Analyse des vorläufigen Berichtsplans des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen für eine Kosten-Nutzen-Bewertung zu Clopidogrel bei der peripheren arteriellen Verschlusskrankheit und beim akuten Koronarsyndrom

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Alternative methods for the treatment of post-menopausal troubles

[english] Menopause is described as the transition from the reproductive phase of a women to the non reproductive. Changes in hormone levels might lead to complaints and health consequences especially during peri- and postmenopause. Hormone therapy has a potential damaging health risk profile and is recommended for temporal limited therapy for acute vasomotor symptoms only.The present HTA-report aims to assess the effectiveness and the cost-effectiveness of alternative treatment methods for women with postmenopausal symptoms in Germany regarding patient relevant endpoints (reduction of symptoms and frequency of adverse events and improvement of quality of life).A systematic literature search was carried out in 33 relevant databases in September 2010. Citations were selected according to pre-defined criteria and were extracted and evaluated.In the systematic research 22 studies are identified for the effectiveness evaluation, 22 primary studies and one review.High doses of isolated genistein reduce the frequency/intensity of hot flashes while low doses of genistein show no significant effect. Intake of isoflavone extract such as genistein, daidzein, glycitein in various combinations does not have an effect on improvement of cognitive function or vaginal dryness. The effect of black cohosh and hop extract for menopausal complaints cannot be determined since results are heterogenous. The combination of isoflavone, black cohosh, monk’s pepper, valerian and vitamin E has a positive effect on menopause symptoms. Ginkgo biloba shows no significant effect on menopause symptoms and cognitive improvement beside mental flexibility. Acupuncture has a significant influence on hot flashes especially in severe cases.No final statement can be drawn regarding the effectiveness of alter­ne treatment methods due to qualitative shortcomings of included studies and a general limited availability of studies in this field. Furthermore, the generalization of the present HTA is limited due to the inclusion of only postmenopausal women.<br><br>[german] Als Wechseljahre wird der Übergang von der reproduktiven Phase der Frau zur nicht-reproduktiven beschrieben. Insbesondere in der Peri- und Postmenopause können Beschwerden aufgrund des sich veränderten Hormonspiegels auftreten. Aktuell wird die Hormontherapie wegen der mit dieser verbundenen Risiken nur noch zur kurzfristigen Behandlung akuter vasomotorischer Symptome empfohlen. Von den betroffenen Frauen werden alternative und komplementäre Heilmethoden eingesetzt.Im vorliegenden Health Technology Assessment (HTA) sollen die Effektivität und Kosteneffektivität alternativer Behandlungsmethoden von postmenopausalen Wechseljahresbeschwerden in Deutschland hinsichtlich der patientenrelevanten Endpunkte Verringerung der Symptomatik, Häufigkeit unerwünschter Ereignisse sowie Verbesserung der Lebensqualität bewertet werden. In 33 relevanten Datenbanken wird im September 2010 eine systematische Literatursuche durchgeführt. Gefundene und relevante Literaturstellen werden gemäß vorab definierter Kriterien selektiert. Die Daten der Literaturstellen werden gezielt herausgesucht, bewertet und zusammenfassend beurteilt.Aus der systematischen Recherche werden 22 Studien, davon 15 Primärstudien und ein Review zur Bewertung der Effektivität identifiziert.Hochdosiertes isoliertes Genistein reduziert die Anzahl/Schwere von Hitzewallungen, während niedrig dosiertes Genistein keinen signifikanten Effekt zeigt. Die Gabe von Isoflavonextrakten, die Genistein, Daidzein, Glycitein in unterschiedlicher Zusammensetzung enthalten, hat keinen signifikanten Einfluss auf die Verbesserung kognitiver Fähigkeiten oder vaginale Trockenheit. Traubensilberkerzen- und Hopfenextrakt führen zu unterschiedlichen Ergebnissen bezüglich der Wirksamkeit bei postmenopausalen Beschwerden, sodass keine abschließende Aussage zur Effektivität getroffen werden kann. Die Kombination von Isoflavonen, Traubensilberkerze, Mönchspfeffer, Baldrian und Vitamin E hat eine positive Wirkung auf postmenopausale Symptome. Ginkgo biloba zeigt keinen signifikanten Effekt auf postmenopausale Symptome und eine kognitive Verbesserung mit Ausnahme der mentalen Flexibilität. Akupunktur hat einen signifikanten Einfluss auf Hitzewallungen, insbesondere auf deren Schweregrad.Aufgrund der qualitativen Mängel (Concealment, Randomisierung, Fallzahlplanung) der eingeschlossenen Studien und der begrenzten Anzahl an Studien kann keine abschließende zusammenfassende Bewertung zur Wirksamkeit alternativer Heilmethoden gegeben werden. Die Verallgemeinerbarkeit des vorliegenden HTA wird durch die Beschränkung auf postmenopausale Frauen reduziert

Elastic robust intramedullary nailing for forearm fracture in children

Background: Forearm fractures are the most common fractures in children (23% of all fractures). Basically there are two treatment options available for diaphyseal forearm fractures in children: closed reduction with cast immobilisation (conservative therapy) and the elastic stable intramedullary nailing (ESIN). Treatment decision is influenced by the doctor's estimation of fracture instability. Stable fractures can be treated conservatively whereas instable forearm shaft fractures can be treated according the following three treatment strategies: 1. conservative therapy in an outpatient setting 2. conservative therapy in the operating room in attendance to change to ESIN in case that no stabilisation can be achieved with cast immobilisation 3. immediate treatment with ESIN in the operating room. Objectives: Aim of this Health Technology Assessment (HTA) report is to assess and report the published evidence concerning effectiveness and cost-effectiveness of ESIN as a treatment option for diaphyseal forearm fractures in children and to identify future research need. Important parameters for the assessment of effectiveness are objective parameters (axis deviation, losses of motion, and numbers of reductions in case of redislocations) and subjective parameters (pain or impairment in quality of life). Furthermore, a health economic evaluation shall be done which refers to the costs of the different therapy strategies. Methods: An extensive, systematic literature search in medical, economic, and HTA literature databases was performed. Relevant data were extracted and synthesised. Results: Three cohort studies and seven case series have been identified. Controlled clinical studies, systematic reviews and/or HTA reports that gave evidence to answer the own study question have not been found. The identified studies partly differed in respect of defined indication for ESIN, study population and treatment strategies. For that reason comparability of results was limited. In the majority of cases the publications reported a successful consolidation of fractures treated with ESIN. The cohort studies reported no differences in mobility after treatment with ESIN compared to patients who were treated conservatively. No publications that argue health economic aspects of the ESIN in children could be identified in the literature search. A cost data assessment conducted by the authors of this report showed that ESIN is associated with higher costs compared to the other treatment strategies (without considering long term costs due to reduction in case of redisplacement).ConclusionsLittle evidence for a dominance of ESIN in treating forearm shaft fractures of children compared to conservative therapy could be found. Accomplishment of ESIN without complications causes more costs than conservative therapy both in outpatient and in inpatient setting. However, if fracture stabilisation cannot be achieved by conservative therapy, further interventions will be necessary. They will result in a burden for the patients and higher costs

Festlegung von Erstattungspreisen für Arzneimittel zur Behandlung der Gastroösophagealen Refluxkrankheit: Eine Machbarkeitsstudie zur 'Modellbeschreibung und Methodik für die Festlegung von Erstattungspreis-Korridoren im generikafähigen GKV-Markt' des Bundesverbandes der Arzneimittelhersteller (BAH)

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Assessing the prevalence of the Metabolic Syndrome according to NCEP ATP III in Germany: feasibility and quality aspects of a two step approach in 1550 randomly selected primary health care practices

Objective: Metabolic Syndrome (MetSyn) describes a cluster of metabolic disorders and is considered a risk factor for development of cardiovascular disease. Although a high prevalence is commonly assumed in Germany data about the degree of its occurrence in the population and in subgroups are still missing. The aim of this study was to assess the prevalence of the MetSyn according to the NCEP ATP-III (National Cholesterol Education Program Adult Treatment Panel III) criteria in persons aged ≥18 years attending a general practitioner in Germany. Here we describe in detail the methods used and the feasibility of determining the MetSyn in a primary health care setting

Impact of 4 different definitions used for the assessment of the prevalence of the Metabolic Syndrome in primary healthcare:The German Metabolic and Cardiovascular Risk Project (GEMCAS)

<p>Abstract</p> <p>Background</p> <p>The metabolic syndrome (MetSyn) places individuals at increased risk for type 2 diabetes and cardiovascular disease. Prevalence rates of the population of the MetSyn are still scarce. Moreover, the impact of different definitions of the MetSyn on the prevalence is unclear. Aim here is to assess the prevalence of the MetSyn in primary health care and to investigate the impact of four different definitions of the MetSyn on the determined prevalence with regard to age, gender and socio-economic status.</p> <p>Methods</p> <p>The German-wide cross-sectional study was conducted during two weeks in October 2005 in 1.511 randomly selected general practices. Blood samples were analyzed, blood pressure and waist circumference assessed, data on lifestyle, medication, chronic disorders, and socio-demographic characteristics collected. MetSyn prevalence was estimated according to the definitions of NCEP ATP III (2001), AHA/NHLBI (2004, 2005), and IDF (2005). Descriptive statistics and prevalence rate ratios using the PROG GENMOD procedure, were calculated. Cohen's kappa was used as measure for interreliability between the different prevalence estimates.</p> <p>Results</p> <p>Data of 35,869 patients (age range: 18–99, women 61.1%) were included. The prevalence was lowest using the NCEP ATP III- (all: 19.8%, men 22.7%, women: 18.0%), highest according to the IDF-definition (32.7%, 40.3%, 28.0%). The increase in prevalence with recent definitions was more pronounced for men than for women, and was particularly high for men and women aged 60–79 years. The IDF-definition resulted in a higher prevalence especially in those with the highest educational status. Agreement (kappa) between the NCEP ATP III- and IDF-definition was 0.68 (men 0.61, women 0.74), between the updated the AHA/NHLBI- (2005) and IDF-definition 0.85 (men 0.79, women 0.89).</p> <p>Conclusion</p> <p>The prevalence of metabolic syndrome is associated with age, gender, and educational status and increases considerably with each newly published definition. Our data highlight the need for a better evidence regarding thresholds of the components of the metabolic syndrome, especially with regard to the IDF-definition – according to which in some populations a majority of subjects are diagnosed with the metabolic syndrome.</p

Decision-analytic modeling to evaluate the long-term effectiveness and cost-effectiveness of HPV-DNA testing in primary cervical cancer screening in Germany

Sroczynski G, Schnell-Inderst P, Muhlberger N, et al. Decision-analytic modeling to evaluate the long-term effectiveness and cost-effectiveness of HPV-DNA testing in primary cervical cancer screening in Germany. GMS health technology assessment. 2010;6:Doc05.Persistent infections with high-risk types of human papillomavirus (HPV) are associated with the development of cervical neoplasia. Compared to cytology HPV testing is more sensitive in detecting high-grade cervical cancer precursors, but with lower specificity. HPV based primary screening for cervical cancer is currently discussed in Germany. Decisions should be based on a systematic evaluation of the long-term effectiveness and cost-effectiveness of HPV based primary screening. What is the long-term clinical effectiveness (reduction in lifetime risk of cervical cancer and death due to cervical cancer, life years gained) of HPV testing and what is the cost-effectiveness in Euro per life year gained (LYG) of including HPV testing in primary cervical cancer screening in the German health care context? How can the screening program be improved with respect to test combination, age at start and end of screening and screening interval and which recommendations should be made for the German health care context? A previously published and validated decision-analytic model for the German health care context was extended and adapted to the natural history of HPV infection and cervical cancer in order to evaluate different screening strategies that differ by screening interval, and tests, including cytology alone, HPV testing alone or in combination with cytology, and HPV testing with cytology triage for HPV-positive women. German clinical, epidemiological and economic data were used. In the absence of individual data, screening adherence was modelled independently from screening history. Test accuracy data were retrieved from international meta-analyses. Predicted outcomes included reduction in lifetime-risk for cervical cancer cases and deaths, life expectancy, lifetime costs, and discounted incremental cost-effectiveness ratios (ICER). The perspective of the third party payer and 3% annual discount rate were adopted. Extensive sensitivity analyses were performed in order to evaluate the robustness of results and identify areas of future research. In the base case analysis screening resulted in a 53% to 97% risk reduction for cervical cancer with a discounted ICER between 2,600 Euro/LYG (cytology alone every five years) and 155,500 Euro/LYG (Annual cytology age 20 to 29 years, and annual HPV age 30 years and older). Annual cytology, the current recommended screening strategy in Germany, was dominated. In sensitivity analyses variation in the relative increase in the sensitivity of HPV testing as compared to cytology, HPV test costs, screening adherence, HPV incidence, and annual discount rate influenced the ICER results. Variation in the screening start age also influenced the ICER. All cytology strategies were dominated by HPV screening strategies, when relative sensitivity increase by HPV testing compared to cytology was higher (scenario analysis with data for test accuracy from German studies). HPV testing every one, two or three years was more effective than annual cytology. With increased screening adherence a longer screening interval and with low screening adherence a shorter interval would be more cost-effective. With a reduction in HPV incidence of more than 70% triennial HPV screening in women aged 30 years and older (and biennial Pap screening in women aged 20 to 29 years) is cost-effective. The discounted ICER increases with increasing annual discount rate. Increasing screening start age to 25 years had no relevant loss in effectiveness but resulted in lower costs. An optimal strategy may be biennial HPV testing age 30 years and older with biennial cytology at age 25 to 29 years (ICER of 23,400 Euro/LYG). Based on these results, HPV-based cervical cancer screening is more effective than cytology and could be cost-effective if performed at intervals of two years or greater. Increasing the age at screening start to 25 years causes no relevant loss in effectiveness but saves resources. In the German context an optimal screening strategy could be biennial HPV testing at age 30 years and older with biennial cytology at the age of 25 to 29 years. An extension to a three-yearly screening interval requires substantially improved screening adherence or a higher relative increase in the sensitivity of HPV testing as compared to cytology. The implementation of an organised screening program for quality-controlled introduction of HPV-screening and -vaccination with continued systematic outcome evaluation is recommended

Traditionelle chinesische Arzneitherapie bei Patienten mit chronischer Rhinosinusitis - eine Therapiebeobachtung mit Berücksichtigung der Arzneimittelherkunft

BACKGROUND The use of Chinese medicinal drugs is becoming more common in Germany. However, the import from China results in aggravated quality controls and potentially jeopardized therapeutic safety. Therefore, in 1999 the Bavarian Department for Agriculture has initiated an interdisciplinary research project to cultivate and analyze important Chinese herbal plants. Currently 16 Bavarian-produced Chinese drugs are in use and distributed to patients by pharmacies. Despite a comparable quality of Bavarian pharmaceutical products, there are concerns remaining as the Bavarian medical drugs have been used for treatment purposes on patients since 2006, without their effect having been compared to the Chinese products. Therefore we performed an observational trial using a parallel group design on patients with chronic rhinosinusitis. METHODS The duration of the trial was 4 weeks. After a 4-week follow-up, the patients were interviewed via telephone. During the trial the patients were given 2 × 50 ml of a decoction of Chinese medicinal herbs, either (a) from Bavarian controlled cultivation (Bavaria group) or (b) from Chinese production (China group). The therapeutic success was evaluated using numerical rating scales. RESULTS In total, 64 patients completed the observational trial (31 Bavaria group, 33 China group). Both groups showed significant improvements in the main symptom scores of chronic rhinosinusitis as well as in secondary symptoms, such as the overall state of health or the tendency to catch a cold. There were no significant differences between the groups concerning the main symptoms scores. Overall the herbal decoctions had no severe side effects. CONCLUSION This observational trial shows that Chinese herbal drugs from Bavarian cultivation are as effective as medicinal herbs imported from China, but the effects of concomitant therapies must be considered as well. The symptom score improvements during the treatment period were obvious and should stimulate further investigation on the efficacy of this herbal formula in the treatment of chronic rhinosinusitis

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

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