Open Access

Background Practice-based research networks (PBRNs) have been implemented to support clinical research in German general practice since 2020. General practitioners (GPs) are often critical concerning the feasibility of clinical trials. Among others, high workload, lack of resources in GP teams and little acceptance of the trial requirements by the patients are assumed barriers. Therefore, the aim of this study was to evaluate the perspectives of the GP teams and their patients on the set up of BayFoNet during the implementation of the two pilot cluster-randomized trials to improve this collaboration on a sustainable basis. Methods GPs and medical assistants (MAs) were interviewed using semi-structured interviews based on the Consolidated Framework for Implementation Research. Implementation research and verbatim transcripts were analyzed using qualitative content analysis. Patient attitudes were evaluated quantitatively with questionnaires based on the theoretical domains framework using descriptive statistics. Results A total of 15 GPs and 15 MAs were interviewed, and 109 complete patient questionnaires were returned. Main facilitators for GPs’ active participation in clinical research were networking as well as active participation of GP teams at different levels of the research process. Increased awareness concerning PBRNs might promote a lively network. From the GPs’ perspective, lack of motivation among MAs and patients was a perceived barrier to support clinical research in general practice. MAs emphasized their own increase in knowledge and competence as well as the importance of clinical research for improved patient care. In contrast to the GPs, most MAs were not aware of BayFoNet as a network structure. The surveyed patients rated their own capabilities and opportunities to actively participate in the pilot studies as very good. Prior to the implementations of the interventions, some patients experienced some difficulty in defining clear goals for their own participation. Discussion Increased awareness concerning PBRNs might promote a lively network. Target-group specific dissemination strategies as well as opportunities for GP teams and their patients to participate in clinical research should be elaborated. This might increase the feasibility of clinical trials and the motivation of all participants to conduct clinical trials in general practice. Trial registration Pilot cluster-randomized trial 1 (MicUTI) was prospectively registered on December 19, 2022 at www.clinicaltrials.gov (NCT05667207); Pilot cluster-randomized trial 2 (IMONEDA) was prospectively registered on April 22, 2022 at www.bfarm.de (DRKS00028805).

Even today, patients with schizophrenia often have an unfavorable outcome. Negative symptoms and cognitive deficits are common features in many patients and prevent recovery. In recent years, aerobic endurance training has emerged as a therapeutic approach with positive effects on several domains of patients’ health. However, appropriately sized, multicenter randomized controlled trials that would allow better generalization of results are lacking. The exercise study presented here is a multicenter, rater-blind, two-armed, parallel-group randomized clinical trial in patients with clinically stable schizophrenia being conducted at five German tertiary hospitals. The intervention group performs aerobic endurance training on bicycle ergometers three times per week for 40–50 min/session (depending on the intervention week) for a total of 26 weeks, and the control group performs balance and tone training for the same amount of time. Participants are subsequently followed up for 26 weeks. The primary endpoint is all-cause discontinuation; secondary endpoints include psychopathology, cognition, daily functioning, cardiovascular risk factors, and explorative biological measures regarding the underlying mechanisms of exercise. A total of 180 patients will be randomized. With currently 162 randomized participants, our study is the largest trial to date to investigate endurance training in patients with schizophrenia. We hypothesize that aerobic endurance training has beneficial effects on patients’ mental and physical health, leading to lower treatment discontinuation rates and improving disease outcomes. The study results will provide a basis for recommending exercise interventions as an add-on therapy in patients with schizophrenia.The study is registered in the International Clinical Trials Database (ClinicalTrials.gov identifier [NCT number]: NCT03466112) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804).

The implementation status of clinical guidelines is, despite their important role in connecting research with practice, frequently not satisfactory. This study aims to investigate the implementation status of the current German guideline for schizophrenia. Moreover, the attitude toward a living guideline has been explored for the first time by presenting screenshots of the German schizophrenia guideline transferred to a digital living guideline format called MAGICapp. A cross-sectional online survey was performed under the participation of 17 hospitals for psychiatry and psychosomatic medicine in Southern Germany and one professional association for German neurologists and psychiatrists. 439 participants supplied sufficient data for analysis. 309 provided complete data sets. Regarding the current guideline for schizophrenia and key recommendations, a large awareness-to-adherence gap was found. Group comparisons between different professions (caregivers, medical doctors, psychologists/psychotherapists, psychosocial therapists) detected differences in the implementation status showing higher awareness and agreement with the schizophrenia guideline and its key recommendations among medical doctors compared to psychosocial therapists and caregivers. Moreover, we detected differences in the implementation status of the guideline as a whole and its key recommendations between specialist and assistant doctors. The attitude toward an upcoming living guideline was mostly positive, especially among younger healthcare professionals. Our findings confirm an awareness-to-adherence gap, not only for the current schizophrenia guideline in general but also for its key recommendations with apparent differences between professions. Overall, our results show promising positive attitudes toward the living guideline for schizophrenia among healthcare providers, suggesting that a living guideline may be a supportive tool in everyday clinical practice.

As core symptoms of schizophrenia, cognitive deficits contribute substantially to poor outcomes. Early life stress (ELS) can negatively affect cognition in patients with schizophrenia and healthy controls, but the exact nature of the mediating factors is unclear. Therefore, we investigated how ELS, education, and symptom burden are related to cognitive performance. The sample comprised 215 patients with schizophrenia (age, 42.9 ± 12.0 years; 66.0 % male) and 197 healthy controls (age, 38.5 ± 16.4 years; 39.3 % male) from the PsyCourse Study. ELS was assessed with the Childhood Trauma Screener (CTS). We used analyses of covariance and correlation analyses to investigate the association of total ELS load and ELS subtypes with cognitive performance. ELS was reported by 52.1 % of patients and 24.9 % of controls. Independent of ELS, cognitive performance on neuropsychological tests was lower in patients than controls (p < 0.001). ELS load was more closely associated with neurocognitive deficits (cognitive composite score) in controls (r = −0.305, p < 0.001) than in patients (r = −0.163, p = 0.033). Moreover, the higher the ELS load, the more cognitive deficits were found in controls (r = −0.200, p = 0.006), while in patients, this correlation was not significant after adjusting for PANSS. ELS load was more strongly associated with cognitive deficits in healthy controls than in patients. In patients, disease-related positive and negative symptoms may mask the effects of ELS-related cognitive deficits. ELS subtypes were associated with impairments in various cognitive domains. Cognitive deficits appear to be mediated through higher symptom burden and lower educational level.