ZusammenfassungDie Ankunft einer großen Anzahl Geflüchteter in Deutschland seit 2015 hat zu wachsenden Herausforderungen im Gesundheitssystem geführt, auch im psychosozialen Bereich. Um die Kenntnisse Geflüchteter über die Angebote im psychosozialen Bereich zu verbessern und erste Hilfestellungen anzubieten, wurden an der Klinik für Psychiatrie und Psychotherapie der Charité-Universitätsmedizin Berlin eine manualisierte Peer-to-Peer-Unterstützung (P2P) entwickelt und P2P-Trainer/innen ausgebildet. In der hier beschriebenen Pilotstudie wurden vier P2P-Gruppen mit männlichen und weiblichen farsi / dari- oder arabischsprachigen Geflüchteten ausgewertet. Die Teilnehmenden wurden in Einzelinterviews zu wahrgenommenen Vor- und Nachteilen der P2P-Gruppe sowie ihrer Präferenzen und Erwartungen befragt. Die Daten wurden mithilfe der Software MAXQDA kodiert und thematisch analysiert. Alle Teilnehmenden der Gruppen äußerten Zufriedenheit mit dem P2P-Gruppenangebot. P2P half ihnen dabei, soziale Kontakte aufzubauen und soziale Unterstützung zu finden. Eine Flexibilisierung der P2P-Interventionen, ausgerichtet an individuellen Bedürfnissen, wurde gewünscht. Die Ergebnisse unserer Studie legen nahe, dass P2P-Ansätze die Integration von Geflüchteten in die psychosoziale Versorgung verbessern können.
Background
Refugees and asylum seekers (RAS) in Germany need tailored and resource-oriented mental healthcare interventions.
Aims
To evaluate the cost-effectiveness of group psychotherapy for RAS with moderate depressive symptoms.
Method
This is a post hoc cost-effectiveness analysis of Empowerment group psychotherapy that was embedded in a stratified stepped and collaborative care model (SCCM) from the multicentre randomised controlled MEHIRA trial. One hundred and forty-nine participants were randomly assigned to SCCM or treatment as usual (TAU) and underwent Empowerment (i.e. level 3 of the SCCM for adults) or TAU. Effects were measured with the nine-item Patient Health Questionnaire (PHQ-9) and quality adjusted life-years (QALY) post-intervention. Health service and intervention costs were measured. Incremental cost-effectiveness ratios (ICER) were estimated and net monetary benefit (NMB) regressions with 95% confidence intervals were performed. Cost-effectiveness was ascertained for different values of willingness to pay (WTP) using cost-effectiveness acceptability curves for probable scenarios. Trial registration number: NCT03109028 on ClinicalTrials.gov.
Results
Health service use costs were significantly lower for Empowerment than TAU after 1 year. Intervention costs were on average €409.6. Empowerment led to a significant change in PHQ-9 scores but not QALY. Bootstrapped mean ICER indicated cost-effectiveness according to PHQ-9 and varied considerably for QALY in the base case. NMB for a unit reduction in PHQ-9 score at WTP of €0 was €354.3 (€978.5 to −€269.9). Results were confirmed for different scenarios and varying WTP thresholds.
Conclusions
The Empowerment intervention was cost-effective in refugees with moderate depressive symptoms regarding the clinical outcome and led to a reduction in direct healthcare consumption. Concerning QALYs, there was a lack of confidence that Empowerment differed from TAU.
Background: Very little is known about the practice-oriented challenges and mitigation strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and mitigation strategies for informed consent and study prioritization in a pandemic setting. Methods: We performed semi-structured interviews with German stakeholders involved in human subject research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and mitigation strategies was reached. Results: We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main categories: consent challenges, impact of consent challenges on clinical research, and potential response strategies for consent challenges. For the second topic prioritization of trials, we identified two main categories: need for prioritization of clinical studies and potential response strategies for prioritization of clinical studies. All main categories are further specified with subcategories. A supplementary table provides original quotes from the interviews for all subcategories. Discussion: Mitigation strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core mitigation strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.
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