Consensus-based recommendations for the development and expansion of palliative day care clinics in Germany: results of a Delphi study.

BACKGROUND: Needs-based, patient-oriented palliative care includes palliative day care clinics as a specialized semi-inpatient care offer. However, the establishment and development of these facilities has been unsystematic. Research is needed to strengthen their transparency and ensure their accessibility, quality, and structural adequacy. A national Delphi study was conducted to generate appropriate recommendations for the establishment and development of palliative day care clinics in Germany. METHODS: Recommendations were formulated from focus group data on the development and expansion of palliative day care clinics in Germany. Experts on in- and outpatient palliative care rated 28 recommendations for relevance and feasibility, respectively, using a 4-point Likert-type scale. Suggestions for improvement were captured via free text comments. Items were considered consented when more than 80% of the experts scored them 4 (strongly agree) or 3 (somewhat agree), regarding both relevance and feasibility. RESULTS: A total of 23 experts (32% response rate) completed three Delphi rounds. Following the first round, 10 of 28 recommendations were revised according to participants' comments; 1 recommendation was rejected. After the second round, 3 of these 10 recommendations were revised, while 3 were rejected. Consensus was achieved after the third round for 22 of the initial recommendations. CONCLUSIONS: The Delphi-consented recommendations provide a basis for the targeted evidence- and needs-based development of palliative day care clinics. The findings show a need for standards setting and the meaningful integration of these clinics into existing structures. TRIAL REGISTRATION: The present study was prospectively registered on April 20, 2020, with the German Clinical Trials Register (DRKS00021446).

[Empirically derived recommendations for the development and expansion of day hospices in Germany - Results of a Delphi expert panel]. / Empirisch abgeleitete Empfehlungen für den Auf- und Ausbau von Tageshospizen in Deutschland ­ Ergebnisse einer Delphi-Befragung mit Expert:innen.

INTRODUCTION: A needs-based and patient-oriented hospice and palliative care also includes day hospices as a specialised semi-inpatient care offer. The establishment and development of these facilities in Germany has been rather unsystematic. In order to ensure quality and adequacy of these structures, research is needed. METHODS: A Delphi consensus study was conducted online from November 2022 to February 2023 aiming at generating recommendations for the development and expansion of day hospices in Germany. For each recommendation, the participants indicated on a four-point verbal rating scale how much they agreed upon a) the relevance and b) the feasibility of the recommendation. Items were considered consented when 80% of the participants (strongly) agreed with the recommendation regarding both criteria. If no consensus was reached, the recommendations were revised according to the participants' free text comments and presented in the next Delphi round. Descriptive analyses were applied. RESULTS: A total of 64 experts participated in the first Delphi round and 44 in the second. In round 1, 34 recommendations and in round 2 six recommendations were consented. The final set contains a total of 40 recommendations: 18 on the tasks of day hospices, 13 on cooperation, 7 on funding, and 2 on public relations. DISCUSSION: Recommendations for the development and expansion of day hospices in Germany were developed. Due to their highly rated feasibility, the recommendations should be directly transferable into care practice. It remains to be seen to what extent they will be taken into account in the renegotiation of the framework agreement for day hospices. CONCLUSION: The Delphi-consented recommendations provide a basis to guide action in the currently very dynamic development of hospice work and palliative care in Germany.

Lifestyle interventions for patients with non-alcoholic steato-hepatitis-Design, rationale and protocol of the study "target group-specific optimisation of lifestyle interventions for behavior change in non-alcoholic steato-hepatitis (OPTI-NASH)".

BACKGROUND: Non-alcoholic steato-hepatitis (NASH) is the inflammatory, progressive form of non-alcoholic fatty liver disease (NAFLD). A delayed diagnose interval is typical for the majority of the patients because of the asymptomatic natural course. However, serious sequelae may develop such as cirrhosis or hepatocellular carcinoma. NASH is also associated with an increased risk of metabolic diseases. Obesity developed due to a lack of exercise or a disadvantageous diet often leads to NAFLD or NASH, thereby interventions including enhanced physical activity and calorie reduction form the actual gold standard of treatment. To date, patients rarely use these. The project aims to model lifestyle interventions based on the preferences of the NASH patients. METHODS: Based on a systematic review and focus group discussions, two discrete choice experiments (DCE) will be designed, one on aspects influencing successful uptake of lifestyle interventions and one to analyses parameters contributing to long-term participation. An online survey will be used to elicit patient's preferences on program design and on motivational aspects in a cross-sectional design. The recruitment will take place in nine certified specialist practices and hospital outpatient clinics aiming to reach a sample size of n = 500 which is also required for the DCE design. DISCUSSION: The results will provide an overview of the NASH patient's preferences regarding the successful uptake and long-term implementation of lifestyle interventions. Recommendations for optimized lifestyle change programs will be derived and an intervention manual will be developed to facilitate target group-specific inclusion in programs in practice.

Heterogeneous Preferences for Colorectal Cancer Screening in Germany: Results of a Discrete Choice Experiment.

OBJECTIVES: Colorectal cancer (CRC) screening tests differ in benefits, harms, and processes, making individual informed decisions preference based. The objective was to analyze the preferences of insurees in Germany for characteristics of CRC screening modalities. METHODS: A generic discrete choice experiment with 2-alternative choice sets and 6 attributes (CRC mortality, CRC incidence, complications, preparation, need for transportation, and follow-up; 3 levels each) depicting characteristics of fecal testing, sigmoidoscopy, and colonoscopy was generated. Participants completed 8 choice tasks. Internal validity was tested using a within-set dominated pair. Between June and October 2020, written questionnaires were sent to a stratified random sample (n = 5000) of 50-, 55-, and 60-year-old insurees of the AOK (Allgemeine Ortskrankenkasse) Lower Saxony, who had previously received an invitation to participate in the organized screening program including evidence-based information. Preferences were analyzed using conditional logit, mixed logit, and latent-class model. RESULTS: From 1282 questionnaires received (26% [1282 of 4945]), 1142 were included in the analysis. Approximately 42% of the respondents chose the dominated alternative in the internal validity test. Three heterogeneous preference classes were identified. Most important attributes were preparation (class 1; n = 505, 44%), CRC mortality (class 2; n = 347, 30%), and CRC incidence (class 3; n = 290, 25%). Contrary to a priori expectations, a higher effort was preferred for bowel cleansing (class 1) and accompaniment home (classes 1 and 2). CONCLUSION: Internal validity issues of choice data need further research and warrant attention in future discrete choice experiment surveys. The observed preference heterogeneity suggests different informational needs, although the underlying reasons remained unclear.

The State of Care for Persons With a Diagnosis of Depression.

BACKGROUND: Depression is one of the most common mental illnesses. There are well-known deficiencies in the care of patients with depression, particularly at the interfaces between health service areas or sectors. The aim of this study was to analyze the characteristics and state of care of persons with a diagnosis of depression. METHODS: The analysis was based on diagnosis and billing data obtained from a statutory health insurance carrier in Germany. Patients carrying a diagnosis of depression in 2018 (ICD-10 F32, F33, F34.1) were identified and studied with respect to their utilization of care services for depression. Sociodemographic characteristics and the degree of severity of depression were also taken into account. RESULTS: More than 285 000 individuals with a diagnosis of depression were included in the analysis. Their mean age was 57.5 years, and 67.5% were female. About three-quarters had at least one comorbid mental disorder. Primary care physicians were involved in the treatment of depression for 82.8% of patients with severe depression; 41.1% of such patients had contact with a medical specialist, and 9.2% with a psychologist-psychotherapist. Antidepressants were prescribed for 60.3% of patients with severe depression, and 10.2% were receiving psychotherapeutic services in accordance with the psychotherapy directive. CONCLUSION: Our findings point to existing deficiencies in the care of patients with depression, particularly in the establishment of the diagnosis and in the assessment of disease severity. These are essential matters for the initiation of guideline-oriented therapy and therefore deserve to be more strongly emphasized in continuing medical education.

Analysing the administration of an intermediate level of outpatient palliative care in Germany and developing recommendations for improvement (Polite): A study protocol for a mixed-methods study.

BACKGROUND: To date, there has been no systematic research on the intermediate level service (level 2) in outpatient palliative care that was introduced in Germany in 2017. Accordingly, the Polite research project aims at: (1) investigating the current state of level 2 palliative care and (2) developing recommendations for its optimisation. METHODS: The multi-perspective, observational study will follow a mixed-methods approach across two study phases. In phase 1a, quantitative routinely collected data from a statutory general local health insurance provider will be used to identify patients who received level 2 or other outpatient palliative care in the years 2017-2019. In phase 1b, a questionnaire will be sent to all registered general practitioners (GPs) in Lower Saxony to collect information on the number and characteristics of physicians offering level 2 palliative care. In phase 1c, a quantitative, standardised online questionnaire for teams providing specialised outpatient palliative care will be administered to assess the interfaces of level 2 palliative care. In phase 2a, the results from phases 1a-c will be discussed in an expert workshop with the aim of developing ideas to adapt and optimise level 2 outpatient palliative care. Finally, in phase 2b, the empirically derived recommendations from phases 1 and 2a will be agreed upon via a multi-round Delphi survey involving experts with sufficient influence to promote the project results and recommendations nationally. DISCUSSION: The results of the project will facilitate the optimisation of outpatient palliative care, as well as its administration, nationwide. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00024785); date of registration: 06th May 2021) and is searchable under the International Clinical Trials Registry Platform Search Portal of the World Health Organization, under the German Clinical Trials Register number.

[Healthcare expenditure and the impact of age: a detailed analysis for survivors and decedents]. / Gesundheitsausgaben und die Rolle des Alters: Eine detaillierte Analyse der Kosten von Überlebenden und Verstorbenen.

BACKGROUND: Germany faces various socio-political challenges due to its ongoing ageing population. Significant increases in social security contributions are widely expected. The impact of ageing on healthcare expenditure is a controversial issue. Experts agree that costs for end-of-life care account for a significant part of total healthcare expenditures. For a meaningful forecast, detailed information on healthcare costs differentiated by survivors and decedents is necessary. Extensive data are hardly available for Germany. The aim of the analysis was therefore to describe healthcare costs in the statutory health insurance. METHODS: The basis for the calculation is billing data from the statutory health insurance "AOK Niedersachsen" (Lower Saxony). Persons who survived or died in 2017 were included in the analysis. Average costs were standardised. RESULTS: The data of 2.46 million survivors and 34,307 decedents were analysed. The average annual healthcare costs were 2756 € for survivors and 21,830 € for decedents in the last year of life. The average healthcare costs for survivors increase with age whereas costs for decedents are highest in younger age groups and decline with increasing age. A detailed analysis of end-of-life costs shows an exponential increase of costs in the last three years of life with the highest costs in the quarter before death (10,577 €). DISCUSSION: The analysis gives a detailed overview on the structure of healthcare expenditure in the statutory health insurance and can serve as a basis for future forecasts regarding healthcare expenditure.

Exploring the status of and demand for palliative day-care clinics and day hospices in Germany: a protocol for a mixed-methods study.

BACKGROUND: To date, the establishment and development of palliative day-care clinics and day hospices in Germany have been completely unsystematic. Research is needed to gain insight into these services and to ensure their accessibility and quality. Accordingly, the ABPATITE research project aims at: (1) identifying the characteristics of palliative day-care clinics and day hospices in Germany, (2) determining demand and preferences for these services, and (3) proposing recommendations (with expert agreement) for the needs-based establishment and development of these services. METHODS: The research is a multi-perspective, prospective, observational study following a mixed-methods approach across three study phases. In phase 1a, qualitative expert interviews will be conducted to capture the facility-related characteristics of palliative day-care clinics and day hospices in Germany; the results will feed into a questionnaire sent to all such institutions identified nationwide. In phase 1b, a questionnaire will be sent to local statutory health insurance providers, to gain insight into their contracts and accounting and remuneration models. In phase 2a, a service preference survey will be conducted with patients and family caregivers. In phase 2b, semi-structured interviews with management staff will explore the factors that promote and hinder the provision of service. In phase 2c, the external perspective will be surveyed via focus groups with local actors involved in hospice and palliative care. In phase 3a, focus groups with representatives from relevant areas will be conducted to develop recommendations. Finally, in phase 3b, recommendations will be agreed upon through a Delphi survey. DISCUSSION: The empirically developed recommendations should enable the establishment and development of day hospices and palliative day-care clinics in Germany to be better managed, more oriented to actual demand, and more effectively integrated into wider health care services. Importantly, the findings are expected to optimize the overall development of hospice and palliative care services. TRIAL REGISTRATION: The study was prospectively registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00021446; date of registration: April 20, 2020). The study is searchable under the International Clinical Trials Registry Platform Search Portal of the World Health Organization, under the German Clinical Trials Register number.

Determinants of colorectal cancer screening in Germany: a claims data analysis.

With an incidence of 58,000 cases per year, colorectal cancer (CRC) is the third most common type of cancer in Germany. Although guaiac-based fecal occult blood tests (gFOBT) and colonoscopy are accepted strategies for CRC screening offered for individuals aged 50 or 55 onwards, utilization rates remain low.This study examines various determinants for participation in CRC screening using claims data provided by the AOK Niedersachsen and covering the years 2014 to 2016. Using multivariate logistic regression models, we analyzed sociodemographic factors (sex, age, nationality, type of employment) associated with screening behavior, including individuals who underwent colonoscopy or gFOBT. The effect of school education and professional qualification was estimated using subgroups of employees with social insurance.The analysis consisted of 620,977 insured individuals in the study population for screening colonoscopy, while the gFOBT study population contained 845,191 individuals. With increasing age, individuals were less likely to participate in CRC screening. Participation rates for screening were higher for women than men in younger age groups. However, men in higher age groups showed increased participation rates in gFOBT screening. When compared with German citizens, Turkish citizens use the colonoscopy less often and the gFOBT more often. In contrast to employees with social insurance, unemployed individuals accept the prevention services less frequently, whereas pensioners and voluntarily insured individuals exhibit increased participation rates. In terms of education and professional qualification, we estimated a significantly lower participation rate exclusively for the least educated individuals. The results help to better understand patterns of utilization and can contribute to the development of information programs for specific groups.

Pediatric solid organ injury - frequency of abdominal imaging is determined by the treating department.

To investigate the use of abdominal CT scanning in the management of pediatric blunt abdominal trauma in pediatric and non-pediatric departments.In this observational cohort study, anonymized data were extracted from 2 large German statutory health insurances (∼5.9 million clients) in a 7-year period (2010-2016). All patients with inpatient International Classification of Diseases (ICD) codes S36.- and S37.- (injury of intra-abdominal organs; injury of urinary and pelvic organs) aged ≤18 years were included. Demographic and clinical data were analyzed by logistic regression analysis for associations with the use of abdominal CT.A total of 524 children with blunt abdominal trauma (mean age 11.0 ±â€Š5.2 years; 62.6% males) were included; 164 patients (31.3%) received abdominal CT-imaging. There were no significant differences in traumatic non-intraabdominal comorbidity patterns (injuries of external causes; injuries to the head or thorax). There was substantial variability in the rate of abdominal CT imaging among different medical disciplines ranging from 11.6% to 44.5%. Patients admitted to pediatric departments (Pediatrics and Pediatric Surgery) underwent abdominal CT imaging significantly less frequently (19.7%; N = 55) compared to patients treated in non-pediatric departments (General/Trauma Surgery: 44.5%; N = 109) irrespective of concomitant injuries. The estimated OR for the use of abdominal CT by General/Trauma Surgery was 6.2-fold higher (OR: 6.15 [95-%-CI:3.07-13.21]; P < .001) compared to Pediatric Surgery. Other risk factors associated with the use of abdominal CT were traumatic extra-abdominal comorbidities, increasing age, male gender, and admission to a university hospital.Abdominal CT imaging was significantly less frequently used in pediatric departments. The substantial variability of the abdominal CT rate among different medical disciplines and centers indicates a potential for reduction of CT imaging by implementation of evidence-based guidelines. Furthermore, our study underlines the need for centralization of pediatric trauma care in Germany not only to improve patient outcome but to avoid radiation-induced cancer mortality.

Impact of psychologically tailored hand hygiene interventions on nosocomial infections with multidrug-resistant organisms: results of the cluster-randomized controlled trial PSYGIENE.

Background: Professional hand hygiene compliance represents a multifaceted behaviour with various determinants. Thus, it has been proposed to apply psychological frameworks of behaviour change to its promotion. However, randomized controlled trials of such approaches, which also assess nosocomial infections (NIs), are rare. This study analyses data of the PSYGIENE-trial (PSYchological optimized hand hyGIENE promotion), which has shown improvements in compliance after interventions tailored based on the Health Action Process Approach (HAPA), on rates of NIs with multidrug-resistant organisms (MDROs). Methods: A parallel-group cluster-randomized controlled trial was conducted on all 10 intensive care units and two hematopoietic stem cell transplantation units at Hannover Medical School, a German tertiary care hospital. Educational training sessions for physicians and nurses (individual-level intervention) and feedback discussions with clinical managers and head nurses (cluster-level) were implemented in 2013. In the "Tailoring"-arm (n = 6 wards), interventions were tailored based on HAPA-components, which were empirically assessed and addressed by behaviour change techniques. As active controls, n = 6 wards received untailored educational sessions of the local "Clean Care is Safer Care"-campaign (Aktion Saubere Hände: "ASH"-arm). From 2013 to 2015 compliance was assessed by observation following the World Health Organization, while alcohol-based hand rub usage (AHRU) and NIs with multidrug-resistant gram-negative bacteria, Methicillin-resistant Staphylococcus aureus or Vancomycin-resistant Enterococcus were assessed following national surveillance protocols. Data were analysed at cluster-level. Results: In the "Tailoring"-arm, interventions led to a decrease of 0.497 MDRO-infections per 1000 inpatient days from 2013 to 2015 (p = 0.015). This trend was not found in the "ASH"-arm (- 0 . 022 infections; p = 0.899). These patterns corresponded inversely to the trends in compliance but not in AHRU. Conclusions: While interventions tailored based on the HAPA-model did not lead to a significantly lower incidence rate of MDRO-infections compared to control wards, a significant reduction, compared to baseline, was found in the second follow-up year in the "Tailoring"- but not the "ASH"-arm. This indicates that HAPA-tailored hand hygiene interventions may contribute to the prevention of NIs with MDRO. Further research should focus on addressing compliance by interventions tailored not only to wards, but also leaders, teams, and individuals. Trial registration: German Clinical Trials Register/International Clinical Trials Registry Platform, DRKS00010960. Registered 19 August 2016-Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010960. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00010960.

Outcomes and costs of treating hepatitis C patients with second-generation direct-acting antivirals: results from the German Hepatitis C-Registry.

OBJECTIVE: Chronic hepatitis C virus infection is associated with a significant health burden. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The introduction of direct-acting antivirals (DAA) has led to an increase in sustained virologic response rates (SVR), but is accompanied by higher treatment costs. The aim of this study was to assess the outcomes and costs of treating hepatitis C virus infected patients with DAAs in clinical practice in Germany. PATIENTS AND METHODS: Data were derived from a noninterventional study including a pharmacoeconomic subset of 2673 patients with genotypes 1 and 3 who initiated and completed treatment between February 2014 and February 2017. Sociodemographic and clinical parameters as well as resource utilization were collected using a web-based data recording system. Costs were calculated using official remuneration schemes. RESULTS: The mean age of the patients was 54.6 years; 48% were men. 93.5% of all patients achieved an SVR. The average total treatment costs were &OV0556;67 979 (&OV0556;67 131 medication costs, &OV0556;824 ambulatory care, &OV0556;24 hospital costs). The average costs per SVR of &OV0556;72 705 were calculated. Differences in SVR and costs according to genotype, treatment regimen, treatment experience, and cirrhosis were observed. Quality-of-life data showed no or a minimal decrease during treatment. CONCLUSION: This analysis confirms high SVR rates for newly introduced DAAs in a real-world setting. Costs per SVR estimated are comparable to first-generation DAA. Given the fact that the costs for the currently used treatment regimens have declined, it can be assumed that the costs per SVR have also decreased. Our insight into real-world outcomes and costs can serve as a basis for a comparison with the mentioned newly introduced treatment regimens.

Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany.

BACKGROUND: Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany. MATERIAL AND METHODS: We used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness. RESULTS: Base-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses. CONCLUSIONS: Our analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds.

Ultrasound Elastography Used for Preventive Non-Invasive Screening in Early Detection of Liver Fibrosis.

BACKGROUND: Early discovery of liver fibrosis is becoming more popular because of enhanced incidence of hepatocellular carcinoma. Ultrasound-based liver elastography is a method used to approve suspected liver fibrosis or cirrhosis. We assessed the clinical usefulness of acoustic radiation force impulse shear wave elasticity imaging (ARFI-SWEI) as a preventive screening method to uncover fibrosis. METHODS: We screened 382 patients by native routine sonography for abnormal liver results and divided them into six groups: group 1: normal liver, groups 2-4: fatty liver grade I-III, group 5: liver cirrhosis, and group 6: inhomogenic liver tissue. Then ARFI-SWEI was performed and the results were compared with published shear wave velocity cut-off values that were predictive of each fibrosis stage (F0-4). A control group consisted of 20 healthy volunteers. RESULTS: The part of liver fibrosis ≥ F2 was in groups 1-4: 20-32%, group 5: 100%, and group 6: 91%. Main causes for fibrosis stage ≥ F2 were (non)-alcoholic steatohepatitis, chronic viral or autoimmune hepatitis and chronic heart failure. CONCLUSIONS: Screening of the liver tissue in b-mode ultrasound can underestimate possible liver fibrosis; by using ARFI-SWEI, liver fibrosis can be uncovered early. It is a suitable preventive method comparable to colonoscopy for colon cancer.

Outcomes, costs and cost-effectiveness of treating hepatitis C with direct acting antivirals.

Hepatitis C is a global public health burden. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Introduction of different direct acting antivirals targeting the hepatitis C proteins has considerably increased rates of sustained viral response. First active substances introduced in 2011 were NS3/4A protease inhibitors telaprevir and boceprevir. In 2013/2014 the second generation of direct acting antivirals sofosbuvir, simeprevir, daclatasvir, ledipasvir and 3D therapy containing ombitasvir/paritaprevir/ritonavir and dasabuvir followed. This review focuses on treatment outcomes and costs of introduced direct acting antivirals. We provide an overview on SVR-rates in clinical trials and clinical practice, treatment costs in different countries as well as results of cost-effectiveness analyses for different treatment strategies.

Cost of treating hepatitis C in Germany: a retrospective multicenter analysis.

BACKGROUND: Viral hepatitis is major a public health problem affecting millions of people worldwide. Estimates assume 400 000-500 000 people chronically infected with hepatitis C virus (HCV) in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess the costs for treating patients with chronic HCV in Germany. METHODS: We conducted a retrospective multicenter observational study. The design was approved by an ethics committee, and patients were asked for their informed consent. Patients were grouped in four different health states. Healthcare utilization data were extracted from doctor files of six medical centers in Germany. RESULTS: Data of 315 patients with chronic HCV were analyzed. The mean age was 49.4 years, 57.5% were male and 67.9% had a genotype 1 infection. The most common routes of transmission were injection drug use (39.0%) and infection through blood products (15.9%). The average total cost was €19 147 including ambulatory care and diagnostics (€1686), pharmaceuticals (€14 875), inpatient care (€1293), and sick leave (€1293). For patients in stable health states (mild and moderate HCV, compensated cirrhosis), costs did not differ significantly and were mainly influenced by antiviral treatment. For patients with decompensated cirrhosis, inpatient care accounted for the largest part of the costs. CONCLUSION: Treatment of HCV patients involves high costs, mainly associated with the length of antiviral therapy. Viral eradication can prevent severe disease stages, which are associated with high costs. It is necessary to follow current guidelines and monitor patients closely to avoid unnecessary costs.

High prevalence of hepatitis markers in immigrant populations: a prospective screening approach in a real-world setting.

BACKGROUND: Immigrant populations are believed to be more frequently infected with hepatitis viruses. However, limited unbiased data are available on immigrants outside of academic centres. Therefore, the aim of this study was to perform large-scale screening for hepatitis markers in primary care centres treating mainly individuals with a migrational background in Germany. METHODS: Between November 2010 and January 2012, we prospectively screened 1313 individuals treated by general practitioners at eight primary care centres in North-western Germany. Patients were eligible if they or their parents were not born in Germany. Serological screening for hepatitis B core protein antibodies, hepatitis B surface antigens (HBsAgs), and anti-hepatitis C virus antibodies was performed in each individual. HBsAg-positive and anti-hepatitis C virus-positive patients were further tested for molecular markers of viral replication. RESULTS: The mean age was 49.1±15.8 years. Of the patients, 45.7% were male; 87.3% had migrated to Germany from the Eastern Mediterranean area and 12.0% from Eastern Europe. Of the patients, 32.5% tested positive for hepatitis B core protein antibodies. HBsAgs were found in 3.6% of patients. Overall, hepatitis B virus DNA was detected in 2.2% of patients. Markers for hepatitis C virus infection were found in an almost similar high frequency (1.9%). Individuals with migrational background showed significant deficits in knowledge on general routes of transmission. CONCLUSION: Hepatitis virus infections are indeed significantly more prevalent in immigrant populations as compared with the general German population. These data underline the importance of introducing screening programs in this particular risk group.

Cost-effectiveness of Triple Therapy with Telaprevir for Chronic Hepatitis C Virus Patients in Germany.

Background: About 400,000-500,000 people are infected with hepatitis C in Germany. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The introduction of first generation protease inhibitors has significantly improved the treatment of hepatitis C genotype 1 patients. The aim of the study was to assess the cost-effectiveness of triple therapy with telaprevir in Germany. Methods: We used a Markov model on disease progression and natural history to assess the cost-effectiveness of triple therapy with telaprevir compared to standard treatment with pegylated interferon and ribavirin. Model structure and inputs were discussed with clinical experts. Deterministic and probabilistic sensitivity analyses were performed to verify the robustness of results. Results: The base-case analyses shows that triple therapy results in higher costs (untreated patients: €48,446 vs. €30,691; previously treated patients: €63,228 vs. €48,603) and better outcomes (untreated patients: 16.85 qualily of life years [QALYs] vs. 15.97 QALYs; previously treated patients: 14.16 QALYs vs. 12.89 QALYs). The incremental cost-effectiveness ratio (ICER) was €20,131 per QALY and €30,567 per life year gained (LYG) for previously untreated patients. ICER in treatment experienced patients was €7,664 per QALY for relapse patients, €12,506 per QALY for partial responders and €28,429 per QALY for null responders. Results were robust in sensitivity analyses. Conclusion: Although triple therapy with telaprevir leads to additional costs, there is a high probability of being cost-effective for different thresholds. This health economic analysis makes an important contribution to current debates on cost savings and efficient resource allocation in the German healthcare sector.