivers. A factor analysis was carried out to select the items for the final scale, and Cronbach's alpha assessed the internal consistency. Finally, we examined the test-retest reliability in another group of 10 caregivers. Results. The 21-item scale was grouped into 6 factors. However, some factors were inappropriate. Therefore, the number of factors was reduced using a statistical analysis. The final 12-item scale included two factors: mental health and social activity. The scale had good internal consistency (Cronbach's a = 0.897) and the test-retest associations were good (R = 0.9439; p minor 0.001). Conclusions. The P-DrHy-Q is the first scale for assessment to consider the interaction of biopsychosocial factors on drug allergy that includes the carer-child dyad. It shows good internal consistency and reliability. Its application might be relevant for future research, and provide clinicians and researchers with a solid tool to define which type of psychosocial support is required to provide more comprehensive care in drug hypersensitivity.