GMS health technology assessment最新文献

{"title":"Effectiveness of programmes as part of primary prevention demonstrated on the example of cardiovascular diseases and the metabolic syndrome.","authors":"Dieter Korczak,&nbsp;Markus Dietl,&nbsp;Gerlinde Steinhauser","doi":"10.3205/hta000093","DOIUrl":"https://doi.org/10.3205/hta000093","url":null,"abstract":"<p><strong>Background: </strong>The HTA-report (HTA = Health Technology Assessment) deals with the primary prevention of cardiovascular diseases and diabetes mellitus type 2. In 2009 approximately 356,000 people died in Germany due to cardiovascular diseases. According to estimations about 6.3 million people are suffering from diabetes mellitus type 2. The interventions that are subsidized by the public health insurance are mainly focused on sufficient physical activities, healthy nutrition, stress management and the reduction of the consumption of addictive drugs and luxury food.</p><p><strong>Objectives: </strong>Which lifestyle-related measures and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are effective? To what extent will the health status be improved by these offers? To what extent will existing health resources and skills be strengthened by these offers? Are there any differences regarding the effectiveness among the interventions with respect to different settings or subgroups? Which lifestyle-related interventions and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are sustainable and cost-effective? Which outcome parameters are in the view of the contributors decisive for the evaluation of the effectiveness? In the view of the contributor are there different values between the outcome parameters? In the view of the payers and other actors are there different values between the outcome parameters? Which ethical and juridical factors have to be considered? Which social and/or socio-economic parameters influence the use of the services and effectiveness?</p><p><strong>Methods: </strong>A systematic literature research is done in 35 databases. For the period 2005 to 2010, reviews, epidemiological and clinical studies as well as economical evaluations which deal with primary prevention programmes regarding cardiovascular diseases or the metabolic syndrome are included.</p><p><strong>Results: </strong>44 publications meet the inclusion criteria. These studies confirm the effectiveness of the primary prevention programmes. Physical activity programs seem to have a stronger effect than nutrition programmes. Psychological programmes prove as well effectiveness, if they include cognitive behaviour therapy. The identified economical studies indicate that programmes for cardiovascular prevention can be conducted cost-effectively. Interventions that focus on the general population turn out to be particularly cost-effective and sustainable.</p><p><strong>Discussion: </strong>There is a wide range of primary preventive effective lifestyle-related interventions with high evidence. The outcomes and results are consistent with the recommendations of the two identified evidence-based guidelines regarding the recommendations on lifestyle and healthy nutrition. Furthermore, the cost-effectiveness of primary prevention services is proven. With regard to the econ","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"7 ","pages":"Doc02"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f4/14/HTA-07-02.PMC3070433.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29795521","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":"Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA).","authors":"Christian Brettschneider,&nbsp;Dagmar Lühmann,&nbsp;Heiner Raspe","doi":"10.3205/hta000092","DOIUrl":"https://doi.org/10.3205/hta000092","url":null,"abstract":"<p><strong>Background: </strong>\"Patient-Reported Outcome\" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents.</p><p><strong>Methods: </strong>For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner.</p><p><strong>Results: </strong>Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, wh","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"7 ","pages":"Doc01"},"PeriodicalIF":0.0,"publicationDate":"2011-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ac/d4/HTA-07-01.PMC3070434.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29795520","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":"Prevention of alcohol misuse among children, youths and young adults.","authors":"Dieter Korczak,&nbsp;Gerlinde Steinhauser,&nbsp;Markus Dietl","doi":"10.3205/hta000095","DOIUrl":"https://doi.org/10.3205/hta000095","url":null,"abstract":"<p><strong>Background: </strong>Despite many activities to prevent risky alcohol consumption among adolescents and young adults there is an increase of alcohol intoxications in the group of ten to twenty year old juveniles.</p><p><strong>Objectives: </strong>This report gives an overview about the recent literature as well as the German federal prevention system regarding activities concerning behavioral and policy prevention of risky alcohol consumption among children, adolescents and young adults. Furthermore, effective components of prevention activities are identified and the efficiency and efficacy of ongoing prevention programs is evaluated.</p><p><strong>Methods: </strong>A systematic literature review is done in 34 databases using Bool'sche combinations of the key words alcohol, prevention, treatment, children, adolescents and young adults.</p><p><strong>Results: </strong>401 studies were found and 59 studies were selected for the health technology assessment (HTA). Most of the studies are done in USA, nine in Germany. A family strengthening program, personalized computer based intervention at schools, colleges and universities, brief motivational interventions and policy elements like increase of prices and taxes proved effective.</p><p><strong>Discussion: </strong>Among the 59 studies there are three meta-analyses, 15 reviews, 17 randomized controlled trials (RCT) and 18 cohort studies. Despite the overall high quality of the study design, many of them have methodological weaknesses (missing randomization, missing or too short follow-ups, not clearly defined measurement parameters). The transferability of US-results to the German context is problematic. Only a few prevention activities reach a sustainable reduction of frequency and/or amount of alcohol consumption.</p><p><strong>Conclusion: </strong>The HTA-report shows the need to develop specific and target group focused prevention activities for the German situation. Essential for that is the definition of target goals (reduction of consumption, change of behaviour) as well as the definition and empirical validation of risky alcohol consumption. The efficacy of prevention activities should be proven before they are launched. At present activities for the reduction or prevention of risky alcohol consumption are not sufficiently evaluated in Germany concerning their sustainable efficacy.</p>","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"7 ","pages":"Doc04"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3205/hta000095","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30049076","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 effectiveness of interventions in workplace health promotion as to maintain the working capacity of health care personal.","authors":"Barbara Buchberger,&nbsp;Romy Heymann,&nbsp;Hendrik Huppertz,&nbsp;Katharina Friepörtner,&nbsp;Natalie Pomorin,&nbsp;Jürgen Wasem","doi":"10.3205/hta000097","DOIUrl":"https://doi.org/10.3205/hta000097","url":null,"abstract":"<p><strong>Background: </strong>The increasing proportion of elderly people with respective care requirements and within the total population stands against aging personnel and staff reduction in the field of health care where employees are exposed to high load factors. Health promotion interventions may be a possibility to improve work situations and behavior.</p><p><strong>Methods: </strong>A systematic literature search is conducted in 32 databases limited to English and German publications since 1990. Moreover, internet-searches are performed and the reference lists of identified articles are scanned. The selection of literature was done by two reviewers independently according to inclusion and exclusion criteria. Data extraction and tables of evidence are verified by a second expert just like the assessment of risk of bias by means of the Cochrane Collaboration's tool.</p><p><strong>Results: </strong>We identified eleven intervention studies and two systematic reviews. There were three randomized controlled trials (RCT) and one controlled trial without randomization (CCT) on the improvement of physical health, four RCT and two CCT on the improvement of psychological health and one RCT on both. Study duration ranged from four weeks to two years and the number of participants included from 20 to 345, with a median of 56. Interventions and populations were predominantly heterogeneous. In three studies intervention for the improvement of physical health resulted in less complaints and increased strength and flexibility with statistically significant differences between groups. Regarding psychological health interventions lead to significantly decreased intake of analgesics, better stress management, coping with workload, communication skills and advanced training.</p><p><strong>Discussion: </strong>Taking into consideration the small to very small sample sizes, other methodological flaws like a high potential of bias and poor quality of reporting the validity of the results has to be considered as limited. Due to the heterogeneity of health interventions, study populations with differing job specializations and different lengths of study durations and follow-up periods, the comparison of results would not make sense.</p><p><strong>Conclusions: </strong>Further research is necessary with larger sample sizes, with a sufficient study duration and follow-up, with a lower risk of bias, by considering of relevant quality criteria and with better reporting in publications.</p>","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"7 ","pages":"Doc06"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8d/8f/HTA-07-06.PMC3198117.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30234685","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":"Percutaneous coronary intervention with optimal medical therapy vs. optimal medical therapy alone for patients with stable angina pectoris.","authors":"Vitali Gorenoi,&nbsp;Matthias P Schönermark,&nbsp;Anja Hagen","doi":"10.3205/hta000098","DOIUrl":"https://doi.org/10.3205/hta000098","url":null,"abstract":"<p><strong>Scientific background: </strong>Stable Angina Pectoris (AP) is a main syndrome of chronic coronary artery disease (CAD), a disease with enormous epidemiological and health economic relevance. Medical therapy and percutaneous coronary interventions (PCI) are the most important methods used in the treatment of chronic CAD.</p><p><strong>Research questions: </strong>The evaluation addresses questions on medical efficacy, incremental cost-effectiveness as well as ethic, social and legal aspects in the use of PCI in CAD patients in comparison to optimal medical therapy alone.</p><p><strong>Methods: </strong>A systematic literature search was conducted in June 2010 in the electronic databases (MEDLINE, EMBASE etc.) and was completed by a hand search. The medical analysis was initially based on systematic reviews of randomized controlled trials (RCT) and was followed by the evaluation of RCT with use of current optimal medical therapy. The results of the RCT were combined using meta-analysis. The strength and the applicability of the determined evidence were appraised. The health economic analysis was initially focused on the published studies. Additionally, a health economic modelling was performed with clinical assumptions derived from the conducted meta-analysis and economic assumptions derived from the German Diagnosis Related Groups 2011.</p><p><strong>Results: </strong>Seven systematic reviews (applicability of the evidence low) and three RCT with use of optimal medical therapy (applicability of the evidence for the endpoints AP and revascularisations moderate, for further endpoints high) were included in the medical analysis. The results from RCT are used as a base of the evaluation. The routine use of the PCI reduces the proportion of patients with AP attacks in the follow-up after one and after three years in comparison with optimal medical therapy alone (evidence strength moderate); however, this effect was not demonstrated in the follow-up after five years (evidence strength low). The difference in effect in the follow-up after four to five years was not found for the further investigated clinical endpoints: death, cardiac death, myocardial infarction and stroke (evidence strength high) as well as for severe heart failure (evidence strength moderate). Two studies were included in the health economic analysis. The costs estimations from these studies are not directly transferable to the corresponding costs in Germany. The average difference in the total costs for PCI in comparison with optimal medical therapy alone, which was calculated in the modelling, was found to be 4,217 Euro per patient. The incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was estimated to be 24,805 Euro (evidence strength moderate). No publication was identified concerning ethical, social or legal aspects.</p><p><strong>Discussion: </strong>Important methodical problems of the studies are a lack of blinding of the patien","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"7 ","pages":"Doc07"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ec/a6/HTA-07-07.PMC3244729.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30354702","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":"Individual health services.","authors":"Petra Schnell-Inderst,&nbsp;Theresa Hunger,&nbsp;Katharina Hintringer,&nbsp;Ruth Schwarzer,&nbsp;Vanadin Regina Seifert-Klauss,&nbsp;Holger Gothe,&nbsp;Jürgen Wasem,&nbsp;Uwe Siebert","doi":"10.3205/hta000096","DOIUrl":"https://doi.org/10.3205/hta000096","url":null,"abstract":"<p><strong>Background: </strong>The German statutory health insurance (GKV) reimburses all health care services that are deemed sufficient, appropriate, and efficient. According to the German Medical Association (BÄK), individual health services (IGeL) are services that are not under liability of the GKV, medically necessary or recommendable or at least justifiable. They have to be explicitly requested by the patient and have to be paid out of pocket.</p><p><strong>Research questions: </strong>The following questions regarding IGeL in the outpatient health care of GKV insurants are addressed in the present report: What is the empirical evidence regarding offers, utilization, practice, acceptance, and the relation between physician and patient, as well as the economic relevance of IGeL?What ethical, social, and legal aspects are related to IGeL? FOR TWO OF THE MOST COMMON IGEL, THE SCREENING FOR GLAUCOMA AND THE SCREENING FOR OVARIAN AND ENDOMETRIAL CANCER BY VAGINAL ULTRASOUND (VUS), THE FOLLOWING QUESTIONS ARE ADDRESSED: What is the evidence for the clinical effectiveness?Are there sub-populations for whom screening might be beneficial?</p><p><strong>Methods: </strong>The evaluation is divided into two parts. For the first part a systematic literature review of primary studies and publications concerning ethical, social and legal aspects is performed. In the second part, rapid assessments of the clinical effectiveness for the two examples, glaucoma and VUS screening, are prepared. Therefore, in a first step, HTA-reports and systematic reviews are searched, followed by a search for original studies published after the end of the research period of the most recent HTA-report included.</p><p><strong>Results: </strong>29 studies were included for the first question. Between 19 and 53% of GKV members receive IGeL offers, of which three-quarters are realised. 16 to 19% of the insurants ask actively for IGeL. Intraocular tension measurement is the most common single IGeL service, accounting for up to 40% of the offers. It is followed by ultrasound assessments with up to 25% of the offers. Cancer screening and blood or laboratory services are also frequent and represent a major proportion of the demand. The ethical, social, and legal aspects discussed in the context of IGeL concern eight subject areas: autonomous patient decisions versus obtrusion,commercialization of medicine, duty of patient information, benefit, evidence, and (quality) control, role and relation of physicians and patients,relation to the GKV, social inequality,formally correct performance. For glaucoma screening, no randomized controlled trial (RCT) is identified that shows a patient relevant benefit. For VUS three RCT are included. However, they do not yet present mortality data concerning screened and non-screened persons. VUS screening shows a high degree of over-diagnosis in turn leading to invasive interventions. To diagnose one invasive carcinoma, 30 to 35 surgical procedures a","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"7 ","pages":"Doc05"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1b/67/HTA-07-05.PMC3182028.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30181750","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":"Effectiveness of pharmaceutical therapy of ADHD (Attention-Deficit/Hyperactivity Disorder) in adults - health technology assessment.","authors":"Diana Benkert,&nbsp;Klaus-Henning Krause,&nbsp;Jürgen Wasem,&nbsp;Pamela Aidelsburger","doi":"10.3205/hta000091","DOIUrl":"https://doi.org/10.3205/hta000091","url":null,"abstract":"<p><strong>Background: </strong>Attention-Deficit/Hyperactivity Disorder (ADHD) is a mental disorder. Symptoms include hyperactivity, lack of attentiveness, and frivolousness. This disorder always begins in childhood, but can remain through adulthood. ADHD affects all areas of life and limits the quality of life due to its symptoms and the high rate of associated disorders that can develop. An established form of therapy is using stimulant medications, most commonly, containing Methylphenidate as the active ingredient. However, in Germany this ingredient is not approved for adults suffering from ADHD. Therefore, many adults cannot obtain appropriate medication to treat this disorder.</p><p><strong>Objective: </strong>The following report (Health Technology Assessment [HTA]) examines the effectiveness and cost-effectiveness of the medical treatment of ADHD in adults as well as the ethical, social and legal aspects thereof.</p><p><strong>Methods: </strong>In August 2009, a systematic literature search is performed in all relevant scientific databases. The selected citations fulfill predetermined inclusion criteria. The data in the publications is then systematically extracted, reviewed and assessed. A manual search of citations is conducted as well.</p><p><strong>Results: </strong>NINETEEN STUDIES FULFILL THE INCLUSION CRITERIA: nine randomised controlled studies (RCT), five meta-analyses, three economic studies and two studies relevant to the legal aspects of the HTA. All RCT reveal that adult patients who receive medication containing a stimulant (Methylphenidate and Amphetamine) and Atomoxetine, see a reduction of ADHD symptoms compared to the placebo-treated patients. The drug response rate among the control group ranges from 7 to 42%; in the treatment group from 17 to 59.6%. The meta-analyses confirm the findings of the RCT. In light of the control group, it can be ascertained that there are higher annual costs (both direct and indirect) for patients with ADHD. The average annual medical expenses for an adult with ADHD were 1,262 $ in 1998 and 1,673 $ in 2001 (the converted and inflation-adjusted rate for 2009: between 1,270 and 1,619 Euro). The use of stimulants use may impair the patient's ability to drive, travel or do sports. No relevant studies can be identified concerning the ethical, social and/or legal aspects of stimulant medication for ADHD patients.</p><p><strong>Discussion/conclusion: </strong>Medical treatment, particularly including Methylphenidate and Atomoxetine, proves to have a positive effect. In order to attain an optimal drug response, dosing must be determined on an individual basis. There is a need of high-quality studies that directly compare various agents - an aspect which is relevant to medical effectiveness of a therapy. No definite statement can be made about the cost-effectiveness of the medical treatment of ADHD in adults. More health economic studies are therefore required. Apart from the unquestionable mental i","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"6 ","pages":"Doc13"},"PeriodicalIF":0.0,"publicationDate":"2010-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3b/00/HTA-06-13.PMC3010888.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645017","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 importance of growth factors for the treatment of chronic wounds in the case of diabetic foot ulcers.","authors":"Barbara Buchberger,&nbsp;Markus Follmann,&nbsp;Daniela Freyer,&nbsp;Hendrik Huppertz,&nbsp;Alexandra Ehm,&nbsp;Jürgen Wasem","doi":"10.3205/hta000090","DOIUrl":"https://doi.org/10.3205/hta000090","url":null,"abstract":"<p><strong>Introduction: </strong>Ulcers as a result of diabetes mellitus are a serious problem with an enormous impact on the overall global disease burden due to the increasing prevalence of diabetes. Because of long hospital stays, rehabilitation, often required home care and the use of social services diabetic foot complications are costly. Therapy with growth factors could be an effective and innovative add-on to standard wound care.</p><p><strong>Research questions: </strong>What is the benefit of therapies with growth factors alone or in combination with other technologies in the treatment of diabetic foot ulcer assessed regarding medical, economical, social, ethical and juridical aspects?</p><p><strong>Methods: </strong>We systematically searched relevant databases limited to English and German language and publications since 1990. Cost values were adjusted to the price level of 2008 and converted into Euro. A review and an assessment of the quality of publications were conducted following approved methodical standards conforming to evidence-based medicine and health economics.</p><p><strong>Results: </strong>We identified 25 studies (14 randomized controlled trials (RCT), nine cost-effectiveness analyses, two meta-analyses). The RCT compared an add-on therapy to standard wound care with standard wound care/placebo alone or extracellular wound matrix: in six studies becaplermin, in two rhEGF, in one bFGF, and in five studies the metabolically active skin grafts Dermagraft and Apligraf. The study duration ranged from twelve to 20 weeks and the study population included between 17 to 382 patients, average 130 patients. The treatment with becaplermin, rhEGF and skin implants Dermagraft and Apligraf showed in eight out of 13 studies an advantage concerning complete wound closure and the time to complete wound healing. Evidence for a benefit of treatment with bFGF could not be found. In four out of 14 studies the proportion of adverse events was 30% per study group with no difference between the treatment groups. The methodological quality of the studies was affected by significant deficiencies. The results showed becaplermin being cost-effective whereas no obvious statement can be made regarding Dermagraft and Apligraf because of diverging cost bases and incremental cost-effectiveness ratios.</p><p><strong>Discussion: </strong>Differences in standard wound care are complicating the comparison of study results. Taking into consideration the small to very small sample sizes and other methodological flaws with high potential of bias, the validity of the results with regard to effectiveness and cost-effectiveness has to be considered limited. The duration of treatment and follow-up examinations is not long enough to assess the sustainability of the intervention and the surveillance of ulcer recurrences or treatment related adverse events like the development of malignancy.</p><p><strong>Conclusions: </strong>There are indications of an advantage ","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"6 ","pages":"Doc12"},"PeriodicalIF":0.0,"publicationDate":"2010-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/40/47/HTA-06-12.PMC3010891.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645016","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":"Outpatient pulmonary rehabilitation - rehabilitation models and shortcomings in outpatient aftercare.","authors":"Dieter Korczak,&nbsp;Beate Huber,&nbsp;Gerlinde Steinhauser,&nbsp;Markus Dietl","doi":"10.3205/hta000089","DOIUrl":"https://doi.org/10.3205/hta000089","url":null,"abstract":"<p><strong>Background: </strong>The chronic obstructive pulmonary disease (COPD) and the bronchial asthma are widespread diseases. They need long-lasting and sustainable rehabilitation.</p><p><strong>Objectives: </strong>The goal of this HTA is to describe the present supply and the economic relevance of out-patient pulmonary rehabilitation in conjunction with its social aspects. A further target is to derivate options for actions in the health-care system and possible research necessities.</p><p><strong>Methods: </strong>Relevant publications are identified by means of a structured search in 37 database accessed through the German Institute of Medical Documentation and Information (DIMDI). In addition a manual search of identified reference lists has been done. The present report includes German and English literature published from 2004 to 2009. The methodological quality was assessed by two independent researchers according to pre-defined quality criteria of evidence based medicine.</p><p><strong>Results: </strong>Among 860 publications 31 medical studies, four economic studies and 13 ethical studies meet the inclusion criteria. The studies cover rehabilitation programmes in 19 countries. The majority of them has a high level of evidence (1A to 2C). The pulmonary rehabilitation programmes differ by the setting (in-patient, out-patient, in-home, community-based), by the length of intervention (from two weeks to 36 months), by the way and the frequency of intervention and by the duration of the follow-up treatment. Overall out-patient rehabilitation programmes achieve the same positive effects for COPD patients as in-patient programmes do. This is especially true for physical performance and health related quality of life. There are only a few studies dealing with asthma. Therefore, valid statements cannot be given. The results for cost-effectiveness are not distinct enough.</p><p><strong>Discussion: </strong>Goals of pulmonary rehabilitation like prevention and adequate treatment of acute exacerbations, the minimisation of hospitalisation and the reduction of mortality are attained in out-patient as well as in in-patient pulmonary rehabilitation. Regarding the best frequency of training units per week or the duration and the content of a unit further research is needed. Final results for the ideal length of an in-patient rehabilitation are still missing. None of the studies deals with the analysis of the different treatment forms of a COPD which are frequently defined by an alteration of in-patient and out-patient treatments and participation in sports clubs or self-help groups. There are some other limitations of the studies. The results concerning self-management programmes are not distinct. (Self-) Selection leads to high drop-out rates. Many studies have only small sample sizes. Confounder and long-time effects are seldom researched, relevant economic evaluations do not exist The improvement of health related quality of life is primarily ob","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"6 ","pages":"Doc11"},"PeriodicalIF":0.0,"publicationDate":"2010-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/78/f7/HTA-06-11.PMC3010890.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645015","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":"Prevention of infection after knee arthroplasty.","authors":"Vitali Gorenoi,&nbsp;Matthias P Schönermark,&nbsp;Anja Hagen","doi":"10.3205/hta000088","DOIUrl":"https://doi.org/10.3205/hta000088","url":null,"abstract":"<p><strong>Scientific background: </strong>Man-made joints (joint endoprostheses), including knee endoprostheses, are used in some irreversible diseases of the human joints. The implantation of joint endoprostheses (arthroplasty) is associated with an increased risk for infection. To prevent infections, different interventions without and with the use of antibiotics (hygiene procedures and antibiotic prophylaxis) are used. The benefits of these interventions are not clear yet.</p><p><strong>Research questions: </strong>The presented report addresses the questions regarding the medical effectiveness, the cost-effectiveness as well as the ethical, social and legal aspects related to the use of interventions to prevent infections after knee arthroplasty.</p><p><strong>Methods: </strong>A systematic literature search is conducted in the medical electronic databases MEDLINE, EMBASE, SciSearch etc. in June 2009 and has been completed by a hand search. The analysis includes publications which describe and/or evaluate clinical data from randomized controlled trials (RCT), systematic reviews of RCT, registers of endoprostheses or databases concerning interventions to prevent infections after knee arthroplasty. The conducted literature search also aims to identify health-economic studies and publications dealing explicitly with ethical, social or legal aspects in the use of interventions to prevent infections after knee arthroplasty. The synthesis of information from different publications has been performed qualitatively.</p><p><strong>Results: </strong>The systematic literature search yields 1,030 hits. Based on the predefined inclusion and exclusion criteria a total of ten publications is included in the analysis. The presented report does not find evidence of the effectiveness of different hygiene interventions with a high evidence level. Most of the unspecific interventions are recommended on the basis of results from non-RCT, from studies for other clinical indications and/or for clinically not relevant endpoints, as well as on the basis of expert opinions. The evidence of the effectiveness of intravenous prophylaxis with antibiotics in knee arthroplasty on a high level of evidence is also missing. The recommendations use evidence on the intravenous antibiotic prophylaxis transferred from RCT in hip arthroplasty to the arthroplasty of all joints including knee replacement. Moreover, no evidence is found for differences in the effectiveness between various antibiotics in knee arthroplasty. The presented report finds strong hints for the effectiveness of antibiotics in cement in addition to the intravenous prophylaxis; however, evidence of the effectiveness may be accepted only for operating rooms without clean-air measures.</p><p><strong>Discussion: </strong>The conclusiveness of the results from non-RCT and from studies for clinically non-relevant endpoints is relatively low. The determined evidence from studies for other clinical indications may be ","PeriodicalId":89142,"journal":{"name":"GMS health technology assessment","volume":"6 ","pages":"Doc10"},"PeriodicalIF":0.0,"publicationDate":"2010-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b1/81/HTA-06-10.PMC3010886.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29645014","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}