[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.

Assessing oral health-related quality of life among older people in home-based care - survey results of the InSEMaP study in Germany.

BACKGROUND: Older people receiving home-based care (HBC) often face barriers to access preventive oral health care (OHC) and dental treatments. Leading to deterioration of their oral healthcare. It is further deteriorated by factors such as increasing burden of systemic diseases, medicinal side effects, limited mobility, financial constraints and lack of professional OHC at home. Older people also struggle to maintain necessary daily oral hygiene, leading to malnutrition, weight loss, and a risk of a further health degradation. This cross-sectional survey aimed to investigate the oral health-related quality of life (OHRQoL) and their associated factors in HBC recipients. METHODS: 5,280 older people (≥ 60 years) living in Hamburg, who were in need of care and insured with statutory health insurance DAK-Gesundheit received the questionnaire, which included the German version of the Oral Health Impact Profile (OHIP G-14) and, the EQ-5D health-related quality of life (HRQoL) measure as well as further questions regarding the extent of informal social support, subjective oral health status, oral health behaviour, subjective cognitive status, and socio-demographic variables. RESULTS: The participants (n = 1,622) had a median age of 83.2 years, with 72.0% of the sample being female. Nearly two thirds of the sample reported that their independence or abilities were significantly impaired (care level 2). Regarding oral health impacts, 40.0% of the participants reported experiencing at least one of the fourteen possible prevalent impacts of the OHIP-G14 fairly often or very often. A multivariate regression model on the severity of oral health impacts revealed, that a better HRQoL, a positive perception of one's own dental status, fewer visits to dental practices, and no need for support in OHC were associated with better OHRQoL. Conversely, respondents with a negative perception of their oral health status, more frequent visits to a dental practice, a need for support in OHC, and subjective memory impairment showed poorer OHRQoL. CONCLUSIONS: The results highlight the risk for poor oral health among older people in HBC. We conclude that there is an urgent need to prioritise oral health, especially as poor oral health can further compromise the systemic wellbeing of these already care dependent population.

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 ).

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.

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.

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.

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.

Rationale and Design of the Hamburg City Health Study.

The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several important risk and prognostic factors in major chronic diseases. A random sample of 45,000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, are taking part in an extensive baseline assessment at one dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting major organ system function and structures including extensive imaging examinations. The protocol includes validate self-reports via questionnaires regarding lifestyle and environmental conditions, dietary habits, physical condition and activity, sexual dysfunction, professional life, psychosocial context and burden, quality of life, digital media use, occupational, medical and family history as well as healthcare utilization. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to gather valid prevalence and incidence, and to develop complex models predicting health outcomes based on a multitude of examination data, imaging, biomarker, psychosocial and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia are invited for a visit to conduct an additional MRI examination of either heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and surveys as well as related individual routine data from involved health and pension insurances. The study is targeting the complex relationship between biologic and psychosocial risk and resilience factors, chronic disease, health care use, survivorship and health as well as favorable and bad prognosis within a unique, large-scale long-term assessment with the perspective of further examinations after 6 years in a representative European metropolitan population.

Patient-Centered Placement Matching of Alcohol-Dependent Patients Based on a Standardized Intake Assessment: Primary Outcomes of an Exploratory Randomized Controlled Trial.

BACKGROUND: Placement matching guidelines are promising means to optimize patient-centered care and to match patients' treatment needs. Despite considerable research regarding placement matching approaches to optimize alcohol abuse treatment, findings are inconclusive. OBJECTIVES: To investigate whether the use of patient-centered placement matching (PCPM) guidelines is more effective in reducing heavy drinking and costs 6 months after discharge from an inpatient alcohol withdrawal treatment compared to usual referral to aftercare. Secondary aims were to investigate whether age, gender, trial site or level of care (LOC) are moderators of efficacy and whether patients who were actually referred to the recommended LOC had better treatment outcomes compared to patients who were treated under- or overmatched. METHODS: Design. Exploratory randomized controlled trial with measurements during withdrawal treatment and 6 months after initial assessment. SETTING: Four German psychiatric clinics offering a 7-21 day inpatient qualified withdrawal program for patients suffering from alcohol dependence. PARTICIPANTS: From 1,927 patients who had a primary diagnosis of alcohol dependence and did not have organized aftercare when entering withdrawal treatment, 299 were invited to participate. Of those, 250 were randomized to the intervention group (IG, n = 123) or the control group (CG, n = 127). INTERVENTION: The PCPM were applied to patients of the IG by feeding back a recommendation to a LOC for aftercare that was calculated from the Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff of the treatment unit. Patients of the CG received a general feedback regarding their MATE interview on request. MEASUREMENTS: The MATE, the Client Socio-Demographic and Service Receipt Inventory--European Version and the MATE-Outcomes were administered. Data were analyzed using generalized linear models. RESULTS: In the intention-to-treat analysis, there were no significant differences between IG and CG regarding days of heavy drinking (incident risk ratio [IRR] 1.09; p = 0.640), direct (IRR 1.06; p = 0.779), indirect (IRR 0.77; p = 0.392) and total costs (IRR 0.89; p = 0.496). Furthermore, none of the investigated moderator variables affected statistically significant drinking or cost-related primary outcomes. Regardless of group allocation, patients who received matched aftercare reported significantly fewer days of heavy drinking than undermatched patients (IRR 2.09; p = 0.004). For patients who were overmatched, direct costs were significantly higher (IRR 1.79; p = 0.024), but with no additional effects on alcohol consumption compared to matched patients. CONCLUSIONS: While the use of PCPM failed to affect the actual referral to aftercare, our findings suggest that treating patients on the recommended LOC may have the potential to reduce days of heavy drinking compared to undertreatment and costs compared to overtreatment.

The allocation of resources in the care for patients with panic disorder in Germany: an excess cost analysis informing policy and science.

BACKGROUND: Panic disorder is a mental disorder of high prevalence, which frequently co-occurs with agoraphobia. There is a lack of studies measuring excess costs of panic disorder patients with and without agoraphobia. We compared costs of panic disorder patients with or without agoraphobia with costs of the anxiety-free population in Germany. METHODS: Primary data from a cluster-randomized trial of adults suffering from panic disorder (n = 419) and from a representative survey of the German general population (N = 5005) were collected between 2012 and 2014. Missing data from the cluster-randomized trial were first imputed by multiple imputation using chained equations and subsequently balanced with the data from the survey by Entropy Balancing. The societal perspective was chosen. Excess costs were calculated by generalized linear models and two-part-models. RESULTS: Entropy Balancing led to an exact match between the groups. We found 6-month total excess costs of 3220€ (95% CI 1917€-4522€) for panic disorder patients without agoraphobia and of 3943€ (95% CI 2950€-4936€) for patient with agoraphobia. Panic disorder patients with or without agoraphobia had significantly higher costs for psychotherapy, general practitioners, general hospital stays and informal care Indirect costs accounted for approximately 60% of the total excess costs. CONCLUSIONS: Panic disorder with or without agoraphobia is associated with significant excess costs. Agoraphobia changes the pattern of resource utilization. Especially indirect costs are relevant. Agoraphobia influences resource utilization in the inpatient sector.Trial registration ISRCTN64669297.

Out-of-pocket-payments and the financial burden of 502 cancer patients of working age in Germany: results from a longitudinal study.

PURPOSE: Cancer patients in Germany often face payments related to their disease or treatment which are not covered by their health insurance. The aim of this study was to analyze the amount of out-of-pocket payments (OOPPs) among cancer patients in Germany, to explore potential socioeconomic determinants of OOPPs, and to identify how cancer patients are burdened by these payments. METHODS: Cancer ptients were consecutively enrolled in 16 clinics in Leipzig, Germany. Data on OOPPs for the past 3 months and on socioeconomic status were obtained at the end of their hospital stay (t0) and 3 (t1) and 15 months (t2) after t0. Financial burden was calculated by dividing the monthly OOPPs by the midpoint of the income category, and the perceived burden was assessed by using the financial difficulties scale of the EORTC QLQ-C30. A two-part regression model was used to estimate the determinants of OOPPs. RESULTS: At baseline (t0), 502 cancer patients participated in the study and provided data on OOPPs and socioeconomic status. The mean 3-month OOPPs were the following: €205.8 at baseline, €179.2 at t1, and €148.1 at t2. Compared to the lowest income group (< €500 monthly), all other income groups (€500-999, €1000-1499, and ≥ €1500) had higher 3-month OOPPs of €52.3 (p = 0.241), €90.2 (p = 0.059), or €62.2 (p = 0.176). Financial burden at t0 was 6.4% (SD 9.2%) on average, 5.4% (SD 9.9%) at t1, and to 3.9% (SD 7.0%) of monthly income at t2. CONCLUSION: German cancer patients face relatively high OOPPs during their cancer journey. These payments may burden cancer patients, especially certain subgroups like low-income groups.

[The Costs of Overweight and Obesity: a Systematic Review]. / Die Kosten von Übergewicht und Adipositas in Deutschland ­ ein systematischer Literaturüberblick.

AIM OF THE STUDY: The aim of this paper was to conduct a systematic review of cost-of-illness studies for overweight and adiposity in Germany. METHODS: We conducted a PubMed search to identify relevant studies. To increase comparability, all cost data were inflated to 2014 prices. For bottom-up studies, we additionally calculated relative cost-differences between normal weight and overweight, as well as adiposity. These relative differences were pooled using meta-analytical techniques and extrapolated to the German population. RESULTS: We identified 15 bottom-up studies, 6 top-down studies and 2 Markov simulations. On average, top-down studies reported direct costs of 7.9 billion Euros and indirect costs of 3.6 billion Euros. Due to between-study heterogeneity, we were not able to pool absolute costs reported in bottom-up studies. The pooled relative cost-differences for studies conducted with adult persons were +22% for the difference between normal weight and overweight and +53% for the difference between normal weight and adiposity. The corresponding effect sizes were 0.07 (- 0.05; 0.19) and 0.15 (0.02; 0.28), respectively. In studies conducted with children and adolescents, relative cost-differences were considerably smaller with corresponding effect sizes being close to zero. Extrapolation of relative pooled cost-differences from bottom-up studies to the German total population yielded direct and indirect excess costs of 22.2 billion Euros for overweight and 23.0 billion Euros for adiposity. CONCLUSION: We found substantial heterogeneity of cost findings between studies for top-down and bottom-up studies as well, which points to substantial uncertainty and strongly hampers clear statements about the costs of overweight and adiposity. Our findings imply that costs are underestimated by top-down studies, whereas overestimated by our extrapolation. The true costs presumably lie between the findings of both approaches.

The "no problems"-problem: an empirical analysis of ceiling effects on the EQ-5D 5L.

AIM: To analyze the association between ceiling effects on the EQ-5D 5L and morbidity in a general population sample. METHODS: We used a cross-sectional sample of the German general population (n = 5007) to describe the frequency of health state "11111" and "no problems"-answers on the five single dimensions stratified by the number of diseases for which participants utilized health care during the last 6 months. For the five single dimensions we also used specific criteria to analyze their discriminative ability. A logit-model was applied for a multivariate analysis of ceiling effects. RESULTS: 31% of participants reported the health state "11111." This percentage strongly decreased with increasing morbidity, down to 4.9% if four or more diseases were present. The dimensions "mobility," "usual activities," and "pain/discomfort" showed good discriminative abilities. The dimensions "anxiety/depression" and "self -care" were able to discriminate between different levels of morbidity, but nevertheless showed strong ceiling effects, in particular "self-care." CONCLUSION: When analyzing ceiling effects of the EQ-5D 5L, one has to draw attention to morbidity since high proportions of participants indicating the best health state might result from being healthy regarding the dimensions assessed by the EQ-5D, in particular in general population datasets.

[Calculation of Standardised Unit Costs for the Economic Evaluation of Mental Disorders]. / Kostensätze zur monetären Bewertung von Versorgungsleistungen bei psychischen Erkrankungen.

Introduction: Assessing resource utilisation and costs for treating mental disorders in Germany is difficult. This pertains especially to the numerous non-medical services that are financed by a considerable number of payers. To standardise and simplify cost calculation, we created a database of unit costs for the most important services for mental disorders. Method: We performed a literature and internet search to identify services provided to persons with mental disorders. Unit costs were calculated either by means of public statistics or data directly obtained from payers. If data could not be obtained that way, health care providers were interviewed to collect data relevant for cost estimation. Results: Unit costs were calculated for medical and vocational rehabilitation, assisted living, sociopsychiatric services, counselling centres, daycare facilities, ambulant psychiatric nursing care, occupational therapy, sociotherapy, psychoeducation, caretaker, domestic help, creative therapies, physical therapy, and relaxation techniques. Discussion and Conclusion: Calculating unit costs for non-medical services was essential, since these services constitute a central element in the treatment of persons with mental disorders. Nevertheless, the large amount of different services and payers complicated a comprehensive assessment of costs. Thus, uncertainty associated with the calculation of costs should be taken into account.

Long-term cost-effectiveness of cognitive behavioral therapy versus psychodynamic therapy in social anxiety disorder.

BACKGROUND: To determine the cost-effectiveness of cognitive behavioral therapy (CBT) versus psychodynamic therapy (PDT) in the treatment of social anxiety disorder after a follow-up of 30 months from a societal perspective. METHODS: This analysis was conducted alongside the multicenter SOPHO-NET trial; adults with a primary diagnosis of social anxiety disorder received CBT (n = 209) or PDT (n = 207). Data on health care utilization and productivity loss were collected at baseline, after 6 months (posttreatment), and three further follow-ups to calculate direct and indirect costs. Anxiety-free days (AFDs) calculated based on remission and response were used as measure of effect. The incremental cost-effectiveness ratio (ICER) was determined. Net benefit regressions, adjusted for comorbidities and baseline differences, were applied to derive cost-effectiveness acceptability curves. RESULTS: In the descriptive analysis, the unadjusted ICER favored CBT over PDT and the adjusted analysis showed that CBT's cost-effectiveness relative to PDT depends on the willingness to pay (WTP) per AFD. As baseline costs differed substantially the unadjusted estimates might be deceptive. If additional WTPs for CBT of €0, €10, and €30 were assumed, the probability of CBT being cost-effective relative to PDT was 65, 83, and 96%. Direct costs increased compared to baseline across groups, whereas indirect costs did not change significantly. Results were sensitive to considered costs. CONCLUSIONS: If the society is willing to pay ≥€30 per additional AFD, CBT can be considered cost-effective, relative to PDT, with certainty. To further increase the cost-effectiveness more knowledge regarding predictors of treatment outcome seems essential.

The responsiveness of the EQ-5D and time trade-off scores in schizophrenia, affective disorders, and alcohol addiction.

OBJECTIVE: To compare the responsiveness of the EQ-5D index (German and British tariff), the EQ-5D visual analogue scale (EQ VAS), and time trade-off (TTO) scores in schizophrenia, affective disorders, and alcohol addiction. METHODS: We used a sample of 502 patients and examined the measures at baseline and after 14 months. We used the generic "WHO Quality of Life BREF" (WHOQOL) and the disorder-specific "Global Severity Index" (GSI) as anchors for a relevant improvement in a patient's health status. In a complete case analysis, we assessed the responsiveness, which is the ability to detect a change given a relevant change on the anchor. We computed the effect sizes (ESs) and standardised response means (SRMs). RESULTS: In patients with schizophrenia, the ESs and SRMs were large (ES/SRM > 0.8) for the British EQ-5D index (ESGSI: 0.93; SRMGSI: 0.89; SRMWHOQOL: 0.82). In patients with affective disorders, we found large ESs and SRMs for the EQ VAS (ESGSI: 1.79; ESWHOQOL: 0.90; SRMGSI: 1.52; SRMWHOQOL: 0.93) and a large ES for the British EQ-5D index (ESGSI: 0.88). In patients with alcohol addiction, the ESs and SRMs were large for the EQ VAS (ESGSI: 1.40; ESWHOQOL: 0.94; SRMGSI: 1.04; SRMWHOQOL: 0.83). The ESs and SRMs of the German EQ-5D index were consistently lower than those of the British EQ-5D index. Regarding TTO score, ESs and SRMs were generally less than 0.5. CONCLUSIONS: No preference-based instrument was consistently more responsive than others across all mental disorders. While the EQ VAS was the most responsive instrument in patients with affective disorders or alcohol addiction, the British EQ-5D index was reasonably responsive in patients with schizophrenia.

Determinants of direct and indirect costs in anorexia nervosa.

OBJECTIVE: To estimate direct and indirect costs of anorexia nervosa (AN), and to identify cost determinants. METHODS: In a subsample (n = 225) of the ANTOP trial (Anorexia Nervosa Treatment of OutPatients) health care utilization and productivity losses were assessed at baseline for the previous 3 months and monetarily valued. Included were females aged 18 years and older diagnosed with AN or subsyndromal AN, and a body mass index (BMI) between 15 and 18.5 kg/m(2) . To account for missing data multiple imputation was employed. Cost determinants were derived from generalized linear models with gamma distribution and log link function. RESULTS: Mean 3-months costs per patient amounted to €5,866 (SE = €576). The largest share of costs (€3,374) resulted from hospitalizations. Determinants of direct costs were analyzed separately for those with hospitalizations for AN, and those without. In the group only treated as outpatients, participants with binge/purge subtype, and those diseased for more than 6 years had higher costs. Moreover, costs were increased in patients with a comorbid mental disorder. In the group with hospitalizations, direct costs increased with BMI. BMI was measured at the end of the observation period, indicating that longer duration of treatment yielded higher weight gain. Indirect costs were not significantly associated with any disease-related characteristic. DISCUSSION: Costs resulting from health care utilization and productivity loss are substantial, although the sample studied had not received sufficient treatment. Future research should analyze the development of costs over time.

Placement matching of alcohol-dependent patients based on a standardized intake assessment: rationale and design of a randomized controlled trial.

BACKGROUND: Despite considerable research on substance-abuse placement matching, evidence is still inconclusive. The aims of this exploratory trial are to evaluate (a) the effects of following matching guidelines on health-care costs and heavy drinking, and (b) factors affecting the implementation of matching guidelines in the treatment of alcohol-dependent patients. METHODS: A total of 286 alcohol-dependent patients entering one of four participating detoxification units and having no arrangements for further treatment will be recruited. During the first week of treatment, all patients will be administered Measurements in the Addictions for Triage and Evaluation (MATE), European Quality of Life-Five Dimensions health status questionnaire (EQ-5D), and the Client Socio--Demographic and Service Receipt Inventory-European Version (CSSRI-EU). Patients who are randomly allocated to the intervention group will receive feedback regarding their assessment results, including clear recommendations for subsequent treatment. Patients of the control group will receive treatment as usual and, if requested, global feedback regarding their assessment results, but no recommendations for subsequent treatment. At discharge, treatment outcome and referral decisions will be recorded. Six months after discharge, patients will be administered MATE-Outcome, EQ-5D, and CSSRI-EU during a telephone interview. DISCUSSION: This trial will provide evidence on the effects and costs of using placement-matching guidelines based on a standardized assessment with structured feedback in the treatment of alcohol-dependent patients. A process evaluation will be conducted to facilitate better understanding of the relationship between the use of guidelines, outcomes, and potential mediating variables. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005035. Registered 03 June 2013.

Cost measurement of mental disorders in Germany.

BACKGROUND AND AIMS OF THE STUDY: Mental disorders are frequently investigated in economic evaluations. However, measuring direct costs of mental disorders is complex, in particular in Germany. We conducted a systematic review that investigated the following research questions: Which cost categories are assessed? Is the used data source (patient-reported data from interviews or questionnaires; claims data from health insurance; medical records from patient charts) associated with specific study characteristics? METHODS: We conducted a systematic literature search in PubMed. We included cost-of-illness studies (COIs) and cost-effectiveness analyses (CEAs) that measured patient level data on direct costs of mental disorders in Germany. RESULTS: We found 31 COIs and 17 CEAs. Cost items could be assigned to the cost categories outpatient medical, outpatient non-medical, sheltered living, hospital, rehabilitation, nursing care, outpatient goods (medication and medical goods), other direct costs, and indirect costs. Most studies, in particular COIs and studies conducted from a societal perspective, used patient-reported data which suited to assess cost categories comprehensively. Studies based on claims data or medical records tended to include fewer cost categories. DISCUSSION: The sample size of 48 analyzed studies was rather small. However, our study investigated three methods to assess health care utilization -- using patient-reported data, claims data, or medical records -- and identified their respective strengths and weaknesses in the context of covered cost categories and further attributes. CONCLUSION: Studies measuring the direct costs of mental disorders in Germany mostly relied on patient-reported data to assess resource consumption. Although more objective, claims data were used less frequently and covered less cost categories. IMPLICATIONS FOR HEALTH POLICIES: The direct costs of mental disorders are likely to be underreported as relevant cost factors such as non-medical services or sheltered living were often neglected in the studies. Policy makers should consider this when deciding on measures that aim at reducing the costs of care. IMPLICATIONS FOR FURTHER RESEARCH: Eliciting data from patients seems to constitute an adequate instrument to assess a broad range of cost categories, even though this bears various methodological challenges. Further research should (i) ameliorate the methods of collecting data from patients in ensuring that all relevant costs are covered and that methodological flaws are minimised (ii) develop or improve methods for the combination of claims data from different data holders.