ABSTRACT
BACKGROUND: Very little is known about the practice-oriented challenges and potential response 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 potential response strategies for informed consent and study prioritization in a pandemic setting. METHODS: We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response 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 themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes. DISCUSSION: Potential response 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 response 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.
Subject(s)
COVID-19 , Clinical Trials as Topic , Informed Consent , Pandemics , Humans , COVID-19/epidemiology , COVID-19/psychology , Informed Consent/ethics , Clinical Trials as Topic/ethics , SARS-CoV-2 , Stakeholder Participation , Germany , Interviews as TopicABSTRACT
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.
ABSTRACT
The arrival of a large number of forcibly displaced people in Germany since 2015 has led to increased challenges in the mental health care system. To build up knowledge and raise awareness of refugees regarding mental health services and to provide practical support, a manual for peer-to-peer (P2P) counseling was developed at Charité-University Medical Center Berlin and refugees were trained as peer counsellors. In a pilot study, we qualitatively evaluated four P2P groups with Farsiâ/âDari or Arabic speaking male and female refugees. Individual interviews were conducted, which assessed perceived benefits and pitfalls of the P2P group as well as preferences and expectations of the participants. Data were coded and analyzed with the software package MAXQDA. All P2P participants expressed their satistfaction with the intervention. The P2P group helped them to find friends and to strengthen social support. Participants suggested to modify group sessions according to individual needs. The results of our study suggest that integrating P2P approaches in the mental health services for refugees may increase access to the health care system on the one hand and reduce access barriers on the other hand.
