CHAPTER 6 138 Ethical Considerations All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards (World Medical Association, 2013). The ethical board of the regional research committee provided its consent (ethical board approval number 2018-4169). All parents and professionals signed informed consent. Where indicated, the children also signed the informed consent to recognize their volition/agency (Stafford et al., 2003). Results To reach the aims, three cycles have been conducted for the first aim of improving the process of gaining video material suitable for scoring with the PRPP-Assessment, and two cycles for the second aim of optimizing the application of the PRPP- Assessment by OTs based on parent-provided videos. The cycles will be summarized in chronological order, organized according to the steps of ADR (Figure 1) and elaborated in Table 2. For specific results by cycle, we refer to the supplementary data in Appendix 1. Following this, the overall distant outcomes will be discussed briefly. Overall, the ADR process was spread over 27 months, in which the first four cycles covered 13 months. Throughout the process, 13 parents, one teacher and 25 healthcare professionals participated in data-collection. Table 2 gives an overview of all cycles. Summary of ADR Cycles Aim 1: Optimize the Process of Gaining Video Material for Assessing Everyday Functioning of Children with Mitochondrial Disorder Cycle 1: Improving instructions to parents in order to collect adequate video material. Existing instructions for parents to provide video material on their children’s activities were improved by adding information and were accompanied by a short questionnaire (see Methods). The eight respondents (see Methods) provided written feedback on content validity, which was mainly on the level of formulating sentences. Improvements were implemented by rephrasing and shortening the text and adding examples from practice. Respondents stated that the process of transferring video material seemed time-consuming and professionals worried about the ethical considerations. Therefore, the next cycle focused on the feasibility of the process of gaining video material according to General Data Protection Regulation (GDPR).
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