gms | German Medical Science

Background and status of (inter)national research: Infants and toddlers represent an important population for juvenile dermatoses. Because skin diseases lead to significant impairments in physical (e.g. pain, burning), social and psychological quality of life (QoL), which in turn can hinder psychosocial development, it is essential for researchers and clinicians to have a valid and reliable tool for assessing QoL in paediatric populations. The InToDermQoL is a 10-item skin-generic proxy QoL questionnaire that was developed simultaneously in seven European countries to address this need [1], [2]. Its German version has been pilot-tested but a full psychometric evaluation is still pending.

Research question and objective: The objective of this study is to evaluate the psychometric properties of the InToDermQoL questionnaire and to assess disease burden and QoL of infants and toddlers with a skin disease, from the parents’ perspective.

Method or hypothesis: In total, 300 parents with a child aged 0–4 years having any skin disease will be included. Parents and doctors will be asked to fill in a series of questionnaires on QoL, disease severity, and other sociodemographic/clinical features. Internal consistency, inter-rater reliability (between parents), factor structure, convergent validity, and known-groups validity across diagnoses and severity levels will be tested; additionally, 25% of families are requested to fill in the same questionnaires after two weeks to determine test-retest reliability. Lastly, predictors of parent-reported health-related QoL experiences of young children will be examined.

Discussion: The contribution of this study will be a psychometrical validation of a novel patient reported outcome instrument assessing health-related QoL in infants and toddlers with dermatological diseases from the parents’ or caregivers’ perspective. This is in line with the World Health Organization’s call for a shift to people-centred health care as it broadens the view on paediatric dermatoses from a medical to a biopsychosocial perspective, and facilitates parent participation. Moreover, this study will deliver further insights into the predictors of health-related QoL in this specific target group.

Practical implications: The availability of a psychometrically sound tool to measure skin-generic health-related QoL in children below the age of four will contribute to a better understanding of short- and long-term consequences of skin diseases on paediatric patients and their families.

Appeal for practice (science and/or care) in one sentence: The InToDermQoL tool will allow researchers and clinicians to take a people-centred health care approach, and to assess disease burden and care holistically in order to tailor pharmacological and non-pharmacological treatment to the paediatric patients.

Funding: Sonstige Förderung; Eli Lilly