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Overview of health technology assessment in France.

Health technology assessment (HTA) in France covers a variety of activities performed for different customers (e.g., health professionals in the field and policy makers in government) for the benefit of patients. To promote the improvement of quality in health care, France has set up a series of distinct agencies that report to the Ministry of Health but are also accountable to their other customers. We place particular emphasis on ANAES (National Agency for Accreditation and Evaluation in Health) whose main remit is HTA. We show how the diversity of HTA activities and their decentralization suggests tight collaboration among all the different bodies which perform HTA or are closely involved with HTA, and we provide examples of such collaboration.

Delivery of Health Care↗

Priority setting for health technology assessment in The Netherlands: principles and practice.

The resources for health technology assessment fall short of that needed to evaluate all health technologies. Therefore, priorities have to be set. In The Netherlands, the Health Care Insurance Board tried to address this issue by developing a more explicit priority setting procedure for the Fund for Investigative Medicine, which is the most important health technology assessment programme in The Netherlands. The procedure provides one of the first examples of the application of theoretical principles for priority setting. The aim is to select those health technologies for assessment that are most relevant for policy-making. To determine the policy relevance of research proposals, different procedures for categorising, scoring, and weighting policy criteria were defined, and different classification strategies were explored. Our first experiences using the priority setting procedure are described by means of an example on low back pain. Subsequently, the procedure has been applied to research proposals submitted to the Fund for Investigative Medicine in 1998 to illustrate how decisions on the funding of health technology assessments can be guided. The results show a different rating of research proposals into one of three predefined categories of policy relevance, high, intermediate and low, implying that decisions about funding can heavily dependent on the selected procedure. Therefore, it seems to be important that the selected procedure reflects the viewpoint of the organisation wishing to set priorities. The different ratings of the research proposals using a more explicit procedure suggest that there may be scope for further development and application of the procedure.

Health Policy↗

Assessing the learning curve effect in health technologies. Lessons from the nonclinical literature.

INTRODUCTION: Many health technologies exhibit some from of learning effect, and this represents a barrier to rigorous assessment. It has been shown that the statistical methods used are relatively crude. Methods to describe learning curves in fields outside medicine, for example, psychology and engineering, may be better. METHODS: To systematically search non-health technology assessment literature (for example, PsycLit and Econlit databases) to identify novel statistical techniques applied to learning curves. RESULTS: The search retrieved 9,431 abstracts for assessment, of which 18 used a statistical technique for analyzing learning effects that had not previously been identified in the clinical literature. The newly identified methods were combined with those previously used in health technology assessment, and categorized into four groups of increasing complexity: a) exploratory data analysis; b) simple data analysis; c) complex data analysis; and d) generic methods. All the complex structured data techniques for analyzing learning effects were identified in the nonclinical literature, and these emphasized the importance of estimating intra- and interindividual learning effects. CONCLUSION: A good dividend of more sophisticated methods was obtained by searching in nonclinical fields. These methods now require formal testing on health technology data sets.

Biomedical Technology↗

Health technology assessment and its influence on health-care priority setting.

In this article, we review the development of health technology assessment (HTA) in England and Wales, France, The Netherlands, and Sweden, and we summarize the reaction to these developments from a variety of different disciplinary and stakeholder perspectives (political science, sociology, economics, ethics, public health, general practice, clinical medicine, patients, and the pharmaceutical industry). We conclude that translating HTA into policy is a highly complex business and that, despite the growth of HTA over the past two decades, its influence on policy making, and its perceived relevance for people from a broad range of different perspectives, remains marginal.

Europe↗

Use of the Internet in scanning the horizon for new and emerging health technologies: a survey of agencies involved in horizon scanning.

BACKGROUND: A number of countries worldwide have structured horizon scanning systems which provide timely information on the impact of new health technologies to decision makers in health care. In general, the agencies that are responsible for horizon scanning have limited resources in terms of budget and staff. In contrast, the number of new and emerging health technologies, i.e. pharmaceuticals, medical devices, and medical and surgical procedures, is growing rapidly. This requires the Horizon Scanning Systems (HSSs) to devise efficient procedures for identification of new health technologies. The role of the Internet for this purpose has as yet not been documented. OBJECTIVE: To describe and analyse how the Internet is used by horizon scanning systems to systematically identify new health technologies. METHODS: A questionnaire was developed and distributed among 10 agencies known to work within this specific area. The questionnaire specifically focussed on type of sites scanned, frequency of scanning, and importance of a site for the identification of a new health technology. RESULTS: A 100% response rate was obtained. Seven out of 10 agencies used the Internet to systematically identify new health technologies, of which 6 provided complete information. A total of 110 web sites were scanned by these 6 agencies. The number of sites scanned per agency ranged from 11 to 27. Most sites were scanned weekly (41%) or monthly (33%). Thirty-one percent (31%) of the total number of sites was considered as highly important. The agencies spent at least 2 hours a week and at most 8 hours per week scanning the Internet. Although each agency's remit differed somewhat in scope, on average the same types of sites were scanned. These include sites from regulatory agencies, sites with information on new drugs or new devices, and sites with news from newswires. However, within these types there was not much correlation between the individual sites that agencies judged important to scan. CONCLUSION: The use of the Internet for identifying new health technologies is increasing in the majority of horizon scanning systems around the world. At the same time there is considerable variation between individual agencies in their approach to this source of information. This can only be partially explained by differences in scope of scanning activities of the individual agencies. A coordinated effort to develop Internet search strategies for either different categories of health technologies or different clinical specialties may improve efficiency and quality of scanning in terms of the number of potentially relevant technologies identified.

Biomedical Technology↗

Health care policy: qualitative evidence and health technology assessment.

Since the late 1990s health technology assessment (HTA) has gained influence as a research and evaluation approach supporting health care policy. The focus on this methodology is congruent with the growing importance of evidence-based health care. Although HTA is a multidisciplinary discipline from a theoretical point of view, practice shows that social, ethical and psychological aspects are seldom truly integrated into the assessment of health technology. HTA is still very much biased by the medical and pharmaceutical research traditions. This contribution focuses on the question of how qualitative research findings could be useful as an additional source of information or as 'evidence' in HTA. Medical and health care scientists are seldom acquainted with qualitative research or judge it as a less (or un-)reliable form of research. 'Qualitative dimensions' of health care are not considered 'real' evidence. This contribution argues that qualitative findings could be put higher in the hierarchy of evidence generating research in health care. First it can be realized by improving the knowledge of the nature of qualitative research. Second qualitative findings can become more trustworthy information, if researchers themselves respect methodological prerequisites and clarify their theoretical perspective, research aims and use of research methods. Some methodological characteristics of qualitative research and 'evidence' are discussed for their contribution to HTA and evidence-based health care.

Evidence-Based Medicine↗

Health technology assessment: history and demand.

Health technology assessment (HTA)--the provision to decision makers of information on the value of treatments and tests--has come of age in the last two decades. But it has deep roots in health care, with notable landmarks in (1) the mid eighteenth-century development of empiricism, (2) the twentieth century interest in outcomes and variation in health care, and (3) the pioneering work of Archie Cochrane and others in the 1970s. Three main forces have driven the recent developments of HTA: a combination of concerns about the adoption of unproven technologies, rising costs, and an inexorable rise in consumer expectations. The HTA response, essentially initiatives supporting the provision of reliable synthesised research information on the effects and costs of health technologies, have been well supported in the United Kingdom and internationally. We can be sure that HTA is here to stay.

Cost-Benefit Analysis↗

Health technology assessment in Luxembourg.

Luxembourg's public health insurance is a compulsory insurance for all employees, self-employed professionals, farmers, and pensioners. It is financed through contributions of the insured people, as well as by state taxes. Providers of health care are mainly private nonprofit institutions and self-employed professionals. All healthcare procedures are defined in fee schedules determined by a common decision of the Ministers of Social Security and Health according to proposals of a board of experts. The relative value of a service is also determined by the corresponding fee schedule. Hospitals are financed by individual budgets negotiated between each hospital and the health insurance. These hospital budgets do not cover services provided in hospitals by medical specialists, who are reimbursed on a fee-for-service basis. A low on hospital planning and organization allows the government to restrict the installation in hospitals of very expensive equipment or of equipment for which there is only a limited need in Luxembourg hospitals. Until recently there has been limited interest in or use of health technology assessment (HTA). However, large hospital investments have provoked some interest in the last few years. The Ministry of Health has asked for some HTA studies when a concrete decision had to be taken. Luxembourg decision makers have become more aware that HTA may help them to become more informed about the short- and long-term consequences of the application of health technology.

Delivery of Health Care↗

Effectiveness, safety and cost-effectiveness of homeopathy in general practice - summarized health technology assessment.

INTRODUCTION: The Health Technology Assessment report on effectiveness, cost-effectiveness and appropriateness of homeopathy was compiled on behalf of the Swiss Federal Office for Public Health (BAG) within the framework of the 'Program of Evaluation of Complementary Medicine (PEK)'. MATERIALS AND METHODS: Databases accessible by Internet were systematically searched, complemented by manual search and contacts with experts, and evaluated according to internal and external validity criteria. RESULTS: Many high-quality investigations of pre-clinical basic research proved homeopathic high-potencies inducing regulative and specific changes in cells or living organisms. 20 of 22 systematic reviews detected at least a trend in favor of homeopathy. In our estimation 5 studies yielded results indicating clear evidence for homeopathic therapy. The evaluation of 29 studies in the domain 'Upper Respiratory Tract Infections/Allergic Reactions' showed a positive overall result in favor of homeopathy. 6 out of 7 controlled studies were at least equivalent to conventional medical interventions. 8 out of 16 placebo-controlled studies were significant in favor of homeopathy. Swiss regulations grant a high degree of safety due to product and training requirements for homeopathic physicians. Applied properly, classical homeopathy has few side-effects and the use of high-potencies is free of toxic effects. A general health-economic statement about homeopathy cannot be made from the available data. CONCLUSION: Taking internal and external validity criteria into account, effectiveness of homeopathy can be supported by clinical evidence and professional and adequate application be regarded as safe. Reliable statements of cost-effectiveness are not available at the moment. External and model validity will have to be taken more strongly into consideration in future studies.

Cost-Benefit Analysis↗

Health technology assessment in Germany. Status, challenges, and development.

The objectives of this paper are to describe the status and development of health technology regulation with regard to coverage decisions and utilization, and to analyze the current situation of health technology assessment (HTA) in Germany. The relevant literature for controlling health technologies was identified by searching the literature and databases and through personal contacts. The literature was analyzed with regard to the different sectors in the healthcare system. For the analysis of the current state of HTA in Germany, a national survey was carried out. In addition, the names of topics under assessment were collected. The results show that coverage decisions in the ambulatory sector appear to be much more regulated than those in the inpatient sector. The same is true for diffusion and usage of technologies. The strict separation of the hospital and the ambulatory care sector in Germany constitutes a barrier to regulation and to making HTA an effective instrument in Germany. Until recently, HTA in Germany focused on biotechnology, such as gene technology. Recently the German Scientific Working Group of Technology Assessment in Health Care has adopted a systematic methodology to undertake HTAs. It can be concluded that regulation of health technologies in Germany is characterized by inconsistencies ranging from strict regulation in the ambulatory sector to almost no regulation in the rehabilitation sector. Increasing interest in HTA, in conjunction with a high priority assigned to evaluation of health technologies by the newly elected government, is likely to improve this situation in the future.

Ambulatory Care↗

Health technology assessment in Ireland.

Ireland's health system is primarily funded from general taxation and is publicly provided, although private health care retains a considerable role. It is a unique structure, a mixture of universal health service free at the point of consumption and a fee-based private system where individuals subscribe to private health insurance that covers some of their medical expenses. The recent history of the Irish health services saw consolidation of existing services and an expansion into new areas to adapt to changing practices and needs. There has also been a drive to extract maximum efficiency so as to maintain the volume and quality of patient services at a time of very tight financial constraints. Introduction of new health technologies continued to accelerate. New technologies tended to spread rapidly before systematic appraisal of their costs and benefits. When the state is involved in funding the public hospital system, acceptance of new technology is a matter for discussion between agencies and the Department of Health and Children. Decisions about spending annual "development funding" have generally not been based on careful assessment of proposals for new technology. In 1995, a healthcare reform put new Public Health Departments in Health Boards in a prime position in Ireland's health services organization. These departments now emphasize evidence-based medicine. While Ireland does not have a national health technology assessment (HTA) program, there are plans to form an advisory group on HTA in 1998. HTA is seen as a significant element of future health policy in Ireland.

Delivery of Health Care↗

Setting priorities for the adoption of health technologies on a national level -- the Israeli experience.

The rapid development of new and expensive health technologies together with the limited resources available for the health care system, makes priority setting or rationing inevitable. The Israeli Health Insurance Law, enacted in 1995, determined a basic list of health services to be provided to all residents by public funding. Although the Israeli health care system has reached a high standard of medical care as expressed by parameters such as long life expectancy and low infant mortality, the social and professional demand for new and expensive health technologies is increasing. Towards the fiscal year of 1999, the Medical Technologies Administration of the Ministry of Health recommended a list of new technologies to be added to the list of health services. The Ministry of Finance allocated that year US dollars 35 million for this purpose, while a rough assessment found that there are new important technologies to be added at a cost of more than US dollars 350 million. The Medical Technologies Administration took a systematic approach of health technology assessment - ad-hoc teams were established for evaluating clinical safety, efficacy and effectiveness, conducting needs assessment and cost-effectiveness descriptions. Assessment of the data was based on evidence-based medicine. A set of criteria was determined in order to enable the prioritizing of the assessed new technologies. This procedure led to a list of technologies suggested for inclusion. The Minister of Health appointed a public committee whose purpose was to decide the technologies to be added to the list of health services. The committee, made up of representatives from the government, the sick-funds and the public, had to evaluate each technology, based on the analysis submitted to the committee, taking into consideration clinical, economic, social, ethical and legal aspects according to predefined criteria. The thorough work of the Medical Technologies Administration enabled the committee to adopt its recommended list with minor changes within a limited timeframe. In conclusion, we propose a practical and pragmatic model for the inclusion of new health technologies at a national level, based on health technology assessment and explicit priority setting.

Decision Making, Organizational↗

A short history of INAHTA. International Network of Agencies for Health Technology Assessment.

The need for better communication and collaboration between health technology assessment agencies led to the formation of an International Network of Agencies for Health Technology Assessment (INAHTA). The network now comprises 27 agencies and has been successful in improving exchange of information and in undertaking joint health technology assessment projects. Issues for the future include possible changes to criteria for membership and identification of resources for more extensive programs.

Databases, Bibliographic↗

[Health technology in Mexico].

The features of the health technology cycle are presented, and the effects of the demographic, epidemiologic and economic transition on the health technology demand in Mexico are discussed. The main problems of science and technology in the context of a decreasing scientific and technological activity due to the economic crisis and the adjustment policies are also analyzed: administrative and planning problems, low impact of scientific production, limitations of the Mexican private sector, and the obstacles for technology assessment. Finally, this paper also discusses the main support strategies for science and technology implemented by the Mexican government during the 1980s and the challenges and opportunities that lie ahead.

Epidemiology↗

Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment.

OBJECTIVES: To estimate the feasibility, utility and resource implications of electronically captured routine data for health technology assessment by randomised controlled trials (RCTs), and to recommend how routinely collected data could be made more effective for this purpose. DATA SOURCES: Four health technology assessments that involved patients under care at five district general hospitals in the UK using four conditions from distinct classical specialties: inflammatory bowel disease, obstructive sleep apnoea, female urinary incontinence, and total knee replacement. Patient-identifiable, electronically stored routine data were sought from the administration and clinical database to provide the routine data. REVIEW METHODS: Four RCTs were replicated using routine data in place of the data already collected for the specific purpose of the assessments. This was done by modelling the research process from conception to final writing up and substituting routine for designed data activities at appropriate points. This allowed a direct comparison to be made of the costs and outcomes of the two approaches to health technology assessment. The trial designs were a two-centre randomised trial of outpatient follow-up; a single-centre randomised trial of two investigation techniques; a three-centre randomised trial of two surgical operations; and a single-centre randomised trial of perioperative anaesthetic intervention. RESULTS: Generally two-thirds of the research questions posed by health technology assessment through RCTs could be answered using routinely collected data. Where these questions required analysis of NHS resource use, data could usually be identified. Clinical effectiveness could also be judged, using proxy measures for quality of life, provided clinical symptoms and signs were collected in sufficient detail. Patient and professional preferences could not be identified from routine data but could be collected routinely by adapting existing instruments. Routine data were found potentially to be cheaper to extract and analyse than designed data, and they also facilitate recruitment as well as have the potential to identify patient outcomes captured in remote systems that may be missed in designed data collection. The study confirmed previous evidence that the validity of routinely collected data is suspect, particularly in systems that are not under clinical and professional control. Potential difficulties were also found in identifying, accessing and extracting data, as well as in the lack of uniformity in data structures, coding systems and definitions. CONCLUSIONS: Routine data have the potential to support health technology assessment by RCTs. The cost of data collection and analysis is likely to fall, although further work is required to improve the validity of routine data, particularly in central returns. Better knowledge of the capability of local systems and access to the data held on them is also essential. Routinely captured clinical data have real potential to measure patient outcomes, particularly if the detail and precision of the data could be improved.

Arthroplasty, Replacement, Knee↗

[The health technology assessment].

The aim of this paper was to describe exhaustively, but concisely, the matter of the health technology assessment. It is a method of evaluating health technologies based on principles and tools of Evidence Based Medicine. We started from etymology to speak about its definition and implementation methodology. Moreover we guide the reader throughout the constellation of international societies of health technology assessment and the meaning of their international cooperation. Finally, we deal with the health technology assessment as a tool being an integral part of the clinical governance process.

Evidence-Based Medicine↗