95 Development and evalutation of the Hospital Hero app 4 to the age of the participating child (see Additional file 3). Only the topic list for older children included temporal questions (e.g. when was that, how did you feel at that moment). An interview toolbox was developed containing screenshots of the app, photographs of the outpatient clinic and the PAM tool. These were used, if deemed helpful, to help retrieve memories and as conversation starters. Interviews were conducted by an experienced qualitative researcher and a remedial educationalist in training. After each interview, field notes were taken, including reflective notes of one’s role. Data analysis and data handling Quantitative data were analysed using descriptive statistics on the SUS and UEQ-S scores (SPSS version 25; IBM, Amonk, NY, USA). A-priori defined subgroup analyses were performed among subgroups for age (dichotomized into age 4 till 8 years and 9 till 12 years) and gender. Considering the fact that our evaluation was formative by design (i.e. gain understanding for improvements) instead of summative (i.e. to measure performance or specific end-points), we did not perform a power calculation. We did consider the size of the study population (20 – 25 appointments per day), an expected participation rate of 0.2 and recommendations by developers of the UEQ who recommend 51 and 70 participants for pragmatic and hedonic scale respectively (sampling confidence level 95%, margin of error = 0.01) (25). Responses to the online questionnaire were used to triangulate the qualitative findings (e.g., to find out how many participants indicated difficulties operating the app and to inform understanding of use and user feedback). Interviews were audio recorded and transcribed verbatim and anonymised. Qualitative data were analysed following the Framework Method (27). Data were coded inductively and deductively, guided by constructs of the ISO norm but also leaving room for newly emerging codes (Atlas. ti, version 7.5.15). Codes were explored, recoded and used to identify categories (i.e. group of codes around similar and interrelated ideas or concepts). Categories were mapped and discussed, which resulted in the formulation of themes. Ethical considerations The study was cleared for ethics by the Medical Ethical Review Committee of the Leiden University Medical Centre (No N20.199). Written informed consent to participate in this study was provided by the participants’ legal guardian/next of kin. Children were verbally informed about participations in the study. Information was tailored to the age of the child. Results pilot study In total, 44 child-caregiver pairs expressed their interest in participating in the semistructured interview. In the end, we included 21 child-caregiver pairs for the semistructured interview and received the observational booklet from 31 caregivers. Children had diverse ages (range 4 to 11 years), gender and medical background (see Additional File 4). In addition, we sent out the online questionnaire to 71 child-
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