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).

[An Experience Report on the Evaluation of New Forms of Care for People with Mental Illness: Pros and Cons of the Use of SHI Claims Data]. / Evaluation von neuen Versorgungsformen für Menschen mit psychischen Erkrankungen: Pro & Contra zum Einsatz von GKV-Routinedaten ­ Ein Erfahrungsbericht.

The present article describes the special features of an evaluation of research in mental health services in Germany. The experiences of the evaluation of flexible and integrated treatment options with a global treatment budget in psychiatric hospitals based on routine data of more than 70 statutory health insurance (SHI) funds (EVA64 study) are systematically presented. Using the EVA64 study as an example, recommendations for the use of claims data in the field of mental health services research and in general are derived. (1) First, the study and its use of claims data is described and classified. (2) The individual outcomes of the study are presented and evaluated in order to (3) derive criteria, identify strengths and suggest potential uses of claims data. (4) Finally, recommendations for the further development of claims data from SHI funds as a basis for evaluation are described.

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.

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).

[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.

[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.

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.

[Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. / Methodische Herausforderungen bei der Nutzung von Daten von mehr als 70 gesetzlichen Krankenkassen ­ Ein Werkstattbericht aus der EVA64-Studie.

AIM OF THE STUDY: The adequate and need-based medical care of mentally ill patients places special demands on psychiatric care. The §64b Social Code Book (SGB) V enables mentoring mentally ill people through multiprofessional, cross-sectoral model projects across the treatment phase and implementing new forms of financing. These model projects have been evaluated in a prospective and retrospective claims data-based controlled cohort study (EVA64) since 2015. METHODS: In September 2016 and since then annually, the data transfer of all statutory health insurance funds (SHI) involved in this evaluation took place for the first time on the basis of a consented data set description. For later analysis, the clear identification of the index hospital admission and the assignment to the model or control group are important. The methodological challenges of data provision by the data owner, the formal and content-related data preparation as well as the subsequent establishing of an evaluation data set are discussed in detail. RESULTS: So far, data from 71 SHI has been taken into account. In each case 20 tables with claims data from outpatient and inpatient care (including psychiatric institute outpatient departments [PIA]), drug and medical supplies as well as data from incapacity to work and personal data of the insurees. Not all tables could be filled completely by the SHIs. In addition, updates of the study designs require the adaptation of the data selection process. Even though data sets have been delievered regularly the data preparation process is still not routine. CONCLUSION: The scientific use of claims data of numerous SHIs in the context of an evaluation study represents a great challenge. In the absence of reference values for abnormalities and implausibilities, an a priori determination of test algorithms was limited; instead they had to be updated every year. The individual examination of the data of all health insurance companies remains very complex. The detailed documentation of these algorithms provides support for future comparable studies.

The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64).

BACKGROUND: Close, continuous and efficient collaboration between different professions and sectors of care is necessary to provide patient-centered care for individuals with mental disorders. The lack of structured collaboration between in- and outpatient care constitutes a limitation of the German health care system. Since 2012, a new law in Germany (§64b Social code book (SGB) V) has enabled the establishment of cross-sectoral and patient-centered treatment models in psychiatry. Such model projects follow a capitation budget, i.e. a total per patient budget of inpatient and outpatient care in psychiatric clinics. Providers are able to choose the treatment form and adapt the treatment to the needs of the patients. The present study (EVA64) will investigate the effectiveness, costs and efficiency of almost all model projects established in Germany between 2013 and 2016. METHODS/DESIGN: A health insurance data-based controlled cohort study is used. Data from up to 89 statutory health insurance (SHI) funds, i.e. 79% of all SHI funds in Germany (May 2017), on inpatient and outpatient care, pharmaceutical and non-pharmaceutical treatments and sick leave for a period of 7 years will be analyzed. All patients insured by any of the participating SHI funds and treated in one of the model hospitals for any of 16 pre-defined mental disorders will be compared with patients in routine care. Sick leave (primary outcome), utilization of inpatient care (primary outcome), utilization of outpatient care, continuity of contacts in (psychiatric) care, physician and hospital hopping, re-admission rate, comorbidity, mortality, disease progression, and guideline adherence will be analyzed. Cost and effectivity of model and routine care will be estimated using cost-effectiveness analyses. Up to 10 control hospitals for each of the 18 model hospitals will be selected according to a pre-defined algorithm. DISCUSSION: The evaluation of complex interventions is an important main task of health services research and constitutes the basis of evidence-guided advancement in health care. The study will yield important new evidence to guide the future provision of routine care for mentally ill patients in Germany and possibly beyond. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713 ).

Invitation to cervical cancer screening does increase participation in Germany: Results from the MARZY study.

The effect of different invitation models on participation in cervical cancer screening (CCS) was investigated in a randomized population-based cohort study in Germany. Participants were randomly selected via population registries and randomized into intervention Arm A (invitation letter) and Arm B (invitation letter and information brochure) or control Arm C (no invitation). The intervention and control arms were compared with regard to 3-year participation and the two invitation models were compared between intervention arms. Of the 7,758 eligible women aged 30-65 years, living in the city of Mainz and in the rural region of Mainz-Bingen, 5,265 were included in the analysis. Differences in proportions of women attending CCS were investigated and logistic regression was performed to analyze various factors influencing participation. In the intervention group, 91.8% participated in CCS compared to 85.3% in the control group (p < 0.0001), with a 6.6 percentage point increase in participation [95% confidence interval (CI) 4.6-8.6] and an adjusted odds ratio (OR) of 2.69 (95% CI 2.15-3.37). Effect estimators increased to 21.9 percentage points (95% CI 16.7-27.1) and an OR of 3.64 (95% CI 2.74-4.82), respectively, when women who participated in screening annually were excluded from the analysis. The invitation letter was particularly effective among women with lower school education, migrant women and older women. No difference in participation was found between the intervention Arm A and Arm B. An accompanying information brochure did not motivate more women to undergo CCS. However, a written invitation statistically significantly increased participation in CCS in Germany.

Immunosuppressive capabilities of mesenchymal stromal cells are maintained under hypoxic growth conditions and after gamma irradiation.

BACKGROUND AIMS: The discovery of regenerative and immunosuppressive capacities of mesenchymal stromal cells (MSCs) raises hope for patients with tissue-damaging or severe, treatment-refractory autoimmune disorders. We previously presented a method to expand human MSCs in a bioreactor under standardized Good Manufacturing Practice conditions. Now we characterized the impact of critical treatment conditions on MSCs with respect to immunosuppressive capabilities and proliferation. METHODS: MSC proliferation and survival after γ irradiation were determined by 5-carboxyfluorescein diacetate N-succinimidyl ester and annexinV/4',6-diamidino-2-phenylindole (DAPI) staining, respectively. T-cell proliferation assays were used to assess the effect of γ irradiation, passaging, cryopreservation, post-thaw equilibration time and hypoxia on T-cell suppressive capacities of MSCs. Quantitative polymerase chain reaction and ß-galactosidase staining served as tools to investigate differences between immunosuppressive and non-immunosuppressive MSCs. RESULTS: γ irradiation of MSCs abrogated their proliferation while vitality and T-cell inhibitory capacity were preserved. Passaging and long cryopreservation time decreased the T-cell suppressive function of MSCs, and postthaw equilibration time of 5 days restored this capability. Hypoxic culture markedly increased MSC proliferation without affecting their T-cell-suppressive capacity and phenotype. Furthermore, T-cell suppressive MSCs showed higher CXCL12 expression and less ß-galactosidase staining than non-suppressive MSCs. DISCUSSION: We demonstrate that γ irradiation is an effective strategy to abrogate MSC proliferation without impairing the cells' immunosuppressive function. Hypoxia significantly enhanced MSC expansion, allowing for transplantation of MSCs with low passage number. In summary, our optimized MSC expansion protocol successfully addressed the issues of safety and preservation of immunosuppressive MSC function after ex vivo expansion for therapeutic purposes.

Nanoporous silica nanoparticles as biomaterials: evaluation of different strategies for the functionalization with polysialic acid by step-by-step cytocompatibility testing.

Nanoporous silica materials have become a prominent novel class of biomaterials which are typically applied as nanoparticles or thin films. Their large surface area combined with the rich surface chemistry of amorphous silica affords the possibility to equip this material with variable functionalities, also with several different ones on the same particle or coating. Although many studies have shown that nanoporous silica is apparently non-toxic and basically biocompatible, any surface modification may change the surface properties considerably and, therefore, the modified materials should be checked for their biocompatibility at every step. Here we report on different silane-based functionalization strategies, firstly a conventional succinic anhydride-based linker system and, secondly, copper-catalyzed click chemistry, to bind polysialic acid, a polysaccharide important in neurogenesis, onto nanoporous silica nanoparticles (NPSNPs) of MCM-41 type. At each of the different modification steps, the materials are characterized by cell culture experiments. The results show that polysialic acid can be immobilized on the surface of NPSNPs by using different strategies. The cell culture experiments show that the kind of surface immobilization has a strong influence on the toxicity of the material versus the cells. Whereas most modifications appear inoffensive, NPSNPs modified by click reactions are toxic, probably due to residues of the Cu catalyst used in these reactions.

Health-related quality of life for pre-diabetic states and type 2 diabetes mellitus: a cross-sectional study in Västerbotten Sweden.

BACKGROUND: Type 2 diabetes (T2D) decreases health-related quality of life, but there is a lack of information about the health status of people in pre-diabetic states. However, information on health utility weights (HUWs) for pre-diabetic states and T2D are essential to estimate the effect of prevention initiatives. We estimated and compared HUWs for healthy individuals, those with pre-diabetes and those with T2D in a Swedish population and evaluated the influence of age, sex, education and body mass index on HUWs. METHODS: Participants of the Västerbotten Intervention Program, Sweden, between 2002 and 2012, who underwent an oral glucose tolerance test or indicated they had T2D and who filled in the Short Form-36 questionnaire (SF-36) were included. Individuals were categorized as healthy, being in any of three different pre-diabetic states, or as T2D. The pre-diabetic states are impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or a combination of both (IFG&IGT). The SF-6D index was used to convert SF-36 responses to HUWs. HUWs were stratified by age, sex, education and body mass index. Beta regression analyses were conducted to estimate the effect of multiple risk factors on the HUWs. RESULTS: In total, 55 882 individuals were included in the analysis. The overall mean HUW was 0.764. The mean HUW of healthy individuals was 0.768, 0.759 for those with IFG, 0.746 for those with IGT, 0.745 for those with IFG&IGT, and 0.738 for those with T2D. In the overall model, all variables except underweight vs. normal weight were significantly associated with HUW. Younger age, male sex, and higher education were associated with increased HUW. Normal weight, or being overweight was associated with elevated HUW, while obesity was associated with lower HUW. CONCLUSIONS: Healthy individuals had higher HUWs than participants with T2D, while individuals with IFG, IGT or IFG&IGT had HUWs that ranged between those for NGT and T2D. Therefore, preventing the development of pre-diabetic states would improve health-related quality of life in addition to lowering the risk of developing T2D.

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.

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.

Direct patient costs for drugs and consumables at fifteen health facilities in Southern Madagascar, a secondary analysis of patient invoices.

BACKGROUND: Financial risk protection in health is a key objective of the Sustainable Development Goals. However, financial risk protection mechanisms are limited, especially in low-income countries, such as Madagascar. To design effective financial risk protection mechanisms, solid and reliable data on the costs patients incur when seeking care are essential. With this study, we therefore aim to describe medical costs for drugs and consumables for patients as well as model the likelihood of catastrophic health expenditure at fifteen health facilities in Southern Madagascar. METHODS: We conducted a costing analysis of patient invoices from fifteen health facilities (four primary and eleven secondary facilities) in Southern Madagascar, including public, private, and faith-based facilities. We included invoices from patients accessing care for life-threatening conditions, accidents and injuries, paediatric, or maternity care between February 2021 and July 2022. Costing data were limited to costs for drugs and consumables. We used regional household expenditure data from a representative household survey to calculate the incidence of catastrophic health expenditure in our sample. RESULTS: We analysed data from 9,855 cases, including 4,980 outpatient cases, 3,447 inpatient cases without surgical intervention, and 1,419 surgical cases. The average patient cost for drugs and medical consumables across all cases was USD 39.52 (range: USD 0.13-1,381.18, IQR: USD 9.07-46.91). Average costs for surgical treatment were USD 119.33 (range: USD 8.10-522.88, IQR: USD 73.81-160.49), for inpatient treatment USD 47.07 (range: USD 1.82-1,381.19, IQR: USD 22.38-58.91), and for outpatient treatment USD 11.73 (range: USD 0.15-207.79, IQR USD: 6.00-15.53). On average patients at faith-based facilities paid USD 47.20 (range: USD 0.49-530.33, IQR: 10.74-58.54), USD19.47 (range: USD 0.40-1,381.23, IQR: 6.77-24.07) at private facilities, and USD 34.65 (range: USD 0.58-245.24, IQR: USD 6.08-60.11) at public facilities. Patients requiring surgical care were most likely to experience catastrophic health expenditure and average costs for maternity care were significantly higher than for other patient groups. CONCLUSIONS: Financial risk protection schemes in Madagascar, such as the national UHC policy, and the national solidarity fund, as well as interventions by non-governmental and multilateral organisations, need to focus on surgical cases and maternity care to protect vulnerable populations from catastrophic health expenditures for life-threatening conditions, accidents and injuries, and maternity and paediatric care.

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.

Risk equations for the development of worsened glucose status and type 2 diabetes mellitus in a Swedish intervention program.

BACKGROUND: Several studies investigated transitions and risk factors from impaired glucose tolerance (IGT) to type 2 diabetes mellitus (T2D). However, there is a lack of information on the probabilities to transit from normal glucose tolerance (NGT) to different pre-diabetic states and from these states to T2D. The objective of our study is to estimate these risk equations and to quantify the influence of single or combined risk factors on these transition probabilities. METHODS: Individuals who participated in the VIP program twice, having the first examination at ages 30, 40 or 50 years of age between 1990 and 1999 and the second examination 10 years later were included in the analysis. Participants were grouped into five groups: NGT, impaired fasting glucose (IFG), IGT, IFG&IGT or T2D. Fourteen potential risk factors for the development of a worse glucose state (pre-diabetes or T2D) were investigated: sex, age, education, perceived health, triglyceride, blood pressure, BMI, smoking, physical activity, snus, alcohol, nutrition and family history. Analysis was conducted in two steps. Firstly, factor analysis was used to find candidate variables; and secondly, logistic regression was employed to quantify the influence of the candidate variables. Bootstrap estimations validated the models. RESULTS: In total, 29 937 individuals were included in the analysis. Alcohol and perceived health were excluded due to the results of the factor analysis and the logistic regression respectively. Six risk equations indicating different impacts of different risk factors on the transition to a worse glucose state were estimated and validated. The impact of each risk factor depended on the starting or ending pre-diabetes state. High levels of triglyceride, hypertension and high BMI were the strongest risk factors to transit to a worsened glucose state. CONCLUSIONS: The equations could be used to identify individuals with increased risk to develop any of the three pre-diabetic states or T2D and to adapt prevention strategies.