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Finn Borlum Kristensen - One of the best experts on this subject based on the ideXlab platform.
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improving the contribution of regulatory Assessment reports to health Technology Assessments a collaboration between the european medicines agency and the european network for health Technology Assessment
Value in Health, 2014Co-Authors: Michael Berntgen, Hansgeorg Eichler, Anne Gourvil, Mira Pavlovic, W Goettsch, Finn Borlum KristensenAbstract: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.
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european network for health Technology Assessment eunethta planning development and implementation of a sustainable european network for health Technology Assessment
International Journal of Technology Assessment in Health Care, 2009Co-Authors: Finn Borlum Kristensen, Marjukka Makela, Susanna Allgurin Neikter, Nina Rehnqvist, Lise Lund Haheim, Berit Morland, Ruairidh Milne, Camilla Palmhoj Nielsen, Reinhard Busse, Sun Hae LeerobinAbstract: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.
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a history of health Technology Assessment at the european level
International Journal of Technology Assessment in Health Care, 2009Co-Authors: David Banta, Finn Borlum Kristensen, Egon JonssonAbstract: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.
Keith R Abrams - One of the best experts on this subject based on the ideXlab platform.
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use of indirect and mixed treatment comparisons for Technology Assessment
PharmacoEconomics, 2008Co-Authors: Alex J Sutton, A E Ades, Nicola J Cooper, Keith R AbramsAbstract:Indirect and mixed treatment comparison (MTC) approaches to synthesis are logical extensions of more established meta-analysis methods. They have great potential for estimating the comparative effectiveness of multiple treatments using an evidence base of trials that individually do not compare all treatment options. Connected networks of evidence can be synthesized simultaneously to provide estimates of the comparative effectiveness of all included treatments and a ranking of their effectiveness with associated probability statements. The potential of the use of indirect and MTC methods in Technology Assessment is considerable, and would allow for a more consistent Assessment than simpler alternative approaches. Although such models can be viewed as a logical and coherent extension of standard pair-wise meta-analysis, their increased complexity raises some unique issues with far-reaching implications concerning how we use data in Technology Assessment, while simultaneously raising searching questions about standard pair-wise meta-analysis. This article reviews pair-wise meta-analysis and indirect and MTC approaches to synthesis, clearly outlining the assumptions involved in each approach. It also raises the issues that the National Institute for Health and Clinical Excellence (NICE) needed to consider in updating their 2004 Guide to the Methods of Technology Appraisal, if such methods are to be used in their Technology appraisals.
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bayesian methods in health Technology Assessment a review
Health Technology Assessment, 2000Co-Authors: David Spiegelhalter, Jonathan P Myles, David R Jones, Keith R AbramsAbstract:Background Bayesian methods may be defined as the explicit quantitative use of external evidence in the design, monitoring, analysis, interpretation and reporting of a health Technology Assessment. In outline, the methods involve formal combination through the use of Bayes's theorem of: 1. a prior distribution or belief about the value of a quantity of interest (for example, a treatment effect) based on evidence not derived from the study under analysis, with 2. a summary of the information concerning the same quantity available from the data collected in the study (known as the likelihood), to yield 3. an updated or posterior distribution of the quantity of interest. These methods thus directly address the question of how new evidence should change what we currently believe. They extend naturally into making predictions, synthesising evidence from multiple sources, and designing studies: in addition, if we are willing to quantify the value of different consequences as a 'loss function', Bayesian methods extend into a full decision-theoretic approach to study design, monitoring and eventual policy decision-making. Nonetheless, Bayesian methods are a controversial topic in that they may involve the explicit use of subjective judgements in what is conventionally supposed to be a rigorous scientific exercise. Objectives This report is intended to provide: 1. a brief review of the essential ideas of Bayesian analysis 2. a full structured review of applications of Bayesian methods to randomised controlled trials, observational studies, and the synthesis of evidence, in a form which should be reasonably straightforward to update 3. a critical commentary on similarities and differences between Bayesian and conventional approaches 4. criteria for assessing the reporting of a Bayesian analysis 5. a comprehensive list of published 'three-star' examples, in which a proper prior distribution has been used for the quantity of primary interest 6. tutorial case studies of a variety of types 7. recommendations on how Bayesian methods and approaches may be assimilated into health Technology Assessments in a variety of contexts and by a variety of participants in the research process. Methods The BIDS ISI database was searched using the terms 'Bayes' or 'Bayesian'. This yielded almost 4000 papers published in the period 1990-98. All resultant abstracts were reviewed for relevance to health Technology Assessment; about 250 were so identified, and used as the basis for forward and backward searches. In addition EMBASE and MEDLINE databases were searched, along with websites of prominent authors, and available personal collections of references, finally yielding nearly 500 relevant references. A comprehensive review of all references describing use of 'proper' Bayesian methods in health Technology Assessment (those which update an informative prior distribution through the use of Bayes's theorem) has been attempted, and around 30 such papers are reported in structured form. There has been very limited use of proper Bayesian methods in practice, and relevant studies appear to be relatively easily identified. Results Bayesian methods in the health Technology Assessment context 1. Different contexts may demand different statistical approaches. Prior opinions are most valuable when the Assessment forms part of a series of similar studies. A decision-theoretic approach may be appropriate where the consequences of a study are reasonably predictable. 2. The prior distribution is important and not unique, and so a range of options should be examined in a sensitivity analysis. Bayesian methods are best seen as a transformation from initial to final opinion, rather than providing a single 'correct' inference. 3. The use of a prior is based on judgement, and hence a degree of subjectivity cannot be avoided. However, subjective priors tend to show predictable biases, and archetypal priors may be useful for identifying a reasonable range of prior opinion.
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methods in health service research an introduction to bayesian methods in health Technology Assessment
BMJ, 1999Co-Authors: David Spiegelhalter, Jonathan P Myles, David R Jones, Keith R AbramsAbstract:This is the third of four articles Bayes's theorem arose from a posthumous publication in 1763 by Thomas Bayes, a non-conformist minister from Tunbridge Wells. Although it gives a simple and uncontroversial result in probability theory, specific uses of the theorem have been the subject of considerable controversy for more than two centuries. In recent years a more balanced and pragmatic perspective has emerged, and in this paper we review current thinking on the value of the Bayesian approach to health Technology Assessment. A concise definition of bayesian methods in health Technology Assessment has not been established, but we suggest the following: the explicit quantitative use of external evidence in the design, monitoring, analysis, interpretation, and reporting of a health Technology Assessment. This approach acknowledges that judgments about the benefits of a new Technology will rarely be based solely on the results of a single study but should synthesise evidence from multiple sources—for example, pilot studies, trials of similar interventions, and even subjective judgments about the generalisability of the study's results. A bayesian perspective leads to an approach to clinical trials that is claimed to be more flexible and ethical than traditional methods,1 and to elegant ways of handling multiple substudies—for example, when simultaneously estimating the effects of a treatment on many subgroups.2 Proponents have also argued that a bayesian approach allows conclusions to be provided in a form that is most suitable for decisions specific to patients and decisions affecting public policy.3 #### Summary points Bayesian methods interpret data from a study in the light of external evidence and judgment, and the form in which conclusions are drawn contributes naturally to decision making Prior plausibility of hypotheses is taken into account, just as when interpreting the results of a diagnostic test Scepticism about large treatment effects can be formally …
David Banta - One of the best experts on this subject based on the ideXlab platform.
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office of Technology Assessment health program
International Journal of Technology Assessment in Health Care, 2009Co-Authors: David Banta, Clyde J BehneyAbstract:The U.S. Congressional Office of Technology Assessment (OTA) established a health program in 1975. During the next few years, OTA's health program published a series of reports dealing with different aspects of health Technology Assessment (HTA) in some depth. The key report in this series concerned the efficacy and safety of health Technology, which in many ways played a ground-breaking role. It pointed out the pervasive lack of accessible information on efficacy and safety, despite more-than-adequate methods of Assessment. It also pointed to many problems that resulted from this lack, and the limited use of such information in clinical practice and policy making. It promoted synthesis of existing literature as a practical method of Assessment. Other key reports developed other aspects of HTA, including cost-effectiveness. These reports are generally considered to have shaped the field of HTA at least into the 1990s. OTA also pioneered the use of HTA in determining what preventive services to cover in public healthcare programs.
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a history of health Technology Assessment at the european level
International Journal of Technology Assessment in Health Care, 2009Co-Authors: David Banta, Finn Borlum Kristensen, Egon JonssonAbstract: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.
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the development of health Technology Assessment
Health Policy, 2003Co-Authors: David BantaAbstract:The field of health Technology Assessment (HTA) is still relatively new, but it has shown remarkable growth over the last decade, having spread first from the United States to Europe, and now to the entire world. HTA seeks to couple evidence with decision-making, and thus has similarities to evidence-based health care and evidence-based policy-making. The early history of HTA, beginning around 1975, reveals a first period of synthesising available evidence-principally that dealing with efficacy and cost-effectiveness of health care interventions-so as to put it in a format helpful to health policy-makers, especially those in national governments. From 1985 or so, the focus of the second period was on seeking more effective links with these policy-makers, particularly in Europe. The most recent period, beginning in the late 1990s, has been increasingly devoted to more effective dissemination and implementation in order to influence administrators and clinicians. While early Assessments tended to focus on large, expensive, machine-based technologies, the scope has gradually widened to include smaller technologies, 'softer' technologies (such as counselling), and health care needs. Actual Assessments have also taken on broader issues, such as organisational, social, and ethical implications. In the Member States of the European Union (EU), HTA activities are increasingly visible, and almost all now have a national focus for HTA associated with the Ministry of Health or its equivalent. Central and Eastern European countries are also developing HTA activities. Most recently, HTA has been highlighted by health policy documents from the European Commission. It seems likely that HTA will in the future be institutionalised in some form as part of EU activities.
Mariepierre Gagnon - One of the best experts on this subject based on the ideXlab platform.
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effects and repercussions of local hospital based health Technology Assessment hta a systematic review
Systematic Reviews, 2014Co-Authors: Mariepierre Gagnon, Marie Desmartis, Thomas G Poder, William WittemanAbstract:Background Health Technology Assessment (HTA) is increasingly performed at the local or hospital level where the costs, impacts, and benefits of health technologies can be directly assessed. Although local/hospital-based HTA has been implemented for more than two decades in some jurisdictions, little is known about its effects and impact on hospital budget, clinical practices, and patient outcomes. We conducted a mixed-methods systematic review that aimed to synthesize current evidence regarding the effects and impact of local/hospital-based HTA.
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hospital based health Technology Assessment developments to date
PharmacoEconomics, 2014Co-Authors: Mariepierre GagnonAbstract:Health Technology Assessment (HTA) uses a multidisciplinary approach to answer relevant questions regarding the safety, efficacy, effectiveness and cost-effectiveness of health technologies. There is growing interest in implementing HTA methods at the hospital level because it could facilitate decision-making regarding acquisition, implementation or discontinuation of technologies or interventions within the hospital. First, this article provides an overview of current international experiences and knowledge of hospital-based HTA. Then, it presents the different types of hospital-based HTA, providing examples of each of these models, as well as their strengths and limitations. Finally, it proposes a set of emerging issues that could help inform decision-makers who consider implementing hospital-based HTA, or other stakeholders interested in the field.
Martin Buxton - One of the best experts on this subject based on the ideXlab platform.
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assessing the impact of england s national health service r d health Technology Assessment program using the payback approach
International Journal of Technology Assessment in Health Care, 2009Co-Authors: James Raftery, Steve Hanney, Colin Green, Martin BuxtonAbstract:Objectives: this study assesses the impact of the English National Health Service (NHS) Health Technology Assessment (HTA) program using the “payback” framework. Methods: a survey of lead investigators of all research projects funded by the HTA program 1993–2003 supplemented by more detailed case studies of sixteen projects. Results: of 204 eligible projects, replies were received from 133 or 65 percent. The mean number of peer-reviewed publications per project was 2.9. Seventy-three percent of projects claimed to have had had an impact on policy and 42 percent on behavior. Technology Assessment Reports for the National Institute for Health and Clinical Excellence (NICE) had fewer than average publications but greater impact on policy. Half of all projects went on to secure further funding. The case studies confirmed the survey findings and indicated factors associated with impact. Conclusions: the HTA program performed relatively well in terms of “payback.” Facilitating factors included the program's emphasis on topics that matter to the NHS, rigorous methods and the existence of “policy customers” such as NICE.
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An Assessment of the impact of the NHS Health Technology Assessment Programme.
Health Technology Assessment, 2007Co-Authors: Steve Hanney, Martin Buxton, Colin Green, D Coulson, James RafteryAbstract:OBJECTIVES: To consider how the impact of the NHS Health Technology Assessment (HTA) Programme should be measured. To determine what models are available and their strengths and weaknesses. To assess the impact of the first 10 years of the NHS HTA programme from its inception in 1993 to June 2003 and to identify the factors associated with HTA research that are making an impact. DATA SOURCES: Main electronic databases from 1990 to June 2005. The documentation of the National Coordinating Centre for Health Technology Assessment (NCCHTA). Questionnaires to eligible researchers. Interviews with lead investigators. Case study documentation. REVIEW METHODS: A literature review of research programmes was carried out, the work of the NCCHTA was reviewed, lead researchers were surveyed and 16 detailed case studies were undertaken. Each case study was written up using the payback framework. A cross-case analysis informed the analysis of factors associated with achieving payback. Each case study was scored for impact before and after the interview to assess the gain in information due to the interview. The draft write-up of each study was checked with each respondent for accuracy and changed if necessary. RESULTS: The literature review identified a highly diverse literature but confirmed that the 'payback' framework pioneered by Buxton and Hanney was the most widely used and most appropriate model available. The review also confirmed that impact on knowledge generation was more easily quantified than that on policy, behaviour or especially health gain. The review of the included studies indicated a higher level of impact on policy than is often assumed to occur. The survey showed that data pertinent to payback exist and can be collected. The completed questionnaires showed that the HTA Programme had considerable impact in terms of publications, dissemination, policy and behaviour. It also showed, as expected, that different parts of the Programme had different impacts. The Technology Assessment Reports (TARs) for the National Institute for Health and Clinical Excellence (NICE) had the clearest impact on policy in the form of NICE guidance. Mean publications per project were 2.93 (1.98 excluding the monographs), above the level reported for other programmes. The case studies revealed the large diversity in the levels and forms of impacts and the ways in which they arise. All the NICE TARs and more than half of the other case studies had some impact on policy making at the national level whether through NICE, the National Screening Committee, the National Service Frameworks, professional bodies or the Department of Health. This underlines the importance of having a customer or 'receptor' body. A few case studies had very considerable impact in terms of knowledge production and in informing national and international policies. In some of these the principal investigator had prior expertise and/or a research record in the topic. The case studies confirmed the questionnaire responses but also showed how some projects led to further research. CONCLUSIONS: This study concluded that the HTA Programme has had considerable impact in terms of knowledge generation and perceived impact on policy and to some extent on practice. This high impact may have resulted partly from the HTA Programme's objectives, in that topics tend to be of relevance to the NHS and have policy customers. The required use of scientific methods, notably systematic reviews and trials, coupled with strict peer reviewing, may have helped projects publish in high-quality peer-reviewed journals. Further research should cover more detailed, comprehensive case studies, as well as enhancement of the 'payback framework'. A project that collated health research impact studies in an ongoing manner and analysed them in a consistent fashion would also be valuable.
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the iterative use of economic evaluation as part of the process of health Technology Assessment
Journal of Health Services Research & Policy, 1997Co-Authors: Mark Sculpher, Michael Drummond, Martin BuxtonAbstract:The Economic evaluation of health care technologies has a key role within the new National Health Service health Technology Assessment process. There has, however, been little discussion of the bes...
