Factors influencing deceased organ donation rates in OECD countries: a panel data analysis.

OBJECTIVES: This study aims to investigate factors with a significant influence on deceased organ donation rates in Organisation for Economic Co-operation and Development (OECD) countries and determine their relative importance. It seeks to provide the necessary data to facilitate the development of more efficient strategies for improving deceased organ donation rates. DESIGN: Retrospective study. SETTING: Publicly available secondary annual data. PARTICIPANTS: The study includes 36 OECD countries as panel members for data analysis. OUTCOME MEASURES: Multivariable panel data regression analysis was employed, encompassing data from 2010 to 2018 for all investigated variables in the included countries. RESULTS: The following variables had a significant influence on deceased organ donation rates: 'opt-in' system (ß=-4.734, p<0.001, ref: 'opt-out' system), only donation after brain death (DBD) donors allowed (ß=-4.049, p=0.002, ref: both DBD and donation after circulatory death (DCD) donors allowed), number of hospital beds per million population (pmp) (ß=0.002, p<0.001), total healthcare employment pmp (ß=-0.00012, p=0.012), World Giving Index (ß=0.124, p=0.008), total tax revenue as a percentage of gross domestic product (ß=0.312, p=0.009) and percentage of population aged ≥65 years (ß=0.801, p<0.001) as well as high education population in percentage (ß=0.118, p=0.017). CONCLUSIONS: Compared with the promotion of socioeconomic factors with a positive significant impact on deceased organ donation rates, the following policies have been shown to significantly increase rates of deceased organ donation, which could be further actively promoted: the adoption of an 'opt-out' system with presumed consent for deceased organ donation and the legal authorisation of both DBD and DCD for transplantation.

Is there a place for sigmoidoscopy in colorectal cancer screening? A systematic review and critical appraisal of cost-effectiveness models.

INTRODUCTION: Screening for colorectal cancer (CRC) is effective in reducing both incidence and mortality. Colonoscopy and stool tests are most frequently used for this purpose. Sigmoidoscopy is an alternative screening measure with a strong evidence base. Due to its distinct characteristics, it might be preferred by subgroups. The aim of this systematic review is to analyze the cost-effectiveness of sigmoidoscopy for CRC screening compared to other screening methods and to identify influencing parameters. METHODS: A systematic literature search for the time frame 01/2010-01/2023 was conducted using the databases MEDLINE, Embase, EconLit, Web of Science, NHS EED, as well as the Cost-Effectiveness Registry. Full economic analyses examining sigmoidoscopy as a screening measure for the general population at average risk for CRC were included. Incremental cost-effectiveness ratios were calculated. All included studies were critically assessed based on a questionnaire for modelling studies. RESULTS: Twenty-five studies are included in the review. Compared to no screening, sigmoidoscopy is a cost-effective screening strategy for CRC. When modelled as a single measure strategy, sigmoidoscopy is mostly dominated by colonoscopy or modern stool tests. When combined with annual stool testing, sigmoidoscopy in 5-year intervals is more effective and less costly than the respective strategies alone. The results of the studies are influenced by varying assumptions on adherence, costs, and test characteristics. CONCLUSION: The combination of sigmoidoscopy and stool testing represents a cost-effective screening strategy that has not received much attention in current guidelines. Further research is needed that goes beyond a narrow focus on screening technology and models different, preference-based participation behavior in subgroups.

Evaluation of a multimodal pain therapy approach with relapse prophylaxis for back pain (MMS-RFP study): a study protocol for a cluster randomised controlled trial.

INTRODUCTION: The need for an interdisciplinary multimodal approach to the treatment of back pain has already been demonstrated by various studies. However, when considering the periods of incapacity to work in the longitudinal course after the multimodal pain therapy (MPT), limits in terms of its sustainable effect become clear. Patients who receive MPT subsequently return to standard outpatient care, which is associated with a risk of relapse. A 12-month relapse prophylaxis (RP) programme, intended to follow a 4-week MPT, was developed to help patients make the transition to health-conscious and physically active behaviour in everyday life and to identify and prevent impending relapses at an early stage. The evaluation, based on a cluster randomised controlled trial, seeks to provide information on the benefits of early and intensive RP as part of MPT, examine whether it is cost effective, reduces the days of incapacity to work and increases functional capacity, as well as to examine other parameters. METHODS AND ANALYSIS: The study population comprises members of a regional statutory health insurance fund in Germany, who are ≤62 years old, gainfully employed and have been incapacitated for work for at least 21 days due to a diagnosis of back pain. Over a recruitment period of 24 months, a maximum of 368 individuals can potentially be included in the MPT. The intervention group (IG) and control group (CG) will both receive MPT, after randomisation IG will receive RP and CG will receive no further therapy or support as part of the trial. The evaluation is carried out on the following levels: structural, process and results quality. Cost effectiveness is also assessed by means of a health economic evaluation. In addition to the collection of qualitative and quantitative primary data, claims data from the regional health insurance fund are also included in the analysis. ETHICS AND DISSEMINATION: This study has received approval by the ethics committee of the Hannover Medical School (reference number: 8548_BO_S_2019). The study results will be disseminated in national and international journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00017654.

Real-world experience for the outcomes and costs of treating hepatitis C patients: Results from the German Hepatitis C-Registry (DHC-R).

BACKGROUND & AIMS: With long-term consequences like the development of liver cirrhosis and hepatocellular carcinoma, chronic hepatitis C virus (HCV) infection is associated with a significant health burden. Information on HCV treatment outcomes and costs in routine care is still rare, especially for subgroups. The aim of this study was to analyse the treatment outcomes and costs of subgroups in routine care and to compare them over time with previous analyses. METHODS: Data were derived from a noninterventional study including a subset of 10298 patients receiving DAAs with genotypes 1 and 3. Sociodemographic, clinical parameters and costs were collected using a web-based data recording system. The total sample was subdivided according to treatment regimen, cirrhosis status as well as present HIV infection and opioid substitution treatment (OST). RESULTS: 95% of all patients achieved SVR. Currently used DAA showed higher SVR-rates and less adverse events (AE) compared to former treatments. Concerning subgroups, cirrhotic patients, HIV-coinfected patients and OST patients showed lower but still high SVR-rates. In comparison, cirrhotic had considerably longer treatment duration and more frequent (serious) AE. Overall, average treatment costs were €48470 and costs per SVR were €51129; for currently used DAAs costs amounted to €30330 and costs per SVR to €31692. After the end of treatment, physical health is similar to the general population in all patients except cirrhotic. Mental health remains far behind in all subgroups, even for currently used DAA. CONCLUSIONS: Over time, some relevant factors developed positively (SVR-rates, costs, treatment duration, adverse events, health-related quality of life (HRQoL)). Further research on HRQoL, especially on mental health, is necessary to evaluate the differences between subgroups and HRQoL over time and to identify influencing factors.

Assessment of health-related quality of life in individuals with depressive symptoms: validity and responsiveness of the EQ-5D-3L and the SF-6D.

BACKGROUND: The EQ-5D and the SF-6D are examples of commonly used generic preference-based instruments for assessing health-related quality of life (HRQoL). However, their suitability for mental disorders has been repeatedly questioned. OBJECTIVE: To assess the responsiveness and convergent validity of the EQ-5D-3L and SF-6D in patients with depressive symptoms. METHODS: The data analyzed were from cardiac patients with depressive symptoms and were collected as part of the SPIRR-CAD (Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease) trial. The EQ-5D-3L and SF-6D were compared with the HADS (Hospital Anxiety and Depression Scale) and PHQ-9 (Patient Health Questionnaire) as disease-specific instruments. Convergent validity was assessed using Spearman's rank correlation. Effect sizes were calculated and ROC analysis was performed to determine responsiveness. RESULTS: Data from 566 patients were analysed. The SF-6D correlated considerably better with the disease-specific instruments (|rs|= 0.63-0.68) than the EQ-5D-3L (|rs|= 0.51-0.56). The internal responsiveness of the SF-6D was in the upper range of a small effect (ES: - 0.44 and - 0.47), while no effect could be determined for the EQ-5D-3L. Neither the SF-6D nor the EQ-5D-3L showed acceptable external responsiveness for classifying patients' depressive symptoms as improved or not improved. The ability to detect patients whose condition has deteriorated was only acceptable for the EQ-5D-3L. CONCLUSION: Overall, both the convergent validity and responsiveness of the SF-6D are better than those of the EQ-5D-3L in patients with depressive symptoms. The SF-6D appears, therefore, more recommendable for use in studies to evaluate interventions for this population.

Additional offer of sigmoidoscopy in colorectal cancer screening in Germany: rationale and protocol of the decision-analytic modelling approach in the SIGMO study.

INTRODUCTION: In Germany, statutory insured persons are entitled to a stool test (faecal immunochemical test (FIT)) or colonoscopy for colorectal cancer (CRC) screening, depending on age and sex, yet participation rates are rather low. Sigmoidoscopy is a currently not available screening measure that has a strong evidence base for incidence and mortality reduction. Due to its distinct characteristics, it might be preferred by some, who now reject colonoscopy. The objective of this study is to estimate the economic consequences of the additional offer of sigmoidoscopy for CRC screening in Germany compared with the present screening practice while considering the preferences of the general population. METHODS AND ANALYSIS: A decision-analytic modelling approach will be developed that compares the present CRC screening programme in Germany (FIT, colonoscopy) with a programme extended by sigmoidoscopy from a societal perspective. A decision tree and Markov model will be combined to assess both short-term and long-term effects, such as CRC and adenoma detection rates, the number of CRC cases, CRC mortality as well as complications. The incremental cost per quality-adjusted life year gained for each alternative will be calculated. The model will incorporate the general population's preferences based on a discrete choice experiment. Further, input parameters will be taken from the literature, the German cancer registry and health insurance claims data. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained from the Ethics Committee of Hannover Medical School (ID: 8671_BO_K_2019). The findings of the study will be published in peer-reviewed journals and presented at national and/or international conferences. TRIAL REGISTRATION NUMBER: DRKS00019010.

Study protocol: a non-randomised community trial to evaluate the effectiveness of the communities that care prevention system in Germany.

BACKGROUND: The Communities That Care (CTC) prevention planning and implementation system trains communities throughout a five-phase cycle to (1) build capacity for prevention, (2) adopt science-based prevention, (3) assess the prevention needs of adolescents living in the community, (4) select, and (5) implement evidence-based programs according to their needs. After CTC proved to be effective and cost-effective in the U.S., it is being used by an increasing number of communities in Germany. The aim of this study is to evaluate the effectiveness and cost-effectiveness of CTC in Germany. METHODS: Communities in CTC-phases 1 to 3 (n = 21) and individually-matched comparison communities (n = 21) were recruited for a non-randomised trial. To assess long-term outcomes, (1) a cohort of 5th Grade students will be surveyed biennially concerning behaviours (antisocial behaviour and substance use) and well-being as well as risk and protective factors. Additionally, (2) biennial cross-sectional surveys will be conducted in 6th, 8th, 10th, and 11th Grade in each community. To assess short-term outcomes, a cohort of ten key informants per community will be surveyed biennially concerning adoption of science-based prevention, collaboration, community support and community norms. (4) In a cross-sectional design, all ongoing prevention programs and activities in the communities will be assessed biennially and data will be collected about costs, implementation and other characteristics of the programs and activities. (5) To monitor the CTC implementation, the members of the local CTC-boards will be surveyed annually (cross-sectional design) about team functioning and coalition capacity. Data analysis will include general and generalised mixed models to assess the average treatment effect of CTC. Mediation analyses will be performed to test the logical model, e.g., adoption of science-based prevention as a mediator for the effectiveness of the CTC approach. DISCUSSION: This is the first controlled study to evaluate the effectiveness of a comprehensive community prevention approach in Germany. Evaluating the effectiveness of CTC in Germany is an important prerequisite for further diffusion of the CTC approach. TRIAL REGISTRATION: This study was registered with German Clinical Trial Register: DRKS00022819 on Aug 18, 2021.

[Frequency of diagnosed non-alcololic fatty liver disease (NAFLD) in the German population - An analysis based on health insurance data]. / Die Häufigkeit von diagnostizierten Fettlebererkrankungen (NAFLD) in der deutschen Bevölkerung ­ Eine Analyse auf der Basis von GKV-Routinedaten.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in Germany. In the long term, there is an increased risk of developing liver cirrhosis and subsequent diseases. Epidemiologic studies on NAFLD prevalence in Germany are scarce. The aim of the study was to assess administrative incidence and prevalence or, more specifically, the number of patients diagnosed with NAFLD in the period from 2008 to 2018. METHODS: Analyses are based on administrative data of a large statutory health insurance fund. All individuals who were insured in the year of analysis and in the three-year pre-observation period were included (between 1.7-2 million insured per analysis year). NAFLD-patients were identified using relevant ICD-10 codes (K76.0 und K75.8). RESULTS: In 2018, 4.66 % of insured persons had a NAFLD diagnosis, 0.87 % were diagnosed first-time. Diagnoses of nonalcoholic steatohepatitis (NASH) were comparatively rare (0.09 %). Data show an uptake of NAFLD diagnoses over time. The number of incident cases per year has hardly changed. Patients with diseases of the metabolic syndrome had an increased chance of being diagnosed with NAFLD. CONCLUSION: It becomes evident that NAFLD is frequently diagnosed in everyday medical practice, although data from population-based studies suggest an even higher prevalence.

Public preferences for the allocation of donor organs for transplantation: Focus group discussions.

BACKGROUND: Deceased donor organs are scarce resources because of a large supply-and-demand mismatch. This scarcity leads to an ethical dilemma, forcing priority-setting of how these organs should be allocated and whom to leave behind. OBJECTIVE: To explore public preferences for the allocation of donor organs in regard to ethical aspects of distributive justice. METHODS: Focus groups were facilitated between November and December 2018 at Hannover Medical School. Participants were recruited locally. Transcripts were assessed with content analysis using the deductive framework method. All identified and discussed criteria were grouped according to the principles of distributive justice and reported following the COREQ statement. RESULTS: Six focus groups with 31 participants were conducted. Overall, no group made a final decision of how to allocate donor organ; however, we observed that not only a single criterion/principle but rather a combination of criteria/principles is relevant. Therefore, the public wants to allocate organs to save as many lives as possible by both maximizing success for and also giving priority to urgent patients considering the best compatibility. Age, waiting time, reciprocity and healthy lifestyles should be used as additional criteria, while sex, financial status and family responsibility should not, based on aspects of equality. CONCLUSIONS: All participants recognized the dilemma that prioritizing one patient might cause another one to die. They discussed mainly the unclear trade-offs between effectiveness/benefit and medical urgency and did not establish an agreement about their importance. The results suggest a need of preference studies to elucidate public preferences in organ allocation.

Evaluation of the pediatric-centered integrated care AOK Junior: protocol for a mixed-method study.

BACKGROUND: The "AOK-Junior" care program of the AOK Nordost (a German statutory health insurance) completes the primary care for children and adolescents (C&A) in the federal states of Berlin, Brandenburg and Mecklenburg-Vorpommern in Germany. The focus of this program is on prevention and early detection of illness on C&A. Furthermore, the aim is to maintain the health of C&A and to prevent, detect and treat illness on time. Elements of the program are not only the integrated care of C&A, but also, for example, weight reduction and additional medical checkups U10, U11 and J2. The evaluation of the complex intervention should provide information about the effectiveness of early disease detection and costs-effectiveness as well as of other parameters like satisfaction. METHODS: The evaluation is performed on the levels of structural-, process- and results-quality. The cost effectiveness is also assessed by means of a health economic evaluation. In addition to the collection of qualitative and quantitative primary data from participating and non-participating C&A and paediatricians, routine data from a statutory health insurance are used in the evaluation. Furthermore, a cross-sectional design is used to evaluate the structure and process quality. The effectiveness is evaluated in longitudinal section design on the basis of the secondary data. The quantitative surveys include net n = 1096 C&A and n = 340 pediatricians. For the focus groups, a sample of 72 to 96 parents as well as pediatricians will be sought by using the method of theoretical sampling. DISCUSSION: Around 560 pediatricians and 63,000 C&A currently participate in the AOK Nordost care program. The project provides information to what extent secondary preventive measures can lead to the early detection of diseases and on the associated cost-effectiveness. Furthermore, potentials and barriers of the program implementation are identified. The results of the evaluation study are expected not only to contribute to the further development of the care program, but also to derive recommendations for action. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00015280. Prospectively registered on 18 March 2019.

Comparing preferences of physicians and patients regarding the allocation of donor organs: A systematic review.

In order to improve the demand-supply-mismatch in transplantation medicine, policy makers have to think about adapting existing legal frameworks for donor organ allocation. This study aims to systematically review preferences of physicians as well as patients in the field of transplantation medicine. PubMed, Web of Science, EBSCO and PsycINFO were searched from January 2000 to December 2018 without language restrictions. Fourteen publications were identified, six aiming at physicians, seven focusing on patients and one on both groups. The criteria used in these studies to elicit preferences can be grouped into six different main categories, all deriving from the general principle of equality: "Effectiveness/Benefit", "Medical urgency", "Own fault", "Social value", "Medical background" and "Socio-demographic status". Whilst patients on the one hand show a high demand for equal access, outcome maximization and punishment for damaging behaviors, they would still allocate organs to people with very low survival chances. Physicians decide against equal access to transplantation in cases where clinical evidence is weighed more heavily, e.g. in the cases of ethnicity and sex. Also, they seem more informed regarding the involvement of medical factors and give less importance to those with uncertain effects on transplantation outcome, such as tissue or blood group match. It is important to continuously monitor preferences of all involved stakeholders in order to achieve fair and accessible transplantation systems.

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies.

BACKGROUND: Chronic hepatitis C is a major public health burden. With new interferon-free direct-acting agents (showing sustained viral response rates of more than 98%), elimination of HCV seems feasible for the first time. However, as HCV infection often remains undiagnosed, screening is crucial for improving health outcomes of HCV-patients. Our aim was to assess the long-term cost-effectiveness of a nationwide screening strategy in Germany. METHODS: We used a Markov cohort model to simulate disease progression and examine long-term population outcomes, HCV associated costs and cost-effectiveness of HCV screening. The model divides the total population into three subpopulations: general population (GEP), people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM), with total infection numbers being highest in GEP, but new infections occurring only in PWIDs and MSM. The model compares four alternative screening strategies (no/basic/advanced/total screening) differing in participation and treatment rates. RESULTS: Total number of HCV-infected patients declined from 275,000 in 2015 to between 125,000 (no screening) and 14,000 (total screening) in 2040. Similarly, lost quality adjusted life years (QALYs) were 320,000 QALYs lower, while costs were 2.4 billion EUR higher in total screening compared to no screening. While incremental cost-effectiveness ratio (ICER) increased sharply in GEP and MSM with more comprehensive strategies (30,000 EUR per QALY for total vs. advanced screening), ICER decreased in PWIDs (30 EUR per QALY for total vs. advanced screening). CONCLUSIONS: Screening is key to have an efficient decline of the HCV-infected population in Germany. Recommendation for an overall population screening is to screen the total PWID subpopulation, and to apply less comprehensive advanced screening for MSM and GEP.

A systematic review of decision analytic modeling techniques for the economic evaluation of dental caries interventions.

OBJECTIVES: Dental caries occur through a multifactorial process that may influence all tooth surfaces throughout an individual's life. The application of decision analytical modeling (DAM) has gained an increasing level of attention in long-term outcome assessment and economic evaluation of interventions on caries in recent years. The objective of this study was to systematically review the application of DAM and assess their methodological quality in the context of dental caries. METHODS: A systematic review of the literature published to 31st December 2018 was conducted in Medline, EMBASE, NHSEED, and Web of Science electronic databases. The main information and model characteristics of studies was extracted with the methodological quality of included studies reviewed and assessed using the Philips' checklist. RESULTS: Twenty five studies from different settings were included. Modeling techniques mainly comprised main type of modeling including Markov models (n = 12), Markov/microsimulation mixed model (n = 7), systematic dynamic models (n = 3), microsimulation models (n = 2) and decision tree (n = 1). The mean number of criteria fulfilled was 25.1 out of 60 items, which varied between year of study and research groups. The percentage of criteria fulfilled for data dimension was lower than for the structure and consistency dimension. Critical issues were data quality, incorporation of utility values, and uncertainty analysis in modeling. CONCLUSION: The current review revealed that the methodological quality of DAM in dental caries economic evaluations is unsatisfied. Future modeling studies should adhere more closely to good practice guidelines, especially with respect to data quality evaluation, utility values incorporation, and uncertainty analysis in DAM based studies.

Systematic Review of Public Preferences for the Allocation of Donor Organs for Transplantation: Principles of Distributive Justice.

BACKGROUND: Solid organ transplantation is the treatment of choice for organ failure, but donor organs are a scarce resource because of a large mismatch between supply and demand. This scarcity leads to an ethical dilemma, forcing priority setting in organ allocation to individual patients. Little is known about public preferences regarding priority setting in organ allocation. A systematic review was performed to review the existing evidence and provide an overview of the criteria and criterion levels in regard to ethical aspects of distributive justice. METHODS: The PubMed, Web of Science, EBSCO and PsycINFO databases were searched for literature published between January 2000 and December 2018. Only original studies were selected. The criteria were identified, extracted and grouped into a self-developed matrix according to the principles of distributive justice to ascertain public preferences. RESULTS: Overall, 9645 references were identified, and 15 studies were included. In total, 27 criteria clustered in seven theory-guided groups could be identified: "equality", "effectiveness/benefit", "medical urgency", "own fault", "value for society", "medical background" and "sociodemographic status". It was shown that not only a single principle but rather a combination of principles are relevant for the allocation. Therefore, a public propensity towards a rational utilitarian ethical model of allocation could be recognised. CONCLUSIONS: The general public not only wanted to allocate organs mainly to those with a good probability of having a successful transplantation but also wanted to consider those who need an organ most urgently to prevent fatal consequences, resulting in unclear trade-offs between effectiveness/benefit and medical urgency. Public preferences for organ allocation are therefore complex, and data regarding clear trade-offs are still lacking.

[Primary Healthcare Provision and Introduction of New Models of Care in Hard to Serve Regions: A Population Survey]. / Hausärztliche Versorgungssituation und Einführung neuer Versorgungsformen in schwer zu versorgenden Regionen: Eine Befragung der Bevölkerung.

OBJECTIVE OF THE STUDY: One of the central challenges in health policy is to ensure nationwide provision of primary healthcare services. However, it is not clear how the general public rates the current primary healthcare provision in their region. Furthermore, there is very little information on whether people are willing to make use of new models of care that could contribute to ensuring a nationwide provision of healthcare services. Thus, the objective of this study was to analyse the general public's ratings of the local primary healthcare provision as well as their acceptance of selected new models of care. Furthermore, potential differences in the ratings of the population between hard to serve regions and normal regions will be analysed. METHODOLOGY: Focus group discussions and a literature review were conducted in order to develop a questionnaire to elicit the expectations of the population concerning the local provision of primary healthcare as well as their acceptance of new models of care. A postal questionnaire was sent to a random sample of 2,000 persons in 8 regions in Lower Saxony. RESULTS: The adjusted response rate of the postal survey was 51% (n=996). 97% of respondents saw a general practitioner regularly, with 5.4 visits per year on average. Patients could reach the practice in 13 min on average. Respondents predominantly rated the current healthcare provision as being good. However, the majority of respondents expected the local primary healthcare provision to deteriorate in the future. New models of care most preferred by the respondents were the delegation of medical tasks to non-medical professionals and mobility-oriented models. On the other hand, the provision of healthcare via telemedicine was rejected. DISCUSSION: According to the results of this study, respondents believe that new models of care can play an important role in ensuring the nationwide provision of healthcare services. Introducing, at an early stage, those new models of care that people accept could contribute to ensuring a sustainable provision of primary healthcare services. Furthermore, the introduction of these new models of care could reduce the public's concerns regarding a worsening provision of primary healthcare services in their regions. Additionally, pilot projects with those new models of care that are rather rejected might increase acceptance with these models of care if they prove to be successful.

Potential savings in the treatment pathway of liver transplantation: an inter-sectorial analysis of cost-rising factors.

INTRODUCTION: Identification of cost-driving factors in patients undergoing liver transplantation is essential to target reallocation of resources and potential savings. AIM: The aim of this study is to identify main cost-driving factors in liver transplantation from the perspective of the Statutory Health Insurance. METHODS: Variables were analyzed with multivariable logistic regression to determine their influence on high cost cases (fourth quartile) in the outpatient, inpatient and rehabilitative healthcare sectors as well as for medications. RESULTS: Significant cost-driving factors for the inpatient sector of care were a high labMELD-score (OR 1.042), subsequent re-transplantations (OR 7.159) and patient mortality (OR 3.555). Expenditures for rehabilitative care were significantly higher in patients with a lower adjusted Charlson comorbidity index (OR 0.601). The indication of viral cirrhosis and hepatocellular carcinoma resulted in significantly higher costs for medications (OR 21.618 and 7.429). For all sectors of care and medications each waiting day had a significant impact on high treatment costs (OR 1.001). Overall, cost-driving factors resulted in higher median treatment costs of 211,435 €. CONCLUSIONS: Treatment costs in liver transplantation were significantly influenced by identified factors. Long pre-transplant waiting times that increase overall treatment costs need to be alleviated by a substantial increase in donor organs to enable transplantation with lower labMELD-scores. Disease management programs, the implementation of a case management for vulnerable patients, medication plans and patient tracking in a transplant registry may enable cost savings, e.g., by the avoidance of otherwise necessary re-transplants or incorrect medication.

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.

Decision modelling for economic evaluation of liver transplantation.

As the gap between a shortage of organs and the immense demand for liver grafts persists, every available donor liver needs to be optimized for utility, urgency and equity. To overcome this challenge, decision modelling might allow us to gather evidence from previous studies as well as compare the costs and consequences of alternative options. For public health policy and clinical intervention assessment, it is a potentially powerful tool. The most commonly used types of decision analytical models include decision trees, the Markov model, microsimulation, discrete event simulation and the system dynamic model. Analytic models could support decision makers in the field of liver transplantation when facing specific problems by synthesizing evidence, comprising all relevant options, generalizing results to other contexts, extending the time horizon and exploring the uncertainty. For modeling studies of economic evaluation for transplantation, understanding the current nature of the disease is crucial, as well as the selection of appropriate modelling techniques. The quality and availability of data is another key element for the selection and development of decision analytical models. In addition, good practice guidelines should be complied, which is important for standardization and comparability between economic outputs.

Evaluation of published assessment tools for comorbidity in liver transplantation: a systematic review protocol.

INTRODUCTION: Liver transplantation is considered the best therapy option for end-stage liver disease. Different factors including recipient comorbidity at time of transplantation are supposed to have substantial impact on outcomes. Although several studies have focused on comorbidity assessment indices for liver transplant recipients, there is no systematic review available on the methodological details and prognostic accuracy of these instruments. The aim of this study is to systematically review recipient comorbidity assessment indices in the context of liver transplantation. METHODS AND ANALYSIS: PubMed, Embase, Web of Science and PsyINFO databases will be searched. Studies describing, using or evaluating specific assessment tools to predict the effect of comorbidity on clinical outcomes after liver transplantation will be included. The selection will be conducted independently by two reviewers. The study characteristics and methodological information on published comorbidity assessment tools will be extracted into a predefined structural table. This approach will be deployed to systematically extract information on the validity, reliability and practical feasibility of investigated comorbidity assessment tools for comparative evaluation. Narrative information synthesis will be conducted, and additional meta-analytical comparison will be performed, if appropriate. ETHICS AND DISSEMINATION: All data are collected from published literature. Thus, formal ethics review for the research is not required. The findings of this systematic review will be published in a peer-reviewed journal and presented at relevant conferences. The results of this systematic review will be highly relevant for further research on prognostic models, clinical decision making and optimisation of donor organ allocation. PROSPERO REGISTRATION NUMBER: CRD42017074609.

[HBV-infections in Germany - health care costs in a real-life-setting]. / HBV-Infektionen in Deutschland ­ Versorgungskosten in einem Real-life-Setting.

Background An estimated 500 000 people are infected with hepatitis B in Germany, inducing an enormous burden on infected patients and the health care system. The aim of our study was to estimate the real-life costs of treating hepatitis B and to analyze sociodemographic factors. Methods We conducted a retrospective, non-interventional, single-center study from 07/2009 to 12/2012. Information on health care delivery was extracted from patient records. Besides that, a questionnaire survey regarding sociodemographic parameters and quality of life of HBV-infected patients was performed. Results A total of 117 patients were included in our study and grouped in six different disease stages. The response rate of our survey was 80 %. We determined annual total costs of €â€Š3509. The different groups altered between €â€Š221 and €â€Š5618. The main costs (80 %) were caused by the antiviral therapy. Costs of co-medication and hospitalizations were of minor importance. Laboratory costs were primarily caused by determination of virological parameters. Route of transmission of HBV-infection was unknown in 2/3 of all cases. Restrictions in quality of life due to the HBV-infection were reported by 60 % of the patients. Patients receiving interferon treatment reported highest restrictions. In an extrapolation, we estimated total annual hepatitis B treatment costs of 430 million € in Germany. Conclusion This is the first study estimating real-life treatment costs of hepatitis B infections in Germany. Further research should follow in the context of newly introduced generic antivirals.