We performed a cost-effectiveness analysis to examine the relative efficacy and costs of percutaneous ultrasonic lithotripsy (PUL), extracorporeal shock-wave lithotripsy (ESWL), and surgery for the treatment of upper urinary tract stones. We developed a Markov model with 35 states, cycles of 3 months, and a time frame of 5 years. Probability estimates were derived from a meta-analysis of the published literature. For stones less than or equal to 2 cm, ESWL is preferred to PUL, since it prevents 2 additional days of morbidity and saves $440. For larger stones, PUL is preferable to ESWL, avoiding 4 more days of morbidity, and saving $722. Both ESWL and PUL were superior to surgery. Sensitivity analysis showed that the results are sensitive to ESWL efficacy rates, the stone recurrence rate, and the hospital component of the ESWL cost. Our analysis suggests that although ESWL is preferable, relatively small changes in the efficacy and cost can shift the preferred strategy; in addition, these findings underscore the need for more reliable data.

The ethical principles of beneficence (doing the best for one's patients and clients), nonmaleficence (doing no harm), autonomy, justice, and equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such important questions as appropriate design and documentation, participation rates, withdrawals or losses to follow-up, careful monitoring of safety and efficacy, timely completion, generalizability, and publication and dissemination of findings. When conflicts between ethical considerations and the trial's scientific quality do occur, the ethical considerations must be paramount.

Magnetic resonance imaging (MRI) is a high-cost, new technology with great potential for improving patient care. The lack of a coherent public policy for MRI, or its predecessor computed tomography (CT), has caused considerable problems. Lack of an enunciated public policy has led to inconsistent reimbursement and reimbursement levels that develop in haphazard ways. Furthermore, diffusion has been unpredictable and has led to geographical excesses and deficiencies.

Technology assessments of MRI, although numerous, have used inconsistent criteria to rate MRI's clinical efficacy. The lack of methodologically sound studies of MRI severely hampered early evaluation. This article examines these problems and suggests that the medical profession take a stronger leadership role in developing policies for expensive, promising new diagnostic technologies. The profession should promote, demand, and perform rigorous clinical evaluations of new technologies, and help develop a consensus regarding the criteria for what constitutes a clinically valuable advance in diagnostic technology.

The traditional approach to treating dental decay and periodontal disease has often focused on caries, neglecting periodontal infection. The past 15 years have seen significant advances in the treatment of periodontal disease with antimicrobial therapy, both with and without moretraditional debridement or surgery. This article presents an overview of the use of antimicrobials, including an examination of treatment philosophies and the diagnosis of periodontal infection.

Objectives: A cost-effectiveness analysis was conducted comparing diagnostic strategies for determining the HER2 status of invasive breast carcinomas, as an indication for trastuzumab at metastatic relapse.

Methods: A decision tree compared five strategies distinguished by (i) the use of immunohistochemical (IHC) and/or fluorescent in situ hybridization (FISH) techniques, and (ii) the test schedule (at initial diagnosis or metastatic relapse). Most cost and effectiveness data came from a French multicentric study of 2,045 patients from eight hospitals. We were not able to select final criteria for trastuzumab effectiveness, because published data rely on IHC techniques not used in France (i.e., HercepTest). We, therefore, selected two intermediate criteria for inappropriate treatment at relapse, that is, patients with HER2-amplified tumors not receiving trastuzumab (Criterion 1) and HER2-nonamplified tumors improperly treated with trastuzumab (Criterion 2). Sensitivity analyses were then performed to assess the robustness of the results to (i) discount rate, (ii) cost of FISH, and (iii) tissue fixation technique.

Results: The strategy using IHC at diagnosis was dominated by the four other strategies. Among these approaches, the only efficient strategy for both criteria was IHC used alone at metastatic relapse; strategies using FISH, or IHC followed by FISH on IHC2+ cases were efficient for Criterion 1, whereas IHC followed by FISH on IHC2+ and 3+ cases was efficient for Criterion 2.

Conclusions: Determining HER2 status at diagnosis, as an indication for trastuzumab at metastatic relapse, incurs substantial incremental costs, which do not appear to be justified. No other strategy can be excluded at first.

In the last several years, the development of an effective breast cancer screening procedure has increased the possibility of the early detection of this cancer. We investigated the cost-effectiveness of a breast cancer screening program to screen 100,000 women 50–64 years of age in Catalonia (Spain). The cost-effectiveness ratio was measured in terms of the cost per cancer detected comparing program costs to the estimated number of cancers detected. We assumed a participation rate, sensitivity, and specificity of 70%, 92%, and 94%, respectively, and that 0.36 breast cancers could be detected per 100 women screened. We estimated a total cost of $2.1 million with $1.4 million for the mammographic stage and $0.7 million for the detection of the true positive mammographic results. The cost per woman screened was $30. We estimated that 252 cases of breast cancer could be detected with the program. The cost-effectiveness ratio obtained in this study was $8,424 per cancer detected. Sensitivity analysis has shown that cost-effectiveness results are sensitive to the variations in the following variables: specificity, cancer detection rate, and screening costs. In planning preventive programs, breast cancer screening should be considered one of the priorities.

Numerous recent studies use risk-adjusted patient mortality rates to measure hospital performance, focusing on such hospital characteristics as volume of patients, teaching status, and ownership. This article summarizes the empirical findings of these studies, critiques their methods and models, and offers recommendations for overcoming several obstacles to meaningful correlation of patient outcomes and provider performance.

Conceptual issues arise in translating the results of technology assessment into policy. A 3 × 3 typology suggests that tough decisions occur when interventions promise increased benefit for increased cost or less benefit for less cost. These decisions are value based; technology assessment alone cannot determine who should receive an intervention and under what circumstances.

Objectives: Our objectives were to assess the current implementation of health technology assessment (HTA) in Hungary and to identify country-specific patterns of challenges and potential improvements.

Methods: We applied a structure that can be used to create HTA implementation roadmaps to evaluate various issues regarding HTA implementation. A comprehensive description of the Hungarian HTA system is presented according to relevant literature and experiences of the authors.

Results: By investigating eight components of HTA implementation, we identified the most important strengths and weaknesses of the Hungarian system. More specifically, we were mainly focusing on the emergence of HTA capacity, the establishment and current role of Department of HTA, the complex process of decision making, the quality elements developed in the near past, and the activity of Hungarian experts at international collaborations.

Conclusions: We concluded that there is a sophisticated methodological and educational basis for HTA in Hungary. A permanent focus on capacity building and changes to the reimbursement procedure can further improve transparency and the scientific basis of decision making in the country.

Objectives: Although psychiatric comorbidity is relevant for a number of diseases, it is often ignored in technology assessment. This study examines the service use rate in mental healthcare facilities and related costs for stroke patients discharged from the University Hospital Maastricht between 1987 and 1995.

Methods: Through anonymous record linkage, the medical registration of the hospital and the registration of the Maastricht Mental Health Case Register were linked.

Results: Linkage succeeded for 16% of the 2,020 stroke patients, indicating that these patients used mental health services during a 10-year period around the stroke (±5 years). Of the users' group, 88% had a mental healthcare contact following stroke. Regression analysis shows that age, length of hospital stay, and mental healthcare contact before stroke are associated with mental healthcare use after stroke. It is remarkable in that there is already an increase in the consumption of mental health care in the prodromal phase just before the stroke occurred. When comparing costs before and after stroke, the outpatient costs increased on average by \epsfbox{cj108-4-euro.eps}42.64, semi-institutionalized costs increased on average by \epsfbox{cj108-4-euro.eps}208.10, and intramural costs by \epsfbox{cj108-4-euro.eps}1,189.21. The total increase in costs is \epsfbox{cj108-4-euro.eps}1,439.95. For all mental healthcare facilities, the increase in costs is significant.

Conclusions: No study so far has revealed the total costs of mental healthcare facilities following stroke. Extrapolating these costs to the Netherlands illustrates that stroke patients have a high psychiatric comorbidity, inducing about 1.3% of total mental healthcare costs.

It is now established that the mucosal immune system is a separate entity and is regulated in a different fashion than that in peripheral lymphoid tissues (the systemic immune system). In this brief review, five selected areas within the field of mucosal immunity are discussed in the context of the goals for vaccines for the Children's Vaccine Initiative.

In Japan, a nationwide mass screening system for neonatal metabolic diseases was established in 1977. This system consisted of screening programs for five main congenital metabolic diseases, including phenylketonuria (PKU). To evaluate the efficiency of the mass screening system, a costbenefit analysis of the screening program for PKU (as a typical case in Japan) was carried out. The costs of the detection and the treatment program were compared with the projected benefit (avoided costs) that results from prevention of the mental retardation associated with the disorders due to PKU. Costs and benefits were discounted at an annual rate of 7%. Assuming that the incidence of PKU was 1/80,500 and the total number of infants screened was 1.2 million, net benefits for the screening program were $283,000, and the cost-benefit ratio was 1:2.5. The sensitivity analysis for the incidence of PKU showed that the cost-benefit ratios exceeded one.

Objectives: The objective of this study was to develop a method to allocate treatment effects when patients switch medication frequently in longitudinal observational studies and apply the approach to assess the cost-effectiveness of treatments in the Schizophrenia Outpatient Health Outcomes (SOHO) study.

Methods: Data were collected on patients at entry to the SOHO study at 3, 6, and 12 months. The 12-month follow-up period was considered as three epochs: 0–3 months, 3–6 months, and 6–12 months. Patients who switched treatment at 3 months had their new treatment considered as a new baseline observation, as these two 3-month observations provide two sets of information on the cost-effectiveness of a drug in the first 3 months after initiation. Multivariate regression analysis was used to adjust for baseline covariates. The model allowed for flexible functional forms, and the cost data were modeled using an exponential mean function. Bootstrapping assessed the uncertainty of the estimated parameters and incremental cost-effectiveness analysis decision rule.

Results and Conclusions: We show the feasibility of the epoch analysis approach using data from the SOHO study comparing two antipsychotics. Estimates for the incremental cost and effectiveness per epoch over the full 12-month period are presented. Using the estimates of 200 bootstrap samples, we demonstrate how one drug is cost-effective compared with another.

Objectives: To collect and summarize information published by INAHTA agencies on the indications, habitual attitudes and practices, and economic and legal implications of preoperative evaluation in elective surgeries.

Method: The authors appraised the information contained in six papers published between 1989 and 1999 in Sweden, France, Basque Country, the Netherlands, United Kingdom, and Catalonia. The section on indications in preoperative evaluation does not present global conclusions. The sections addressing habitual attitudes and practices among physicians and those addressing economic and legal considerations cover only the similarities among the reports and the main ideas relating to these issues.

Results: The conclusions found in the reports about indications in preoperative evaluation are similar or differ slightly, e.g., as regards age limits in patients for whom the tests are recommended. However, more important differences are shown in other areas, especially in reports where consensus methods were used. In some instances, the opinions, attitudes, and customary practices of professionals during the preoperative stage do not concur with the recommendations extracted from the assessment reports and the customary practice of doctors. In relation to economic considerations, a substantial quantity of resources could be liberated if the recommended general clinical practices were followed. From the point of view of civil law, the evidence-based recommendations could be considered as a kind of coded lex artis.

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was recently evaluated. We summarize the evaluation process, report, and 17 recommendations for enhancing CCOHTA's effectiveness. This paper may be useful for evaluators of agencies for technology assessment.

In 1983 a health reform aimed to assure universal coverage and equity in the distribution of services in Greece. The reform implied state responsibility for the financing and delivery of services and a reduction of the private sector. The model was a Bismarckian scheme for social insurance. However, healthcare delivery remains fragmented and uncoordinated and the private sector is getting stronger. The dominant payment system is fee-for-service for the private sector and administered prices and salaries for public hospitals and social insurance funds. The many insurers have their own eligibility requirements, validation procedures, etc. Coverage of services by social security funds, probably among the most comprehensive in Europe, is determined more on historical and political grounds than on efficiency or cost-effectiveness. The system is plagued by problems, including geographical inequalities, overcentralization, bureaucratic management, poor incentives in the public sector, open-ended financing, inefficient use of hospital beds, and lack of cost-effectiveness. There are no specific legal provisions for the control of health technology. Technologies are introduced without standards or formal consideration of needs. There are no current efforts to control health technology in Greece. However, health technology assessment (HTA) has gained increasing visibility. In 1997 a law provided for a new government agency responsible for quality control, economic evaluation of health services, and HTA. The hope is that the new law may introduce evaluation and assessment elements into health policy formulation and assure that cost effectiveness, quality, and appropriate use of health technology will receive more attention.

The objective of this study was to explain the variation in cesarean section rates among hospitals (obstetrical departments) in Sweden, and to discuss its potential economic consequences. Using data from The Swedish Medical Birth Registry 1991, we made a cross-sectional study of the cesarean section rate at the departmental level. We identified some 20 determinants, demand-related as well as supply-related. A general model including all these regressors was specified. After reducing this model, we were able to explain about one-quarter of the variation. We conclude that the large variation in cesarean section rates indicates inefficiency, due mainly to overutilization, but perhaps also underutilization. It is difficult to calculate the economic consequences or the welfare loss to society. We estimated an additional cost for unnecessary cesarean sections of 13—16 million Swedish crowns (SEK) per year.

This paper analyzes medical technology decision making in the United States and England in terms of the appropriateness of different decision-making models to the organization and delivery of medical care, and to the rationing of technology among and within hospitals. It examines the effect on the American hospital of prospective payment programs from the perspective of organizational structure and decision making. The strategies of central control and specification which characterize these programs are contrasted with decision-making procedures in the English National Health Service, which have emphasized decentralization, delegation, and consensus. The analysis suggests that decentralized models of decision making are more supportive of essential elements of medical care including doctor-patient trust and professional responsibility and are more able to achieve rationing decisions which are compatible with professional and consumer preferences.

Objectives: The aim of this study was to examine the gaps between researchers and policy makers in perceptions and influencing factors of knowledge translation (KT) of health technology assessment (HTA) in China.

Methods: A sample of 382 HTA researchers and 112 policy makers in China were surveyed using structured questionnaires. The questionnaires contained two sections: perceptions of HTA research and assessments of six-stage KT activities. Wilcoxon rank sum test was applied to compare the differences in these two sections between HTA researchers and policy makers. Multivariate linear regression was performed to explore KT determinants of HTA for researchers and policy makers separately.

Results: Policy makers and researchers differed in their perceptions of HTA research in all items except collaboration in research development and presentation of evidence in easy-to-understand language. Significant differences in KT activities existed in all the six stages except academic translation. Regarding KT determinants, close contact between research unit and policy-making department, relevance of HTA to policy making, and importance of HTA on policy making were considered facilitators by both groups. For researchers, practicality of HTA report and presentation of evidence in easy-to-understand language can facilitate KT. Policy makers, on the other hand, considered an overly pedantic nature of HTA research as an obstacle to effective KT.

Conclusions: Substantial gaps existed between HTA researchers and policy makers regarding the perceptions of HTA research and KT activities. There are also some differences in KT determinants by these two groups. Enhancing collaboration, promoting practicality and policy relevance of HTA research, and making HTA findings easily understood are likely to further the KT of HTA evidence.

Assessment of the impact of genetic technologies requires an understanding of the ethical issues that such technologies raise, which in turn requires an understanding of the social context of genetics. This article discusses 10 factors that characterize the social context of contemporary genetics, and considers two presumptions that usually are unquestioned—first, that more choice is always better; second, that what can be improved should be improved. Recent experience with genetic screening and testing to increase reproductive choice indicates that it is sometimes an ambiguous good. Prenatal testing, which has been guided by an ideology of nondirective counseling, will become increasingly problematic as the menu of possible genetic tests grows longer, because nondirectiveness offers no way to distinguish between significant disease and parental whim. In the realm of reproduction, more choice may also come to mean increasing parental responsibility to have genetically “healthy” offspring. Technologies intended to improve health outcomes may also be used for non-health-related goals—such as to increase athletic performance or to capitalize on social prejudices. Genetic technologies increasingly will challenge the troubled distinction between therapy and enhancement.