Effects of Ginkgo biloba in dementia: systematic review and meta-analysis

<p>Abstract</p> <p>Background</p> <p>The benefit of Ginkgo biloba has been discussed controversially. The aim of this review was to assess the effects of Ginkgo biloba in Alzheimer's disease as well as vascular and mixed dementia covering a variety of outcome domains.</p> <p>Methods</p> <p>We searched MEDLINE, EMBASE, the Cochrane databases, CINAHL and PsycINFO for controlled trials of ginkgo for Alzheimer's, vascular or mixed dementia. Studies had to be of a minimum of 12 weeks duration with at least ten participants per group. Clinical characteristics and outcomes were extracted. Meta-analysis results were expressed as risk ratios or standardized mean differences (SMD) in scores.</p> <p>Results</p> <p>Nine trials using the standardized extract EGb761^®met our inclusion criteria. Trials were of 12 to 52 weeks duration and included 2372 patients in total. In the meta-analysis, the SMDs in change scores for cognition were in favor of ginkgo compared to placebo (-0.58, 95% confidence interval [CI] -1.14; -0.01, p = 0.04), but did not show a statistically significant difference from placebo for activities in daily living (ADLs) (SMD = -0.32, 95% CI -0.66; 0.03, p = 0.08). Heterogeneity among studies was high. For the Alzheimer subgroup, the SMDs for ADLs and cognition outcomes were larger than for the whole group of dementias with statistical superiority for ginkgo also for ADL outcomes (SMD = -0.44, 95% CI -0.77; -0.12, p = 0.008). Drop-out rates and side effects did not differ between ginkgo and placebo. No consistent results were available for quality of life and neuropsychiatric symptoms, possibly due to the heterogeneity of the study populations.</p> <p>Conclusions</p> <p>Ginkgo biloba appears more effective than placebo. Effect sizes were moderate, while clinical relevance is, similar to other dementia drugs, difficult to determine.</p

Behavioural and skill-based early interventions in children with autism spectrum disorders

Introduction: Autism spectrum disorders (ASD) comprise typical or infantile autism (Kanner syndrome), Asperger’s disorder and atypical autism or pervasive developmental disorder - not otherwise specified. The syndrome is characterized by deficits in (1) verbal and nonverbal communication, (2) reciprocal social interaction and (3) repetitive patterns of behaviour, interests and activities. Early behavioural interventions are based on learning theory and behaviour therapy. They take into account specific deficits in perception, emotional reactions, social interaction and communication. In Germany, these comprehensive models are not widely evaluated and implemented. Research questions: * What are the clinical effectiveness and safety of early behavioural or skills-based early interventions in autism compared to other interventions or to treatment as usual? * What are specific factors responsible for the effectiveness? * What are the cost-effectiveness and cost consequences of different early interventions in autism? * Which legal, social and ethical aspects are relevant with regard to the implementation of the respective interventions in persons with autism? Methods: Following a systematic review of the literature, controlled studies on early behavioural or skills-based interventions published since 2000 in English or German with children until the age of twelve are included and critically appraised. Studies must have at least ten participants per intervention group. Results: In total, 15 publications based on 14 studies, eight systematic reviews and one health economic study are included. Most studies evaluate early interventions based upon the Lovaas model (Early intensive behavioural treatment (EIBT), Applied behavioural analysis (ABA)). Other evaluate pragmatic interventions or interventions based on other theoretical models like specific parent interventions, responsive education and prelinguistic milieu teaching, joint attention, symbolic play, and picture exchange communication system. Behaviour analytic interventions referring to the Lovaas model remain the most empirically evaluated early interventions in autism. Preschool children with autism can achieve improvements in cognitive and functional domains when treated within behavioural interventions with a frequency of at least 20 hours per week. It is not clear which is the minimum duration of effective interventions, and which active components are necessary for the effectiveness. There was no high quality evidence for other comprehensive early interventions. The identified health economic study is not suitable to evaluate the cost-effectiveness or cost consequences of early interventions. No publications concerning legal, ethical or social aspects were identified. The financial situation of persons with autisms and their families will be improved through the implementation of the “Pflege-Weiterententwicklungsgesetz” (Pf-WG). Further questions concern the organisation of care and the legal representation of autistic patients. Ethical questions arise mainly in the context of the equal supply of care to each individual patient in all regions of the country and the situation of the caregivers. Discussion: There are only a few studies with high methodology evaluating early interventions in children with autism. Most studies have a short duration with a lack of blinded outcome assessment in many cases. The lack of high quality comparative studies does not allow answering questions of comparative effectiveness of early interventions in autism. It can be concluded that interventions referring to the Lovaas model seem to have the highest effectiveness. This seems to be especially true when they are run clinic-based. However, there was no solid evidence with regard to factors responsible for the effectiveness of programms according to the ABA model. With regard to communication improvement, a systematic parent training seems to be superior to treatment as usual where a mixture of therapeutic elements is used. As well for clinical and health economic studies there is a substantial problem of generalisability into the German context. The identified health economic study is not suitable to evaluate the cost-effectiveness or cost consequences of early interventions. Conclusion: Based on the available studies, there is no sufficient evidence for any of the evaluated behavioural early intervention programmes. Studies suggest that preschool children with autism in behavioural intervention programmes with a frequency of at least 20 hours per week can achieve improvements in cognitive and functional domains. There is no evidence that in a substantial portion of the children a normal development can be achieved by early interventions. Most research evidence is available for ABA. A minimal necessary intensity of interventions to achieve positive outcomes cannot be derived from literature. There are no valid statements possible as to cost-effectiveness or consequences of these interventions. Effective early interventions may reduce total autism costs in the long run. This may be achieved when the initial high treatment expenditures are more than compensated later if persons with this disorder have better social functioning

Human papillomavirus (HPV) vaccination for the prevention of HPV 16/18 induced cervical cancer and its precursors

Introduction: Essential precondition for the development of cervical cancer is a persistent human papillomavirus (HPV) infection. The majority - approximately 70% - of cervical carcinomas is caused by two high-risk HPV types (16 and 18). Recently, two vaccines have been approved to the German market with the potential to induce protection against HPV 16 and HPV 18 among additional low-risk virus types. Objectives: To analyse whether HPV vaccination is effective with regard to the reduction of cervical cancer and precursors of cervical carcinoma (CIN), respectively? Does HPV vaccination represent a cost-effective alternative or supplement to present screening practice? Are there any differences concerning cost-effectiveness between the two available vaccines? Should HPV vaccination be recommended from a health economic point of view? If so, which recommendations can be conveyed with respect to a (re)organization of the German vaccination strategy? Which ethical, social and legal implications have to be considered? Methods: Based on a systematic literature review, randomized controlled trials (RCT) looking at the effectiveness of HPV vaccination for the prevention of cervical carcinoma and its precursors - cervical intraepithelial neoplasia - have been identified. In addition, health economic models were identified to address the health economic research questions. Quality assessment of medical and economic literature was assured by application of general assessment standards for the systematic and critical appraisal of scientific studies. Results: Vaccine efficacy in prevention of CIN 2 or higher lesions in HPV 16 or HPV 18 negative women, who received all vaccination doses, ranges between 98% and 100%. Side effects of the vaccination are mainly associated with injection site reactions (redness, turgor, pain). No significant differences concerning serious complications between the vaccination- and the placebo-groups were reported. Results of base case scenarios in the identified health economic modeling analyses range from approximately 3,000 Euro to 40,000 Euro per additional QALY (QALY = Quality-adjusted life year) and approximately 9,000 Euro to 65,000 Euro per additional life year (LYG), respectively. Discussion: The included studies show that both available HPV vaccines are effective in preventing HPV 16 and HPV 18 infections and probable resulting premalignant lesions of the cervix. However, the duration of protection is currently unclear. With regard to side effects, the vaccination can be considered as secure. Nevertheless, the number of cases within the clinical studies is not sufficient to determine the occurrence of rarely occurring (severe) adverse events in a reliable way. A reduction in the incidence and induced mortality through cervical cancer in Germany is not only depending on the vaccine’s clinical efficacy. Effects of the new technology on the overall participation rate in screening programs and the resulting vaccination rate and immunization status are also important factors. The results of identified health economic models vary substantially due to the heterogeneity of methodological approaches as well as chosen input parameters. However, almost all model-based analyses reached the conclusion that the implementation of a vaccination with lifelong protection can be considered as cost-effective, if the present screening practice continues. A comparison of the two vaccines shows, that the cost effectiveness ratios are more favorable with the quadrivalent vaccine than with the bivalent alternative when considering QALY as primary outcome parameter. The reason for this finding might be that in the case of the quadrivalent vaccine the prevention of genital warts can also be incorporated into the analysis. Variations of the duration of protection as well as the discounting rate were identified as the primary influencing factors of cost-effectiveness results. Conclusion: Implementation of HPV vaccination might lead to a reduction of cervical cancer in immunized women. However, uptake of immunization should be accompanied by further studies in order to assess long-term effectiveness and safety aiming at an optimization of possible implementation processes. High numbers of participants are of particular importance regarding immunization. This has to be backed up by programs to optimize early detection – as this affects even those women who already underwent immunization. Since cost-effectiveness evidence might be significantly affected by the unclear duration of protective benefits, a final verdict on the vaccination’s cost-effectiveness in the German setting is not possible. Hence, risk-sharing-agreements between third-party payers and manufacturers would pose an option to balance the consequences of uncertainty towards the duration of protection on cost-effectiveness

Dental indications for the instrumental functional analysis in additional consideration of health-economic aspects

Background Besides clinical and radiological examination instrumental functional analyses are performed as diagnostic procedures for craniomandibular dysfunctions. Instrumental functional analyses cause substantial costs and shows a considerable variability between individual dentist practices. Objectives On the basis of published scientific evidence the validity of the instrumental functional analysis for the diagnosis of craniomandibular dysfunctions compared to clinical diagnostic procedures; the difference of the various forms of the instrumental functional analysis; the existence of a dependency on additional other factors and the need for further research are determined in this report. In addition, the cost effectiveness of the instrumental functional analysis is analysed in a health-policy context, and social, legal and ethical aspects are considered. Methods A literature search is performed in over 27 databases and by hand. Relevant companies and institutions are contacted concerning unpublished studies. The inclusion criteria for publications are (i) diagnostic studies with the indication "craniomandibular malfunction", (ii) a comparison between clinical and instrumental functional analysis, (iii) publications since 1990, (iv) publications in English or German. The identified literature is evaluated by two scientists regarding the relevance of content and methodical quality. Results The systematic database search resulted in 962 hits. 187 medical and economic complete publications are evaluated. Since the evaluated studies are not relevant enough to answer the medical or health economic questions no study is included. Discussion The inconsistent terminology concerning craniomandibular dysfunctions and instrumental functional analyses results in a broad literature search in databases and an extensive search by hand. Since no relevant results concerning the validity of the instrumental functional analysis in comparison to the clinical functional analysis are found, it is impossible to make relevant statements concerning the underlying research questions. Conclusion Studies comparing the instrumental functional analysis to the clinical functional analysis for the diagnosis of craniomandibular dysfunctions are missing. So far the instrumental functional analysis is not systematically and independently validated in comparison to the clinical functional analysis as the reference standard. It is uncertain, whether conducting an instrumental functional analysis with a clinical functional analysis for the diagnostics of craniomandibular dysfunctions is recommendable. Further research is strongly recommended.Hintergrund Neben der klinischen Untersuchung und bildgebenden Verfahren werden instrumentelle Funktionsanalysen als Untersuchungsverfahren bei kraniomandibulären Funktionsstörungen (Fehlregulationen der Muskel- oder Kiefergelenkfunktion) durchgeführt. Die instrumentellen Funktionsanalysen sind derzeit nicht im Leistungskatalog der Gesetzlichen Krankenversicherung (GKV) abrechnungsfähig und weisen ausgesprochene Praxisvariabilität auf. Fragestellung Im Rahmen dieser Arbeit soll auf der Basis der derzeitigen publizierten wissenschaftlichen Evidenz festgestellt werden, wie aussagekräftig (valide) die instrumentelle Funktionsanalyse zur Diagnose kraniom andib ulärer Funktionsstörungen im Vergleich zu klassischen Untersuchungsverfahren ist; ob sich verschiedene Formen der instrumentellen Funktionsanalyse unterscheiden; ob dabei eine Abhängigkeit von anderen Faktoren besteht; und ob weiterer Forschungsbedarf besteht. Außerdem sollen die Kosten-Effektivität der instrumentellen Funktionsanalyse im Zusammenhang gesundheitspolitischer Entscheidungen analysiert werden sowie soziale, juristische und ethische Implikationen Beachtung finden. Methodik Die Literaturrecherche erfolgt in über 27 Datenbanken sowie per Handrecherche. Relevante Unternehmen und Institutionen werden bezüglich unveröffentlichter Studien angeschrieben. Einschlusskriterien sind (i) diagnostische Studien zur Indikation "kraniomandibuläre Funktionsstörung", (ii) Vergleich zwischen klassischer und instrumenteller Funktionsanalyse, (iii) Publikationen ab 1990, (iv) Publikationen in Englisch oder Deutsch. Die identifizierte Literatur wird von zwei Wissenschaftlern hinsichtlich inhaltlicher Relevanz und methodischer Qualität beurteilt. Ergebnisse Systematische Datenbankrecherchen ergeben 962 Treffer. Als Volltexte werden 187 medizinische und ökonomische Publikationen bewertet. Die Beurteilung aller Publikationen ergibt, dass weder für die medizinischen noch für die gesundheitsökonomischen Fragestellungen Studien eingeschlossen werden können. Diskussion Die uneinheitliche Terminologie kraniomandibulärer Funktionsstörungen und instrumenteller Funktionsanalysen führt zu einer breiten Literatur- sowie zu einer umfangreichen Handrecherche. Da keine relevanten Ergebnisse zur Beantwortung der Validität der instrumentellen im Vergleich zur klinischen Funktionsanalyse gefunden werden, ist es nicht möglich, relevante Aussagen zu den Forschungsfragen zu treffen. Schlussfolgerung Studien, die die instrumentelle Funktionsanalyse zur Diagnose von kraniomandibulären Funktionsstörungen im Vergleich zur klinischen Funktionsanalyse beurteilen, fehlen. Die instrumentelle Funktionsanalyse ist gegenüber der klinischen als Referenzstandard bisher nicht systematisch und unabhängig validiert. Es ist unklar, ob die Durchführung einer instrumentellen neben einer klinischen Funktionsanalyse empfehlenswert zur Diagnostik von kraniomandibulären Funktionsstörungen ist. Es besteht weiterhin unbedingter Forschungsbedarf

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis

Background: Radiotherapy for patients suffering from malignant neoplasms has developed greatly during the past decades. Stereotactic radiosurgery (SRS) is one important radiotherapeutic option which is defined by a single and highly focussed application of radiation during a specified time interval. One of its important indications is the treatment of brain metastases. Objectives: The objective of this HTA is to summarise the current literature concerning the treatment of brain metastasis and to compare SRS as a single or additional treatment option to alternative treatment options with regard to their medical effectiveness/efficacy, safety and cost-effectiveness as well as their ethical, social and legal implications. Methods: A structured search and hand search of identified literature are performed from January 2002 through August 2007 to identify relevant publications published in English or German. Studies targeting patients with single or multiple brain metastases are included. The methodological quality of included studies is assessed according to quality criteria, based on the criteria of evidence based medicine. Results: Of 1,495 publications 15 medical studies meet the inclusion criteria. Overall study quality is limited and with the exception of two randomized controlleed trials (RCT) and two meta-analyses only historical cohort studies are identified. Reported outcome measures are highly variable between studies. Studies with high methodological quality provide evidence, that whole-brain radiotherapy (WBRT) in addition to SRS and SRS in addition to WBRT is associated with improved local tumour control rates and neurological function. However, only in patients with single brain metastasis, RPA-class 1 (RPA = Recursive partitioning analysis) and certain primary tumour entities, this combination of SRS and WBRT is associated with superior survival compared to WBRT alone. Studies report no significant differences in adverse events between treatment groups. Methodologically less rigorous studies provide no conclusive evidence with regard to medical effectiveness and safety, comparing SRS to WBRT, neurosurgery (NS) or hypofractionated radiotherapy (HCSRT). The quality of life is not investigated in any of the studies. Within the searched databases a total of 320 economic publications are identified. Five publications are eligible for this report. The five reports have a quiet variable quality. Concerning the economic efficiency of alternative equipment, while assuming equal effectiveness, the calculations show, that economic efficiency depends to a large extend on the number of patients treated. In case the two alternative equipments are used solely for SRS, the Gamma Knife might be more cost-efficient. Otherwise an adapted linear accelerator is most likely to be beneficial because of its flexibility. One Health Technology Assessment (HTA) states, that the cost for a Gamma Knife and a dedicated linear accelerator are comparable, while an adapted version is cheaper. No reports concerning ethical, legal and social aspects are identified. Discussion: Overall, quantity and quality of identified studies is limited. However, the identified studies indicate that the prognosis of patients with brain metastases is despite highly developed and modern treatment regimes still limited. Conclusive evidence with regard to the effectiveness of identified interventions is only available for the combined treatment of SRS and WBRT compared to SRS or WBRT alone. Furthermore, there is insufficient evidence to compare SRS with WBRT, NS or HCSRT. The efficiency of the different equipments depends to a great extent on the number and the indications of the patients treated. If dedicated systems are used to their full capacity, there is some evidence for superior cost-effectiveness. If more treatment flexibility is required, adapted systems seem to be advantageous. However, equal treatment effectiveness is a necessary assumption for these conclusions. The need for a treatment precision can influence the purchase decision. No reports concerning more recent therapeutic alternatives are currently available. Conclusion: Combination of SRS and WBRT is associated with improved local tumour control and neurological function compared to SRS or WBRT alone. However, only for patients with single metastasis there is strong evidence that this results in improved survival compared to WBRT alone. Methodologically rigorous studies are warranted to investigate SRS compared to WBRT and NS and to investigate the quality of life in patients undergoing these treatment regimes.Concerning the type of equipment used, economic efficiency depends to a great extend on the capacity at which the system can be used. Dedicated systems might be favourable for a high number of patients, while lower patient counts probably favour adapted systems with their superior treatment flexibility. Using the equipment at its full capacity may result in a limited number of machines, what in turn may give rise to the question of an equal and easy access to this technology. Studies focusing on the comparative effectiveness and cost-effectiveness of different treatment options and their combinations, especially for the German setting, are warranted

Efficacy and cost-effectiveness of the 13C-urea breath test as the primary diagnostic investigation for the detection of Helicobacter pylori infection compared to invasive and non-invasive diagnostic tests

Background: Helicobacter pylori (H. pylori) is one of the most common bacterial infections in humans. There is a risk factor for gastric or duodenal ulcers, gastric cancer and MALT (Mucosa Associated Lymphoid Tissue)-Lymphomas. There are several invasive and non-invasive methods available for the diagnosis of H. pylori. The 13C-urea breath test is a non-invasive method recommended for monitoring H. pylori eradication therapy. However, this test is not yet used for primary assessment of H. pylori in Germany. Objectives: What are the clinical and health economic benefits of the 13C-urea breath test in the primary assessment of H. pylori compared to other invasive and non-invasive methods? Methods: A systematic literature search including a hand search was performed for studies investigating test criteria and cost-effectiveness of the 13C-urea breath test in comparison to other methods used in the primary assessment of H. pylori. Only studies that directly compared the 13C-urea breath test to other H. pylori-tests were included. For the medical part, biopsy-based tests were used as the gold standard. Results: 30 medical studies are included. Compared to the immunoglobulin G (IgG) test, the sensitivity of the 13C-urea breath test is higher in twelve studies, lower in six studies and one study reports no differences. The specificity is higher in 13 studies, lower in three studies and two studies report no differences. Compared to the stool antigen test, the sensitivity of the 13C-urea breath test is higher in nine studies, lower in three studies and one study reports no difference. The specificity is higher in nine studies, lower in two studies and two studies report no differences. Compared to the urease test, the sensitivity of the 13C-urea breath test is higher in four studies, lower in three studies and four studies report no differences. The specificity is higher in five studies, lower in five studies and one study reports no difference. Compared to histology, the sensitivity of the 13C-urea breath test is higher in one study and lower in two studies. The specificity is higher in two studies and lower in one study. One study each compares the 13C-urea breath test to the 14C-urea breath test and the polymerase chain reaction (PCR) test, respectively, and reports no difference in sensitivity and specificity with the 14C-urea breath test, and lower sensitivity and higher specificity compared to PCR. The statistical significance of these differences is described for six of the 30 studies. Nine health economic evaluations are included in the Health Technology Assessment (HTA) report. Among these studies, the test-and-treat strategy using the 13C-urea breath test is compared to test-and-treat using serology in six analyses and to test and treat using the stool antigen test in three analyses. Thereby, test-and-treat using the breath test is shown to be cost-effective over the serology based strategy in three models and is dominated by a test-and-treat strategy using the stool antigen test in one model. A cost-effectiveness comparison between the urea breath test approach and the empirical antisecretory therapy is carried out in four studies. Of these, two studies report that the strategy using the urea breath test is cost-effective over the empirical antisecretory therapy. In two studies, test-and-treat using the 13C-urea breath test is compared to the empirical eradication therapy and in five studies to endoscopy-based strategies. The breath test approach dominates endoscopy in two studies and is dominated by this strategy in one study. Discussion: All included medical and economic studies are limited to a greater or lesser extent. Additionally, the results of the studies are heterogeneous regarding medical and economic outcomes respectively. Thus, the majority of the medical studies do not report the statistical significance of the differences in sensitivity and specificity. In direct comparisons the 13C- urea breath test shows higher sensitivity and specificity than the IgG and stool antigen tests. In comparison to the urease test, results for sensitivity are inconsistent, and the specificity is slightly higher for the 13C-urea breath test. There are not enough results for comparisons between the 13C-urea breath test and the 14C-urea breath test, histology and PCR to describe tendencies. The included economic studies suggest that the test-and-treat strategy using the 13C-urea breath test is cost-effective compared to test-and-treat using serology as well as empirical antisecretory therapies. Due to a lack of valid studies, it is not possible to assess the breath test approach in comparison to test-and-treat using the stool antigen test and the empirical eradication therapy respectively, regarding the cost-effectiveness. The results of economic analyses comparing test-and-treat using the breath test to endoscopy strategies are too heterogeneous to draw any conclusions. Overall, none of the included economic models is able to completely capture the complexity of managing patients with dyspeptic complaints. Conclusions/Recommendations: Based on available medical and economic studies, there is no sufficient evidence to recommend test and-treat using 13C-urea breath testing for the detection of H. pylori infection as the standard procedure for the management of uninvestigated dyspepsia in the German health care system. In addition, it must be considered that the DVGS guidelines of the Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DVGS) recommend endoscopy based methods for the management of patients with dyspeptic complaints

Concepts of care for people with dementia

Introduction: Today there are approximately one million people with dementia in Germany. If current demographic trends continue, this number is likely to rise substantially in the coming years. In the older population, dementia is the most frequent reason for long-term care. Because most forms of dementia cannot be cured, the aim of treatment is to delay disease progression and to maintain functioning and quality of life. Research questions: What is the evidence on different approaches to the long-term usual care of patients with dementia in terms of common endpoints such as quality of life, and social behaviour? How is the cost-effectiveness of these concepts to be evaluated? Which ethical, social, or legal issues are discussed in this context? Methods: Based on a systematic literature review, we include randomized, controlled studies that had at least 30 participants and investigated one or more of the following approaches of dementia care: validation therapy/emotion-oriented usual care, ergotherapy, sensory stimulation, relaxation techniques, reality orientation therapy, and reminiscence therapy. Studies had to be published after 1996 (after 1990 for the economic part) in English or German. Results: A total of 20 studies meet the inclusion criteria. Of these, three focus on validation therapy/emotion-oriented usual care, five on ergotherapy, seven on different kinds of sensory stimulation, two on reality orientation, two on reminiscence therapy, and one on a type of relaxation technique. There are no significant differences between the intervention and control groups in two of the three studies on validation therapy or emotion-oriented usual care, in two of the five studies on ergotherapy, in three of the seven studies on sensory stimulation, in both of the two studies on reminiscence therapy, and in the one study on relaxation. In the remaining ten studies, seven report some positive results in favour of the respective interventions, and three studies (ergotherapy, aroma therapy, and music/massage) report positive effects with respect to all of the endpoints measured. Six publications present economic results for usual-care-concepts. One study reports additional costs of 16 GBP (24.03 Euro (2006)) per patient per week for occupational therapie. Two publications declare incremental cost of 24.30 USD (25.62 Euro (2006)) per mini-mental-state-examination-(MMSE)-point gained per month respectively 1,380,000 ITL (506.21 Euro (2006)) per MMSE-point gained. Two publications focus on mixed interventions. One study reports the additional costs of an activity program (1.13 USD (1.39 Euro (2006)) per day per patient) and the other additional time for the usual care for mobile demented patients (average of 45 minutes per day per patient). With respect to ethical and social aspects the discussion focusses on the problem of autonomy: dementia does not necessarily mean inability to decide over the participtation in studies. Legal questions address the financial situation of patients, the organisation of their care and the legal representation of dementia patients. Discussion: Only a few studies on the nursing interventions considered in this report are methodologically robust. Most of the studies have a small number of participants and show substantial differences in terms of their inclusion criteria, implementation, and endpoints. This heterogeneity is reflected in the results: in half of the studies, the interventions have no positive effects compared to the control group. The other half of the studies reports some positive effects with regard to specific endpoints. All of the economic studies are, from a methodologial and a thematic standpoint, not suitable to answer the questions raised. Ethical, social and legal aspects are discussed but not systematically analysed. Conclusion: The studies conducted to date do not provide sufficient evidence of neither efficacy nor cost-effectiveness for any of the nursing interventions considered in the present HTA. However, lack of evidence does not mean lack of efficacy. Instead, more methodologically sound studies are needed. Particullary desireable are studies reflecting the framework of dementia care in Germany. This holds also for the healtheconomic evaluations of the chosen interventions

Bypass materials in vascular surgery

Introduction: Arteriosclerotic changes can lead to circulatory disturbances in various areas of the human vascular system. In addition to pharmacological therapy and the management of risk factors (e. g. hypertension, diabetes, lipid metabolism disorders, and lifestyle), surgical interventions also play an important role in the treatment of arteriosclerosis. Long-segment arterial occlusions, in particular, can be treated successfully with bypass sur-gery. A number of different materials are available for this type of operation, such as autologous vein or pros-thetic grafts comprised of polytetrafluoroethylene (PTFE) or Dacron®. Prosthetic materials are used especially in the treatment of peripheral artery disease, such as in aortoiliac or femoropopliteal bypass surgery. The present report will thus focus on this area in order to examine the effectiveness of different bypass materials. Among the efforts being made to refine the newly introduced DRG system in Germany, analysing the different bypass materials used in vascular surgery is particularly important. Indeed, in its current version the German DRG system does not distinguish between bypass materials in terms of reimbursement rates. Differences in cost structures are thus of especial interest to hospitals in their budget calculations, whereas both private and statutory health insurance funds are primarily interested in long-term results and their costs. Objectives: The goal of this HTA is to compare the different bypass materials used in vascular surgery in terms of their medical efficiency and cost-effectiveness, as well as with regard to their ethical, social and legal implications. In addition, this report aims to point out the areas in which further medical, epidemiological and health economic research is still needed. Methods: 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 for-mer 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), El-sevier BIOBASE (EB94), BIOSIS Previews (BA93), EMBASE (EM95), EMBASE Alert (EA08), SciSearch (IS90), Cochrane Library - CDSR (CDSR93), NHS-CRD-DARE (CDAR94), NHS-CRD-HTA (INAHTA), and NHS-EED (NHSEED). The present report included German and English literature published between the years 1999 and 2004. A list of the search parameters can be found in the appendix. No limits were placed on the target population, and the methodical quality of the included studies was determined using standardised checklists. Results: The studies included in this health technology assessment compared the following bypass materials: autologous vein, human umbilical vein (HUV) and synthetic materials such as PTFE or Dacron®. Both the systematic reviews and the randomised controlled trials comparing autologous vein grafts to other bypass materials come to the conclusion that autologous vein is superior to all other materials. From a medical viewpoint, there are no clear differences between the various synthetic materials.To date, the subject of bypass materials in vascular surgery has not been addressed comprehensively from an economic point of view. Indeed, we were able to identify only one publication that compared the cost of various bypass materials. The remaining health economic studies did not compare costs, cost effectiveness, or quality of life associated with the use of various bypass materials. Discussion: When deciding which bypass material to use, vascular surgeons take a number of medical considerations into account, including the bypass area, the availability of autologous vein, the amount of operation time available, and the health status of the patient. The studies included in this health technology assessment demonstrate that autologous vein is usually the preferred material for bypass grafts. In contrast, comparisons of various synthetic materials did not show any specific differences. It remains to be seen whether studies on newly developed synthetic materials will show these to have any particular advantages. The randomised controlled trials included in the present report were limited by a number of methodological weaknesses, such as different methods for determining patency rates, sample size and power problems, the interpretation of non-significant results, and a lack of consideration of additional factors. From an economic point of view, there is still great need for further research, and we have attempted to describe a number of pressing questions for health economic studies in the present report

Sonographic diagnosis of "acute abdomen" in children and adults

Introduction The acute abdomen is the main term for an at first unclear emergency situation of the abdominal cavity. The acute abdomen belongs to the three most important reasons for the admission of patients into the emergency room. Further, this illness ranks 40% of all consultations in the ambulant care sector. The acute abdomen requires an early and direct diagnosis because of its potential of having a life threatening differential diagnosis. This HTA report aimed to assess the ultrasound diagnosis of the acute abdomen considering children and adults. This will be done from a medical and economic perspective. The differential diagnosis respectively the cause of the acute abdomen binds high direct treatment costs, especially in the stationary sector. Ultrasound diagnosis is a procedure that plays a big part in the differential diagnosis process and it is widely used in practise. Other research methods of diagnosing acute abdominal illness are: clinical examinations with inspection and palpation, surgical exploration and laparocopy as well as computer tomography and x-ray examination. Objectives The main objective of this HTA report is to assess what significance sonography should have within the examination strategy of the acute abdomen from the medical and economical view. Second, this HTA report will evaluate under which circumstances the ultrasonographic diagnosis of the acute abdomen, considering medical and economical quality classifications, is the alternative of choice to comparable diagnostic measures. Methods The target population this HTA report is aimed at are children and adults with acute abdomen or embedded differential diagnosis. A systematic literature search was conducted covering all relevant medical and HTA-databases. Furthermore, handsearch was conducted inside of the known data bases of HTA-institutions as well as from medical and economical journals. The following databases were searched in cooperation with DIMDI to identify relevant literature: Biosis-Previews (BA93), Biotechnobase (ET80), Cab-Health (AZ72), Elsevier Biobase (EB94), EMBASE (EM74), Embase Alert (EA08), Ethmed (ED93), Euroethics (EU93), Gerolit (GE79), Heclinet (HN69), IHTA ( HT83), IPA (IA70), MEDLINE (ME90, Medline Alert (MEOA) and SciSearch (IS74). The search parameters were orientated by the embedded differential diagnosis's as well as diagnostic measures considering the acute abdomen. The bibliographic search covered the period from 1990 to 2003. The relevant languages are English, German in connection to French. The evaluation of the information has been graduated. It must be clear that the abstract follows the topic of the acute abdomen. The as such identified literature will be structured by its methodological quality and relevance. This will be analysed and later valued after it is clear that the minimum requirements are met. Results The identified and assessed primary studies, reviews and metaanalytic studies demonstrated the medical effectiveness as well as the economical efficiency of the sonographical diagnosis for individual questions or indications. The evaluated papers of the target population 'children' demonstrated that sonography resp. ultrasound as the basic examination is recommended for children with acute abdominal pain. Discussion The identified studies have not used an extensive setting of the ultrasound diagnosis of the acute abdomen. Instead they focus only on small sections, orientated on certain indications. Blinded medical studies have not been identified. Also, there is no health-economics study that evaluated the diagnostic measures by comparing all available technologies. Altogether, the identified and assessed publications show that sonography is an alternative of choice considering particular questions in comparison to other diagnostic measures of analyzing the acute abdomen. A general deflected dominance from the sonography facing the computer tomography for instance can not be seen as the result of this structured review of the published literature. Conclusion During a structured examination strategy, e.g. guidelines, sonography of children has become the diagnostic method of choice. Taking up sonography as a primary diagnostic evaluation into the guidelines of the analysis of the considered literature is recommended. The usage of already existing ultrasound systems is also recommended. Seeing that existing publications of this subject are scarce, it is not possible to prognose the economical effects of an obligatory primary sonographical diagnostic.Einleitung Das akute Abdomen ist der Oberbegriff für eine ätiologisch zunächst unklare Akutsituation im Bereich des Abdomens. Als 'akuter Bauch(schmerz)' gehört das Syndrom zu den drei wichtigsten Ursachen bei der Aufnahme von Patienten in die Notaufnahme und stellt bis zu 40% der Konsultationen im ambulanten Bereich. Das akute Abdomen erfordert aufgrund seiner potenziell lebensbedrohlichen Differenzialdiagnosen eine frühzeitige und unmittelbare Diagnostik. Ziel dieses HTA-Berichts ist es, die sonographische Diagnostik des akuten Abdomens bei Kindern und Erwachsenen aus medizinischer und aus ökonomischer Perspektive zu bewerten. Die Differenzialdiagnosen bzw. die Ursachen des akuten Abdomens bedingen hohe direkte Behandlungskosten, die in der Regel aufgrund der potenziell lebensbedrohlichen Lage im stationären Bereich anfallen. Als bildgebendes Verfahren ist die Sonographie an der Differenzialdiagnostik beteiligt und in der Praxis bereits weit verbreitet. Neben der Sonographie werden die Untersuchungsmethoden der klinischen Untersuchung mit Inspektion und Palpation, chirurgische Exploration und Laparoskopie, sowie die bildgebenden Verfahren Computertomographie (CT) und Röntgenuntersuchung bei der Diagnostik des akuten Abdomens angewandt. Fragestellung Es ist zu bewerten, welchen Stellenwert die Sonographie innerhalb der Untersuchungsstrategie beim akuten Abdomen aus medizinischer und aus ökonomischer Sicht einnimmt. Dieser HTA-Bericht wird insbesondere die Frage beantworten, unter welchen Bedingungen die sonographische Diagnostik des akuten Abdomens hinsichtlich medizinischer und ökonomischer Gütekriterien eine Alternative der ersten Wahl zu anderen vergleichbaren diagnostischen Maßnahmen ist. Methodik Die Zielpopulation dieses HTA-Berichts sind Kinder und Erwachsene mit akutem Abdomen oder einer der eingeschlossenen Differenzialdiagnosen. Die Literaturrecherche erfolgt per Handrecherche in den Datenbanken der bekannten HTA-Institutionen, in verschiedenen medizinischen und ökonomischen Fachzeitschriften sowie strukturiert mit Hilfe des DIMDI in den Datenbanken Biosis-Previews (BA93), Biotechnobase (ET80), Cab-Health (AZ72), Elsevier Biobase (EB94), EMBASE (EM74), EMBASE Alert (EA08), Ethmed (ED93), Euroethics (EU93), Gerolit (GE79), Heclinet (HN69), IHTA (HT83), IPA (IA70), MEDLINE (ME90), MEDLINE Alert (ME0A) und SciSearch (IS74). Die Suchparameter orientieren sich an den eingeschlossenen Differenzialdiagnosen sowie den diagnostischen Maßnahmen beim akuten Abdomen. Der Suchzeitraum beginnt 1990. Relevante Sprachen sind englisch, deutsch sowie im Zusammenhang mit der Handrecherche französisch. Die Bewertung der Information erfolgt gestaffelt. Aus der Zusammenfassung muss hervorgehen, dass sich dieses mit dem berücksichtigten Themenumfeld des akuten Abdomens befasst. Die so identifizierte Literatur wird strukturiert hinsichtlich ihrer methodischen Qualität und Relevanz analysiert und anschließend bei Erfüllung qualitativer Mindestanforderungen im Rahmen dieses HTA-Berichts bewertet. Ergebnisse Die medizinische Effektivität sowie die ökonomische Effizienz der sonographischen Diagnostik können anhand der identifizierten und bewerteten Studien, Metaanalysen und Übersichtsarbeiten für einzelne Fragestellungen bzw. Indikationen gezeigt werden. Die beurteilten Arbeiten für die Zielpopulation Kinder kommen zu dem Ergebnis, dass die Sonographie als Basisuntersuchung bei akuten abdominellen Schmerzen bei Kindern zu empfehlen ist. Diskussion Die vorliegenden Studien verdeutlichen kein breites und ganzheitliches Bild von der sonographischen Diagnostik des akuten Abdomens, sondern geben jeweils nur einen kleinen Ausschnitt wieder. Leider fehlen weitestgehend medizinische Studien, die eine Verblindung vorgenommen haben. Des Weiteren gibt es keine gesundheitsökonomischen Arbeiten, die die derzeit verfügbaren Technologien bei der Diagnostik des akuten Abdomens im Vergleich zueinander beurteilen. Insgesamt jedoch zeigen die identifizierten und bewerteten Publikationen, dass die Sonographie bei einzelnen Fragestellungen die Alternative der ersten Wahl im Vergleich zu anderen diagnostischen Maßnahmen bei der Untersuchung des akuten Abdomens ist. Eine sich daraus ableitende allgemeine Dominanz der Sonographie gegenüber z. B. der CT kann auf Basis der vorliegenden Literatur nicht bestätigt werden. Schlussfolgerung Im Rahmen einer strukturierten Untersuchungsstrategie, z. B. Leitlinien, ist die Sonographie bei Kindern bereits heute das diagnostische Mittel der ersten Wahl. Die Aufnahme der Sonographie als Primärdiagnostik in die noch aufzustellende Leitlinie für die Untersuchung des akuten Abdomens beim Erwachsenen kann sowohl auf Basis der berücksichtigten Literatur, als auch der bereits breiten Verfügbarkeit sonographischer Geräte empfohlen werden. Konkrete ökonomische Auswirkungen einer obligatorischen sonographischen Primärdiagnostik beim akuten Abdomen können aufgrund der nur begrenzt vorhandenen Publikationen nicht prognostiziert werden

Attitudes to antipsychotic drugs and their side effects: a comparison between general practitioners and the general population

BACKGROUND: Attitudes towards antipsychotic medication play an important part in the treatment for schizophrenia and related disorders. We aimed measuring general practitioners' attitudes to antipsychotic drugs and their adverse side effects and comparing these with the attitudes of the general population. METHODS: Analysis and comparison of two representative samples, one comprising 100 General Practitioners (GPs), the other 791 individuals randomly selected from the general population. The setting was the German speaking cantons of Switzerland. RESULTS: General practitioners have significantly more positive attitudes towards anti-psychotic drugs than the general public. They reject widespread prejudices about the use of anti-psychotic medication significantly more than the general population. In particular the risk of dependency was assessed as 'low' by GP's (80%), in contrast to only 18% of the general population sample. In no instance did a majority of the GPs advise not tolerating any of the 10 possible adverse effects presented in this study. This is in marked contrast to the general population sample, where a majority recommended discontinuation for movement disorder (63%), strong tremor (59%), risk of dependency (55%) and feelings of unrest (54%). CONCLUSION: As well as effective management of side-effects being a vital aspect of patient and carer education, prescribing doctors need to be aware that their mentally ill patients are likely to be confronted with extremely negative public attitudes towards antipsychotic medication and with strong pressures to stop taking their medication in the event of side-effects