Background: Coronary artery bypass graft (CABG) and percutaneous revascularisations with implantation of drug-eluting stents (DES) are important treatment methods in coronary heart disease (CHD).
Research questions: The evaluation addresses questions on medical efficacy, health economic parameters as well as ethic, social and legal implications in the use of DES vs. CABG in CHD patients.
Methods: A systematic literature search was conducted in December 2006 in the most important electronic databases beginning from 2004. Register data and controlled clinical studies were included in the evaluation. Additionally, a health economic modelling was conducted.
Results: MEDICAL EVALUATION : The literature search yielded 2,312 hits. 14 publications about six controlled clinical studies and five publications about two registers were included into the evaluation. Register data showed low mortality (0.2% to 0.7%) and low rates of myocardial infarction (0.5% to 1.4%) during hospital stay. In patients with stenosis of the left anterior descending coronary artery one study showed in several analyses a significantly higher rate of reinterventions and a significantly higher rate of repeated angina pectoris for DES up to two years after the implantation (16.8% vs. 3.6% and 35% vs. 8%). In patients with left main coronary artery stenosis two studies revealed a significantly higher survival without myocardial infarction and stroke for DES up to one year (96% vs. 79% and 95% vs. 91%) and two studies a significantly higher rate of revascularisations up to two years (20% vs. 4% and 25% vs. 5%) after the primary intervention. In patients with multivessel disease, one study found a significantly higher mortality and myocardial infarction rate for CABG at one year (2.7% vs. 1.0% and 4.2% vs. 1.3%). The rate of revascularisations was significantly higher in two studies up to two years after DES implantation (8.5% vs. 4.2% and 14.2% vs. 5.3%). The rate at repeated angina pectoris was significantly higher in one study in DES patients during two-years follow-up (28% vs. 12%). HEALTH ECONOMIC EVALUATION: The one-year total costs per patient after CABG were calculated to be 13,373 euro and after DES 10,443 euro, leading to a difference of 2,930 euro in favour of DES implantation. The three-year total costs per patient after CABG were estimated to be 13,675 euro and after DES 10,989 euro, showing a cost difference of 2,686 euro in favour of DES implantation. In the performed sensitivity analyses no break even point was reached.
Discussion: Existing data should be viewed only as limited evidence for possible medical and health economic effects.
Conclusions: There is limited evidence for the possible advantage of DES vs. CABG with respect to mortality and the rate of myocardial infarction in some indications as well as disadvantages with regard to
Health political background: Caries is one of the most prevalent diseases worldwide. For (direct) restaurations of carious lesions, tooth-coloured composite materials are increasingly used. The compulsory health insurance pays for composite fillings in front teeth; in posterior teeth, patients have to bear the extra cost.
Scientific background: Amalgam is an alloy of mercury and other metals and has been used in dentistry for more than one hundred and fifty years. Composites consist of a resin matrix and chemically bonded fillers. They have been used for about fifty years in front teeth. Amalgam has a long longevity; the further development of composites has also shown improvements regarding their longevity.
Research questions: This HTA-report aims to evaluate the longevity (failure rate, median survival time (MST), median age) of direct amalgam fillings in comparison to direct composite fillings in permanent teeth from a medical and economical perspective and discusses the ethical, legal and social aspects of using these filling materials.
Methods: The systematic literature search yielded a total of 1,149 abstracts. After a two-step selection process based on defined criteria 25 publications remained to be assessed.
Results: The medical studies report a longer longevity for amalgam fillings than for composite fillings. However, the results of these studies show a large heterogeneity. No publication on the costs or the cost-effectiveness of amalgam and composite fillings exists for Germany. The economic analyses (NL, SWE, GB) report higher costs for composite fillings when longevity is assumed equal (for an observation period of five years) or longer for amalgam compared to composite fillings. These higher costs are due to the higher complexity of placing composite fillings.
Discussion: Due to different study designs and insufficient documentation of study details, a comparison of different studies on longevity of direct amalgam and composite fillings in posterior teeth is difficult. Apart from the difficulties in conducting a randomized, controlled long-term study comparing the longevity of direct fillings, the fact that composites and adhesives used in a study have often already been replaced by the next generation of the product at the time of study publication presents an additional problem. Not only the filling material, but also patient parameters and local, intraoral factors (e. g. localisation of the filling) as well as the treating dentist have an impact on the longevity of dental fillings. In evaluating economic studies, one has to refer to the heterogeneity of data on longevity in the medical evaluation. The only effect parameter used in the studies is longevity, other aspects (e. g. long-term functionality) are only referred to in discussions. Extensive counselling of patients regarding the selection o
Background: The hazardous health effects of smoking and second hand smoke have been confirmed in numerous studies. For Germany, the mortality attributable to smoking is estimated at 110,000 to 140,000 deaths per year, associated with annual smoking-related costs of 17 to 21 billion euro. Because the majority of smokers initiate this habit early in life, behavioural preventive strategies usually tried to prevent the uptake of smoking among children and youths.
Objectives: The goal of this HTA is to summarise the current literature on behavioural strategies for smoking prevention and to evaluate their medical effectiveness/efficacy and cost-effectiveness as well as the ethical, social and legal implications of smoking prevention programs. In addition, this report aims to compare the effectiveness and efficacy of different intervention components and to evaluate the reliability of results in the German context.
Methods: Relevant publications were identified by means of a structured search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI). In addition a manual search of identified reference lists was conducted. The present report includes German and English literature published between August 2001 and August 2006 targeting youths up to 18 years old. The methodological quality of included studies was assessed according to pre-defined quality criteria, based on the criteria of evidence-based medicine.
Results: Among 3,580 publications 37 medical studies met the inclusion criteria. Overall study quality was satisfactory but only half the studies reported smoking uptake as an outcome, while the remaining studies reported alternative outcome parameters. The follow-up duration varied between twelve and 120 months. Although overall effectiveness of prevention programs showed considerable heterogeneity, there was evidence for the long-term effectiveness of behavioural smoking prevention programs. However, the reduction in smoking rates was only moderate. Community and multisectorial interventions reported more conclusive evidence for reductions in smoking rates, while the evidence for school-based programs alone was inconclusive. Only one study from Germany fulfilled the methodological criteria and was included in this report. Three included economic studies focused on school-based interventions. Study results suggested, that the cost-effectiveness of school-based behavioural interventions is positive.
Discussion: Behavioural preventive strategies were effective to delay or decrease uptake of smoking behaviour among children and youth. The effect size, however, was only moderate. Similar to previous research, there was no conclusive evidence for the long-term effectiveness of school-based interventions, whereas community and multisectorial interventions provided more conclusive evidence. However, su
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system which is accompanied by considerable disability and high costs. This report summarises the evidence on effectiveness and costs of beta-interferons and natalizumab in the treatment of multiple sclerosis.The review included systematic reviews and randomised controlled trials (with an observation time of at least one year) in patients with MS which assessed outcome parameters such as progression, exacerbations and adverse effects. An extensive literature search included databases such as MEDLINE, EMBASE, the Cochrane Library and various HTA-databases. Studies were selected according to predefined criteria, their quality was assessed according to criteria defined prospectively, and data were summarised systematically in tables. Cost-effectiveness evaluations were also included.Two systematic reviews and 24 randomised controlled trials of beta-interferon therapy were included, as well as three trials on the effectiveness of natalizumab. A total of 22 cost-effectiveness analyses for interferons were included, whereas no economic evaluations for natalizumab were identified.Use of interferon beta-1a or interferon beta-1b after a first demyelinating event led to a reduction of the conversion to definite MS during an observation time of two to three years. In relapsing remitting MS, interferon beta-1a reduced progression. The effects of interferon beta-1b on progression are unclear. Interferon beta-1a and interferon beta-1b reduced in some but not all studies outcomes relating to exacerbations. In direct comparison trials, interferon beta-1b (Betaferon(®) or Betaseron(®)) and interferon beta-1a (Rebif(®), higher dosage of 44 µg three subcutaneous injections per week) proved superior to interferon beta-1a (Avonex(®), 30 µg per week intramuscular) with respect to exacerbation outcomes. For secondary progressive MS, only one of five studies found a reduced progression with interferon beta-1a and only a part of the studies found an improvement with respect to outcomes relating to exacerbations. For primary progressive MS no advantage of therapy with beta-interferons was found with respect to patient-related outcomes. Beta-interferons showed characteristic and frequently occurring adverse effects, including reactions at the injection site and flu-like symptoms. A large proportion of patients stop interferon therapy because of adverse events. The other main reason for stopping therapy is the felt ineffectiveness of the treatment when patients experience a new exacerbation while on treatment. Many patients produce interferon-neutralising antibodies during therapy. The ultimate effect of neutralising antibodies on the efficacy of interferon treatment is unclear.In patients with relapsing remitting (and partially with secondary progressive) MS, treatment with natalizumab led to a reduction of progression and of exacerbation rates. However, a number of cases of progressive
Scientific background: Percutaneous transluminal angioplasties (PTA) through balloon dilatation with or without stenting, i.e. vessel expansion through balloons with or without of implantation of small tubes, called stents, are used in the treatment of peripheral artery occlusive disease (PAOD). The intravascular vessel irradiation, called intravascular brachytherapy, promises a reduction in the rate of repeated stenosis (rate of restenosis) after PTA.
Research questions: The evaluation addresses questions on medical efficacy, cost-effectiveness as well as ethic, social and legal implications in the use of brachytherapy in PAOD patients.
Methods: A systematic literature search was conducted in August 2007 in the most important medical electronic databases for publications beginning from 2002. The medical evaluation included randomized controlled trials (RCT). The information synthesis was performed using meta-analysis. Health economic modeling was performed with clinical assumptions derived from the meta-analysis and economical assumptions derived from the German Diagnosis Related Groups (G-DRG-2007).
Results: MEDICAL EVALUATION : Twelve publications about seven RCT on brachytherapy vs. no brachytherapy were included in the medical evaluation. Two RCT showed a significant reduction in the rate of restenosis at six and/or twelve months for brachytherapy vs. no brachytherapy after successful balloon dilatation, the relative risk in the meta-analysis was 0.62 (95% CI: 0.46 to 0.84). At five years, time to recurrence of restenosis was significantly delayed after brachytherapy. One RCT showed a significant reduction in the rate of restenosis at six months for brachytherapy vs. no brachytherapy after PTA with optional stenting, the relative risk in the meta-analysis was 0.76 (95% CI: 0.61 to 0.95). One RCT observed a significantly higher rate of late thrombotic occlusions after brachytherapy in the subgroup of stented patients. A single RCT for brachytherapy vs. no brachytherapy after stenting did not show significant results for the rate of restenosis at six months. Both, early and late thrombotic occlusions appeared more frequently in the brachytherapy group. HEALTH ECONOMIC EVALUATION : Additional costs of brachytherapy were estimated to be 1,655 or 1,767 Euro according to the used G-DRG. The incremental cost-effectiveness ratio per avoided restenosis was calculated to be 8,484 Euro or 9,058 Euro for brachytherapy use after successful balloon dilatation, 19,027 Euro or 20,314 Euro for brachytherapy after PTA with optional stenting and -39,646 Euro or -48,330 Euro for brachytherapy after stenting.
Discussion: Partially poor performing and reporting quality of the RCT exacerbate the interpretation and the transferability of the study results. The used methodical approach enables the highest evidence level for the determined results and prese
Background: Coronary artery disease (CAD) is one of the leading causes of premature death in Germany. Percutaneous coronary interventions (PCI) are frequently performed in patients with angiographically intermediate stenoses. However, the necessity of PCI has not been proven for all patients. Pressure-based fractional flow reserve (FFR) is an invasive test that can be used to assess the functional significance of intermediate coronary stenoses in order to guide decisions on PCI.
Objectives: This health technology assessment (HTA) aims to evaluate (1) the diagnostic accuracy, (2) the risk-benefit trade-off and (3) the long-term cost-effectiveness of FFR measurement to guide the decision on PCI in patients with stable angina pectoris and intermediate coronary stenoses.
Methods: We performed a literature search in medical and HTA databases. We used the DIMDI instruments (DIMDI = Deutsches Institut für Medizinische Dokumentation und Information/German Institute for Medical Information and Documentation) to assess study quality and to extract and summarize the information in evidence tables. We performed a meta-analysis to calculate the pooled overall estimate for sensitivity and specificity of FFR with 95% confidence intervals (95% CI). Individual studies' case numbers were used as weights. The influence of single studies and important covariates on the results was tested in sensitivity analyses. We developed the German Coronary Artery Disease Outcome Model (German CADOM), a decision-analytic Markov model, to estimate the long-term effectiveness and cost-effectiveness of FFR measurement in the context of the German healthcare system.
Results: Our literature search identified twelve studies relevant to this HTA-report including ten diagnostic accuracy studies of FFR measurement, one randomized clinical trial (RCT) investigating the clinical benefits of this technique as well as one economic evaluation. Pooled estimates for sensitivity and specificity were 81.7% (95% CI: 77.0-85.7%) and 78.7% (95% CI: 74.3-82.7%). Sensitivity analyses indicated robust results. The RCT investigating the efficacy of an FFR-based treatment strategy provided evidence of the advantages of this strategy for patients with respect to freedom from angina and major adverse cardiac events. The published cost-effectiveness study demonstrates that the FFR-based strategy is cost-saving in the US context. Based on our own decision analysis for the German context, the FFR-based strategy improves (quality-adjusted) life-expectancy when compared to universal PCI and is cost-effective in the German healthcare context. This HTA is limited by the use of poor gold standards in several of the included diagnostic studies as well as the ongoing advance of technology and treatment options in interventional cardiology. Results of the decision analysis are limited by the necessary underlying assumptions and t
Background: Obesity with its associated medical, psychological, social, and economic complications is considered a chronic, multifactorial disorder. Given the magnitude of the challenge obesity, there is a clear need for preventive as well as therapeutic measures and strategies on an individual and a public health level.
Objectives: The goal of this health technology assessment (HTA)-report is to summarise the current literature on bariatric surgery, to evaluate their medical effectiveness/efficacy and cost-effectiveness as well as the ethical, social and legal implications of these procedures in comparison to conventional therapies and compared to each other.
Methods: Relevant publications are identified by means of a structured search of databases accessed on 13.11.2006 and an update conducted on 12.11.2007. In addition, a manual search of identified reference lists is conducted. The present report includes German and English literature published since 2001 and targeting adult subjects with morbid obesity (body mass index (BMI) >=40 kg/m² or BMI >=35 kg/m² with severe comorbidities). The methodological quality of studies included is assessed according to pre-defined quality criteria by two independent scientists.
Results: Among 5910 retrieved publications, 25 medical articles, as well as seven health economic studies meet the inclusion criteria. The medical studies show a superior weight loss following bariatric surgery compared to conventional therapy. Malabsorptive procedures lead to a more profound weight loss than purely restrictive procedures. Weight reduction in general is accompanied by a reduced frequency of comorbidities (mostly diabetes type 2). The evidence is not sufficient to quantify these effects for individual procedures or to assess long-term outcomes. However, recent studies show a profound survival benefit for surgically treated patients up to a period of eleven years. The economic studies illustrate that bariatric surgery is cost-effective compared to no treatment or conservative treatment. The comparison between surgical therapies does not allow to draw any conclusions on cost-effectiveness. Appropriate studies/surveys, which are concerned with ethical, legal and social aspects, are not available.
Discussion: Concerning clinical outcomes as well as cost-effectiveness, there is a lack of high quality studies. Clinical effectiveness and safety as well as cost-effectiveness of bariatric procedures in the short- and medium-term course are agreed on, but long-term evaluations that focus not exclusively on weight loss, but also on comorbidities and patient relevant outcomes such as quality of life, are needed. Also within the economic views are missing long-term evaluation particularly for the German health care system.
Conclusion: Based upon the available literature the short- and medium-term eff
Parkinson's disease is a chronic degenerative organic disease with unknown causes. A disappearance of cells with melanin in the substantia nigra is considered as biological artefact of the disease, which causes a degenerative loss of neurons in the corpus striatum of mesencephalon. This structure produces also the transmitter substance dopamine. Due to this disappearance of cells dopamine is not produced in a sufficient quantity which is needed for movement of the body.The questions of this report are concerned the efficiency and safety of a treatment with dopamine agonists. Furthermore the cost-effectiveness is investigated as well as ethic questions. The goal is to give recommendation for the use of dopamine agonists to the German health system.A systematic literature search was done. The identified studies have different methodological quality and investigate different hypothesis and different outcome criteria. Therefore a qualitative method of information synthesis was chosen.Since the introduction of L-Dopa in the 1960´s it is considered as the most effective substance to reduce all the cardinal symptoms of Parkinson disease. This substance was improved in the course of time. Firstly some additional substances were given (decarbonxylase inhibitors, catechol-o-transferase inhibitors (COMT-inhibitors), monoaminoxydase-inhibitors (MAO-inhibitors) and NMDA-antagonists (N-Methyl-d-aspartat-antagonists).In the practical therapy of Parkinson dopamine agonists play an important role, because they directly use the dopamine receptors. The monotherapy of Parkinson disease is basically possible and is used in early stages of the disease. Clinical practise has shown, that an add on therapy with dopamine agonists can led to a reduction of the dose of L-dopa and a reduction of following dyskinesia.The studies for effectiveness include studies for the initial therapy, monotherapy and add-on-therapy. Basically there is a good effectiveness of dopamine agonists the reduce dyskinesia and this differences are statistically significant. The effect of dopamine agonists is weaker then levodopa generally. The initial therapy with dopamine agonists can postpone the use of levodopa medication or keep the dose small for a longer period of time. There are more other side effects to levodopa, these are not statistically significant. The idea, which strategy for the treatment should be chosen is dependent of several factors and has to be evaluated with the individual patient. An important criterion is the age of the patient at the beginning of the treatment. For younger patients (under 65 years) the risk of developing motoric fluctuation and dyskinesia is much higher and therefore it is proposed to use levodopa at later stages. The evidence of the evaluated studies show a good effectiveness with the therapy of Parkinson disease as monotherapy of younger patients or as additional medication to levodopa as well as older patients with progressive stages of this diseas
Introduction: Obesity is a worldwide health problem whose prevalence is on the increase. Many obesity-associated diseases require intensive medical treatment and are the cause of a large proportion of health-related expenditures in Germany. Treatment of obesity includes nutritional, exercise and behaviour therapy, usually in combination. The goal of behaviour therapy for obesity is to bring about a long-term alteration in the eating and exercise habits of overweight and obese individuals. Under certain circumstances, drug treatment may be indicated.
Objectives: What is the effectiveness of behaviour therapy for obesity considering approved drugs reduce weight under medical, economic, ethical-social and legal aspects?
Methods: A systematic review was conducted using relevant electronic literature databases. Publications chosen according to predefined criteria are evaluated by approved methodical standards of the evidence-based medicine systematically and qualitatively.
Results: In total 18 studies, included one HTA and one meta-analysis could be identified according to the predefined inclusion criteria. Three studies compare behaviour therapy to other therapy forms (advice or instruction on nutritional changes, physical activity or a combination of the two), six studies evaluate different forms of behaviour therapy, four studies and four studies compare behaviour therapies mediated by Internet or telephone. Three studies could be identified examining the effect of the combination of behaviour and drug therapy. Furthermore one HTA and one meta-analysis could be included in the evaluation. The behaviour therapy in comparison with other therapy forms reveals a higher effectiveness. In comparison of the different therapeutic approaches of the behaviour therapy intensive behaviour therapy forms and group therapy show a higher effectiveness. Studies related to behaviour therapy based on media support demonstrate a weight reduction both through the interventions of media alone as well as through the intervention of media in conjunction with personal support within the groups. However, analyses of the inter-group comparisons offer no statistically significant difference. However, analyses of the inter-group comparisons offer no statistically significant difference. Comparative analyses confirm the effectiveness of behaviour therapy in combination with additional drug treatment when compared to behaviour therapy alone. In all the studies presented here, relevant changes in weight of -5% to -10% are only partially achieved. High weight losses of less than -10% were found among the intervention group in two of the studies. One study reported a weight loss of -11.4% with the "group therapy" intervention method, while another study reported a weight loss of -11.2% with the "behaviour therapy plus drug treatment" intervention method. Studies with a subsequent follow-up peri
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