Objectives: The aim of this study was to describe a comprehensive continuum that has developed in Ontario between government and key stakeholder groups, including hospitals, physicians, academic institutions, clinical epidemiologists, health economists, industry, and bioethicists to achieve evidence-based recommendations for policy development.

Methods: The various components of the comprehensive model that has evolved to develop an evidentiary platform for policy development are summarized, and the flow between these components is described.

Results: The development of the Ontario Health Technology Advisory Committee (OHTAC) and associated programs demonstrate the need to go beyond the traditional steps taken within most health technology assessment paradigms. These components include pragmatic postmarketing studies, human factors, and safety analyses, and formalized interactions with a broad spectrum of potential end-users of each technology, experts, and industry. These components, taken together with an expanded systematic review to include a range of economic analyses, and societal impacts augment the traditional systematic review processes. This approach has been found to be important in assisting decision making and has resulted in an 81 percent conversion from evidence to policy consideration for eighty-three technologies that had been assessed at the time this article was submitted.

Conclusions: The comprehensive model, centered around OHTAC, has added important new dimensions to health policy by improving its relevance to decision makers and providing an accountable and transparent basis for government to invest appropriately in health technologies. This study could also form a basis for further research into appropriate methodologies and outcome measurements as they relate to each component of this approach.

Objectives: The objective of this study was to develop and implement a decision-making process for public funding of health services that links policy areas with health technology assessment and input from interested parties.

Methods: Health authorities, assessment organizations, and healthcare professionals were consulted as a follow-up to recommendations of an expert panel established by the Alberta government. The methods involved formulation of an eight-stage, collaborative process that incorporates identification through the health ministry of health technologies requiring review, assessment of the technologies using expert groups in Alberta, and consultation and formulation of advice within the ministry to inform ministerial funding decisions.

Results: All components of the decision process have been put in place and have collaborated to provide advice to inform policy on provincial health services. Of nineteen technologies selected for review, five have been completed and decisions made: laparoscopic adjustable gastric banding, fetal fibronectin assay for premature labor, newborn screening for cystic fibrosis, newborn screening for inborn errors of metabolism, and gastric electrical stimulation. A further six reviews are in progress, and reviews of the remaining technologies are planned for 2007.

Conclusions: Bridging the evidence-to-policy gap is more likely to succeed when the policy community is actively engaged and an explicit model is used to put health technology assessment into practice.

Objectives: Ethical evaluation has become an important part of health technology assessment (HTA), but so far no generally accepted method for doing this exists. This article explains the eclectic approach developed at the Finnish HTA office.

Methods: Each HTA report is produced in cooperation with the methodological and clinical experts from various levels of healthcare organizations. An open framework for ethical evaluation when assessing different types of interventions is used to identify all possible stakeholders for each particular intervention. The ethical consequences for each party are identified during the entire process of the HTA project.

Results: The results of an ethical evaluation in four different HTA projects (two on screening, one on surgical intervention, and one in rehabilitation) show that an open framework is useful for opening discussion and understanding the scope of each ethical evaluation. Both content and methodological experts have found the process to be useful in capturing the broad consequences of implementing a new method.

Conclusions: Ethical evaluation is a continuous process that considers the prevalent morals, values, and behavioral models of the society. An in-depth ethical evaluation helps the decision-makers to realize the consequences that implementing a new method has on individual citizens, the healthcare system, and society.

Background: There is a need for innovative methodologies to identify and prioritize topics for health technology assessment (HTA). A pilot project to evaluate the methodology for specialty mapping was undertaken in the area of child and adolescent health. Two case studies are presented, in the area of sexually transmitted infections and acute pain.

Methods: The methodology comprised sequential stages, based on principles of systematic review. A “stakeholder model” encouraged wider participation. Key stages included identifying the topic area and setting the scope; developing a care pathway; searching for clinical guidelines/guidance, and evaluation literature; synthesis and mapping of literature to the “nodes” of the care pathway to highlight gaps; prioritizing the topics with stakeholders; and referring priorities to the appropriate agencies.

Results: A total of thirty guidelines/guidance documents and sixteen evaluation studies were mapped across the two case studies. In some nodes of the care pathway, more literature was mapped than others, suggesting important gaps in research and policy guidance. Sixty-two policy questions were identified and were rated by stakeholders in prioritization workshops. The highest priorities have been considered by senior committees for likely commissioning as research or guidelines/guidance.

Conclusions: This is one of the few published examples of innovative methodology to identify and prioritize topics for HTA. Specialty mapping can make a positive contribution to the policy agenda, with several research and policy gaps being fed into existing prioritization channels. Adequate time, resources, and capacity is required particularly in engaging stakeholders and developing a care pathway. Implementation of specialty mapping in other topic areas with on-going evaluation is recommended.

Objectives: Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case. Constructive technology assessment (CTA) was first described in the 1980s. In addition to the traditional HTA elements, this approach also takes into account the technology dynamics by emphasizing sociodynamic processes. With a CTA approach, comprehensive assessment can be combined with an intentional influence in a favorable direction to improve quality.

Methods: In this study, the methodological aspects mainly concerning the diagnostic use of CTA are explained. The methodology will be illustrated using the controlled introduction of a new technology, called microarray analysis, into the clinical practice of breast cancer treatment as a case study. Attention is paid to the operationalization of the phases of development and implementation and the research methods most appropriate for CTA.

Conclusions: In addition to HTA, CTA can be used as a complementary approach, especially in technologies that are introduced in an early stage of development in a controlled way.

Background: Since its inception, the field of health technology assessment (HTA) has stressed the need for consideration of ethical and social issues. However, few concepts or analytic tools have been developed, and because of the complexity of the endeavor and a lack of integration of work already produced, such concepts remain difficult to apply in HTA.

Objectives: Through a descriptive “map” of concepts, tools, and processes, we summarize the most tangible efforts on the part of HTA producers to address social and ethical issues.

Methods: A literature review and content analysis of HTA reports in the Centre for Reviews and Dissemination database enables a synthesis of the reflections on, initiatives around, and gaps in knowledge related to the integration of social and ethical issues in HTA.

Results: We examine: (i) the aim of integrating ethical and social issues in HTA, (ii) the theoretical approaches used, (iii) the methods and processes applied, and (iv) the implications for HTA producers. We highlight two levels at which social and ethical issues can be considered: throughout the production process of HTA reports and as part of the organizational structure of HTA agencies.

Conclusions: Given the profound societal changes that occur in relation to healthcare technology development, HTA producers have a responsibility to inform and enlighten technology-related public and policy debates. Fulfilling this role, though, requires that socioethical dimensions of technology and HTA are made explicit.

Objectives: The aim of the study is to make an international comparison of Health Technology Assessment (HTA) Agencies, to show their similarities and differences.

Methods: An e-mail questionnaire was sent to thirty HTA agencies internationally. Questions related to the structure of the agency, the relationship with health-related institutions, the prescriptiveness of the decisions taken, the main core and the modalities to spread the assessment, and the type of funding.

Results: Twenty-four HTA Agencies answered the questionnaire: 25 percent in America, 4.2 percent in Australia, and 70.8 percent in Europe. Fifty-four percent of HTA Agencies are governmental institutions (83.3 percent have central government funding), while 62.5 percent have relationships with health-related governmental institutions. Of the agencies, 87 percent reported that their decisions are not prescriptive, while for 20.8 percent and 8.3 percent of them stated that this was the case totally or partially, respectively, especially for the governmental and American Agencies. Seventeen agencies (70.8 percent) declared their work on multiannual programs (77 percent of the governmental HTA Agencies and 100 percent of the American ones). The assessments mainly addressed diagnostic procedures (85.7 percent) and pharmaceuticals (25 percent). The most common way to disseminate results is by means of paper report (91.7 percent), followed by the Internet (16.7 percent), and seminars to expert audiences (12.5 percent).

Conclusions: The comparative analysis of HTA Agencies showed that governmental and American Agencies have a profound impact on the prescriptiveness of their assessment, and this could be linked to the fact that these types of Agencies work on multiannual programs. European and American HTA Agencies have many similarities in terms of type of assessment, funding, and dissemination of results.

Objectives: This study sought to identify and compare various practical and current approaches of health technology assessment (HTA) priority setting.

Methods: A literature search was performed across PubMed, MEDLINE, EMBASE, BIOSIS, and Cochrane. Given an earlier review conducted by European agencies (EUR-ASSESS project), the search was limited to literature indexed from 1996 onward. We also searched Web sites of HTA agencies as well as HTAi and ISTAHC conference abstracts. Agency representatives were contacted for information about their priority-setting processes. Reports on practical approaches selected through these sources were identified independently by two reviewers.

Results: A total of twelve current priority-setting frameworks from eleven agencies were identified. Ten countries were represented: Canada, Denmark, England, Hungary, Israel, Scotland, Spain, Sweden, The Netherlands, and United States. Fifty-nine unique HTA priority-setting criteria were divided into eleven categories (alternatives; budget impact; clinical impact; controversial nature of proposed technology; disease burden; economic impact; ethical, legal, or psychosocial implications; evidence; interest; timeliness of review; variation in rates of use). Differences across HTA agencies were found regarding procedures for categorizing, scoring, and weighing of policy criteria.

Conclusions: Variability exists in the methods for priority setting of health technology assessment across HTA agencies. Quantitative rating methods and consideration of cost benefit for priority setting were seldom used. These study results will assist HTA agencies that are re-visiting or developing their prioritization methods.

Objectives: To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).

Methods: We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.

Results: There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.

Conclusions: The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

Objectives: The practical significance of health technology assessment (HTA) in policy decisions or clinical practice has been challenged. Possibly, problem definitions underlying HTA do not concur sufficiently with the problem definitions held by policy makers or clinicians. We performed an in-depth case study on mebeverine, a drug prescribed to patients with irritable bowel syndrome, to explore this hypothesis.

Methods: The theoretical framework was provided by the theory of argumentative policy analysis. We analyzed documents and held semistructured interviews to collect data. We reconstructed interpretative frames to analyze actors' argumentation.

Results: The funding and usage problems relating to mebeverine were ill-structured. Actors disagreed on the information needed and the norms at stake. As a result, the problem definition shifted, and the resulting problem definitions failed to correspond with the problems perceived by the target populations.

Conclusions: To ensure that future studies on healthcare problems are useful, it is imperative that policy makers take the problem definitions of potential users into account.

The application of conditionality to coverage decisions for healthcare technologies is increasing. Coverage with Evidence Development (CED) represents a specific approach to coverage for promising technologies for which the evidence remains uncertain. CED demands that additional evidence is generated to address the sources of uncertainty and secure ongoing coverage. This study explores the conceptual and policy issues relating to CED and discusses issues involved in operationalizing CED in practice, including presenting criteria for which technologies may be most suitable for CED. This study is intended to further the debate on the use of CED as well as highlight areas that warrant further research.

Objectives: After 4 years of deepening recession, Argentina's economy plummeted after default in 2002. This crisis critically affected health expenditures and triggered acute rationing. Our objective was to explore health decision-makers' knowledge and attitudes about economic evaluations (EE) and whether health technology assessment (HTA) were increasingly used for decision making.

Methods: A qualitative design based on semistructured interviews and focus groups was used to explore how decision makers belonging to different health sectors implement resource allocation decisions.

Results: Informants were mostly unaware of EE. The most important criteria mentioned to adopt a treatment were evidence of effectiveness, social/stakeholder demand, or resource availability. Despite general positive attitudes about EE, knowledge was rather limited. Although cost considerations were widely accepted by purchasers and managers, clinicians argued about these issues as interfering with the doctor–patient relationship. Other important perceived barriers to HTA use were lack of confidence in the transferability of studies conducted in developed countries and institutional fragmentation of the Argentine healthcare system. The new macroeconomic context was cited as a justification of implicit rationing measures. Although explicit priority setting was implemented by many purchasers and managers, HTA was not used to improve technical and/or allocative efficiency.

Conclusions: The crisis seems to be a strong incentive to extend the use of HTA in Argentina, provided decision makers are aware as well as involved in the generation of local studies.

This study discusses the value of primary data collection as part of health technology assessment (HTA). Primary data collection can help reduce uncertainty in HTA and better inform evidence-based decision making. However, methodological issues such as choosing appropriate study design and practical concerns such as the value of collecting additional information need to be addressed. The authors emphasize the conditions required for successful primary data collection in HTA: experienced researchers, sufficient funding, and coordination among stakeholders, government, and researchers. The authors conclude that, under specific conditions, primary data collection is a worthwhile endeavor in the HTA process.

The study by Hutton, Trueman, and Henshall provides a thoughtful and helpful set of observations about the potential benefits of linking reimbursement to requirements for further clinical research (coverage with evidence development—CED), as well as the likely challenges and obstacles to implementation. In this commentary, we will expand upon several of the key points made in their study and offer some additional suggestions for moving this policy discussion forward

Objectives: The aim of this study was to define an effective early warning system, to identify and rank the characteristics of an effective early warning system for emerging health technologies, and to evaluate current early warning systems against these characteristics.

Methods: An iterative Delphi-type process with the thirteen members of the International Information Network on New and Changing Health Technologies (EuroScan). We synthesized key characteristics that network members had graded. Members were then asked whether these characteristics were present or fulfilled in their system.

Results: The definition of an effective early warning system developed was the following: a system that identifies innovations in the field of health technology likely to have a significant impact; and disseminates information relevant to the needs of the customer which is timely, so as to enable appropriate decision making (such as resource allocation), facilitate appropriate adoption, and identify further research requirements. Five primary and eleven secondary components of effective early warning systems were identified. The five primary characteristics concerned relevance, independence, resourcing, a clear pathway for the outputs to reach decision makers, and defined customers. Although the primary characteristics were present or fulfilled to some extent in the majority of evaluated early warning systems, there was considerable variability in the presence of the secondary characteristics in the evaluated systems.

Conclusions: Our study provides a definition for an effective early warning system and a shared understanding of the important characteristics and components of such systems. This work should provide guidance to those setting up new early warning systems as well as for those managing and reviewing current systems.

Objectives: The Finnish Diabetes Prevention Study (DPS) was a randomized intervention program that evaluated the effect of intensive lifestyle modification on the development of diabetes mellitus type 2 in patients with impaired glucose tolerance. As such, a program is demanding in terms of resources; it is necessary to assess whether it would be money well spent. This determination was the purpose of this study.

Methods: We developed a simulation model to assess the economic consequences of an intervention like the one studied in DPS in a Swedish setting. The model used data from the trial itself to assess the effect of intervention on the risk of diabetes and on risk factors for cardiovascular disease. Results from the United Kingdom Prospective Diabetes Study were used to estimate the risk of cardiovascular disease and stroke. Cost data were derived from Swedish studies. The intervention was assumed to be applied to eligible patients from a population-based screening program of 60-year-olds in the County of Stockholm from which the baseline characteristics of the patients was used.

Results: The model predicted that implementing the program would be cost-saving from the healthcare payers' perspective. Furthermore, it was associated with an increase in estimated survival of .18 years. Taking into consideration the increased consumption by patients due to their longer survival, the predicted cost-effectiveness ratio was 2,363€ per quality-adjusted life-year gained.

Conclusions: Lifestyle intervention directed toward high-risk subjects would be cost-saving for the healthcare payer and highly cost-effective for society as a whole.

Objectives: The aim of this study was to estimate thresholds for production volume, durability, and cost of care for the cost-effective adoption of liver organ replacement technologies (ORTs).

Methods: We constructed a discrete-event simulation model of the liver allocation system in the United States. The model was calibrated against UNOS data (1994–2000). Into this model, we introduced ORTs with varying durability (time to failure), cost of care, and production volume. Primary outputs of interest were time to 5 percent reduction in the waiting list and time to 5 percent increase in expected transplant volume.

Results: Model output for both calibration and validation phases closely matched published data: waiting list length (±2 percent), number of transplants (±2 percent), deaths while waiting (±5 percent), and time to transplant (±11 percent). Reducing the waiting list was dependent on both ORT durability and production volume. The longer the durability, the less production volume needed to reduce the waiting list and vice versa. However, below 250 ORT/year, durability needed to be >2 years for any significant change to be seen in the waiting list. For base-case costs, all ORT production volume and durability scenarios result in more transplants per year at less total cost of care/patient than the current system. ORTs remain cost saving until manufacturing costs are >5 times base-case costs, production is less 500 ORT/year, and durability <6 months.

Conclusions: Although there remain many technical challenges to overcome, as long as ORTs can meet these threshold criteria, they have the potential of transforming the world of end-stage liver disease.

Objectives: The long-term cost-utility of a disease management program (DMP) for adults with asthma was assessed compared to usual care.

Methods: A DMP for patients with asthma has been developed and implemented in the region of Maastricht (The Netherlands). By integrating care, the program aims to continuously improve quality of care within existing budgets. A clinical trial was performed over a period of 15 months to collect data on costs and effects of the program and usual care. These data were used to inform a probabilistic decision-analytic model to estimate the 5-year impact of the program beyond follow-up. A societal perspective was adopted, with outcomes assessed in terms of costs per quality-adjusted life-year (QALY).

Results: The DMP is associated with a gain in QALYs compared to usual care (2.7±.2 versus 3.4±.8), at lower costs (€3,302±314 versus €2,973±304), thus leading to dominance. The probability that disease management is the more cost-effective strategy is 76 percent at a societal willingness to pay (WTP) for an additional QALY of €0, reaching 95 percent probability at a WTP of €1,000 per additional QALY.

Conclusions: Organizing health care according to the principles of disease management for adults with asthma has a high probability of being cost-effective and is associated with a gain in QALYs at lower costs.

Objectives: Previously in Finland, each municipality selected which methods to use in screening for fetal abnormalities. This resulted in practice variation and inequity. The national health technology assessment (HTA) office Finohta compared the methods and time frames available when screening for chromosomal and structural abnormalities. The assessment identified a need to discuss several value-laden questions before policy decisions could be taken.

Methods: The National Screening Committee (NSC) at the Ministry of Health and Social Affairs (MOH) formulated a statement based on the HTA report to inform policy makers. This article describes the steps in the policy process.

Results: The national screening committee organized an open forum to discuss the ethically relevant aspects of fetal screening, and a lengthy public discussion highlighted the viewpoints of various stakeholders. Based on the assessment, public discussion, and several committee meetings that heard further experts, the NSC formulated a conclusion based on equity of access. This also offered options for families unwilling to terminate a pregnancy due to fetal abnormality. The MOH sent the conclusion to a comment round, and the proposal was accepted with minor adjustments. The Ministry decided to unify the regulation of all public screening programs by one statute. The policy process lasted three years, and the methods to screen for fetal abnormalities will be unified after a further 3 years.

Conclusions: The assessment of screening programs for fetal abnormalities reached beyond its original mandate. The process of examining values behind screening resulted in a program that respects the differing objectives and ethical values of pregnant families, and to national legislation on screening programs.

Background: In conjunction with other important movements in contemporary medicine, including evidence-based medicine (EBM), health technology assessment (HTA) has promoted a culture of critical evaluation. Despite this impact, institutional and methodological challenges are associated with HTA. For example, only in recent years has HTA attempted an open dialogue with patients; however, this is normally done by giving them a “seat” at the HTA decision-making table, rather than by more scientific means.

Objectives: The aim of this study was to develop a working definition of patient-based HTA, to identify the current barriers to adopting a patient-based model, and to formulate a vision of how a patient-based HTA could be used to promote patient empowerment and patient-centered care.

Results: In the ideal setting, a patient-based HTA would promote patient knowledge by providing access to information and promoting an informed dialogue between patients and their healthcare professionals. To implement a patient-based HTA, the focus must turn to the patient's issues and incorporate each patient's unique perspective and preferences. Processes must change to increase patient participation in all levels of HTA and aim to promote empowered patients who can make informed decisions.

Conclusions: Present-day HTA is broad and has numerous stakeholders, with none so important as the patient. By asking patient-oriented questions in HTA and better involving patients throughout the entire process, we can easily promote patient empowerment, and as such make patients more capable to play a more active role in healthcare decision making.