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Chapter 6148was necessary. Only the principal investigator (AvE) and researcher (AM) had access to the code for each participant that was solely accessible in the secure network environment of the Erasmus Medical Center. Data were stored in LimeSurvey and exported to R for statistical analyses. Ethics approval and consent to participateMedical ethical permission for this study was provided at all participating organizations, with the initiating center the Erasmus University Medical Center Rotterdam in the Netherlands (MEC-2018-1507). Consent forms to participate were provided, and competency to fill in the questionnaire was assessed by the involved healthcare professional. In case the individual was not mentally competent to decide on participation, the legal representative decided on behalf of that person.ResultsStudy 1: PROM developmentConcept elicitationConcept elicitation resulted in a draft version of the TSC-PROM for both self and proxy-report (73 items from prior exploratory interviews;10 supplementary 6 items from TSC literature on adult manifestations; 9 items from the TAND checklist;4 11 items from the expert group). After an expert meeting, some items were divided into separate items or combined, resulting in a total of 96 items (24 items within the physical functions domain, 43 items within the mental functions domain, 19 items within the activities and participation domain, and 9 items within the social support domain). The TSC-PROM starts with 15 questions on demographic and clinical information, including clinical and sociodemographic information (age, sex, nationality, age of TSC diagnosis, genetic testing, organs involved, use of medication, epilepsy, level of functioning, educational level, other diagnoses or health conditions, life events). Visual analog scales from 0 to 100 were included on physical functions, mental functions, the ability to perform daily activities, and satisfaction with social support, and a HRQoL VAS was included. During item development, response options were defined using Likert scales with higher scores indicating overall less impairment. To Annelieke Muller sHL.indd 148 14-11-2023 09:07