Introduction: mass screening, health technology assessment, and health policy in some European countries.

OBJECTIVE: The series of papers in this issue was developed to examine the use of health technology assessment in policies toward prevention-specifically toward mass screening-in European countries. The papers actually examined three screening strategies: mammography screening for breast cancer, prostate-specific antigen screening for prostate cancer, and routine ultrasound in normal pregnancy. METHODS: Papers were sought from the member states of the European Union, plus Switzerland. Ultimately, nine acceptable papers were received, and were reviewed, revised, and edited. RESULTS: Screening is an accepted strategy in many countries for reducing the burden of disease through early detection and intervention. In part, this is because of successful screening programs that have been evaluated and implemented in many countries. At the same time, unevaluated and even useless and harmful screening programs-unjustified medically or economically-are widespread. Health technology assessment could help assure that only effective and cost-effective screening programs are implemented. CONCLUSION: The main conclusion is that screening is an important preventive strategy. Any screening program, however, should be carefully assessed before implementation.

Health technology assessment and screening in The Netherlands: case studies of mammography in breast cancer, PSA screening in prostate cancer, and ultrasound in normal pregnancy.

OBJECTIVE: To review the assessment and implementation of three screening methods: mammography for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy. METHODS: To review policy documents and published papers dealing with prevention and screening in the Netherlands, focusing on the three screening methods specified. RESULTS: The results indicate that the Netherlands has an active establishment devoted to health technology assessment (HTA). The Netherlands government has also made prevention a high priority in the health services system. Within prevention policy, HTA is given an important place. The general policy is that prevention programs should meet high standards of effectiveness and efficiency, as well as ethical, legal, and social acceptability. In addition, the Netherlands may be unique in the world in having a specific law requiring that proposals for population screening must be carefully assessed before they are implemented. CONCLUSIONS: The three cases examined in this paper have all been assessed, and the conclusions are similar to those presented in the synthesis published in this issue (33). In the case of mammography, the assessment was followed by a rational implementation of a national screening program for breast cancer. In the other two cases, however, despite negative conclusions from assessment, the tests are frequently carried out, especially in what has been termed opportunistic screening. Prostate cancer screening seems to be spreading rapidly. Use of ultrasound in pregnancy is frequent, not necessarily for medical reasons but because parents wish to have a picture of their fetus. The conclusion is that HTA is well established in the Netherlands, as illustrated in these three cases, and policy is based on the assessments done. However, practice is not in accord with the assessment in the cases of prostate cancer and routine ultrasound. Policies to deal effectively with opportunistic screening are difficult to imagine.

Health technology assessment and screening in Sweden.

OBJECTIVES: To describe health technology assessment (HTA) and policies concerning three screening procedures in Sweden. METHODS: The main source of information was reports from the Swedish Council for Technology Assessment in Health Care (SBU) and other governmental reports, supplemented by the professional literature. RESULTS: Prevention is emphasized in the healthcare services of Sweden. Specifically, screening is encouraged and supported when it is deemed beneficial. Sweden has a strong orientation toward evidence-based health care and HTA. Since its inauguration in 1987, SBU has fostered the use of HTA in making policy and clinical decisions in Sweden. Government policy in Sweden is to encourage services that are beneficial and cost-effective and discourages services that are not. Screening is no exception to this general rule. The three cases examined in this paper-mammography screening, PSA screening, and routine ultrasound screening in pregnancy-have all been formally assessed in Sweden. Assessments have been an integral part of policy making concerning these and other preventive measures. Mammography screening has been widely implemented. However, as in other countries, screening is often carried out in an opportunistic fashion, so that PSA screening, in particular, is carried out more in Sweden than can be justified by the evidence. CONCLUSIONS: Mammography screening is promoted and is completely available to the target group. PSA screening is discouraged, but not with complete success. Ultrasound in pregnancy is widely used, not because of good evidence of impact on mortality and morbidity among newborns, but because it increases the detection rate of congenitally malformed fetuses and because of evidence of positive effects on the management and planning of deliveries, as well as because of psychological and ethical implications of the technology. HTA is an important part of health policy making in Sweden.

Health policy, health technology assessment, and screening in Europe.

OBJECTIVE: To present a summary of the papers in this volume, illustrating the links between health technology assessment (HTA), health policies and specifically policies toward prevention and screening, and implementation of screening tests in the case of three screening methods: mammography screening for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy. METHOD: To commission papers from eight European countries based on a set of questions to be answered, as well as a paper synthesizing the scientific literature on the three screening procedures. RESULTS: Indicate that few of the countries examined have developed effective links between HTA, health policy, and implementation related to screening procedures. Only Sweden and the Netherlands appear to have developed such links. In the other countries, HTA has a limited role in determining health policy. It also seems to be uncommon for countries to have a specific prevention strategy. CONCLUSION: The major conclusion is that countries of Europe need to develop HTA as part of prevention policies.

The ethics of assessing health technologies.

Health technology assessment (HTA) consists of the systematic study of the consequences of the introduction or continued use of the technology in a particular context, with the explicit objective to arrive at a judgment of the value or merit of the technology. Ideally, it is aimed at assessing all aspects of a given technology or group of technologies, including non-technical, e.g. socio-ethical, aspects. However, methods for assessing socio-ethical implications of health technology are relatively undeveloped and few mechanisms exist to take action based on the results of such evaluations. Still, the examples of cochlear inplants (CI) and other cases illustrate that HTA is not a matter of merely collecting the facts about a technology. The facts must be plausible and relevant from a particular framework, which is not always shared by different groups. It is here that socio-ethical aspects are encountered. If health technology assessment aims to enhance the accountability of the decision making process regarding funding and use of health technology, it is a major challenge to assessors of health technologies to deal adequately with existing value pluralism. In this respect interactive evaluation may have something to offer.

An early system for the identification and assessment of future health care technology. The Dutch STG Project.

This article is based on the report, Anticipating and Assessing Health Care Technology, written in the Netherlands between 1985-88. The project was carried out because of increasing concern in the Dutch Ministry of Health (STG, then WVC) about the costs and benefits of new technologies for health care. At that time, there were no established models for early identification, so the project was not only the most extensive such effort to that date, but had to develop its own methods. Overseen by a special commission, the project staff identified many future and emerging technologies in health care and assessed selected technologies. Although the actual information produced was quickly dated and the project was discontinued in 1988, it did stimulate the Ministry of Health to ask the Dutch Health Council (Gezondheidsraad) to continuously identify important new technologies. The reports also demonstrated the potential usefulness of such an effort to Dutch policy makers, and probably to those in other countries as well.

A training course in health technology assessment in Malaysia.

This article describes a 1-week training course in health technology assessment (HTA) presented in Malaysia by the Ministry of Health in 1996. Malaysia established an HTA unit in the Ministry of Health in 1995 and a National Health Technology Assessment Program in 1996. The purpose of the course was to develop HTA knowledge and skills in Malaysia, since these are largely lacking. The course consisted of didactic sessions and group work. Didactic sessions covered the principles of HTA. Group work was for the purpose of developing practical skills, and was based on reports from HTA agencies, published articles, and candidates for assessment suggested by course participants. Course participants were a mix of physicians, nurses, hospital administrators, and Ministry of Health officials. Experiences in this course may be helpful to others who wish to organize training courses in developing countries.

A history of ISTAHC. A personal perspective on its first 10 years. International Society of Technology Assessment in Health Care.

This reflection on the history of the International Society of Technology Assessment in Health Care is an effort to describe the creation of the Society and its first 10 years of activity. Without analyzing the forces that spurred the growth of technology assessment internationally or linking events, policies, and changes in the various countries, this essay focuses on the persons and events that surrounded the birth and growth of the Society in the past decade.

Health care technology as a policy issue.

Health care technology has become an increasingly visible issue in many countries, primarily because of the rising costs of health care. In addition, many questions concerning quality of care are being raised. Health care technology assessment has been seen as an aid in addressing questions concerning technology, including benefits and costs. A number of industrialized countries have developed active programs of health care technology assessment during the past two decades. Eight countries at similar levels of socio-economic and health development--Australia, Canada, France, Germany, the Netherlands, Sweden, the United Kingdom and the United States--have been examined to gain insights into how they manage health care technology and what place technology assessment has in such management. In addition to seeking general information, specific cases--treatment for coronary artery disease, medical imaging, laparoscopic surgery, treatment of end-stage renal disease, neonatal intensive care, and breast cancer screening--were examined in each country.

Health care technology in Sweden.

Health care in Sweden is a public sector responsibility and equity in access to care is quite important. The Swedish system is organized into several levels, with the Federation of County Councils at the top, and with regional, county, and local levels. In theory, the four hospital tiers developed by these different levels provide a clear hierarchy for acquisition of sophisticated new technologies. In practice, certain problems have emerged, especially rigidity of the system. Reforms are underway. Sweden was one of the first countries to become involved in the assessment of health care technology. From the beginning, technologies were assessed to determine if they were 'consistent with proven scientific knowledge and good experience'. Sweden has a national program in health care technology assessment (TA), and TA is increasingly visible to policy makers and physicians. Health care TA has been effectively institutionalized in Sweden and has a bright future. The greatest problem in the Swedish context is the large number of unassessed technologies. Because of this, international cooperation is essential.

Lessons from the eight countries.

While the eight countries presented in this issue differ considerably from each other, they have important similarities. All have faced the problem of increasing health care expenditures, and all are coming to recognize problems with health care technology such as inappropriate use and poor quality of care. Health reforms appear to be accelerating in the countries examined. In addition, all countries now have stated policy goals of assessing the benefits of health care technologies and most have established formal programs for health care technology assessment. Technology assessments impact varies, but it is becoming an important factor in technology acquisition. These trends point to a future for technology assessment and perhaps to better management of health care technology. International cooperation is important if this goal is to be realized.

Strategies for successful evaluation and policy-making toward health care technology on the move: the case of medical lasers.

Evaluating new health care technology that is rapidly diffusing is one of the greatest challenges to researchers and policy-makers. If no evaluation is done until the technology is mature, evaluation will not influence processes of diffusion. If evaluation is done early, it may be irrelevant when it is completed, because of developments in the technology and changing indications for its use. Nonetheless, early evaluation seems to be the only strategy possible to improve the integration of evaluation and diffusion. These difficulties are illustrated by the case of lasers. Lasers are diffusing relatively rapidly into health care, and yet few laser applications have been well-evaluated. Looking back over the past 20 years or so, only one public body, the National Eye Institute of the U.S. National Institutes of Health (NIH) seems to have tried to address the problem of laser evaluation. In the case of the Eye Institute, it has consistently identified new technologies for treatment of eye conditions and has mounted well-designed prospective evaluations aimed at influencing clinical practice. However, these evaluations have not been integrated with public policy-making, and therefore their influence has been relatively slow to develop. In recent years, concerns about technology have brought more active attempts to develop public policies to affect diffusion. Excimer laser treatment of coronary artery disease, especially as dealt with in the Netherlands, illustrates how a strategy can be developed. Regulation has allowed diffusion to be constrained while evaluation is carried out. Results of the evaluation will guide subsequent diffusion. In the future, such results will probably be used in determining if the laser treatment should be included in the benefit package of health insurance. A strategy for improving diffusion processes requires continuous monitoring of technological developments in health care to identify candidates for such early assessment. Since assessment resources are limited, setting priorities between candidates for assessment is necessary. Once priorities have been determined, an evaluative strategy can be formulated. As in the case of laser treatment of coronary disease, a mechanism for constraining diffusion until evaluations are completed is necessary. Once the studies are completed, policy-making must be done promptly. The problem of successful implementation of this strategy lies with the public bodies, which are often not prepared to develop an integrated strategy of diffusion based on technology assessment and economic appraisal. Developing such a strategy, which would involve slowing diffusion in some cases and speeding it up in others, seems to have clear benefits.(ABSTRACT TRUNCATED AT 400 WORDS)

The future and health care technology: implications of a system for early identification.

Future and emerging health care technologies are increasingly high-impact events for society in terms of the quality and costs of health care. They raise issues of efficacy, safety, resource allocation, ethics, impact on the organization and delivery of care, and broad social effects. This article describes an analysis of future and emerging health care technology, initiated by the government of the Netherlands and carried out formally from 1985 to 1988, and its potential usefulness in a policy and decision-making context. Using the results and experiences of this analysis, it is argued that rational health care planning and decision-making can be strengthened by paying more attention to the possible implications of emerging and future technology.

Minimally invasive surgery. Implications for hospitals, health workers, and patients.

Minimally invasive surgery is one of the great innovations of health care in the 20th century. It promises to revolutionise surgery by allowing many more operations to be performed with minimal hospitalisation. Pressure from patients has caused many techniques to spread rapidly before they have been adequately assessed. This must be resisted, and policy makers must pay more attention to minimally invasive surgery to ensure that good assessments are made. The widespread use of minimally invasive techniques has important implications for hospitals and health workers. As more patients are treated on an outpatient basis, fewer hospital beds will be needed, and traditional operating rooms will have to adapt to a greater turnover of patients. Surgeons will have to acquire new operating skills, possibly requiring formal training and accreditation, and, as different specialties fight for control of new technologies, surgery may eventually be merged with internal medicine so that specialists will deal with organ systems. Postoperative care will have to be carried out in the community rather than in hospitals, and policy makers will need to reorganise their health systems to cope with these developments.

Quality of life. 1. Perspectives.

Assessing the value of health care interventions is more and more a concern of governments, clinicians, health insurance companies, policy makers, and the general public. One dimension of the outcomes of such interventions that has received relatively little attention until recently is quality of life. However, during the last decade, measuring quality of life has become more frequent. Methodologies have also developed rapidly. At the same time, methodological problems continue to be troubling. In part, this explains the relative lack of use of validated measures of quality of life in clinical trials. In the future, measuring quality of life will certainly become more frequent. It may even be demanded by policy making bodies. Increasingly, too, economic costs will be part of such studies. This requires considering both clinical and economic data.

Implications of minimally invasive therapy.

Minimally invasive therapy (MIT) is a new approach to conditions that previously would have been treated by open surgery. It is made possible by developments in endoscopes, medical imaging and vascular catheters. Minimally invasive therapy has many implications for the health system, as it makes it possible to perform many procedures on an outpatient basis or with a short hospital stay. In addition, surgical training is not always necessary to carry out MIT procedures, which means that other specialties such as internal medicine and radiology have become involved in the field. Minimally invasive therapy has already led to conflicts between different specialties in some countries. It also is giving further stimulus to the reduction in numbers of hospital beds. On the other hand, full implementation of MIT requires attention to the system of out-of-hospital care, which generally is not prepared to monitor patients after discharge or to deal with complications that may arise. Quality of care in the out-of-hospital setting also needs attention.