Evidence-based healthcare: A challenge for biomedical engineeringHealthcare is in a process of change that has significance for the health care market and thus for the driving forces behind technological innovation. In general, healthcare is highly effective thanks to modern medical technologies. New treatment methods often result in simplified procedures for patients and shorter treatment periods and lower costs per treatment. Paradoxically, however, total healthcare costs often rise as indications for the treatment in question are expanded and demand increases. Healthcare providers are under pressure from the fact that what is technologically possible to an increasing degree is limited by economics. In this environment it is natural that we have seen a trend toward concern about effectiveness and cost-effectiveness, which changes the conditions for successful marketing of innovations. In the future, the healthcare market will increasingly demand measurable healthcare gains at reasonable costs. Adapting to these conditions is required in research and development of medical equipment. Demands to systematically analyse and monitor quality, benefits for patients and cost-effectiveness in the healthcare systems have given rise to organisations that review medical technologies. A recent American survey identified 103 such organisations in Europe, North America, South America, South Africa, Asia (Japan and China), Australia and New Zealand. Regardless of which country they operate in, these organisations focus primarily on pharmaceuticals, medical technology equipment and medical procedures. Their evaluations comprise technologies under clinical testing, those recently introduced on the market and others that are already well-established. To a large extent they involve diagnostic and therapeutic methods, and to a significantly lesser extent preventive and rehabilitative ones. Demand for these organisations evaluation results comes primarily from health care providers and industry. With the exception of the USA, there is a strong involvement from the governments. This development is leading to a transition of so called evidence-based healthcare, in which political representatives and administrations have a significant influence in the decision-making process. The trend today is toward the integration of administrative and medical decision-making. In many countries, strategies are being developed to formulate objectives for the healthcare sector and prioritise activities. Practical implementation may vary between countries depending on their cultural and organisational background and financial systems, but regardless of the solution that is decided on, there are a number of common trends. Demands for scientific data have been heightened prior to the introduction and implementation of new technologies. Recommendations for care giving are linked to the quality and stringency of available studies. Well designed, large-scale, randomised, controlled studies rank at the top, while individual case studies, expert opinions and descriptive studies are assigned the lowest rankings. Intensive work is under way to review and compile existing knowledge. The Cochrane Collaboration is a worldwide program to synthesise studies of treatment efficacy, where high demands are placed on the methodology of the studies involved. In this way, effective technologies can be identified much more quickly. Several databases provide access to compilations that are of great value in the decision-making process in a manner that differs from traditional literature reviews. Monitoring of healthcare results has developed significantly through improved methods for measuring healthcare benefits - among other ways, in terms of health-related quality of life. The distinction between a technologys effectiveness under ideal conditions and the effectiveness achieved in its routine use has also come into greater focus. Today greater demands are being placed on relating the value of new diagnostic methods not only to improved diagnostic reliability but also to their significance for continued research and treatment and to the healthcare benefits that they can produce. Even though the gap between the technologically possible and what is economically feasible has been discussed for years, it was not until recently that the problem of setting priorities has become an issue of open debate and explicit prioritisation proposals have been set forth. It is a long road, however, to proposals for concrete measures based on a balance between ethical considerations and cost-effectiveness. There are certainly competitive advantages to be gained by the industry by meeting the markets new demands and participating in studies of comprehensive analyses of the consequences of technology in terms of socio-economic costs and healthcare benefits. This is a challenge that affects both research and development and the introduction and implementation of routine healthcare. Contributions are invited to forthcoming conferences with subtopics on various themes in this area:
(In parts printed in Asian Hospital, 1998).
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