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.

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: The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources.

Methods: We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information.

Results: The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria.

Conclusions: While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the “pragmatic” HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.

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.

Interest in Bayesian analyses has increased recently, in part as a response to policy makers wanting sound scientific bases for health technology assessments, and associated healthcare funding decisions. This paper provides a brief and simplified description of Bayesian reasoning. Bayes is illustrated in a clinical setting of an expert helping a woman understand the potential risk of passing on an inheritable disease (hemophilia) to her next child, based on disease occurrence in two living children. The illustration describes fundamental concepts and derivations, such as Bayes theorem, likelihood functions, prior probability, and posterior probability. A second illustration shows the use of Bayes for interpreting clinical trial results. The uncertainty in the clinical effect before and after the trial analyses has been completed is characterized by the Bayes prior and posterior probabilities, respectively. Techniques are also shown for estimating the potential loss (e.g., in lives lost) for making the wrong decision with and without knowledge of the trial results, an estimation that cannot be carried out using techniques of hypotheses testing associated with the frequentist school of statistics. Information from Bayes analysis then may be used to help policy makers decide, or justify, whether the analyses provides a sufficient basis for making a treatment recommendation, or whether there remains a need to request more information. Subsequent papers in this volume offer additional examples and clarification of the use of Bayes in clinical practice and in interpretation of clinical studies.

Objectives: The aim of this study was to analyze whether health technology assessment (HTA) reports published by SBU have influenced decisions, guidelines, clinical practice, or research priorities in Sweden.

Methods: All twenty-six SBU reports between 2006 and 2010 were analyzed. For each project, we searched publications and documentation that reflected impact on decisions, guidelines, research or clinical practice. Written documentation, before–after surveys or register-based time series data were used when available. Based on a conceptual model and on the available evidence, we determined whether HTA reports had a high, moderate, or low impact.

Results: HTA reports influenced comprehensive decisions to a high or moderate degree. In the case of fortifying flour with folic acid to a high degree. In ten cases, HTA reports were the primary source of clinical guidelines developed by the National Board of Health and Welfare (NBHW) or professional associations. In the cases of dyspepsia and gastro-esophageal reflux, as well as mild head injury, the HTA reports had a high impact on clinical practice. It was also obvious from this review that research had been initiated as a result of the knowledge gaps identified by HTA reports. In three cases, we had no adequate documentation, suggesting that the impact of the HTA report had been low.

Conclusions: Many interrelated forces change practice, but the cases presented here indicate that HTA reports have had a high impact on clinical guidelines, as well as a moderate or high impact on comprehensive decisions, the initiation of research and changes in clinical practice.

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.

Objectives: Rapid reviews can be conducted in a narrower time frame, as compared to systematic reviews, by featuring restrictions. To estimate the validity of the results, assessment of methodological quality is required. Our aim was to analyze the methodological restrictions of rapid reviews compared with systematic reviews using the AMSTAR checklist and assess its feasibility for rapid reviews.

Methods: A systematic search for literature on rapid reviews of surgical interventions was conducted in three databases: Medline, Embase, and the Cochrane library. Additionally, health technology assessment (HTA) databases were searched. We analyzed reviews using AMSTAR and additionally compared the results with those of an overview of reviews on the same topic.

Results: Items found more frequently in rapid reviews were search for gray literature (65 percent versus 33 percent), listing of excluded studies (59 percent versus 37 percent), and provision of study characteristics (77 percent versus 44 percent), whereas consideration of study quality in formulating conclusions, conduct of meta-analysis, and statement of conflicts of interest were less frequent. Median time between search and publication was 8 months, with a range between 1 and 27.

Conclusions: With some adjustments, AMSTAR can be used as a checklist for rapid reviews to describe methodological restrictions in comparison to systematic reviews and to roughly estimate the validity of the results. Strikingly, only 14.3 percent of rapid reviews were published within 3 months.

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: Long-term follow-up of the Caries Management System (CMS) protocol demonstrated that regular monitoring and noninvasive management of dental caries is effective in reducing the number of caries-related events over a 7-year period. This analysis complements the authors’ original economic evaluation of the CMS by re-evaluating the per-protocol cost-effectiveness of the CMS approach.

Methods: An individual patient-simulation Markov model was developed previously, based on 3-year randomized-controlled trial (RCT) data, to simulate the incidence and progression of dental caries, and resultant interventions, and to evaluate the lifetime cost-effectiveness of the CMS versus standard dental care from the Australian private dental practitioner perspective (in which the baseline age distribution was similar to that of the Australian population). The 4-year posttrial follow-up data are used to re-evaluate the long-term cost-effectiveness of the CMS in a more real-life setting.

Results: The reduction in caries risk was maintained among those practices within which the CMS protocols were adhered to. The per-protocol model appears to be reasonably accurate at predicting the risk of restorative events in the posttrial follow-up period. The per-protocol lifetime cost per restorative event avoided is AUD1,980 (USD1,409; 1 AUD = 0.71 USD).

Conclusions: The current analysis confirms that the CMS approach is both effective, when the protocols are adhered to appropriately, and cost-effective compared with standard care in the Australian private practice setting.

Objectives: This study was carried out to evaluate the opinions of stakeholders on their roles in health technology assessment (HTA) in Iran and to determine the barriers and facilitators existing in the organizations to help increase their involvement in the HTA program.

Methods: The study was conducted in two stages, semi-structured interviews, and “policy dialogue” with stakeholders. The data were analyzed through the framework approach.

Results: The interviews were held with ten stakeholder representatives from various organizations. In addition, Twenty-one representatives participated in the policy dialogue. Based on the findings, all the stakeholder organizations considered themselves as interest groups in all the stages of the HTA process; however, their tendencies and methods of involvement differed from one another. According to the participants, the most important issue to be considered in the context of HTA was that the structures, stages, and procedures of the HTA process must be made transparent.

Conclusions: Stakeholder involvement in the HTA program cannot readily take place. Various stakeholders have different interests, responsibilities, infrastructures, and barriers. If a program does not meet these considerations, its chances of succeeding will substantially decrease. Therefore, to prevent overlooking the needs and expectations of stakeholders from the HTA process, it is essential to create opportunities in which their thoughts and ideas are taken into account.

Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.

Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.

Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.

Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.

Background: The classic cut and sew surgical Maze procedure has been shown to reduce atrial fibrillation (AF), and recently newer surgical ablation techniques with reduced technical complexity have been introduced. This study sought to systematically review the efficacy and safety of these newer techniques and to evaluate their long-term cost-effectiveness at the time of scheduled mitral valve (MV) surgery.

Methods: A systematic literature search and meta-analysis was performed to generate the most reliable efficacy and safety parameter estimates for a Markov decision analysis model comparing MV surgery alone to MV surgery plus an ablation Maze procedure. Both basic and probabilistic sensitivity analyses were conducted.

Results: Based on the six randomized controlled trials (RCTs) identified, the pooled 1-year estimate of AF after surgery alone was 71 percent (95 percent confidence interval [CI], 64 percent to 78 percent). The pooled risk ratio of AF after surgical ablation treatment at the time of mitral valve surgery relative to valve surgery alone was 0.33 (95 percent CI, 0.19 to 0.55). The pooled analyses showed that no statistical significant increases in operative mortality, permanent pacemaker implantation, and postoperative bleeding with the ablative Maze procedures. An ablation-based Maze procedure at the time of mitral valve surgery had an incremental cost-effectiveness ratio (ICER) of $4,446CAD ($3,850US) per quality-adjusted life-year (QALY) compared with valve surgery alone. Specifically costs were an extra $900CAD but with improved clinical outcomes (0.20 QALYs), including a prolonged life expectancy of 0.10 life-years. In one-way sensitivity analyses, survival time after MV surgery had the largest impact on ICER. Other variables influencing the ICER included the risk ratio of AF, utility, and cost estimates. Probabilistic sensitivity analysis suggests that 58.1 percent, 73.9 percent, and 89.3 percent of the simulations of the Maze strategy are cost-effective at willingness to pay thresholds of $20,000, $50,000, and $100,000CAD per QALY gained, respectively.

Conclusions: Our meta-analysis suggests that a Maze surgical ablation procedure at the time of MV surgery is associated with a reduced postoperative AF risk. Our economic model further suggests that the surgical ablation strategy at the time of mitral valve surgery is likely a cost-effective intervention, provided patients have a good long-term postsurgical prognosis.

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.

To better understand technology diffusion in an ambulatory care setting, we analyzed adult outpatients’ use of magnetic resonance (MR) and computed tomography (CT) imaging in a group-model HMO between 1986 and 1989. The use of MR, but not CT, Increased at a rapid pace with only a small proportion of the scans being accounted for by primary care physicians.

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.

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.

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.