PerEpi - Personalized diagnosis and treatment of refractory focal epilepsy in children and adults.

Partner

• Westphalian Wilhelms University Münster (WWU)
• Université de Picardie Jules Verne (UPJV)
• Tampere University (TAU)

Subproject

The working group of Prof. Alena Buyx at the Institute for History and Ethics of Medicine at the Technical University of Munich has two main goals: First, it supports the other work packages in the ethical planning, design, and conduct of the research and advises on relevant ethical issues, e.g., secondary data use, ethical approvals, consideration of stimulation side effects, design of a clinical trial protocol, and any other ethical issues that arise during the course of the project.

Second, the research group of Prof. Alena Buyx will conduct an empirical mixed-methods study with the aim of enabling future socially and ethically responsible clinical integration of novel personalized methods. Qualitative interviews with experts as well as patients (n=10-15) are planned to explore in depth the views on the novel stimulation methods and their relative comparison with surgical approaches. Interviews will be semi-structured and guide-based (feedback from patient advisors will be obtained on the guides), recorded and transcribed, and then coded and analyzed according to standard qualitative methods and published. In addition, focus groups will be conducted in a cohort of epilepsy patients (n=100) to assess potential patients' expectations and attitudes regarding new personalized stimulation approaches. Validated scales on new technologies (e.g., Stakeholder Panel) will be combined with newly developed scales for publication.

Recommendations for future clinical practice and policy will be developed from the empirical findings: To enable future ethical translation into broader clinical practice, the empirical results from the above study will be integrated with findings from a review of the literature on ethical medical innovation and technology development and an analysis of ethical and social issues using the method known as wide reflective equilibrium. Based on these findings and a comparative policy analysis between the regulatory frameworks of the participating countries (D, F, FIN), preliminary recommendations for clinical translation will be developed and discussed at a stakeholder workshop towards the end of the project and the refined recommendations will be published.