The French healthcare system combines freedom of medical practice with nationwide social security. It is compulsory for every legal resident. A range of public and private institutions provide care, and patients have free access to physicians. The health coverage system is characterized by solidarity and universal responsibility. Although the French system is highly regulated, funding of health-related expenses is a chronic social problem. Since the 1996 healthcare reform, the national objective for reimbursed healthcare expenditures is voted by the parliament, and the annual increase of hospital funding is controlled at the regional level. An agency for hospitals has been established in every region, and it quantifies needs indexes for future equipment and beds. However, establishing appropriate reference ratios based on objective assessment is difficult. The idea of basing policy and practice decisions on objective assessment grew for years, until the National Agency for the Development of Medical Evaluation was established in 1989. The 1996 healthcare reform expanded this agency to encompass hospital accreditation and renamed it the National Agency for Accreditation and Evaluation in Health. In March 1999, the National Agency for Health Products was established. It controls the safety of medical products and evaluates products' medical benefits before reimbursement decisions. Health technology assessment is now related to virtually every health policy process in France, and its role increases continually.

Objectives: This paper considers the methodological problems that arise in conducting cost analyses in economic evaluations where only observational (rather than experimental) data are available and where the technology being evaluated is diffuse, such that the unit of analysis has to be the institution rather than the patient.

Methods: A case study is reported that concerns the application of computer technology in radiology: picture archiving and communication systems (PACS). A range of different approaches were used to estimate changes in running costs, including time series analyses of routine data and direct observation of resource use.Results:The analysis illustrates some of the difficulties involved in costing the introduction of a diffuse technology. Nevertheless, it provides a firm indication that, overall, the introduction of PACS was found to be associated with a significant increase in hospital costs, suggesting that the initial expectations of financial savings were unduly optimistic.

Conclusions: The research demonstrates that, using multiple methods, it is possible to estimate cost changes within a single hospital. In addition, the paper discusses the nature of the uncertainties in such analyses and possible ways of representing such uncertainty in terms of confidence intervals.

Objective: To compare two methods of measuring willingness to pay (WTP): closed-ended questions with and without follow-up.

Methods: A measurement experiment based on dichotomous choice contingent valuation survey data is reported. Marginal WTP estimates for alleviation of rheumatoid arthritis symptoms resulting from treatment with a novel anti-rheumatic agent, cA2 (TNF-α blockade), were calculated. Monte Carlo simulations were undertaken to evaluate the methods with respect to their statistical power.

Results: The estimated marginal WTP values using closed-ended questions with and without follow-up were DKK 637 (US $91) and DKK 1,268 (US $181), respectively. A Wilcoxon's signed-rank test showed that the difference of DKK 631 was significant. Moreover, including a follow-up question increases the precision of the result. Monte Carlo simulations showed that trade-offs between power (i.e., the probability of a correct rejection of a false null hypothesis), efficiency, and size may exist in the two models.

Conclusions: There was a significant difference between the WTP estimates when using closed-ended questions with and without follow-up. When choosing between the models, however, power, efficiency, and size could be used as selection criteria.

Clinical practice guidelines are expanding their scope of authority from clinical decision making to collective policy making, and promise to gain ground as resource allocation tools in coming years. A close examination of how guidelines approach patient selection criteria offers insight into their ethical implications when used as resource allocation or rationing instruments. The purposes of this paper are: a) to examine the structure of allocative reasoning found in clinical guidelines; b) to identify the ethical principles implied and compare how guidelines enact these principles with how explicit systems-level rationing exercises and health policy analyses have approached them; and c) to offer some preliminary suggestions for how these ethical issues might be addressed in the process of guideline development. The resulting framework can be used by guideline developers and users to understand and address some of the ethical issues raised by guidelines for the use of scarce technologies.

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.

Objective: The objective was to develop an economic prioritization model to assist those involved in the selection and prioritization of health technology assessment topics and commissioning of HTA projects.

Methods: The model used decision analytic techniques to estimate the expected costs and benefits of the health care interventions that were the focus of the HTA question(s) considered by the NHS Health Technology Assessment Programme in England. Initial estimation of the value for money of HTA was conducted for several topics considered in 1997 and 1998.

Results: The results indicate that, using information routinely available in the literature and from the vignettes, it was not possible to estimate the absolute value of HTA with any certainty for this stage of the prioritization process. Overall, the results were uncertain for 65% of the HTA questions or topics analyzed. The relative costs of the interventions or technologies compared to existing costs of care and likely levels of utilization were critical factors in most of the analyses. The probability that the technology was effective with the HTA and the impact of the HTA on utilization rates were also key determinants of expected costs and benefits.

Conclusions: The main conclusion was that it is feasible to conduct ex ante assessments of the value for money of HTA for specific topics. However, substantial work is required to ensure that the methods used are valid, reliable, consistent, and an efficient use of valuable research time.

Objectives: Guidelines for colorectal cancer screening and surveillance in people at average risk and at increased risk have recently been published by the American Gastroenterological Association. The guidelines for the population at average risk were evaluated using cost-effectiveness analyses.

Methods: Since colorectal cancers primarily arise from precancerous adenomas, a state transition model of disease progression from adenomatous polyps was developed. Rather than assuming that polyps turn to cancer after a fixed interval (dwell time), such transitions were modeled to occur as an exponential function of the age of the polyps. Screening strategies included periodic fecal occult blood test, flexible sigmoidoscopy, double-contrast barium enema, and colonoscopy. Screening costs in 1994 dollars were estimated using Medicare and private claims data, and clinical parameters were based upon published studies.

Results: Cost per life-year saved was $12,636 for flexible sigmoidoscopy every 5 years and $14,394 for annual fecal occult blood testing. The assumption made for polyp dwell time critically affected the attractiveness of alternative screening strategies.

Conclusions: Sigmoidoscopy every 5 years and annual fecal blood testing were the two most cost-effective strategies, but with low compliance, occult blood testing was less cost-effective. Lowering colonoscopy costs greatly improved the cost-effectiveness of colonoscopy every 10 years.

Practice guidelines are rapidly becoming preferred decision-making resources in medicine, as advances in technology and pharmaceutics continue to expand. An evidence-based approach to the development of practice guidelines serves to anchor healthcare policy to scientific documentation, and in conjunction with practitioner opinion can provide a powerful and practical clinical tool. Three sources of information are essential to an evidence-based approach: a) an exhaustive literature synthesis; b) meta-analysis; and c) consensus opinion. The systematic merging of evidence from these sources offers healthcare providers a scientifically supportable document that is flexible enough to deal with clinically complex problems. Evidence-based practice guidelines, in conjunction with practice standards and practice advisories, are invaluable resources for clinical decision making. The judicious use of these documents by practitioners will serve to improve the efficiency and safety of health care well.

Objective: Economic evaluations such as cost-effectiveness and cost-utility analyses generally fail to incorporate elements of intangible costs and benefits, such as anxiety and discomfort associated with the screening test and diagnostic test, as well as the magnitude of utility associated with a reduction in the risk of dying from cancer. This paper seeks to include all costs and effects incurred by introducing mammography screening through the application of discrete ranking modeling.

Methods: In the present analysis, 207 women were interviewed and asked to rank, according to priority, a number of alternative breast cancer screening setups. The alternative programs varied with respect to number of tests performed, risk reduction obtained, probability of a false-positive outcome, and extent of copayment. Using discrete ranking modeling, the stated preferences were analyzed and the relative weighting of the program attributes identified. For a range of hypothetical breast cancer programs, relative utilities and corresponding willingness-to-pay estimates were derived.

Results: A comparison of cost and willingness to pay for each of the programs suggested that net benefits are maximized when screening person aged 50–74 years biennially. More intensive screening produces lower or similar levels of utility at a higher cost.

Conclusion: Discrete ranking modeling can aid decision making by identifying inferior healthcare programs, i.e., programs that are more costly but less beneficial.

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.

Objectives: To identify and examine the methodologic issues related to evaluating the effectiveness of treatment adherence to clinical guidelines. The example of antiretroviral therapy guidelines for human immunodeficiency virus (HIV) disease is used to illustrate the points.

Methods: Regression analysis was applied to observational HIV clinic data for patients with CD4+ cell counts less than 500 per μL and greater than 50 per μL at baseline (n = 704),using Cox proportional hazards time-varying covariates models controlling for baseline risk. The results are compared with simpler models (Cox model [without time-varying covariates] and logistic regression). In addition, the effect of including a measure of exposure to antiretroviral guidelines in the model is explored.

Results: This study has three implications for modeling clinical guideline effectiveness. To capture events that are time-sensitive, a duration model should be used, and covariates that are time-varying should be modeled as time-varying. Thirdly, incorporating a threshold measure of exposure to reflect the minimum period of time for guideline adherence required for a measurable effect on patient outcome should be considered.

Conclusions: The methods proposed in this paper are important to consider if guidelines are to evolve from being a tool for summarizing and transferring the results of research from the literature to clinicians into a practical tool that influences clinical practice patterns. However, the methodology tested in this study needs to be validated using additional data on similar patients and using data on patients with other diseases.

Objectives: To investigate doctors' and nurses' attitudes toward 14 potential prioritization criteria.

Methods: This study was performed by using the random paired scenario method. The respondents received a questionnaire with 12 pairs of scenarios, imaginary patient cases, each of which contained two to three different prioritization criteria (e.g., child, old patient, poor patient). Respondents were asked which one of each scenario pair they would choose if only one patient could be treated. The scenarios were randomly put into 30 different questionnaire sets. There was a random selection of 241 doctors and 151 nurses in Finland, with response rates of 60.3% and 50.3%, respectively.

Results: Doctors prioritized young patients, severe disease, expensive treatments and posteriorized (negatively prioritized) demented or institutionalized patients, and patients having a self-caused disease. Children were strongly prioritized, even over serious diseases. Expensive treatments appeared to be favored by doctors, and this result cannot be explained by severity of disease. Nurses' attitudes were similar to those of doctors.

Conclusions: Children were strongly prioritized. Elderly persons were posteriorized if they had dementia or were living in institutions. Patients having a self-caused disease are posteriorized, more often by nurses than by doctors.

Objective: To define the relative benefits of screening for diabetes and improved treatment programs and ways of improving the efficiency of screening for a population-based cohort derived from the Third National Health and Nutrition Examination Survey (NHANES III).

Methods: A Markov decision model is used to estimate microvascular benefits of glucose control for four different screening and treatment scenarios, including either universal screening or improved glucose control of known diabetic subjects, neither, or both.

Results: A population cohort of subjects with recent onset of diabetes (<5 years) was derived from NHANES III (of whom close to half were unaware that they had diabetes). In this population-based cohort, the total benefit achievable by universal screening and improved treatment (limiting HbA1c to less than 9%) is a reduction of about 30,000 cases of blindness over the lifetime of the cohort. Screening alone results in 7% of this benefit, and improved treatment alone provides 65%. Screening a targeted group of patients with three or more risk factors for developing diabetes would reduce the number of required fasting glucose measurements needed by 82% and provide 50% of the total benefit of screening the entire population with a fasting glucose measurement.

Conclusions: Morbidity from type 2 diabetes can be most effectively reduced by developing ways to modestly improve the glycemic control of known diabetic subjects, particularly those with high A1c's and early onset of disease. Targeting can significantly reduce the number of persons who need to be screened with a fasting blood test while preserving a large component of the benefit of screening.

Objectives: To test the feasibility of obtaining a baseline level of quality of reporting for cost-utility analysis (CUA) studies using the British Medical Journal economic submissions checklist, test interrater reliability of this tool, and discuss its longer term implications.

Methods: CUA studies in peer-reviewed English language journals in 1996, assessed using the British Medical Journal checklist, a quality index, and interrater reliability correlations.

Results: Forty-three CUA studies were assessed, with 23 checklist items acceptable and 10 items inadequate. Lowest quality scores were reported in specialist medical journals. Proportional agreement between assessors was over 80%.

Conclusions: The British Medical Journal checklist is a feasible tool to collect baseline information on the quality of reporting in journals other than the British Medical Journal. Editors of specialist medical journals are in greatest need of economic guidance. If handled carefully, they might consider adopting the British Medical Journal checklist.

Objective: To identify and compare clinical practice guideline appraisal instruments.

Methods: Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966–99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments.

Results: Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated.

Conclusions: A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.

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.

Objectives: Although cost-utility analysis (CUA) has been recommended by some experts as the preferred technique for economic evaluation, there is controversy regarding what costs should be included and how they should be measured. The purpose of this study was to: a) identify the cost components that have been included in published CUAs; b) catalogue the sources of valuation used; c) examine the methods employed for estimating costs; and d) explore whether methods have changed over time.

Methods: We conducted a comprehensive search of the published literature and systematically collected data on the cost estimation of CUAs. We audited the cost estimates in 228 CUAs.

Results: In most studies (99%), analysts included some direct healthcare costs. However, the inclusion of direct non-healthcare and time costs (17%) was generally lacking, as was productivity costs (8%). Only 6% of studies considered future costs in added life-years. In general, we found little evidence of change in methods over time. The most frequently used source for valuation of healthcare services was published estimates (73%). Few studies obtained utilization data from RCTs (10%) or relied on other primary data (23%). About two-thirds of studies conducted sensitivity analyses on cost estimates.

Conclusions: We found wide variations in the estimation of costs in published CUAs. The study underscores the need for more uniformity and transparency in the field, and continued vigilance over cost estimates in CUAs on the part of analysts, reviewers, and journal editors.

Objectives: To identify major differences and similarities in the development of clinical guidelines in different European countries.

Methods: A collaboration of researchers is funded by the European Commission to compare the approaches to guideline development in collaborators' countries. The program encompasses a series of tasks, the first being to identify and document current guideline procedures in the collaborating countries. A survey gathered information on guideline production, dissemination, and implementation in the 10 European countries involved in the project consortium: Denmark, England and Wales, Finland, France, Germany, Italy, the Netherlands, Scotland, Spain (both the Basque Country and Catalonia), and Switzerland.

Results: Seven countries have a national policy on guideline production, dissemination, and implementation, and three countries are discussing their policies. A majority of guidelines are currently produced at the national level in six of the countries and at the regional or local level in the other four. Central or national funding supports guideline production in six countries. Additional sources of funding include medical societies, pharmaceutical companies, and health insurance companies. Several of the countries have published or are preparing evaluations of their dissemination strategies.

Conclusions: The survey highlighted wide variation in the methods and policies of guideline development in Europe. The Appraisal of Guidelines, Research, and Evaluation in Europe (AGREE) Collaboration research program will identify the characteristics of the “better” guideline programs and will provide the basis for more research-generated policy initiatives in the future, helping to ensure that guidelines play a major role in improving patient care in the millennium.

Objectives: The evaluation of the diagnostic value of endoscopic procedures usually lacks a gold standard when performed in cross-sectional studies. The objective is to demonstrate an easily applicable method to assess the possible range of sensitivity, specificity, and predictive values of endoscopic procedures in the absence of a gold standard method.

Methods: Data from a study of 328 endoscopies comparing two different methods to diagnose superficial bladder cancer were used as a numerical example. Both endoscopic procedures were performed in the same patients in one session. Under the assumption of a systematic misclassification process, a model to correct sensitivity estimates is developed.

Results: The lowest possible sensitivity estimate for a new fluorescence endoscopy technique (FE) was 78%, the maximum 97.5%. Depending on realistic assumptions made upon the misclassification, a reasonable estimate for sensitivity was 93.4% (95% confidence interval [CI]: 90%–97.3%) for the FE technique. The sensitivity of the traditional white-light endoscopy method ranged from 47.2% to 53%, with a reasonable estimate of 46.7% (95% CI: 39.4%–54.3%).

Conclusions: This method to determine the theoretically possible range of sensitivity estimates in endoscopic procedures is helpful in cross-sectional studies with a missing gold standard method. It is easily applicable for a variety of endoscopic procedures, including upper and lower gastro-intestinal tract, urogenital tract, or diagnostic laparoscopic surgery.

Italy has a national health service (SSN) dating to 1978. Italy's system of government is characterized by a rather high degree of decentralization of power, and the health system is likewise decentralized. Most of the responsibilities for health care have been ceded to the regions. The state retains only limited coordinating and supervisory powers. The state has a financial responsibility for the national health service, but state contributions are limited and expenditures in excess of this made by the region must be financed from other sources. Health reforms of 1992–93 aimed at making the regions more sensitive to the need to control aggregate expenditure and to monitor measures to promote efficiency, quality, and citizen-patient satisfaction. The diffusion of individual health technologies has been relatively uncontrolled in many regions in Italy, although tight central constraints on capital spending have contained diffusion of new technology. Regulation of placement of services is a planning function and is the responsibility of both the Ministry of Health and the regions. Health technology assessment (HTA) activities have been expanding since the early 1990s, but these activities tend to be untargeted, uncoordinated, and without priorities. Nonetheless, the principal actors in the SSN at national, regional, and local levels are becoming more sensitive to the need to apply criteria of clinical and cost-effectiveness and to be more rigorous in deciding what services to guarantee. There are reasons to be guardedly optimistic about the future of HTA in Italy.