Evaluation of 3D Footprint Morphology of Knee-Related Muscle Attachments Based on CT Data Reconstruction: A Feasibility Study.

A three-dimensional (3D) understanding of muscle attachment footprints became increasingly relevant for musculoskeletal modeling. The established method to project attachments as points ignores patient-specific individuality. Research focuses on investigating certain muscle groups rather than comprehensively studying all muscles spanning a joint. Therefore, we present a reliable method to study several muscle attachments in order to reconstruct the attachment sites in 3D based on CT imaging for future applications in musculoskeletal modeling. For the present feasibility study, 23 knee-related muscle attachments were CT-scanned postmortem from four nonadipose male specimens. For this, the specific muscle attachments were dissected and marked with a barium sulfate containing paint (60 g BaSO4 in 30 mL water and 10 mL acrylic paint). Subsequently, bone geometries and muscle attachments were reconstructed and evaluated from CT datasets. Bone morphology and footprint variations were studied. Exemplarily, variations were high for pes anserinus insertions (mean 56%) and the origins of M. biceps femoris (mean 54%). In contrast, the origins of the vastus muscles as well as the insertion of the Achilles tendon showed low variation (mean 9% and 13%, respectively). Most attachment sites showed variation exceeding the individuality of bone morphology. In summary, the present data were consistent with the few published studies of specific muscle footprints. Our data shed light on the high variability of muscle attachments, which need to be addressed when studying muscle forces and movements through musculoskeletal modeling. This is the first step to achieving a more profound understanding of muscle morphology to be utilized in numerical simulations.

Molecular Genetics of Acquired Temporal Lobe Epilepsy.

An epilepsy diagnosis reduces a patient's quality of life tremendously, and it is a fate shared by over 50 million people worldwide. Temporal lobe epilepsy (TLE) is largely considered a nongenetic or acquired form of epilepsy that develops in consequence of neuronal trauma by injury, malformations, inflammation, or a prolonged (febrile) seizure. Although extensive research has been conducted to understand the process of epileptogenesis, a therapeutic approach to stop its manifestation or to reliably cure the disease has yet to be developed. In this review, we briefly summarize the current literature predominately based on data from excitotoxic rodent models on the cellular events proposed to drive epileptogenesis and thoroughly discuss the major molecular pathways involved, with a focus on neurogenesis-related processes and transcription factors. Furthermore, recent investigations emphasized the role of the genetic background for the acquisition of epilepsy, including variants of neurodevelopmental genes. Mutations in associated transcription factors may have the potential to innately increase the vulnerability of the hippocampus to develop epilepsy following an injury-an emerging perspective on the epileptogenic process in acquired forms of epilepsy.

Adipositas Care and Health Therapy (ACHT) after Bariatric-Metabolic Surgery: A Prospective, Non-Randomized Intervention Study.

INTRODUCTION: Almost 25% of German adults have obesity and numbers are rising, making it an important health issue. Bariatric-metabolic surgery reduces body weight and complications for persons with obesity, but therapeutic success requires long-term postoperative care. Since no German standards for follow-up by family physicians exist, follow-up is provided by surgical obesity centers, but they are reaching their limits. The ACHT study, funded by the German Innovation Fund, is designed to establish and evaluate the follow-up program, with local physicians following patients supported remotely by obesity centers. METHODS: ACHT is a multicenter, prospective, non-randomized control group study. The 18-month ACHT follow-up program is a digitally supported, structured, cross-sectoral, and close-to-home program to improve success after bariatric-metabolic surgery. Four groups are compared: intervention group 1 starts the program immediately (3 weeks) after Roux-en-Y gastric bypass or sleeve gastrectomy (months 1-18 postoperatively), intervention group 2 begins the program 18 months after surgery (months 19-36 postoperatively). Intervention groups are compared to respective control groups that had surgery 18 and 36 months previously. In total, 250 patients, enrolled in the intervention groups, are compared with 360 patients in the control groups, who only receive standard care. RESULTS: The primary endpoint to compare intervention and control groups is the adapted King's score, a composite tool evaluating physical, psychological, socioeconomic, and functional health status. Secondary endpoints include changes in care structures and care processes for the intervention groups. Multivariate regression analyses adjusting for confounders (including the type of surgery) are used to compare intervention and control groups and evaluate determinants in longitudinal analyses. The effect of the intervention on healthcare costs will be evaluated based on health insurance billing data of patients who had bariatric-metabolic surgery in the 3 years prior to the start of the study and of patients who undergo bariatric-metabolic surgery during the study period. CONCLUSIONS: ACHT will be the one of the first evaluated structured, close-to-home follow-up programs for bariatric surgery in Germany. It will evaluate the effectiveness of the implemented program regarding improvements in health status, mental health, quality of life, and the feasibility of such a program outside of specialized obesity centers.

Changes in patient care through flexible and integrated treatment programs in German psychiatric hospitals: meta-analyses based on a series of controlled claims-based cohort studies.

BACKGROUND: Global treatment budgets, i.e. predefined budgets for patients treated in hospital independent of the setting within the hospital, together with flexible and integrated treatment (FIT) have been introduced in some German psychiatric hospitals since 2013. We investigated pooled changes in inpatient, day-care, outpatient treatment, and continuity of care for patients with mental disorders in 12 FIT-hospitals. METHODS: We conducted a series of 12 controlled cohort studies regarding FIT hospitals using anonymized patient claims data from more than 70 German statutory health insurance funds. Each study compared one FIT-hospital to matched patients from equivalent non-FIT-hospitals (routine care). We included only those patients without treatment in the respective hospital within two years prior to first hospital treatment (either FIT or routine care). We contrasted results between the year prior to with the first and second year after patient's first treatment (treatment continuity: only group comparison) using multivariate multi-level models. To approximate the difference-in-difference effect in the meta-analysis, we used the interaction terms group (FIT hospital vs. routine care) x time (year before vs. first or second patient year after study inclusion) in the Poisson models. RESULTS: The 12 studies included 36,069 patients with 2,358 patients from a Department of child and adolescent psychiatry. The pooled effect revealed a 5.1 days lower increase in inpatient treatment in FIT-hospitals during the first patient year compared to routine care. Results were statistically significant for adult care FIT-hospitals but not for child and adolescent FIT-hospitals. Utilization of day-care treatment increased more in most FIT-hospitals during the first year, while outpatient contacts increased in some and decreased in others. The odds of treatment continuity increased by 1.4 in FIT-hospitals compared to non-FIT-hospitals. CONCLUSIONS: Global treatment budgets lead to the intended changes in mental health care in the majority of FIT-hospitals compared to routine care in this large real-world evidence study from Germany. For child and adolescent psychiatry, more evidence is needed to draw firm conclusions. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

Agreement between self-reports and statutory health insurance claims data on healthcare utilization in patients with mental disorders.

BACKGROUND: Data on resource use are frequently required for healthcare assessments. Studies on healthcare utilization (HCU) in individuals with mental disorders have analyzed both self-reports and administrative data. Source of data may affect the quality of analysis and compromise the accuracy of results. We sought to ascertain the degree of agreement between self-reports and statutory health insurance (SHI) fund claims data from patients with mental disorders. METHODS: Claims data from six German SHI and self-reports were obtained along with a cost-effectiveness analysis performed as a part of a controlled prospective multicenter cohort study conducted in 18 psychiatric hospitals in Germany (PsychCare), including patients with pre-defined psychiatric disorders. Self-reports were collected using the German adaption of the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire with a 6-month recall period. Data linkage was performed using a unique pseudonymized identifier. Missing responses were coded as non-use for all analyses. HCU was calculated for inpatient and outpatient care, day-care services, home treatment, and pharmaceuticals. Concordance was measured using Cohen's Kappa (κ) and intraclass correlation coefficient (ICC). Regression approaches were used to investigate the effect of independent variables on the agreements. RESULTS: In total 274 participants (mean age 47.8 [SD = 14.2] years; 47.08% women) were included in the analysis. No significant differences were observed between the linked and unlinked patients in terms of baseline characteristics. Total agreements values were 63.9% (κ = 0.03; PABAK = 0.28) for outpatient contacts, 69.3% (κ = 0.25; PABAK = 0.39) for medication use, 81.0% (κ = 0.56; PABAK = 0.62) for inpatient days and 86.1% (κ = 0.67; PABAK = 0.72) for day-care services. There was varied quantitative agreement between data sources, with the poorest agreement for outpatient care (ICC [95% CI] = 0.22 [0.10-0.33]) and the best for psychiatric day-care services (ICC [95% CI] = 0.72 [0.66-0.78]). Marital status and time since first treatment positively affected the chance of agreement on utilization of outpatient services. CONCLUSIONS: Although there were high levels of absolute agreement, the measures of concordance between administrative records and self-reports were generally minimal to moderate. Healthcare investigations should consider using linked or at least different data sources to estimate HCU for specific utilization areas, where unbiased information can be expected. TRIAL REGISTRATION: This study was part of the multi-center controlled PsychCare trial (German Clinical Trials Register No. DRKS00022535; Date of registration: 2020-10-02).

Challenges in heart failure care in four European countries: a comparative study.

BACKGROUND: In Europe, more than 15 million people live with heart failure (HF). It imposes an enormous social, organizational and economic burden. As a reaction to impending impact on healthcare provision, different country-specific structures for HF-care have been established. The aim of this report is to provide an overview and compare the HF-care approaches of Germany, Ireland, the Netherlands and the UK, and to open the possibility of learning from each other's experience. METHODS: A mixed methods approach was implemented that included a literature analysis, interviews and questionnaires with HF-patients and caregivers, and expert interviews with representatives from healthcare, health service research and medical informatics. RESULTS: The models of HF-care in all countries analyzed are based on the European Society of Cardiology guidelines for diagnosis and treatment of HF. Even though the HF-models differed in design and implementation in practice, key challenges were similar: (i) unequal distribution of care between urban and rural areas, (ii) long waiting times, (iii) unequal access to and provision of healthcare services, (iv) information and communication gaps and (v) inadequate implementation and financing of digital applications. CONCLUSION: Although promising approaches exist to structure and improve HF-care, across the four countries, implementation was reluctant to embrace novel methods. A lack of financial resources and insufficient digitalization making it difficult to adopt new concepts. Integration of HF-nurses seems to be an effective way of improving current models of HF-care. Digital solutions offer further opportunities to overcome communication and coordination gaps and to strengthen self-management skills.

Health-related quality of life among patients with treated alcohol use disorders, schizophreniform disorders or affective disorders and the influence of flexible and integrative psychiatric care models in Germany (PsychCare).

Introduction: Flexible and integrated treatment options (FIT) have been established in German psychiatric hospitals to enhance continuous and patient-centered treatment for patients with mental disorders. We hypothesized that patients with experience in FIT treatment showed higher health-related quality of life (HRQoL) and comparable symptom severity compared with patients treated as usual (TAU). Further, we expected that some sub-dimensions of HRQoL determined HRQoL results clearer than others, while certain factors influenced HRQoL and symptom severity stronger in the FIT compared to the TAU group. In addition, we hypothesized that HRQoL is correlated with symptom severity. Methods: We undertook a controlled, prospective, multicenter cohort study (PsychCare) conducted in 18 psychiatric hospitals in Germany, using the questionnaires Quality of Well Being Self-Administered (QWB-SA) (HRQoL) and Symptom-Checklist-K-9 (SCL-K-9) (symptom severity) at recruitment (measurement I) and 15 months later (measurement II). We assessed overall HRQoL (measured in health utility weights (HUW) and symptom severity score for patients from FIT and TAU treatment. We investigated the QWB-SA dimensions and separated the results by diagnosis. We used beta regressions to estimate the effect of multiple co-variates on both outcomes. To investigate the correlation between HRQoL and symptom severity, we used Pearson correlation. Results: During measurement I, 1,150 patients were recruited; while 359 patients participated during measurement II. FIT patients reported higher HUWs at measurement I compared to TAU patients (0.530 vs. 0.481, p = 0.003) and comparable HUWs at measurement II (0.581 vs. 0.586, p = 0.584). Symptom severity was comparable between both groups (I: 21.4 vs. 21.1, p = 0.936; II: 18.8 vs. 19.8, p = 0.122). We found lowest HRQoL and highest symptom severity in participants with affective disorders. HRQoL increased and symptom severity decreased over time in both groups. The QWB-SA dimension acute and chronic symptoms was associated with highest detriments in HRQoL. We identified risk/protective factors that were associated with lower quality of life and higher symptom severity in both groups. We confirmed that HRQoL was negatively associated with symptom severity. Discussion: Health-related quality of life (during hospital treatment) was higher among patients treated in FIT hospitals compared to patients in routine care, while symptom severity was comparable between both groups.

[Is the relationship between depressive symptoms and work-related factors mediated by pain self-efficacy in non-specific chronic low back pain?] / Mediiert die schmerzspezifische Selbstwirksamkeit die Beziehung zwischen Depressivität und arbeitsbezogenen Faktoren bei nichtspezifischen chronischen Rückenschmerzen?

BACKGROUND: The transition from acute to non-specific chronic low back pain (CLBP) is especially associated with psychological factors. However, working mechanisms of psychological factors have been little examined in non-specific CLBP, especially the mediator effect of pain self-efficacy. OBJECTIVE: Does pain self-efficacy mediate the long-term prediction of work-related factors by depressive symptoms? METHODS: Within the framework of an exploratory secondary analysis, simple mediation analyses were conducted to longitudinally predict prognosis of gainful employment, as well as subjective physical and mental work ability by depressive symptoms mediated by pain self-efficacy in 382 inpatients with non-specific CLBP. RESULTS: The findings suggest that depressive symptoms prior to rehabilitation predicted levels of all three work-related factors 24 months after rehabilitation, and pain self-efficacy 12 months after rehabilitation mediated this relationship. CONCLUSION: To improve the success of work-related rehabilitation in the long-term, pain self-efficacy in particular, but also depressive symptoms should be targeted by treatments of non-specific CLBP.

[Debora: Long-Term Effectiveness of an Inpatient Combined Pain Competence and Depression Prevention Training for Non-Specific Chronic Low Back Pain and Depressive Symptoms]. / Debora: Langfristige Wirksamkeit eines stationären störungsspezifischen Schmerzkompetenz- und Depressionspräventionstrainings bei chronisch unspezifischem Rückenschmerz und Depressivität.

OBJECTIVE: To investigate the effects of an intervention for pain competence and depression prevention for multidisciplinary inpatient rehabilitation of non-specific chronic low back pain on psychological and work-related outcomes over a 2-year period. METHODS: This prospective randomized controlled multicenter trial evaluated the effects of pain competence training with and without depression prevention on depressive symptoms (General Depression Scale; ADS; primary outcome), anxiety (Hospital Anxiety and Depression Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire) and subjective prognosis of gainful employment (SPE; secondary outcomes) in n=422 patients aged 32-64 years from four rehabilitation clinics. Per protocol analyses were conducted. In the three-factorial design with a repeated-measures factor, patients were stratified by treatment condition; the control group (CG) received only pain management training but the intervention group (IG) was additionally treated with depression prevention training (Debora). Based on the ADS, patients were assigned to without or low depressive symptoms (ADS<23; n=208) and medium or high depressive symptoms (ADS≥23; n=214). The fivefold repeated-measures factor included the following sample points: admission, immediately after and 6, 12, and 24 months after rehabilitation. Per protocol results of univariate 2×2×5 analyses of variance were validated by n=1225 multiple imputed data. RESULTS: No significant effects of treatment condition over the 2-year period were yielded in the primary outcome "depressive symptoms", but only patients with the combined training Debora benefited in pain self-efficacy in the long term. Intention-to-treat analyses suggest incremental effects of Debora on pain self-efficacy and anxiety at 24-month follow-up. In the long term, patients with high levels of depressive symptoms improved exclusively in depressive symptoms or they benefited more than patients with low depression in anxiety. However, favorable effects receded in general from post rehabilitation to 24-month follow-up. DISCUSSION: The results support that a disorder-specific depression prevention training is needed for the long-term improvement in pain self-efficacy, which is considered a crucial psychological protective factor in pain chronification. Findings on depressive symptoms support the effectiveness of multidisciplinary inpatient rehabilitation in high depression, but also the great importance of early treatment of depressive symptoms. CONCLUSION: Overall, the results strengthen the need to implement psychotherapeutic treatment elements and, in particular, cognitive-behavioral methods and, moreover, a systematic allocation of patients to needs-based treatments in order to improve long-term effects.

Lengths of inpatient stay and sick leave of patients with mental diseases: disorder-specific effects of flexible and integrated treatment programs in Germany.

Mental disorders pose a worldwide growing public health burden. One of the major challenges for healthcare systems remains to respond to the need of patients with mental disorders for continuous and flexible treatment. The EVA64 study evaluates novel programs of flexible and integrative treatment (FIT) in hospitals. This manuscript presents results from the evaluation of FIT hospitals in comparison to hospitals from regular routine care. In addition to data from adult patients, we also present data from affiliated child and adolescent psychiatric wards employing FIT programs. Using comprehensive claims data, primary outcomes are the utilization of inpatient care and sick leave for a priori defined clusters of mental disorders. We stratify between patients already under treatment (ongoing treatment) and patients with incident treatment cases (initial treatment) at the point of inclusion in the study. In the initial treatment group, we found a significant reduction in the length of inpatient stay of 4.1 days in FIT hospitals compared to routine care. While patients with mood affective disorders (-1.8 days) and patients with neurotic, stress-related, and somatoform disorders (-3.6 days) showed an even stronger effect of the reduction of inpatient lengths of stay, the effect was significantly weaker in patients with mental and behavioral disorders due to use of alcohol (+3.3 days). Regarding the duration of sick leave, we found no significant treatment effect of FIT programs compared to routine care. In the ongoing treatment group of adult patients, we found a significantly lower utilization of inpatient treatment by 1.3 days as well as a shorter duration of sick leave by 4.3 days in FIT hospitals compared to routine care. In the cohort of children and adolescent patients, we also did not observe a significant treatment effect in either the initial treatment group or the ongoing treatment group. Registration: this study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

Long-term effects of rehabilitation and prevention of further chronification of pain among patients with non-specific low back pain.

BACKGROUND: Psychological factors influence the development and persistence of chronic low back pain (CLBP) and may impair the psychosocial rehabilitation success. OBJECTIVE: To examine the effects of a combined pain competence and depression prevention training compared to the pain competence training alone and as well as the patients' stages of pain on the long-term psychosocial rehabilitation success. METHODS: In this controlled multicentre study with cluster-block randomization, patients with CLBP in different stages of pain (I-III) received either pain competence training (control group, CG; n= 255) or combined pain competence and depression prevention training (intervention group, IG; n= 271; per protocol). Depressive symptoms (primary outcome), anxiety, somatization, health status, and average pain intensity (secondary outcomes) were assessed up to 12 months of follow-up. Standardised questionnaires were used to record the outcomes, which were filled out by the patients themselves. Analyses after multiple imputation (N= 1225) were conducted to validate multi- and univariate analyses of variance. RESULTS: Patients in stage of pain I and II showed significant improvements in depressive symptoms, anxiety, mental health, and average pain intensity at the 12-month follow-up, irrespective from treatment condition. CONCLUSIONS: Multidisciplinary rehabilitation seems to be appropriate for patients with CLBP in stage of pain I and II. However, patients in stage of pain III need more psychological treatments to manage their mental comorbidities.

[Biometric properties of QUALIFY: a tool for assessing quality indicators]. / Biometrische Eigenschaften des QUALIFY-Instruments zur Bewertung von Qualitätsindikatoren.

INTRODUCTION: Accurate health care evaluation using quality indicators (QIs) is of vital clinical importance for a quality-oriented health care system. The QUALIFY tool is the current research standard for assessing QIs of health care; however, its biometric properties in psychiatry have not yet been evaluated empirically. Our aim was to evaluate the internal consistency and structure of QUALIFY. METHODS: This study applies a literature-based post-hoc analytical design to a sample of 289 QIs of mental health care. First, the indicators were assessed on the basis of nineteen ordinal QUALIFY criteria as a single measuring tool. Second, using Cronbach's alpha the internal consistency of the measuring tool was evaluated and the structure of QUALIFY using an explorative principal component analysis was tested. RESULTS AND DISCUSSION: The tool showed an acceptable internal consistency (Cronbach's α=0.75), with three criteria (consideration of potential risks/side effects when using the indicator, implementation barriers taken into account, and the ability to influence the indicator) being inconsistent with the full scale. If these three criteria were not taken into account, the tool had a good internal consistency (Cronbach's α=0.81). The QUALIFY structural matrix comprises three components, one of which reflected six from eight original quality criteria of the scientific category. The other two components represent the semiotic structure of the QIs. CONCLUSION: QUALIFY is an internally inconsistent instrument, which may be useful to assess mental health care QIs. The information about the structure of QUALIFY can be applied for the purposes of research planning as well as the interpretation and development of QIs.

Needs and Experiences in Psychiatric Treatment (NEPT)- Piloting a Collaboratively Generated, Initial Research Tool to Evaluate Cross-Sectoral Mental Health Services.

BACKGROUND: Research tools to evaluate institutions or interventions in the field of mental health have rarely been constructed by researchers with personal experience of using the mental health system ("experiential expertise"). This paper presents a preliminary tool that has been developed within a participatory-collaborative process evaluation as part of a controlled, multi-center, prospective cohort study (PsychCare) to evaluate psychiatric flexible and integrative treatment, FIT for short, models in Germany. METHOD: The collaborative research team consisting of researchers with and without experiential expertise developed 12 experiential program components of FIT models by an iterative research process based on the Grounded Theory Methodology. These components were transformed into a preliminary research tool that was evaluated by a participatory expert panel, and during a pilot and validation study, the latter using a random sample of 327 users from 14 mental health departments. Internal consistency of the tool was tested using Cronbach's alpha. Construct validity was evaluated using a Principal Components Analysis (PCA) and a Jonckheere Terpstra test in relation to different implementation levels of the FIT model. Concurrent validity was tested against a German version of the Client Satisfaction Questionnaire (ZUF-8) using correlation analysis and a linear regression model. RESULTS: The evaluation of the expert panel reduced 29 initial items to 16 that were further reduced to 11 items during the pilot study, resulting into a research tool (Needs and Experiences in Psychiatric Treatment-NEPT) that demonstrated good internal consistency (Cronbach's alpha of 0.89). PCA yielded a 1-component structure, which accounted for 49% of the total variance supporting the unidimensional structure of the tool. The total NEPT score increased alongside the increasing implementation of the FIT model (p < 0.05). There was evidence (p < 0.001) for convergent validity assessed against the ZUF-8 as criterion measure. CONCLUSIONS: The NEPT tool seems to be promising for further development to assess the experiences with and fulfillment of needs of psychiatric care models from the perspective of users. This paper demonstrates that it is possible to use a participatory-collaborative approach within the methodologically rigorous confines of a prospective, controlled research design.

[Flexible and integrative treatment in psychiatry: implementation of specific care components at model and standard care clinics in Germany (PsychCare study)]. / Settingübergreifende Behandlung in der Psychiatrie: Umsetzung spezifischer Versorgungsmerkmale an Kliniken der Modell- und Regelversorgung (PsychCare-Studie).

BACKGROUND: Since 2003 a new remuneration and care model has been implemented in currently 22 psychiatric clinics in Germany, which provides flexible and integrative treatment (FIT) across different settings of treatment, including assertive outreach care. The FIT is based on a global treatment budget covering costs for all psychiatric hospital services and is related to the number of patients treated per year. Previous research identified 11 program components that describe treatment structures and processes of FIT. The present analysis quantitatively compared FIT with standard care, aiming to validate these components. METHODS: As part of the PsychCare study, grading according to FIT-specific components was carried out and comparatively analyzed in nine hospitals that used FIT and seven hospitals of standard care. The FIT models were examined in depth in subgroups, which were divided according to the share of the FIT model in the total hospital budget. RESULTS: Of the 11 FIT program components 7 (flexible care management across settings, therapeutic group sessions across all settings, outreach home care, involvement of informal caregivers, accessibility of services, cooperation across sectors and expansion of professional expertise) showed a high statistical differentiation. These differences were even stronger in the subgroup of those hospitals that had a model contract with all health insurers. CONCLUSION: Specific components of FIT are suitable for evaluating the quality of implementation of intersectoral, flexible and outreach psychiatric care.

[Implementing a Global Treatment Budget for Psychiatric Hospital Services - What are Incentives, Requirements, and Challenges?] / Implementierung eines globalen Behandlungsbudgets in der Psychiatrie ­ Welche Anreize, Voraussetzungen und Herausforderungen gibt es?

OBJECTIVE: Since 2013, flexible and integrative psychiatric treatment models (FIT64b) have been set up in 22 German hospitals. FIT64b is based on a global treatment budget (GTB) covering costs for all psychiatric hospital services and is related to the number of patients treated. As part of the "PsychCare"-study we are examining incentives, requirements and challenges which relate to the introduction of FIT64b. METHODS: Expert interviews and focus groups (n = 29) were led with management and controlling staff from 7 FIT64b adopting hospitals and 3 statutory health insurance funds (SHI). A thematic analysis was conducted. RESULTS: A central component for the introduction of a GTB is a cooperative relation based on mutual trust between hospitals and SHI. Challenging are, above all, performance documentation and performance control of cross-sectoral treatment as well as the parallel structure of FIT64b and standard care. CONCLUSION: Apart from several surmountable obstacles to implementation, the GTB seems to be a strong driver for the future-oriented transformation of psychiatric hospital services in Germany. In the further development of GTB, the obligation to contract with all SHI should be considered.

Dietary induction of obesity and insulin resistance is associated with changes in Fgf21 DNA methylation in liver of mice.

DNA methylation is dynamically regulated in metabolic diseases, but it remains unclear whether the changes are causal or consequential. Therefore, we used a longitudinal approach to refine the onset of metabolic and DNA methylation changes at high temporal resolution. Male C57BL/6N mice were fed with 60 % high-fat diet (HFD) for up to 12 weeks and metabolically characterized weekly. Liver was collected after 1, 2, 4, 5, 6, 7, 8, and 12 weeks and hepatic DNA methylation and gene expression were analyzed. A subset of obese mice underwent vertical sleeve gastrectomy (VSG) or metformin treatment and livers were studied. Distinct hepatic gene expression patterns developed upon feeding HFD, with genes from the fatty acid metabolism pathway being predominantly altered. When comparing metabolic data with gene expression and DNA methylation, in particular Fgf21 DNA methylation decreased before the onset of increased Fgf21 expression and metabolic changes. Neither weight loss induced by VSG nor improved glucose tolerance by metformin treatment could revert hepatic Fgf21 DNA methylation or expression. Our data emphasize the dynamic induction of DNA methylation upon metabolic stimuli. Reduced Fgf21 DNA methylation established before massive overexpression of Fgf21, which is likely an adaptive effort of the liver to maintain glucose homeostasis despite the developing insulin resistance and steatosis. Fgf21 DNA methylation resisted reversion by intervention strategies, illustrating the long-term effects of unhealthy lifestyle. Our data provide a temporal roadmap to the development of hepatic insulin resistance, comprehensively linking DNA methylation with gene expression and metabolic data.

Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tübingen, Germany: study protocol (EVA_TIBAS).

BACKGROUND: Model projects for flexible and integrated treatment (FIT) in Germany aim at advancing the quality of care for people with mental disorders. A new FIT model project was established in 2017 at the Department of child and adolescent psychiatry (KJP) of the University Hospital Tübingen (Universitätsklinikum Tübingen, UKT). The study design of EVA_TIBAS presented here describes the evaluation of the FIT model project at the KJP of the UKT. This evaluation aims at quantifying the anticipated FIT model project changes, which are to improve patients' cross-sectoral care at the same maximum cost as standard care. METHODS: EVA_TIBAS is a controlled cohort study using a mix of quantitative and qualitative methods. The FIT evaluation consists of three modules. In Module A, anonymized claims data of a statutory health insurance fund will be used to compare outcomes (duration of inpatient and day care psychiatric treatment, inpatient and day care psychiatric length of stay, outpatient psychiatric treatment in hospital, inpatient hospital readmission, emergency admission rate, direct medical costs) of patients treated in the model hospital with patients treated in structurally comparable control hospitals (estimated sample size = ca. 600 patients). In Module B, patient-reported outcomes (health related quality of life, symptom burden, return to psychosocial relationships (e.g. school, friends, hobbies), treatment satisfaction, societal costs) will be assessed quantitatively using validated questionnaires for the model and two control hospitals (estimated sample size = ca. 300 patients). A subsequent health economic evaluation will be based on cost-effectiveness analyses from both the insurance fund's and the societal perspective. In Module C, about 30 semi-structured interviews will examine the quality of offer, effects and benefits of the service offered by the social service of the AOK Baden-Württemberg (for stabilizing the overall situation of care in the family) in the model hospital. A focus group discussion will address the quality of cooperation between employees of the university hospital and the social services. DISCUSSION: The results of this evaluation will be used to inform policy makers whether this FIT model project or aspects of it should be implemented into standard care. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov PRS (ID: NCT04727359 , date: 27 January 2021).

[DNVF-Discussion paper - Specificities, Challenges and Aims of Mental Health Service Research in Germany]. / DNVF-Diskussionspapier ­ Besonderheiten, Herausforderungen und Ziele der Versorgungsforschung im Feld der seelischen Gesundheit.

Research in mental health services in Germany is of increasing relevance. To this end, the recently founded "Mental Health Working Group" as part of the German Network of Health Services Research (DNVF) has written a discussion paper presenting key specifics, challenges, and goals of health service research in the field of mental health. Some research-relevant specifics in the area of mental health care, pragmatic challenges of research organization, ethical problems, and particular research topics in this field are presented and discussed critically.