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Abstract Background Though Dialectical Behavior Therapy (DBT) and other treatment models for individuals with Borderline Personality Disorder (BPD) have shown to be efficient in inpatient and outpatient settings, there is a general shortage of these treatments. In Germany, most resources are spent on inpatient treatments and unspecific crisis interventions, while it is difficult to implement the necessary team structures in an outpatient setting. This study is testing an alternative approach focussing on outpatient treatment: Integrated Care Borderline (ICB) provides DBT for persons with severe BPD within the structures of an Assertive Community Treatment (ACT). ICB is team-based, integrating psychiatric and social support as well as crisis interventions into a DBT-strategy. Methods ICB was compared to TAU in a prospective, randomized controlled trial. This study is part of RECOVER, a comprehensive stepped care approach in Germany, which enrolled a total of 891 participants. 146 persons were diagnosed with BPD as main diagnosis. Of these, 100 were allocated to the highest level of severe mental illness (SMI) and randomly assigned to either ICB (n = 50) or TAU (n = 50). Data were collected at baseline and 12 months later. The main outcomes were psychosocial functioning (GAF), severity of BPD (BSL-23) and other mental symptoms (BSI, PHQ-9, GAD-7, self-harm), employment status (VILI), as well as hospital days and associated costs. Results Data show a significant increase of psychosocial functioning and a significant decrease of BPD and other psychiatric symptoms in both groups (r = .28 – .64), without any significant differences between the groups. The proportion of self-harming persons decreased in both groups without statistical significance. Patients were significantly more likely to be employed after a year of treatment in ICB (p = .001), but not in the TAU group (p = .454). Analyses showed a significant difference between the groups (p = .032). Moreover, psychiatric hospital days were significantly reduced in ICB (-89%, p

Abstract Background Orthogeriatric co-management (OGCM) addresses the special needs of geriatric fracture patients. Most of the research on OGCM focused on hip fractures while results concerning other severe fractures are rare. We conducted a health-economic evaluation of OGCM for pelvic and vertebral fractures. Methods In this retrospective cohort study, we used German health and long-term care insurance claims data and included cases of geriatric patients aged 80 years or older treated in an OGCM (OGCM group) or a non-OGCM hospital (non-OGCM group) due to pelvic or vertebral fractures in 2014–2018. We analyzed life years gained, fracture-free life years gained, healthcare costs, and cost-effectiveness within 1 year. We applied entropy balancing, weighted gamma and two-part models. We calculated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. Results We included 21,036 cases with pelvic (71.2% in the OGCM, 28.8% in the non-OGCM group) and 33,827 with vertebral fractures (72.8% OGCM, 27.2% non-OGCM group). 4.5–5.9% of the pelvic and 31.8–33.8% of the vertebral fracture cases were treated surgically. Total healthcare costs were significantly higher after treatment in OGCM compared to non-OGCM hospitals for both fracture cohorts. For both fracture cohorts, a 95% probability of cost-effectiveness was not exceeded for a willingness-to-pay of up to €150,000 per life year or €150,000 per fracture-free life year gained. Conclusion We did not obtain distinct benefits of treatment in an OGCM hospital. Assigning cases to OGCM or non-OGCM group on hospital level might have underestimated the effect of OGCM as not all patients in the OGCM group have received OGCM.

Abstract Orthogeriatric co-management (OGCM) describes a collaboration of orthopedic surgeons and geriatricians for the treatment of fragility fractures in geriatric patients. While its cost-effectiveness for hip fractures has been widely investigated, research focusing on fractures of the upper extremities is lacking. Thus, we conducted a health economic evaluation of treatment in OGCM hospitals for forearm and humerus fractures. In a retrospective cohort study with nationwide health insurance claims data, we selected the first inpatient stay due to a forearm or humerus fracture in 2014–2018 either treated in hospitals that were able to offer OGCM (OGCM group) or not (non-OGCM group) and applied a 1-year follow-up. We included 31,557 cases with forearm (63.1% OGCM group) and 39,093 cases with humerus fractures (63.9% OGCM group) and balanced relevant covariates using entropy balancing. We investigated costs in different health sectors, length of stay, and cost-effectiveness regarding total cost per life year or fracture-free life year gained. In both fracture cohorts, initial hospital stay, inpatient stay, and total costs were higher in OGCM than in non-OGCM hospitals. For neither cohort nor effectiveness outcome, the probability that treatment in OGCM hospitals was cost-effective exceeded 95% for a willingness-to-pay of up to €150,000. We did not find distinct benefits of treatment in OGCM hospitals. Assigning cases to study groups on hospital-level and using life years and fracture-free life years, which might not adequately reflect the manifold ways these fractures affect the patients’ health, as effectiveness outcomes, might have underestimated the effectiveness of treatment in OGCM hospitals.

Abstract 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.

Abstract Background In Germany, geriatricians deliver acute geriatric care during acute hospital stay and post-acute rehabilitation after transfer to a rehabilitation clinic. The rate patients receive acute geriatric care (AGC) or are transferred to post-acute rehabilitation (TPR) differs between hospitals. This study analyses the association between the two geriatric treatment systems (AGC, TPR) and second hip fracture in patients following an index hip fracture. Methods Nationwide health insurance data are used to identify the rate of AGC and TPR per hospital following hip fracture surgery in patients aged ≥ 80 years. Outcomes are a second hip fracture after surgery or after discharge within 180 or 360 days and new specific anti-osteoporotic drugs. Cox proportional hazard models and generalised linear models are applied. Results Data from 29,096 hip fracture patients from 652 hospitals were analysed. AGC and TPR are not associated with second hip fracture when follow-up started after surgery. However, during the first months after discharge patients from hospitals with no AGC or low rates of TPR have higher rates of second hip fracture than patients from hospitals with high rates of AGC or high rates of TPR (Hazard Ratio (95% CI) 1.35 (1.01–1.80) or 1.35 (1.03–1.79), respectively). Lower rates of AGC are associated with lower probabilities of new prescriptions of specific anti-osteoporotic drugs. Conclusions Our study suggests beneficial relationships of geriatric treatment after hip fracture with a) the risk of second hip fractures during the first months after discharge and b) an improvement of anti-osteoporotic drug treatment.

Abstract Background Effective care coordination may increase clinical efficiency, but its measurement remains difficult. The established metric “care density” (CD) measures care coordination based on patient-sharing among physicians, but it may be too rigid to generalize across disorders and countries. Therefore, we propose an extension called fragmented care density (FCD), which allows varying weights for connections between different types of providers. We compare both metrics in their ability to predict hospitalizations due to schizophrenia. Methods We conducted a longitudinal cohort study based on German claims data from 2014 through 2017 to predict quarterly hospital admissions. 21,016 patients with schizophrenia from the federal state Baden-Württemberg were included. CD and FCD were calculated based on patient-sharing networks. The weights of FCD were optimized to predict hospital admissions during the first year of a 24-month follow-up. Subsequently, we employed likelihood ratio tests to assess whether adding either CD or FCD improved a baseline model with control variables for the second follow-up year. Results The inclusion of FCD significantly improved the baseline model, Χ2(1) = 53.30, p

Abstract 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.

Abstract 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.

Abstract 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.

Abstract 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 ).

Abstract Background The EQ-5D is a generic questionnaire providing a preference-based index score applicable to cost-utility analysis. This is the first study to validate the EQ-5D in patients with somatoform disorders. Methods Data of the EQ-5D descriptive system, the British and the German EQ-5D index and the EQ Visual Analogue Scale, the Patient Health Questionnaire 15, the Patient Health Questionnaire 9, the Whiteley Index 7 and the Short Form 36 were collected from 294 patients at baseline, 244 at 6 months and 256 at 12 months after baseline. The discriminative ability of the EQ-5D was evaluated by comparison with a general population sample and by the ability to distinguish between different symptom severities. Convergent validity was analysed by assessing associations between the EQ-5D and the other instruments. Responsiveness was evaluated by analysing the effects on scores between two measurements in groups of patients reporting worse, same or better health. The Bonferroni correction was employed. Results For all items of the EQ-5D except ‘self-care’, patients with somatoform disorders reported more problems than the general population. The EQ-5D showed discriminative ability in patients with different symptom severities. For nearly all reference instruments there were significant differences in mean scores between respondents with and without problems in the various EQ-5D items and strong correlations with the EQ Visual Analogue Scale and the EQ-5D index scores. Evidence for the responsiveness of the EQ-5D could only be found for patients with better health; effects were medium at the utmost. Conclusions The EQ-5D showed a considerable validity and a limited responsiveness in patients with somatoform disorders. Trial registration Current Controlled Trials ISRCTN55280791

Abstract Background Psychiatric comorbidity is common in back pain patients undergoing disc surgery and increases economic costs in many areas of health. The objective of this study was to analyse psychiatric comorbidity as predictor of direct and indirect costs in back pain patients undergoing disc surgery in a longitudinal study design. Methods A sample of 531 back pain patients was interviewed after an initial disc surgery (T0), 3 months (T1) and 15 months (T2) using the Composite International Diagnostic Interview to assess psychiatric comorbidity and a modified version of the Client Sociodemographic and Service Receipt Inventory to assess resource utilization and lost productivity for a 3-month period prior interview. Health care utilization was monetarily valued by unit costs and productivity by labour costs. Costs were analysed using random coefficient models and bootstrap techniques. Results Psychiatric comorbidity was associated with significantly (p Conclusion Psychiatric comorbidity presents an important predictor of direct and indirect costs in back pain patients undergoing disc surgery, even if patients do not utilize mental health care. This effect seems to be stable over time. More attention should be given to psychiatric comorbidity and cost-effective treatments should be applied to treat psychiatric comorbidity in back pain patients undergoing disc surgery to reduce health care utilization and costs associated with psychiatric comorbidity.

IntroductionFamily 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.MethodsN = 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.ResultsFamily 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).DiscussionFindings 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.

Introduction People receiving home care usually have complex healthcare needs requiring the involvement of informal caregivers and various health professionals. In this context, successful collaboration is an important element of person-centred care, which is often insufficiently implemented. Consequences might be found in avoidable hospitalisations. The aim of the study is to develop a care concept to improve person-centred interprofessional collaboration for people receiving home care considering the perspectives of all person groups involved.Methods and analysis This study uses a mixed-methods design consisting of a literature review, several qualitative inquiries, a cross-sectional quantitative study and a final structured workshop. After a literature review (work package (WP) 1), we will explore the perspectives of people receiving home care (n=20), their relatives (n=20) and representatives of statutory health insurances (n=5) in semistructured interviews (WP2). Moreover, 100 individuals of each group (people receiving home care, relatives, registered nurses, general practitioners and therapists) involved in home care will answer a survey on collaboration that will be analysed descriptively (WP3). Additionally, monoprofessional focus groups (n=9) of registered nurses, general practitioners and therapists, respectively, will discuss current practices. Data will be analysed by qualitative content analysis. Best practice cases (n=8) will be analysed by a case-based qualitative content analysis based on data of observations of home visits and interviews (WP4). The findings of WP2 will be discussed in mixed focus groups (n=4) with 10 participants each (WP5). Considering the results of joint displays of WP3, WP4 and WP5, the interprofessional care concept and its implementation will be elaborated in an expert workshop (WP6).Ethics and dissemination Ethical approval was obtained from all ethics committees of the project partners. Study results will be disseminated through publications, conference presentations, student education and advanced training of health professionals.Trial registration number NCT05149937.

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.

Abstract Background In Germany, geriatricians deliver acute geriatric care during an acute hospital stay and subacute rehabilitation after transfer to a rehabilitation clinic. However, the proportion of patients who receive acute geriatric care (AGC) or are transferred to subacute rehabilitation (TSR) differs considerably between hospitals. The aim of this study was to analyse the association between the two geriatric treatment systems and care home admission or mortality in patients following hip fracture. Methods Health insurance claims data were used to identify the rate of AGC per hospital and the rate of TSR per hospital following hip fracture surgery in patients aged ≥ 80 years. Outcomes were cumulative admission to a care home and cumulative mortality within 6 months after hospital admission. Results Data from 23,046 hip fracture patients from 561 hospitals were analysed. The rate of AGC was not associated with care home admission. However, compared to high rates of AGC medium rates or no AGC were associated with increased death rates by 12% or 20%, respectively. Treatment in hospitals with low rates of TSR was associated with a 8% higher risk of care home admission and a 10% increased risk of death compared to treatment in hospitals with high rates of TSR. Conclusions Our study suggests potential effects of geriatric treatment: reduction of mortality in hospitals with high rates of AGC or reduction of care home admission and mortality in hospitals with high rates of TSR.

Abstract Background Fractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about “safety in the living environment.” The aim of this study was to evaluate this complex preventive intervention in a routine health care setting. Methods This cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70–85 years with prior fragility fractures and (b) all community-living women aged 75–80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days). Results Nine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. Of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase “safety in the living environment.” The incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80–1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59–0.99). Mortality and nursing home admission did not differ between the intervention and the control group. Conclusions A comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance. Trial registration German Clinical Trials Register DRKS-ID: 00009000

Abstract 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.

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).

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.

[Background] This study aims to provide a transparent and replicable documentation approach for the cultural adaptation of a cognitive-behavioural transdiagnostic intervention (Common Elements Treatment Approach, CETA) for Arabic-speaking refugees with common mental disorders in Germany. [Method] A mixed-methods approach was used, including literature review, interviews, expert decisions and questionnaires, in order to adapt the original CETA as well as an internet-based guided version (eCETA). The process of cultural adaptation was based on a conceptual framework and was facilitated by an adaptation monitoring form as well as guidelines which facilitate the reporting of cultural adaptation in psychological trials (RECAPT). [Results] Consistent with this form and the guidelines, the decision-making process of adaptation proved to be coherent and stringent. All specific CETA treatment components seem to be suitable for the treatment of Arabic-speaking refugees in Germany. Adaptations were made to three different elements: 1) Cultural concepts of distress: a culturally appropriate explanatory model of symptoms was added; socially accepted terms for expressing symptoms (for eCETA only) and assessing suicidal ideation were adapted; 2) Treatment components: no adaptations for theoretically/empirically based components of the intervention, two adaptations for elements used by the therapist to engage the patient or implement the intervention (nonspecific elements), seven adaptations for skills implemented during sessions (therapeutic techniques; two for eCETA only) and 3) Treatment delivery: 21 surface adaptations (10 for eCETA only), two eCETA-only adaptations regarding the format. [Conclusion] The conceptual framework and the RECAPT guidelines simplify, standardise and clarify the cultural adaptation process.

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.

Pain relief has been shown to be the most frequently reported goal by patients undergoing lumbar disc surgery. There is a lack of systematic research investigating the course of postsurgical pain intensity and factors associated with postsurgical pain. This systematic review focuses on pain, the most prevalent symptom of a herniated disc as the primary outcome parameter. The aims of this review were (1) to examine how pain intensity changes over time in patients undergoing surgery for a lumbar herniated disc and (2) to identify socio-demographic, medical, occupational and psychological factors associated with pain intensity.Selection criteria were developed and search terms defined. The initial literature search was conducted in April 2015 and involved the following databases: Web of Science, Pubmed, PsycInfo and Pubpsych. The course of pain intensity and associated factors were analysed over the short-term (≤ 3 months after surgery), medium-term (> 3 months and < 12 months after surgery) and long-term (≥ 12 months after surgery).From 371 abstracts, 85 full-text articles were reviewed, of which 21 studies were included. Visual analogue scales indicated that surgery helped the majority of patients experience significantly less pain. Recovery from disc surgery mainly occurred within the short-term period and later changes of pain intensity were minor. Postsurgical back and leg pain was predominantly associated with depression and disability. Preliminary positive evidence was found for somatization and mental well-being.Patients scheduled for lumbar disc surgery should be selected carefully and need to be treated in a multimodal setting including psychological support.

Abstract 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

Introduction Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care.Methods and analysis The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions.Ethics and dissemination Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration number and registry name ClinicalTrials.gov (NCT03459664), RECOVERProtocol version 19 March 2020 (V.3.0)

This study aims to investigate (1) motives, motivations and expectations regarding the choice for a specific rehabilitation setting after herniated disc surgery and (2) how rehabilitation-related motivations and expectations are associated with rehabilitation outcome (ability to work, health-related quality of life and satisfaction with rehabilitation) three months after disc surgery.The longitudinal cohort study refers to 452 disc surgery patients participating in a subsequent rehabilitation. Baseline interviews took part during acute hospital stay (pre-rehabilitation), follow-up interviews three months later (post-rehabilitation). Binary logistic regression and multiple linear regression analyses were applied.(1) Motives, motivations and expectations: Inpatient rehabilitation (IPR) patients stated "less effort/stress" (40.9%), more "relaxation and recreation" (39.1%) and greater "intensity of care and treatment" (37.0%) regarding their setting preference, whereas outpatient rehabilitation (OPR) patients indicated "family reasons" (45.3%), the wish for "staying in familiar environment" (35.9%) as well as "job-related reasons" (11.7%) as most relevant. IPR patients showed significantly higher motivation/expectation scores regarding regeneration (p < .001), health (p < .05), coping (p < .001), retirement/job (p < .01), psychological burden (p < .05) and physical burden (p < .001) compared to OPR patients. (2) Associations with rehabilitation outcome: Besides other factors (e.g. age, gender and educational level) rehabilitation-related motivations/expectations were significantly associated with rehabilitation outcome measures. For example, patients with less motivations/expectations to achieve improvements regarding "physical burden" showed a better health-related quality of life (p < .01) three months after disc surgery. Less motivations/expectations to achieve improvements regarding "psychological burden" was linked to a better mental health status (p < .001) and a greater satisfaction with rehabilitation (OR = .806; p < .05).Rehabilitation-related motivations and expectations differed substantially between IPR and OPR patients before rehabilitation and were significantly associated with rehabilitation outcome. Taking motivational and expectation-related aspects into account may help to improve allocation procedures for different rehabilitation settings and may improve rehabilitation success.

OBJECTIVES:The aims of this study are to answer the following questions (1) How does the pain intensity of lumbar and cervical disc surgery patients change within a postoperative time frame of 5 years? (2) Which sociodemographic, medical, work-related, and psychological factors are associated with postoperative pain in lumbar and cervical disc surgery patients? METHODS:The baseline survey (T0; n = 534) was conducted 3.6 days (SD 2.48) post-surgery in the form of face-to-face interviews. The follow-up interviews were conducted 3 months (T1; n = 486 patients), 9 months (T2; n = 457), 15 months (T3; n = 438), and 5 years (T4; n = 404) post-surgery. Pain intensity was measured on a numeric rating-scale (NRS 0-100). Estimated changes to and influences on postoperative pain by random effects were accounted by regression models. RESULTS:Average pain decreased continuously over time in patients with lumbar herniated disc (Wald Chi² = 25.97, p

OBJECTIVE: To examine rehabilitation preferences, participation and determinants for the choice of a certain rehabilitation setting (inpatient vs. outpatient) and setting-specific rehabilitation outcomes. METHODS: The longitudinal observational study referred to 534 consecutive disc surgery patients (18-55 years). Face-to-face baseline interviews took place about 3.6 days after disc surgery during acute hospital stay. 486 patients also participated in a follow-up interview via telephone three months later (dropout-rate: 9%). The following instruments were used: depression and anxiety (Hospital Anxiety and Depression Scale), pain intensity (numeric analog scale), health-related quality of life (Short Form 36 Health Survey), subjective prognosis of gainful employment (SPE-scale) as well as questions on rehabilitation attendance, return to work, and amount of sick leave days. RESULTS: The vast majority of patients undergoing surgery for a herniated disc attended a post-hospital rehabilitation treatment program (93%). Thereby two-thirds of these patients took part in an inpatient rehabilitation program (67.9%). Physical, psychological, vocational and health-related quality of life characteristics differed widely before as well as after rehabilitation depending on the setting. Inpatient rehabilitees were significantly older, reported more pain, worse physical quality of life, more anxiety and depression and a worse subjective prognosis of gainful employment before rehabilitation. Pre-rehabilitation differences remained significant after rehabilitation. More than half of the outpatient rehabilitees (56%) compared to only one third of the inpatient rehabilitees (33%) returned to work three months after disc surgery (p