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.

Objectives: In the Netherlands, allocation decisions have not yet been explicitly based on the Value of Statistical Life. However, when policy makers decide whether or not to implement life saving interventions this trade-off is made implicitly. This study aimed to gain insights into this trade-off, hereafter referred to as Implicit Value of Statistical Life (IVSL), by means of a retrospective investment analysis of life saving interventions implemented in the Netherlands.

Methods: A literature search was conducted to find life saving intervention cases meeting the requirements for IVSL calculation. A final sample of ten cases was included in the study concerning interventions implemented in different societal sectors. For each case, an IVSL estimate was calculated according to a uniform method.

Results: IVSL estimates derived from the intervention cases differed considerably and ranged from €1 to almost €11 million. Differences were most extreme when comparing IVSL estimates concerning interventions implemented in different societal sectors. However, IVSL estimates also varied greatly between interventions in the same sector and even within the same interventions when critical assumptions were altered.

Conclusion: Our findings suggest that there are great imbalances between societal investments for preventing a statistical death. This highlights the need for further deliberation about how to improve transparency of policy decisions. An approach ex ante determining the Value of Statistical Life by means of empirical methods and based on societal preferences might circumvent the problems associated with the IVSL and needs further exploration.

Objectives: The objectives of the study were to identify the current standards of clinical practice regarding prostate cancer screening in western Europe, Canada, and the United States, and to highlight major characteristics of current prostate cancer screening programs or patterns of practice.

Methods: We performed a semi-structured interview by means of a self-administered questionnaire sent by fax to 26 institutes pertaining to the International Network of Agencies for Health Technology Assessment.

Results: None of the countries surveyed had a formal national screening policy. Despite that, all the countries answering the questionnaire had discretionary, public-financed screening practices. Moreover, some scientific and professional organizations recommended population screening for prostate cancer, and few of the surveyed countries offered it as experimental practice within a randomized controlled trial. Survey results showed variation regarding screening policies, in particular test of choice, age cut-off points, and treatment prescribed for positive test results.

Conclusions: Despite the lack of conclusive evidence on the benefits of prostate cancer screening, the availability of simple and easy-to-administer tests has lead to an enormous variation on screening policies around the world. Practice variations also affect prostate cancer therapy.

Objectives: An example of technology assessment in dental care by evaluating the (cost-)effectiveness of types of three-surface inlays (gold, laboratory-fabricated ceramic, and chairside CAD/CAM ceramic) is provided.

Methods: MEDLINE, EMBASE, and the Cochrane Library were searched for studies published between 1966 and June 2003 that reported annual survival probabilities and annual observations. The longevity of different types of inlays was measured by the number of failure-free years. Annual survival rates from different studies were pooled by weighing the rates of each study by the inverse of the variance of the effect estimate. A cost-effectiveness analysis from the perspective of German private health insurers was performed using billing charges.

Results: Three, five, and two case series on laboratory-fabricated ceramic, chairside CAD/CAM ceramic, and gold inlays, respectively, were included. Over a 9-year observation period, the number of undiscounted failure-free years was 8.62 (95 percent confidence interval, 8.40–8.85), 8.65 (8.58–8.73), and 8.76 (8.72–8.80) for laboratory-fabricated ceramic, chairside CAD/CAM ceramic, and gold inlays, respectively. Laboratory-fabricated ceramic inlays were the most expensive.

Conclusions: While laboratory-fabricated ceramic, chairside CAD/CAM ceramic, and gold inlays had a strikingly similar failure-free survival rate, laboratory-fabricated ceramic inlays had the highest costs and, thus, were less cost-effective than chairside CAD/CAM ceramic and gold inlays.

In the Central African Republic (CAR) malaria is a major public health problem and hampers socioeconomic development. It accounts for 40 percent of complaints and 10 percent of deaths in health facilities (15;17). Pregnant women, who make up 4 percent of the population, and children under 5 years of age, who represent 17.3 percent, are the groups most vulnerable to malaria owing to their low levels of immunity.

Objectives: Reported is the importance of properly reflecting uncertainty associated with prognostic model estimates when calculating the survival benefit of a treatment or technology, using liver transplantation as an example.

Methods: Monte Carlo simulation techniques were used to account for the uncertainty of prognostic model estimates using the standard errors of the regression coefficients and their correlations. These methods were applied to patients with primary biliary cirrhosis undergoing liver transplantation using a prognostic model from a historic cohort who did not undergo transplantation. The survival gain over 4 years from transplantation was estimated.

Results: Ignoring the uncertainty in the prognostic model, the estimated survival benefit of liver transplantation was 16.7 months (95 percent confidence interval [CI], 13.5 to 20.1), and was statistically significant (p<.001). After adjusting for model uncertainty using the standard errors of the regression coefficients, the estimated survival benefit was 17.5 months (95 percent CI, −3.9 to 38.5) and was no longer statistically significant. An additional adjustment for the correlation between regression coefficients widened the 95 percent confidence interval slightly: the estimated survival benefit was 17.0 months (95 percent CI: −4.6 to 38.6).

Conclusions: It is important that the precision of regression coefficients is available for users of published prognostic models. Ignoring this additional information substantially underestimates uncertainty, which can then impact misleadingly on policy decisions.

In A Theory of Justice, John Rawls demands from citizens who decide upon principles of justice and the rules derived from such principles that they abstract from all particularities that constitute their identity as unique individuals. This demand is unrealistic in policy settings where actual policy-makers convene to provide guidance, establish rules regarding public good, and enact legislation. In practice, I argue, policy-makers, legislators, and others involved in developing social rules that pertain to distributive justice formulate such rules as reasonably partial spectators. To illustrate, I show how clinical practice guidelines are established and mediated by a reasonably partial expert panel whose partial action is publicly justifiable, yet whose claims to impartiality are not.

Medical technology will contribute to improving the health status of people in developing countries only when it is carefully implemented after proper planning. Providers, users, health ministry employees, and industry all share responsibility for proper planning and careful implementation.

The delivery of rehabilitation services requires an infrastructure if service provision is to be given any priority. This article discusses some characteristics of handicaps, technical aids, the service delivery process, and habilitation/rehabilitation, and recommends developments of national structures for service delivery based upon the characteristics of rehabilitation technology, user need, and the country frameworks.

Less developed countries (LDCs) are limited in medical resources. Medical technology and the management talent required to handle it play a particularly major role in their national health care and has significant economic, political, and ethical ramifications. This study of the assessment process of medical technology in the LDCs proposes a limited framework for the analysis of the major parameters involved, i.e., stakeholders, boundaries and constraints, goals and objectives, criteria to be met, performance measures, and measurement of performance. The importance of the intangible factors is elucidated.

Background: Health-related quality of life (HRQoL) is an important endpoint of many healthcare interventions. This study develops guidance on how to select appropriate HRQoL measures for inclusion in a clinical trial, given the purposes of the HRQoL measurement.

Methods: The guidance is based on a systematic literature review, discussions with members of the European Network for Health Technology Assessment (EUnetHTA) and two rounds of public consultation.

Results: A set of twelve recommendations was developed, addressing the requirements for HRQoL data for relative effectiveness assessment, for cost-utility analyses and for informing clinical decision making. Recommendations relate to the choice of the type of measure as well as to aspects such as measurement frequency, target population and presentation.

Conclusions: The purpose and context of HRQoL measurement is crucial for the relevance of the data obtained with a specific HRQoL measure. It is recommended to always include a generic HRQoL instrument in clinical trials to cover a wide range of possible future uses of the HRQoL data.

Objectives: The aim of this study was to evaluate the success of search strategies in retrieving key documents for a technology assessment report (TAR) on a social care topic.

Methods: This study measured the differential yield of relevant studies from various information sources and evaluated strategies in different databases, with particular reference to capturing randomized controlled trials (RCTs) as a study design.

Results: A combination of four major databases would have found all thirty-two key references. One database alone would have found 78 percent, with another two each locating 59 percent. Sixteen percent of the trials were unique references. In non–health care databases, more sensitive search strategies would have resulted in a higher yield of relevant studies, in part due to inconsistent indexing and in part to attempts to restrict searches to RCTs. Although additional terms could be used to increase the sensitivity of the original strategies, this raises the question of trading off time against exhaustiveness, given the greater number of irrelevant references likely to be retrieved.

Conclusions: A successful search for evidence on this social care topic would be possible using a combination of MEDLINE, EMBASE, the Cochrane Library and PsycINFO, supplemented by only limited use of supplementary databases. In areas such as social care where evidence-based research is not yet well established, attempts to replicate searches based on study design do not seem to be advisable, although this may be an area for future research.

Objectives: To describe the adoption and take up of thrombolytic agents for acute myocardial infarction since 1980 in England and compare use with the estimated ceiling of need.

Methods: Data on national sales and use of thrombolysis since 1980 (supplied by IMS Health) was used to draw an adoption and diffusion curve. The epidemiological ceiling of acute myocardial infarction, from hospital activity statistics, was modified to an estimated clinical need by accounting for diagnostic difficulty and contraindications using information from published surveys of thrombolysis use in the United Kingdom.

Results: There was a rapid uptake of thrombolytic agents in the first 2 years after availability in 1987, then a plateau, followed by a rise to a peak use in 1995. The shortfall in doses resulting from the difference between estimated ceiling of clinical need and doses purchased and provided in the 14 years since availability is estimated as 167,800 (95 percent confidence range 94,000 to 241,700).

Conclusions: Although there was a rapid initial uptake of thrombolysis in England, usage took 8 years to reach the ceiling of clinical need of 65 percent of patients with acute myocardial infarction, with many patients missing the opportunity to benefit. Monitoring of uptake of innovations known to be cost-effective is required to identify those developments that need additional stimulus for change to ensure that patients do not miss out on the opportunity to benefit.

Objective: A United Kingdom Department of Health directive (EL[94]72) asked Health Authorities to manage the entry of new drugs into practice. There seem to be costs associated with the decision-making process of managed entry, but no clear evidence of benefit to patient populations. The objective of this study was to assess the potential costs and outcomes of different models of managed entry, using the example of donepezil in the North West Health Region of the U.K. National Health Service. This is a preliminary study designed to identify the key pieces of information required to evaluate the value of managed entry.

Methods: Decision analytic models of three Health Authorities' approaches to manage the entry of donepezil were used to estimate the expected costs and effectiveness of the process. Resource use data were obtained from published sources and the relevant Health Authority. Probabilistic sensitivity analysis was used to determine the robustness of the results.

Results: The process of managed entry of donepezil was associated with higher expected costs and higher expected outcome than no managed entry. The 95% confidence intervals for the net expected costs and net expected outcomes were relatively narrow and did not cross zero, which suggests a statistical difference between managed entry and no managed entry for donepezil. The incremental cost-effectiveness ratios for managed entry of donepezil indicate that, compared with no managed entry, there were substantial differences between the different models used in the three study sites. The expected cost per unit of cognitive function gained was between £18,000 in study site 001 to £28,000 in study site 010. The expected cost per person with a clinically significant improvement was between £140,000 and £230,000. The expected cost per QALY ranged from £470,000 to £19.3 million.

Conclusions: Managed entry does not appear to be a worthwhile mechanism to introduce drugs into practice. However, poor accessibility and availability of data means that the results are highly uncertain. The lack of data presents serious obstacles for both researchers and policy makers wishing to develop evidence-based policy and practice.

Objectives: Gender as a social construct is a recognized health determinant. Because best practice in reporting health technology assessment (HTA) clearly specifies the need to appraise a technology's social impact within the target population, the extent to which gender issues are taken into account in HTA production is of interest, not only in light of equitable practices but also for reasons of effectiveness. The aim of this study is to provide a first assessment of the degree of gender sensitivity shown by HTA agencies around the world today.

Methods: The Web sites of sixty HTA agencies were analyzed. The consideration of gender aspects was specifically looked for in each agency's general mission statement, its priority setting process, and its methodological approach. Additionally, specific gender-oriented initiatives not belonging to any of the aforementioned categories were identified.

Results: Of the sixty agencies, less than half mention a commitment to addressing the social implication of health technologies. Only fifteen institutions make information on their priority setting principles available on their Web sites and gender was an issue in two of those cases. Data on methodology were obtainable online from18 agencies, two of which mentioned gender issues explicitly. Finally, gender-oriented initiatives were identified by thirteen agencies.

Conclusions: A gender-sensitive approach is apparently rarely adopted in current HTA production. Exceptional practices and relevant tools do exist and could serve as examples to be promoted by international collaborative networks.

Objectives: The aim of this study was to describe the Norwegian contribution to the broad picture of our international health technology assessment (HTA) history.

Methods: A general examination of some pre-HTA activities, as consensus conferences, closer reading of all background papers to the establishment of an HTA agency in Norway, the ongoing activities of this agency, its evaluation, and its merge into a broader knowledge center for the health services were performed. All information and statements are the authors’ own understandings, but also were reviewed by some of the people taken part in these processes.

Results: The Norwegian HTA activity was set up rather late compared to, for instance, Sweden, and our involvement in Nordic early warning activities. This may be related to Norwegian scientists being more involved in the Cochrane Collaboration. However, when established, the HTA agency was regarded as highly successful in involving clinical experts and responding to questions arising from the macro- as well as micro-levels of decision makers. International collaboration was essential in building the capacity to serve all levels. After 6 years, the agency was merged with some related health service knowledge activities, into a new center.

Conclusions: During the 10 years’ time, HTA has become a well-established activity in Norway.

Current thinking about the methodology of health technology assessment (HTA) seems to be dominated by two fundamental tensions: [1] between maintaining a tight focus on quality-adjusted life-years and broadening its concern out to pay attention to a broader range of factors, and [2] between thinking of the evaluative dimensions that matter as being objectively important factors or as ones that are ultimately of merely subjective importance. In this study, I will argue that health is a tremendously important all-purpose means to enjoying basic human capabilities, but a mere means, and not an end. The ends to which health is a means are manifold, requiring all those engaged in policy making to exercise intelligence in a continuing effort to identify them and to think through how they interrelate. Retreating to the subjective here would be at odds with the basic idea of HTA, which is to focus on certain objectively describable dimensions of what matters about health and to collect empirical evidence rigorously bearing on what produces improvements along those dimensions. To proceed intelligently in doing HTA, it is important to stay open to reframing and refashioning the ends we take to apply to that arena. The only way for that to happen, as an exercise of public, democratic policy making, is for the difficult value questions that arise when ends clash not to be buried in subjective preference information, but to be front-and-center in the analysis.

Objectives: Guidelines for economic evaluation studies recommend that modeling be undertaken to estimate long-term, downstream costs. In this study, we conduct a review of a sample of studies that estimated the lifetime medical care costs for a variety of conditions.

Methods: We developed a categorization of the elements for a lifetime-costing study and based on these elements, we abstracted information from a sample of 33 papers in the following areas: study subject, purpose, scope, methods (including time profile, utilization, and cost), and results.

Results: We analyzed papers that were observational, models or that combined the two approaches. The time profiles were estimated from registry and published data. Utilization data were obtained from administrative data, chart reviews, and professional opinion. Costs were obtained from administrative and financial records and were estimated using all charges, allocated costs, and provider payments. We noted wide variations in methods and reporting practices.

Conclusions: Following current guidelines (CCOHTA), lifetime models can be more easily interpreted and applied if investigators are more clear in their study aims, if they incorporate assumptions that are based on current data, if they follow current methodological practices (such as deflation, discounting, and sensitivity analyses), and if reporting is more transparent.