GMS health technology assessment最新文献

Health political background: In 2006, the prevalence of overweight and adiposity among children and adolescents aged three to 17 years is 15%, 6.3% (800,000) of these are obese.

Scientific background: Obese children and adolescents have an increased body fat ratio. The reasons for overweight are - among others - sociocultural factors, and a low social status as determined by income and educational level of the parents. The consequences of adiposity during childhood are a higher risk of metabolic and cardiovascular diseases and increased mortality in adulthood. Possible approaches to primary prevention in children and adolescents are measures taken in schools and kindergarten, as well as education and involvement of parents. Furthermore, preventive measures geared towards changing environmental and living conditions are of particular importance.

Research questions: What is the effectiveness and efficiency of different measures and programs (geared towards changing behaviour and environmental and living conditions) for primary prevention of adiposity in children and adolescents, with particular consideration of social aspects?

Methods: The systematic literature search yielded 1,649 abstracts. Following a two-part selection process with predefined criteria 31 publications were included in the assessment.

Results: The majority of interventions evaluated in primary studies take place in schools. As the measures are mostly multi-disciplinary and the interventions are often not described in detail, no criteria of success for the various interventions can be extrapolated from the reviews assessed. An economic model calculation for Australia, which compares the efficiency of different interventions (although on the basis of low evidence) comes to the conclusion that the intervention with the greatest impact on society is the reduction of TV-ads geared towards children for foods and drinks rich in fat and sugar. There is a significant correlation between adiposity and socioeconomic deprivation. The lack of interventions (especially preventive measures geared towards changing environmental and living conditions) and studies focusing on this population group is noticeable.

Discussion: There are only a few primary studies of high quality on adiposity prevention in children and adolescents. Especially studies which compare different measures are lacking. This holds also true for the economic analysis, which seems logical insofar, as the basis for economic analyses are usually primary studies (preferably randomized controlled trials (RCT)) due to their evidence level). Studies on interventions geared towards changing environmental and living conditions and towards specific population groups (i. e. the socially disadvantaged) are hardly available.

Conclusions: There are hardly any primary studies of high qu

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

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

Health political background: Colorectal cancer (CC) is the second most common cancer and cause of cancer death for both men and women in Germany. Various methods for early detection of CC exist, including conventional coloscopy which is reimbursed within the scope of cancer screening, as well as computertomography-coloscopy (CTC) which is currently not reimbursed.

Scientific background: CTC is a mere diagnostic procedure which has a lower risk of perforation than conventional coloscopy. However, as it is an x-ray procedure, it exposes the patient to radiation. Conventional coloscopy is considered the gold standard due to its high sensitivity and specificity for locating adenomas. Furthermore, it offers the advantage that in addition to extended diagnostic measures therapeutic measures can be undertaken during the procedure.

Research questions: This HTA-report aims to evaluate the effectiveness and efficiency of CTC in comparison to conventional coloscopy in the early detection and diagnosis of colorectal cancer and/or its precursors and which ethical and legal aspects have to be considered.

Methods: The systematic literature search (27 international literature data bases) yielded a total of 1,713 abstracts. After a two-step selection process 36 publications remained to be assessed.

Results: The results regarding the effectivity of CTC in diagnosis and screening for colorectal cancer and/or its precursors are partly promising, however, they are very heterogeneous. Therefore, regarding its sensitivity and specificity, CTC cannot be considered an equivalent alternative to conventional coloscopy for diagnosis and screening. The heterogeneity of results is due to technical (device type, settings), patient dependent (preparation) and operator dependent (training) factors. No economic results for a comparison of the procedures for diagnosis exist. Regarding the cost-effectiveness of a CTC-screening, international model calculations are available. According to this calculation, the CTC-screening is cost-effective compared to the option 'no screening'; however, conventional coloscopy-screening is generally more cost-effective.

Discussion: If modern CTC-devices are used with adequate technical settings, software, appropriate patient preparation and training of the operator, better results regarding sensitivity can be expected. Basically, the fact that no therapeutic measures (polypectomy) can be taken during CTC compared to conventional coloscopy needs to be considered. Unanswered medical questions pertain to the interval of examinations for screening (considering the radiation exposure), the approach to small polyps and the significance of flat and depressed lesions. Regarding its cost-effectiveness, conventional coloscopy-screening results in greater health benefits and lower costs than CTC-screening in most model calcula

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