Objectives: The aim of this study was to analyze the EuroScan Database and to describe and compare the characteristics of the included technologies and participating agencies.

Methods: Data of interest were exported from the EuroScan Database to Excel and to SPSS. A descriptive analysis depending on the agency, type of technology, stage of diffusion, and technology purpose was conducted. A frequency distribution analysis of the diffusion stage for different technology types and assigned purposes was made with the EpiCalc 2000 statistical calculator. A p value of less than .05 was considered to be statistically significant.

Results: Four agencies introduced the great majority of the technologies (81 percent), with drugs representing the 46.26 percent of the total, followed by devices (21.21 percent). The purpose of 24.45 percent of the identified technologies was not specified, and 34.58 percent of them were identified at the investigational or phase III stage. The frequency distribution of diffusion stage at identification was found to be similar for devices and diagnostics (p = .543), whereas drugs were identified earlier than devices (p <.001). Some agencies were found to focus their work on drugs, whereas others focused mainly on devices. Interagency differences were also observed with regard to the stage of diffusion at which technologies were identified.

Conclusions: This is the first analysis of one of the most important databases on new and emerging health technologies. Our study suggests that more active strategies should be designed to provide an earlier identification, mainly in the case of devices.

Objectives: This paper gives an overview of health technology assessment (HTA) in Belgium.

Methods: The information included in the overview is based on legal documents and publicly available year reports of the Belgian Health Care Knowledge Centre (KCE).

Results: Belgium has a relatively young history in HTA. The principle of evidence-based medicine (EBM) was introduced in the drug reimbursement procedure in 2001, with the establishment of the Drug Reimbursement Committee (DRC). The DRC assesses the efficacy, safety, convenience, applicability, and effectiveness of a drug relative to existing treatment alternatives. For some drugs, relative cost-effectiveness is also evaluated. The activities of the DRC can, therefore, be considered to be the first official HTA activities in Belgium. Later, in 2003, KCE was established. Its mission was to perform policy preparing research in the healthcare and health insurance sector and to give advice to policy makers about how they can obtain an efficient allocation of limited healthcare resources that optimizes the quality and accessibility of health care. This broad mission has been operationalized by activities in three domains of research: HTA, health services research, and good clinical practice. KCE is independent from the policy maker. Its HTAs contain policy recommendations that may inform policy decisions but are not binding.

Conclusions: Although the Belgian history of HTA is relatively short, its foundations are strong and the impact of HTA increasing. Nevertheless KCE has many challenges for the future, including continued quality assurance, further development of international collaboration, and further development of methodological guidance for HTA.

Objectives: The increasing availability of information about health care suggests an expanding role for consumers to exercise their preferences in health-care decision-making. Numerous methods are available to assess consumer preferences in health care. We conducted a systematic review to characterize the study of women's preferences about health care

Methods: A MEDLINE search from 1965 to July 1999 was conducted as well as hand searches of the itshape Medical Decision Making Journal (1981–1999) and references from retrieved articles. Only original articles on women's health issues were selected. Information on thirty-one variables related to study characteristics and preferences were extracted by two independent investigators. A third investigator resolved disagreements. Qualitative and quantitative analyses were conducted to synthesize the data.

Results: Four hundred eighty-three studies were identified in the initial search. Seventy articles were selected for review based on title, abstract, and inclusion criteria. There was an increase in published articles and number of methods used to elicit preferences. White women were studied more than black women (p<.001). Preferences were mainly studied in outpatient settings (p<.005) and in the United States, United Kingdom, and Canada (83 percent). Preferences related to participation in decision-making were the most common (21 percent). Only 4 percent of the studies were performed to inform the debate for public policy questions. Willingness to pay was the method most used (11 percent), followed by category scaling (10 percent), rating scale (9 percent), standard-gamble (6 percent). Preferences for individual particular (opposed to sequential and health states) outcomes (68 percent), different treatments/tests (47 percent), and related to a treatment episode (31 percent) were addressed. Information regarding diseases, conditions, or procedures was given in 57 percent of studies. Information provided was mainly written (37 percent) and included positive and negative potential outcomes (67 percent). There is no relationship between the method or tool used for delivery information and the choice performed.

Conclusions: The literature on preferences in women's health care is limited to a fairly homogeneous population (white women from the United States, United Kingdom, and Canada). Additionally, use of utility-based measures to capture preferences has decreased over time while others methods (e.g., time trade-off [TTO], contingent valuation) have increased. Women's preferences are not necessarily uniform even when asked similar questions using similar tools. Little information on women's preferences exists to inform policy-makers about women's health care.

When it is well conducted, a randomized clinical provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding between in their design, execution, analysis, and reporting. In a trial, we seek evidence for a causal link between treatment and observed outcomes. Becaues the controlled trial depends on an argument based on exculsion (i.e., no other causes or differences affected the experimental groups), we strengthen its inference by taking steps to exclude any such differences.

This article discusses a number of issues that deserve consideration: problems of multiplicity and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.

This article comments on the four country papers in this volume from an economic perspective. Different phases of the decision-making process, which can be supported by Health Technology Assessment (HTA), are considered. For each of these, there is large cross-country variation in the way in which HTA influences policy. Furthermore, economic themes regarding the relevance of HTA evidence for policy making, the position of cost-effectiveness in relation to other criteria vis-à-vis reimbursement decisions, the use of a cost per quality-adjusted life year threshold, and the incorporation of economic considerations in practice guidelines are discussed.

This study examined the conclusions of published reports that review the literature and make recommendations about appropriate applications of bone density measurement. It is based on a survey of 22 organizations producing such reports between 1986 and Spring 1995. Overall, the application of bone density measurement for the diagnosis of osteoporosis was supported by 65% of reports, by 44% for the monitoring and follow-up of patients with previously diagnosed disease, and by 59% for monitoring and follow-up of patients receiving treatment that may affect their bone density. A smaller proportion of reports from government and public organizations compared with other types of organizations and a smaller proportion of reports using more rigorous methods supported the applications for bone density measurement identified in the survey. A larger proportion of the reports published after 1990 compared with those published between 1986 and 1990 support the applications of bone density measurement, with the exception of population screening. The results of this survey suggest that there is considerable disagreement about the potential applications of bone density measurement. Publicly funded organisations and those using more rigorous methods tended to be more conservative in their conclusions.

Two functions of home care, assistance to improve disabled and aged patients' mobility and function, and self-care that includes treatment, screening-monitoring, exercise assistance, and information exchange, are described, as are the technologies used for these functions. Social and economic pressures as well as professional rationales that expand the use of technologies at home are noted, as is their impact on the site of care and on the patient-doctor relationship.

Objectives: The aim of this study was to develop an health technology assessment (HTA) decision tool to support the decision-making process on health technologies for hospital decision makers in cross-border regions.

Methods: Several methods were used to collect information necessary to develop the cross-border mini-HTA decision tool. The literature was inventoried on HTA in border regions and local settings and the use of HTA by local decision makers. Semi-structured interviews with hospital decision makers in cross-border regions were also performed. Based on group discussion of the resulting information, it was decided to use the Danish mini-HTA guideline as a starting point for development of the decision tool. After finishing the first version of the decision tool it was tested in two pilot studies

Results: Some questions in the Danish mini-HTA guideline were not relevant. Other questions needed rephrasing and questions about cross-border situations were added. The pilots showed several missing topics, including legal questions and reimbursement issues. The final decision tool consists of three sections: a general section, a section for hospitals not cooperating cross-border and a section for hospitals that are cooperating with hospitals across a national or regional border.

Conclusions: Based on our literature search, this may be the first cross-border mini-HTA decision tool. The decision tool will be of help for healthcare professionals and decision makers in border settings who would like to use HTA evidence to support their decision-making process.

With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.

Objectives: The aim of this study was to compare the clinical effectiveness and cost of percutaneous radiofrequency ablation (PRFA) and surgical resection (SRS) for the management of early stage Hepatocellular Carcinoma.

Methods: A systematic literature search of articles in English, French, and Chinese was performed using online databases. Only articles with patients classified as Child-Pugh Class A or B, with tumor size <5 cm were included. A meta-analysis was carried out to estimate the survival rate and disease-free survival rate following PRFA or SRS treatments. The cost of each treatment was estimated from the third party perspective. Univariate sensitivity analyses were used to study the relative importance of each component cost.

Results: We identified six studies (one randomized controlled trial (RCT) and five comparative cohort studies) meeting our inclusion criteria. There is good evidence that among Child-Pugh A patients for whom both SRS and PRFA are available options, survival rates following either procedure are comparable, while complications are more frequent and hospitalization longer following SRS. The evidence concerning recurrence rates and disease-free survival is less clear. Whereas the RCT indicates comparable outcomes with either procedure up to 3 years, the results of five cohort studies (with possible selection bias), particularly those with a mix of Child-Pugh A and B patients, favor the surgical option. SRS, costs approximately Canadian $8,275 more per case than PRFA.

Conclusions: Continuing doubts on this issue can only be resolved by a substantial RCT. Meanwhile, for early stage HCC patients classified as Child-Pugh A, who despite a possibly higher recurrence rate, prefer the less invasive PRFA to open surgery with its attendant risks, there is sufficient evidence to justify such a choice. For those classified as Child-Pugh (B) it is possible that overall survival is equally good with PRFA, but the evidence is less certain.

Objective: To identify training programs and educational resources in health technology assessment (HTA) in Europe.

Methods: A postal survey among potential informants in European countries and Israel, expanding on surveys among ISTAHC and INAHTA members. Informants were identified either using HTA networks or by means of Internet sources.

Results: The combined results of the three surveys show that in the European Union (EU), including Norway and Switzerland, 13 of 17 countries (76%) provide either university level courses or continuing education HTA courses. In the candidate EU countries, 4 of 10 countries (40%) provide HTA courses. In the remainder of countries, only Israel provides HTA courses. Ten different types of courses were identified, mainly applying traditional teaching methods. A substantial number of the courses were first organized in recent years. Many countries in central and eastern Europe expressed the wish to become more involved in HTA.

Conclusion: There is a rapid increase in the number and diversity of courses in HTA in Europe. In particular, countries in the EU are well represented. Education and training in HTA is scarce in EU candidate membership countries, and virtually absent in the remainder of countries. In general, HTA as a field is in the process of becoming established and institutionalized both in individual countries and internationally. To stimulate this development in the area of education and training, both bilateral cooperation and an EU-wide coordinated effort are recommended.

Objectives: The aim of this study was to examine the impact of the multi-hundred million dollar investment by the federal government in the developing Patient Outcomes Research Teams (PORTs) in over a dozen major academic medical centers in the United States throughout the 1990s. The objective of the PORTs was to reduce unnecessary clinical variation in medical treatment.

Methods: Using an economic derivation of welfare loss attributable to medical practice variation and hospital admission claims data for 2 million elderly patients generalizable to the nation, we estimate the change in welfare between 1991 and 2000, the period within which the PORTs were designed and executed and their results disseminated.

Results: Our results show inpatient admission types targeted by the PORTs did have less welfare loss relative to their total expenditure by 2000, but that there was not a net decrease in the welfare loss for all hospital admissions affected by the PORT.

Conclusions: We conclude that PORTs may have had favorable effects on welfare, most likely by reducing variation in clinical care, but that causality cannot be proved, and the effects were not equal across all conditions targeted by PORTs. This research provides a methodological template that may be used to evaluate the impact of patient safety research on welfare loss and on variation in medical treatment in both hospital and ambulatory settings.

Objectives: Value assessment frameworks have gained prominence recently in the context of U.S. healthcare. Such frameworks set out a series of factors that are considered in funding decisions. The UK's National Institute of Health and Care Excellence (NICE) is an established health technology assessment (HTA) agency. We present a novel application of text analysis that characterizes NICE's Technology Appraisals in the context of the newer assessment frameworks and present the results in a visual way.

Methods: A total of 243 documents of NICE's medicines guidance from 2007 to 2016 were analyzed. Text analysis was used to identify a hierarchical set of decision factors considered in the assessments. The frequency of decision factors stated in the documents was determined and their association with terms related to uncertainty. The results were incorporated into visual representations of hierarchical factors.

Results: We identified 125 decision factors, and hierarchically grouped these into eight domains: Clinical Effectiveness, Cost Effectiveness, Condition, Current Practice, Clinical Need, New Treatment, Studies, and Other Factors. Textual analysis showed all domains appeared consistently in the guidance documents. Many factors were commonly associated with terms relating to uncertainty. A series of visual representations was created.

Conclusions: This study reveals the complexity and consistency of NICE's decision-making processes and demonstrates that cost effectiveness is not the only decision-criteria. The study highlights the importance of processes and methodology that can take both quantitative and qualitative information into account. Visualizations can help effectively communicate this complex information during the decision-making process and subsequently to stakeholders.

This paper reviews the evolution of U.S. policy toward medical technology in areas such as cost containment, regulation of devices and drugs, and third party reimbursement. In addition the authors chronicle the diffusion of major medical technologies, procedures, and organizational innovations in the United States. Finally, the article provides tentative observations on the effect of recent policy changes and concludes with some recommendations for the future.

Although there have been numerous technological devices introduced for the diagnosis and treatment of temporomandibular disorders, many are either ineffective or are research tools without direct clinical application. This article reviews the various modalities and makes recommendations regarding their effectiveness based on the available clinical and scientific evidence.

Objectives: Japanese authorities have announced a plan to introduce a health technology assessment (HTA) system in 2016. This study assessed the potential impact of such a policy on the price of the antivirologic drug simeprevir.

Methods: Taking the antivirologic drug simeprevir as an example, we compared the current Japanese price with hypothetical prices that might result if a U.K. (cost-utility) or German (efficiency frontier) style HTA assessment was in place.

Results: The simeprevir unit price under the current Japanese pricing scheme is 13,122 Japanese yen (equivalent to 109.35 U.S. dollars as of April 2015). Depending on the selection of comparators and the pricing method, and assuming that HTA will be used as a basis for price setting, the estimated prices of simeprevir vary up to four times higher than under the current Japanese pricing scheme.

Conclusions: Although the analysis is based on only one drug, it cannot be taken for granted that a new HTA system would reduce public healthcare expenditure in Japan.

This paper analyzes the cost-effectiveness of screening and treating diabetic retinopathy (DR) by simulating the disease progress continuously with existing data. A new computer simulation based on Monte Carlo techniques and logistic transformation follows cohorts from diabetes onset until death in five care scenarios. For younger-onset patients, ophthalmic care reduces the prevalence of blindness by 52% or greater while savings in disability facilities and production losses surpass direct costs. For older-onset patients, less favorable results appear. Financial benefits surpass costs for juvenile-onset patients. For other patients, the net costs of ophthalmic care seem lower than in other health care programs.

Commodification of low-cost diagnostic technologies (LCDTs) carries the risk of an unintended and potentially worrisome shift in how we conceive of health assessment. Optimizing practice requires a balanced understanding of both the beneficial and harmful impact of the use of LCDTs and the development of system incentives for appropriate use.

Background: The intelligent bed is a medical bed with several home healthcare functions. It includes, among others, an “out of bed” detector, a moisture detector, and a catheter bag detector. The design purpose of the intelligent bed is to assist patients in their daily living, facilitate the work of clinical staff, and improves the quality of care. The aim of this sub-study of the iCare project was to explore how health professionals (HPs) experience and use the intelligent bed in patients’ homes.

Methods: The overall research design is inspired by case study methodology. A triangulation of data collection techniques has been used: log book, documentation study, participant observations (n = 45 hr), and qualitative interviews (n = 23). The data have been analyzed by means of Nvivo 9.0.

Findings: We identified several themes: HP transformation from passive technology recipient to innovator; individualized care; work flow redesign; and sensor technology intruding on patient privacy.

Conclusions: It is suggested that functions of the intelligent bed can result in more individualized care, workflow redesign, and time savings for the health professionals in caring for elderly patients. However, the technology intruded on patients’ privacy.