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.

Objective: To review published data regarding the accuracy and effectiveness of three screening tests: mammography, prostate-specific antigen (PSA), and prenatal ultrasound.

Methods: Published evidence regarding the accuracy and effectiveness of the three tests was collected by computerized literature search and supplemented by manual review of relevant bibliographies.

Results: Screening mammograms lower breast cancer mortality by about 20%. Most data come from women aged 50–64 years; women aged 40–49 years may also benefit, but the absolute risk reduction is lower. Up to 1,500 to 2,500 women must undergo screening to prevent one death from breast cancer. Mammograms miss approximately 12% to 37% of cancers, generate false-positive results, and cause anxiety while abnormal results are evaluated. PSA screening can detect 80% to 85% of prostate cancers but has a high false-positive rate. There is little direct evidence that early detection reduces morbidity or mortality. Indirect evidence includes a trend toward earlier stage tumors and steadily declining mortality rates in geographic areas where PSA screening has become common. Potential harms include the morbidity associated with evaluating abnormal results, and complications from treatment (e.g., impotence, incontinence). The overall balance of benefits and harms remains uncertain in the absence of better evidence. Prenatal ultrasound may reduce perinatal mortality, primarily through elective abortions for congenital anomalies, but does not appear to lower live birth rates. Although ultrasound has no proven effect on neonatal morbidity, it provides more accurate estimates of gestational age that prevent unnecessary inductions for post-term pregnancy. Screening detects multiple gestations, congenital anomalies, and intrauterine growth retardation, but direct health benefits from having this knowledge are unproved. Ultrasound has both positive and negative psychological effects on parents. The scans do not appear to harm childhood development.

Conclusions: Even for the most established screening tests, the appropriateness of routine testing depends on subjective value judgments about the quality of supporting evidence and about the trade-offs between benefits and harms. Individuals, clinicians, policy makers, and governments must weigh the evidence in light of these values and the constraints imposed by available resources.

Objective: To study cases of screening in Austria to learn about national strategies to handle the health policy challenge of early detection of widespread diseases and about the outcome of those strategies. The article describes three healthcare interventions (mammography, PSA testing, and routine use of ultrasound in pregnancy) and the instruments of Austrian health policy that are used—with or without explicit intention—to enforce or to control the widespread use of (early) diagnoses.

Methods: Data and information collection on healthcare services, their accessibility, rate of use, expert consensus, and official regulations. For all three case studies, expert interviews were carried out with main actors.

Results: Risk-group screening is not a priority in Austrian federal health policy. Although health promotion and prevention is a national task, examinations for early detection of specific diseases (i.e., carcinoma) are left to the health insurance funds, which delegate the decision to offer early diagnoses to their contracted physicians. In this opportunistic screening, general practitioners or specialists are encouraged by their health insurance funds or motivated by professional guidelines to offer certain examinations.

Conclusions: Screening is a coordinated effort to acquire a grasp of a common disease at an early stage in a specified population. To achieve this objective, a culture of coordination and centralization has to be implemented. The collection of data is an essential element in coordination of decentralized medical interventions as much as quality control is an essential task in looking at and comparing the outcome of interventions. In the three case studies, neither of these two essential criteria were met. Evaluations and scientific evidence on the effectiveness of interventions were not used.

Objective: To describe how scientific evidence has influenced healthcare policy making in Belgium in the field of sickness prevention for mammography, PSA testing in prostate cancer screening, and use of ultrasound in pregnancy.

Methods: Review of published and gray literature and interviews with stakeholders and experts.

Results: At the end of 1999, a systematic national/regional screening program had not yet been implemented for any of the three screening strategies. A systematic breast cancer screening program is being prepared for implementation only in Flanders. This limited impact can be attributed to the fragmentation in healthcare policy, the different options among the different regions, fragmentation in healthcare practice, the strong impact of healthcare stakeholders (provider groups and sickness funds) on decision making, and limited attention to scientific evidence in health policy and technology assessment.

Conclusions: Health technology assessment has had very little impact on policy and practice in use of mammography, PSA testing, and ultrasound in pregnancy in Belgium.

Objective: In this article, three preventive strategies—mammography screening for breast cancer, PSA screening for prostate cancer, and routine ultrasound in normal pregnancy—are discussed in the context of German health care.

Methods: Epidemiologic data and German studies evaluating different aspects of these preventive measures were identified and analyzed.

Results: Only a few studies could be identified that investigate these preventive measures. Despite sufficient evidence, in part derived from a German study, there is not yet a mammography screening program. In contrast, ultrasound in pregnancy is offered routinely, although there are controversies regarding the benefit of this practice. PSA screening is not offered as part of the screening program for prostate cancer. However, PSA tests as well as mammographies are done in large numbers in German ambulatory care—a practice that could be considered wild or opportunistic screening.

Conclusions: These case studies show that preventive programs and practices in Germany are not sufficiently based on sound evidence. The paucity of evaluation activities related to prevention in Germany is probably due to the low threshold to introduce new preventive programs into the German healthcare system in the past.

Objective: To explore the impact of health technology assessment (HTA) on health policy and practice in Greece through selected screening case studies in the prevention area. The three cases studied were mammography screening, PSA screening, and routine ultrasonography in normal pregnancy.

Methods: Official policy recommendations or reports, a literature review of Greek published research as well as gray literature from various sources, and interviews with specialists and medical associations were performed, and their impact on health policy formulation was examined.

Results: The implementation of the screening tests does not take the form of structured mass screening programs. Almost all physicians (urologists-pathologists, gynecologists) apply PSA and routine ultrasonography in normal pregnancy respectively with the purpose of either prevention or diagnosis. Mammography is applied generally for prevention or diagnosis, but there are some mass screening programs at a local level. In addition, the results show no evidence that the efficacy and the cost-effectiveness of the three screening programs have been a matter of serious concern and investigation for the purposes of policy formulation in Greece.

Conclusion: The results point to a need for the implementation of HTA methods on mass screening preventive programs in which real value and cost remain unclear and whose use is based on empirical and personal assessments.

Objective: To present current scientific statements and practice on mammography, ultrasonography in pregnancy, and PSA within the Italian National Health Service (NHS).

Methods: Information on the three screenings was found in several position papers prepared by working groups at national and regional levels.

Results: For mammography the adjusted mortality rate for breast cancer increased in the last four decades and decreased in the last few years. Only 4.9% of women aged 50–70 years are covered by screening. In 1996 a consensus paper stated that biennial examination for women aged 50–69 years should be offered to reduce breast cancer mortality. A national program for breast cancer screening was launched under the responsibility of regional governments, but data about its implementation are not yet available. Regarding PSA screening, the results show that prostate cancer is the fourth most frequent neoplasm in males. A formal evaluation of prostate cancer screening was done in 1995 by the National Research Council and the Italian Association for Cancer Research; they did not recommend the NHS implement this service. In the National Health Plan 1998–2000, prostate cancer screening is not mentioned. So far, an organized and standardized screening program, based on routine PSA testing, does not exist in Italy. Nevertheless, a lot of PSA tests are performed at the clinical level to detect early prostate cancers. The results with regard to routine ultrasonography in pregnancy show that in 1996 the birth rate was 9.30 per 1,000 inhabitants, with 536,740 live births. In the period from 1992–94, the percentage of babies with a birth weight less than 2,500 gm and less than 1,500 gm were 5.85% and 0.91%, respectively. A formal screening program for detecting fetal growth retardation, based on the routine ultrasonography in the third trimester of the normal pregnancy, doesn't exist in Italy, but this test is widely performed. It is paid for under NHS coverage.

Conclusion: In 1998 the National Health Plan 1998–2000 stated that the NHS should offer only evidence-based preventive and diagnostic interventions and stressed the importance of appropriate use of health technology.

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.

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.

Objective: To describe the level of health technology assessments for three screening methods in Switzerland.

Methods: Analysis of documents and expert opinions on mammography screening, ultrasound examinations during normal pregnancy, and screening for prostate-specific antigen (PSA) with a focus on services provided, recommendations, formal regulations, national papers, projects, and formal assessments.

Results: Preventive services are explicitly recommended by the Swiss federal law on health insurance. Two routine ultrasound examinations during normal pregnancy as well as PSA analysis for men over 40 years of age on medical indication are covered by basic health insurance. Mammography screening every 2 years has been covered since 1997 for women over 50 years. A systematic screening program for mammography exists in the western part of Switzerland, and a nationwide program is planned. However, a national program may not come into being until a quality assurance program for evaluation is established, and a nationwide fee for reimbursement—to include all costs of such a program—is accepted by providers and insurers.

Conclusion: According to the Swiss health insurance law, the effectiveness of mammography screening and ultrasound examinations during normal pregnancy have to be proven. Systematic evaluation of these screening methods is in preparation. PSA is not part of current evaluation. It can be concluded that health technology assessment in Switzerland is now required by law for several medical services. However, limited financial and personnel resources as well as the lack of disease registers may hamper progress in the near future.

Objective: To review the assessment of screening in the United Kingdom, focusing on three methods: mammography for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy.

Method: To review policy documents and published papers dealing with prevention and screening in the United Kingdom.

Results: Indicate that the United Kingdom has an active policy concerning the assessment of screening methods. Generally speaking, this assessment policy is part of the national program for health technology assessment (HTA). The government has given HTA an important place within health care in the United Kingdom, and prevention and screening is no exception to this general rule. The assessment of screening is now implemented through the National Screening Committee, established in 1997. The three issues reviewed in this paper have all been assessed within the context of the Department of Health. In the case of mammography, the assessment was done more than 10 years ago and was followed by a rational implementation of a national screening program for breast cancer. In the case of prostate cancer screening, two systematic reviews have concluded that screening should not be carried out. In general, this recommendation has been accepted in the United Kingdom. Use of ultrasound in pregnancy has been assessed by the National Screening Committee. This complex technology is difficult to assess, and the screening procedure is deeply embedded in clinical practice in the United Kingdom, so assessment has not had much impact on the frequency of screening.

Conclusion: HTA and the assessment of screening are well established in the United Kingdom. Policy is generally based on the assessments done, and practice generally follows the results of assessment. Assessment of screening is expected to become increasingly important in the United Kingdom during the next years.

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.

In this article we analyze the influence of the legal regulatory framework in Europe, established by the two directives on medical devices and active implantable devices, on the performance of innovation in a single European market. First, we describe in general the possible influence of a single European market on innovation and the institutional features of the particular harmonization approach (“New Approach”) we are looking at here. The empirical results presented derive from a survey investigation involving 150 firms that we defined as best innovators in the European medical devices industry from a pre-survey. The results confirm that the total impact of the New Approach regulation on firms' innovation in the long term is positive. However, it also becomes clear that the impact of regulation on innovation is limited if the factors are looked at individually and that there is a clear difference regarding short-term effects. To improve the regulatory framework, several policy actions are recommended.

Objective: This paper presents the method we used in programming research on the efficacy of therapeutic interventions for nine chronic benign pain disorders.

Methods: We started with an inventory to identify commonly applied interventions. For these interventions we searched the literature to identify gaps in evidence. First, we searched for recent reviews, of which we assessed the methodologic quality. If only reviews of poor or moderate quality were found, a new systematic review was recommended. When we found no recent reviews, we searched for randomized controlled trials (RCTs). If there was insufficient or inconsistent evidence, the performance of a new RCT was advised. This structured procedure resulted in a list with topics for which new systematic reviews were recommended and topics for which new RCTs were needed. These lists were the starting points for priority setting by four Centers for Pain Management and Research. All members of the centers were asked to state the priority of each topic. The resulting hierarchy of topics for their own center was discussed in a meeting in each center, giving participants the opportunity to elucidate their views and considerations.

Results: The final result was a robust priority list for the need of research (systematic reviews and RCTs) on chronic benign pain syndromes.

Discussion: The strength and weaknesses of this approach are discussed. This method of priority setting is by no means restricted to treatments for chronic pain; it is also a useful approach for programming research to enable evidence-based medicine in other fields of interest.

Objective: The aim of this paper is to examine the costs of introducing a nursing-led ward program together with examining the impact this may have on patients' outcomes.

Methods: The study had a sample size of 177 patients with a mean age of 77, and randomized to either a treatment group (care on a nursing-led ward, n = 97) or a control group (standard care usually on a consultant-led acute ward, n = 80). Resource use data including length of stay, tests and investigations performed, and multidisciplinary involvement in care were collected.

Results: There were no significant differences in outcome between the two groups. The inpatient costs for the treatment group were significantly higher, due to the longer length of stay in this group. However, the postdischarge costs were significantly lower for the treatment group.

Conclusions: The provision of nursing-led intermediate care units has been proposed as a solution to inappropriate use of acute medical wards by patients who require additional nursing rather than medical care. Whether the treatment group is ultimately cost-additive is dependent on how long reductions in postdischarge resource use are maintained.

Last year in the summer issue of this journal, Khandker et al. (3) published the results of an interesting modeling study following the cost-effectiveness of various strategies for detecting cases of colon cancer. In addition to the baseline alternative, the authors investigated eight different screening strategies and calculated the incremental cost-effectiveness of these eight strategies. Table 1 contains the results of their study in terms of cost and effectiveness as well as incremental cost-effectiveness (see Table 3, Khandler et al.).