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Objectives: Type 2 diabetes (T2D) management requires behavioural engagement to achieve optimal outcomes and continuous glucose monitoring (CGM) technologies may facilitate self-management. In this study, we describe the development and validation of a self-report instrument, the Impact of Glucose Monitoring on Self-Management Scale (IGMSS), assessing the impact of device use (primarily CGM but also self-monitored blood glucose [SMBG]) on the capability, motivation, and opportunity to engage in self-management., Methods: Potential items were generated from 3 sources: themes and quotes from 13 adults with T2D motivated by CGM use who participated in a qualitative study; behaviour change theory identifying capability, opportunity, and motivation to self-manage; and expert committee review of items. An initial pool of 42 items were generated describing CGM as promoting personalized knowledge, improved health (Capability), improved relationships, having positive device characteristics (Opportunity), and improved engagement in self-management (Motivation). Based on expert committee consensus, items were written so as to be completed by those using any glucose-sensing device (SMBG and CGM). Psychometric evaluation was conducted with 514 English-speaking Canadians. Scale reduction (22 final items) was completed using item-response distribution, internal consistency, factor analysis, and expert opinion. Construct and convergent validity were evaluated using the Impact of Glucose Monitoring Satisfaction Scale, the Diabetes Self-Management Questionnaire, the Diabetes Distress Scale, the 5-item World Health Organization Well-Being Index, and the Centre for Epidemiology Depression Scale. Test-retest reliability was determined for 130 participants., Results: Internal consistency was high for all scales, ranging from 0.73 to 0.91. Test-retest reliability ranged from 0.58 to 0.79, except for Device Characteristics. Construct and convergent validity indices were acceptable. There was substantial overlap between the IGMSS and established measures of CGM satisfaction. IGMSS findings were also predictive of self-management behaviour and emotional functioning., Conclusions: The IGMSS has positive psychometric characteristics and has the potential to screen people with T2D for engagement in diabetes self-management using CGM or any sensing device. Scores can be determined for various aspects of Capability (Personalized Knowledge, Improved Health), Opportunity (Relationships and Device Characteristics), and Motivation., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: Patients with end-stage renal disease (ESRD) have an increased risk of cardiovascular disease, but interpreting cardiac troponin is difficult in this population. The effect of renal replacement therapy (RRT) is important to consider when interpreting serial cardiac troponin T (cTnT) results for patients with ESRD suspected of acute coronary syndrome (ACS). The aim of this systematic review is to answer how low-flux hemodialysis (LF-HD), high-flux hemodialysis (HF-HD), and hemodiafiltration (HDF) affect the blood concentration of high-sensitive cardiac troponin T (hs-cTnT)., Method: Several databases were searched and identified records were evaluated independently by two of the authors. Pre- and postdialysis hs-cTnT concentrations together with other relevant data were extracted from the included studies. The quality (potential bias and applicability issues) were assessed for each of the included studies., Results: The literature search identified 2,540 records and 15 studies were included. The relative pre- to postdialysis change of hs-cTnT varied from -41 to 29%. LF-HD increased the hs-cTnT concentration with relative changes between 2 and 17%. HDF decreased the concentration with relative changes from -41% to -9%. Both increases and decreases were seen for HF-HD (-16% to 12%)., Discussion/conclusion: In this systematic review, we found LF-HD to increase the hs-cTnT concentration and HDF to decrease the concentration. Results for HF-HD and unspecified HD are more heterogeneous. Because of the differences between the included studies, a meta-analysis was not meaningful. This systematic review can help with the assessment of patients with ESRD suspected of ACS in relation to hemodialysis/HDF treatment., (© 2023 The Authors. Seminars in Dialysis published by Wiley Periodicals LLC.)

Objectives: Motivation to adhere to clinical recommendations requires engagement, and the urgency to act is one of many factors that contribute to achieving glycemic benefits in people with type 2 diabetes (PwT2D). Continuous glucose monitoring (CGM) devices are associated with improved glycemic benefits. We conducted a qualitative assessment of PwT2D who found using CGM extremely beneficial and examined the potential for CGM to elicit motivation to engage in self-management behaviours., Methods: Participants using CGM were recruited through social media and interviewed, and transcripts were analyzed (template analysis using thematic analysis) to generate coded responses and inductive themes by 2 raters., Results: Thirteen participants (84.6% women, with a duration of T2D >5 years and CGM use for >6 months) were interviewed. Codes were organized around 3 themes: improved self-management, experience of glucose-sensing technology vis-à-vis general positive or negative experience, and positive impact of CGM on living with diabetes. Improved self-management was reflected in how the CGM technology provided personalized knowledge and ability to self-manage, particularly in contrast to finger pricking. Positive experience included motivation for behaviour changes as well as improved relationships with health-care providers and in social situations. This translated into a sense of improved health and an avoidance of complications. Negative experience included costs, concern over location of the sensor, and discomfort with the device., Conclusions: CGM technology profoundly impacts multiple aspects of self-management and care for PwT2D. Developing a validated instrument to assess identified constructs could contribute to developing interventions and leveraging benefits of this technology, particularly the motivational constructs of engagement and urgency., (Copyright © 2023 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.)

Telemedicine in diabetes care has been evolving over several years, particularly since the advent of cloud-connected technologies for diabetes management, such as glucose monitoring devices, including continuous glucose monitoring (CGM) systems, that facilitate sharing of glucose data between people with diabetes and their healthcare professionals in near-real time. Extreme social distancing and shielding in place for vulnerable patients during the COVID-19 pandemic has created both the challenge and the opportunity to provide care at a distance on a large scale. Available evidence suggests that glucose control has in fact improved during this period for people with diabetes who are able to use CGM devices for remote glucose monitoring. The development of telemedicine as part of the standard of care in diabetes faces significant challenges in the European context, particularly in terms of providing consistent and effective care at a distance to large populations of patients while using robust systems that can be supported by large regional and national healthcare services. These challenges include a fragmented approach to healthcare technology assessment and reimbursement, lack of eHealth education and literacy, particularly amongst healthcare professionals, lack of data integration, as well as concerns about electronic health records, patient consent and privacy. Here we review the benefits of and challenges to wider application of telemedicine and telemonitoring in the post-pandemic future, with the aim to ensure that the value of these eHealth services is provided to patients, healthcare providers and health systems., (© 2021. The Author(s).)

Introduction: Lower-income European countries have a worse health status and less funds for health care compared to Western Europe. Despite their limited human and financial capacities for conducting Health Technology Assessment (HTA), the need for evidence-based decision-making is growing. Two main approaches emerged as potential solutions: joint clinical assessments on the European level, and simplified procedures relying on the judgments of well-established HTA agencies of Western countries., Areas Covered: Based on considerations of transferability, the European Network for Health Technology Assessment (EUnetHTA) was built up to harmonize HTA methodologies across the European Union, and to develop an HTA Core Model by focusing on joint production of relative effectiveness assessment, which can be used as a basis for national value assessments. The second approach has been suggested in various forms without considering transferability issues., Expert Opinion: Joint clinical assessments reduce duplication of efforts based on appropriate scientific rationale. On the other hand, recent examples show that relying on judgments of HTA agencies from wealthier countries with potentially different health-care priorities can lead to suboptimal allocation decisions. In the short term, some stakeholders may benefit from ignoring transferability, but it will ultimately lead to limited access in other disease areas.

Introduction: Implementation of health technology assessment (HTA) is still in an early stage with some heterogeneity in the Middle East and North Africa (MENA). Our objective was to assess the current and future status of HTA implementation in the MENA region by focusing on regional commonalities., Methods: Preparatory discussions for the first ISPOR conference in the MENA region indicated some potentially generalizable trends of HTA roadmaps. To widen the perspective, a policy survey was conducted among conference participants by applying an HTA implementation scorecard. Discussion group members helped to validate key conclusions during and after the conference., Results: Health policy experts in MENA countries would like to facilitate HTA implementation and expect significant changes with some generalizable directions in 10 years compared to the current status according. HTA capacity building has to be strengthened by more graduate and postgraduate programs. Increased public budget and enhanced institutionalization are necessary success factors of HTA implementation. The scope of HTA has to be extended from pharmaceuticals to non-pharmaceutical technologies and to revision of previous policy decisions. Although cost-effectiveness with explicit threshold remains the most preferred HTA criterion, several other criteria have to be considered, maybe even by applying an explicit MCDA framework. The role of local evidence and data has to be strengthened in MENA countries, which translates to the extended use of local patient registries and payers' databases. Duplication of efforts can be reduced if international collaboration is integrated into national HTA implementation., Discussion: Our results should be viewed as an initial step in a multi-stakeholder dialogue on HTA implementation. Each MENA country should develop its context-specific HTA roadmap, as such roadmaps are not transferable without taking into account country size, economic status, public health priorities and adopted systems of health care financing., (Copyright © 2020 Fasseeh, Karam, Jameleddine, George, Kristensen, Al-Rabayah, Alsaggabi, El Rabbat, Alowayesh, Chamova, Ismail, Abaza and Kaló.)

Objectives: The aim of this study was to review the impact of new reimbursement requirements for medicines in the Slovak Republic based on legislation that came into force in January 2018. Methods: The new legislation was reviewed. The reimbursement dossiers for medicines and health technology assessments and appraisals, justifications for reimbursement decisions, final reimbursement decisions, and all aspects of the appeal mechanisms have been transparently published on the website of the Slovak Ministry of Health and were used for this analysis. Results: Based on the new legislation, there was no need to submit information about relative effectiveness and cost-effectiveness of medicines with less than 1:50,000 eligible patients prior to reimbursement decisions, and the cost-effectiveness threshold has been increased for all other medicines. The estimated impact of the 2-year budget for the 59 medicines submitted for reimbursement without relative effectiveness and cost-effectiveness analysis was €181,273,698, based on the published submission dossiers. The estimated impact of the 2-year budget for the 45 medicines with evidence of relative effectiveness and cost-effectiveness was €178,566,634. In contrast to the easier market access criteria for new original medicines, the new legislation enforces stricter price erosion criteria for generic and biosimilar medicines. Consequently, the number of generic and biosimilar entries was reduced from 242 in 2017 to 224 in 2018. Conclusions: Although some of the new reimbursement applications were not approved by the Ministry of Health, many new medicines were added to the Slovak pharmaceutical reimbursement list based on "balanced assessment" requirements; hence, the system became financially unsustainable. It was necessary to change the legislation from January 2019.

The systematic use of evidence to inform healthcare decisions, particularly health technology assessment (HTA), has gained increased recognition. HTA has become a standard policy tool for informing decision makers who must manage the entry and use of pharmaceuticals, medical devices, and other technologies (including complex interventions) within health systems, for example, through reimbursement and pricing. Despite increasing attention to HTA activities, there has been no attempt to comprehensively synthesize good practices or emerging good practices to support population-based decision-making in recent years. After the identification of some good practices through the release of the ISPOR Guidelines Index in 2013, the ISPOR HTA Council identified a need to more thoroughly review existing guidance. The purpose of this effort was to create a basis for capacity building, education, and improved consistency in approaches to HTA-informed decision-making. Our findings suggest that although many good practices have been developed in areas of assessment and some other key aspects of defining HTA processes, there are also many areas where good practices are lacking. This includes good practices in defining the organizational aspects of HTA, the use of deliberative processes, and measuring the impact of HTA. The extent to which these good practices are used and applied by HTA bodies is beyond the scope of this report, but may be of interest to future researchers., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

In February and September of 2017, the International Society for Pharmacoeconomics and Outcomes Research Health Technology Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes., Methods: This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017., Results: Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders., Conclusions: Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.

Objectives: The HTA Core Model® was developed to improve the transferability of health technology assessment (HTA) between settings. The model has been used by HTA agencies but is also of interest to manufacturers, for improving internal evidence generation and communicating with other HTA stakeholders. To establish if the model is fit for purpose from an industry perspective, the pharmaceutical company Roche, collaborating with the European Network for HTA (EUnetHTA), conducted an assessment of the model., Methods: A questionnaire was developed to evaluate all assessment elements in the HTA Core Model v2.0 for their usefulness in meeting payers' evidence needs and demonstrating value. The questionnaire was completed by country affiliate teams working in evidence generation and reimbursement submissions for pharmaceuticals. Survey results were discussed in workshops to ensure consistency and alignment between teams., Results: The questionnaire was completed by six teams. An additional team from global pricing and market access participated in workshops. Model domains pertaining to the health problem and current technology use, technology description, clinical effectiveness, and economic value were considered most important because they meet payers' evidence needs. Overall, the model was considered useful to improve the efficiency of HTA evidence generation, share evidence internally, and communicate value to payers and HTA agencies., Conclusions: From an industry perspective, the HTA Core Model provides a useful framework and common terminology for efficient generation of transferable HTA evidence. The timeliness, efficiency, and transparency of HTA processes could be improved by a more standardized approach to HTA across settings.

Background and Objectives: The HTA Core Model ® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions., Methods: It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work., Results: The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020., Conclusion: The HTA Core Model is now available for everyone around the world as a framework for assessing value., (Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The opportunity cost of inappropriate health policy decisions is greater in Central and Eastern European (CEE) compared with Western European (WE) countries because of poorer population health and more limited healthcare resources. Application of health technology assessment (HTA) prior to healthcare financing decisions can improve the allocative efficiency of scarce resources. However, few CEE countries have a clear roadmap for HTA implementation. Examples from high-income countries may not be directly relevant, as CEE countries cannot allocate so much financial and human resources for substantiating policy decisions with evidence. Our objective was to describe the main HTA implementation scenarios in CEE countries and summarize the most important questions related to capacity building, financing HTA research, process and organizational structure for HTA, standardization of HTA methodology, use of local data, scope of mandatory HTA, decision criteria, and international collaboration in HTA. Although HTA implementation strategies from the region can be relevant examples for other CEE countries with similar cultural environment and economic status, HTA roadmaps are not still fully transferable without taking into account country-specific aspects, such as country size, gross domestic product per capita, major social values, public health priorities, and fragmentation of healthcare financing., (© 2016 The Authors. Health Economics published by John Wiley & Sons Ltd.)

Objective: The objective of this study is to identify the possible barriers and critical success factors for the implementation of European collaboration in the field of relative effectiveness assessment (REA) of drugs., Methods: Data were gathered through semi-structured interviews with representatives from eight European health technology assessment (HTA) organisations involved in assessment of drugs for coverage decision-making (AAZ, AIFA, AHTAPol, HAS, HVB, IQWIG, NICE and ZiN)., Results: Potential barriers identified mainly relate to methodology, resources and challenges with implementation in the respective national processes (e.g. legal restrictions). The most critical success factors for production of cross-border assessments were the continuous cooperation of competent partners, and the quality and timely availability of the assessment., Conclusion: Further adaptation of the process and methods is required for optimal collaboration. In the near future it can be expected that cross-border assessments will meet in particular the needs of smaller/middle-sized European countries and also European countries with less developed HTA systems as the potential efficiency/quality gains are the highest for these countries. Therefore, national implementation of cross-border assessments is especially likely in these countries in the coming years. Once more experience is gained with cross-border assessments, and successes become more evident, efficiency/quality gains may also be likely for some larger countries with well established processes., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulators and payers become the gatekeepers. Regulators, starting in the late 1980s/early 1990s, and, more recently, payers have implemented a variety of early-access pathways or initiatives, and this practice is continuing even today. This article describes the specific approaches that have been taken in four economically developed regions, reviews their success rates, and suggests possible new directions.

In response to a recommendation from the Pharmaceutical Forum, the European Medicines Agency and the European network for Health Technology Assessment initiated a collaboration with the aim to improve the contribution regulatory assessment reports can make to the assessment of relative effectiveness of medicinal products by health technology assessment bodies. This collaboration on improving European Public Assessment Reports (EPARs) started in February 2010 and was performed over 2 years. As a result, the templates for preparing EPARs were revised to better address the needs of heath technology organizations. The better understanding of information needs was a key outcome of the collaboration. To ascertain whether these template changes led to the inclusion of relevant information, a review of a small set of EPARs for recently approved medicinal products was carried out in parallel by both the European network for Health Technology Assessment and the European Medicines Agency. This report provides an account of this project on improving EPARs, which is part of the ongoing dialogue between regulators and health technology assessment bodies on a European level to support policymaker decisions in the future., (Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objective: To provide an overview of health services research related to health technology assessment (HTA) and to identify research priorities from a European perspective., Methods: Several methods were used: systematic review of articles indexed with the MeSH term 'technology assessment' in PubMed from February 1999-2009; online survey among experts; and conference workshop discussions., Results: Research activity in HTA varies considerably across Europe. The research was categorised into six areas: (1) the breadth of analysis in HTA (such as economic, organizational and social aspects); (2) HTA products developed to meet the needs of policy-makers (such as horizon scanning, mini-HTA, and core HTA); (3) handling life-cycle perspectives in relation to technologies; (4) topics that challenge existing methods and for which HTA should be developed to address the themes more comprehensively (such as public health interventions and organizational interventions); (5) development of HTA capacity and programmes; and (6) links between policy and HTA. An online survey showed that the three areas that were given priority were the relationship between HTA and policy-making (71%), the impact of HTA (62%) and incorporating patient aspects in HTA (50%). Policy-makers highlighted HTA and innovation processes as their main research priority (42%). Areas that the systematic review identified as future priorities include issues within the six existing research areas such as disinvestment, developing evidence for new technologies, assessing the wider effects of technology use, and determining how HTA affects decision-making. In addition, relative effectiveness and individualized treatments are areas of growing interest., Conclusions: The research priorities identified are important for obtaining high quality and cost-effective health care in Europe. Managing the introduction, use and phasing out of technologies challenges health services throughout Europe, and these processes need to be improved to successfully manage future more general challenges. An ageing population and a diminishing workforce both require strong efforts to ensure effective and well-organized use of human resources and technologies. Furthermore, Europe needs to focus on innovation. This is closely linked to use of technologies and calls for future research.

The European Union has named genomics as one of the promising research fields for the development of new health technologies. Major concerns with regard to these fields are, on the one hand, the rather slow and limited translation of new knowledge and, on the other hand, missing insights into the impact on public health and health care practice of those technologies that are actually introduced. This paper aims to give an overview of the major assessment instruments in public health [health technology assessment (HTA), health needs assessment (HNA) and health impact assessment (HIA)] which could contribute to the systematic translation and assessment of genomic health applications by focussing at population level and on public health policy making. It is shown to what extent HTA, HNA and HIA contribute to translational research by using the continuum of translational research (T1-T4) in genomic medicine as an analytic framework. The selected assessment methodologies predominantly cover 2 to 4 phases within the T1-T4 system. HTA delivers the most complete set of methodologies when assessing health applications. HNA can be used to prioritize areas where genomic health applications are needed or to identify infrastructural needs. HIA delivers information on the impact of technologies in a wider scope and promotes informed decision making. HTA, HNA and HIA provide a partly overlapping and partly unique set of methodologies and infrastructure for the translation and assessment of genomic health applications. They are broad in scope and go beyond the continuum of T1-T4 translational research regarding policy translation., (Copyright © 2010 S. Karger AG, Basel.)

Health systems are placing more and more emphasis on the design and delivery of services that are focused on the patient, and there is a growing interest in patient involvement in health policy research and health technology assessment (HTA). Furthermore, there is a growing research interest in eliciting patients' views, not only on 'what works' for patients but also on the need for intervention and on factors influencing the implementation of particular health technologies, their appropriateness and acceptability. This article focuses on qualitative research synthesis in eliciting patients' perspectives. Its aim is to bring research closer to policy development and decision making, to facilitate better use of research findings for health and welfare, to generate a body of evidence, and to ensure that effective and appropriate information is used in health policy decision design. A variety of synthesizing approaches in qualitative research are explored, such as meta-synthesis, meta-summary, meta-ethnography, and meta-study, focusing especially on methodology. Meta-synthesis and meta-ethnography are probably the most frequently cited approaches in qualitative research synthesis and have perhaps the most developed methodology. The implications of these various synthesizing approaches in relation to health policy and HTA are discussed, and we suggest that meta-synthesis and meta-summary are particularly useful approaches. They have an explicit focus on 'evidence synthesis', fairly clear methodologies, and they are designed to not only present interpretations of the findings but also integrate research findings. Qualitative research synthesis enables researchers to synthesize findings from multiple qualitative studies on patients' perspectives instead of establishing new, expensive, and perhaps redundant studies that might intrude on the lives of patients. Qualitative research synthesis is highly recommended by decision makers and in health policy research and HTA. In cases where patient assessment is important to overall success, it can provide those responsible for policy and decision making with a broad and varied range of knowledge about patients' perspectives before they make decisions on the application of health technologies.

Objectives: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs)., Methods: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook., Results: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available., Conclusions: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

Objectives: The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations., Methods: Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders., Results: EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration., Conclusions: The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

Objectives: This article explains how the issue of stakeholder involvement was addressed in the European network for Health Technology Assessment (EUnetHTA) Project and describes the structures of future stakeholder involvement in the EUnetHTA Collaboration., Methods: Initiatives led to a dialogue with stakeholders and exchanging views and expectations on health technology assessment (HTA) processes and the future development of EUnetHTA. The methods of involving different stakeholder groups in EUnetHTA included general information to stakeholders about EUnetHTA, targeted information on a Web site, analysis of stakeholder opinions on HTA and EUnetHTA, and development of a draft stakeholder policy., Results: First steps were taken to organize processes to consolidate the legitimacy of EUnetHTA and its products and encourage the representation of interests, thus contributing to promoting the utilization of HTA in national/regional policy making. A stakeholder Web site, analyses of stakeholder opinions on HTA and EUnetHTA in a discussion topic catalog, and a draft stakeholder policy resulted from the work., Conclusions: Stakeholder involvement in EUnetHTA is necessary to ensure the legitimacy and prospects for utilization of EUnetHTA and its products. The described activities and results create the foundation for a continued dialogue with, and involvement of, stakeholders. The EUnetHTA stakeholder meeting can be considered as a successful experience of dialogue between EUnetHTA and stakeholders, which should be continued. Our experience shows the challenge of obtaining balanced stakeholder representation across the identified stakeholder groups. Continued attention should be given to achieving balanced stakeholder representation.

Objectives: This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations., Methods: The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation., Results: Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA., Conclusions: The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

Objectives: The mainly tax-paid healthcare system in Denmark is decentralized with three defined policy and management levels. Health technology assessment (HTA) as a concept was introduced in the beginning of the 1980s. Significant implementation only happened when the first national strategy for HTA was developed by relevant stakeholders and issued as an official document in 1996. The introduction and the further development are described., Methods: The Danish Institute for HTA was established in the National Board of Health in 1997 with responsibility for coordination and production of HTA. A local government reform from 2007 provides several new challenges to HTA and its coordination., Results: An external evaluation in 2003 indicated that HTA was widely disseminated and that HTA results were benefitting political, administrative, and clinical decision making at all levels of the healthcare system., Conclusions: The first national strategy for HTA, the broad HTA model covering four elements: Technology (clinical aspects), Patient, Organization, and Economy, and the development and introduction of mini-HTA as a tool for HTA-related activities in institutions and municipalities are major contributions to international HTA.

This study summarizes the experience with health technology assessment (HTA) at the European level. Geographically, Europe includes approximately fifty countries with a total of approximately 730 million people. Politically, twenty-seven of these countries (500 million people) have come together in the European Union. The executive branch of the European Union is named the European Commission, which supports several activities, including research, all over Europe and in many other parts of the world. The European Commission has promoted HTA by several policy positions and has funded a series of projects aimed at strengthening HTA in Europe. Around fifteen of the European countries now have formal national programs on HTA and some also have regional public programs. All countries that are members of the European Union and do not have a national approach to HTA have an interest in becoming more involved. The HTA projects sponsored by the European Commission have focused on networking and collaboration among established agencies and institutions for HTA, however, also on capacity building, support, and facilitation in creating mechanisms for HTA in European countries that still do not have any program in the field.

Objectives: The purpose of this project was to evaluate local decision support tools used in the Danish hospital sector from a theoretical and an empirical point of view., Methods: The use of local decision support was evaluated through questionnaires sent to all county health directors, all hospital managers, and all heads of clinical departments in cardiology, orthopedic surgery, and intensive care. In addition, respondents were asked to submit whatever decision support tools they were using (including mini-HTAs, other forms or checklists, and special procedures for decision making concerning new health technologies). A theoretical analysis of the decision support tools (decision theory) was performed as well as a comparison with the business case method used in private companies. Finally, the Danish mini-HTA was compared with foreign production and use of HTA and HTA-like assessments as local decision support., Results: The response rate was high (87 percent, 94 percent, 85 percent, respectively). We collected sixty different forms (of which forty-nine were mini-HTAs) and twenty variants of written procedures. We found theoretical and empirical evidence that local involvement in the process of making the HTA could be important for the use of the results from the HTA and for the process of implementing the new technology., Conclusions: Doing mini-HTA in hospitals seems to balance the need for quality and depth with the limited time and resources for assessment.

EUnetHTA is a recently initiated EU network aiming at connecting national HTA agencies, research institutions, and health ministries to enable an effective exchange of information and to lend support to health policy decisions by the Member States. The article briefly discusses the policy background, the specific objectives, and the project structure of the network.

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.

Health technology assessment (HTA) was introduced in Denmark 20 years ago. However, it only came into fashion a few years ago. This happened when politicians and health service decision-makers realized that due to the increasing pressure on resources prioritization was an inescapable fact. HTA was supposed to support this effort by providing a broad spectrum of information designed for decision-making. Events speeded up from that point on: a national HTA strategy, a national HTA institution, satellite institutions, and many HTA projects were set up - at national, regional, and local levels. The diversity and decentralization of decision-making combined with a broad and interdisciplinary approach to methodology guided the development of Danish HTA. Experiences with HTA were gained from successful applications and disappointing encounters with uncontrollable political processes. Politicians seem in general to be content with the development. An evaluation of the impact of HTA has not yet been undertaken, and a good deal of work lies ahead. The implementation of HTA results will be one of the greatest challenges of the years ahead.