GMS health technology assessment最新文献

{"title":"Pharmacogenomics Bias - Systematic distortion of study results by genetic heterogeneity.","authors":"Uwe Siebert,&nbsp;Gaby Sroczynski,&nbsp;Vera Zietemann","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Decision analyses of drug treatments in chronic diseases require modeling the progression of disease and treatment response beyond the time horizon of clinical or epidemiological studies. In many such models, progression and drug effect have been applied uniformly to all patients; heterogeneity in progression, including pharmacogenomic effects, has been ignored.</p><p><strong>Objective: </strong>We sought to systematically evaluate the existence, direction and relative magnitude of a pharmacogenomics bias (PGX-Bias) resulting from failure to adjust for genetic heterogeneity in both treatment response (HT) and heterogeneity in progression of disease (HP) in decision-analytic studies based on clinical study data.</p><p><strong>Methods: </strong>We performed a systematic literature search in electronic databases for studies regarding the effect of genetic heterogeneity on the validity of study results. Included studies have been summarized in evidence tables. In the case of lacking evidence from published studies we sought to perform our own simulation considering both HT and HP. We constructed two simple Markov models with three basic health states (early-stage disease, late-stage disease, dead), one adjusting and the other not adjusting for genetic heterogeneity. Adjustment was done by creating different disease states for presence (G+) and absence (G-) of a dichotomous genetic factor. We compared the life expectancy gains attributable to treatment resulting from both models and defined pharmacogenomics bias as percent deviation of treatment-related life expectancy gains in the unadjusted model from those in the adjusted model. We calculated the bias as a function of underlying model parameters to create generic results. We then applied our model to lipid-lowering therapy with pravastatin in patients with coronary atherosclerosis, incorporating the influence of two TaqIB polymorphism variants (B1 and B2) on progression and drug efficacy as reported in the DNA substudy of the REGRESS trial.</p><p><strong>Results: </strong>We found four studies that systematically evaluated heterogeneity bias. All of them indicated that there is a potential of heterogeneity bias. However, none of these studies explicitly investigated the effect of genetic heterogeneity. Therefore, we performed our own simulation study. Our generic simulation showed that a purely HT-related bias is negative (conservative) and a purely HP-related bias is positive (liberal). For many typical scenarios, the absolute bias is smaller than 10%. In case of joint HP and HT, the overall bias is likely triggered by the HP component and reaches positive values >100% if fractions of \"fast progressors\" and \"strong treatment responders\" are low. In the clinical example with pravastatin therapy, the unadjusted model overestimated the true life-years gained (LYG) by 5.5% (1.07 LYG vs. 0.99 LYG for 56-year-old men).</p><p><strong>Conclusions: </strong>We have been able","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"4 ","pages":"Doc03"},"PeriodicalIF":0.0,"publicationDate":"2008-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/aa/f6/HTA-04-03.PMC3011301.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29644927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oral health with fixed appliances orthodontics.","authors":"Wilhelm Frank,&nbsp;Karin Pfaller,&nbsp;Brigitte Konta","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Orthodontic treatment represents an important fraction in dental interventions. According to other medical methods the question for scientific evidence for the effectiveness of these treatments arises. The question of the effectiveness is connected with the question what is understood as an effect. In principle, the effect of the intervention is understood on the basis of the occlusion or dental health, what disregards further functions of oral health. The generalization to oral health is therefore a necessary consideration in science now. If one appreciates this further development, then there is no one single randomised study available which examines the long-term effect of the orthodontic intervention or for the effects on the oral health.The question, whether the application of a fixed appliance in an orthodontic treatment causes a long-term improvement in oral health, cannot be answered at the present time. The scientific status is the definition of oral health at present. Also the question, whether in the long run the dental health can be improved by fixed appliances cannot be answered with a quality usually achieved by evidence-based medicine. Whether correction of a dental malposition is an effective prerequisite for the preservation of the natural teeth, cannot be answered. There is no generalizing study with sufficient scientific background for Europe or Germany to this topic. The risk for caries cannot be quantified. Caries is identified as a central topic in general but due to numerous factors influencing the risk it is not quantified. The question of the indications is completely open from the scientific literature. For the question of the therapy need or therapy priority some indexes were developed, which lead to a quantification. These indices however are fundamentally criticised by recent research in their meaning and the empirical relevance.There is an impression that there exists a big gap between the practical application and the scientific investigation of this effectiveness of fixed appliances or orthodontic treatment in general. There is much research in the area of diagnostics or further development of appliances or techniques done, however extremely few in the area of need for intervention, analysis of the sustainability; influence factors on the success, like caries or quantification of side effects e. g. root resorption. This research to evaluate the indications is completely lacking, also the required evaluation parameters (e. g. means long-term dental maintenance). This gap is in this respect dubious since a link of determining the demand (inducing demand) and supply in Central European health systems is economically given. This enables to create a possibility for a so-called supply induced demand. To get rid of discussions that the professional work of orthodontics can be near to induced demand or unnecessary indications, research of this topic is quite essential. This requires much stronger information for indi","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"4 ","pages":"Doc02"},"PeriodicalIF":0.0,"publicationDate":"2008-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d2/41/HTA-04-02.PMC3011300.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29644926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health Technology Assessment of laparoscopic compared to conventional surgery with and without mesh for incisional hernia repair regarding safety, efficacy and cost-effectiveness.","authors":"Meik Friedrich,&nbsp;Falk Müller-Riemenschneider,&nbsp;Stephanie Roll,&nbsp;Werner Kulp,&nbsp;Christoph Vauth,&nbsp;Wolfgang Greiner,&nbsp;Stefan Willich,&nbsp;Johann-Matthias von der Schulenburg","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>Incisional hernias are a common complication following abdominal surgery and they represent about 80% of all ventral hernia. In uncomplicated postoperative follow-up they can develop in about eleven percent of cases and up to 23% of cases with wound infections or other forms of wound complications. Localisation and size of the incisional hernia can vary according to the causal abdominal scar. Conservative treatment (e. g. weight reduction) is only available to relieve symptoms while operative treatments are the only therapeutic treatment option for incisional hernia. Traditionally, open suture repair was used for incisional hernia repair but was associated with recurrence rates as high as 46%. To strengthen the abdominal wall and prevent the development of recurrences the additional implantation of an alloplastic mesh is nowadays commonly used. Conventional hernia surgery as well as minimally invasive surgery, introduced in the early 90s, make use of this mesh-technique and thereby showed marked reductions in recurrence rates. However, there are possible side effects associated with mesh-implantation. Therefore recommendations remain uncertain on which technique to apply for incisional hernia repair and which technique might, under specific circumstances, be associated with advantages over others.</p><p><strong>Objectives: </strong>The goal of this HTA-Report is to compare laparoscopic incisional hernia repair (LIHR) and conventional incisional hernia repair with and without mesh-implantation in terms of their medical efficacy and safety, their cost-effectiveness as well as their ethical, social und legal implications. In addition, this report aims to compare different techniques of mesh-implantation and mesh-fixation as well as to identify factors, in which certain techniques might be associated with advantages over others.</p><p><strong>Methods: </strong>Relevant publications were identified by means of a structured search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI) as well as by a manual search. The former included the following electronic resources: SOMED (SM78), Cochrane Library - Central (CCTR93), MEDLINE Alert (ME0A), MEDLINE (ME95), CATFILEplus (CATLINE) (CA66), ETHMED (ED93), GeroLit (GE79), HECLINET (HN69), AMED (CB85), CAB Abstracts (CV72), GLOBAL Health (AZ72), IPA (IA70), Elsevier BIOBASE (EB94), BIOSIS Previews (BA93), EMBASE (EM95), EMBASE Alert (EA08), SciSearch (IS90), Cochrane Library - CDSR (CDSR93), NHS-CRD-DARE (CDAR94), NHS-CRD-HTA (INAHTA) as well as NHSEED (NHSEED). The present report includes German and English literature published until 31.08.2005. The search parameters can be found in the appendix. No limits were placed on the target population. The methodological quality of the included clinical studies was assessed using the criteria recommended by the \"Scottish Intercollegiate Guidelines Network Grading Review Group\". Economic s","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"4 ","pages":"Doc01"},"PeriodicalIF":0.0,"publicationDate":"2008-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d8/3b/HTA-04-01.PMC3011306.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29644925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interventions for enhancing medication compliance/adherence with benefits in treatment outcomes.","authors":"Vitali Gorenoi,&nbsp;Matthias P Schönermark,&nbsp;Anja Hagen","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Scientific background: </strong>Poor compliance or adherence in drug therapy can cause increased morbidity, mortality and enormous costs in the healthcare system (in Germany annually approximately 10 billion euros). Different methods are used for enhancing the compliance or adherence.</p><p><strong>Research questions: </strong>The evaluation addresses the questions about existence, efficacy, cost-benefit relation as well as ethical-social and juridical implications of strategies for enhancing compliance or adherence in drug therapy with concomitant improvements in treatment outcomes.</p><p><strong>Methods: </strong>A systematic literature search was conducted in the medical, also health economic relevant, literature databases in January 2007, beginning from 2002. Systematic reviews on the basis of (randomised controlled trials (RCT) concerning interventions to enhance compliance or adherence with regard to treatment outcomes as well as systematic reviews of health economic analyses were included in the evaluation. Additionally, it was also searched for publications which primarily considered ethical-social and juridical aspects of these interventions for the German context.</p><p><strong>Results: </strong>One systematic review with data for 57 RCT was included in the medical evaluation and one systematic review with data for six studies into the health economic evaluation. No publication primary concerning ethical-social or juridical implications could be identified. A significant positive effect on the treatment outcome was reported for 22 evaluated interventions. For many interventions the results can be classified as reliable: counseling with providing an information leaflet and compliance diary chart followed by phone consultation for helicobacter pylori positive patients, repeated counseling for patients with acute asthma symptoms, telephone calls to establish the level of compliance and to make recommendations based on that for the therapy of cardiovascular diseases, calls of an automated telephone system with phone counseling in problem cases for diabetics, different family based interventions including repeated family counseling, education and \"culturally modified family therapy\" in patients with schizophrenia, repeated \"compliance therapy\" sessions for patients with acute psychosis. For other interventions the results should be viewed with more concern (because of the poor methodical quality of the underlying studies). The effect size of the interventions can not be estimated from the available data. From the available data, no reliable results can be provided concerning the cost-benefit relation of these strategies.</p><p><strong>Discussion: </strong>Many of the reported studies had a poor reporting and methodological quality. The reliability of the conclusions of the studies is restricted because of methodical shortcomings. Efficacy and cost estimates determined in the health economic studies are not transferable to the curr","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc14"},"PeriodicalIF":0.0,"publicationDate":"2008-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cc/da/HTA-03-14.PMC3011336.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Procedures and Criteria for the regulation of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances.","authors":"Ulrike Neumann,&nbsp;Anja Hagen,&nbsp;Matthias Schönermark","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Because great interest in an efficient range of effective medicinal innovations and achievements has arisen, many countries have introduced procedures to regulate the adoption of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances. With this as a background, this report will describe procedures for the adoption of innovative non-medicinal technologies by solidly financed health care insurances in Germany, England, Australia and Switzerland. This report was commissioned by the German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information.In order to find the relevant literature and information, systematic literature research, a hand search and a written survey were carried out. All the selected documents (chosen according to defined criteria for inclusion and exclusion) were qualitatively evaluated, summarized and presented on a chart using a framework developed for this purpose. All the countries in this report require that some innovative non-medicinal technologies undergo evaluation by a central governing body. This evaluation is a prerequisite for adoption into the benefit catalogue. The process of evaluation can differ (e. g. the people and institutions concerned, the division of the synthesis of evidence and overall evaluation, processing the evidence). Similarities do exist, such as the size and composition of the governing bodies or the overreaching criteria according to which institutions must make their recommendations. This is how all the countries examined in this report determine how the benefits and effectiveness of the innovations, as well as their cost-effectiveness, can be chosen as criteria for the evaluation. Furthermore, there are many criteria which differ from country to country (social and ethical aspects, possible effects on the health system, etc.) and which are also relevant to an evaluation. The preferred types of clinical studies for these evaluations are randomized controlled trials. However, all institutions do allow for other types of evidence (e. g. expert opinion) when no other study types of a higher evidence level are available. In addition, all the countries are willing to allow unpublished or confidential information (e. g. from manufacturers) to be included in an evaluation. It is important to remember that the decisions made by the central governing bodies do not necessarily become conditions for the introduction of innovative non-medicinal technologies. There is a host of other requirements which determine how these innovations can be introduced. This means that a large number of non-medicinal technologies make it into the medical care system via these other decision-making processes. Often, these innovations are unevaluated and differ from region to region. Every country has established a system of observation and registration for medicinal products. These systems are meant to document any incide","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc13"},"PeriodicalIF":0.0,"publicationDate":"2008-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5f/70/HTA-03-13.PMC3011333.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Measels-Mumps-Rubella Vaccination from a health political and economical point of view.","authors":"Ingrid Rosian-Schikuta,&nbsp;Barbara Fröschl,&nbsp;Claudia Habl,&nbsp;Heidi Stürzlinger","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>Measels, Mumps and Rubella (MMR) are highly contagious infectious diseases which may lead to severe complications. These diseases are vaccine-preventable. The present Health Technology Assessment report (report on technological consequences, HTA report) was commissioned by the German Institute of Medical Documentation and Information (DIMDI) and addresses various aspects of the MMR vaccination, the key question being how the MMR immunisation coverage rate can be increased in Germany.</p><p><strong>Objectives: </strong>The objectives of this report were to describe the benefits of the MMR vaccination for Germany and to analyse how the desired MMR immunisation coverage of >95% can be achieved.</p><p><strong>Methods: </strong>A systematic literature search was performed in 29 literature data bases. Particularly for epidemiological data and information on vaccination programs, this systematic search was supplemented by an extensive hand search, written and oral enquiries, as well as interviews with experts. A total of 200 texts were used to prepare this report.</p><p><strong>Results: </strong>At 92.5% (as of 2004) based on the whole of Germany, the current immunisation coverage for measles in children is above the weighted EC-15-average of 90.67%. Statements can only be made regarding the probability of illness for measles, as no data is available for mumps and rubella. With 2.8 infections (per 100,000 residents) in 2006, Germany has not achieved the WHO target. Of cases submitted to the laboratory, only 32% were validated by diagnostic laboratory findings and 45% confirmed clinical-epidemiologically. There are only few economic analyses of vaccination programs in Germany. In international publications, mainly measels are validated economically. An analysis of the cost of measles for Germany shows potential cost savings. Unfortunately, no complete economic evaluation (cost-effectiveness, cost-benefit, or cost-utility analyses) for MMR vaccination has been performed for Germany. Analyses conducted in the US and a model calculation for a hypothetical Western-European country show a considerable cost saving potential for society in general as well as for the health care system. INTERVENTIONS TO INCREASE THE IMMUNISATION RATE WERE CATEGORIZED IN THREE MAIN GROUPS ACCORDING TO THEIR GOALS: interventions increasing the demand for vaccinations, those improving access to vaccination services and those aiming at the providers (e.g. physicians) of vaccinations.</p><p><strong>Discussion: </strong>Various studies concluded that reminders to clients, provided in written, electronic or oral form, are a highly recommendable intervention. Provider based interventions were also strongly advised. DESPITE EFFORTS MADE DURING THE PAST YEARS TO ACHIEVE HERD IMMUNITY IN GERMANY, SOME DEFICITS REMAIN: i. e. there are still ample regional differences between and within German federal states.</p><p><strong>Conclusions: </strong>In the author","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc12"},"PeriodicalIF":0.0,"publicationDate":"2007-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0c/5f/HTA-03-12.PMC3011330.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of Homocysteine as a predictor for coronary heart disease.","authors":"Dagmar Lühmann,&nbsp;Susanne Schramm,&nbsp;Heiner Raspe","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background and objective: </strong>There is an ongoing debate on the role of the cytotoxic aminoacid homocysteine as a causal risk factor for the development of coronary heart disease. Results from multiple case control-studies demonstrate, that there is a strong association between high plasma levels of homoysteine and prevalent coronary heart disease, independent of other classic risk factors. Furthermore, results from interventional studies point out that elevated plasma levels of homocysteine may effectively be lowered by the intake of folic acid and B vitamins. In order to use this information for the construction of a new preventive strategy against coronary heart disease, more information is needed: first, whether homocysteine actually is a causal risk factor with relevant predictive properties and, second, whether by lowering elevated homocysteine plasma concentrations cardiac morbidity can be reduced. Currently in Germany the determination of homocysteine plasma levels is reimbursed for by statutory health insurance in patients with manifest coronary heart disease and in patients at high risk for coronary heart disease but not for screening purposes in asymptomatic low risk populations. Against this background the following assessment sets out to answer four questions: Is an elevated homocysteine plasma concentration a strong, consistent and independent (of other classic risk factors) predictor for coronary heart disease?Does a therapeutic lowering of elevated homoysteine plasma levels reduce the risk of developing coronary events?What is the cost-effectiveness relationship of homocysteine testing for preventive purposes?Are there morally, socially or legally relevant aspects that should be considered when implementing a preventive strategy as outlined above?</p><p><strong>Methods: </strong>In order to answer the first question, a systematic overview of prospective studies and metaanalyses of prospective studies is undertaken. Studies are included that analyse the association of homocysteine plasma levels with future cardiac events in probands without pre-existing coronary heart disease or in population-based samples. To answer the second question, a systematic overview of the literature is prepared, including randomised controlled trials and systematic reviews of randomised controlled trials that determine the effectiveness of homocysteine lowering therapy for the prevention of cardiac events. To answer the third question, economic evaluations of homocysteine testing for preventive purposes are analysed. Methodological quality of all materials is assessed by widely accepted instruments, evidence was summarized qualitatively.</p><p><strong>Results: </strong>For the first question eleven systematic reviews and 33 single studies (prospective cohort studies and nested case control studies) are available. Among the studies there is profound heterogeneity concercing study populations, classification of exposure (homocysteine measur","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc11"},"PeriodicalIF":0.0,"publicationDate":"2007-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/a1/HTA-03-11.PMC3011327.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ventricular assist devices for heart failure.","authors":"Lucia Angermayr,&nbsp;Marcial Velasco Garrido,&nbsp;Reinhard Busse","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Heart failure is a clinical syndrome of major epidemiological and economical importance. In Germany as in other industrialised countries it is one of the leading causes of mortality, morbidity and disability. For patients not responding to medical therapies ventricular assist devices are used as bridge to transplant, bridge to recovery or as destination therapy alternative to transplantation.</p><p><strong>Research questions: </strong>This report aims to present the actual evidence on clinical effectiveness, psychological and social aspects and economical aspects of left ventricular assist devices.</p><p><strong>Methods: </strong>We conducted a systematic research of the literature in different databases (EMBASE, MEDLINE, Cochrane Library). The included studies were assessed by two reviewers and were presented in tables and in a narrative form. We also conducted a survey among hospitals using the technology.</p><p><strong>Results and discussion: </strong>We included 40 references, six of them were HTA-reports. LVAD patients as bridge to transplant had better survival rates and a better quality of life as compared to medical therapy. Mechanical assistance was associated with frequent and often serious adverse events which were often the cause of death. There were numerous psychological and psychiatric problems.</p><p><strong>Conclusions/recommendations: </strong>LVAD showed to be clinically effective, however with high complications rate and seriousness of them. The use of technology is very costly. Cost-effective should be analysed for Germany. There is a need to further develop the technology before it can contribute seriously to a reduction of the need for heart transplantation.</p>","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc10"},"PeriodicalIF":0.0,"publicationDate":"2007-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8f/18/HTA-03-10.PMC3011328.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corticosteroid therapy in the treatment of pediatric patients with atopic dermatitis.","authors":"Barbara Fröschl,&nbsp;Danielle Arts,&nbsp;Christine Leopold","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Health political background: </strong>In developed countries 2.5% of the population - mainly children - are affected by atopic dermatitis. During the past few years its prevalence amongst school children has risen decisively and now lies between 8% to 16%. It is the most frequent chronic skin disease amongst school-aged children.</p><p><strong>Scientific background: </strong>Current methods of treating atopic dermatitis among children focus on containing and preventing the illness's further progression. Preventing dry skin, relieving symptoms (such as pruritis and inflammation of the skin) and identifying and avoiding provocating factors are elementary goals of treatment. Successful treatment can substantially increase the children's quality of life. Possible therapies of children affected by atopic dermatitis include both topically and systemically applied pharmaceuticals. During the past ten years the use of corticosteroids has been the standard topical anti-inflammatory therapy in case of aggravating inflammations. In 2002 a new group of pharmaceutical substances (topical calcineurin inhibitors tacrolimus and pimecrolimus) was authorised in Germany for topical anti-inflammatory treatment of patients. Because of its high prevalence atopic dermatitis represents a major expense factor to the German health care system. In 1999 the costs of the treatment of atopic dermatitis with corticosteroids in Germany amounted to 230 million Euro. If other direct costs for the treatment are included, for example hospitalisation or doctor appointments, the total costs amount to 3.57 billion Euro.</p><p><strong>Research question: </strong>How effective and efficient are topical anti-inflammatory treatments of children with atopic dermatitis?</p><p><strong>Methods: </strong>A systematic literature search was performed in 35 international databases which yielded 1335 articles. Following a two-part selection process according to predefined criteria 24 publications were included in the assessment.</p><p><strong>Results: </strong>Of 19 randomised controlled clinical trials, which were included in the assessment, only two evaluated the effect of topical corticosteroids in comparison to tacrolimus, which is one of the calcineurin inhibitors. Both studies show that tacrolimus is more effective than hydrocortisone acetate in children with moderate to severe atopic dermatitis. No study was found that directly compares corticosteroids with pimecrolimus in the treatment of paediatric patients with atopic dermatitis. However, two trials show that an intermittent treatment with pimecrolimus can reduce the need for topical corticosteroids. Two publications focusing on the costs of atopic dermatitis, provide model calculations comparing the use of topical corticosteroids and calcineurin inhibitors. The calculations show that the treatment with topical corticosteroids is inferior to the treatment with pimecrolimus in children with mild to moderate atopic dermatitis. F","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc09"},"PeriodicalIF":0.0,"publicationDate":"2007-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/80/42/HTA-03-09.PMC3011329.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of effectiveness and cost-effectiveness of HPV testing in primary screening for cervical.","authors":"Thomas Mittendorf,&nbsp;Marc Nocon,&nbsp;Stephanie Roll,&nbsp;Nikolai Mühlberger,&nbsp;Gaby Sroczynski,&nbsp;Uwe Siebert,&nbsp;Stefan N Willich,&nbsp;J-Matthias von der Schulenburg","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>The introduction of a screening programme for cervical carcinoma in Germany has led to a significant reduction in incidence of the disease. To date, however, diagnosis in Germany has been based solely on cervical cytology, which has been criticised because of a low sensitivity and consequently high rate of false negative results. Because an infection with the human papillomavirus (HPV) previously was found to be a necessary aetiological factor in the development of cervical cancer, there has been some discussion that HPV testing should be included in cervical cancer screening.</p><p><strong>Objectives: </strong>How do HPV tests compare to cytological tests in terms of sensitivity and specificity, and what are the effects of screening for cervical carcinoma in Germany? Is there health economic evidence that may foster an inclusion of HPV testing into national screening programms?</p><p><strong>Methods: </strong>A systematic literature review was performed, including studies that compared the HPV test to cervical cytology in terms of sensitivity and specificity in the diagnosis of CIN 2+ (CIN=Cervical Intraepithelial Neoplasia). In addition, a systematic review of the relevant health economic literature was performed to analyze cost-effectiveness in the German setting.</p><p><strong>Results: </strong>A total of 24 studies fulfilled the inclusion criteria. One study consisted of three substudies. Hence, results of 26 comparisons of HPV and cytology are reported. In 25 of these, the HPV test was more sensitive than cytology, whereas cytology had better specificity in 21 studies. The combination of HPV test and cytology increased sensitivity. Variability in results was considerably larger for cytology than for HPV testing. Results of the economic meta-analysis suggest that in health care settings with already established PAP screening programms, cost-effectiveness strongly depends on screening intervals. In analyses comparing HPV screening to conventional PAP screening with two-yearly intervals, only 25% of the HPV strategies were found to be cost-effective, whereas in comparison with one-, three-, and five-yearly PAP screening, the percentage of overall cost-effective HPV strategies was 83%, 55%, and 92%, respectively. Results for annual screening intervals are based on the assumption of complete screening compliance, which has to be further evaluated in decision analyses in the future adapting to the German health care setting.</p><p><strong>Discussion: </strong>Including HPV testing in screening procedures for cervical carcinoma could lead to a reduction in false positive results. Doing so would involve one of the following approaches: a) combining the HPV test with cytology, or b) using cytology as triage in HPV-positive women. The most appropriate interval between screening tests and the best age to start or stop screening remains to be determined. At this point a formal health economic decision analyses may help","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"3 ","pages":"Doc08"},"PeriodicalIF":0.0,"publicationDate":"2007-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/43/55/HTA-03-08.PMC3011325.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}