GMS health technology assessment
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GMS Health Technol Assess · Nov 2005
Minimally invasive surgical procedures for the treatment of lumbar disc herniation.
In up to 30% of patients undergoing lumbar disc surgery for herniated or protruded discs outcomes are judged unfavourable. Over the last decades this problem has stimulated the development of a number of minimally-invasive operative procedures. The aim is to relieve pressure from compromised nerve roots by mechanically removing, dissolving or evaporating disc material while leaving bony structures and surrounding tissues as intact as possible. In Germany, there is hardly any utilisation data for these new procedures - data files from the statutory health insurances demonstrate that about 5% of all lumbar disc surgeries are performed using minimally-invasive techniques. Their real proportion is thought to be much higher because many procedures are offered by private hospitals and surgeries and are paid by private health insurers or patients themselves. So far no comprehensive assessment comparing efficacy, safety, effectiveness and cost-effectiveness of minimally-invasive lumbar disc surgery to standard procedures (microdiscectomy, open discectomy) which could serve as a basis for coverage decisions, has been published in Germany. ⋯ Conclusions that can be drawn from the results of the present assessment refer in detail to the specified minimally-invasive procedures of lumbar disc surgery but they may also be considered exemplary for other fields where optimisation of results is attempted by technological development and widening of indications (e.g. total hip replacement). Compared to standard technologies (open discectomy, microdiscectomy) and with the exception of chemonucleolysis, the developmental status of all other minimally-invasive procedures assessed must be termed experimental. To date there is no dependable evidence-base to recommend their use in routine clinical practice. To create such a dependable evidence-base further research in two directions is needed: a) The studies need to include adequate patient populations, use realistic controls (e.g. standard operative procedures or continued conservative care) and use standardised measurements of meaningful outcomes after adequate periods of time. b) Studies that are able to report effectiveness of the procedures under everyday practice conditions and furthermore have the potential to detect rare adverse effects are needed. In Sweden this type of data is yielded by national quality registries. On the one hand their data are used for quality improvement measures and on the other hand they allow comprehensive scientific evaluations. Since the year of 2000 a continuous rise in utilisation of minimally-invasive lumbar disc surgery is observed among statutory health insurers. Examples from other areas of innovative surgical technologies (e.g. robot assisted total hip replacement) indicate that the rise will probably continue - especially because there are no legal barriers to hinder introduction of innovative treatments into routine hospital care. Upon request by payers or providers the "Gemeinsamer Bundesausschuss" may assess a treatments benefit, its necessity and cost-effectiveness as a prerequisite for coverage by the statutory health insurance. In the case of minimally-invasive disc surgery it would be advisable to examine the legal framework for covering procedures only if they are provided under evaluation conditions. While in Germany coverage under evaluation conditions is established practice in ambulatory health care only ("Modellvorhaben") examples from other European countries (Great Britain, Switzerland) demonstrate that it is also feasible for hospital based interventions. (ABSTRACT TRUNCATED)
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GMS Health Technol Assess · Nov 2005
The impact of HTA reports on health policy: a systematic review.
The objective of health technology assessment (HTA) is to support decision-making in the health sector by assessing health technologies systematically under medical, economic, social, and ethical aspects. The present study aims at identifying ways of enabling the impact of HTA on decision-making processes in the German health sector. The authors formulate three research questions: (1) Can methods be identified that allow a valid assessment of the impact of HTA reports on the decision-making processes? (2) Has been shown an impact of HTA reports on decision-making processes in the health sector? (3) Which are the factors responsible for a high or a low impact of HTA? ⋯ There is little experience with study designs or methods that allow a valid assessment of the impact of HTA reports on the decision-making process in the health sector. However, some approaches, such as the use of pre-defined indicators, were identified that should be pursued and elaborated in further studies. Due to the lack of a developed methodology only limited conclusions related to the impact of HTA reports can be drawn. Among the studies that show a relevant impact, most are methodological. However, results from qualitative studies caution against assuming a causal relationship where a mere coincidence between the recommendations of an HTA report and health policy is identified. In order to produce evidence-based conclusions regarding the impact of HTA reports, validated indicators should be used. Study design should also aim at controlling for other influencing factors. None of the studies explicitly aim at examining the role of the factors that might be responsible for a low or high impact of the HTA reports. The non-systematic retrospective analyses do not allow reliable conclusions regarding the relevance of these factors. Therefore the factors identified here should only serve for hypothesis formation. On the basis of these studies it is not possible to give evidence-based recommendations on the way how to increase the impact of HTA on decision-making in Germany. Instead a concept for evaluation should be developed that combines quantitative and qualitative methods and considers the following questions:(1) What kind of impact should be measured? (2) Which are the target groups and at which level of the health system are they located? (3) Which are the outcome parameters and how can they be measured? (4) Which are the potential impact enhancing or limiting factors?