[Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders]. / Minderjährige in klinischen Prüfungen: Ethische Abwägungen ihres Einbezugs am Beispiel der indizierten Prävention psychotischer Erkrankungen.

Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders Abstract: As a vulnerable group, minors require special protection in studies. For this reason, researchers are often reluctant to initiate studies, and ethics committees are reluctant to authorize such studies. This often excludes minors from participating in clinical studies. This exclusion can lead to researchers and clinicians receiving only incomplete data or having to rely on adult-based findings in the treatment of minors. Using the example of the study "Computer-Assisted Risk Evaluation in the Early Detection of Psychotic Disorders" (CARE), which was conducted as an 'other clinical investigation' according to the Medical Device Regulation, we present a line of argumentation for the inclusion of minors which weighs the ethical principles of nonmaleficence (especially regarding possible stigmatization), beneficence, autonomy, and fairness. We show the necessity of including minors based on the development-specific differences in diagnostics and early intervention. Further, we present specific protective measures. This argumentation can also be transferred to other disorders with the onset in childhood and adolescence and thus help to avoid excluding minors from appropriate evidence-based care because of insufficient studies.

Farmers' knowledge in the Swiss canton Valais: cultural heritage with future significance for European veterinary medicine?

BACKGROUND: The demand for natural product-based treatment options for livestock is increasing by animals' owners, veterinarians and policy makers. But at the same time, the traditional knowledge about it is at risk of falling into oblivion in Europe. The present study recorded this knowledge for the linguistically and geographically interesting Swiss canton of Valais. METHOD: Open, semi-structured interviews were used to collect detailed information on formulations and applications, including plant species and natural substances, origin of material, extraction and preparation of herbal products, indication and type of application, dosage, sources of knowledge, frequency of usage and self-assessment of the treatment. RESULTS AND DISCUSSION: In the course of 43 interviews, 173 homemade single species herbal remedy report (HSHR) were recorded. They included 53 plant species from 30 botanical families. Plant species from the botanical families of Asteraceae, Rubiaceae and Cupressaceae were mentioned the most, while the most frequently documented plant species were Coffea arabica L., Juniperus sabina L., Arnica montana L. and Matricaria chamomilla L. For the 173 HSHR, a total of 215 uses were mentioned, most of which were for the treatment of gastrointestinal and metabolic disorders, followed by skin lesions and genito-urinary tract problems. Regional peculiarities emerged, such as the use of Leontopodium alpinum Cass. for diarrhea in the French-speaking Valais, while Matricaria chamomilla and Camellia sinensis L. were used in the German-speaking part instead. In comparison with other regions of Switzerland, 10 plants were reported for the first time, including Juniperus sabina with 18 use reports. CONCLUSION: The daily use on farms and the high satisfaction of farmers with homemade herbal remedies demonstrate their high practical relevance. In conclusion, the traditional regional knowledge about the use of medicinal plants is not only a cultural heritage worth protecting, but also an essential resource for the further development of European veterinary medicine.

soulspace: Integrated youth mental health care in Berlin, Germany-An introduction to the program and a description of its users.

AIM: A substantial gap between young people's need for mental health care services and their actual access to such services led worldwide organizations (e.g., the WHO) to recommend the implementation of early intervention programs and youth mental health services. Some countries around the world have established structures to meet this recommendation. In this paper, we describe soulspace as the first integrated youth mental health service for young people aged between 15 and 35 years in Berlin, Germany. METHODS: We introduce soulspace as easily accessible mental health care for young people, and we characterize soulspace along the lines of the internationally established eight key principles of integrated youth mental health services (Killackey, et al., 2020, World Economic Forum). Soulspace is a cooperation between clinical outpatient units of psychiatric clinics for adolescents and young adults as well as a community-based counselling service. It provides initial contact, counselling, diagnostics, and treatment. RESULTS: Our analyses of the pathways to soulspace and the characteristics of the soulspace users suggest that the low threshold is a facilitator to help finding for young people in comparison to more conventional early intervention models. That is, having transferred the early intervention center in a youth-facing counselling service as was done in soulspace seems to have reduced the threshold to seek help for families and for young people in need for support. CONCLUSIONS: In summary, with soulspace, an easily accessible mental health care service was established that integrates counselling and specialized psychiatric treatment if needed.