Objectives: Recent concerns have been raised for the safety after drug-eluting stents (DES) implantation compared with the use of bare-metal stents (BMS) in patients with ST-elevation acute myocardial infarction (STEMI). The objective of this study was to estimate the relative impact of DES versus BMS on mortality, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST) in STEMI patients by performing comprehensive meta-analyses of randomized controlled trials (RCTs) and observational studies.

Methods: We performed an electronic search and manual search of studies presented through September 2009, without language restrictions. An approach of “using systematic reviews” was used. Two independent reviewers extracted prespecified data from each study. A random-effects model was used to combine trials and to perform stratified analyses based on study designs and the duration of follow-up.

Results: Fourteen RCTs were identified (N = 7,654). Compared with BMS, DES significantly reduced TVR (risk ratio [RR], 0.48; 95 percent confidence interval [CI], 0.41–0.56) and MI (RR, 0.77; 95 percent CI, 0.61–0.97), without increasing mortality (RR, 0.88; 95 percent CI, 0.70–1.10) and ST (RR, 0.93; 95 percent CI, 0.72–1.21). Among 35 observational studies (N = 44,849), the use of DES was associated with a significant reduction in mortality (RR, 0.85; 95 percent CI, 0.79–0.91) and TVR (RR, 0.61; 95 percent CI, 0.48–0.77). MI and ST were significantly lower in the DES group within 1-year follow-up, but there were no differences within 2 years of follow-up. There was no evidence of statistical heterogeneity and publication bias.

Conclusions: These data in aggregate suggest that using DES in STEMI patients is safe and efficacious, but there are differences between RCT and observational data comparing DES and BMS.

Objectives: Although the clinical benefits of endovenous thermal ablation are widely recognized, few studies have evaluated the health economic implications of different treatments. This study compares 6-month clinical outcomes and cost-effectiveness of endovenous laser ablation (EVLA) compared with radiofrequency ablation (RFA) in the setting of a randomized clinical trial.

Methods: Patients with symptomatic primary varicose veins were randomized to EVLA or RFA and followed up for 6 months to evaluate clinical improvements, health related quality of life (HRQOL) and cost-effectiveness.

Results: A total of 131 patients were randomized, of which 110 attended 6-month follow-up (EVLA n = 54; RFA n = 56). Improvements in quality of life (AVVQ and SF-12v2) and Venous Clinical Severity Scores (VCSS) achieved at 6 weeks were maintained at 6 months, with no significant difference detected between treatment groups. There were no differences in treatment failure rates. There were small differences in favor of EVLA in terms of costs and 6-month HRQOL but these were not statistically significant. However, RFA is associated with less pain at up to 10 days.

Conclusions: EVLA and RFA result in comparable and significant gains in quality of life and clinical improvements at 6 months, compared with baseline values. EVLA is more likely to be cost-effective than RFA but absolute differences in costs and HRQOL are small.

Objective: Health technology assessment (HTA) can be used both to promote access to safe, efficacious, and cost-effective technologies, and to discourage access to undesirable ones. Yet HTA has had less success than might be hoped in pursuing the latter goal. This paper examines the scope of HTA as currently practiced to contribute to regulation of access to undesirable technologies.

Design: The study design is a critical analysis of HTA's methods, based on an exposition of the normative issues involved in restriction of access to health technologies. The paper classifies technologies that might figure as potential candidates for exclusion into five categories and underscores the key social and ethical dilemmas associated with limiting their use.

Results: For four of the five categories of technology outlined, limitation of access necessarily involves denial of benefit. Limitation of access thus inevitably raises difficult normative issues. We show that these are ill-addressed by the range of “evidence” typically considered in technology assessments, which centers predominantly on clinical and technical features such as efficacy, safety, and costs.

Conclusions: If HTA is to enhance our ability to make reasonable decisions concerning the use and diffusion of health technologies, it must better integrate consideration of the social, political, and ethical dimensions of health technologies into the process of technology assessment. We suggest a framework within which to approach this goal.

Background and Purpose: Outcome in patients hospitalized for acute stroke varies considerably between populations. Within the framework of the GAIN International trial, a large multicenter trial of a neuroprotective agent (gavestinel, glycine antagonist), stroke outcome in relation to health care resource use has been compared in a large number of countries, allowing for differences in case mix.

Methods: This substudy includes 1,422 patients in 19 countries grouped into 10 regions. Data on prognostic variables on admission to hospital, resource use, and outcome were analyzed by regression models.

Results: All results were adjusted for differences in prognostic factors on admission (NIH Stroke Scale, age, comorbidity). There were threefold variations in the average number of days in hospital/institutional care (from 20 to 60 days). The proportion of patients who met with professional rehabilitation staff also varied greatly. Three-month case fatality ranged from 11% to 28%, and mean Barthel ADL score at three months varied between 64 and 73. There was no relationship between health care resource use and outcome in terms of survival and ADL function at three months. The proportion of patients living at home at three months did not show any relationship to ADL function across countries.

Conclusions: There are wide variations in health care resource use between countries, unexplained by differences in case mix. Across countries, there is no obvious relationship between resource use and clinical outcome after stroke. Differences in health care traditions (treatment pathways) and social context seem to be major determinants of resource use. In making comparisons between countries, great care should be exercised in using outcome variables as indicators of quality of stroke care.

Throughout the history of the development and use of medical technologies (phar-maceuticals, laboratory tests, invasive and noninvasive procedures, and medical devices), physicians and their patients have been the primary assessors of a technology's worth. If a drug, test, or procedure produces consistent beneficial effects, with little or no risk, then such a technology is commonly added to the clinician's arsenal of weapons against illness and disease. Academic researchers, however, with their keen desires to find new and better ways to diagnose, treat, and cure, are relied upon to produce evidence documenting a technology's efficacy. Others engaged in technology assessment activities—from their own perspectives—include manufacturers, who produce data showing the value of the products they hope to sell; hospitals that wish to make cost-effective purchases; and government agencies, with mandates to protect the public and to spend public dollars wisely. Still, it is the practicing physician who ultimately judges a technology's value based upon its use in individual clinical situations. Until very recently, with the apparent adequacy of these evaluative methods, medical professional societies were not required to enter the technology assessment arena.

This paper presents the results of a contingent valuation study measuring willingness to pay (WTP) for treatment of patients with von Willebrand's disease. Median WTP for treatment of this disorder was $1,500 or $3,500, depending on how the initial bid was structured. Regression analysis shows that income, education, and a category rating scale for health status were significant in predicting WTP. The adjusted annual WTP was $2,178. WTP surveys may increasingly be useful for health technology assessment. Starting point bias in how the bids are structured must be recognized.

In Hungary, the history of the health technology assessment (HTA) dates back to 1993 when HTA and related activities started by professional initiatives. The legal background, institutionalization, and training capacities were created between 1998 and 2004. The main challenges for HTA in Hungary are partly similar to the ones in countries with a developed economy; no question it is time for cost-effectiveness. However, there are very important differences as well, that is why transferability and adaptability issues have to be considered. This article describes the characteristic features of the Hungarian healthcare system, the history and the current role of HTA, and the most important challenges.

In an effort to control ambulatory care costs, regulatory practice guidelines (références médicales opposables or RMOs) were introduced by law in France in 1993. RMOs are short sentences, negatively formulated (“it is inappropriate to \ldots”), covering medical and surgical topics, diagnosis, and treatment. Since their introduction, physicians who do not comply with RMOs can be fined. The fine is determined by a weighted combination of indices of harm, cost, and the number of violations.

The impact of the RMO policy on physician practice has been questioned, but so far few evaluations had been performed. At the end of 1997, only 121 physicians had been fined (0.1% of French private physicians). The difficulty of controlling physicians, the large number of RMOs, and the lack of a relevant information system limit the credibility of this policy.

The simultaneous development of a clinical guideline program to improve the quality of care and of a program to control medical practice can lead to a misunderstanding among clinicians and health policy makers. Financial incentives or disincentives could be used to change physician behavior, in addition to other measures such as education and organizational changes, if they are simple, well explained, and do not raise any ethical conflict. But these measures are dependent on the structure and financing of the healthcare system and on the socioeconomic and cultural context. More research is needed to assess the impact of interventions using financial incentives and disincentives on physician behavior.

Health care technology assessment is broadly and ambiguously interpreted, diluting its role. It is time to recast the field. We must elucidate it in the contemporary context of health inquiry, explicitly relating it to such pursuits as quality assurance, health services research, effectiveness research, medical informatics, and technological innovation.

Five “big ticket” medical technologies (BTTs) in 1990 were compared in the 24 OECD countries in relation to population, the number of physicians, gross domestic product (GDP), and health care expenditures (HCE). Wide variations were observed between and within countries for all measures. Regression analysis revealed that HCE explains part of the variation in the distribution of computed tomography scanners (excluding Japan), magnetic resonance imaging units, and radiation therapy units (R2 between 0.40 and 0.69), but not extracorporeal shock wave lithotripters. To a lesser extent, GDP was also found to correlate with the distribution of these technologies, but no correlation was found with number of physicians. Other factors affecting the diffusion of these technologies are proposed for study.

The collective experience of health technology assessment (HTA) in different countries delineates a pattern of development, a “natural history,” of HTA in three phases: emergence, consolidation, and expansion. This study examines the rationale for HTA, definitions of its scope and breadth, its methods and organizational models, and its knowledge translation strategies, as HTA moves from one phase to the next. The study then identifies factors that facilitate or delay the transitions.

Objectives. In a democratic system, decision makers are accountable for the reasonableness of their decisions. This presumes (i) transparency, (ii) relevance of the decision criteria, (iii) revisability of decisions, and (iv) enforcement/regulation. We aim to (i) evaluate the extent to which drug reimbursement decision-making processes in different contexts meet these conditions and (ii) develop, starting from these findings, a framework for improving the transparency and the relevance of used decision criteria.

Methods. We evaluated the Austrian, Belgian, French, Dutch, and Swedish drug reimbursement systems. Based on this evaluation, we developed a framework for improving the transparency of drug reimbursement decision-making processes. It makes explicit the questions often addressed implicitly during decision-making processes as well as criteria for answering each question.

Results. Transparency of appraisal processes varies across systems. Justification with explicit criteria is generally limited. Although relevant criteria are similar across systems, their operationalization varies and their role in the appraisal process is not always clear. All systems seem to implicitly address five key questions, relating to (i) the medical, therapeutic, and societal need for treatment; (ii) preparedness to pay for treating the condition as a principle and (iii) for using the treatment under consideration; (iv) preparedness to pay more compared with alternatives; and (v) actual willingness to pay from public resources.

Conclusions. Transparency of the appraisal process can be improved by using an explicit decision framework. Systematic use of such a framework enhances consistency across decisions, allows justification of value judgments, and thus enhances legitimacy of societal decision making.

Objectives and Methods: Health technology assessment (HTA) often requires the identification and review of economic evaluations and models. This study surveys the available specific and general resources to search to identify economic evaluations. It also provides information on efficient searching of those resources and comments on the current evidence-base.

Results: Published checklists recommend searching for economic evaluations in specific information resources which collect economic evaluations such as NHS EED and HEED, followed by top-up searches of large biomedical bibliographic databases (such as MEDLINE and EMBASE). Other resources such as the HTA and DARE databases can yield reports of economic evaluations. Searches within NHS EED and HEED can be made more efficient by using database-specific search options. Searches within large biomedical databases such as MEDLINE and EMBASE require the use of economic search terms called search filters. Search filters are highly sensitive, retrieving most economic evaluations, but suffer from low precision returning many irrelevant records which need to be assessed.

Conclusions: It is relatively easy to identify rapidly a high proportion of economic evaluations but more research is required to improve the efficiency of this process. There are key high yield resources to search but more evidence is required on their overlap and unique contribution to searches. The value of other resources, particularly those providing access to gray literature, should be explored. Research into efficient retrieval requires clear definitions of economic evaluations to allow comparison across studies.

This review of the advantages (peaks) and problems (pits) of large data bases to study quality contrasts their suitability with randomized control trials. Researchers need to advise policymakers and others about when statistically significant differences in quality are also politically and socially significant and deserve responsible reactions.

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.

Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.

Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.

Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.

This article describes the findings of an ongoing assessment of prostatectomy that relied on the use of administrative data bases. Examples of the use of claims data for monitoring outcomes and treatment comparisons are provided, as well as a discussion of the strengths and limitations of administrative data for technology assessment.