Human resource crises in German hospitals--an explorative study.

BACKGROUND: The complexity of providing medical care in a high-tech environment with a highly specialized, limited labour force makes hospitals more crisis-prone than other industries. An effective defence against crises is only possible if the organizational resilience and the capacity to handle crises become part of the hospitals' organizational culture. To become more resilient to crises, a raised awareness--especially in the area of human resource (HR)--is necessary. The aim of this paper is to contribute to the process robustness against crises through the identification and evaluation of relevant HR crises and their causations in hospitals. METHODS: Qualitative and quantitative methods were combined to identify and evaluate crises in hospitals in the HR sector. A structured workshop with experts was conducted to identify HR crises and their descriptions, as well as causes and consequences for patients and hospitals. To evaluate the findings, an online survey was carried out to rate the occurrence (past, future) and dangerousness of each crisis. RESULTS: Six HR crises were identified in this study: staff shortages, acute loss of personnel following a pandemic, damage to reputation, insufficient communication during restructuring, bullying, and misuse of drugs. The highest occurrence probability in the future was seen in staff shortages, followed by acute loss of personnel following a pandemic. Staff shortages, damage to reputation, and acute loss of personnel following a pandemic were seen as the most dangerous crises. CONCLUSIONS: The study concludes that coping with HR crises in hospitals is existential for hospitals and requires increased awareness. The six HR crises identified occurred regularly in German hospitals in the past, and their occurrence probability for the future was rated as high.

Risks and crises for healthcare providers: the impact of cloud computing.

We analyze risks and crises for healthcare providers and discuss the impact of cloud computing in such scenarios. The analysis is conducted in a holistic way, taking into account organizational and human aspects, clinical, IT-related, and utilities-related risks as well as incorporating the view of the overall risk management.

Overview of the socio-economic consequences of heart failure.

Heart failure (HF) is a frequent cause of morbidity and mortality worldwide. The prevalence of HF increases, and in high-income countries, 1-2% of total healthcare expenditure is spent on HF. This article gives an overview on the impact of HF on health-related quality of life (HRQoL) and the economic burden of HF. Those suffering from HF are associated with a substantial decrease of HRQoL compared to individuals with most other chronic diseases and to individuals without HF. Therapeutic approaches, which decrease risk factors and lead to an improvement of the clinical status of patients, have a positive effect on HRQoL of the patients. Hospitalization rates have been shown to be correlated with disease severity, mortality, and HRQoL. Inpatient treatments of HF patients are cost intensive and the most important component for the economic burden of HF, responsible for at least half of direct cost. Prevention strategies, diagnostic and therapeutic approaches should focus on avoiding need for hospitalizations, and in particular, readmissions. Outpatient care including medication represents the second largest cost component. The cost of HF varies from less than 1,000 USD per patient in low-income countries to between 5,000 and 15,000 EUR in Europe, and between 17,000 and 30,000 USD in the US. There is a lack of study results on indirect costs. All study results on the socio-economic burden of HF clearly underscore the public health relevance of HF, showing a large economic burden for healthcare systems all over the world and a considerable impact on patients' HRQoL. The results on HRQoL are relatively homogeneous, but there are large differences across countries in respect of the economic burden they have to bear. Despite the large number of studies on the socio-economic consequences of HF further research is necessary, especially on indirect cost and for low- and middle-income countries. Future studies would benefit from a greater standardization of methods and presentation of results.

The applicability and generalizability of findings from clinical trials for health-policy decisions.

Randomized controlled trials provide unbiased estimates of treatment effect through reducing the attribution of observed differences in outcome to the play of chance or the treatment of interest. Issues in the design of randomized trials may lead to a dilution or magnification of treatment effect when compared with clinical practice. The intention-to-treat principle will lead to dilution in the treatment effect, while the selective recruitment of adherent and motivated subjects may lead to enhanced treatment effect estimates. Observational data, on the other hand, may reflect clinical practice but cannot provide unbiased estimates of treatment effect. Health policy may be informed by the combination of randomized and observational data in decision-analytic models.

Economic evaluation of the artificial liver support system MARS in patients with acute-on-chronic liver failure.

BACKGROUND: Acute-on-chronic liver failure (ACLF) is a life threatening acute decompensation of a pre-existing chronic liver disease. The artificial liver support system MARS is a new emerging therapeutic option possible to be implemented in routine care of these patients. The medical efficacy of MARS has been demonstrated in first clinical studies, but economic aspects have so far not been investigated. Objective of this study was to estimate the cost-effectiveness of MARS. METHODS: In a clinical cohort trial with a prospective follow-up of 3 years 33 ACLF-patients treated with MARS were compared to 46 controls. Survival, health-related quality of life as well as direct medical costs for in- and outpatient treatment from a health care system perspective were determined. Based on the differences in outcome and indirect costs the cost-effectiveness of MARS expressed as incremental costs per life year gained and incremental costs per QALY gained was estimated. RESULTS: The average initial intervention costs for MARS were 14600 EUR per patient treated. Direct medical costs over 3 years follow up were overall 40000 EUR per patient treated with MARS respectively 12700 EUR in controls. The 3 year survival rate after MARS was 52% compared to 17% in controls. Kaplan-Meier analysis of cumulated survival probability showed a highly significant difference in favour of MARS. Incremental costs per life-year gained were 31400 EUR; incremental costs per QALY gained were 47200 EUR. CONCLUSION: The results after 3 years follow-up of the first economic evaluation study of MARS based on empirical patient data are presented. Although high initial treatment costs for MARS occur the significantly better survival seen in this study led to reasonable costs per live year gained. Further randomized controlled trials investigating the medical efficacy and the cost-effectiveness are recommended.

Financial incentives for disease management programmes and integrated care in German social health insurance.

As a result of recent health care reforms sickness funds and health care providers in German social health insurance face increased financial incentives for implementing disease management and integrated care. Sickness funds receive higher payments form the risk adjustment system if they set up certified disease management programmes and induce patients to enrol. If health care providers establish integrated care projects they are able to receive extra-budgetary funding. As a consequence, the number of certified disease management programmes and the number of integrated care contracts is increasing rapidly. However, contracts about disease management programmes between sickness funds and health care providers are highly standardized. The overall share of health care expenses spent on integrated care still is very low. Existing integrated care is mostly initiated by hospitals, is based on only one indication and is not fully integrated. However, opportunity to invest in integrated care may open up innovative processes, which generate considerable productivity gains. What is more, integrated care may serve as gateway for the introduction of more widespread selective contracting.

Neonatal hearing screening: modelling cost and effectiveness of hospital- and community-based screening.

BACKGROUND: Children with congenital hearing impairment benefit from early detection and management of their hearing loss. These and related considerations led to the recommendation of universal newborn hearing screening. In 2001 the first phase of a national Newborn Hearing Screening Programme (NHSP) was implemented in England. Objective of this study was to assess costs and effectiveness for hospital and community-based newborn hearing screening systems in England based on data from this first phase with regard to the effects of alterations to parameter values. DESIGN: Clinical effectiveness analysis using a Markov Model. OUTCOME MEASURE: quality weighted detected child months (QCM). RESULTS: Both hospital and community programmes yielded 794 QCM at the age of 6 months with total costs of 3,690,000 pound sterling per 100,000 screened children in hospital and 3,340,000 pound sterling in community. Simulated costs would be lower in hospital in 48% of the trials. Any statistically significant difference between hospital and community in prevalence, test sensitivity, test specificity and costs would result in significant differences in cost-effectiveness between hospital and community. CONCLUSION: This modelling exercise informs decision makers by a quantitative projection of available data and the explicit and transparent statements about assumptions and the degree of uncertainty. Further evaluation of the cost-effectiveness should focus on the potential differences in test parameters and prevalence in these two settings.

Comparing the clinical effectiveness of different new-born hearing screening strategies. A decision analysis.

BACKGROUND: Children with congenital hearing impairment benefit from early detection and treatment. At present, no model exists which explicitly quantifies the effectiveness of universal newborn hearing screening (UNHS) versus other programme alternatives in terms of early diagnosis. It has yet to be considered whether early diagnosis (within the first few months) of hearing impairment is of importance with regard to the further development of the child compared with effects resulting from a later diagnosis. The objective was to systematically compare two screening strategies for the early detection of new-born hearing disorders, UNHS and risk factor screening, with no systematic screening regarding their influence on early diagnosis. DESIGN: Clinical effectiveness analysis using a Markov Model. DATA SOURCES: Systematic literature review, empirical data survey, and expert opinion. TARGET POPULATION: All newborn babies. TIME SCALE: 6, 12 and 120 months. PERSPECTIVE: Health care system. COMPARED STRATEGIES: UNHS, Risk factor screening (RS), no systematic screening (NS). OUTCOME MEASURES: Quality weighted detected child months (QCM). RESULTS: UNHS detected 644 QCM up until the age of 6 months (72,2%). RS detected 393 child months (44,1%) and no systematic screening 152 child months (17,0%). UNHS detected 74,3% and 86,7% weighted child months at 12 and 120 months, RS 48,4% and 73,3%, NS 23,7% and 60,6%. At the age of 6 months UNHS identified approximately 75% of all children born with hearing impairment, RS 50% and NS 25%. At the time of screening UNHS marked 10% of screened healthy children for further testing (false positives), RS 2%. UNHS demonstrated higher effectiveness even under a wide range of relevant parameters. The model was insensitive to test parameters within the assumed range but results varied along the prevalence of hearing impairment. CONCLUSION: We have shown that UNHS is able to detect hearing impairment at an earlier age and more accurately than selective RS. Further research should be carried out to establish the effects of hearing loss on the quality of life of an individual, its influence on school performance and career achievement and the differences made by early fitting of a hearing aid on these factors.

Economic evaluation and survival analysis of immunoglobulin adsorption in patients with idiopathic dilated cardiomyopathy.

Idiopathic dilated cardiomyopathy (DCM) is a life-threatening heart disease and a major reason for heart transplantations. The medical efficacy of immunoadsorption (IA) for DCM patients has been demonstrated in initial clinical studies. This prospective matched-case control study examined 5-year survival rates, direct medical costs, and cost-effectiveness in Germany (n=34) from a health-care system perspective. In a cost-effectiveness analysis costs per life year gained were calculated. Patients treated with IA showed a greater survival rate: 5-year survival rate in the intervention group was 82% vs. 41% in controls. Log rank statistics after Kaplan-Meier analysis of cumulated survival probability were highly significant. Initial intervention costs for IA were found to be 28,400 euro per patient treated. Direct medical costs for a 5-year follow-up were 128,600 euro per patient treated with IA and 75,500 euro in controls. Considering only the actual survival time we calculated annual treatment costs of 24,900 euro in the IA group and 28,900 euro in controls. The cost-effectiveness ratio expressed in costs per life year gained was 34,400 euro. This is the first controlled study to perform 5-year survival analysis and economic evaluation of this new emerging technology for patients with DCM. Although high initial treatment costs for IA are incurred, the significantly better survival rates lead to reasonable costs per live year gained.

Effect of guideline orientation on the outcomes of peripheral arterial disease in primary care.

OBJECTIVE: Peripheral arterial disease (PAD), an established marker of premature death and cardiovascular risk in general, is highly prevalent. We analysed factors associated with poor outcomes in an observational cohort, with particular focus on the effect of guideline orientation in the management of these patients. METHODS: PACE-PAD is a multicentre, prospective, observational study of PAD patients in primary care. PAD guideline orientation was stated, if patients received the following: exercise training, (if applicable) advice for smoking cessation and diet, therapy for diabetes mellitus, hypertension, hypercholesterolaemia, or antiplatelets/anticoagulants. Multivariate regression models were applied to assess factors associated with all cause death, cardiovascular/cerebrovascular death, or cardiovascular/cerebrovascular/peripheral vascular non-fatal events. RESULTS: After an 18-month follow-up, of the 5099 PAD patients analysed (mean age 68.0 ± 9.0 years, 68.5% males), only 28.4% of patients met all applicable quality indicators for guideline-oriented treatment. However, most patients were to a large extent managed in line with guidelines. While exercise training was reported in 41.8%, rates were very high for smoking cessation (90.7%), therapy for hypertension (92.5%), diabetes mellitus (82.0%), hypercholesterolemia (83.3%) and antiplatelet therapy (86.7%). Regarding events, there were inhomogeneous results with a statistically significant higher rate of cardiovascular/cerebrovascular deaths and all-cause deaths, but a lower rate of non-fatal vascular events in patients treated according to guidelines compared to those who were not. Limitations of this study include the open, non-controlled design, possible patient selection bias and misclassification of events. CONCLUSION: Even if the guideline orientation for the various indicators was remarkably stable across the three follow-up visits, the rate of patients comprehensively treated according to the guidelines was relatively low, which calls for optimisation. There was a lack of differentiation between the guideline-oriented and non-guideline-oriented therapy in terms of outcomes, which may be due to patient-related or other factors, and warrants further research.

Development and Testing of the Insulin Treatment Experience Questionnaire (ITEQ).

OBJECTIVES: : To develop and psychometrically evaluate a domain-specific questionnaire to assess subtle but clinically relevant differences in treatment experiences and satisfaction over a wide range of currently available insulin therapy regimens. The study focussed on patients with type 2 diabetes mellitus and placed particular attention on the impact of different forms of insulin therapy on diabetes self-management. METHODS: : The development of the Insulin Treatment Experience Questionnaire (ITEQ) was conducted in three steps: (i) a qualitative phase to generate relevant items and identify relevant domains; (ii) a pilot study to reduce the number of generated items; and (iii) a validation study to assess major psychometric properties of the final ITEQ version. RESULTS: : The final version of the questionnaire comprised 28 items with the subscales 'leisure activities' (four items), 'psychological barriers' (two items), 'handling' (five items), 'diabetes control' (six items), 'dependence' (five items), 'weight control' (three items), 'sleep' (two items), and one further item assessing general treatment satisfaction. The subscales' internal consistencies (Cronbach's alpha) ranged from 0.52 to 0.83. Motivated by the homogenous structure of inter-scale-correlations (range 0.10-0.46), a summary composite score was calculated (alpha = 0.86). Construct validity showed statistically significant correlations with other scales (ITEQ vs the Problem Areas in Diabetes [PAID] questionnaire total score -0.60, ITEQ vs the Diabetes Treatment Satisfaction Questionnaire [DTSQ] total score 0.52). CONCLUSION: : The newly developed ITEQ displayed satisfactory to good psychometric properties, thereby allowing the assessment of everyday life experience and treatment satisfaction in patients with insulin-treated type 2 diabetes. Additional research is needed to assess test-retest reliability and sensitivity to change.

Cost-effectiveness of the artificial liver support system MARS in patients with acute-on-chronic liver failure.

BACKGROUND: For patients with an acute exacerbation of chronic liver failure (ACLF), the molecular adsorbent recirculating system (MARS) can result in a prolongation of life, but data on costs and cost-effectiveness are lacking. METHODS: A health economic evaluation of a prospective controlled cohort trial in patients with ACLF not eligible for liver transplantation with 3 years follow-up and consecutive modelling of long-term costs, outcomes and cost-effectiveness was conducted. Costs were calculated from the perspective of the German health-care system. RESULTS: One hundred and forty-nine patients with ACLF were included of which 67 (44.9%) were treated with MARS and 82 (55.1%) assigned to the control group. Mean survival was 692 days in MARS-treated patients (33% survival after 3 years) and 453 days in control patients (15% after 3 years, logrank P = 0.022). MARS patients gained 0.66 [95% confidence interval (CI): -0.12 to 1.46] life years (LYs), determined by the bootstrap method. The mean cost difference was 19.835 euro (95% CI: 13.308-25.429) with 35639 euro for MARS-treated patients and 15804 euro for controls. Incremental costs per LY gained were 29.985 euro (95% CI: 9.441-321.761) and 43.040 euro (95% CI: 13.551-461.856) per quality-adjusted LY gained. CONCLUSION: There is an acceptable cost-effectiveness of MARS, compared with other medical technologies presently reimbursed. Randomized controlled trials with sufficient sample size are necessary before a final recommendation for MARS can be given.

Orchiectomy versus medical therapy with LH-RH analogues for the treatment of advanced prostatic carcinoma.

BACKGROUND: In Germany prostatic cancer is the most frequent cancer in men. The therapy of advanced prostatic cancer has changed significantly from the sub capsulate and / or total orchiectomy to the medical LH-RH analogues therapy during the last ten years, which has considerable effects on results and on costs. Both treatment procedures are based on a slowing down regulation of the growth of the hormone sensitive, neoplastic prostatic cells by the withdrawal of testosterone, which is clinically accompanied by a slowed tumor progression. OBJECTIVES: This health technology assessment depicts and evaluates international data of medical effectiveness and efficiency of orchiectomy and medical therapy with LH-RH-analogues in patients with advanced prostate cancer. METHODS: A systematic, diversified literature analysis in the common medical, economic and HTA data bases and further media was conducted. RESULTS: Five identified, randomized and controlled studies concerning the application of LH-RH analogues showed the same medical effectiveness of orchiectomy and treatment with LH-RH analogues. Four different studies regarding the quality of life revealed no significant difference between the treatment with LH-RH analogues and the therapy with orchiectomy. Dealing with health economic aspects seven cost-minimizing studies and one cost effectiveness study could be identified. All cost-minimizing studies show methodological restrictions. In general all studies draw the conclusion that the treatment of advanced prostatic cancer with orchiectomy is the most cost effective method, if one assumes a remaining life expectancy of more than one year. CONCLUSIONS: According to available studies, there is clear evidence for the equivalent effectiveness of LH-RH analogues and orchiectomy. Until now the studies - due to immense methodological restrictions - could not supply sufficient scientific evidence concerning the aspects of quality of life. In cases of a remaining life expectancy of more than one year, the orchiectomy is the more cost-effective alternative of therapy.

Extracorporal hemodialysis with acute or decompensated chronical hepatic failure.

BACKGROUND: Conventional diagnostic procedures and therapy of acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) focus on to identify triggering events of the acute deterioration of the liver function and to avoid them. Further objectives are to prevent the development respectively the progression of secondary organ dysfunctions or organ failure. Most of the times the endocrinological function of the liver can to a wide extent be compensated, but the removal of toxins can only marginally be substituted by conventional conservative therapy. To improve this component of the liver function is the main objective of extracorporal liver support systems. The following principles of liver support systems can be differentiated: Artificial systems, bioartifical systems and extracorporal liver perfusion systems. This HTA report focuses on artificial systems (e.g. BioLogic-DT/-DTPF, MARS, Prometheus), because only these approaches currently are relevant in the German health care system. In 2004 a category "Extracorporal liver assist device" was introduced in the list of "additional payments" in the German DRG-system, which makes reimbursement for hospitals using the technology in inpatient care possible, based on an hospital's individual contract with statutory sickness funds. OBJECTIVES: To report the present evidence and future research need on medical efficacy and economic effectiveness of extracorporal liver support devices for treatment of patients with ALF or ACLF based on published literature data. Are artificial liver support systems efficient and effective in the treatment of ALF or ACLF? METHODS: An extensive, systematic literature search in medical, economic, and HTA literature data bases was performed. Relevant data were extracted and synthesised. RESULTS: Relevant controlled trials were detected for BioLogic-DT and MARS. No randomised controlled trial on Prometheus was found. None of the included studies on BioLogic-DT showed advantages of the technology compared with standard conventional therapy concerning survival, clinical scores or clinical surrogate parameter like laboratory tests of liver function. Some studies reported complications and side effects of BioLogic-DT. All studies were methodologically insufficient. Concerning the use of MARS overall five studies - three of them randomised - were identified. Two studies reported a significant higher 30d-survival after MARS compared to controls, one study showed a non-significant trend to a better survival probability after one year. The studies showed statistically significant advantages in severity of hepatic encephalopathy, routine lab tests and hemodynamic parameter of the MARS group. None of the studies reported relevant complications or side effects. Although the methodological quality of the studies is seen as slightly better than in the studies on BioLogic-DT, there are methodological limitations: The largest sample size of the randomised trials was twelve patients per group and the study population was highly selected. Because of the methodological limitations the results can hardly be generalised. Only two economic publications presenting analyses of MARS could be de-tected. One publication shows major methodological mistakes which make a further interpretation of the results impossible. The other publication presents an incremental cost-effectiveness of MARS of 29,719 EUR per life year gained after one year from a payer's perspective (German statutory sickness fund, neglecting the intervention costs because of lacking reimbursement at this time), respectively 79,075 EUR per life year gained from a societal perspective. Including health related quality of life aspects the incremental costs per QALY (Quality adjusted life years) gained were calculated to be 44,784 EUR from a payer's perspective respectively 119,162 EUR from a societal perspective. The authors state that prolonging the time horizon of the calculations would improve cost-effectiveness ratios. The limitations of the study design also limit the scientific evidence of the results. CONCLUSION: The results of the detected publications do not give any evidence for a positive medical efficacy of BioLogic-DT. Concerning MARS there is some evidence for positive effects on 30d-survival, clinical parameter, and some lab tests, although the evidence is limited by the small number of studies and their methodological weakness. The currently strongly limited evidence shows a trend to an acceptable cost-effectiveness of MARS, although the results are based on only one non-randomised trial. To give valid recommendations concerning the medical efficacy as well as the cost-effectiveness of artificial liver support systems further studies are necessary.

Screening of the hearing of newborns - Update.

INTRODUCTION: Permanent congenital bilateral hearing loss (CHL) of moderate or greater degree (≥40 dB HL) is a rare disease, with a prevalence of about 1 to 3 per 1000 births. However, it is one of the most frequent congenital diseases. Reliance on physician observation and parental recognition has not been successful in the past in detecting significant hearing loss in the first year of life. With this strategy significant hearing losses have been detected in the second year of life. With two objective technologies based on physiologic response to sound, otoacoustic emissions (OAE) and auditory brainstem response (ABR) hearing screening in the first days of life is made possible. OBJECTIVES: The objective of this health technology assessment report is to update the evaluation on clinical effectiveness and cost-effectiveness of newborn hearing screening programs. Universal newborn hearing screening (UHNS) (i), selective screening of high risk newborns (ii), and the absence of a systematic screening program are compared for age at identification and age at hearing aid fitting of children with hearing loss. Secondly the potential benefits of early intervention are analysed. Costs and cost-effectiveness of newborn hearing screening programs are determined. This report is intended to make a contribution to the decision making whether and under which conditions a newborn hearing screening program should be reimbursed by the statutory sickness funds in Germany. METHODS: This health technology assessment report updates a former health technology assessment (Kunze et al. 2004 [1]). A systematic review of the literature was conducted, based on a documented search and selection of the literature using predefined inclusion and exclusion criteria and a documented extraction and appraisal of the included studies. To assess the cost-effectiveness of the different screening strategies in Germany the decision analytic Markov state model which had been developed in our former health technology assessment report was updated. RESULTS: Universal newborn hearing screening programs are able to substantially reduce the age at identification and the age at intervention of children with CHL to six months of age in the German health care setting. High coverage rates, low fail rates and - if tracking systems are implemented - high follow-up-rates to diagnostic evaluation for test positives were achieved. New publications on potential benefits of early intervention could not be retrieved. For a final assessment of cost-effectiveness of newborn hearing screening evidence based long-term data are lacking. Decision analytic models with lifelong time horizon assuming that early detection results in improved language abilities and lower educational costs and higher life time productivity showed a potential of UNHS for long term cost savings compared to selective screening and no screening. For the short-term cost-effectiveness with a time horizon up to diagnostic evaluation more evidence based data are available. The average costs per case diagnosed range from 16,000 EURO to 33,600 EURO in Germany and hence are comparable to the cost of other implemented newborn screening programs. Empirical data for cost of selective screening in the German health care setting are lacking. Our decision analytic model shows that selective screening is more cost-effective but detects only 50% of all cases of congenital hearing loss. DISCUSSION: There is good evidence that UNHS-Programs with appropriate quality management can reduce the age at start of intervention below six months. Up to now there is no indication of considerable negative consequences of screening for children with false positive test results and their parents. However, it is more difficult to prove the efficacy of early intervention to improve long-term outcomes. Randomized clinical trials of the efficacy of early intervention for children with CHL hearing losses are inappropriate because of ethical reasons. Prospective cohort studies with long-term outcomes of rare diseases are costly, take a long time and simultaneously substantial benefits of early intervention for language development seem likely. CONCLUSIONS: A UNHS-Program should be implemented in Germany and be reimbursed by the statutory sickness funds. To achieve high coverage and because of better conditions for obtaining low false positive rates UNHS should be performed in hospital after birth. For outpatient deliveries additionally screening measures in an outpatient setting must be provided.

Reimbursement for high-priced innovative medical devices in a DRG-based hospital care system: the German situation.

The implementation of high-priced innovative medical technologies in a diagnosis-related group-type hospital-care reimbursement system is a challenge. If the extra costs are not reimbursed, there will be no financial incentive for a hospital to use a new technology, except for marketing reasons and research projects. A continuous in-time adaptation of the catalog of reimbursed items is necessary.

Cost-effectiveness of quantitative ultrasound as a technique for screening of osteoporotic fracture risk: report on a health technology assessment conducted in 2001.

AIM: On behalf of the German Agency for Health Technology Assessment (DAHTA@DIMDI) a rapid economic HTA was conducted. Aim of the HTA was to evaluate the cost-effectiveness of quantitative ultrasound (QUS) for screening of osteoporotic fracture risk. Study population was formed by postmenopausal women. QUS was compared to the dual X-ray absorptiometry (DXA) as the most frequently used method of measurement. METHODS: According to the recommendations for rapid economic HTA a comprehensive literature search was conducted. Data of identified and relevant publications have been extracted in form of a qualitative and quantitative information synthesis. The authors calculated incremental cost-effectiveness ratios for different screening procedures: (1) one-step proceeding comparing QUS with DXA, (2) two-step proceeding starting with QUS followed by DXA in pathologic cases. RESULTS: An additional case diagnosed by DXA in a one-step proceeding rises additional costs of about 1,000 EURO. A two-step proceeding with QUS is cost-effective as long as the costs of one QUS examination are lower than 31%-51% of the costs of one DXA examination. DISCUSSION: All considered studies showed methodological limitations. None of them included long term effects like avoided bone fractures. Considering long-term effects probably would change the results. Due to the weakness of data no concluding judgement about the cost-effectiveness of QUS can be given.

Economic evaluation of MARS--preliminary results on survival and quality of life.

OBJECTIVES: The short-term medical benefit of the liver dialysis system MARS in patients with severe acute liver disease has clearly been demonstrated. An economic analysis of MARS has not been presented previously. Objective of the study is to calculate the costs per life saved and life year gained and to measure health related quality of life in patients who survived acute liver failure. First results on survival and HRQL are presented here. STUDY DESIGN: Cost effectiveness and cost utility analysis of MARS are performed. All patients since 1993 with chronic liver failure (Bilirubin > 300 micro mol/l) of the university hospital Rostock are included in the original sample (n = 141). Survival data are calculated. Surviving patients were contacted personally, thus quality of life data (EQ 5D and SF12) determined. Patients were compared in case control study design. In a later stage inpatient hospital costs, direct and indirect outpatients costs are included in the analysis. PRELIMINARY RESULTS: MARS-Patients show a higher survival: Kaplan-Meier cumulative survival after 100 days: 0.59 after MARS, 0.39 without (P <0.05). There was no significant difference in health related quality of life (SF12 and EQ-D). Calculations of quality adjusted life years (QALYs) result in 0.116 QALYs gained by treatment of one patient with MARS in one year. DISCUSSION: First preliminary results suggest that 1 year after therapy MARS seems to have a positive effect concerning survival rate, survival time and QALYs gained. Final results of cost-effectiveness and cost-utility analysis will soon be presented.

Economic evaluation and 1-year survival analysis of MARS in patients with alcoholic liver disease.

Objective of this study was to determine 1-year survival, costs and cost-effectiveness of the artificial liver support system Molecular Adsorbent Recirculating System (MARS) in patients with acute-on-chronic liver failure (ACLF) and an underlying alcoholic liver disease. In a case-control study, 13 patients treated with MARS were compared to 23 controls of similar age, sex and severity of disease. Inpatient hospital costs data were extracted from patients' files and hospital's internal costing. Patients and treating GPs were contacted, thus determining resource use and survival 1-year after treatment. Mean 1-year survival time in MARS group was 261 days and 148 days in controls. Kaplan-Meier analysis shows advantages of MARS patients (Logrank: P=0.057). Direct medical costs per patient for initial hospital stay and 1-year follow-up from a payer's perspective were Euro 18,792 for MARS patients and Euro 9638 for controls. The costs per life-year gained are Euro 29,719 (time horizon 1 year). From a societal perspective, the numbers are higher (costs per life-year gained: Euro 79,075), mainly because of the fact that there is no regular reimbursement of MARS and therefore intervention costs were not calculated from payer's perspective. A trade-off between medical benefit and higher costs has to be made, but 1-year results suggest an acceptable cost-effectiveness of MARS. Prolonging the time horizon and including indirect costs, which will be done in future research, would probably improve cost-effectiveness.

Economic evaluation of newborn hearing screening: modelling costs and outcomes.

OBJECTIVES: The prevalence of newborn hearing disorders is 1-3 per 1,000. Crucial for later outcome are correct diagnosis and effective treatment as soon as possible. With BERA and TEOAE low-risk techniques for early detection are available. Universal screening is recommended but not realised in most European health care systems. Aim of the study was to examine the scientific evidence of newborn hearing screening and a comparison of medical outcome and costs of different programmes, differentiated by type of strategy (risk screening, universal screening, no systematical screening). METHODS: In an interdisciplinary health technology assessment project all studies on newborn hearing screening detected in a standardized comprehensive literature search were identified and data on medical outcome, costs, and cost-effectiveness extracted. A Markov model was designed to calculate cost-effectiveness ratios. RESULTS: Economic data were extracted from 20 relevant publications out of 39 publications found. In the model total costs for screening of 100,000 newborns with a time horizon of ten years were calculated: 2.0 Mio.euro for universal screening (U), 1.0 Mio.euro for risk screening (R), and 0.6 Mio.euro for no screening (N). The costs per child detected: 13,395 euro (U) respectively 6,715 euro (R), and 4,125 euro (N). At 6 months of life the following percentages of cases are detected: U 72%, R 43%, N 13%. CONCLUSIONS: A remarkable small number of economic publications mainly of low methodological quality was found. In our own model we found reasonable cost-effectiveness ratios also for universal screening. Considering the outcome advantages of higher numbers of detected cases a universal newborn hearing screening is recommended.