[Updating standardized unit costs from a societal perspective for health economic evaluation]. / Aktualisierung der standardisierten Bewertungssätze aus gesellschaftlicher Perspektive für gesundheitsökonomische Evaluationen.

AIM OF THE STUDY: The aim of this work was to update the 2015 unit costs (UC) for the monetary valuation of health-related resource use from a societal perspective for the years 2019 and 2020 in Germany. METHODS: The update follows the methodology of Bock et al. 2015. Based on the newly established care levels, UC for care degree 1 to 5 are now provided. To account for change in price trends during the Covid-19 pandemic, average growth rates in UC are shown from 2011-2019 and compared to 2019-2020. RESULTS: Updates of UC for the outpatient medical sector, remedies and aids, hospitals, (in)formal care services, and rehabilitation for 2019 and 2020 are provided. CONCLUSION: The updated UC can be used as reference values for the monetary valuation of individual resource use in health economic evaluations in Germany.

Internet-based transdiagnostic treatment for emotional disorders in Arabic- and Farsi-speaking refugees: study protocol of a randomized controlled trial.

BACKGROUND: Refugee populations have an increased risk for mental disorders, such as depression, anxiety, and posttraumatic stress disorders. Comorbidity is common. At the same time, refugees face multiple barriers to accessing mental health treatment. Only a minority of them receive adequate help. The planned trial evaluates a low-threshold, transdiagnostic Internet-based treatment. The trial aims at establishing its efficacy and cost-effectiveness compared with no treatment. METHODS: N = 131 treatment-seeking Arabic- or Farsi-speaking patients, meeting diagnostic criteria for a depressive, anxiety, and/or posttraumatic stress disorder will be randomized to either the intervention or the waitlist control group. The intervention group receives an Internet-based treatment with weekly written guidance provided by Arabic- or Farsi-speaking professionals. The treatment is based on the Common Elements Treatment Approach (CETA), is tailored to the individual patient, and takes 6-16 weeks. The control group will wait for 3 months and then receive the Internet-based treatment. DISCUSSION: The planned trial will result in an estimate of the efficacy of a low-threshold and scalable treatment option for the most common mental disorders in refugees. TRIAL REGISTRATION: German Registry for Clinical Trials DRKS00024154. Registered on February 1, 2021.

Blended-ALMAMAR app for inpatient mental health care for refugees: study protocol for a multicenter implementation study within the I-REACH consortium (Internet based REfugee mentAl healtH Care).

BACKGROUND: Refugees are at high risk for developing mental illnesses. Due to language and cultural barriers, there is need for specifically adapted therapeutic procedures for refugees in inpatient mental health care settings. Internet-based applications in refugee mother tongues have the potential to improve the outcomes of mental health care for this vulnerable population. The key research question of the present implementation study is whether the newly developed "blended ALMAMAR" app for Arabic and Farsi speaking refugees in Germany is used and accepted by patients and professionals in routine inpatient mental health care (blended care). METHODS: We present the design of an observational, prospective multicenter implementation study in eight psychiatric hospitals. We plan to recruit 100 Farsi or Arabic speaking refugees receiving in-patient treatment due to depression, anxiety disorder, posttraumatic stress disorder or substance use disorders. These patients will get access to the "blended ALMAMAR" app during their inpatient stay in a blended-care approach. We will assess the usage (e.g., duration and frequency of use of the app) as well as subjective acceptability and usability of the intervention. To identify sociodemographic and clinical factors associated with "blended ALMAMAR" usage, we will also perform clinical and questionnaire assessments. DISCUSSION: The newly developed "blended ALMAMAR" app may help to close communication gaps for the hard-to reach and vulnerable group of refugees in inpatient mental health care. It is the first blended-care intervention that addresses severely mentally ill refugees in an inpatient psychiatric setting in Germany. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Register on November 11, 2021 (DRKS00025972) and adapted on November 14, 2023.

The identification of economically relevant health and social care services for mental disorders in the PECUNIA project.

BACKGROUND: Health economic research is still facing significant problems regarding the standardization and international comparability of health care services. As a result, comparative effectiveness studies and cost-effectiveness analyses are often not comparable. This study is part of the PECUNIA project, which aimed to improve the comparability of economic evaluations by developing instruments for the internationally standardized measurement and valuation of health care services for mental disorders. The aim of this study was to identify internationally relevant services in the health and social care sectors relevant for health economic studies for mental disorders. METHODS: A systematic literature review on cost-of-illness studies and economic evaluations was conducted to identify relevant services, complemented by an additional grey literature search and a search of resource use measurement (RUM) questionnaires. A preliminary long-list of identified services was explored and reduced to a short-list by multiple consolidation rounds within the international research team and an external international expert survey in six European countries. RESULTS: After duplicate removal, the systematic search yielded 15,218 hits. From these 295 potential services could be identified. The grey literature search led to 368 and the RUM search to 36 additional potential services. The consolidation process resulted in a preliminary list of 186 health and social care services which underwent an external expert survey. A final consolidation step led to a basic list of 56 services grouped into residential care, daycare, outpatient care, information for care, accessibility to care, and self-help and voluntary care. CONCLUSIONS: The initial literature searches led to an extensive number of potential service items for health and social care. Many of these items turned out to be procedures, interventions or providing professionals rather than services and were removed from further analysis. The resulting list was used as a basis for typological coding, the development of RUM questionnaires and corresponding unit costs for international mental health economic studies in the PECUNIA project.

Barriers and needs in mental healthcare of adults with autism spectrum disorder in Germany: a qualitative study in autistic adults, relatives, and healthcare providers.

BACKGROUND: Autism refers to a neurodevelopmental condition with characteristic impairments in social interaction and communication, restrictive and repetitive behaviors, as well as difficulties in sensory information processing and daily living skills. Even though symptoms persist from early childhood throughout the lifespan and often require long-term support, there is a lack of mental health services that sufficiently meet the needs of autistic adults. Previous evidence suggested individual, professional and structural barriers to healthcare for autistic adults. Here, using a peer research approach, we sought to systematically investigate barriers and needs in mental healthcare of autistic adults in Germany at the three relevant levels (individual, professional, structural) and from three relevant perspectives (autistic adults, relatives and healthcare providers), in order to obtain specific recommendations for optimized healthcare. METHODS: Maximum variation sampling was used to account for the complexity of the research field. Semi-structured, open-ended interviews were conducted with autistic adults (n = 15) and focus groups with relatives/partners (n = 12), and healthcare providers of several professions (n = 15). Data analysis was performed using the codebook approach of thematic analysis. RESULTS: Poor mental healthcare of autistic adults in Germany was characterized by six central and overarching themes: (i) lack of knowledge about autism, (ii) a need for increased participation/involvement, (iii) consideration of autism-specific needs in treatment, (iv) lack of services, (v) limited access to services, and (vi) improvement of stakeholder collaboration. Themes were similarly reported across participants, emphasizing dissatisfaction in all stakeholders. CONCLUSIONS: We identified major barriers to mental healthcare for autistic adults in Germany that affect autistic adults, but are also of concern to relatives and healthcare providers. Our results point to specific and generic areas for improvement, independent of stakeholder perspectives, which could guide future development of needs- and evidence-based services, recommendations and guidelines of mental healthcare for people with autism across the lifespan. TRIAL REGISTRATION: This study protocol was preregistered at the Open Science Framework ( https://osf.io/5x8pg ).

Cost-Effectiveness of Inter-Professional Collaboration to Reduce Hospitalisations in Nursing Home Residents: Results from the German Interprof ACT Trial.

Background: The German multi-centre cluster-randomised controlled trial interprof ACT investigated interventions to increase inter-professional collaboration between nursing home (NH) staff and local general practitioners to reduce hospitalisations and improve nursing homes residents' (NHRs) quality of life. The trial was funded by the German Health Care Innovation Fund. Methods: Cost-effectiveness of interprof ACT interventions was evaluated and compared to current standard of care (SOC) over 12 months, including 622 NHRs in 34 NHs in Germany. Multiplying resource use of healthcare services with German-specific unit costs generated costs. Health outcome was measured in quality-adjusted life-years QALYs), utility by multiplying EQ-5D-5L values with German-specific utility weights. Incremental cost-effectiveness analysis used an intention-to-treat approach and scenario analyses (SAs). Net-benefit-regression and cost-effectiveness acceptability curves addressed uncertainty. A German healthcare insurance perspective was assumed. Results: Base case results showed non-significant cost savings of 851.88€ and non-significant QALY loss of -0,056. Discussion: Dependency levels at baseline were non-significantly higher in IG compared to control group (CG). Lack of baseline costing data eliminated possibility to evaluate changes in costs due to the interprof ACT measures for both groups. Conclusion: Interprof ACT interventions are not cost-effective compared to current SOC.

Interaction of Systemic Morbidity and Oral Health in Ambulatory Patients in Need of Home Care (InSEMaP): an observational study at the sector boundary between dental and general practice care in Germany.

INTRODUCTION: Older people in need of home care are at risk of declining oral health as their visits to dentists are becoming less frequent due to restricted mobility. There is increasing evidence that poor oral health and systemic diseases are closely associated, for example, in cardiological, metabolic or neurodegenerative conditions. Thus, Interaction of Systemic Morbidity and Oral Health in Ambulatory Patients in Need of Home Care (InSEMaP) is investigating the need, provision and utilisation of oral healthcare, systemic morbidity and clinical status of the oral cavity in older people. METHODS AND ANALYSIS: InSEMaP consists of four subprojects (SP), all involving the target population of older people in need of home care. In SP1 part a, a sample is surveyed using a self-report questionnaire. In SP1 part b, stakeholders (general practitioners, dentists, medical assistants, family and professional caregivers) are interviewed regarding barriers and facilitators using focus groups and personal interviews. In SP2, a retrospective cohort study, health insurance claims data are examined to investigate the utilisation of oral healthcare, its association with systemic morbidity and healthcare costs. In SP3, a clinical observational study will assess the oral health of participants by a dentist's visit at home. SP4 synthesises the results of SP1, SP2 and SP3 to develop integrated clinical pathways, identifying strategies to uphold oral healthcare in older people. In assessing and evaluating the process of oral healthcare, and its associated systemic morbidity, InSEMaP aims to improve general healthcare across the sector boundary of dental and general practitioner care. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Board of the Hamburg Medical Chamber (approval number: 2021-100715-BO-ff). The results of this study will be disseminated through conference presentations and publications in peer-reviewed journals. An expert advisory board to support the InSEMaP study group will be established. TRIAL REGISTRATION NUMBER: German Clinical Trials Register: DRKS00027020.

Development of an Instrument for the Assessment of Health-Related Multi-sectoral Resource Use in Europe: The PECUNIA RUM.

BACKGROUND: Measuring objective resource-use quantities is important for generating valid cost estimates in economic evaluations. In the absence of acknowledged guidelines, measurement methods are often chosen based on practicality rather than methodological evidence. Furthermore, few resource-use measurement (RUM) instruments focus on the measurement of resource use in multiple societal sectors and their development process is rarely described. Thorn and colleagues proposed a stepwise approach to the development of RUM instruments, which has been used for developing cost questionnaires for specific trials. However, it remains unclear how this approach can be translated into practice and whether it is applicable to the development of generic self-reported RUM instruments and instruments measuring resource use in multiple sectors. This study provides a detailed description of the practical application of this stepwise approach to the development of a multi-sectoral RUM instrument developed within the ProgrammE in Costing, resource use measurement and outcome valuation for Use in multi-sectoral National and International health economic evaluAtions (PECUNIA) project. METHODS: For the development of the PECUNIA RUM, the methodological approach was based on best practice guidelines. The process included six steps, including the definition of the instrument attributes, identification of cost-driving elements in each sector, review of methodological literature and development of a harmonized cross-sectorial approach, development of questionnaire modules and their subsequent harmonization. RESULTS: The selected development approach was, overall, applicable to the development of the PECUNIA RUM. However, due to the complexity of the development of a multi-sectoral RUM instrument, additional steps such as establishing a uniform methodological basis, harmonization of questionnaire modules and involvement of a broader range of stakeholders (healthcare professionals, sector-specific experts, health economists) were needed. CONCLUSION: This is the first study that transparently describes the development process of a generic multi-sectoral RUM instrument in health economics and provides insights into the methodological aspects and overall validity of its development process.

Validation of the Recovering Quality of Life (ReQoL) questionnaires for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders in Germany.

The health-related quality of life (HrQoL) and the recovery process of persons with mental health conditions can be assessed with the Recovering Quality of Life questionnaires (ReQoL-20 and ReQoL-10). The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with anxiety, obsessive-compulsive, stress-related, and somatoform disorders and in patients with disorders of adult personality and behavior. This study was based on a sub-sample of patients that were included in a randomized controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). The internal consistency was assessed using Cronbach's Alpha and the test-retest reliability was assessed by the intra-class correlation coefficient (ICC). Concurrent validity was assessed by Pearson's Correlation Coefficient and the known-group validity was assessed using the Cohen's d. The internal consistency of the ReQoL-20 and ReQoL-10 was excellent and good with Cronbach's alpha of α = 0.91 and α = 0.83 for all items. The test-retest reliability of the ReQoL measures was moderate with ICC of r = 0.72 to 0.74. The concurrent validity of the ReQoL measures with the Global Severity Index was overall high with a correlation coefficient of r = -0.70. In conclusion, for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders, the German version of the ReQoL measures is valid and reliable for the assessment of HrQoL and the recovery process.

Psychometric evaluation of the German version of the Recovering Quality of Life (ReQoL) measures in patients with affective disorders.

BACKGROUND: The generic self-reported Recovering Quality of Life (ReQoL) measures were developed for measuring recovery-focused health-related quality of life (HrQoL) in persons with mental health conditions. The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with affective disorders in Germany. METHODS: Data from a patient sub-sample in a randomized controlled trial have been used (N = 393). The internal consistency and the test-retest reliability of the ReQoL measures were assessed using Cronbach's Alpha and the intra-class correlation coefficient (ICC). The concurrent validity and the known-group validity of the ReQoL measures were assessed using Pearson's Correlation coefficient and Cohen's d. The responsiveness was assessed using Glass' Δ and the standardized response mean (SRM). RESULTS: The reliability among the items of the ReQoL-20 was overall excellent. The ICC of the ReQoL-20 was r = 0.70, indicating moderate test-retest reliability. The concurrent validity of the ReQoL-20 with the clinical measure PHQ-9 was strong with a correlation coefficient of r = - 0.76. The known-group validity of the ReQoL-20 using PHQ-9 cut-off points was large with an effect size of d = 1.63. The ReQoL measures were sensitive to treatment response and remission of symptoms measured by the PHQ-9 with large effect sizes/SRM. DISCUSSION: The psychometric properties of the ReQoL measures for the assessment of patients with affective disorders were overall good. With the ReQoL, valid and reliable measures for the assessment of recovery-focused HrQoL for persons with affective disorders are available in German language.

Excess costs of mental disorders by level of severity.

INTRODUCTION: Mental disorders are highly prevalent in Germany, and associated with decreased quality of life for those affected as well as high economic burden for the society. The purpose of this study was to determine the excess costs of mental disorders and to examine how these differ with respect to disease severity. METHODS: We analyzed mean 6-month costs using the baseline data from the RECOVER trial in Hamburg, Germany, which evaluates an innovative stepped-care model for mental disorders. Four severity levels were classified based on the current level of mental illness, loss of functioning, and psychiatric diagnosis. In this work, direct costs (outpatient, inpatient, and social/informal care) and indirect costs (sick leave, unemployment, and early retirement) were estimated using interview-based data on health care utilization and productivity losses. Excess costs were determined by matching a comparison group of the German general population without mental disorders. Group differences in sociodemographic covariates and somatic comorbidities were balanced using entropy balancing. Excess costs by severity levels were estimated using generalized linear models (GLM) with gamma distribution and log-link function. RESULTS: Overall, the RECOVER group included n = 816 and the comparison group included n = 3226 individuals. Mean total 6-month excess costs amounted to 19,075€, with higher indirect excess costs (13,331€) than direct excess costs (5744€) in total excess costs. The excess costs increased with increasing disease severity, ranging from 6,123€ with mild disease severity (level 1) to 31,883€ with severe mental illness (level 4). Indirect excess costs ranged from 5612€ in level 1 to 21,399€ in level 4, and were statistically significant for all disease severity levels. In contrast, direct excess costs were only statistically significant for the levels 2 to 4, and ranged from 511€ in level 1 to 10,485€ in level 4. The main cost drivers were hospital stays (level 2-4), sick leave and unemployment (all levels), and early retirement (level 3-4). DISCUSSION: Mental disorders are associated with high costs that increase with the level of disease severity, which was also shown for individual ICD-10 diagnosis groups. Due to their influence on costs, indirect costs and disease severity levels should be considered in future cost-of-illness studies of mental disorders. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, trial registration number NCT03459664.

Health-related quality of life in family caregivers of autistic adults.

Introduction: Family members of autistic individuals often provide support for their autistic relative throughout the lifespan which can lead to massive burden themselves. Reduced health-related Quality of Life (HRQoL) in family caregivers is assumed; however, only a handful studies on the HRQoL of family caregivers providing care to adult relatives exist as opposed to autistic children. Thus, the current study aimed to (i) investigate the current state of physical and mental HRQoL of family caregivers of autistic adults compared to the general population, and (ii) examine caregiver-related (e.g., age, subjective caregiver burden) and care recipient-related variables (e.g., symptom severity, utilization of formal services) explaining variance in the caregivers' HRQoL. Methods: N = 149 family caregivers completed a nationwide online survey, including the Short-Form Health Survey (SF-8) in order to assess the HRQoL. T-tests were used to compare the HRQoL of family caregivers with the general population. Bivariate correlational and multiple linear regression analyses were conducted in order to identify predictors explaining variance in family caregivers' HRQoL. Results: Family caregivers of autistic adults reported significantly lower physical (M = 46.71, SD = 8.72, Cohen's d = 0.42) and mental HRQoL (M = 40.15, SD = 11.28, Cohen's d = 1.35) compared to the general population. Multiple linear regression with the mental HRQoL as the outcome showed a significant model (F(11, 95) = 5.53, p < .001, adj. R2 = .32) with increased subjective burden explaining most of the variance in mental HRQoL (ß = .32, GDW = .141, p < .001). Multiple linear regression analysis with the outcome physical HRQoL did not reveal a statistically significant model (F(11,95) = 1.09, p = .38). However, bivariate analyses also showed a positive correlation with the subjective caregiver burden (r= .20, p < .05). Discussion: Findings highlight the need to consider HRQoL (and caregiver burden) of family caregivers of autistic adults in several healthcare settings to monitor a potential comprised health status in early stages, with the long-term goal to improve family caregivers' HRQoL.

Mixed-methods investigation of barriers and needs in mental healthcare of adults with autism and recommendations for future care (BarrierfreeASD): study protocol.

INTRODUCTION: Autism refers to an early-onset neurodevelopmental condition with characteristic impairments and difficulties in practical living skills, which persist across the lifespan such that adults with autism often require substantial support and comprehensive care. Yet, mental health and other services are frequently unavailable for adults with autism despite considerable need for mental healthcare and individual, familial and socioeconomic burdens. This study will (1) examine current needs, barriers and burdens related to ineffective healthcare of adults with autism in Germany, (2) develop specific recommendations for a need-oriented mental healthcare model and (3) evaluate its future implementation. METHODS AND ANALYSIS: A mixed-methods design with three phases will be conducted. In phase 1, current mental healthcare for adults with autism will be assessed at three levels (individual, structural and professional) and from three perspectives (adults with autism, relatives and healthcare providers) using (1) focus groups/interviews (qualitative data) and (2) large-scale online surveys (quantitative data). Furthermore, service utilisation and related costs will be estimated. In phase 2, recommendations for a future healthcare model will be derived based on phase 1, considering the heterogeneous and complex needs within the autism spectrum and specifying indications for recommended services. In phase 3, these will again be evaluated by the three stakeholder groups using mixed-methods and analysed regarding feasibility of implementation and cost-effectiveness. Our study will, thus, contribute to a better translation of recommendations into practice to reduce disability, burden and costs related to ineffective healthcare and improve mental health outcomes for adults with autism and those who support them. ETHICS AND DISSEMINATION: This study was approved by the Local Psychological Ethics Commission of the Center for Psychosocial Medicine at the University Medical Center Hamburg-Eppendorf (LPEK-0227). Findings will be disseminated via scientific meetings and peer-reviewed journals. Cooperating partners and associations will be informed about the study's course and findings by regular newsletters and meetings. TRIAL REGISTRATION NUMBER: This study protocol was preregistered at the Open Science Framework (osf.io/5x8pg).

In Search for Comparability: The PECUNIA Reference Unit Costs for Health and Social Care Services in Europe.

Improving the efficiency of mental healthcare service delivery by learning from international best-practice examples requires valid data, including robust unit costs, which currently often lack cross-country comparability. The European ProgrammE in Costing, resource use measurement and outcome valuation for Use in multi-sectoral National and International health economic evaluAtions (PECUNIA) aimed to harmonize the international unit cost development. This article presents the methodology and set of 36 externally validated, standardized reference unit costs (RUCs) for five health and social care services (general practitioner, dentist, help-line, day-care center, nursing home) in Austria, England, Germany, Hungary, The Netherlands, and Spain based on unambiguous service definitions using the extended DESDE PECUNIA coding framework. The resulting PECUNIA RUCs are largely comparable across countries, with any causes for deviations (e.g., country-specific scope of services) transparently documented. Even under standardized methods, notable limitations due to data-driven divergences in key costing parameters remain. Increased cross-country comparability by adopting a uniform methodology and definitions can advance the quality of evidence-based policy guidance derived from health economic evaluations. The PECUNIA RUCs are available free of charge and aim to significantly improve the quality and feasibility of future economic evaluations and their transferability across mental health systems.

Patient-centered placement matching of alcohol-dependent patients based on a standardized intake assessment: process evaluation within an exploratory randomized controlled trial.

BACKGROUND: In the implementation of placement matching guidelines, feasibility has been concerned in previous research. Objectives of this process evaluation were to investigate whether the patient-centered matching guidelines (PCPM) are consistently applied in referral decision-making from an inpatient qualified withdrawal program to a level of care in aftercare, which factors affect whether patients actually receive matched aftercare according to PCPM, and whether its use is feasible and accepted by clinic staff. METHODS: The study was conducted as process evaluation within an exploratory randomized controlled trial in four German psychiatric clinics offering a 7-to-21 day qualified withdrawal program for patients suffering from alcohol dependence, and with measurements taken during detoxification treatment and six months after the initial assessment. PCPM were used with patients in the intervention group by feeding back to them a recommendation for a level of care in aftercare that had been calculated from Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff on the treatment unit. As measurements, The MATE, the Client Socio-Demographic and Service Receipt Inventory-European Version, a documentation form, the Control Preference Scale, and the Motivation for Treatment Scale were administered. A workshop for the staff at the participating trial sites was conducted after data collection was finished. RESULTS: Among 250 patients participating in the study, 165 were interviewed at follow-up, and 125 had received aftercare. Although consistency in the application of PCPM was moderate to substantial within the qualified withdrawal program (Cohen's kappa ≥ .41), it was fair from discharge to follow-up. In multifactorial multinomial regression, the number of foregoing substance abuse treatments predicted whether patients received more likely undermatched (Odds Ratio=1.27; p=.018) or overmatched (Odds Ratio=0.78; p=.054) treatment. While the implementation process during the study was evaluated critically by the staff, they stated a potential of quality assurance, more transparency and patient-centeredness in the use of PCPM. CONCLUSIONS: While the use of PCPM has the potential to enhance the quality of referral decision making within treatment, it may not be sufficient to determine referral decisions for aftercare. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005035 . Registered 03/06/2013.

Cost-Effectiveness of Magnetic Resonance Imaging-Guided Thrombolysis for Patients With Stroke With Unknown Time of Onset.

OBJECTIVES: Patients waking up with stroke symptoms are often excluded from intravenous thrombolysis with alteplase (IV-tpa). The WAKE-UP trial, a European multicenter randomized controlled trial, proved the clinical effectiveness of magnetic resonance imaging-guided IV-tpa for these patients. This analysis aimed to assess the cost-effectiveness of the intervention compared to placebo. METHODS: A Markov model was designed to analyze the cost-effectiveness over a 25-year time horizon. The model consisted of an inpatient acute care phase and a rest-of-life phase. Health states were defined by the modified Rankin Scale (mRS). Initial transition probabilities to mRS scores were based on WAKE-UP data and health state utilities on literature search. Costs were based on data from the University Medical Center Hamburg-Eppendorf, literature, and expert opinion. Incremental costs and effects over the patients' lifetime were estimated. The analysis was conducted from a formal German healthcare perspective. Univariate and probabilistic sensitivity analyses were performed. RESULTS: Treatment with IV-tpa resulted in cost savings of €51 009 and 1.30 incremental gains in quality-adjusted life-years at a 5% discount rate. Univariate sensitivity analysis revealed incremental cost-effectiveness ratio being sensitive to the relative risk of favorable outcome on mRS for placebo patients after stroke, the costs of long-term care for patients with mRS 4, and patient age at initial stroke event. In all cases, IV-tpa remained cost-effective. Probabilistic sensitivity analysis proved IV-tpa cost-effective in >95% of the simulations results. CONCLUSIONS: Magnetic resonance imaging-guided IV-tpa compared to placebo is cost-effective in patients with ischemic stroke with unknown time of onset.

The Excess Costs of Dementia: A Systematic Review and Meta-Analysis.

BACKGROUND: Dementia is one of the costliest diseases for health care systems with growing importance for policy makers. OBJECTIVE: The aim of this study is to systematically review the current literature of excess cost studies for dementia and to analyze excess costs in a meta-analysis. METHODS: A systematic literature search was conducted in PubMed, EconLit, NHS-EED, and Cochrane Library. 22 studies were included and assigned to one of three subgroups according to the time period that they analyzed during disease progression: the time of diagnosis, the time between diagnosis and death, and the time prior to death. Excess costs were analyzed using the ratio of means (ROM) and meta-analysis was performed by pooling ROMs in a random effects model. RESULTS: Total costs were significantly higher for demented persons compared to non-demented persons at the time of diagnosis (ROM: 2.08 [1.71, 2.54], p < 0.00001, I2 = 98%) and in the time period between diagnosis and death (ROM: 2.19 [1.97, 2.44], p < 0.00001, I2 = 100%). The ROM was highest for professional home care (ROM: 4.96 [2.62, 9.40], p < 0.0001, I2 = 88%) and for nursing facilities (ROM: 4.02 [2.53, 6.40], p < 0.00001, I2 = 100%) for the time period between diagnosis and death. CONCLUSION: This meta-analysis is the first to assess excess costs of dementia by the ROM method on a global scale. We conclude that our findings demonstrate that costs of dementia constitute a substantial economic burden.

Excess costs of type 2 diabetes and their sociodemographic and clinical determinants: a cross-sectional study using data from the German Health Interview and Examination Survey for Adults (DEGS1).

OBJECTIVES: The objectives of this study were to estimate the direct and indirect excess costs of type 2 diabetes mellitus (T2D) using data representative for the German adult population and to investigate the association of sociodemographic and clinical determinants with these excess costs. SETTING: We calculated mean annual costs for individuals with T2D and a control group without diabetes, using data on healthcare utilisation and productivity losses from the cross-sectional German Health Interview and Examination Survey for Adults. We adjusted for group differences using entropy balancing and estimated excess costs for total, direct, indirect costs and additional cost categories using generalised linear models. We performed subgroup analyses to investigate the association of sociodemographic (age, sex and education) and clinical determinants (diabetes duration, glycaemic index and complications) with excess costs. PARTICIPANTS: The final study sample included n=325 individuals with T2D and n=4490 individuals without diabetes in the age between 18 and 79 years. RESULTS: Total excess costs amounted to €927, of which €719 were attributable to direct and €209 to indirect excess costs. Total costs were significantly increased by 28% for T2D compared with controls. Group differences in direct, outpatient and medication costs were statistically significant. Medication costs were 88% higher for T2D and had the highest share in direct excess costs. With respect to specific determinants, direct excess costs ranged from €203 for 4-10 years diabetes duration to €1405 for diabetes complications. Indirect excess costs ranged from €-544 for >10 years diabetes duration to €995 for high education. CONCLUSIONS: T2D was associated with high costs, mainly due to direct costs. As pointed out by our results, diabetes complications and comorbidities have a large impact on the costs, leaving medication costs as main contributor of T2D excess costs.

[Costs of Depression in Germany - Systematic Review]. / Kosten der Depression in Deutschland.

OBJECTIVE: Depression is a common mental disorder associated with a high economic burden. Aim of this study was to review cost-of-illness studies of depression in Germany. METHODS: We conducted a systematic literature search of bottom-up cost-of-illness-studies of depression in adults in Germany. Included studies were classified into three groups depending on their costing approach (total health care cost studies, disease-specific health care cost studies, excess cost studies). RESULTS: Depending on the type of cost calculation the average total costs per patient and year varied between 400-3,300 € for disease-specific costs, 3,000 € for excess costs and 3,000-5,000 € for total health care costs. There were no results for indirect costs in most studies. CONCLUSION: Depression in Germany is associated with high costs, but especially indirect costs are missing in the current literature and should be examined more intensively.