What can economics add to health technology assessment? Please not just another cost-effectiveness analysis!

PubMed

Bridges, John Fp

2006-02-01

Evidence based medicine is not only important for clinical practice, but national governments have embraced it through health technology assessment (HTA). HTA combines data from randomized controlled trials (RCT) and observational studies with an economic component (among other issues). HTA, however, is not taking full advantage of economics. This paper presents five areas in which economics may improve not only HTA, but the RCT methods that underpin it. HTA needs to live up to its original agenda of being a interdisciplinary field and draw methods not just from biostatistics, but from a range of discipline, including economics. By focusing only on cost effectiveness analysis (CEA), however, we go nowhere close to fulfilling this potential.

"It all depends": conceptualizing public involvement in the context of health technology assessment agencies.

PubMed

Gauvin, Francois-Pierre; Abelson, Julia; Giacomini, Mita; Eyles, John; Lavis, John N

2010-05-01

There have been calls in recent years for greater public involvement in health technology assessment (HTA). Yet the concept of public involvement is poorly articulated and little attention has been paid to the context of HTA agencies. This article investigates how public involvement is conceptualized in the HTA agency environment. Using qualitative concept analysis methods, we reviewed the HTA literature and the websites of HTA agencies and conducted semi-structured interviews with informants in Canada, Denmark, and the United Kingdom. Our analysis reveals that HTA agencies' role as bridges or boundary organizations situated at the frontier of research and policymaking causes the agencies to struggle with the idea of public involvement. The HTA community is concerned with conceptualizing public involvement in such a way as to meet scientific and methodological standards without neglecting its responsibilities to healthcare policymakers. We offer a conceptual tool for analyzing the nature of public involvement across agencies, characterizing different domains, levels of involvement, and types of publics. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

HTA and its legal issues: a framework for identifying legal issues in health technology assessment.

PubMed

Widrig, Daniel; Tag, Brigitte

2014-12-01

Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research. After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples. This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions. The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

The concept of health technology assessment. Views of applicants to funding of HTA projects.

PubMed

Lange, M; Jørgensen, T; Kristensen, F B; Stilvén, S

2000-01-01

The purpose of this study is to analyze the perception of the content of health technology assessment (HTA) among health professionals applying for a state grant of DKK 10 million. A total of 113 applications were received and analyzed. When conducting the analysis, it was assumed that the applicants' maximum five-page project description would reflect: a) the applicants' perception of what an HTA is; b) how the assessment was to be conducted; and c) what the results were going to be used for. More than 40% of all applications focused on treatment; in 51% only one or two professional groups were to be involved (thus interdisciplinarity was questionable); only 22% of the HTA cases were intended to form the basis for political/administrative decisions; in general, the HTAs were planned far less comprehensively than was relevant; 76% of the projects did not include a formal synthesis phase; 41% intended to use diffusion as the only method for publication of the HTA result. The analysis reveals several areas where DIHTA has to make an effort in order to secure that HTA in fact constitutes a comprehensive and well-documented basis for decision making. These areas concern the following topics: multidisciplinarity, the objective of HTA, comprehensiveness, the synthesis phase, and publication and utilization of the HTA result.

Best-worst scaling to assess the most important barriers and facilitators for the use of health technology assessment in Austria.

PubMed

Feig, Chiara; Cheung, Kei Long; Hiligsmann, Mickaël; Evers, Silvia M A A; Simon, Judit; Mayer, Susanne

2018-04-01

Although Health Technology Assessment (HTA) is increasingly used to support evidence-based decision-making in health care, several barriers and facilitators for the use of HTA have been identified. This best-worst scaling (BWS) study aims to assess the relative importance of selected barriers and facilitators of the uptake of HTA studies in Austria. A BWS object case survey was conducted among 37 experts in Austria to assess the relative importance of HTA barriers and facilitators. Hierarchical Bayes estimation was applied, with the best-worst count analysis as sensitivity analysis. Subgroup analyses were also performed on professional role and HTA experience. The most important barriers were 'lack of transparency in the decision-making process', 'fragmentation', 'absence of appropriate incentives', 'no explicit framework for decision-making process', and 'insufficient legal support'. The most important facilitators were 'transparency in the decision-making process', 'availability of relevant HTA research for policy makers', 'availability of explicit framework for decision-making process', 'sufficient legal support', and 'appropriate incentives'. This study suggests that HTA barriers and facilitators related to the context of decision makers, especially 'policy characteristics' and 'organization and resources' are the most important in Austria. A transparent and participatory decision-making process could improve the adoption of HTA evidence.

Why not integrate ethics in HTA: identification and assessment of the reasons.

PubMed

Hofmann, Bjørn

2014-01-01

From the conception of HTA in the 1970s it has been argued that addressing ethical issues is an element of HTA, and many methods for integrating ethics in HTA have become available. However, despite almost 40 years with repeated intentions, only few HTA reports include ethical analysis. Why is this so? How come, ethics is a constituent part of HTA, there are many methods available, but ethics is rarely part of practical HTA work? This is the key question of this article and several reasons why ethics is not a part of HTA are identified. A) Ethicists are professional strangers in HTA. B) A common agreed methodology for integrating ethics is lacking. Ethics methodology appears to be C) deficient, D) insufficient, or E) unsuitable. F) Integrating ethics in HTA is neither efficient nor needed for successful HTA. G) Most moral issues are general, and are not specific to a given technology. H) All relevant ethical issues can be handled within other frameworks, e.g., within economics. I) Ethics can undermine or burst the foundation of HTA. Hence, there are many reasons why ethics is not an integrated part of HTA so many years after identifying ethics as constitutive to HTA. These reasons may all explain why it is so, but on closer scrutiny, they do not work as compelling arguments for not addressing ethical issues in HTA. Hence, the identified reasons may work well as explanations, but not as justifications. In order to move on from a situation of failure we can: Exclude ethics from definitions of HTA, and as a consequence, establish a separate kind of evaluation (Health Technology Evaluation - HTE). Take the existing definition seriously and actually integrate ethics in the performance of HTA practice. Amend, expand or change HTA so that ethics is more genuinely incorporated. Which of these options to choose is open for discussion, but we need to move away from a situation where we have a definition of HTA which does not correspond with HTA practice.

Why not integrate ethics in HTA: identification and assessment of the reasons

PubMed Central

Hofmann, Bjørn

2014-01-01

From the conception of HTA in the 1970s it has been argued that addressing ethical issues is an element of HTA, and many methods for integrating ethics in HTA have become available. However, despite almost 40 years with repeated intentions, only few HTA reports include ethical analysis. Why is this so? How come, ethics is a constituent part of HTA, there are many methods available, but ethics is rarely part of practical HTA work? This is the key question of this article and several reasons why ethics is not a part of HTA are identified. A) Ethicists are professional strangers in HTA. B) A common agreed methodology for integrating ethics is lacking. Ethics methodology appears to be C) deficient, D) insufficient, or E) unsuitable. F) Integrating ethics in HTA is neither efficient nor needed for successful HTA. G) Most moral issues are general, and are not specific to a given technology. H) All relevant ethical issues can be handled within other frameworks, e.g., within economics. I) Ethics can undermine or burst the foundation of HTA. Hence, there are many reasons why ethics is not an integrated part of HTA so many years after identifying ethics as constitutive to HTA. These reasons may all explain why it is so, but on closer scrutiny, they do not work as compelling arguments for not addressing ethical issues in HTA. Hence, the identified reasons may work well as explanations, but not as justifications. In order to move on from a situation of failure we can: Exclude ethics from definitions of HTA, and as a consequence, establish a separate kind of evaluation (Health Technology Evaluation – HTE). Take the existing definition seriously and actually integrate ethics in the performance of HTA practice. Amend, expand or change HTA so that ethics is more genuinely incorporated. Which of these options to choose is open for discussion, but we need to move away from a situation where we have a definition of HTA which does not correspond with HTA practice. PMID:25493101

Who's afraid of institutionalizing health technology assessment (HTA)?: Interests and policy positions on HTA in the Czech Republic.

PubMed

Löblová, Olga

2018-04-01

This article identifies the interests and policy positions of key health policy stakeholders regarding the creation of a health technology assessment (HTA) agency in the Czech Republic, and what considerations influenced them. Vested interests have been suggested as a factor mitigating the diffusion of HTA bodies internationally. The Czech Republic recently considered and discarded establishing an HTA agency, making it a good case for studying actors' policy positions throughout the policy debates. Findings are based on in-depth, semi-structured expert and elite interviews with 34 key Czech health policy actors, supported by document analysis and extensive triangulation. Findings show that the HTA epistemic community of 'aspiring agents' was the only actor strongly in favor of an HTA body. Payers and the medical device and diagnostics industry were against it; patients and clinicians had no clear preferences. Original decision-makers were in favor but a new minister of health opted for a simpler policy alternative to solve his need for expertise. Existing institutions, policy alternatives and the institutional design of a future HTA body influence domestic actors' preferences for or against an HTA agency. Domestic and international proponents of HTA should give serious thought to their concerns when advocating for HTA bodies.

A regulatory governance perspective on health technology assessment (HTA) in France: the contextual mediation of common functional pressures.

PubMed

Barron, Anthony J G; Klinger, Corinna; Shah, Sara Mehmood Birchall; Wright, John S F

2015-02-01

The new regulatory governance perspective has introduced several insights to the study of health technology assessment (HTA): it has broadened the scope for the analysis of HTA; it has provided a more sophisticated account of national diversity and the potential for cross-border policy learning; and, it has dissolved the distinction between HTA assessment and appraisal processes. In this paper, we undertake a qualitative study of the French process for HTA with a view to introducing a fourth insight: that the emergence and continuing function of national agencies for HTA follows a broadly evolutionary pattern in which contextual factors play an important mediating role. We demonstrate that the French process for HTA is characterised by distinctive institutions, processes and evidential requirements. Consistent with the mediating role of this divergent policy context, we argue that even initiatives for the harmonisation of national approaches to HTA are likely to meet with divergent national policy responses. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

International survey on attitudes toward ethics in health technology assessment: An exploratory study.

PubMed

Arellano, Luis E; Willett, Jeffrey M; Borry, Pascal

2011-01-01

The objective of this exploratory study was to survey international health technology assessment (HTA) professionals to determine attitudes toward ethics in HTA. An exploratory, quantitative, cross-sectional study design was developed. The sample population (n = 636) was selected from authors of the 206 articles published in the International Journal of Technology Assessment in Health Care between 2005 and 2007. A survey instrument was piloted and e-mailed. The response rate was low (n = 104; 16.4 percent). Respondents were primarily middle-aged (46 ± 11 years) male (62 percent) health professionals from Western countries (n = 92; 88.5 percent), with a mean of 10 (± 6 years) years of HTA experience. Although at least 90 percent of respondents agreed that healthcare decisions involved value judgments and that ethical analysis was important to HTA, respondents were divided as to whether normative (n = 45; 44.6 percent) or descriptive (n = 38; 37.6 percent) ethical recommendations were necessary. Most respondents (n = 83; 81.4 percent) believed that HTA should include citizen participation, but two thirds (n = 67; 67.0 percent) agreed that the final decision should be restricted to decision makers. A majority of respondents thought that ethical analysis could be discussed anywhere within the HTA process, either by an expert trained in ethics (n = 62; 60.8 percent) or by an external consultant (n = 80; 78.4 percent). This study showed that ethical discourse in HTA is constrained by practical considerations, which serves to limit moral inquiry. To increase ethical analysis, a positive attitude toward ethics needs to be fostered within the HTA community.

Impact assessment of Iran's health technology assessment programme.

PubMed

Yazdizadeh, Bahareh; Mohtasham, Farideh; Velayati, Ashraf

2018-02-22

Following approximately 10 years from the beginning of Iran's national Health Technology Assessment (HTA) programme, the present study aims to evaluate its success by examining the impact of HTA and identifying the determinant factors leading to the implementation of HTA report results. The triangulation method was employed herein. HTA reports were initially identified and their impact and determinant factors were then examined from the perspectives of both researchers (by preparing a questionnaire according to the Payback model and sending it to HTA principle investigators) and stakeholders (semi-structured interviews held with each HTA stakeholder). Simultaneously, the quality of the HTA reports was examined with relevant critical appraisal checklists. The impact of 19 equipment technologies and four pharmaceutical technologies were assessed in this study. Twenty researchers replied (response rate, 86.96%) to the questionnaire on the impact of HTA reports from the researcher's perspective. To assess the impact of HTA reports from the stakeholder's perspective, seven policy-makers were chosen and interviewed as the main target audience. The most common step taken to disseminate the results of the HTA projects was publication. Conducting the HTA had taught researchers and their colleagues' new skills and had facilitated the securing of research grants from other organisations. Most reports had used the systematic review method but the relevant details had been scarcely presented regarding outcomes, costs and analysis. The greatest impact of HTA reports on decision-making had been on policy-makers providing and allocating finances. Barriers in stewardship, identification and prioritisation of topics, performance and dissemination of HTA results were the main barriers of implementing HTAs. In most aspects, the status of HTA impact reports need improvement. Thus far, the barriers and facilitators of the HTA programme in Iran have been investigated in other studies. These findings should be pooled to reach a solution that can be actively applied to the health system to improve the status quo of HTA in Iran.

Impact of Working Memory Load on Cognitive Control in Trait Anxiety: An ERP Study

PubMed Central

Qi, Senqing; Zeng, Qinghong; Luo, Yangmei; Duan, Haijun; Ding, Cody; Hu, Weiping; Li, Hong

2014-01-01

Whether trait anxiety is associated with a general impairment of cognitive control is a matter of debate. This study investigated whether and how experimentally manipulated working memory (WM) load modulates the relation between trait anxiety and cognitive control. This question was investigated using a dual-task design in combination with event-related potentials. Participants were required to remember either one (low WM load) or six letters (high WM load) while performing a flanker task. Our results showed that a high WM load disrupted participants' ability to overcome distractor interference and this effect was exacerbated for the high trait-anxious (HTA) group. This exacerbation was reflected by larger interference effects (i.e., incongruent minus congruent) on reaction times (RTs) and N2 amplitudes for the HTA group than for the low trait-anxious group under high WM load. The two groups, however, did not differ in their ability to inhibit task-irrelevant distractors under low WM load, as indicated by both RTs and N2 amplitudes. These findings underscore the significance of WM-related cognitive demand in contributing to the presence (or absence) of a general cognitive control deficit in trait anxiety. Furthermore, our findings show that when limited WM resources are depleted by high WM load, HTA individuals exhibit less efficient recruitments of cognitive control required for the inhibition of distractors, therefore resulting in a greater degree of response conflict. PMID:25369121

Impact of working memory load on cognitive control in trait anxiety: an ERP study.

PubMed

Qi, Senqing; Zeng, Qinghong; Luo, Yangmei; Duan, Haijun; Ding, Cody; Hu, Weiping; Li, Hong

2014-01-01

Whether trait anxiety is associated with a general impairment of cognitive control is a matter of debate. This study investigated whether and how experimentally manipulated working memory (WM) load modulates the relation between trait anxiety and cognitive control. This question was investigated using a dual-task design in combination with event-related potentials. Participants were required to remember either one (low WM load) or six letters (high WM load) while performing a flanker task. Our results showed that a high WM load disrupted participants' ability to overcome distractor interference and this effect was exacerbated for the high trait-anxious (HTA) group. This exacerbation was reflected by larger interference effects (i.e., incongruent minus congruent) on reaction times (RTs) and N2 amplitudes for the HTA group than for the low trait-anxious group under high WM load. The two groups, however, did not differ in their ability to inhibit task-irrelevant distractors under low WM load, as indicated by both RTs and N2 amplitudes. These findings underscore the significance of WM-related cognitive demand in contributing to the presence (or absence) of a general cognitive control deficit in trait anxiety. Furthermore, our findings show that when limited WM resources are depleted by high WM load, HTA individuals exhibit less efficient recruitments of cognitive control required for the inhibition of distractors, therefore resulting in a greater degree of response conflict.

Are Key Principles for improved health technology assessment supported and used by health technology assessment organizations?

PubMed

Neumann, Peter J; Drummond, Michael F; Jönsson, Bengt; Luce, Bryan R; Schwartz, J Sanford; Siebert, Uwe; Sullivan, Sean D

2010-01-01

Previously, our group-the International Working Group for HTA Advancement-proposed a set of fifteen Key Principles that could be applied to health technology assessment (HTA) programs in different jurisdictions and across a range of organizations and perspectives. In this commentary, we investigate the extent to which these principles are supported and used by fourteen selected HTA organizations worldwide. We find that some principles are broadly supported: examples include being explicit about HTA goals and scope; considering a wide range of evidence and outcomes; and being unbiased and transparent. Other principles receive less widespread support: examples are addressing issues of generalizability and transferability; being transparent on the link between HTA findings and decision-making processes; considering a full societal perspective; and monitoring the implementation of HTA findings. The analysis also suggests a lack of consensus in the field about some principles--for example, considering a societal perspective. Our study highlights differences in the uptake of key principles for HTA and indicates considerable room for improvement for HTA organizations to adopt principles identified to reflect good HTA practices. Most HTA organizations espouse certain general concepts of good practice--for example, assessments should be unbiased and transparent. However, principles that require more intensive follow-up--for example, monitoring the implementation of HTA findings--have received little support and execution.

EMERGENCE OF "DRIVERS" FOR THE IMPLEMENTATION OF HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Castro Jaramillo, Hector Eduardo; Moreno-Mattar, Ornella; Osorio-Cuevas, Diana

2016-01-01

Health technology assessment (HTA) examines the consequences of the application of health technologies and is aimed at better informing decision-makers. Over the past 30 years, different countries have implemented HTA organizations. Colombia established by law its own HTA agency (IETS) in 2011 which started operations in November 2012. The aim of this study was to assess the feasibility of conducting and using HTA to inform decision-making in this context. Through a qualitative approach, ten "drivers" emerged with the ability to help or hinder HTA development in this context: availability and quality of data, implementation strategy, cultural aspects, local capacity, financial support, policy/political support, globalization, stakeholder pressure, health system context, and usefulness perception. Semi-structured interviews were conducted with key HTA researchers, after following rigorous transcription, and thematic content analysis, those aspects that may be barriers or facilitator for HTA development and use in Colombia were identified. Although HTA has become a tool to inform decision-making around the world, its use may vary according to setting. Determining those aspects which may enable or interfere with HTA development and use in Colombia may be useful for other countries when considering the establishment of HTA systems. The conceptual transferability of concepts like "drivers" with caveats may be of interest for similar settings trying to incorporate HTA processes and institutions into systematic decision-making.

High Altitude Long Endurance Air Vehicle Analysis of Alternatives and Technology Requirements Development

NASA Technical Reports Server (NTRS)

Nickol, Craig L.; Guynn, Mark D.; Kohout, Lisa L.; Ozoroski, Thomas A.

2007-01-01

The objective of this study was to develop a variety of High Altitude Long Endurance (HALE) Unmanned Aerial Vehicle (UAV) conceptual designs for two operationally useful missions (hurricane science and communications relay) and compare their performance and cost characteristics. Sixteen potential HALE UAV configurations were initially developed, including heavier-than-air (HTA) and lighter-than-air (LTA) concepts with both consumable fuel and solar regenerative (SR) propulsion systems. Through an Analysis of Alternatives (AoA) down select process, the two leading consumable fuel configurations (one each from the HTA and LTA alternatives) and an HTA SR configuration were selected for further analysis. Cost effectiveness analysis of the consumable fuel configurations revealed that simply maximizing vehicle endurance can lead to a sub-optimum system solution. An LTA concept with a hybrid propulsion system (solar arrays and a hydrogen-air proton exchange membrane fuel cell) was found to have the best mission performance; however, an HTA diesel-fueled wing-body-tail configuration emerged as the preferred consumable fuel concept because of the large size and technical risk of the LTA concept. The baseline missions could not be performed by even the best HTA SR concept. Mission and SR technology trade studies were conducted to enhance understanding of the potential capabilities of such a vehicle. With near-term technology SR-powered HTA vehicles are limited to operation in favorable solar conditions, such as the long days and short nights of summer at higher latitudes. Energy storage system specific energy and solar cell efficiency were found to be the key technology areas for enhancing HTA SR performance.

Revealed preferences towards the appraisal of orphan drugs in Poland - multi criteria decision analysis.

PubMed

Kolasa, Katarzyna; Zwolinski, Krzysztof Miroslaw; Zah, Vladimir; Kaló, Zoltán; Lewandowski, Tadeusz

2018-04-27

A Multi Criteria Decision Analysis (MCDA) technique was adopted to reveal the preferences of the Appraisal Body of the Polish HTA agency towards orphan drugs (OMPs). There were 34 positive and 23 negative HTA recommendations out of 54 distinctive drug-indication pairs. The MCDA matrix consisted of 13 criteria, seven of which made the most impact on the HTA process. Appraisal of clinical evidence, cost of therapy, and safety considerations were the main contributors to the HTA guidance, whilst advancement of technology and manufacturing costs made the least impact. MCDA can be regarded as a valuable tool for revealing decision makers' preferences in the healthcare sector. Given that only roughly half of all criteria included in the MCDA matrix were deemed to make an impact on the HTA process, there is certainly some room for improvement with respect to the adaptation of a new approach towards the value assessment of OMPs in Poland.

[The role of the scientific librarian in HTA:what is the status quo and what are the prospects].

PubMed

Balduini, Anna; Guizzetti, Giovanni; Molinari, Silvia; Truccolo, Ivana; Motta, Saba; Bernardini, Fabio; Curti, Moreno

2013-10-01

The first Italian experiences of HTA are born inside single hospitals and, lately, regional health care systems. In Italy, anyway, no agency had health technology assessment as an institutional duty until 2007, the year of the founding of the Italian Society of Health Technology Assessment (SIHTA). In times of "spending review", the HTA, whose purpose is to make decisions about health technologies rational and consistent with a context of scarce resources, is increasingly emerging as a priority need of the National Health System. The objective of this paper is to analyze if and how the librarian is involved in the process of health technology assessment, analyzing the results of a survey performed at a selection of Italian research organizations. The analysis of the results shows that the Italian situation is still very varied, from the point of view of HTA, and health technologies are often introduced without any preliminary analysis. The librarian is almost never represented within the HTA evaluation group and his/her knowledge of HTA should be improved.

The impact of the National Institute for Health Research Health Technology Assessment programme, 2003-13: a multimethod evaluation.

PubMed

Guthrie, Susan; Bienkowska-Gibbs, Teresa; Manville, Catriona; Pollitt, Alexandra; Kirtley, Anne; Wooding, Steven

2015-08-01

The National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme supports research tailored to the needs of NHS decision-makers, patients and clinicians. This study reviewed the impact of the programme, from 2003 to 2013, on health, clinical practice, health policy, the economy and academia. It also considered how HTA could maintain and increase its impact. Interviews (n = 20): senior stakeholders from academia, policy-making organisations and the HTA programme. Bibliometric analysis: citation analysis of publications arising from HTA programme-funded research. Researchfish survey: electronic survey of all HTA grant holders. Payback case studies (n = 12): in-depth case studies of HTA programme-funded research. We make the following observations about the impact, and routes to impact, of the HTA programme: it has had an impact on patients, primarily through changes in guidelines, but also directly (e.g. changing clinical practice); it has had an impact on UK health policy, through providing high-quality scientific evidence - its close relationships with the National Institute for Health and Care Excellence (NICE) and the National Screening Committee (NSC) contributed to the observed impact on health policy, although in some instances other organisations may better facilitate impact; HTA research is used outside the UK by other HTA organisations and systematic reviewers - the programme has an impact on HTA practice internationally as a leader in HTA research methods and the funding of HTA research; the work of the programme is of high academic quality - the Health Technology Assessment journal ensures that the vast majority of HTA programme-funded research is published in full, while the HTA programme still encourages publication in other peer-reviewed journals; academics agree that the programme has played an important role in building and retaining HTA research capacity in the UK; the HTA programme has played a role in increasing the focus on effectiveness and cost-effectiveness in medicine - it has also contributed to increasingly positive attitudes towards HTA research both within the research community and the NHS; and the HTA focuses resources on research that is of value to patients and the UK NHS, which would not otherwise be funded (e.g. where there is no commercial incentive to undertake research). The programme should consider the following to maintain and increase its impact: providing targeted support for dissemination, focusing resources when important results are unlikely to be implemented by other stakeholders, particularly when findings challenge vested interests; maintaining close relationships with NICE and the NSC, but also considering other potential users of HTA research; maintaining flexibility and good relationships with researchers, giving particular consideration to the Technology Assessment Report (TAR) programme and the potential for learning between TAR centres; maintaining the academic quality of the work and the focus on NHS need; considering funding research on the short-term costs of the implementation of new health technologies; improving the monitoring and evaluation of whether or not patient and public involvement influences research; improve the transparency of the priority-setting process; and continuing to monitor the impact and value of the programme to inform its future scientific and administrative development.

Revealing and acknowledging value judgments in health technology assessment.

PubMed

Hofmann, Bjørn; Cleemput, Irina; Bond, Kenneth; Krones, Tanja; Droste, Sigrid; Sacchini, Dario; Oortwijn, Wija

2014-12-01

Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments

PubMed Central

Scott, Anna Mae; Hofmann, Björn; Gutiérrez-Ibarluzea, Iñaki; Bakke Lysdahl, Kristin; Sandman, Lars; Bombard, Yvonne

2017-01-01

Introduction: Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically underdeveloped in comparison to other areas of HTA, such as clinical or cost effectiveness. Objective: To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use. Methods: To develop a list of items for the Q-SEA instrument, we systematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations’ websites, and solicited views from 32 experts in the field of ethics for HTA at two 2-day workshops. We subsequently refined Q-SEA through its application to an ethics analysis conducted for HTA. Results: Q-SEA instrument consists of two domains – the process domain and the output domain. The process domain consists of 5 elements: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values. Conclusion: Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue. PMID:28326147

Application of HTA research on policy decision-making.

PubMed

Youngkong, Sitaporn

2014-05-01

This article provides an overview of the potential uses of health technology assessment (HTA) in health technology or health intervention-related policy decision-making. It summarises the role of HTA in policy planning, health system investment, price negotiation, development of clinical practice guidelines, and communication with health professionals. While the multifaceted nature of HTA means that some aspects of the data can result in conflicting conclusions, the comprehensive approach of HTA is still recommended. To help minimise the potential conflicts within HTA data, a multicriteria decision analysis (MCDA) approach is recommended as a way to assess a number of decision criteria simultaneously. A combination of HTA with MCDA allows policy decision-making to be undertaken in an empirically rigorous and rational way. This combination can be used to support policy decision-makers in Thailand and help them prioritise topics for assessment and make informed health benefit package coverage decisions. This approach enhances the legitimacy of policy decisions by increasing the transparency, systematic nature, and inclusiveness of the process.

Towards a more transparent HTA process in Poland: new Polish HTA methodological guidelines

PubMed Central

Lach, Krzysztof; Dziwisz, Michal; Rémuzat, Cécile; Toumi, Mondher

2017-01-01

ABSTRACT Introduction: Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016. Methods: We identified key changes introduced by the update and, before guideline publication, analysed discrepancies between AOTMiT assessments and the submitting marketing authorisation holders (MAHs) to elucidate the context of the update. We compared the clarity and detail of the new guidelines versus those of the UK’s National Institute for Health and Care Excellence (NICE). Results: The update specified more precise requirements for items such as indirect comparison or input data for economic modelling. Agency–MAH discrepancies relating to the subjects of the HTA update were found in 14.6% of published documents. The new Polish HTA guidelines were as clear and detailed as NICE’s on topics such as assessing quality of evidence and economic modelling, but were less informative when describing (for example) pairwise meta-analysis. Conclusions: The Polish HTA guidelines update demonstrates lessons learned from internal and external experiences. The new guidelines adhere more closely to UK HTA standards, being clearer and more informative. While the update is expected to reduce Agency–MAH discrepancies, there remain areas for development, such as providing templates to aid HTA submissions. PMID:28804603

Variation in Health Technology Assessment and Reimbursement Processes in Europe.

PubMed

Akehurst, Ronald L; Abadie, Eric; Renaudin, Noël; Sarkozy, François

2017-01-01

It has been suggested that differences in health technology assessment (HTA) processes among countries, particularly within Europe, have led to inequity in patient access to new medicines. To provide an up-to-date snapshot analysis of the present status of HTA and reimbursement systems in select European countries, and to investigate the implications of these processes, especially with regard to delays in market and patient access. HTA and reimbursement processes were assessed through a review of published and gray literature, and through a series of interviews with HTA experts. To quantify the impact of differences among countries, we conducted case studies of 12 products introduced since 2009, including 10 cancer drugs. In addition to the differences in HTA and reimbursement processes among countries, the influence of particular sources of information differs among HTA bodies. The variation in the time from the authorization by the European Medicines Agency to the publication of HTA decisions was considerable, both within and among countries, with a general lack of transparency as to why some assessments take longer than others. In most countries, market access for oncology products can occur outside the HTA process, with sales often preceding HTA decisions. It is challenging even for those with considerable personal experience in European HTA processes to establish what is really happening in market access for new drugs. We recommend that efforts should be directed toward improving transparency in HTA, which should, in turn, lead to more effective processes. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Trait anger in relation to neural and behavioral correlates of response inhibition and error-processing.

PubMed

Lievaart, Marien; van der Veen, Frederik M; Huijding, Jorg; Naeije, Lilian; Hovens, Johannes E; Franken, Ingmar H A

2016-01-01

Effortful control is considered to be an important factor in explaining individual differences in trait anger. In the current study, we sought to investigate the relation between anger-primed effortful control (i.e., inhibitory control and error-processing) and trait anger using an affective Go/NoGo task. Individuals low (LTA; n=45) and high (HTA; n=49) on trait anger were selected for this study. Behavioral performance (accuracy) and Event-Related Potentials (ERPs; i.e., N2, P3, ERN, Pe) were compared between both groups. Contrary to our predictions, we found no group differences regarding inhibitory control. That is, HTA and LTA individuals made comparable numbers of commission errors on NoGo trials and no significant differences were found on the N2 and P3 amplitudes. With respect to error-processing, we found reduced Pe amplitudes following errors in HTA individuals as compared to LTA individuals, whereas the ERN amplitudes were comparable for both groups. These results indicate that high trait anger individuals show deficits in later stages of error-processing, which may explain the continuation of impulsive behaviors in HTA individuals despite their negative consequences. Copyright © 2015 Elsevier B.V. All rights reserved.

Trait Anxiety Has Effect on Decision Making under Ambiguity but Not Decision Making under Risk

PubMed Central

Zhang, Long; Wang, Kai; Zhu, Chunyan; Yu, Fengqiong; Chen, Xingui

2015-01-01

Previous studies have reported that trait anxiety (TA) affects decision making. However, results remain largely inconsistent across studies. The aim of the current study was to further address the interaction between TA and decision making. 304 subjects without depression from a sample consisting of 642 participants were grouped into high TA (HTA), medium TA (MTA) and low TA (LTA) groups based on their TA scores from State Trait Anxiety Inventory. All subjects were assessed with the Iowa Gambling Task (IGT) that measures decision making under ambiguity and the Game of Dice Task (GDT) that measures decision making under risk. While the HTA and LTA groups performed worse on the IGT compared to the MTA group, performances on the GDT between the three groups did not differ. Furthermore, the LTA and HTA groups showed different individual deck level preferences in the IGT: the former showed a preference for deck B indicating that these subjects focused more on the magnitude of rewards, and the latter showed a preference for deck A indicating significant decision making impairment. Our findings suggest that trait anxiety has effect on decision making under ambiguity but not decision making under risk and different levels of trait anxiety related differently to individual deck level preferences in the IGT. PMID:26000629

Health technology assessment: research trends and future priorities in Europe.

PubMed

Nielsen, Camilla Palmhøj; Funch, Tina Maria; Kristensen, Finn Børlum

2011-07-01

To provide an overview of health services research related to health technology assessment (HTA) and to identify research priorities from a European perspective. 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. 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. 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.

Potential impact of the implementation of multiple-criteria decision analysis (MCDA) on the Polish pricing and reimbursement process of orphan drugs.

PubMed

Kolasa, Katarzyna; Zwolinski, Krzysztof M; Kalo, Zoltan; Hermanowski, Tomasz

2016-03-10

The objective of this study was to assess the potential impact of the implementation of multiple-criteria decision analysis (MCDA) on the Polish pricing and reimbursement (P&R) process with regard to orphan drugs. A four step approach was designed. Firstly, a systematic literature review was conducted to select the MCDA criteria. Secondly, a database of orphan drugs was established. Thirdly, health technology appraisals (HTA recommendations) were categorized and an MCDA appraisal was conducted. Finally, a comparison of HTA and MCDA outcomes was carried out. An MCDA outcome was considered positive if more than 50% of the maximum number of points was reached (base case). In the sensitivity analysis, 25% and 75% thresholds were tested as well. Out of 2242 publications, 23 full-text articles were included. The final MCDA tool consisted of ten criteria. In total, 27 distinctive drug-indication pairs regarding 21 drugs were used for the study. Six negative and 21 positive HTA recommendations were issued. In the base case, there were 19 positive MCDA outcomes. Of the 27 cases, there were 12 disagreements between the HTA and MCDA outcomes, the majority of which related to positive HTA guidance for negative MCDA outcomes. All drug-indication pairs with negative HTA recommendations were appraised positively in the MCDA framework. Economic details were available for 12 cases, of which there were 9 positive MCDA outcomes. Amongst the 12 drug-indication pairs, two were negatively appraised in the HTA process, with positive MCDA guidance, and two were appraised in the opposite direction. An MCDA approach may lead to different P&R outcomes compared to a standard HTA process. On the one hand, enrichment of the list of decision making criteria means further scrutiny of a given health technology and as such increases the odds of a negative P&R outcome. On the other hand, it may uncover additional values and as such increase the odds of positive P&R outcomes.

Internal evaluation of the European network for health technology assessment project.

PubMed

Håheim, Lise Lund; Imaz, Iñaki; Loud, Marlène Läubli; Gasparetto, Teresa; González-Enriquez, Jesús; Dahlgren, Helena; Trofimovs, Igor; Berti, Elena; Mørland, Berit

2009-12-01

The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe. The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources. First, three yearly cross-sectional studies surveyed the participants' opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents. The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support. Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.

A short history of health technology assessment in Germany.

PubMed

Perleth, Matthias; Gibis, Bernhard; Göhlen, Britta

2009-07-01

To provide an overview of the development of health technology assessment (HTA) in Germany since the 1990s. Analysis of key documents (e.g. literature, laws, and other official documentation) and personal experiences. Health technology assessment (HTA) entered the political agenda in Germany only in the mid-1990s, basically as the result of a top-down approach toward more efficiency in health care, but with a strong impetus of an evidence-based medicine movement. Accordingly, HTA became part of several healthcare reform laws since 1997, which led to the establishment of the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) in 2004. This tandem construction aims at using evidence in decision-making processes for coverage and other decisions. These developments have led to a considerable impact of HTA in Germany. In addition, a broad spectrum of activities at universities and in other organizations, such as the German Institute for Medical Documentation and Information (DIMDI), can be observed that contribute to both teaching and research in HTA. German researchers in the field of HTA are actively involved in international projects, such as EUNetHTA, and contribute to scientific conferences and journals.

TOWARD INTEGRATION IN THE CONTEXT OF HEALTH TECHNOLOGY ASSESSMENT: THE NEED FOR EVALUATIVE FRAMEWORKS.

PubMed

van der Wilt, Gert Jan; Gerhardus, Ansgar; Oortwijn, Wija

2017-01-01

A comprehensive health technology assessment (HTA) enables a patient-centered assessment of the effectiveness, economic, ethical, socio-cultural, and legal issues of health technologies that takes context and implementation into account. A question is whether these various pieces of evidence need to be integrated, and if so, how that might be achieved. The objective of our study is to discuss the meaning of integration in the context of HTA and suggest how it may be achieved in a more structured way. An analysis of the concept of integration in the context of HTA and a review of approaches that were adopted in the INTEGRATE-HTA project that may support integration. Current approaches to integration in HTA are mainly methods of commensuration, which are not optimally geared to support public deliberation. In contrast, articulating evaluative frameworks could be an important means of integration which allows for exploring how facts and values can be brought to bear on each other. Integration is not something that only needs to be addressed at the end, but rather throughout an HTA, right from the start. Integration can be conceived as a matter of accounting for the relevance of empirical evidence in view of a commitment to a set of potentially conflicting values. Various elements of the INTEGRATE-HTA project, such as scoping and the development of logic models, can help to achieve integration in HTA.

Evaluating facts and facting evaluations: On the fact-value relationship in HTA.

PubMed

Hofmann, Bjørn; Bond, Ken; Sandman, Lars

2018-04-03

Health technology assessment (HTA) is an evaluation of health technologies in terms of facts and evidence. However, the relationship between facts and values is still not clear in HTA. This is problematic in an era of "fake facts" and "truth production." Accordingly, the objective of this study is to clarify the relationship between facts and values in HTA. We start with the perspectives of the traditional positivist account of "evaluating facts" and the social-constructivist account of "facting values." Our analysis reveals diverse relationships between facts and a spectrum of values, ranging from basic human values, to the values of health professionals, and values of and in HTA, as well as for decision making. We argue for sensitivity to the relationship between facts and values on all levels of HTA, for being open and transparent about the values guiding the production of facts, and for a primacy for the values close to the principal goals of health care, ie, relieving suffering. We maintain that philosophy (in particular ethics) may have an important role in addressing the relationship between facts and values in HTA. Philosophy may help us to avoid fallacies of inferring values from facts; to disentangle the normative assumptions in the production or presentation of facts and to tease out implicit value judgements in HTA; to analyse evaluative argumentation relating to facts about technologies; to address conceptual issues of normative importance; and to promote reflection on HTA's own value system. In this we argue for a(n Aristotelian) middle way between the traditional positivist account of "evaluating facts" and the social-constructivist account of "facting values," which we call "factuation." We conclude that HTA is unique in bringing together facts and values and that being conscious and explicit about this "factuation" is key to making HTA valuable to both individual decision makers and society as a whole. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Developing the HTA core model for the online environment.

PubMed

Lampe, Kristian; Pasternack, Iris; Saarekas, Oskari; Raustia, Leena; Cleemput, Irina; Corio, Mirella; Endel, Gottfried; Frønsdal, Katrine; Imaz, Iñaki; Kleijnen, Sarah; Kristensen, Finn; Rüther, Alric; Werkö, Sophie; Cerbo, Marina

2014-11-01

A framework for collaborative production and sharing of HTA information, the HTA Core Model, was originally developed within EUnetHTA in 2006-08. In this paper, we describe the further development of the Model to allow implementation and utilization of the Model online. The aim was to capture a generic HTA process that would allow effective use of the HTA Core Model and resulting HTA information while at the same time not interfering with HTA agencies' internal processes. The work was coordinated by a development team in Finland, supported by an international expert group. Two pilot testing rounds were organized among EUnetHTA agencies and two extensive core HTA projects tested the tool in a real setting. The final work was also formally validated by a group of HTA agencies. The HTA Core Model Online--available at http://www.corehta.info--is a web site hosting a) a tool to allow electronic utilization of the HTA Core Model and b) a database of produced HTA information. While access to the HTA information is free to all, the production features are currently available to EUnetHTA member agencies only. A policy was crafted to steer the use of the Model and produced information. We have successfully enabled electronic use of the HTA Core Model and agreed on a policy for its utilization. The system is already being used in subsequent HTA projects within EUnetHTA Joint Action 2. Identified shortcomings and further needs will be addressed in subsequent development.

HTA – Algorithm or Process?

PubMed Central

Culyer, Anthony J.

2016-01-01

Daniels, Porteny and Urrutia et al make a good case for the idea that that public decisions ought to be made not only "in the light of" evidence but also "on the basis of" budget impact, financial protection and equity. Health technology assessment (HTA) should, they say, be accordingly expanded to consider matters additional to safety and cost-effectiveness. They also complain that most HTA reports fail to develop ethical arguments and generally do not even mention ethical issues. This comment argues that some of these defects are more apparent than real and are not inherent in HTA – as distinct from being common characteristics found in poorly conducted HTAs. More generally, HTA does not need "extension" since (1) ethical issues are already embedded in HTA processes, not least in their scoping phases, and (2) HTA processes are already sufficiently flexible to accommodate evidence about a wide range of factors, and will not need fundamental change in order to accommodate the new forms of decision-relevant evidence about distributional impact and financial protection that are now starting to emerge. HTA and related techniques are there to support decision-makers who have authority to make decisions. Analysts like us are there to support and advise them (and not to assume the responsibilities for which they, and not we, are accountable). The required quality in HTA then becomes its effectiveness as a means of addressing the issues of concern to decision-makers. What is also required is adherence by competent analysts to a standard template of good analytical practice. The competencies include not merely those of the usual disciplines (particularly biostatistics, cognitive psychology, health economics, epidemiology, and ethics) but also the imaginative and interpersonal skills for exploring the "real" question behind the decision-maker’s brief (actual or postulated) and eliciting the social values that necessarily pervade the entire analysis. The product of such exploration defines the authoritative scope of an HTA. PMID:27694664

Collaboration in health technology assessment (EUnetHTA joint action, 2010-2012): four case studies.

PubMed

Huić, Mirjana; Nachtnebel, Anna; Zechmeister, Ingrid; Pasternak, Iris; Wild, Claudia

2013-07-01

The aim of this study was to present the first four collaborative health technology assessment (HTA) processes on health technologies of different types and life cycles targeted toward diverse HTA users and facilitators, as well as the barriers of these collaborations. Retrospective analysis, through four case studies, was performed on the first four collaboration experiences of agencies participating in the EUnetHTA Joint Action project (2010-12), comprising different types and life cycles of health technologies for a diverse target audience, and different types of collaboration. The methods used to initiate collaboration, partner contributions, the assessment methodology, report structure, time frame, and factors acting as possible barriers to and facilitators of this collaboration were described. Two ways were used to initiate collaboration in the first four collaborative HTA processes: active brokering of information, so-called "calls for collaboration," and individual contact between agencies after identifying a topic common to two agencies in the Planned and Ongoing Projects database. Several success factors are recognized: predefined project management, high degree of commitment to the project; adherence to timelines; high relevance of technology; a common understanding of the methods applied and advanced experience in HTA; finally, acceptance of English-written reports by decision makers in non-English-speaking countries. Barriers like late identification of collaborative partners, nonacceptance of English language and different methodology of assessment should be overcome. Timely and efficient, different collaborative HTA processes on relative efficacy/effectiveness and safety on different types and life cycles of health technologies, targeted toward diverse HTA users in Europe are possible. There are still barriers to overcome.

Harmonization of ethics in health technology assessment: a revision of the Socratic approach.

PubMed

Hofmann, Bjørn; Droste, Sigrid; Oortwijn, Wija; Cleemput, Irina; Sacchini, Dario

2014-01-01

Ethics has been part of health technology assessment (HTA) from its beginning in the 1970s, and is currently part of HTA definitions. Several methods in ethics have been used in HTA. Some approaches have been developed especially for HTA, such as the Socratic approach, which has been used for a wide range of health technologies. The Socratic approach is used in several ways, and there is a need for harmonization to promote its usability and the transferability of its results. Accordingly, the objective of this study was to stimulate experts in ethics and HTA to revise the Socratic approach. Based on the current literature and experiences in applying methods in ethics, a panel of ethics experts involved in HTA critically analyzed the limitations of the Socratic approach during a face-to-face workshop. On the basis of this analysis a revision of the Socratic approach was agreed on after deliberation in several rounds through e-mail correspondence. Several limitations with the Socratic approach are identified and addressed in the revised version which consists of a procedure of six steps, 7 main questions and thirty-three explanatory and guiding questions. The revised approach has a broader scope and provides more guidance than its predecessor. Methods for information retrieval have been elaborated. The presented revision of the Socratic approach is the result of a joint effort of experts in the field of ethics and HTA. Consensus is reached in the expert panel on an approach that is considered to be more clear, comprehensive, and applicable for addressing ethical issues in HTA.

[Requirements for and expectations of health technology assessment in Galicia (Spain). A qualitative study from the perspective of decision-makers and clinicians].

PubMed

Varela-Lema, Leonor; Merino, Gerardo Atienza; García, Marisa López; Martínez, María Vidal; Triana, Elena Gervas; Mota, Teresa Cerdá

2011-01-01

To explore perceptions of the use of health technology assessment (HTA) in the Galician public health system, identify opinions on the usefulness of the products and services developed by the Galician Health Technology Assessment Agency (avalia-t), and determine the barriers and facilitators to the transfer of results to clinical practice. We performed a qualitative study based on in-depth semi-structured interviews of 20 intentionally selected experts (10 health care professionals and 10 hospital decision makers). The interviews were tape recorded and transcribed for inductive thematic analysis. Interest in HTA activities was high, but most informants considered these activities to be underused as a tool to aid decision making in clinical practice. A series of key factors was identified to guarantee HTA use: greater dissemination of HTA activities and availability of the results, increased involvement and communication among health care professionals in the selection and prioritization of relevant research, contextualization and adaptation of results to the local context, increased organizational support and greater financial resources. The present study allows end-userś opinions on the utility of the various products/services offered by HTA agencies to be contrasted in order to adapt HTA activity to their needs and requirements. The involvement of health care professionals in all HTA fields is perceived as one of the main lines of action for HTA agencies. Such involvement could be achieved by reinforcing personal contact and increasing feedback to collaborators. Copyright © 2010 SESPAS. Published by Elsevier Espana. All rights reserved.

Practical tools and methods for health technology assessment in Europe: structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA.

PubMed

Kristensen, Finn Børlum; Lampe, Kristian; Chase, Deborah L; Lee-Robin, Sun Hae; Wild, Claudia; Moharra, Montse; Garrido, Marcial Velasco; Nielsen, Camilla Palmhøj; Røttingen, John-Arne; Neikter, Susanna Allgurin; Bistrup, Marie Louise

2009-12-01

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. 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. 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. 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.

Methods of international health technology assessment agencies for economic evaluations--a comparative analysis.

PubMed

Mathes, Tim; Jacobs, Esther; Morfeld, Jana-Carina; Pieper, Dawid

2013-09-30

The number of Health Technology Assessment (HTA) agencies increases. One component of HTAs are economic aspects. To incorporate economic aspects commonly economic evaluations are performed. A convergence of recommendations for methods of health economic evaluations between international HTA agencies would facilitate the adaption of results to different settings and avoid unnecessary expense. A first step in this direction is a detailed analysis of existing similarities and differences in recommendations to identify potential for harmonization. The objective is to provide an overview and comparison of the methodological recommendations of international HTA agencies for economic evaluations. The webpages of 127 international HTA agencies were searched for guidelines containing recommendations on methods for the preparation of economic evaluations. Additionally, the HTA agencies were requested information on methods for economic evaluations. Recommendations of the included guidelines were extracted in standardized tables according to 13 methodological aspects. All process steps were performed independently by two reviewers. Finally 25 publications of 14 HTA agencies were included in the analysis. Methods for economic evaluations vary widely. The greatest accordance could be found for the type of analysis and comparator. Cost-utility-analyses or cost-effectiveness-analyses are recommended. The comparator should continuously be usual care. Again the greatest differences were shown in the recommendations on the measurement/sources of effects, discounting and in the analysis of sensitivity. The main difference regarding effects is the focus either on efficacy or effectiveness. Recommended discounting rates range from 1.5%-5% for effects and 3%-5% for costs whereby it is mostly recommended to use the same rate for costs and effects. With respect to the analysis of sensitivity the main difference is that oftentimes the probabilistic or deterministic approach is recommended exclusively. Methods for modeling are only described vaguely and mainly with the rational that the "appropriate model" depends on the decision problem. Considering all other aspects a comparison is challenging as recommendations vary regarding detailedness and addressed issues. There is a considerable unexplainable variance in recommendations. Further effort is needed to harmonize methods for preparing economic evaluations.

Barriers and facilitators influencing ethical evaluation in health technology assessment.

PubMed

Assasi, Nazila; Schwartz, Lisa; Tarride, Jean-Eric; O'Reilly, Daria; Goeree, Ron

2015-01-01

The objective of this study was to explore barriers and facilitators influencing the integration of ethical considerations in health technology assessment (HTA). The study consisted of two complementary approaches: (a) a systematic review of the literature; and (b) an eighteen-item online survey that was distributed to fifty-six HTA agencies affiliated with the International Network of Agencies for Health Technology Assessment. The review identified twenty-six relevant articles. The most often cited barriers in the literature were: scarcity, heterogeneity and complexity of ethical analysis methods; challenges in translating ethical analysis results into knowledge that is useful for decision makers; and lack of organizational support in terms of required expertise, time and financial resources. The most frequently cited facilitators included: usage of value-based appraisal methods, stakeholder and public engagement, enhancement of practice guidelines, ethical expertise, and educational interventions. Representatives of twenty-six (46.5 percent) agencies from nineteen countries completed the survey. A median of 10 percent (interquartile range, 5 percent to 50 percent) of the HTA products produced by the agencies was reported to include an assessment of ethical aspects. The most commonly perceived barriers were: limited ethical knowledge and expertise, insufficient time and resources, and difficulties in finding ethical evidence or using ethical guidelines. Educational interventions, demand by policy makers, and involvement of ethicists in HTA were the most commonly perceived facilitators. Our results emphasize the importance of simplification of ethics methodology and development of good practice guidelines in HTA, as well as capacity building for engaging HTA practitioners in ethical analyses.

The HTA Risk Analysis Chart: Visualising the Need for and Potential Value of Managed Entry Agreements in Health Technology Assessment.

PubMed

Grimm, Sabine Elisabeth; Strong, Mark; Brennan, Alan; Wailoo, Allan J

2017-12-01

Recent changes to the regulatory landscape of pharmaceuticals may sometimes require reimbursement authorities to issue guidance on technologies that have a less mature evidence base. Decision makers need to be aware of risks associated with such health technology assessment (HTA) decisions and the potential to manage this risk through managed entry agreements (MEAs). This work develops methods for quantifying risk associated with specific MEAs and for clearly communicating this to decision makers. We develop the 'HTA risk analysis chart', in which we present the payer strategy and uncertainty burden (P-SUB) as a measure of overall risk. The P-SUB consists of the payer uncertainty burden (PUB), the risk stemming from decision uncertainty as to which is the truly optimal technology from the relevant set of technologies, and the payer strategy burden (PSB), the additional risk of approving a technology that is not expected to be optimal. We demonstrate the approach using three recent technology appraisals from the UK National Institute for Health and Clinical Excellence (NICE), each of which considered a price-based MEA. The HTA risk analysis chart was calculated using results from standard probabilistic sensitivity analyses. In all three HTAs, the new interventions were associated with substantial risk as measured by the P-SUB. For one of these technologies, the P-SUB was reduced to zero with the proposed price reduction, making this intervention cost effective with near complete certainty. For the other two, the risk reduced substantially with a much reduced PSB and a slightly increased PUB. The HTA risk analysis chart shows the risk that the healthcare payer incurs under unresolved decision uncertainty and when considering recommending a technology that is not expected to be optimal given current evidence. This allows the simultaneous consideration of financial and data-collection MEA schemes in an easily understood format. The use of HTA risk analysis charts will help to ensure that MEAs are considered within a standard utility-maximising health economic decision-making framework.

Expanded HTA, Legitimacy and Independence

PubMed Central

Syrett, Keith

2016-01-01

This brief commentary seeks to develop the analysis of Daniels, Porteny and Urrutia of the implications of expansion of the scope of health technology assessment (HTA) beyond issues of safety, efficacy, and cost-effectiveness. Drawing in particular on experience in the United Kingdom, it suggests that such expansion can be understood not only as a response to the problem of insufficiency of evidence, but also to that of legitimacy. However, as expansion of HTA also renders it more visibly political in character, it is plausible that its legitimacy may be undermined, rather than enhanced by, independence from the policy process. PMID:27694685

Guidelines for health technology assessment in Thailand (second edition)--the development process.

PubMed

Chaikledkaew, Usa; Kittrongsiri, Kankamon

2014-05-01

The first Thai-specific HTA guidelines were completed in 2008 with the aim of ensuring that all HTA data was accurate, of high quality, and relevant for making decisions pertaining to healthcare resource allocation. Based on a quality assessment of 89 economic evaluation studies in the Thai context published in international academic journals between 1982 and 2012, the analysis revealed a significant increase in quality of data sources and result reporting in studies published after the dissemination of the first Thai HTA guidelines. As the first Thai HTA guidelines were developed in 2008, a number of areas for improvement have been identified. Therefore, the objective of this chapter is to describe the development process of this second edition of HTA guidelines for Thailand which builds on the success of the first edition, while attempting to address some of the identified limitations of the first edition and reflect the changes that the health care and policy contexts have undergone in the intervening years. It is hoped that this second edition will continue to build on these successes so that policy decision making becomes increasingly evidence-based.

Effects and repercussions of local/hospital-based health technology assessment (HTA): a systematic review.

PubMed

Gagnon, Marie-Pierre; Desmartis, Marie; Poder, Thomas; Witteman, William

2014-10-28

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. We identified articles through PubMed and Embase and by citation tracking of included studies. We selected qualitative, quantitative, or mixed-methods studies with empirical data about the effects or impact of local/hospital-based HTA on decision-making, budget, or perceptions of stakeholders. We extracted the following information from included studies: country, methodological approach, and use of conceptual framework; local/hospital HTA approach and activities described; reported effects and impacts of local/hospital-based HTA; factors facilitating/hampering the use of hospital-based HTA recommendations; and perceptions of stakeholders concerning local/hospital HTA. Due to the great heterogeneity among studies, we conducted a narrative synthesis of their results. A total of 18 studies met the inclusion criteria. We reported the results according to the four approaches for performing HTA proposed by the Hospital Based HTA Interest Sub-Group: ambassador model, mini-HTA, internal committee, and HTA unit. Results showed that each of these approaches for performing HTA corresponds to specific needs and structures and has its strengths and limitations. Overall, studies showed positive impacts related to local/hospital-based HTA on hospital decisions and budgets, as well as positive perceptions from managers and clinicians. Local/hospital-based HTA could influence decision-making on several aspects. It is difficult to evaluate the real impacts of local HTA at the different levels of health care given the relatively small number of evaluations with quantitative data and the lack of clear comparators. Further research is necessary to explore the conditions under which local/hospital-based HTA results and recommendations can impact hospital policies, clinical decisions, and quality of care and optimize the use of scarce resources.

Effects and repercussions of local/hospital-based health technology assessment (HTA): a systematic review

PubMed Central

2014-01-01

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. Methods We identified articles through PubMed and Embase and by citation tracking of included studies. We selected qualitative, quantitative, or mixed-methods studies with empirical data about the effects or impact of local/hospital-based HTA on decision-making, budget, or perceptions of stakeholders. We extracted the following information from included studies: country, methodological approach, and use of conceptual framework; local/hospital HTA approach and activities described; reported effects and impacts of local/hospital-based HTA; factors facilitating/hampering the use of hospital-based HTA recommendations; and perceptions of stakeholders concerning local/hospital HTA. Due to the great heterogeneity among studies, we conducted a narrative synthesis of their results. Results A total of 18 studies met the inclusion criteria. We reported the results according to the four approaches for performing HTA proposed by the Hospital Based HTA Interest Sub-Group: ambassador model, mini-HTA, internal committee, and HTA unit. Results showed that each of these approaches for performing HTA corresponds to specific needs and structures and has its strengths and limitations. Overall, studies showed positive impacts related to local/hospital-based HTA on hospital decisions and budgets, as well as positive perceptions from managers and clinicians. Conclusions Local/hospital-based HTA could influence decision-making on several aspects. It is difficult to evaluate the real impacts of local HTA at the different levels of health care given the relatively small number of evaluations with quantitative data and the lack of clear comparators. Further research is necessary to explore the conditions under which local/hospital-based HTA results and recommendations can impact hospital policies, clinical decisions, and quality of care and optimize the use of scarce resources. PMID:25352182

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

PubMed

Tafuri, Giovanni; Lucas, Inês; Estevão, Steve; Moseley, Jane; d'Andon, Anne; Bruehl, Hannah; Gajraj, Elangovan; Garcia, Sonia; Hedberg, Niklas; Massari, Marco; Molina, Andrea; Obach, Mercè; Osipenko, Leeza; Petavy, Frank; Petschulies, Marco; Pontes, Caridad; Russo, Pierluigi; Schiel, Anja; Van de Casteele, Marc; Zebedin-Brandl, Eva-Maria; Rasi, Guido; Vamvakas, Spiros

2018-05-01

The parallel regulatory-health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought. Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint. In terms of uptake of comparator recommendations at the time of PSA in the actual development, our analysis showed that manufacturers implemented comparators to address both the needs of regulators and of at least one HTA body in 12 of 21 studies. For primary endpoints, in all included studies manufacturers addressed both the needs of the regulators and at least one HTA body. One of the key findings of this analysis is that manufacturers tend to implement changes to the development programme based on both regulatory and HTA advice with regards to the choice of primary endpoint and comparator. It also confirms the challenging choice of the study comparator, for which manufacturers seem to be more inclined to satisfy the regulatory advice. Continuous research efforts in this area are of paramount importance from a public health perspective. © 2018 The British Pharmacological Society.

Differences in evaluating health technology assessment knowledge translation by researchers and policy makers in China.

PubMed

Liu, Wenbin; Shi, Lizheng; Pong, Raymond W; Dong, Hengjin; Mao, Yiwei; Tang, Meng; Chen, Yingyao

2014-12-01

The aim of this study was to examine the gaps between researchers and policy makers in perceptions and influencing factors of knowledge translation (KT) of health technology assessment (HTA) in China. A sample of 382 HTA researchers and 112 policy makers in China were surveyed using structured questionnaires. The questionnaires contained two sections: perceptions of HTA research and assessments of six-stage KT activities. Wilcoxon rank sum test was applied to compare the differences in these two sections between HTA researchers and policy makers. Multivariate linear regression was performed to explore KT determinants of HTA for researchers and policy makers separately. Policy makers and researchers differed in their perceptions of HTA research in all items except collaboration in research development and presentation of evidence in easy-to-understand language. Significant differences in KT activities existed in all the six stages except academic translation. Regarding KT determinants, close contact between research unit and policy-making department, relevance of HTA to policy making, and importance of HTA on policy making were considered facilitators by both groups. For researchers, practicality of HTA report and presentation of evidence in easy-to-understand language can facilitate KT. Policy makers, on the other hand, considered an overly pedantic nature of HTA research as an obstacle to effective KT. Substantial gaps existed between HTA researchers and policy makers regarding the perceptions of HTA research and KT activities. There are also some differences in KT determinants by these two groups. Enhancing collaboration, promoting practicality and policy relevance of HTA research, and making HTA findings easily understood are likely to further the KT of HTA evidence.

DEFINING THE RELEVANT OUTCOME MEASURES IN MEDICAL DEVICE ASSESSMENTS: AN ANALYSIS OF THE DEFINITION PROCESS IN HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Jacobs, Esther; Antoine, Sunya-Lee; Prediger, Barbara; Neugebauer, Edmund; Eikermann, Michaela

2017-01-01

Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials. In 2012-14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers. Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes. This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.

Verification of Decision-Analytic Models for Health Economic Evaluations: An Overview.

PubMed

Dasbach, Erik J; Elbasha, Elamin H

2017-07-01

Decision-analytic models for cost-effectiveness analysis are developed in a variety of software packages where the accuracy of the computer code is seldom verified. Although modeling guidelines recommend using state-of-the-art quality assurance and control methods for software engineering to verify models, the fields of pharmacoeconomics and health technology assessment (HTA) have yet to establish and adopt guidance on how to verify health and economic models. The objective of this paper is to introduce to our field the variety of methods the software engineering field uses to verify that software performs as expected. We identify how many of these methods can be incorporated in the development process of decision-analytic models in order to reduce errors and increase transparency. Given the breadth of methods used in software engineering, we recommend a more in-depth initiative to be undertaken (e.g., by an ISPOR-SMDM Task Force) to define the best practices for model verification in our field and to accelerate adoption. Establishing a general guidance for verifying models will benefit the pharmacoeconomics and HTA communities by increasing accuracy of computer programming, transparency, accessibility, sharing, understandability, and trust of models.

GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS.

PubMed

Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris; Wasserfallen, Jean-Blaise; Cicchetti, Americo; Marchetti, Marco; Kidholm, Kristian; Arentz-Hansen, Helene; Rosenmöller, Magdalene; Wild, Claudia; Kahveci, Rabia; Ulst, Margus

2015-01-01

Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units. A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units. Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project. Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

HEALTH TECHNOLOGY ASSESSMENT: THE SCIENTIFIC CAREER OF A POLICY CONCEPT.

PubMed

Benoit, Cyril; Gorry, Philippe

2017-01-01

The aim of this work was to provide a comprehensive overview of the evolution of the health technology assessment (HTA) concept in the scientific literature through a scientometric approach. A literature search was conducted, by selecting publications, as well as news from the media, containing "health technology assessment" in their title, abstracts, or keywords. We then undertook a bibliometric and network analysis on the corpus of 2,865 publications thus obtained. Since a first publication in 1978, interest in HTA remained marginal until a turning point in the late 1980s, when growth of the number of publications took off alongside the creation of the U.K.'s NICE agency. Since then, publications have spread across several journals. The ranking of the organizations that publish such articles does not reflect any hegemonic position. However, HTA-related scientific production is strongly concentrated in Commonwealth and Nordic countries. Despite its transnational aspects, research on HTA has been framed within a small number of scientific networks and by a few opinion leaders. The "career" of the HTA concept may be seen as a scientific-knowledge based institutionalization of a public policy. To succeed in a country, HTA first needs scientific prerequisites, such as an organized scientific community working on the health sector and health services. Then, it appears that the recognition of this research by decision makers plays a key role in the development of the field.

HTA Implementation Roadmap in Central and Eastern European Countries

PubMed Central

Gheorghe, Adrian; Huic, Mirjana; Csanádi, Marcell; Kristensen, Finn Boerlum

2016-01-01

Abstract 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. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26763688

Development of a toolkit and glossary to aid in the adaptation of health technology assessment (HTA) reports for use in different contexts.

PubMed

Chase, D; Rosten, C; Turner, S; Hicks, N; Milne, R

2009-11-01

To develop a health technology assessment (HTA) adaptation toolkit and glossary of adaptation terms for use by HTA agencies within EU member states to support them in adapting HTA reports written for other contexts. The toolkit and glossary were developed by a partnership of 28 HTA agencies and networks across Europe (EUnetHTA work package 5), led by the UK National Coordinating Centre for Health Technology Assessment (NCCHTA). Methods employed for the two resources were literature searching, a survey of adaptation experience, two rounds of a Delphi survey, meetings of the partnership and drawing on the expertise and experience of the partnership, two rounds of review, and two rounds of quality assurance testing. All partners were requested to provide input into each stage of development. The resulting toolkit is a collection of resources, in the form of checklists of questions on relevance, reliability and transferability of data and information, and links to useful websites, that help the user assess whether data and information in existing HTA reports can be adapted for a different setting. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. The accompanying glossary provides descriptions of meanings for HTA adaptation terms from HTA agencies across Europe. It seeks to highlight differences in the use and understanding of each word by HTA agencies. The toolkit and glossary are available for use by all HTA agencies and can be accessed via www.eunethta.net/. These resources have been developed to help HTA agencies make better use of HTA reports produced elsewhere. They can be used by policy-makers and clinicians to aid in understanding HTA reports written for other contexts. The main implication of this work is that there is the potential for the adaptation of HTA reports and, if utilised, this should release resources to enable the development of further HTA reports. Recommendations for the further development of the toolkit include the potential to develop an interactive web-based version and to extend the toolkit to facilitate the adaptation of HTA reports on diagnostic testing and screening.

Enhancing understanding: the development of a glossary of health technology assessment adaptation terms.

PubMed

Rosten, Claire; Chase, Deborah L; Hicks, Nicholas J; Milne, Ruairidh

2009-12-01

The way people use health technology assessment (HTA) terms varies considerably across Europe. Such variation can lead to misunderstandings when reading HTA reports from different contexts. This work is one of the outputs of the EUnetHTA Project and was undertaken between 2006 and 2008. The aim of this study was to develop a glossary of HTA adaptation terms to help reduce the misunderstandings of terms used in HTA reports from contexts other than the reader's own. Several HTA glossaries were examined to identify ways in which an additional glossary could offer readers something new and to identify adaptation terms for inclusion. Twenty-eight European HTA organizations provided terms for the glossary and drafted descriptions and examples of how each specific term was used in their particular setting. The organizations then commented on the descriptions provided by the other groups and worked together to draft a single description for certain terms. A glossary of HTA adaptation terms was developed. It provides a comprehensive range of descriptions, examples, and comments for forty-two potentially confusing HTA terms related to adaptation. This glossary will be a valuable resource for European HTA agencies when reading HTA reports produced in different contexts and for adapting HTA reports produced in other countries. The glossary will help improve understanding and help facilitate the adaptation process.

Multi-criteria decision analysis for health technology assessment in Canada: insights from an expert panel discussion.

PubMed

Diaby, Vakaramoko; Goeree, Ron; Hoch, Jeffrey; Siebert, Uwe

2015-02-01

Multi-criteria decision analysis (MCDA), a decision-making tool, has received increasing attention in recent years, notably in the healthcare field. For Canada, it is unclear whether and how MCDA should be incorporated into the existing health technology assessment (HTA) decision-making process. To facilitate debate on improving HTA decision-making in Canada, a workshop was held in conjunction with the 8th World Congress on Health Economics of the International Health Economics Association in Toronto, Canada in July 2011. The objective of the workshop was to discuss the potential benefits and challenges related to the use of MCDA for HTA decision-making in Canada. This paper summarizes and discusses the recommendations of an expert panel convened at the workshop to discuss opportunities and concerns with reference to the implementation of MCDA in Canada.

History of health technology assessment: Spain.

PubMed

Sampietro-Colom, Laura; Asua, Jose; Briones, Eduardo; Gol, Jordi

2009-07-01

The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain. A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain. HTA was introduced in the late 1980s. The main factors were the trend to an increase in healthcare expenditure, concerns regarding efficiency in providing health care, as well as in the level of rationality introducing high technology. Spain has direct (i.e., regulation) and indirect (i.e., payment systems, evidence-based programs, HTA) mechanisms to control health technologies. A recent high priority regulation has established the need of HTA to decide the introduction of a new health technology in the lists of public healthcare coverage, although similar regulations existed in the past and were scarcely implemented. HTA initiatives started at the regional government level. Its introduction followed a progressive pattern among regions. In the beginning, resources were scarce and expertise limited, with work done at intramural level. With time, expertise increase, and promotion of commissioned work was implemented. HTA knowledge transfer in the healthcare system has been carried out through courses, publications, and commissioned research. Currently, there are seven HTA units/agencies, which coordinate their work. HTA in Spain is in its maturity. Facing the unavoidable change of health care environment over time, HTA is also evolving and, currently, there is a trend to broaden the areas of influence of HTA by devolving capacity to hospitals and applying principles to very early phases of health technology development, under the umbrella of regional HTA units/agencies. However, there are two main challenges ahead. One is to have a real impact at the highest level of healthcare policy coordination among Spanish regions, which is done at the Central Ministry of Health. The other is to avoid the influence of political waves in the level of recognition of HTA at the policy decision-making level and to have an adequate and stable funding of HTA initiatives.

INFLUENCE OF HEALTH TECHNOLOGY ASSESSMENT AND ITS MEASUREMENT.

PubMed

Hailey, David; Werkö, Sophie; Rosén, Måns; Macpherson, Karen; Myles, Susan; Gallegos Rivero, Verónica; Hipólito-Olivares, Cecilia; Sihvo, Sinikka; Pwu, Jasmine; Yang, Wen-Wen; Chen, Yong-Chen; Perez Galán, Ana; Aleman, Alicia; Villamil, Elena

2016-01-01

The aim of this study was to obtain information on methods used to measure health technology assessment (HTA) influence, decisions that were influenced, and outcomes linked to HTA. Electronic databases were used to locate studies in which HTA influence had been demonstrated. Inclusion criteria were studies that reliably reported consideration by decision makers of HTA findings; comparative studies of technology use before and after HTA; and details of changes in policy, health outcomes, or research that could be credibly linked to an HTA. Fifty-one studies were selected for review. Settings were national (24), regional (12), both national and regional (3) hospitals (9), and multinational (3). The most common approach to appraisal of influence was review of policy or administrative decisions following HTA recommendations (51 percent). Eighteen studies (35 percent) reported interview or survey findings, thirteen (26 percent) reviewed administrative data, and six considered the influence of primary studies. Of 142 decisions informed by HTA, the most common types were on routine clinical practice (67 percent of studies), coverage (63 percent), and program operation (37 percent). The most frequent indications of HTA influence were on decisions related to resource allocation (59 percent), change in practice pattern (31 percent), and incorporation of HTA details in reference material (18 percent). Few publications assessed the contribution of HTA to changing patient outcomes. The literature on HTA influence remains limited, with little on longer term effects on practice and outcomes. The reviewed publications indicated how HTA is being used in different settings and approaches to measuring its influence that might be more widely applied, such as surveys and monitoring administrative data.

Combining multi-criteria decision analysis and mini-health technology assessment: A funding decision-support tool for medical devices in a university hospital setting.

PubMed

Martelli, Nicolas; Hansen, Paul; van den Brink, Hélène; Boudard, Aurélie; Cordonnier, Anne-Laure; Devaux, Capucine; Pineau, Judith; Prognon, Patrice; Borget, Isabelle

2016-02-01

At the hospital level, decisions about purchasing new and oftentimes expensive medical devices must take into account multiple criteria simultaneously. Multi-criteria decision analysis (MCDA) is increasingly used for health technology assessment (HTA). One of the most successful hospital-based HTA approaches is mini-HTA, of which a notable example is the Matrix4value model. To develop a funding decision-support tool combining MCDA and mini-HTA, based on Matrix4value, suitable for medical devices for individual patient use in French university hospitals - known as the IDA tool, short for 'innovative device assessment'. Criteria for assessing medical devices were identified from a literature review and a survey of 18 French university hospitals. Weights for the criteria, representing their relative importance, were derived from a survey of 25 members of a medical devices committee using an elicitation technique involving pairwise comparisons. As a test of its usefulness, the IDA tool was applied to two new drug-eluting beads (DEBs) for transcatheter arterial chemoembolization. The IDA tool comprises five criteria and weights for each of two over-arching categories: risk and value. The tool revealed that the two new DEBs conferred no additional value relative to DEBs currently available. Feedback from participating decision-makers about the IDA tool was very positive. The tool could help to promote a more structured and transparent approach to HTA decision-making in French university hospitals. Copyright © 2015 Elsevier Inc. All rights reserved.

HTA Implementation Roadmap in Central and Eastern European Countries.

PubMed

Kaló, Zoltán; Gheorghe, Adrian; Huic, Mirjana; Csanádi, Marcell; Kristensen, Finn Boerlum

2016-02-01

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.

A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?

PubMed Central

Allen, Nicola; Liberti, Lawrence; Walker, Stuart R.; Salek, Sam

2017-01-01

Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization. Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations. Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations. Conclusions: In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe. PMID:28713265

A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?

PubMed

Allen, Nicola; Liberti, Lawrence; Walker, Stuart R; Salek, Sam

2017-01-01

Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization. Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations. Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations. Conclusions: In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe.

Introducing patient perspective in health technology assessment at the local level

PubMed Central

Gagnon, Marie-Pierre; Lepage-Savary, Dolorès; Gagnon, Johanne; St-Pierre, Michèle; Simard, Chantale; Rhainds, Marc; Lemieux, Renald; Gauvin, François-Pierre; Desmartis, Marie; Légaré, France

2009-01-01

Background Recognizing the importance of increased patient participation in healthcare decisions leads decision makers to consider effective ways to incorporate patient perspectives in Health Technology Assessment (HTA) processes. The implementation of local health HTA units in university hospitals in Quebec provides a unique opportunity to foster an increased participation of patients in decisions regarding health technologies and clinical interventions. This project explores strategies that could be effective in involving patients in HTA activities at the local level. To do so, three objectives are pursued: 1) To synthesise international knowledge and experiences on patient and public involvement in HTA activities; 2) To explore the perceptions of stakeholders (administrators, clinical managers, healthcare professionals, HTA producers, and patients) regarding strategies for involving patients in various HTA activities; and 3) To produce a consensual strategic framework that could guide interventions for involving patients in HTA activities at the local level. Methods A systematic review of the literature will be conducted to synthesise international knowledge and experiments regarding the implication of patients and public in HTA. Then, focus groups will be carried out with representatives of various stakeholder groups in order to explore their perceptions regarding patient participation in HTA. Based on findings from the systematic review and the focus groups, a framework to support patient participation in HTA activities will be proposed. It will then be validated during a deliberative meeting with the research team, composed of scientists and decision makers, and representatives from different groups involved in HTA in Quebec. This deliberative meeting will aim at identifying the type and the degree of participation as well as the adequate timing for involving patients in local HTA activities. Discussion Given the actual state of evidence, integrating patient perspective in HTA activities has the potential to improve the quality of healthcare services. This study provides an opportunity to bridge the gap between HTA producers and its ultimate end-user: the patient. It will provide guidance to support local HTA units in Quebec and elsewhere in their decisions regarding patient participation. The framework developed could be applied to design and implement strategies for involving patients in HTA activities. PMID:19327160

The Moral Economy of Health Technology Assessment: An Empirical Qualitative Study

ERIC Educational Resources Information Center

Ducey, Ariel; Ross, Sue; Pott, Terilyn; Thompson, Carmen

2017-01-01

Using data from interviews with Health Technology Assessment (HTA) professionals in Canada, this paper shows their views of the appropriate role of, and evidence required for, HTA are associated with values and norms. Recognizing HTA as a moral economy helps to explain when and why HTA professionals' views of what HTA should and can do are…

Bibliometrics of NIHR HTA monographs and their related journal articles

PubMed Central

Royle, Pamela

2015-01-01

Objectives A bibliometric analysis of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) monographs and their related journal articles by: (1) exploring the differences in citations to the HTA monographs in Google Scholar (GS), Scopus and Web of Science (WoS), and (2) comparing Scopus citations to the monographs with their related journal articles. Setting A study of 111 HTA monographs published in 2010 and 2011, and their external journal articles. Main outcome measures Citations to the monographs in GS, Scopus and WoS, and to their external journal articles in Scopus. Results The number of citations varied among the three databases, with GS having the highest and WoS the lowest; however, the citation-based rankings among the databases were highly correlated. Overall, 56% of monographs had a related publication, with the highest proportion for primary research (76%) and lowest for evidence syntheses (43%). There was a large variation in how the monographs were cited, compared to journal articles, resulting in more frequent problems, with unlinked citations in Scopus and WoS. When comparing differences in the number of citations between monograph publications with their related journal articles from the same project, we found that monographs received more citations than their journal articles for evidence syntheses and methodology projects; by contrast, journal articles related to primary research monographs were more highly cited than their monograph. Conclusions The numbers of citations to the HTA monographs differed considerably between the databases, but were highly correlated. When a HTA monograph had a journal article from the same study, there were more citations to the journal article for primary research, but more to the monographs for evidence syntheses. Citations to the related journal articles were more reliably recorded than citations to the HTA monographs. PMID:25694457

USING THE HEALTH TECHNOLOGY ASSESSMENT TOOLBOX TO FACILITATE PROCUREMENT: THE CASE OF SMART PUMPS IN A CANADIAN HOSPITAL.

PubMed

Poder, Thomas G

2017-01-01

The aim of this study was to present the experience of a Canadian hospital-based health technology assessment (HTA) unit that performed the traditional functions of the HTA process along with many other activities to facilitate the choice of smart pumps. A rapid literature review was initiated, but little evidence was found. Moreover, the evidence provided was too far from our hospital context. To help our decision makers, we offered them a list of various services based on the skills of our HTA unit staff. To involve our HTA unit in the choice of the new smart pumps led to a strong collaboration between hospital services. After a rapid review on smart pumps, we proceeded to establish the clinical needs, followed by an evaluation of technical features. To ascertain clinical needs, we participated in the establishment of a conformity list for the tender, a failure and mode-effect analysis, an audit on the use of actual smart pumps, and simulation exercises with nurses and doctors to evaluate the ease of use and ergonomics. With regard to technical tests, these were mainly conducted to identify potential dysfunction and to assess the efficiency of the pump. This experience with smart pumps was useful for evidence-based procurement and led to the formulation of a nine-step process to guide future work. HTA units and agencies are faced with rapid development of new technologies that may not be supported by sufficient amount of pertinent published evidence. Under these circumstances, approaches other than evidence-based selection might provide useful information. Because these activities may be different from those related to classic HTA, this widens the scope of what can be done in HTA to support decision making.

Health technology assessment agencies: an international overview of organizational aspects.

PubMed

Martelli, Francesco; La Torre, Giuseppe; Di Ghionno, Elena; Staniscia, Tommaso; Neroni, Massimo; Cicchetti, Americo; Von Bremen, Konrade; Ricciardi, Walter

2007-01-01

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

Health Technology Assessment and Its Use in Drug Policies in China.

PubMed

Zhen, Xuemei; Sun, Xueshan; Dong, Hengjin

2018-05-02

To review drug policies, health technology assessment (HTA), and HTA's use in drug policies in China, to further improve the quality and efficiency of drugs. This study draws on multiple methods. A systematic review of the literature, review of Chinese government documents and statistical handbooks, and authors' experiences in drug policies and HTA in China were combined to achieve the objective. Of 571 studies identified in the initial search, 14 eligible articles (6 English, 8 Chinese) were finally included. On the Web site of the National Health and Family Planning Commission, the National Development and Reform Commission, and the Ministry of Human Resources and Social Security, we found that HTA or pharmacoeconomics evaluation is mentioned in recent years and its frequency has been increasing; however, there was not one hit about HTA or PE on the Web site of China Food and Drug Administration. The decision makers have realized the importance and value of HTA and have tried to integrate HTA into drug policies and regulations. However, the application of HTA findings to drug policymaking is not yet widespread and there are a number of challenges in using HTA in China. Therefore, it is necessary to establish a national HTA commission and develop pharmacoeconomics guidelines to support the use of HTA in decision making. Moreover, the most important steps are to encourage technology innovation, groom more HTA experts, and build reliable databases in China. Copyright © 2018. Published by Elsevier Inc.

Health Technology Assessment – science or art?

PubMed Central

Hofmann, Bjørn

2013-01-01

The founding disciplines of HTA are clearly scientific, and have been firmly based among the natural sciences. However, common definitions of HTA indicate that HTA is something more than the “pure application of science”. This article investigates whether this “something” also makes HTA an art. The question of whether HTA is a science or an art is pursued in two specific and historically rich directions. The first is whether HTA is an art in the same way that medicine is described as an art. It has been argued extensively that medicine is based on two different and partly incompatible cultures, i.e., the natural sciences and humanities. Medicine is based on disciplines within the natural sciences, while its value judgments have been placed in the humanities camp. This dichotomy is present in HTA as well, and the first part of the investigation illustrates how HTA is an art in terms of its inherent and constitutive value-judgments. The second part of the science/art-scrutiny leads us to the ancient (Hippocratic) concept of art, téchne, where we find an etymological and a conceptual link between HTA and art. It demonstrates HTA is not an arbitrary process, even though it involves value judgments and relates complex decision making processes. As an art (téchne) HTA has a specific subject matter, requires inquiry and mastery of general rational principles, and is oriented to a specific end. In conclusion, the science-or-art-question makes sense in two specific perspectives, illustrating that HTA is a science based art. This has implications for the practice of HTA, for its education, and for the status of its results. PMID:23935761

Health Technology Assessment - science or art?

PubMed

Hofmann, Bjørn

2013-01-01

The founding disciplines of HTA are clearly scientific, and have been firmly based among the natural sciences. However, common definitions of HTA indicate that HTA is something more than the "pure application of science". This article investigates whether this "something" also makes HTA an art. The question of whether HTA is a science or an art is pursued in two specific and historically rich directions. The first is whether HTA is an art in the same way that medicine is described as an art. It has been argued extensively that medicine is based on two different and partly incompatible cultures, i.e., the natural sciences and humanities. Medicine is based on disciplines within the natural sciences, while its value judgments have been placed in the humanities camp. This dichotomy is present in HTA as well, and the first part of the investigation illustrates how HTA is an art in terms of its inherent and constitutive value-judgments. The second part of the science/art-scrutiny leads us to the ancient (Hippocratic) concept of art, téchne, where we find an etymological and a conceptual link between HTA and art. It demonstrates HTA is not an arbitrary process, even though it involves value judgments and relates complex decision making processes. As an art (téchne) HTA has a specific subject matter, requires inquiry and mastery of general rational principles, and is oriented to a specific end. In conclusion, the science-or-art-question makes sense in two specific perspectives, illustrating that HTA is a science based art. This has implications for the practice of HTA, for its education, and for the status of its results.

Health Technology Assessment and Private Payers' Coverage of Personalized Medicine

PubMed Central

Trosman, Julia R.; Van Bebber, Stephanie L.; Phillips, Kathryn A.

2011-01-01

Purpose: Health technology assessment (HTA) plays an increasing role in translating emerging technologies into clinical practice and policy. Private payers are important users of HTA whose decisions impact adoption and use of new technologies. We examine the current use of HTA by private payers in coverage decisions for personalized medicine, a field that is increasingly impacting oncology practice. Study Design: Literature review and semistructured interviews. Methods: We reviewed seven HTA organizations used by private payers in decision making and explored how HTA is used by major US private payers (n = 11) for coverage of personalized medicine. Results: All payers used HTA in coverage decisions, but the number of HTA organizations used by an individual payer ranged from one (n = 1) to all seven (n = 1), with the majority of payers (n = 8) using three or more. Payers relied more extensively on HTAs for reviews of personalized medicine (64%) than for other technologies. Most payers (82%) equally valued expertise of reviewers and rigor of evaluation as HTA strengths, whereas genomic-specific methodology was less important. Key reported shortcomings were limited availability of reviews (73%) and limited inclusion of nonclinical factors (91%), such as cost-effectiveness or adoption of technology in clinical practice. Conclusion: Payers use a range of HTAs in their coverage decisions related to personalized medicine, but the current state of HTA to comprehensively guide those decisions is limited. HTA organizations should address current gaps to improve their relevance to payers and clinicians. Current HTA shortcomings may also inform the national HTA agenda. PMID:21886515

A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR JAPAN? SIMULATING THE POTENTIAL IMPACT ON THE PRICE OF SIMEPREVIR.

PubMed

Mahlich, Jörg; Kamae, Isao; Rossi, Bruno

2017-01-01

Japanese authorities have announced a plan to introduce a health technology assessment (HTA) system in 2016. This study assessed the potential impact of such a policy on the price of the antivirologic drug simeprevir. Taking the antivirologic drug simeprevir as an example, we compared the current Japanese price with hypothetical prices that might result if a U.K. (cost-utility) or German (efficiency frontier) style HTA assessment was in place. The simeprevir unit price under the current Japanese pricing scheme is 13,122 Japanese yen (equivalent to 109.35 U.S. dollars as of April 2015). Depending on the selection of comparators and the pricing method, and assuming that HTA will be used as a basis for price setting, the estimated prices of simeprevir vary up to four times higher than under the current Japanese pricing scheme. Although the analysis is based on only one drug, it cannot be taken for granted that a new HTA system would reduce public healthcare expenditure in Japan.

Development of archetypes for non-ranking classification and comparison of European National Health Technology Assessment systems.

PubMed

Allen, Nicola; Pichler, Franz; Wang, Tina; Patel, Sundip; Salek, Sam

2013-12-01

European countries are increasingly utilising health technology assessment (HTA) to inform reimbursement decision-making. However, the current European HTA environment is very diverse, and projects are already underway to initiate a more efficient and aligned HTA practice within Europe. This study aims to identify a non-ranking method for classifying the diversity of European HTA agencies process and the organisational architecture of the national regulatory review to reimbursement systems. Using a previously developed mapping methodology, this research created process maps to describe national processes for regulatory review to reimbursement for 33 European jurisdictions. These process maps enabled the creation of 2 HTA taxonomic sets. The confluence of the two taxonomic sets was subsequently cross-referenced to identify 10 HTA archetype groups. HTA is a young, rapidly evolving field and it can be argued that optimal practices for performing HTA are yet to emerge. Therefore, a non-ranking classification approach could objectively characterise and compare the diversity observed in the current European HTA environment. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Historical development of health technology assessment in Thailand.

PubMed

Teerawattananon, Yot; Tantivess, Sripen; Yothasamut, Jomkwan; Kingkaew, Pritaporn; Chaisiri, Kakanang

2009-07-01

This study aims to review the development of health technology assessment (HTA), including the socioeconomic context, outputs, and policy utilization in the Thai setting. This study was conducted through extensive document reviews including these published in both domestic and international literature. Evidence suggests that contextual elements of the health system, especially the country's economic status and health financing reforms, as well as their effects on government budgeting for medical and public health services, played an important role in the increasing needs and demands for HTA information among policy makers. In the midst of substantial economic growth during the years 1982 to 1996, several studies reported the rapid diffusion and poor distribution of health technologies, and inequitable access to high-cost technology in public and private hospitals. At the same time, economic analysis and its underpinning concept of efficiency were suggested by groups of scholars and health officials to guide national policy on the investment in health technology equipment. Related research and training programs were subsequently launched. However, none of these HTA units could be institutionalized into national bodies. From 1997 to 2005, an economic recession, followed by the introduction of a universal health coverage plan, triggered the demands for effective measures for cost containment and prioritization of health interventions. This made policy makers and researchers at the Ministry of Public Health (MOPH) pay increasing attention to economic appraisals, and several HTA programs were established in the Ministry. Despite the rising number of Thai health economic publications, a major problem at that period involved the poor quality of studies. Since 2006, economic recovery and demands from different interests to include expensive technologies in the public health benefit package have been crucial factors promoting the role of HTA in national policy decisions. Meanwhile, HTA capacity has been strengthened through the establishment of many health economic and HTA initiatives. An illustration of the work and contributions of the Health Intervention and Technology Assessment Program (HITAP) is provided. In this phase, HTA policy integration has been enhanced through different mechanisms and organizations. Over the past two decades a notable progression has been made in relation to the capacity building of HTA research and its policy utility in Thailand. Such development has been shaped by multiple factors. It is anticipated that experience gained among academics, health officials, and civil society organizations will be helpful not only in sustaining the momentum but also in improving formal HTA systems in the future.

EUnetHTA information management system: development and lessons learned.

PubMed

Chalon, Patrice X; Kraemer, Peter

2014-11-01

The aim of this study was to describe the techniques used in achieving consensus on common standards to be implemented in the EUnetHTA Information Management System (IMS); and to describe how interoperability between tools was explored. Three face to face meetings were organized to identify and agree on common standards to the development of online tools. Two tools were created to demonstrate the added value of implementing interoperability standards at local levels. Developers of tools outside EUnetHTA were identified and contacted. Four common standards have been agreed on by consensus; and consequently all EUnetHTA tools have been modified or designed accordingly. RDF Site Summary (RSS) has demonstrated a good potential to support rapid dissemination of HTA information. Contacts outside EUnetHTA resulted in direct collaboration (HTA glossary, HTAi Vortal), evaluation of options for interoperability between tools (CRD HTA database) or a formal framework to prepare cooperation on concrete projects (INAHTA projects database). While being entitled a project on IT infrastructure, the work program was also about people. When having to agree on complex topics, fostering a cohesive group dynamic and hosting face to face meetings brings added value and enhances understanding between partners. The adoption of widespread standards enhanced the homogeneity of the EUnetHTA tools and should thus contribute to their wider use, therefore, to the general objective of EUnetHTA. The initiatives on interoperability of systems need to be developed further to support a general interoperable information system that could benefit the whole HTA community.

Health Technology Assessment in nursing: a literature review.

PubMed

Ramacciati, N

2013-03-01

The Health Technology Assessment (HTA) approach, which provides scientific support for the decisions taken within the health field, is of increasing importance worldwide. In a context of limited resources, HTA has the potential of being an efficient tool for addressing the sustainability problems and the allocation choices arising from the constant increase in demand. This study aims to investigate HTA use in nursing, both in terms of quantifying HTA evaluations of nursing phenomena which have been conducted and in terms of the extent to which nursing has used the HTA approach. The Italian context has been analysed because of the growing diffusion of the HTA in Italy along with the recent developments in the nursing profession. A narrative review of international literature was undertaken using the following databases: HTA, PubMed, CINAHL, ILISI. Seventy evaluation studies on nursing were identified from the HTA database (1.12% of all studies in the database). The areas of nursing intervention and the country of origin of the studies were identified. Two nursing studies on the HTA approach were found in the PubMed, CINAHL and HTA databases. The first focused on the evaluation of nursing technology process and analysed 126 studies in six main thematic areas; the second was a systematic review on HTA in nursing and analysed 192 studies (46 meta-analyses, 31 Finnish primary studies, 117 international primary studies). Three Italian studies were identified from the ILISI database and Italian grey literature. In the international literature, although analyses regarding the efficacy of nursing interventions have been conducted, there are to date very few research projects that focus exclusively on the HTA process as applied to nursing. The recent development of a standardized nursing language coupled with the open debate as to which research method (qualitative vs. quantitative) best serves to 'read' nursing phenomena may explain the scarce diffusion of HTA in the field of nursing. © 2012 The Author. International Nursing Review © 2012 International Council of Nurses.

Selective attention for masked and unmasked emotionally toned stimuli: effects of trait anxiety, state anxiety, and test order.

PubMed

Edwards, Mark S; Burt, Jennifer S; Lipp, Ottmar V

2010-05-01

We investigated selective attention for masked and unmasked, threat, and positively valenced words, in high trait anxious (HTA) and low trait anxious (LTA) individuals using the emotional Stroop colour-naming task. State anxiety was varied within participants through the threat of electric shock. To investigate whether the sequencing of the state anxiety manipulation affected colour-naming latencies, the ordering of the shock threat and shock safe conditions was counterbalanced across participants. The results indicated that the ordering of the state anxiety manipulation moderated masked and unmasked threat bias effects. Specifically, relative to LTA individuals, HTA individuals showed a threat interference effect, but this effect was limited to those who performed under the threat of shock in the later stages of the experiment. Irrespective of exposure mode and state anxiety status, all individuals showed interference for threat in the early stages of the experiment, relative to a threat facilitation effect in the later stages of the experiment. For the unmasked trials alone, the data also revealed a significant threat interference effect for the HTA group relative to the LTA group in the shock threat condition, and this effect was evident irrespective of shock threat order. The results are discussed with respect to the automatic nature of emotional processing in anxiety.

Health technology assessment in four countries: response from political science.

PubMed

Chinitz, David

2004-01-01

Four studies, each on health technology assessment (HTA) in a different country, are presented in this volume. Conveying differing levels of sensitivity to political aspects of HTA, their storylines are similar in terms of the importance of the institutional structures that produce HTA and mediate its influence on health policy decision making. Regarding the internal politics of HTA, the latter appears to have developed in a relatively depoliticized environment, supported by a dense and varied web of institutional sites for funding, production, and consumption of HTA, buffered from the capricious impacts of electoral politics. Regarding external politics, HTA in all the countries began with relatively politically innocuous studies of technologies recognized to be of major import to national health systems or researcher-initiated studies. However, with increased focus in health systems on explicit determination of health benefits baskets, the role of HTA has become more high profile. This means that political accountability for the entire HTA process will increase. The implication is that future management of HTA programs will require self-conscious attention to the building of institutions capable of handling the delicate process of integrating science and politics in health policy.

Etiologies des hypertensions artérielles endocrines: à propos d'une série de cas

PubMed Central

Bouznad, Naima; El Mghari, Ghizlane; El Ansari, Nawal

2016-01-01

Les hypertensions artérielles (HTA) d'origine endocrine restent une cause rare d'HTA, sa prévalence globale n'excède pas 4% des hypertendus. L'intérêt de la recherche des HTA endocrines réside dans la gravité de certaines formes parfois mortelles et le caractère potentiellement curable et réversible de ces HTA. Le but du travail est de déterminer le profil clinique, para clinique, étiologique et thérapeutique des HTA secondaires d'origine endocrine chez les patients suivis au service d'endocrinologie au CHU Mohamed IV à Marrakech. Il s'agit d'une étude descriptive prospective s’étalant sur une période de 4 ans incluant 45 patients ayant une HTA endocrinienne. La moyenne d’âge est de 44,89 ans, avec une nette prédominance du sexe féminine (sexe ratio de 0,49). Les étiologies des HTA endocrines étaient dominées par le phéochromocytome (17 cas), l'hypercorticisme (11 cas) et l'acromégalie (8 cas). L'HTA était paroxystique dans 24,4%. Elle était d'emblée sevère classée grade 3 dans 40% des cas. L'HTA a été compliquée de cardiopathie dans 24% des cas et de néphropathie dans 20% des cas. Le traitement curatif a permis une guérison de l'HTA chez 60% (27 cas). Le diagnostic des HTA secondaires endocrines est parfois difficile du fait de l'absence de spécificité clinique. Il n'est pas exceptionnel que l'HTA soit l'unique manifestation de la maladie. Dans notre travail nous notons le caractère paroxystique et sévère de l'HTA. Le caractère éventuellement curable des HTA endocrines, dans plus des deux tiers des cas, fait qu'il est important de la dépister devant toute HTA sévère, résistante au traitement, ou en présence de signes cliniques, biologiques ou radiologiques évocateurs. PMID:27303586

Using health technology assessment to identify gaps in evidence and inform study design for comparative effectiveness research.

PubMed

Tunis, Sean R; Turkelson, Charles

2012-12-01

Health technology assessment (HTA) is primarily used as a tool to ensure that clinical and policy decisions are made with the benefit of a systematic analysis of all completed research. This article describes the progress and potential for HTA reports to improve the quality and relevance of future research and to better serve the information needs of patients, clinicians, payers, and other decision makers. We conducted a review of the current published literature and working papers describing past, ongoing, and future initiatives that rely on HTA reports to identify gaps in evidence and improve the design of future research. Although still in a developmental stage, significant progress is under way to improve methods for using HTA reports for the systematic identification of research gaps, prioritization of future research, and improvement of study designs. Several well-defined frameworks have been developed to assist those who produce HTA to become more effective in these additional domains of work. A recurring element of this work is the importance of meaningfully involving stakeholders in the process of defining future research needs and designing studies to address them. Patients, clinicians, and payers are important audiences for completed research and are now recognized as serving an important role in determining what future research is needed. There are substantial opportunities to improve the quality, relevance, and efficiency of clinical research. Recent efforts are beginning to demonstrate the potential to build on the work invested in developing HTA reports to provide a roadmap toward these objectives.

Health technology assessment of medical devices: What is different? An overview of three European projects.

PubMed

Schnell-Inderst, Petra; Mayer, Julia; Lauterberg, Jörg; Hunger, Theresa; Arvandi, Marjan; Conrads-Frank, Annette; Nachtnebel, Anna; Wild, Claudia; Siebert, Uwe

2015-01-01

With the growing use and importance of health technology assessment (HTA) in decision making during recent years, health technology assessors, decision makers and stakeholders are confronted with methodological challenges due to specific characteristics of health technologies (e. g., pharmaceuticals, diagnostic tests, screening programs), their developmental environment, and their regulation process. Being aware of the necessity to use HTA as a policy instrument for sustainable health care systems in a regulatory environment of decentralized Conformité Européenne (CE) marking, the European Union (EU) is increasingly supporting the development of methods for the assessment of medical devices (MD) on different levels: within the scope of European research projects and within joint assessment activities of the member states of the European network for Health Technology Assessment (EUnetHTA). First, this article describes three projects: MedtecHTA-Methods for Health Technology Assessment of Medical Devices, a European Perspective Work Package 3 (WP3), Comparative Effectiveness of Medical Devices led by the University for Health Sciences, Medical Informatics and Technology (UMIT). Second, we discuss the experiences of the Ludwig Boltzmann Institute Health Technology Assessment (LBI HTA) with the joint production of rapid assessments of medical devices by several European HTA agencies within EUnetHTA. Third, a brief outline is given of the framework of joint methodological guideline elaboration by the EUnetHTA partner organizations because a guideline for therapeutic MD is also being developed here. We will describe aims, methods and some preliminary results of MedtecHTA and EUnetHTA Joint Action 2 Work Package 5 Strand B (WP5B) applying the HTA Core Model for Rapid Assessment for national adaptation and reporting, and give an overview of the development process of methodological guidelines within WP 7 of EUnetHTA Joint Action 2. Based on a literature review in MedtecHTA WP3 incremental development, context dependency and the physical mode of action of MD were identified as those characteristics making therapeutic MD different from drugs with regard to evaluation methods. In addition, regulation does not stipulate clinical trials. These characteristics were also identified as challenges for the production of joint assessments of MD within the HTA network EUnetHTA. Furthermore, adequate timing of assessment production, the variety of involved manufacturers, the non-transparent regulation process of MD in Europe and the often poor evidence base pose a challenge to EUnetHTA assessors. As a consequence, processes and methods for the joint production of rapid assessments must be continuously adapted and improved. Research on HTA methods for the assessment of MD tries to provide tools to deal with rapidly developing devices during evidence generation, dependence of clinical effectiveness of MD on user experience and context factors. There are also tools to integrate evidence from different sources adjusting for different levels of validity, but these methods are not established and need high epidemiological and statistical expertise. A framework for deciding whether additional evidence is needed to reduce uncertainty regarding safety, clinical effectiveness and cost-effectiveness will be adapted to MD. The whole process of evidence generation before and after market access has to be considered to provide an environment for conclusive HTA recommendations informing health care decision making. In Joint Action 2, EUnetHTA develops transparent processes for the early dialogue with stakeholders and fosters dissemination of appropriate HTA methods. In the case of MD, there are special accumulated needs for such efforts. Copyright © 2015. Published by Elsevier GmbH.

Bibliometrics of NIHR HTA monographs and their related journal articles.

PubMed

Royle, Pamela; Waugh, Norman

2015-02-18

A bibliometric analysis of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) monographs and their related journal articles by: (1) exploring the differences in citations to the HTA monographs in Google Scholar (GS), Scopus and Web of Science (WoS), and (2) comparing Scopus citations to the monographs with their related journal articles. A study of 111 HTA monographs published in 2010 and 2011, and their external journal articles. Citations to the monographs in GS, Scopus and WoS, and to their external journal articles in Scopus. The number of citations varied among the three databases, with GS having the highest and WoS the lowest; however, the citation-based rankings among the databases were highly correlated. Overall, 56% of monographs had a related publication, with the highest proportion for primary research (76%) and lowest for evidence syntheses (43%). There was a large variation in how the monographs were cited, compared to journal articles, resulting in more frequent problems, with unlinked citations in Scopus and WoS. When comparing differences in the number of citations between monograph publications with their related journal articles from the same project, we found that monographs received more citations than their journal articles for evidence syntheses and methodology projects; by contrast, journal articles related to primary research monographs were more highly cited than their monograph. The numbers of citations to the HTA monographs differed considerably between the databases, but were highly correlated. When a HTA monograph had a journal article from the same study, there were more citations to the journal article for primary research, but more to the monographs for evidence syntheses. Citations to the related journal articles were more reliably recorded than citations to the HTA monographs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Method of making an apparatus for transpiration cooling of substrates such as turbine airfoils

DOEpatents

Alvin, Mary Anne; Anderson, Iver; Heidlof, Andy; White, Emma; McMordie, Bruce

2017-02-28

A method and apparatus for generating transpiration cooling using an oxidized porous HTA layer metallurgically bonded to a substrate having micro-channel architectures. The method and apparatus generates a porous HTA layer by spreading generally spherical HTA powder particles on a substrate, partially sintering under O.sub.2 vacuum until the porous HTA layer exhibits a porosity between 20% and 50% and a neck size ratio between 0.1 and 0.5, followed by a controlled oxidation generating an oxidation layer of alumina, chromia, or silica at a thickness of about 20 to about 500 nm. In particular embodiments, the oxidized porous HTA layer and the substrate comprise Ni as a majority element. In other embodiments, the oxidized porous HTA layer and the substrate further comprise Al, and in additional embodiments, the oxidized porous HTA layer and the substrate comprise .gamma.-Ni+.gamma.'-Ni.sub.3Al.

Integrating ethics in health technology assessment: many ways to Rome.

PubMed

Hofmann, Björn; Oortwijn, Wija; Bakke Lysdahl, Kristin; Refolo, Pietro; Sacchini, Dario; van der Wilt, Gert Jan; Gerhardus, Ansgar

2015-01-01

The aim of this study was to identify and discuss appropriate approaches to integrate ethical inquiry in health technology assessment (HTA). The key question is how ethics can be integrated in HTA. This is addressed in two steps: by investigating what it means to integrate ethics in HTA, and by assessing how suitable the various methods in ethics are to be integrated in HTA according to these meanings of integration. In the first step, we found that integrating ethics can mean that ethics is (a) subsumed under or (b) combined with other parts of the HTA process; that it can be (c) coordinated with other parts; or that (d) ethics actively interacts and changes other parts of the HTA process. For the second step, we found that the various methods in ethics have different merits with respect to the four conceptions of integration in HTA. Traditional approaches in moral philosophy tend to be most suited to be subsumed or combined, while processual approaches being close to the HTA or implementation process appear to be most suited to coordinated and interactive types of integration. The article provides a guide for choosing the ethics approach that appears most appropriate for the goals and process of a particular HTA.

Methodological approaches in conducting overviews: current state in HTA agencies.

PubMed

Pieper, Dawid; Antoine, Sunya-Lee; Morfeld, Jana-Carina; Mathes, Tim; Eikermann, Michaela

2014-09-01

Overviews search for reviews rather than for primary studies. They might have the potential to support decision making within a shorter time frame by reducing production time. We aimed to summarize available instructions for authors intending to conduct overviews as well as the currently applied methodology of overviews in international Health Technology Assessment (HTA) agencies. We identified 127 HTA agencies and scanned their websites for methodological handbooks as well as published overviews as HTA reports. Additionally, we contacted HTA agencies by e-mail to retrieve possible unidentified handbooks or other related sources. In total, eight HTA agencies providing methodological support were found. Thirteen HTA agencies were found to have produced overviews since 2007, but only six of them published more than four overviews. Overviews were mostly employed in HTA products related to rapid assessment. Additional searches for primary studies published after the last review are often mentioned in order to update results. Although the interest in overviews is rising, little methodological guidance for the conduct of overviews is provided by HTA agencies. Overviews are of special interest in the context of rapid assessments to support policy-making within a short time frame. Therefore, empirical work on overviews needs to be extended. National strategies and experience should be disclosed and discussed. Copyright © 2013 John Wiley & Sons, Ltd.

[Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations].

PubMed

Ubago Pérez, Ruth; Castillo Muñoz, María Auxiliadora; Banqueri, Mercedes Galván; García Estepa, Raúl; Alfaro Lara, Eva Rocío; Vega Coca, María Dolores; Beltrán Calvo, Carmen; Molina López, Teresa

The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model ® , has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting "Evidence synthesis reports: pharmaceuticals" in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model ® . In this paper, the methodology that AETSA has developed to create the guideline for "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

STAKEHOLDER INVOLVEMENT IN THE HEALTH TECHNOLOGY ASSESSMENT PROCESS IN LATIN AMERICA.

PubMed

Pichon-Riviere, Andres; Soto, Natalie; Augustovski, Federico; Sampietro-Colom, Laura

2018-06-11

Latin American countries are taking important steps to expand and strengthen universal health coverage, and health technology assessment (HTA) has an increasingly prominent role in this process. Participation of all relevant stakeholders has become a priority in this effort. Key issues in this area were discussed during the 2017 Latin American Health Technology Assessment International (HTAi) Policy Forum. The Forum included forty-one participants from Latin American HTA agencies; public, social security, and private insurance sectors; and the pharmaceutical and medical device industry. A background paper and presentations by invited experts and Forum members supported discussions. This study presents a summary of these discussions. Stakeholder involvement in HTA remains inconsistently implemented in the region and few countries have established formal processes. Participants agreed that stakeholder involvement is key to improve the HTA process, but the form and timing of such improvements must be adapted to local contexts. The legitimization of both HTA and decision-making processes was identified as one of the main reasons to promote stakeholder involvement; but to be successful, the entire system of assessment and decision making must be properly staffed and organized, and certain basic conditions must be met, including transparency in the HTA process and a clear link between HTA and decision making. Participants suggested a need for establishing clear rules of participation in HTA that would protect HTA producers and decision makers from potentially distorting external influences. Such rules and mechanisms could help foster trust and credibility among stakeholders, supporting actual involvement in HTA processes.

Hospital-based health technology assessment (HTA) in Finland: a case study on collaboration between hospitals and the national HTA unit.

PubMed

Halmesmäki, Esa; Pasternack, Iris; Roine, Risto

2016-04-05

This study examines, as a part of the European Union funded Adopting Hospital Based Health Technology Assessment (AdHopHTA) project, the results and barriers of collaboration between Finnish hospitals and the national health technology assessment (HTA) agency, Finohta. A joint collaborative HTA program has existed since 2006 between the Finnish hospitals and the national agency. A case study method was used. Information about the collaboration between Finnish hospitals and Finohta was retrieved from interviews and publications, and categorised per theme. Hypotheses and indicators of successful collaboration were determined beforehand and reflected on the observations from the interviews and literature. Overall, 48 collaborative HTA reports have been performed during 7 years of collaboration. However, there were no clear indications that the use of HTA information or the transparency of decision-making regarding new technologies would have increased in hospitals. The managerial commitment to incorporate HTAs into the decision-making processes in hospitals was still low. The quality of the collaborative HTA reports was considered good, but their applicability in the hospital setting limited. There were differing expectations about the timing and relevance of the content. Signs of role conflict and mistrust were observed. Despite collaborative efforts to produce HTAs for hospitals, the impact of HTA information on hospital decision-making appears to remain low. The difficulties identified in this case study, such as lack of managerial commitment in hospitals, can hopefully be better addressed in the future with the guidance and tools having been developed in the AdHopHTA project. Collaboration between hospitals and national HTA agencies remains important for the efficient sharing of skills and resources.

Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

PubMed

Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

2018-06-01

To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol.

PubMed

Mathes, Tim; Willms, Gerald; Polus, Stephanie; Stegbauer, Constance; Messer, Melanie; Klingler, Corinna; Ehrenreich, Heidi; Niebuhr, Dea; Marckmann, Georg; Gerhardus, Ansgar; Pieper, Dawid

2018-05-23

Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

Challenges in the Assessment of Medical Devices: The MedtecHTA Project.

PubMed

Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael

2017-02-01

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

23-Hydroxytormentic acid protects human dermal fibroblasts by attenuating UVA-induced oxidative stress.

PubMed

Youn, Hae Jeong; Kim, Ki Bbeum; Han, Hyo-Sun; An, In-Sook; Ahn, Kyu Joong

2017-03-01

Ultraviolet A (UVA), one of the major components of sunlight, can penetrate the dermal layer of the skin and generate reactive oxygen species (ROS). It causes alterations in the dermal connective tissue and gene expression, inflammation, photoaging, and DNA damage. Therefore, the harmful effects of UVA and strategies to reduce it have been consistently investigated. 23-Hydroxytormentic acid (23-HTA) has been demonstrated to improve drug-induced nephrotoxicity and exhibit several free radical scavenging effects with other molecules. Therefore, the aim of this study was to investigate the anti-inflammatory effects and extracellular matrix (ECM) reconstructive activity of 23-HTA in UVA-irradiated normal human dermal fibroblasts (NHDFs). The antioxidant capacity of 23-HTA was determined by examining its scavenging activities against hydrogen peroxide, 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulphonic acid), and diphenylpicrylhydrazyl in vitro. Its effect on cell viability was evaluated using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tertazolium bromide, and 2,7-dichlorofluorescin diacetate was used to investigate intracellular ROS scavenging activity. The mRNA levels of antioxidant enzymes and pro-inflammatory cytokines were detected using quantitative real-time polymerase chain reaction. A senescence-associated β-galactosidase (SA-β-gal) staining kit was used to assess senescent cells. 23-HTA showed antioxidant capacity mediated by ROS scavenging and regulation of antioxidant-related gene expression. Further, the SA-β-gal analysis and mRNA expression of matrix metalloproteinases and type I procollagen suggested that 23-HTA regulates the gene expression of ECM proteins and cellular senescence under UVA-irradiated conditions. In conclusion, 23-HTA protects against and attenuates UVA-induced oxidative stress in NHDFs likely via the nuclear factor erythroid-derived 2-like 2 signaling pathway. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Value Assessment Frameworks for HTA Agencies: The Organization of Evidence-Informed Deliberative Processes.

PubMed

Baltussen, Rob; Jansen, Maarten Paul Maria; Bijlmakers, Leon; Grutters, Janneke; Kluytmans, Anouck; Reuzel, Rob P; Tummers, Marcia; der Wilt, Gert Jan van

2017-02-01

Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, health technology assessment agencies (HTAs) presently employ value assessment frameworks that are ill fitted to capture the range and diversity of stakeholder values and thereby risk compromising the legitimacy of their recommendations. We propose "evidence-informed deliberative processes" as an alternative framework with the aim to enhance this legitimacy. This framework integrates two increasingly popular and complementary frameworks for priority setting: multicriteria decision analysis and accountability for reasonableness. Evidence-informed deliberative processes are, on one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making through evidence-informed evaluation of the identified values. The framework has important implications for how HTA agencies should ideally organize their processes. First, HTA agencies should take the responsibility of organizing stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phases, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria and to provide argumentation for how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal. The framework should not be considered a blueprint for HTA agencies but rather an aspirational goal-agencies can take incremental steps toward achieving this goal. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Healthcare Databases in Thailand and Japan: Potential Sources for Health Technology Assessment Research.

PubMed

Saokaew, Surasak; Sugimoto, Takashi; Kamae, Isao; Pratoomsoot, Chayanin; Chaiyakunapruk, Nathorn

2015-01-01

Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases' characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. Forty databases- 20 from Thailand and 20 from Japan-were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed.

CONTRIBUTION OF STAKEHOLDER ENGAGEMENT TO THE IMPACT OF A HEALTH TECHNOLOGY ASSESSMENT: AN IRISH CASE STUDY.

PubMed

Ryan, Máirín; Moran, Patrick S; Harrington, Patricia; Murphy, Linda; O'Neill, Michelle; Whelan, Marty; Teljeur, Conor

2017-01-01

The aim of this study was to illustrate the contribution of stakeholder engagement to the impact of health technology assessment (HTA) using an Irish HTA of a national public access defibrillation (PAD) program. In response to draft legislation that proposed a PAD program, the Minister for Health requested that Health Information and Quality Authority undertake an HTA to inform the design and implementation of a national PAD program and the necessary underpinning legislation. The draft legislation outlined a program requiring widespread installation and maintenance of automatic external defibrillators in specified premises. Stakeholder engagement to optimize the impact of the HTA included one-to-one interviews with politicians, engagement with an Expert Advisory Group, public and targeted consultation, and positive media management. The HTA quantified the clinical benefits of the proposed PAD program as modest, identified that substantial costs would fall on small/medium businesses at a time of economic recession, and that none of the programs modeled were cost-effective. The Senator who proposed the Bill actively publicized the HTA process and its findings and encouraged participation in the public consultation. Participation of key stakeholders was important for the quality and acceptability of the HTA findings and advice. Media management promoted public engagement and understanding. The Bill did not progress. The HTA informed the decision not to progress with legislation for a national PAD program. Engagement was tailored to ensure that key stakeholders including politicians and the public were informed of the HTA process, the findings, and the advice, thereby maximizing acceptance. Appropriate stakeholder engagement optimizes the impact of HTA.

The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries.

PubMed

Oortwijn, Wija; Mathijssen, Judith; Banta, David

2010-05-01

Middle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage. We selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA. All countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation. The study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

The impact of health technology assessment reports on decision making in Austria.

PubMed

Zechmeister, Ingrid; Schumacher, Ines

2012-01-01

Health technology assessment (HTA) was established in Austria in the 1990s and, since then, it has gained considerable importance. In this study, we aim to analyze whether the HTA reports that have been produced at the Institute for Technology Assessment (ITA) and at the Ludwig Boltzmann Institute for HTA (LBI-HTA) have had an impact on decision making within the Austrian health care system. We selected all reports that were intended for supporting (i) reimbursement/investment or (ii) disinvestment decisions. Eleven full HTA reports and fifty-eight rapid assessments fulfilled the inclusion criteria. We used interview data and administrative data on volumes, tariffs and expenditure of products/services to analyze whether and how reports were in reality used in decision making and what the consequences for health care expenditure and resource distribution have been. Five full HTA reports and fifty-six rapid technology assessments were used for reimbursement decisions. Four full HTA reports and two rapid assessments were used for disinvestment decisions and resulted in reduced volumes and expenditure. Two full HTA reports showed no impact on decision making. Impact was most evident for hospital technologies. HTA has played some role in reducing volumes of over-supplied hospital technologies, resulting in reduced expenditure for several hospital providers. Additionally, it has been increasingly included in prospective planning and reimbursement decisions of late, indicating re-distribution of resources toward evidence-based technologies. However, further factors may have influenced the decisions, and the impact could be considerably increased by systematically incorporating HTA into the decision-making process in Austria.

Healthcare Databases in Thailand and Japan: Potential Sources for Health Technology Assessment Research

PubMed Central

Saokaew, Surasak; Sugimoto, Takashi; Kamae, Isao; Pratoomsoot, Chayanin; Chaiyakunapruk, Nathorn

2015-01-01

Background Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. Method Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases’ characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. Results Forty databases– 20 from Thailand and 20 from Japan—were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. Conclusion Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed. PMID:26560127

STAKEHOLDERS' PERCEPTIONS OF HEALTH TECHNOLOGY ASSESSMENT IN TURKEY.

PubMed

Ozturk, Kirstin; Karadayı, Bilgehan; Şener, Olgun

2018-01-01

In April of 2014, the Turkish Ministry of Health held the First Annual Health Technology Assessment (HTA) Meeting in Antalya. The objectives were to understand the perceptions of stakeholders regarding the current status of HTA and document their recommendations and strategies for promoting systematic use of HTA in Turkey. The study was conducted using a qualitative written survey assessing current compliance with the fifteen HTA principles suggested by Drummond et al. (Key principles for the improved conduct of health technology assessments for resource allocation decision. Int J Technol Assess Health Care. 2008;24:244-258) and a qualitative method referred to as the Collective Intelligence Platform®. A total of 216 stakeholders representing academic, public, and the private health sector attended the annual meeting; 178 completed the survey and 183 participated in the Platform. Quantitative Results: Survey participants reported that, although Turkey does not currently fully comply with any of the fifteen HTA principles, there is some compliance with all of them. The overall average score for all fifteen principles was 3.04. Quantitivate Results: Participants recommended a more transparent, independent, and evidence-based policy decision-making system through better coordination of HTA activities, data aggregation, capacity development, and a national HTA core model and framework. Platform participants described the current HTA environment as disjointed and lacking in resources and support from policy-making leaders. Despite the persisting challenges, awareness of the strengths and weaknesses of the current system combined with increasing interaction among Turkish stakeholders and the international HTA community can meaningfully contribute to the continued development and promotion of HTA in Turkey.

Key Recommendations from the MedtecHTA Project.

PubMed

Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael

2017-02-01

There are particular characteristics of Medical Devices, such as the device-user interaction, the incremental nature of innovation and the broader organizational impact that lead to additional challenges for health technology assessment (HTA). The project explored key aspects of the conduct and methods of HTA for MDs. Systematic reviews and original research studies were conducted to determine improvements in processes and methods that could enhance the potential for HTA and optimize the diffusion of MDs. Regulatory processes for MDs should be more closely aligned, the HTA evaluative framework should be harmonized and processes for conditional coverage and evidence development should be used. The methods for HTA should consider MDs as complex interventions, require the establishment of high quality registries, consider an iterative approach to the evaluation over time, recognize and allow for the particular characteristics of devices and use appropriate approaches for confounder adjustment in comparative effectiveness studies. To optimize the diffusion, a common classification should be developed across countries in order to facilitate international comparisons, factors driving diffusion should be explored in HTA reports and physicians' personal goals and motivation should be better understood. The key recommendations of the MedtecHTA project should improve the conduct and use of HTA for MDs. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis.

PubMed

Woodford Guegan, Eleanor; Cook, Andrew

2014-06-01

The European network for Health Technology Assessment Joint Action (EUnetHTA JA) project's overarching objective was to 'establish an effective and sustainable HTA [Health technology assessment] collaboration in Europe that brings added value at the regional, national and European level'. Specific objectives were to develop a strategy and business model for sustainable European collaboration on HTA, develop HTA tools and methods and promote good practice in HTA methods and processes. We describe activities performed on behalf of the National Institute for Health Research HTA programme; evaluating the project processes and developing a data set for a registry of planned clinical studies of relevance to public funders. Annual self-completion online questionnaires were sent to project participants and external stakeholders to identify their views about the project processes. Documentary review was undertaken at the project end on the final technical reports from the work packages to examine whether or not their deliverables had been achieved. The project's impact was assessed by whether or not the deliverables were produced, the objectives met and additional 'added value' generated. The project's effectiveness was evaluated by its processes, communication, administration, workings of individual work packages and involvement of external stakeholders. A two-stage Delphi exercise was undertaken to identify the data elements that should be included in a registry of planned clinical studies of relevance to public funders. The data set was validated by an efficacy testing exercise. High response rates were achieved for the questionnaires sent to project participants and this was attributed to the evidence-based strategy implemented. Response rates to questionnaires sent to external stakeholders were disappointingly lower. Most of the high-level objectives were achieved, although applying the developed tools in practice will be implemented in the European network for Health Technology Assessment Joint Action 2 (EUnetHTA JA2). Most work packages produced their planned deliverables. Networking emerged as one of the main benefits of the project and face-to-face meetings were important. However, the overarching objective did not appear to have been met because there will be a follow-up EUnetHTA JA2 project (reliant on project funding) before the establishment of any permanent network. Twelve organisations from three continents participated in the Delphi exercise to develop the data set. It was demonstrated that a registry for matching pragmatic clinical studies under consideration by funders could be built on a very small data set. This would include 10 unique items, of which five are required to describe a study and the rest are metadata. In the test sample the data set with an appropriate matching rule was able to deliver a sensitivity of between 50% and 100% and a specificity of between 43% and 86% for matching different elements. A number of recommendations have been made for the next EUnetHTA JA2 project and its evaluation. This included that the evaluation of the EUnetHTA JA2 project should extend beyond the end of the project to allow assessment of its impact; that the quality, usability and cost-effectiveness of tools in 'real-world HTA practice' should be assessed and tangible benefits of international networking should be evaluated. It is worth proceeding to develop a database registry aimed at identifying trials in development based on the data set developed. The study was funded by the National Institute for Health Research Health Technology Assessment programme (50%) and the European Union Commission (50%).

European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis.

PubMed Central

Woodford Guegan, Eleanor; Cook, Andrew

2014-01-01

BACKGROUND The European network for Health Technology Assessment Joint Action (EUnetHTA JA) project's overarching objective was to 'establish an effective and sustainable HTA [Health technology assessment] collaboration in Europe that brings added value at the regional, national and European level'. Specific objectives were to develop a strategy and business model for sustainable European collaboration on HTA, develop HTA tools and methods and promote good practice in HTA methods and processes. We describe activities performed on behalf of the National Institute for Health Research HTA programme; evaluating the project processes and developing a data set for a registry of planned clinical studies of relevance to public funders. METHODS Annual self-completion online questionnaires were sent to project participants and external stakeholders to identify their views about the project processes. Documentary review was undertaken at the project end on the final technical reports from the work packages to examine whether or not their deliverables had been achieved. The project's impact was assessed by whether or not the deliverables were produced, the objectives met and additional 'added value' generated. The project's effectiveness was evaluated by its processes, communication, administration, workings of individual work packages and involvement of external stakeholders. A two-stage Delphi exercise was undertaken to identify the data elements that should be included in a registry of planned clinical studies of relevance to public funders. The data set was validated by an efficacy testing exercise. RESULTS AND DISCUSSION High response rates were achieved for the questionnaires sent to project participants and this was attributed to the evidence-based strategy implemented. Response rates to questionnaires sent to external stakeholders were disappointingly lower. Most of the high-level objectives were achieved, although applying the developed tools in practice will be implemented in the European network for Health Technology Assessment Joint Action 2 (EUnetHTA JA2). Most work packages produced their planned deliverables. Networking emerged as one of the main benefits of the project and face-to-face meetings were important. However, the overarching objective did not appear to have been met because there will be a follow-up EUnetHTA JA2 project (reliant on project funding) before the establishment of any permanent network. Twelve organisations from three continents participated in the Delphi exercise to develop the data set. It was demonstrated that a registry for matching pragmatic clinical studies under consideration by funders could be built on a very small data set. This would include 10 unique items, of which five are required to describe a study and the rest are metadata. In the test sample the data set with an appropriate matching rule was able to deliver a sensitivity of between 50% and 100% and a specificity of between 43% and 86% for matching different elements. CONCLUSIONS A number of recommendations have been made for the next EUnetHTA JA2 project and its evaluation. This included that the evaluation of the EUnetHTA JA2 project should extend beyond the end of the project to allow assessment of its impact; that the quality, usability and cost-effectiveness of tools in 'real-world HTA practice' should be assessed and tangible benefits of international networking should be evaluated. It is worth proceeding to develop a database registry aimed at identifying trials in development based on the data set developed. FUNDING The study was funded by the National Institute for Health Research Health Technology Assessment programme (50%) and the European Union Commission (50%). PMID:24913263

[How can the impact of Health Technology Assessment (HTA) in the Austrian healthcare system be assessed? Design of a conceptual framework].

PubMed

Schumacher, I; Zechmeister, I

2012-04-01

In Austria research in Health Technology Assessment (HTA) has been conducted since the 1990s. Research in HTA aims at supporting an adequate and efficient use of health care resources in order to sustain a publicly financed and solidary health care system. Ultimately, HTA research should result in better health of the population. Research results should provide independent information for decision makers. For legitimizing further research resources and for prioritizing future HTA research and guaranteeing the value of future research, HTA research needs itself to undergo evaluation. Aim of the study is to design a conceptual framework for evaluating the impact of HTA research in Austria on the basis of the existing literature. An already existing review which presents methods and concepts how to evaluate HTA-impact was updated by a systematic research including literature of the years 2004-January 2010. Results were analysed in regard to 4 categories: definition of the term impact, target groups and system levels, operationalisation of indicators and evaluation methods. Overall, 19 publications were included. Referring to the 4 categories, an explanation of impact has to take into account HTAs multidisciplinary setting and needs a context related definition. Target groups, system levels, indicators and methods depend on the impact defined. Studies investigated direct and indirect impact and were focused on different target groups like physicians, nurses and decision makers on the micro-, and meso level, as well as politicians and reimbursement institutions on the macro level. Except for one reference all studies applied already known and mostly qualitative methods for measuring the impact of HTA research. Thus, an appropriate pool of instruments seems to be available. There is a lack of information about validity of applied methods and indicators. By adapting adequate methods and concepts a conceptual framework for the Austrian HTA-Impact evaluation has been designed. The paper presents an overview of existing methods for the evaluation of the HTA research. This has been used to identify useful approaches for measuring the HTA-impact in Austria. By providing a context sensitive framework for impact evaluation in Austria the Austrian HTA-research contributes to the international trend of impact-evaluation. © Georg Thieme Verlag KG Stuttgart · New York.

Early dialogue with health technology assessment bodies: a European perspective.

PubMed

Cuche, Matthieu; Beckerman, Rachel; Chowdhury, Cyrus A; van Weelden, Marije A

2014-12-01

Evidence requirements may differ across HTA bodies, and so pharmaceutical companies must plan to synergize their evidence generation strategy, across global regulatory and HTA bodies. Until recently, companies had no official platform to discuss the clinical development of a drug with HTA bodies; however, this is changing. To achieve broad usage in the EU, products must achieve both regulatory and reimbursement approval, the latter of which is based on HTA appraisal in many markets. The objective of this study is to present and evaluate the different options available for early HTA consultation (during drug development/Phase III) in the major European markets from the industry perspective. An exploratory (nonsystematic) literature review was performed to identify the European markets offering early HTA consultations, and each process was analyzed using a set of predefined metrics that are relevant to industry (the ability to consult with the regulatory body in parallel, consultation fees, length of consultation meeting, language of consultation meeting, maximum number of pharmaceutical company employees attending, procedural timelines, nature of data for which consultative advice can be sought, the output of the process, and the ability to involve external experts). Four different types of early HTA consultation processes were identified across the major European HTA markets. The nature of these processes varied in terms of the types and number of questions that can be addressed, the length of the meeting, the reporting output, and the ability to involve external experts. The availability of various options for early HTA consultation may help to avoid a mismatch between the evidence generated by means of a product's clinical development program, and the evidence expected by HTA bodies and payers, which can facilitate the pricing and reimbursement process upon a product's market authorization.

Health technology assessment of medical devices: a survey of non-European union agencies.

PubMed

Ciani, Oriana; Wilcher, Britni; Blankart, Carl Rudolf; Hatz, Maximilian; Rupel, Valentina Prevolnik; Erker, Renata Slabe; Varabyova, Yauheniya; Taylor, Rod S

2015-01-01

The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies. In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices. The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.

HARMONIZING HEALTH TECHNOLOGY ASSESSMENT PRACTICES IN UNIVERSITY HOSPITALS: TO WHAT EXTENT IS THE MINI-HTA MODEL SUITABLE IN THE FRENCH CONTEXT?

PubMed

Martelli, Nicolas; Devaux, Capucine; van den Brink, Hélène; Billaux, Mathilde; Pineau, Judith; Prognon, Patrice; Borget, Isabelle

2017-01-01

The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis. The aim of this study was to assess a mini-HTA model as a potential solution to harmonize HTA methodology in French UHs. A systematic review was conducted on Medline, Embase, Health Technology Assessment database, and Google Scholar to identify published articles reporting the use of mini-HTA tools and decision support-like models. A survey was also carried out in eighteen French UHs to identify in-house decision support tools. Finally, topics evaluated in the Danish mini-HTA model and in French UHs were compared using Jaccard similarity coefficients. Our findings showed differences between topics evaluated in French UHs and those assessed in decision support models from the literature. Only five topics among the thirteen most evaluated in French UHs were similar to those assessed in the Danish mini-HTA model. The organizational and ethical/social impacts were rarely explored among the surveyed models used in French UHs when introducing new medical devices. Before its widespread and harmonized use in French UHs, the mini-HTA model would first require adaptations to the French context.

HTA programme response to the challenges of dealing with orphan medicinal products: Process evaluation in selected European countries.

PubMed

Nicod, Elena; Annemans, Lieven; Bucsics, Anna; Lee, Anne; Upadhyaya, Sheela; Facey, Karen

2017-03-28

Challenges commonly encountered in HTA of orphan medicinal products (OMPs) were identified in Advance-HTA. Since then, new initiatives have been developed to specifically address issues related to HTA of OMPs. This study aimed to understand why these new HTA initiatives in England, Scotland and at European-level were established and whether they resolve the challenges of OMPs. The work of Advance-HTA was updated with a literature review and a conceptual framework of clinical, regulatory and economic challenges for OMPs was developed. The new HTA programmes were critiqued against the conceptual framework and outstanding challenges identified. The new programmes in England and Scotland recognise the challenges identified in demonstrating the value of ultra-OMPs (and OMPs) and that they require a different process to standard HTA approaches. Wider considerations of disease and treatment experiences from a multi-stakeholder standpoint are needed, combined with other measures to deal with uncertainty (e.g. managed entry agreements). While approaches to assessing this new view of value of OMPs, extending beyond cost/QALY frameworks, differ, their criteria are similar. These are complemented by a European initiative that fosters multi-stakeholder dialogue and consensus about value determinants throughout the life-cycle of an OMP. New HTA programmes specific to OMPs have been developed but questions remain about whether they sufficiently capture value and manage uncertainty in clinical practice. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

HTA IN CENTRAL-EASTERN-SOUTHERN EUROPE: FINDING ITS WAY TO HEALTH POLICY.

PubMed

Zawada, Anna; Mäkelä, Marjukka

2017-01-01

The number of publications on health technology assessment (HTA) from Central, Eastern, and Southern Europe (CESE countries) is still low compared with the north and west of Europe. It is not surprising, as the idea of HTA originated from high-income Western economies and was afterward adopted by the south-eastern part of Europe, which mostly consists of middle-income countries. These CESE countries, with less capacity and experience with HTA processes, must deal with even tougher decisions on financing health technologies than north-western Europe. There may even be a lack of confidence to open discussions on their specific needs for HTA.

Information technology law and health systems in the European Union.

PubMed

Mossialos, Elias; Thomson, Sarah; Ter Linden, Annemarie

2004-01-01

This study aims to examine the impact of European Union (EU) law relating to information technology (IT) on health systems. The study identifies EU directives relating to IT, analyzes them in terms of their impact on the use of IT in health systems, and outlines their implications for health technology assessment (HTA). Analysis is based on a review of literature identified through relevant databases and Internet searches. Developments in IT have serious implications for EU health systems, presenting policy makers with new challenges. The European Commission has adopted a range of legal measures to protect consumers in the "information society" However, as few of them are health-specific, it is not evident that they have implications for health, health systems, or HTA, and they may not be effective in protecting consumers in the health sector. In light of the growing importance of IT in the health sector, legal and nonlegal measures need to be further developed at EU and international level. Where possible, future initiatives should pay attention to the particular characteristics of health goods and services and health systems. Although definitions of HTA usually recognize the importance of evaluating both the indirect, unintended consequences of health technologies and the legal aspects of their application, it seems that, in practice, HTA often overlooks or underestimates legislative matters. Those involved in HTA should be aware of the legal implications of using IT to provide health goods and services and compile, store, transfer, and disseminate health information electronically.

Value-based approaches to healthcare systems and pharmacoeconomics requirements in Asia: South Korea, Taiwan, Thailand and Japan.

PubMed

Kamae, Isao

2010-01-01

Asian healthcare systems are very diverse, representing cultures, political systems and economies from more than 30 countries with varying histories. Despite the diversity in the region, there has been enormous growth in health economics and outcomes research since the beginning of the 21st century. Whilst Japan has seen very limited use of health technology assessment (HTA), South Korea, Taiwan and Thailand have had remarkable success in establishing government agencies for HTA, employing HTA concepts from the UK National Institute for Health and Clinical Excellence (NICE). These three countries are driven by the following common factors: (i) a desire to establish universal healthcare insurance coverage in their respective nations; (ii) the need for rational allocation of scarce resources; (iii) a desire for government to provide leadership in HTA; and (iv) availability of HTA professionals and faculties through international networks. The HTA models introduced by these three countries are both similar to and different from those of HTA agencies in Europe, but might work well as examples for other countries in the region.

The safer clinical systems project in renal care.

PubMed

Weale, Andy R

2013-09-01

Current systems in place in healthcare are designed to detect harm after it has happened (e.g critical incident reports) and make recommendations based on an assessment of that event. Safer Clinical Systems, a Health Foundation funded project, is designed to proactively search for risk within systems, rather than being reactive to harm. The aim of the Safer Clinical Systems project in Renal Care was to reduce the risks associated with shared care for patients who are undergoing surgery but are looked after peri-operatively by nephrology teams on nephrology wards. This report details our findings of the diagnostic phase of Safer Clinical Systems: the proactive search for risk. We have evaluated the current system of care using a set of risk evaluation and process mapping tools (Failure Modes and Effects Analysis (FMEA) and Hierarchical Task Analysis HTA). We have engaged staff with the process mapping and risk assessment tools. We now understand our system and understand where the highest risk tasks are undertaken during a renal in-patient stay during which a patient has an operation. These key tasks occur across the perioperaive period and are not confined to one aspect of care. A measurement strategy and intervention plan have been designed around these tasks. Safer Clinical Systems has identified high risk, low reliability tasks in our system. We look forward to fully reporting these data in 2014. © 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Breaking up is hard to do: why disinvestment in medical technology is harder than investment.

PubMed

Haas, Marion; Hall, Jane; Viney, Rosalie; Gallego, Gisselle

2012-05-01

Healthcare technology is a two-edged sword - it offers new and better treatment to a wider range of people and, at the same time, is a major driver of increasing costs in health systems. Many countries have developed sophisticated systems of health technology assessment (HTA) to inform decisions about new investments in new healthcare interventions. In this paper, we question whether HTA is also the appropriate framework for guiding or informing disinvestment decisions. In exploring the issues related to disinvestment, we first discuss the various HTA frameworks which have been suggested as a means of encouraging or facilitating disinvestment. We then describe available means of identifying candidates for disinvestment (comparative effectiveness research, clinical practice variations, clinical practice guidelines) and for implementing the disinvestment process (program budgeting and marginal analysis (PBMA) and related techniques). In considering the possible reasons for the lack of progress in active disinvestment, we suggest that HTA is not the right framework as disinvestment involves a different decision making context. The key to disinvestment is not just what to stop doing but how to make it happen - that is, decision makers need to be aware of funding disincentives.

Health technology assessment in Saudi Arabia.

PubMed

Al-Aqeel, Sinaa

2018-05-16

The Saudi government, similar to any other government, is committed to making public spending more efficient, using resources more effectively, and limiting waste. Health technology assessment (HTA) is a tool that informs policy and decision makers regarding the formulation of safe and effective policies that are patient-focused and help to achieve efficiency when allocating limited health-care resources. Areas covered: After a brief description of HTA in the international context, this review provides a brief introduction to Saudi Arabia's health-care system, followed by a delineation of the decision maker(s) and influencers and the decision-making process for pricing and reimbursement. The article then discusses the current status of HTA in Saudi Arabia and proposes four strategic objectives that can form the first step in the development of a formal HTA process. Expert commentary: In Saudi Arabia, facilitators for incorporating HTA into the decision-making process exist. Future local research is needed to guide the implementation of full HTA.

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

PubMed

Frosini, Francesco; Miniati, Roberto; Grillone, Saverio; Dori, Fabrizio; Gentili, Guido Biffi; Belardinelli, Andrea

2016-11-14

The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

High Altitude Long Endurance UAV Analysis of Alternatives and Technology Requirements Development

NASA Technical Reports Server (NTRS)

Nickol, Craig L.; Guynn, Mark D.; Kohout, Lisa L.; Ozoroski, Thomas A.

2007-01-01

An Analysis of Alternatives and a Technology Requirements Study were conducted for two mission areas utilizing various types of High Altitude Long Endurance (HALE) Unmanned Aerial Vehicles (UAV). A hurricane science mission and a communications relay mission provided air vehicle requirements which were used to derive sixteen potential HALE UAV configurations, including heavier-than-air (HTA) and lighter-than-air (LTA) concepts with both consumable fuel and solar regenerative propulsion systems. A HTA diesel-fueled wing-body-tail configuration emerged as the preferred concept given near-term technology constraints. The cost effectiveness analysis showed that simply maximizing vehicle endurance can be a sub-optimum system solution. In addition, the HTA solar regenerative configuration was utilized to perform both a mission requirements study and a technology development study. Given near-term technology constraints, the solar regenerative powered vehicle was limited to operations during the long days and short nights at higher latitudes during the summer months. Technology improvements are required in energy storage system specific energy and solar cell efficiency, along with airframe drag and mass reductions to enable the solar regenerative vehicle to meet the full mission requirements.

The HTA core model: a novel method for producing and reporting health technology assessments.

PubMed

Lampe, Kristian; Mäkelä, Marjukka; Garrido, Marcial Velasco; Anttila, Heidi; Autti-Rämö, Ilona; Hicks, Nicholas J; Hofmann, Björn; Koivisto, Juha; Kunz, Regina; Kärki, Pia; Malmivaara, Antti; Meiesaar, Kersti; Reiman-Möttönen, Päivi; Norderhaug, Inger; Pasternack, Iris; Ruano-Ravina, Alberto; Räsänen, Pirjo; Saalasti-Koskinen, Ulla; Saarni, Samuli I; Walin, Laura; Kristensen, Finn Børlum

2009-12-01

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). 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. 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. 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.

Policies for Use of Real-World Data in Health Technology Assessment (HTA): A Comparative Study of Six HTA Agencies.

PubMed

Makady, Amr; Ham, Renske Ten; de Boer, Anthonius; Hillege, Hans; Klungel, Olaf; Goettsch, Wim

2017-04-01

Randomized controlled trials provide robust data on the efficacy of interventions rather than on effectiveness. Health technology assessment (HTA) agencies worldwide are thus exploring whether real-world data (RWD) may provide alternative sources of data on effectiveness of interventions. Presently, an overview of HTA agencies' policies for RWD use in relative effectiveness assessments (REA) is lacking. To review policies of six European HTA agencies on RWD use in REA of drugs. A literature review and stakeholder interviews were conducted to collect information on RWD policies for six agencies: the Dental and Pharmaceutical Benefits Agency (Sweden), the National Institute for Health and Care Excellence (United Kingdom), the Institute for Quality and Efficiency in Healthcare (Germany), the High Authority for Health (France), the Italian Medicines Agency (Italy), and the National Healthcare Institute (The Netherlands). The following contexts for RWD use in REA of drugs were reviewed: initial reimbursement discussions, pharmacoeconomic analyses, and conditional reimbursement schemes. We identified 13 policy documents and 9 academic publications, and conducted 6 interviews. Policies for RWD use in REA of drugs notably differed across contexts. Moreover, policies differed between HTA agencies. Such variations might discourage the use of RWD for HTA. To facilitate the use of RWD for HTA across Europe, more alignment of policies seems necessary. Recent articles and project proposals of the European network of HTA may provide a starting point to achieve this. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments.

PubMed

Ciani, Oriana; Wilcher, Britni; van Giessen, Anoukh; Taylor, Rod S

2017-02-01

Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

CHANGING HEALTH TECHNOLOGY ASSESSMENT PARADIGMS?

PubMed

Husereau, Don; Henshall, Chris; Sampietro-Colom, Laura; Thomas, Sarah

2016-01-01

Health technology assessment (HTA) has to innovate to best support changing health system environments and to help provide access to valuable innovation under fiscal constraint. Issues associated with changing HTA paradigms were identified through scoping and explored through deliberation at a meeting of industry and HTA leaders. Five broad areas of change (engagement, scientific dialogue, research prioritization, adaptive approaches, and real world data) were identified. The meeting focused on two themes derived from these: re-thinking scientific dialogue and multi-stakeholder engagement, and re-thinking value, affordability, and access. Earlier and ongoing engagement to steer the innovation process and help achieve appropriate use across the technology lifecycle was perceived as important but would be resource intensive and would require priority setting. Patients need to be involved throughout, and particularly at the early stages. Further discussion is needed on the type of body best suited to convening the dialogue required. There was agreement that HTA must continue to assess value, but views differed on the role that HTA should play in assessing affordability and on appropriate responses to challenges around affordability. Enhanced horizon scanning could play an important role in preparing for significant future investments. Early and ongoing multi-stakeholder engagement and revisiting approaches to valuing innovation are required. Questions remain as to the most appropriate role for HTA bodies. Changing HTA paradigms extend HTA's traditional remit of being responsive to decision-makers demands to being more proactive and considering whole system value.

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT IN IRAN.

PubMed

Mohtasham, Farideh; Majdzadeh, Reza; Jamshidi, Ensiyeh

2017-01-01

Hospitals with health technology assessment (HTA) programs have reported its positive effects on the management of resources and costs. This study aimed to identify the barriers faced by hospital-based HTA (HBHTA) in Iran by inductive content analysis of stakeholders' and decision-makers' points of view. The key individuals and organizations that could provide rich, relevant, and diverse data in response to the research question were purposively selected for the interviews and focus group discussion. Twelve stakeholders from seven public hospitals participated in the interviews. Another eighteen stakeholders from twelve HBHTA-related organizations took part in the focus group discussion. Most of the hospitals' senior management team did not feel the need for HBHTA and believed that in Iran a systematic process like HTA faces many challenges. The stakeholders participating in this study highlighted the significance of certain points that needed to be addressed before establishing HBHTA in Iran.

The use of non-economic criteria in pricing and reimbursement decisions in Central and Eastern Europe: issues, trends and recommendations.

PubMed

Kolasa, Katarzyna; Kalo, Zoltan; Zah, Vladimir

2016-08-01

According to some experts, there is still room for improvement with regard to the inclusion of ethical considerations in Health Technology Assessment (HTA). The pros and cons of the introduction of non-economic criteria in the HTA process in Central and Eastern Europe (CEE) are discussed. In comparison to Western Europe, financial considerations are even more important in CEE settings; however, it could also be said that attachment to equity and justice is part of CEE's heritage. Therefore, the trade-off between conflicting principles is evaluated. Expert commentary: To ensure the right balance between equity and efficiency in decision making, the current HTA framework has to be further augmented to allow all conflicting criteria to be addressed to a satisfactory degree. Following other examples, the applicability of multi criteria decision analysis technique to CEE settings should be further investigated.

Diffusion and use of health technology assessment in policy making: what lessons for decentralised healthcare systems?

PubMed

Ciani, Oriana; Tarricone, Rosanna; Torbica, Aleksandra

2012-12-01

The Italian National Healthcare System (NHS) is one of the most decentralised systems since the devolution reform approved in 2001. HTA is spreading as an important tool for decision-making processes both at central and local levels. The aims of this study were to review the state of the health technology assessment (HTA) programmes in Italy - with a focus on regional and central initiatives - and to discuss consequences of a multi-level structure of HTA agencies in highly regionalised healthcare systems. Our method combined documentary review with interviews. We reviewed scientific literature about HTA's activities in decentralised systems, legislative and administrative documents from national as well as regional authorities. Semi-structured interviews were conducted with 18 key individuals associated with HTA both at the national and regional levels. Data on HTA programmes implemented or under development in nine regions were collected and analysed according to key principles for the improved conduct of health technology assessments for resource allocation decisions. HTA is in the early stage of development in Italy, although with great heterogeneity across regions. The National Agency for Health Services has certainly contributed to HTA diffusion through supporting and training activities. However, the multi-level structure of HTA in Italy has not yet provided full coordination and harmonisation of practices and outcomes across the country, with a consequent exacerbate inequality of access to services and technologies. There is probably need to rethink the multi-layer organizational framework of HTA in Italy by leveraging on current knowledge and efficient redistribution of activities across regions. We would advise for different jurisdictions playing different roles while achieving similar health outcomes for their patients, rather than jurisdictions aiming at doing exactly the same things resulting in unequal access to healthcare service provision. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The impact of HTA and procurement practices on the selection and prices of medical devices.

PubMed

Callea, Giuditta; Armeni, Patrizio; Marsilio, Marta; Jommi, Claudio; Tarricone, Rosanna

2017-02-01

Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices. This paper focuses on medical devices (MDs) and investigates the combined effect of various HTA governance models and procurement practices on the two steps of the MD purchasing process (i.e., selecting the product and setting the unit price). Our analyses are based on primary data collected through a national survey of Italian public hospitals. The Italian National Health Service is an ideal case study because it is highly decentralized and because regions have adopted different HTA governance models (i.e., regional, hospital-based, double-level or no HTA), often in combination with centralized regional procurement programs. Hence, the Italian case allows us to test the impact of different combinations of HTA models and procurement programs in the various regions. The results show that regional HTA increases the probability of purchasing the costliest devices, whereas hospital-based HTA functions more like a cost-containment unit. Centralized regional procurement does not significantly affect MD selection and is associated with a reduction in the MD unit price: on average, hospitals located in regions with centralized procurement pay 10.1% less for the same product. Hospitals located in regions with active regional HTA programs pay higher prices for the same device (+23.2% for inexpensive products), whereas hospitals that have developed internal HTA programs pay 8.3% on average more for the same product. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

[Health technology assessment (HTA). Developments in healthcare and potential for radiology].

PubMed

Gizewski, E R; Forsting, M; Krombach, G A; Schöffski, O

2014-06-01

Cost-intensive measures and procedures, such as also employed in radiology, have far-reaching economic implications in respect to increasing expenditure with limited resources. Health technology assessment (HTA) describes the systematic evaluation of medical procedures and technologies which in recent years has been introduced by many countries into healthcare politics. In many cases HTA analyses can be directly implemented into practice as shown by the examples given in this article; however, in the current form of HTA the practical implementation for radiology often presents the problem that the cost-benefit ratio does not yet have a comprehensive view in the HTA report but is limited to a subsection, e.g. current costs versus sensitivity of a method. Since its inception radiology has had a high power of innovation and new developments will also substantially determine the future years. These procedures must not only be evaluated with respect to feasibility but also in the sense of the HTA in the total concept. In radiology there are also a large number of possibilities for radiologists not only as passive consumers of HTA reports but also to become active participants in this process, an opportunity which should be taken advantage of.

HTA and decision-making processes in Central, Eastern and South Eastern Europe: Results from a survey.

PubMed

García-Mochón, Leticia; Espín Balbino, Jaime; Olry de Labry Lima, Antonio; Caro Martinez, Araceli; Martin Ruiz, Eva; Pérez Velasco, Román

2017-03-31

To gain knowledge and insights on health technology assessment (HTA) and decision-making processes in Central, Eastern and South Eastern Europe (CESEE) countries. A cross-sectional study was performed. Based on the literature, a questionnaire was developed in a multi-stage process. The questionnaire was arranged according to 5 broad domains: (i) introduction/country settings; (ii) use of HTA in the country; (iii) decision-making process; (iv) implementation of decisions; and (v) HTA and decision-making: future challenges. Potential survey respondents were identified through literature review-with a total of 118 contacts from the 24 CESEE countries. From March to July 2014, the survey was administered via e-mail. A total of 22 questionnaires were received generating an 18.6% response rate, including 4 responses indicating that their institutions had no involvement in HTA. Most of the CESEE countries have entities under government mandates with advisory functions and different responsibilities for decision-making, but mainly in charge of the reimbursement and pricing of medicines. Other areas where discrepancies across countries were found include criteria for selecting technologies to be assessed, stakeholder involvement, evidence requirements, use of economic evaluation, and timeliness of HTA. A number of CESEE countries have created formal decision-making processes for which HTA is used. However, there is a high level of heterogeneity related to the degree of development of HTA structures, and the methods and processes followed. Further studies focusing on the countries from which information is scarcer and on the HTA of health technologies other than medicines are warranted. Reviews/comparative analyses. Copyright © 2017 Elsevier B.V. All rights reserved.

Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries.

PubMed

Oortwijn, Wija; Determann, Domino; Schiffers, Krijn; Tan, Siok Swan; van der Tuin, Jeroen

2017-09-01

To assess the level of comprehensiveness of health technology assessment (HTA) practices around the globe and to formulate recommendations for enhancing legitimacy and fairness of related decision-making processes. To identify best practices, we developed an evaluation framework consisting of 13 criteria on the basis of the INTEGRATE-HTA model (integrative perspective on assessing health technologies) and the Accountability for Reasonableness framework (deliberative appraisal process). We examined different HTA systems in middle-income countries (Argentina, Brazil, and Thailand) and high-income countries (Australia, Canada, England, France, Germany, Scotland, and South Korea). For this purpose, desk research and structured interviews with relevant key stakeholders (N = 32) in the selected countries were conducted. HTA systems in Canada, England, and Scotland appear relatively well aligned with our framework, followed by Australia, Germany, and France. Argentina and South Korea are at an early stage, whereas Brazil and Thailand are at an intermediate level. Both desk research and interviews revealed that scoping is often not part of the HTA process. In contrast, providing evidence reports for assessment is well established. Indirect and unintended outcomes are increasingly considered, but there is room for improvement. Monitoring and evaluation of the HTA process is not well established across countries. Finally, adopting transparent and robust processes, including stakeholder consultation, takes time. This study presents a framework for assessing the level of comprehensiveness of the HTA process in a country. On the basis of applying the framework, we formulate recommendations on how the HTA community can move toward a more integrated decision-making process using HTA. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Hospital-based health technology assessment: developments to date.

PubMed

Gagnon, Marie-Pierre

2014-09-01

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.

Expression Profiling Smackdown: Human Transcriptome Array HTA 2.0 vs. RNA-Seq

PubMed Central

Palermo, Meghann; Driscoll, Heather; Tighe, Scott; Dragon, Julie; Bond, Jeff; Shukla, Arti; Vangala, Mahesh; Vincent, James; Hunter, Tim

2014-01-01

The advent of both microarray and massively parallel sequencing have revolutionized high-throughput analysis of the human transcriptome. Due to limitations in microarray technology, detecting and quantifying coding transcript isoforms, in addition to non-coding transcripts, has been challenging. As a result, RNA-Seq has been the preferred method for characterizing the full human transcriptome, until now. A new high-resolution array from Affymetrix, GeneChip Human Transcriptome Array 2.0 (HTA 2.0), has been designed to interrogate all transcript isoforms in the human transcriptome with >6 million probes targeting coding transcripts, exon-exon splice junctions, and non-coding transcripts. Here we compare expression results from GeneChip HTA 2.0 and RNA-Seq data using identical RNA extractions from three samples each of healthy human mesothelial cells in culture, LP9-C1, and healthy mesothelial cells treated with asbestos, LP9-A1. For GeneChip HTA 2.0 sample preparation, we chose to compare two target preparation methods, NuGEN Ovation Pico WTA V2 with the Encore Biotin Module versus Affymetrix's GeneChip WT PLUS with the WT Terminal Labeling Kit, on identical RNA extractions from both untreated and treated samples. These same RNA extractions were used for the RNA-Seq library preparation. All analyses were performed in Partek Genomics Suite 6.6. Expression profiles for control and asbestos-treated mesothelial cells prepared with NuGEN versus Affymetrix target preparation methods (GeneChip HTA 2.0) are compared to each other as well as to RNA-Seq results.

Using health technology assessment to support optimal use of technologies in current practice: the challenge of "disinvestment".

PubMed

Henshall, Chris; Schuller, Tara; Mardhani-Bayne, Logan

2012-07-01

Health systems face rising patient expectations and economic pressures; decision makers seek to enhance efficiency to improve access to appropriate care. There is international interest in the role of HTA to support decisions to optimize use of established technologies, particularly in "disinvesting" from low-benefit uses. This study summarizes main points from an HTAi Policy Forum meeting on this topic, drawing on presentations, discussions among attendees, and an advance background paper. Optimization involves assessment or re-assessment of a technology, a decision on optimal use, and decision implementation. This may occur within a routine process to improve safety and quality and create "headroom" for new technologies, or ad hoc in response to financial constraints. The term "disinvestment" is not always helpful in describing these processes. HTA contributes to optimization, but there is scope to increase its role in many systems. Stakeholders may have strong views on access to technology, and stakeholder involvement is essential. Optimization faces challenges including loss aversion and entitlement, stakeholder inertia and entrenchment, heterogeneity in patient outcomes, and the need to demonstrate convincingly absence of benefit. While basic HTA principles remain applicable, methodological developments are needed better to support optimization. These include mechanisms for candidate technology identification and prioritization, enhanced collection and analysis of routine data, and clinician engagement. To maximize value to decision makers, HTA should consider implementation strategies and barriers. Improving optimization processes calls for a coordinated approach, and actions are identified for system leaders, HTA and other health organizations, and industry.

Applying rapid 'de-facto' HTA in resource-limited settings: experience from Romania.

PubMed

Lopert, Ruth; Ruiz, Francis; Chalkidou, Kalipso

2013-10-01

In attempting to constrain healthcare expenditure growth, health technology assessment (HTA) can enable policy-makers to look beyond budget impact and facilitate more rational decision-making. However lack of technical capacity and poor governance can limit use in some countries. Undertaking de facto HTA by adapting decisions taken in countries with established processes is a method that may be applied while building domestic HTA capacity. We explored the potential for applying this approach in Romania. As part of a review of the basic health benefits available to insured Romanians we examined the listing process and content of the Romanian drug reimbursement formulary. We assessed value for money indirectly by drawing on appraisals by UK's NICE, and for products considered cost effective in the UK, adjusting prices by the ratio of Romanian per capita GDP to UK per capita GDP. We found more than 30 of the top 50 medicines on the Romanian formulary unlikely to be cost-effective, suggesting that existing external reference pricing mechanisms may not be delivering good value for money. While not taking into account local costs or treatment patterns, absent local considerations of value for money, this method offers a guide for both drug selection and pricing. Until robust local HTA processes are established this approach could support further analysis of existing prices and pricing mechanisms. Applied more generally, it is arguably preferable to external reference pricing, product delisting or arbitrary price cuts, and may support the future development of more rigorous, evidence-based decision-making. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Commissioning and operation of the horizontal test apparatus at SNS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, Sang-Ho; Neustadt, Thomas S.; Howell, Matthew P.

2015-07-01

The Spallation Neutron Source (SNS) at Oak Ridge National Lab (ORNL) has built, commissioned and operated a Horizontal Test Apparatus (HTA) vessel in the Radiofrequency Test Facility (RFTF) test cave. It can be operated at 4.5 K using the independent Cryogenic Test Facility (CTF). The HTA is designed to be a single cavity version of an SNS cryomodule with the ability to demount and replace the cavity. It provides the functionality for testing a single dressed SNS medium or high beta Superconducting Radiofrequency (SRF) cavity. The HTA is currently being used in support of R&D for in-situ plasma processing ofmore » the cavity's inner niobium surface. The design and commissioning of the HTA at 4.5 K will be presented as well as results from operating the HTA including cool-down, warm-up and steady state operations. Results from plasma processing a warm SCRF cavity in-between cold HTA tests will also be reported.« less

KNOW ESSENTIALS: a tool for informed decisions in the absence of formal HTA systems.

PubMed

Mathew, Joseph L

2011-04-01

Most developing countries and resource-limited settings lack robust health technology assessment (HTA) systems. Because the development of locally relevant HTA is not immediately viable, and the extrapolation of external HTA is inappropriate, a new model for evaluating health technologies is required. The aim of this study was to describe the development and application of KNOW ESSENTIALS, a tool facilitating evidence-based decisions on health technologies by stakeholders in settings lacking formal HTA systems. Current HTA methodology was examined through literature search. Additional issues relevant to resource-limited settings, but not adequately addressed in current methodology, were identified through further literature search, appraisal of contextually relevant issues, discussion with healthcare professionals familiar with the local context, and personal experience. A set of thirteen elements important for evidence-based decisions was identified, selected and combined into a tool with the mnemonic KNOW ESSENTIALS. Detailed definitions for each element, coding for the elements, and a system to evaluate a given health technology using the tool were developed. Developing countries and resource-limited settings face several challenges to informed decision making. Models that are relevant and applicable in high-income countries are unlikely in such settings. KNOW ESSENTIALS is an alternative that facilitates evidence-based decision making by stakeholders without formal expertise in HTA. The tool could be particularly useful, as an interim measure, in healthcare systems that are developing HTA capacity. It could also be useful anywhere when rapid evidence-based decisions on health technologies are required.

Toward a new information infrastructure in health technology assessment: communication, design, process, and results.

PubMed

Neikter, Susanna Allgurin; Rehnqvist, Nina; Rosén, Måns; Dahlgren, Helena

2009-12-01

The aim of this study was to facilitate effective internal and external communication of an international network and to explore how to support communication and work processes in health technology assessment (HTA). STRUCTURE AND METHODS: European network for Health Technology Assessment (EUnetHTA) connected sixty-four HTA Partner organizations from thirty-three countries. User needs in the different steps of the HTA process were the starting point for developing an information system. A step-wise, interdisciplinary, creative approach was used in developing practical tools. An Information Platform facilitated the exchange of scientific information between Partners and with external target groups. More than 200 virtual meetings were set up during the project using an e-meeting tool. A Clearinghouse prototype was developed with the intent to offering a single point of access to HTA relevant information. This evolved into a next step not planned from the outset: Developing a running HTA Information System including several Web-based tools to support communication and daily HTA processes. A communication strategy guided the communication effort, focusing on practical tools, creating added value, involving stakeholders, and avoiding duplication of effort. Modern technology enables a new information infrastructure for HTA. The potential of information and communication technology was used as a strategic tool. Several target groups were represented among the Partners, which supported collaboration and made it easier to identify user needs. A distinctive visual identity made it easier to gain and maintain visibility on a limited budget.

Is There a European View on Health Economic Evaluations? Results from a Synopsis of Methodological Guidelines Used in the EUnetHTA Partner Countries.

PubMed

Heintz, Emelie; Gerber-Grote, Andreas; Ghabri, Salah; Hamers, Francoise F; Rupel, Valentina Prevolnik; Slabe-Erker, Renata; Davidson, Thomas

2016-01-01

The objectives of this study were to review current methodological guidelines for economic evaluations of all types of technologies in the 33 countries with organizations involved in the European Network for Health Technology Assessment (EUnetHTA), and to provide a general framework for economic evaluation at a European level. Methodological guidelines for health economic evaluations used by EUnetHTA partners were collected through a survey. Information from each guideline was extracted using a pre-tested extraction template. On the basis of the extracted information, a summary describing the methods used by the EUnetHTA countries was written for each methodological item. General recommendations were formulated for methodological issues where the guidelines of the EUnetHTA partners were in agreement or where the usefulness of economic evaluations may be increased by presenting the results in a specific way. At least one contact person from all 33 EUnetHTA countries (100 %) responded to the survey. In total, the review included 51 guidelines, representing 25 countries (eight countries had no methodological guideline for health economic evaluations). On the basis of the results of the extracted information from all 51 guidelines, EUnetHTA issued ten main recommendations for health economic evaluations. The presented review of methodological guidelines for health economic evaluations and the consequent recommendations will hopefully improve the comparability, transferability and overall usefulness of economic evaluations performed within EUnetHTA. Nevertheless, there are still methodological issues that need to be investigated further.

Integration of health technology assessment recommendations into organizational and clinical practice: A case study in Catalonia.

PubMed

Gagnon, Marie-Pierre; Sánchez, Emília; Pons, Joan M V

2006-01-01

Evaluating the impact of recommendations based upon health technology assessment (HTA) represents a challenge for both HTA agencies and healthcare policy makers. This research sought to understand factors affecting the uptake of HTA recommendations to support decision making with respect to the introduction of three health technologies. Using a multidimensional framework, based upon a combination of theoretical models, a case study was conducted. A total of twenty-eight semistructured interviews were done with physicians from fifteen hospitals and other stakeholders in Catalonia. Interview content was analyzed iteratively and classified according to theoretical dimensions and contextual factors. At the sociopolitical level, factors related to the organization and financing of the health system were found to affect the utilization of HTA recommendations. At the healthcare organization level, existing collaborations between the hospital and the HTA agency favored the integration of recommendations into practices. Formalism in the organization also influenced the utilization of HTA recommendations. At the professional level, the high degree of autonomy of specialists, the importance of peers and collegial control, and the definition of professional roles and responsibilities influenced physicians' willingness to integrate HTA recommendations into their practice. This study offers a comprehensive framework to understand the complex dynamics that affect adoption of health technologies in organizational and professional practices. The findings suggest some avenues to promote the integration of HTA recommendations into practices and, thus, increase the utilization of scientific evidence to support decision making in health care.

Prioritizing investments in health technology assessment. Can we assess potential value for money?

PubMed

Davies, L; Drummond, M; Papanikolaou, P

2000-01-01

The objective was to develop an economic prioritization model to assist those involved in the selection and prioritization of health technology assessment topics and commissioning of HTA projects. The model used decision analytic techniques to estimate the expected costs and benefits of the health care interventions that were the focus of the HTA question(s) considered by the NHS Health Technology Assessment Programme in England. Initial estimation of the value for money of HTA was conducted for several topics considered in 1997 and 1998. The results indicate that, using information routinely available in the literature and from the vignettes, it was not possible to estimate the absolute value of HTA with any certainty for this stage of the prioritization process. Overall, the results were uncertain for 65% of the HTA questions or topics analyzed. The relative costs of the interventions or technologies compared to existing costs of care and likely levels of utilization were critical factors in most of the analyses. The probability that the technology was effective with the HTA and the impact of the HTA on utilization rates were also key determinants of expected costs and benefits. The main conclusion was that it is feasible to conduct ex ante assessments of the value for money of HTA for specific topics. However, substantial work is required to ensure that the methods used are valid, reliable, consistent, and an efficient use of valuable research time.

PUBLIC AND PATIENT INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT: A FRAMEWORK FOR ACTION.

PubMed

Abelson, Julia; Wagner, Frank; DeJean, Deirdre; Boesveld, Sarah; Gauvin, Franςois-Pierre; Bean, Sally; Axler, Renata; Petersen, Stephen; Baidoobonso, Shamara; Pron, Gaylene; Giacomini, Mita; Lavis, John

2016-01-01

As health technology assessment (HTA) organizations in Canada and around the world seek to involve the public and patients in their activities, frameworks to guide decisions about whom to involve, through which mechanisms, and at what stages of the HTA process have been lacking. The aim of this study was to describe the development and outputs of a comprehensive framework for involving the public and patients in a government agency's HTA process. The framework was informed by a synthesis of international practice and published literature, a dialogue with local, national and international stakeholders, and the deliberations of a government agency's public engagement subcommittee in Ontario, Canada. The practice and literature synthesis failed to identify a single, optimal approach to involving the public and patients in HTA. Choice of methods should be considered in the context of each HTA stage, goals for incorporating societal and/or patient perspectives into the process, and relevant societal and/or patient values at stake. The resulting framework is structured around four actionable elements: (i) guiding principles and goals for public and patient involvement (PPI) in HTA, (ii) the establishment of a common language to support PPI efforts, (iii) a flexible array of PPI approaches, and (iv) on-going evaluation of PPI to inform adjustments over time. A public and patient involvement framework has been developed for implementation in a government agency's HTA process. Core elements of this framework may apply to other organizations responsible for HTA and health system quality improvement.

STAKEHOLDER INVOLVEMENT IN HEALTH TECHNOLOGY ASSESSMENT AT NATIONAL LEVEL: A STUDY FROM IRAN.

PubMed

Yazdizadeh, Bahareh; Shahmoradi, Safoura; Majdzadeh, Reza; Doaee, Shila; Bazyar, Mohammad; Souresrafil, Aghdas; Olyaeemanesh, Alireza

2016-01-01

This study was carried out to evaluate the opinions of stakeholders on their roles in health technology assessment (HTA) in Iran and to determine the barriers and facilitators existing in the organizations to help increase their involvement in the HTA program. The study was conducted in two stages, semi-structured interviews, and "policy dialogue" with stakeholders. The data were analyzed through the framework approach. The interviews were held with ten stakeholder representatives from various organizations. In addition, Twenty-one representatives participated in the policy dialogue. Based on the findings, all the stakeholder organizations considered themselves as interest groups in all the stages of the HTA process; however, their tendencies and methods of involvement differed from one another. According to the participants, the most important issue to be considered in the context of HTA was that the structures, stages, and procedures of the HTA process must be made transparent. Stakeholder involvement in the HTA program cannot readily take place. Various stakeholders have different interests, responsibilities, infrastructures, and barriers. If a program does not meet these considerations, its chances of succeeding will substantially decrease. Therefore, to prevent overlooking the needs and expectations of stakeholders from the HTA process, it is essential to create opportunities in which their thoughts and ideas are taken into account.

Method Designed to Respect Molecular Heterogeneity Can Profoundly Correct Present Data Interpretations for Genome-Wide Expression Analysis

PubMed Central

Chen, Chih-Hao; Hsu, Chueh-Lin; Huang, Shih-Hao; Chen, Shih-Yuan; Hung, Yi-Lin; Chen, Hsiao-Rong; Wu, Yu-Chung

2015-01-01

Although genome-wide expression analysis has become a routine tool for gaining insight into molecular mechanisms, extraction of information remains a major challenge. It has been unclear why standard statistical methods, such as the t-test and ANOVA, often lead to low levels of reproducibility, how likely applying fold-change cutoffs to enhance reproducibility is to miss key signals, and how adversely using such methods has affected data interpretations. We broadly examined expression data to investigate the reproducibility problem and discovered that molecular heterogeneity, a biological property of genetically different samples, has been improperly handled by the statistical methods. Here we give a mathematical description of the discovery and report the development of a statistical method, named HTA, for better handling molecular heterogeneity. We broadly demonstrate the improved sensitivity and specificity of HTA over the conventional methods and show that using fold-change cutoffs has lost much information. We illustrate the especial usefulness of HTA for heterogeneous diseases, by applying it to existing data sets of schizophrenia, bipolar disorder and Parkinson’s disease, and show it can abundantly and reproducibly uncover disease signatures not previously detectable. Based on 156 biological data sets, we estimate that the methodological issue has affected over 96% of expression studies and that HTA can profoundly correct 86% of the affected data interpretations. The methodological advancement can better facilitate systems understandings of biological processes, render biological inferences that are more reliable than they have hitherto been and engender translational medical applications, such as identifying diagnostic biomarkers and drug prediction, which are more robust. PMID:25793610

Health technology assessment: the process in Brazil.

PubMed

Lessa, Fernanda; Ferraz, Marcos Bosi

2017-06-08

To describe, analyze, and compare the opinions of decisionmakers involved in the health technology assessment (HTA) process in Brazil in 2011. A cross-sectional study was conducted using a structured questionnaire to evaluate the opinions of a convenience sample of health care professionals from both the public and private health care systems (HCS). The survey collected demographic data for each respondent along with their input on national regulations. Data analysis included descriptive statistics, including chi-square tests to compare groups. Of the 200 completed questionnaires, 65% of the respondents were 31-50 years of age; 36% were HCS managers, 49.3% from the public and 50.7% from the private system. The majority of respondents (85%) considered the time permitted for submission of new technology to be inadequate; 88% also stated that the composition of the evaluation committee needed improvement. Respondents from the private health system more frequently stated that submission times were inappropriate (P = 0.019) and that the deadline for a decision by the committee should be defined (P = 0.021), with a maximum of no more than 180 days / 6 months (P < 0.001). Respondents indicated that the HTA process should be improved to meet their expectations. Given that new legislation has been enacted to continuously accept submissions, to make decisions within 180 days, and to expand the committee to represent more stakeholders, most of the respondents concerns have been addressed. This study is valuable as an historical analysis of HTA process improvement. Further surveys are needed to track the new HTA process, its application, and its contribution to health care needs in Brazil.

AN INTEGRATED PERSPECTIVE ON THE ASSESSMENT OF TECHNOLOGIES: INTEGRATE-HTA.

PubMed

Wahlster, Philip; Brereton, Louise; Burns, Jacob; Hofmann, Björn; Mozygemba, Kati; Oortwijn, Wija; Pfadenhauer, Lisa; Polus, Stephanie; Rehfuess, Eva; Schilling, Imke; van der Wilt, Gert Jan; Gerhardus, Ansgar

2017-01-01

Current health technology assessment (HTA) is not well equipped to assess complex technologies as insufficient attention is being paid to the diversity in patient characteristics and preferences, context, and implementation. Strategies to integrate these and several other aspects, such as ethical considerations, in a comprehensive assessment are missing. The aim of the European research project INTEGRATE-HTA was to develop a model for an integrated HTA of complex technologies. A multi-method, four-stage approach guided the development of the INTEGRATE-HTA Model: (i) definition of the different dimensions of information to be integrated, (ii) literature review of existing methods for integration, (iii) adjustment of concepts and methods for assessing distinct aspects of complex technologies in the frame of an integrated process, and (iv) application of the model in a case study and subsequent revisions. The INTEGRATE-HTA Model consists of five steps, each involving stakeholders: (i) definition of the technology and the objective of the HTA; (ii) development of a logic model to provide a structured overview of the technology and the system in which it is embedded; (iii) evidence assessment on effectiveness, economic, ethical, legal, and socio-cultural aspects, taking variability of participants, context, implementation issues, and their interactions into account; (iv) populating the logic model with the data generated in step 3; (v) structured process of decision-making. The INTEGRATE-HTA Model provides a structured process for integrated HTAs of complex technologies. Stakeholder involvement in all steps is essential as a means of ensuring relevance and meaningful interpretation of the evidence.

The judgement process in evidence-based medicine and health technology assessment.

PubMed

Kelly, Michael P; Moore, Tessa A

2012-02-01

This article describes the judgements used to interpret evidence in evidence-based medicine (EBM) and health technology assessment (HTA). It outlines the methods and processes of EBM and HTA. Respectively, EBM and HTA are approaches to medical clinical decision making and efficient allocation of scarce health resources. At the heart of both is a concern to review and synthesise evidence, especially evidence derived from randomised controlled trials (RCTs) of clinical effectiveness. The driver of the approach of both is a desire to eliminate, or at least reduce, bias. The hierarchy of evidence, which is used as an indicator of the likelihood of bias, features heavily in the process and methods of EBM and HTA. The epistemological underpinnings of EBM and HTA are explored with particular reference to the distinction between rationalism and empiricism, developed by the philosopher David Hume and elaborated by Immanuel Kant in the Critique of Pure Reason. The importance of Humian and Kantian principles for understanding the projects of EBM and HTA is considered and the ways in which decisions are made in both, within a judgemental framework originally outlined by Kant, are explored.

Identification of publicly available data sources to inform the conduct of Health Technology Assessment in India

PubMed Central

Downey, Laura; Rao, Neethi; Guinness, Lorna; Asaria, Miqdad; Prinja, Shankar; Sinha, Anju; Kant, Rajni; Pandey, Arvind; Cluzeau, Francoise; Chalkidou, Kalipso

2018-01-01

Background: Health technology assessment (HTA) provides a globally-accepted and structured approach to synthesising evidence for cost and clinical effectiveness alongside ethical and equity considerations to inform evidence-based priorities. India is one of the most recent countries to formally commit to institutionalising HTA as an integral component of the heath resource allocation decision-making process. The effective conduct of HTA depends on the availability of reliable data.   Methods: We draw from our experience of collecting, synthesizing, and analysing health-related datasets in India and internationally, to highlight the complex requirements for undertaking HTA, and explore the availability of such data in India. We first outlined each of the core data components required for the conduct of HTA, and their availability in India, drawing attention to where data can be accessed, and different ways in which researchers can overcome the challenges of missing or low quality data. Results: We grouped data into the following categories: clinical efficacy; cost; epidemiology; quality of life; service use/consumption; and equity. We identified numerous large local data sources containing epidemiological information. There was a marked absence of other locally-collected data necessary for informing HTA, particularly data relating to cost, service use, and quality of life. Conclusions: The introduction of HTA into the health policy space in India provides an opportunity to comprehensively assess the availability and quality of health data capture across the country. While epidemiological information is routinely collected across India, other data inputs necessary for HTA are not readily available. This poses a significant bottleneck to the efficient generation and deployment of HTA into the health decision space. Overcoming these data gaps by strengthening the routine collection of comprehensive and verifiable health data will have important implications not only for embedding economic analyses into the priority setting process, but for strengthening the health system as a whole. PMID:29770210

Left-handed skeletally mature baseball players have smaller humeral retroversion in the throwing arm than right-handed players.

PubMed

Takenaga, Tetsuya; Goto, Hideyuki; Sugimoto, Katsumasa; Tsuchiya, Atsushi; Fukuyoshi, Masaki; Nakagawa, Hiroki; Nozaki, Masahiro; Takeuchi, Satoshi; Otsuka, Takanobu

2017-12-01

It is known that the humeral retroversion of baseball players is greater in the throwing arm than in the nonthrowing arm. An investigation measuring dry bone specimens also showed that the right humerus had greater retroversion than the left. Considering these facts, it was hypothesized that humeral retroversion would differ between right- and left-handed players. This study aimed to compare the bilateral humeral retroversion between right- and left-handed skeletally mature baseball players. We investigated 260 (196 right-handed and 64 left-handed) male baseball players who belonged to a college or amateur team. Bilateral humeral retroversion was assessed using an ultrasound-assisted technique (humeral torsion angle [HTA]) as described by previous studies. Analysis of covariance, adjusted for handedness and baseball position, assessed the effect of throwing arm dominance on HTA. In comparison of the throwing arm, HTA was significantly smaller in left-handed (left humerus) than in right-handed (right humerus) players (77° vs. 81°; P < .001). In comparison of the nonthrowing arm, HTA was significantly greater in left-handed (right humerus) than in right-handed (left humerus) players (73° vs. 69°; P < .001). The mean side-to-side difference of HTA was significantly smaller in left-handed than in right-handed players (3° vs. 12°; P < .001). Humeral retroversion of left-handed skeletally mature baseball players was significantly smaller in the throwing arm, greater in the nonthrowing arm, and smaller in side-to-side differences than that of right-handed players. These findings may be key to understanding some of the biomechanical differences between right- and left-handed baseball players. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

New Drug Reimbursement and Pricing Policy in Taiwan.

PubMed

Chen, Gau-Tzu; Chang, Shu-Chen; Chang, Chee-Jen

2018-05-01

Taiwan has implemented a national health insurance system for more than 20 years now. The benefits of pharmaceutical products and new drug reimbursement scheme are determined by the Expert Advisory Meeting and the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee in Taiwan. To depict the pharmaceutical benefits and reimbursement scheme for new drugs and the role of health technology assessment (HTA) in drug policy in Taiwan. All data were collected from the Expert Advisory Meeting and the PBRS meeting minutes; new drug applications with HTA reports were derived from the National Health Insurance Administration Web site. Descriptive statistics were used to analyze the timeline of a new drug from application submission to reimbursement effective, the distribution of approved price, and the approval rate for a new drug with/without local pharmacoeconomic study. After the second-generation national health insurance system, the timeline for a new drug from submission to reimbursement effective averages at 436 days, and that for an oncology drug reaches an average of 742 days. New drug approval rate is 67% and the effective rate (through the approval of the PBRS Joint Committee and the acceptance of the manufacturer) is 53%. The final approved price is 53.6% of the international median price and 70% of the proposed price by the manufacturer. Out of 95 HTA reports released during the period January 2011 to February 2017, 28 applications (30%) conducted an HTA with a local pharmacoeconomic study, and all (100%) received reimbursement approval. For the remaining 67 applications (70%) for which HTA was conducted without a local pharmacoeconomic analysis, 54 cases (81%) were reimbursed. New drug applications with local pharmacoeconomic studies are more likely to get reimbursement. Copyright © 2018. Published by Elsevier Inc.

Why do health technology assessment coverage recommendations for the same drugs differ across settings? Applying a mixed methods framework to systematically compare orphan drug decisions in four European countries.

PubMed

Nicod, Elena

2017-07-01

Health technology assessment (HTA) coverage recommendations differ across countries for the same drugs. Unlike previous studies, this study adopts a mixed methods research design to investigate, in a systematic manner, these differences. HTA recommendations for ten orphan drugs appraised in England (NICE), Scotland (SMC), Sweden (TLV) and France (HAS) (N = 35) were compared using a validated methodological framework that breaks down these complex decision processes into stages facilitating their understanding, analysis and comparison, namely: (1) the clinical/cost-effectiveness evidence, (2) its interpretation (e.g. part of the deliberative process) and (3) influence on the final decision. This allowed qualitative and quantitative identification of the criteria driving recommendations and highlighted cross-country differences. Six out of ten drugs received diverging HTA recommendations. Reasons for cross-country differences included heterogeneity in the evidence appraised, in the interpretation of the same evidence, and in the different ways of dealing with the same uncertainty. These may have been influenced by agency-specific evidentiary, risk and value preferences, or stakeholder input. "Other considerations" (e.g. severity, orphan status) and other decision modulators (e.g. patient access schemes, lower discount rates, restrictions, re-assessments) also rendered uncertainty and cost-effectiveness estimates more acceptable. The different HTA approaches (clinical versus cost-effectiveness) and ways identified of dealing with orphan drug particularities also had implications on the final decisions. This research contributes to better understanding the drivers of these complex decisions and why countries make different decisions. It also contributed to identifying those factors beyond the standard clinical and cost-effectiveness tools used in HTA, and their role in shaping these decisions.

Dealing with Uncertainty and Accounting for Social Value Judgments in Assessments of Orphan Drugs: Evidence from Four European Countries.

PubMed

Nicod, Elena; Berg Brigham, Karen; Durand-Zaleski, Isabelle; Kanavos, Panos

To better understand the reasons for differences in reimbursement decisions for orphan drugs in four European countries that were not readily apparent from health technology assessment (HTA) reports and operating procedures. Semistructured interviews with representatives of HTA bodies in England, Scotland, Sweden, and France were conducted. An interview topic guide was developed on the basis of findings from a systematic comparison of HTA decisions for 10 orphan drugs. Qualitative thematic data analysis was applied to the interview transcripts using the framework approach. Eight representatives from the four HTA bodies were interviewed between March and June 2015. Evidentiary requirements and approaches to dealing with imperfect or incomplete evidence were explored, including trial design and duration, study population and subgroups, comparators, and end points. Interviewees agreed that decisions regarding orphan drugs are made in a context of lower quality evidence, and the threshold of acceptable uncertainty varied by country. Some countries imposed higher evidentiary standards for greater clinical claims, which may be more challenging for orphan diseases. The acceptability of surrogate end points was not consistent across countries nor were the validation requirements. The most common social value judgments identified related to innovation, disease severity, and unmet need. Differences were seen in the way these concepts were defined and accounted for across countries. Although agreement was seen in evidentiary requirements or preferences, there were subtle differences in the circumstances in which uncertain evidence may be considered acceptable, possibly explaining differences in HTA recommendations across countries. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Primary data collection in health technology assessment.

PubMed

McIsaac, Michelle L; Goeree, Ron; Brophy, James M

2007-01-01

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.

Health technology assessment in the Philippines.

PubMed

De Rosas-Valera, Madeleine

2009-07-01

The aim of this study was to discuss the development of health technology assessment (HTA) in the Philippines. A new national health insurance program began to be implemented in the Philippines in 1995 after passage of the Health Insurance Act. The program is known as the Philippine Health Insurance Corporation (PhilHealth). HTA was introduced to the Philippines in 1998. PhilHealth began to develop an HTA program subsequently. As a developing country struggling to provide comprehensive health care to all citizens, PhilHealth sees HTA as an essential part of assuring that only effective and cost-effective care is provided for the public sector.

HEALTH TECHNOLOGY ASSESSMENT FOR DECISION MAKING IN LATIN AMERICA: GOOD PRACTICE PRINCIPLES.

PubMed

Pichon-Riviere, Andrés; Soto, Natalie C; Augustovski, Federico Ariel; García Martí, Sebastián; Sampietro-Colom, Laura

2018-06-11

The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. Forty-two representatives from ten Latin American countries participated. Good practice principles proposed at the international level were considered valid and potentially relevant to Latin America. Five principles were identified as priority and with the greatest potential to be strengthened at this time: transparency in the production of HTA, involvement of relevant stakeholders in the HTA process, mechanisms to appeal decisions, clear priority-setting processes in HTA, and a clear link between HTA and decision making. The main challenge identified was to find a balance between the application of these principles and the available resources in a way that would not detract from the production of reports and adaptation to the needs of decision makers. The main recommendation was to progress gradually in strengthening HTA and its link to decision making by developing appropriate processes for each country, without trying to impose, in the short-term, standards taken from examples at the international level without adequate adaptation of these to local contexts.

HEALTH TECHNOLOGY ASSESSMENT IN EVALUATION OF PHARMACEUTICALS IN THE CZECH REPUBLIC.

PubMed

Vostalová, Lenka; Mazelová, Jana; Samek, Jiří; Vocelka, Milan

2017-01-01

In the Czech Republic, the health technology assessment (HTA) approaches have been implemented in evaluation of medicinal products since 2008. The aim of this study was to provide an overview of the implementation of HTA and different levels thereof in the evaluation process conducted by the State Institute for Drug Control (SUKL) and to describe the impact of HTA on the entrance of new medicinal entities into out-patient healthcare system including highly innovative and orphan drugs. Materials supporting this overview were collected using the records in the database of administrative proceedings of SUKL, in-house standard operating procedures, and the legislation in force. Based on these sources as well as the hands-on knowledge of the current practice, a brief description of the general rules of administrative proceedings involving HTA of varying complexity was elaborated. Characteristic features of the individual types of proceedings, basic differences in the complexity of HTA employed, and its most important challenges were summarized. In Czech Republic, HTA in the formal administrative proceedings ensures a transparent process of introduction of new medicinal products into clinical practice and leaves space for restriction of reimbursement conditions to minimize budget impact. As a robust as well as pragmatic HTA methodology has been implemented by SUKL, relevant stakeholders (marketing authorization holders, Health Care Funds, clinical expert groups) are now able to influence reimbursement of new technologies.

The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

PubMed

Kristensen, Finn Børlum; Lampe, Kristian; Wild, Claudia; Cerbo, Marina; Goettsch, Wim; Becla, Lidia

2017-02-01

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. 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. 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. 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.

Patients' perspectives in health technology assessment: a route to robust evidence and fair deliberation.

PubMed

Facey, Karen; Boivin, Antoine; Gracia, Javier; Hansen, Helle Ploug; Lo Scalzo, Alessandra; Mossman, Jean; Single, Ann

2010-07-01

There is increasing emphasis on providing patient-focused health care and ensuring patient involvement in the design of health services. As health technology assessment (HTA) is meant to be a multidisciplinary, wide-ranging policy analysis that informs decision making, it would be expected that patients' views should be incorporated into the assessment. However, HTA is still driven by collection of quantitative evidence to determine the clinical and cost effectiveness of a health technology. Patients' perspectives about their illness and the technology are rarely included, perhaps because they are seen as anecdotal, biased views. There are two distinct but complementary ways in which HTAs can be strengthened by: (i) gathering robust evidence about the patients' perspectives, and (ii) ensuring effective engagement of patients in the HTA process from scoping, through evidence gathering, assessment of value, development of recommendations and dissemination of findings. Robust evidence eliciting patients' perspectives can be obtained through social science research that is well conducted, critically appraised and carefully reported, either through meta-synthesis of existing studies or new primary research. Engagement with patients can occur at several levels and we propose that HTA should seek to support effective patient participation to create a fair deliberative process. This should allow two-way flow of information, so that the views of patients are obtained in a supportive way and fed into decision-making processes in a transparent manner.

Toward a sustainable European Network for Health Technology Assessment. The EUnetHTA project.

PubMed

Kristensen, F B; Chamova, J; Hansen, N W

2006-03-01

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.

The judgement process in evidence-based medicine and health technology assessment

PubMed Central

Kelly, Michael P; Moore, Tessa A

2012-01-01

This article describes the judgements used to interpret evidence in evidence-based medicine (EBM) and health technology assessment (HTA). It outlines the methods and processes of EBM and HTA. Respectively, EBM and HTA are approaches to medical clinical decision making and efficient allocation of scarce health resources. At the heart of both is a concern to review and synthesise evidence, especially evidence derived from randomised controlled trials (RCTs) of clinical effectiveness. The driver of the approach of both is a desire to eliminate, or at least reduce, bias. The hierarchy of evidence, which is used as an indicator of the likelihood of bias, features heavily in the process and methods of EBM and HTA. The epistemological underpinnings of EBM and HTA are explored with particular reference to the distinction between rationalism and empiricism, developed by the philosopher David Hume and elaborated by Immanuel Kant in the Critique of Pure Reason. The importance of Humian and Kantian principles for understanding the projects of EBM and HTA is considered and the ways in which decisions are made in both, within a judgemental framework originally outlined by Kant, are explored. PMID:23226973

HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES IN EUROPE: PROCESSES, PRACTICES, AND METHODS.

PubMed

Fuchs, Sabine; Olberg, Britta; Panteli, Dimitra; Busse, Reinhard

2016-01-01

To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions. A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution. Information was obtained from eighty-four institutions, forty-seven of which were analyzed. Fifty-four methodological documents from twenty-three agencies in eighteen countries were identified. Only five agencies had separate documents for the assessment of MDs. A few agencies made separate provisions for the assessment of MDs in their general methods. The amount of publicly available HTA reports on MDs varied by device category and agency remit. Despite growing consensus on their importance and international initiatives, such as the EUnetHTA Core Model®, specific tools for the assessment of MDs are rarely developed and implemented at the national level. Separate additional signposts incorporated in existing general methods guides may be sufficient for the evaluation of MDs.

Determinants of orphan drugs prices in France: a regression analysis.

PubMed

Korchagina, Daria; Millier, Aurelie; Vataire, Anne-Lise; Aballea, Samuel; Falissard, Bruno; Toumi, Mondher

2017-04-21

The introduction of the orphan drug legislation led to the increase in the number of available orphan drugs, but the access to them is often limited due to the high price. Social preferences regarding funding orphan drugs as well as the criteria taken into consideration while setting the price remain unclear. The study aimed at identifying the determinant of orphan drug prices in France using a regression analysis. All drugs with a valid orphan designation at the moment of launch for which the price was available in France were included in the analysis. The selection of covariates was based on a literature review and included drug characteristics (Anatomical Therapeutic Chemical (ATC) class, treatment line, age of target population), diseases characteristics (severity, prevalence, availability of alternative therapeutic options), health technology assessment (HTA) details (actual benefit (AB) and improvement in actual benefit (IAB) scores, delay between the HTA and commercialisation), and study characteristics (type of study, comparator, type of endpoint). The main data sources were European public assessment reports, HTA reports, summaries of opinion on orphan designation of the European Medicines Agency, and the French insurance database of drugs and tariffs. A generalized regression model was developed to test the association between the annual treatment cost and selected covariates. A total of 68 drugs were included. The mean annual treatment cost was €96,518. In the univariate analysis, the ATC class (p = 0.01), availability of alternative treatment options (p = 0.02) and the prevalence (p = 0.02) showed a significant correlation with the annual cost. The multivariate analysis demonstrated significant association between the annual cost and availability of alternative treatment options, ATC class, IAB score, type of comparator in the pivotal clinical trial, as well as commercialisation date and delay between the HTA and commercialisation. The orphan drug pricing is a multivariate phenomenon. The complex association between drug prices and the studied attributes and shows that payers integrate multiple variables in decision making when setting orphan drug prices. The interpretation of the study results is limited by the small sample size and the complex data structure.

Dissemination of health technology assessments: identifying the visions guiding an evolving policy innovation in Canada.

PubMed

Lehoux, Pascale; Denis, Jean-Louis; Tailliez, Stéphanie; Hivon, Myriam

2005-08-01

Health technology assessment (HTA) has received increasing support over the past twenty years in both North America and Europe. The justification for this field of policy-oriented research is that evidence about the efficacy, safety, and cost-effectiveness of technology should contribute to decision and policy making. However, concerns about the ability of HTA producers to increase the use of their findings by decision makers have been expressed. Although HTA practitioners have recognized that dissemination activities need to be intensified, why and how particular approaches should be adopted is still under debate. Using an institutional theory perspective, this article examines HTA as a means of implementing knowledge-based change within health care systems. It presents the results of a case study on the dissemination strategies of six Canadian HTA agencies. Chief executive officers and executives (n = 11), evaluators (n = 19), and communications staff (n = 10) from these agencies were interviewed. Our results indicate that the target audience of HTA is frequently limited to policy makers, that three conflicting visions of HTA dissemination coexist, that active dissemination strategies have only occasionally been applied, and that little attention has been paid to the management of diverging views about the value of health technology. Our discussion explores the strengths, limitations, and trade-offs associated with the three visions. Further efforts should be deployed within agencies to better articulate a shared vision and to devise dissemination strategies that are consistent with this vision.

HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT FOR THE ADOPTION OF INNOVATIVE MEDICAL DEVICES WITHIN FRENCH HOSPITALS: OPPORTUNITIES AND CHALLENGES FOR INDUSTRY.

PubMed

Dutot, Camille; Mercier, Grégoire; Borget, Isabelle; de Sauvebeuf, Côme; Martelli, Nicolas

2017-01-01

Within French university hospitals, some internal committees are in charge of conducting hospital-based health technology assessment (Hb-HTA) to support managerial decisions regarding the adoption of innovations. For manufacturers, hospitals are usually the entry point for new and innovative medical devices, which cannot be accessed without the Hb-HTA committees' approval. Thus, the main objective of this pilot survey was to explore manufacturers' insights into Hb-HTA processes. A two-step pilot survey was conducted in 2014. First, semi-structured phone interviews were carried out to capture manufacturers' feedback on the Hb-HTA procedure. Second, a prospective and iterative questionnaire designed to explore manufacturers' market access strategies was administered. Eight manufacturers from the medical device industry completed the retrospective phone interviews, and five of them participated in the prospective survey. According to the overall feedback, the Hb-HTA process timeline and transparency are major issues, and the expectations of internal committees, especially in terms of clinical evidence, remain difficult to understand. However, despite this and due to the complexity of reimbursement processes at the national level, manufacturers are increasingly considering hospital adoption through Hb-HTA submission as a viable market access and coverage opportunity. Our study reaffirms the primary role of hospitals in the diffusion of innovative medical devices. However, to ensure efficient and broad access to innovation, cooperation between local and national HTA bodies is critical and should be promoted.

History of health technology assessment in Belgium.

PubMed

Cleemput, Irina; Van Wilder, Philippe

2009-07-01

This paper gives an overview of health technology assessment (HTA) in Belgium. The information included in the overview is based on legal documents and publicly available year reports of the Belgian Health Care Knowledge Centre (KCE). Belgium has a relatively young history in HTA. The principle of evidence-based medicine (EBM) was introduced in the drug reimbursement procedure in 2001, with the establishment of the Drug Reimbursement Committee (DRC). The DRC assesses the efficacy, safety, convenience, applicability, and effectiveness of a drug relative to existing treatment alternatives. For some drugs, relative cost-effectiveness is also evaluated. The activities of the DRC can, therefore, be considered to be the first official HTA activities in Belgium. Later, in 2003, KCE was established. Its mission was to perform policy preparing research in the healthcare and health insurance sector and to give advice to policy makers about how they can obtain an efficient allocation of limited healthcare resources that optimizes the quality and accessibility of health care. This broad mission has been operationalized by activities in three domains of research: HTA, health services research, and good clinical practice. KCE is independent from the policy maker. Its HTAs contain policy recommendations that may inform policy decisions but are not binding. Although the Belgian history of HTA is relatively short, its foundations are strong and the impact of HTA increasing. Nevertheless KCE has many challenges for the future, including continued quality assurance, further development of international collaboration, and further development of methodological guidance for HTA.

Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA)

PubMed Central

Brettschneider, Christian; Lühmann, Dagmar; Raspe, Heiner

2011-01-01

Background “Patient-Reported Outcome” (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. Methods For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report’s chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Results Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. Conclusions As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively – in case of missing data the need for further research is stated. PMID:21468289

Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA).

PubMed

Brettschneider, Christian; Lühmann, Dagmar; Raspe, Heiner

2011-02-02

"Patient-Reported Outcome" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively - in case of missing data the need for further research is stated.

RNA-Seq reveals seven promising candidate genes affecting the proportion of thick egg albumen in layer-type chickens.

PubMed

Wan, Yi; Jin, Sihua; Ma, Chendong; Wang, Zhicheng; Fang, Qi; Jiang, Runshen

2017-12-22

Eggs with a much higher proportion of thick albumen are preferred in the layer industry, as they are favoured by consumers. However, the genetic factors affecting the thick egg albumen trait have not been elucidated. Using RNA sequencing, we explored the magnum transcriptome in 9 Rhode Island white layers: four layers with phenotypes of extremely high ratios of thick to thin albumen (high thick albumen, HTA) and five with extremely low ratios (low thick albumen, LTA). A total of 220 genes were differentially expressed, among which 150 genes were up-regulated and 70 were down-regulated in the HTA group compared with the LTA group. Gene Ontology (GO) analysis revealed that the up-regulated genes in HTA were mainly involved in a wide range of regulatory functions. In addition, a large number of these genes were related to glycosphingolipid biosynthesis, focal adhesion, ECM-receptor interactions and cytokine-cytokine receptor interactions. Based on functional analysis, ST3GAL4, FUT4, ITGA2, SDC3, PRLR, CDH4 and GALNT9 were identified as promising candidate genes for thick albumen synthesis and metabolism during egg formation. These results provide new insights into the molecular mechanisms of egg albumen traits and may contribute to future breeding strategies that optimise the proportion of thick egg albumen.

Toward a procedure for integrating moral issues in health technology assessment.

PubMed

Hofmann, Bjørn

2005-01-01

Although ethics has been on the agenda in health technology assessment (HTA) since its inception, the integration of moral issues is still not standard and is performed in a vast variety of ways. Therefore, there is a need for a procedure for integrating moral issues in HTA. Literature review of existing approaches together with application of various theories in moral philosophy and axiology. The article develops a set of questions that addresses a wide range of moral issues related to the assessment and implementation of health technology. The issues include general moral issues and moral issues related to stakeholders, methodology, characteristics of technology, and to the HTA process itself. The questions form a kind of checklist for use in HTAs. The presented approach for integrating moral issues in HTA has a broad theoretical foundation and has shown to be useful in practice. Integrating ethical issues in HTAs can be of great importance with respect to the dissemination of HTA results and in efficient health policy making.

INSIGHTS FROM THE FRONT LINES: A COLLECTION OF STORIES OF HTA IMPACT FROM INAHTA MEMBER AGENCIES.

PubMed

Schuller, Tara; Söderholm Werkö, Sophie

2017-01-01

This mini-theme contains six stories of health technology assessment (HTA) impact from member agencies of The International Network of Agencies for Health Technology Assessment (INAHTA), which were originally shared at the 2015 and 2016 INAHTA Congresses. The INAHTA impact story sharing is an innovative network activity where member agency representatives share experiences of HTA impact in a loosely structured story format. Through this process, members gain insights from other agencies on new ways of thinking about and approaching HTA impact assessment. A guide is provided to members to prepare their story, and the best story receives the David Hailey Award for Best Impact Story. This mini-theme contains stories of HTA impact from six member agencies in different parts of the world: the Health Assessment Division of the Ministry of Public Health (Uruguay), the Institute of Quality and Efficiency in Health Care (Germany), the Health Information and Quality Authority (Ireland), the Finnish Office for Health Technology Assessment (Finland), the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (Australia), and the Institut national d'excellence en santé et en services sociaux (Canada). Across the papers, common themes emerge about the importance of appropriate engagement of stakeholders and the broadening scope of HTA beyond reimbursement decision making.

Fair Processes for Priority Setting: Putting Theory into Practice Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".

PubMed

Jansen, Maarten P; Helderman, Jan-Kees; Boer, Bert; Baltussen, Rob

2016-07-03

Embedding health technology assessment (HTA) in a fair process has great potential to capture societal values relevant to public reimbursement decisions on health technologies. However, the development of such processes for priority setting has largely been theoretical. In this paper, we provide further practical lead ways on how these processes can be implemented. We first present the misconception about the relation between facts and values that is since long misleading the conduct of HTA and underlies the current assessment-appraisal split. We then argue that HTA should instead be explicitly organized as an ongoing evidence-informed deliberative process, that facilitates learning among stakeholders. This has important consequences for whose values to consider, how to deal with vested interests, how to consider all values in the decision-making process, and how to communicate decisions. This is in stark contrast to how HTA processes are implemented now. It is time to set the stage for HTA as learning. © 2017 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

A DECADE OF HEALTH TECHNOLOGY ASSESSMENT IN POLAND.

PubMed

Lipska, Iga; McAuslane, Neil; Leufkens, Hubert; Hövels, Anke

2017-01-01

The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources. We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information. The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria. While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the "pragmatic" HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.

Health technology assessment to optimize health technology utilization: using implementation initiatives and monitoring processes.

PubMed

Frønsdal, Katrine B; Facey, Karen; Klemp, Marianne; Norderhaug, Inger Natvig; Mørland, Berit; Røttingen, John-Arne

2010-07-01

The way in which a health technology is used in any particular health system depends on the decisions and actions of a variety of stakeholders, the local culture, and context. In 2009, the HTAi Policy Forum considered how health technology assessment (HTA) could be improved to optimize the use of technologies (in terms of uptake, change in use, or disinvestment) in such complex systems. In scoping, it was agreed to focus on initiatives to implement evidence-based guidance and monitoring activities. A review identified systematic reviews of implementation initiatives and monitoring activities. A two-day deliberative workshop was held to discuss key papers, members' experiences, and collectively address key questions. This consensus paper was developed by email and finalized at a postworkshop meeting. Evidence suggests that the impact and use of HTA could be increased by ensuring timely delivery of relevant reports to clearly determined policy receptor (decision-making) points. To achieve this, the breadth of assessment, implementation initiatives such as incentives and targeted, intelligent dissemination of HTA result, needs to be considered. HTA stakeholders undertake a variety of monitoring activities, which could inform optimal use of a technology. However, the quality of these data varies and is often not submitted to an HTA. Monitoring data should be sufficiently robust so that they can be used in HTA to inform optimal use of technology. Evidence-based implementation initiatives should be developed for HTA, to better inform decision makers at all levels in a health system about the optimal use of technology.

Surrogate outcomes in health technology assessment: an international comparison.

PubMed

Velasco Garrido, Marcial; Mangiapane, Sandra

2009-07-01

Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports. We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics. HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.

How health technology assessment agencies address the issue of unpublished data.

PubMed

Kreis, Julia; Panteli, Dimitra; Busse, Reinhard

2014-01-01

Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data. We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts. Eighteen HTA agencies and seventy-three reports were included. Agencies' methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings. International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

Planned and ongoing projects (pop) database: development and results.

PubMed

Wild, Claudia; Erdös, Judit; Warmuth, Marisa; Hinterreiter, Gerda; Krämer, Peter; Chalon, Patrice

2014-11-01

The aim of this study was to present the development, structure and results of a database on planned and ongoing health technology assessment (HTA) projects (POP Database) in Europe. The POP Database (POP DB) was set up in an iterative process from a basic Excel sheet to a multifunctional electronic online database. The functionalities, such as the search terminology, the procedures to fill and update the database, the access rules to enter the database, as well as the maintenance roles, were defined in a multistep participatory feedback loop with EUnetHTA Partners. The POP Database has become an online database that hosts not only the titles and MeSH categorizations, but also some basic information on status and contact details about the listed projects of EUnetHTA Partners. Currently, it stores more than 1,200 planned, ongoing or recently published projects of forty-three EUnetHTA Partners from twenty-four countries. Because the POP Database aims to facilitate collaboration, it also provides a matching system to assist in identifying similar projects. Overall, more than 10 percent of the projects in the database are identical both in terms of pathology (indication or disease) and technology (drug, medical device, intervention). In addition, approximately 30 percent of the projects are similar, meaning that they have at least some overlap in content. Although the POP DB is successful concerning regular updates of most national HTA agencies within EUnetHTA, little is known about its actual effects on collaborations in Europe. Moreover, many non-nationally nominated HTA producing agencies neither have access to the POP DB nor can share their projects.

Oncology drugs for orphan indications: how are HTA processes evolving for this specific drug category?

PubMed

Adkins, Elizabeth M; Nicholson, Lindsay; Floyd, David; Ratcliffe, Mark; Chevrou-Severac, Helene

2017-01-01

Orphan drugs (ODs) are intended for the diagnosis, prevention, or treatment of rare diseases. Many cancer subtypes, including all childhood cancers, are defined as rare diseases, and over one-third of ODs are now intended to treat oncology indications. However, market access for oncology ODs is becoming increasingly challenging; ODs are prone to significant uncertainty around their cost-effectiveness, while payers must balance the need for these vital innovations with growing sensitivity to rising costs. The objective of this review was to evaluate different mechanisms that have been introduced to facilitate patient access to oncology ODs in five different countries (Australia, Canada, England, France, and Sweden), using eight oncology ODs and non-orphan oncology drugs as examples of their application. A targeted literature review of health technology assessment (HTA) agency websites was undertaken to identify country-specific guidance and HTA documentation for recently evaluated oncology ODs and non-orphan oncology drugs. None of these countries were found to have explicit HTA criteria for the assessment of ODs, and therefore, oncology ODs are assessed through the usual HTA process. However, distinct and additional processes are adopted to facilitate access to oncology ODs. Review of eight case-study drugs showed that these additional assessment processes were rarely used, and decisions were largely driven by proving cost-effectiveness using standard incremental cost-effectiveness ratio (ICER) thresholds. The predominant implication arising from this study is that application of standard HTA criteria to oncology ODs in many countries fails to take into account any uncertainties around their clinical- and cost-effectiveness, resulting in disparities in HTA reimbursement decisions based on differences in addressing or accepting uncertainty. In order to address this issue, HTA agencies should adopt a more flexible approach to cost-effectiveness, as typified by the Tandvårds-och Läkemedelsförmånsverket in Sweden, which takes into account the small patient numbers involved, limited budget impact, and high unmet medical needs.

Oncology drugs for orphan indications: how are HTA processes evolving for this specific drug category?

PubMed Central

Adkins, Elizabeth M; Nicholson, Lindsay; Floyd, David; Ratcliffe, Mark; Chevrou-Severac, Helene

2017-01-01

Orphan drugs (ODs) are intended for the diagnosis, prevention, or treatment of rare diseases. Many cancer subtypes, including all childhood cancers, are defined as rare diseases, and over one-third of ODs are now intended to treat oncology indications. However, market access for oncology ODs is becoming increasingly challenging; ODs are prone to significant uncertainty around their cost-effectiveness, while payers must balance the need for these vital innovations with growing sensitivity to rising costs. The objective of this review was to evaluate different mechanisms that have been introduced to facilitate patient access to oncology ODs in five different countries (Australia, Canada, England, France, and Sweden), using eight oncology ODs and non-orphan oncology drugs as examples of their application. A targeted literature review of health technology assessment (HTA) agency websites was undertaken to identify country-specific guidance and HTA documentation for recently evaluated oncology ODs and non-orphan oncology drugs. None of these countries were found to have explicit HTA criteria for the assessment of ODs, and therefore, oncology ODs are assessed through the usual HTA process. However, distinct and additional processes are adopted to facilitate access to oncology ODs. Review of eight case-study drugs showed that these additional assessment processes were rarely used, and decisions were largely driven by proving cost-effectiveness using standard incremental cost-effectiveness ratio (ICER) thresholds. The predominant implication arising from this study is that application of standard HTA criteria to oncology ODs in many countries fails to take into account any uncertainties around their clinical- and cost-effectiveness, resulting in disparities in HTA reimbursement decisions based on differences in addressing or accepting uncertainty. In order to address this issue, HTA agencies should adopt a more flexible approach to cost-effectiveness, as typified by the Tandvårds-och Läkemedelsförmånsverket in Sweden, which takes into account the small patient numbers involved, limited budget impact, and high unmet medical needs. PMID:28652787

Hesperetin-5,7,3'-O-triacetate suppresses airway hyperresponsiveness in ovalbumin-sensitized and challenged mice without reversing xylazine/ketamine-induced anesthesia in normal mice.

PubMed

Yang, You-Lan; Chen, Chi-Li; Chen, Chi-Ming; Ko, Wun-Chang

2017-05-30

We recently reported that hesperetin-5,7,3'-O-triacetate (HTA) dually inhibited phosphodiesterase (PDE)3/4 with a therapeutic ratio of 20.8. The application and development of PDE4 inhibitors for treating asthma or COPD are limited by their side effects, such as nausea, vomiting and gastric hypersecretion. PDE4 inhibitors were reported to reverse xylazine/ketamine-induced anesthesia in rats and triggered vomiting in ferrets. Thus the reversing effect of HTA on xylazine/ketamine-induced anesthesia in mice was studied to assess emetic effect of HTA. The aim of this study was to prove the therapeutic effect of HTA without vomiting effect at an effective dose for treating COPD. Ten female BALB/c mice in each group were sensitized by ovalbumin (OVA) on days 0 and 14. On day 21, these mice were emphasized the sensitization by Freund's complete adjuvant. Mice were challenged by 1% OVA nebulization on days 28, 29, and 30. Airway hyperresponsiveness (AHR) was assessed on day 32 in each group, using the FlexiVent system to determine airway resistance (R L ) and lung dynamic compliance (C dyn ) in anesthetized ovalbumin (OVA)-sensitized and challenged mice. Each group was orally administered HTA (10 ~ 100 μmol/kg), roflumilast (1 and 5 mg/kg) or vehicles (controls) 2 h before and 6 and 24 h after OVA provocation. For comparison, sham-treated mice were challenged with saline instead of 1% OVA. The ability to reverse xylazine/ketamine-induced anesthesia by HTA or roflumilast for 3 h was determined in normal mice. We used roflumilast, a selective PDE4 inhibitor and bronchodilator for severe COPD approved by the US Food and Drug Administration, as a reference drug. In the results, HTA (100 μmol/kg, p.o.) or roflumilast (5 mg/kg, p.o.) significantly suppressed all R L values of MCh at 0.78 ~ 25 mg/mL and enhanced C dyn values of MCh at 3.125 ~ 25 mg/mL compared to OVA-sensitized and -challenged control mice. Orally administered 1, 3 or 10 mg/kg roflumilast, but not 30 or 100 μmol/kg HTA, significantly reversed xylazine/ketamine-induced anesthesia. In contrast to roflumilast, HTA may ameliorate COPD but induce few side effects of nausea, vomiting and gastric hypersecretion at an effective dose for treating COPD, because HTA did not reverse xylazine/ketamine-induced anesthesia in mice.

Market uptake of orphan drugs--a European analysis.

PubMed

Picavet, E; Annemans, L; Cleemput, I; Cassiman, D; Simoens, S

2012-12-01

Variations in market uptake of an orphan drug have important implications with respect to access to care and inequality of treatment. Therefore, the aim of this study was to quantify both the sales and volume uptake of orphan drugs in Europe and to assess whether a country's gross domestic product (GDP) and/or health technology assessment (HTA) influences the orphan drugs' market uptake. We analysed the numbers of orphan drugs launched and the sales and volume uptake for 17 orphan drugs in 23 European countries from 2001 until the beginning of 2010 using the IMS Health database. Countries were clustered based on GDP and the availability of a formal HTA-organization. The uptake of orphan drugs varied across European countries. The highest volumes and contributions of orphan drugs in the first year occurred in countries with a high GDP (and implicitly, a higher budget for healthcare), independently of the existence of an HTA-organization. In contrast, in countries with a low GDP, orphan drugs were less available when there was a formal HTA-organization. There, budgetary restrictions can cause the exclusion of less cost-effective orphan drugs. We observed substantial variation in the market uptake of orphan drugs. Such variation may have important implications with respect to access to care and inequality of treatment. The uptake of orphan drugs could be promoted through the clinical added value of orphan drugs (CAVOD) project and various conditional pricing and reimbursement mechanisms. © 2012 Blackwell Publishing Ltd.

Expanding Health Technology Assessments to Include Effects on the Environment.

PubMed

Marsh, Kevin; Ganz, Michael L; Hsu, John; Strandberg-Larsen, Martin; Gonzalez, Raquel Palomino; Lund, Niels

2016-01-01

There is growing awareness of the impact of human activity on the climate and the need to stem this impact. Public health care decision makers from Sweden and the United Kingdom have started examining environmental impacts when assessing new technologies. This article considers the case for incorporating environmental impacts into the health technology assessment (HTA) process and discusses the associated challenges. Two arguments favor incorporating environmental impacts into HTA: 1) environmental changes could directly affect people's health and 2) policy decision makers have broad mandates and objectives extending beyond health care. Two types of challenges hinder this process. First, the nascent evidence base is insufficient to support the accurate comparison of technologies' environmental impacts. Second, cost-utility analysis, which is favored by many HTA agencies, could capture some of the value of environmental impacts, especially those generating health impacts, but might not be suitable for addressing broader concerns. Both cost-benefit and multicriteria decision analyses are potential methods for evaluating health and environmental outcomes, but are less familiar to health care decision makers. Health care is an important and sizable sector of the economy that could warrant closer policy attention to its impact on the environment. Considerable work is needed to track decision makers' demands, augment the environmental evidence base, and develop robust methods for capturing and incorporating environmental data as part of HTA. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

INTEGRATING HEALTH TECHNOLOGY ASSESSMENT PRINCIPLES IN FORMULARY MANAGEMENT.

PubMed

Teng, Monica; Khoo, Ai Leng; Zhao, Ying Jiao; Lin, Liang; Lim, Boon Peng

2016-01-01

Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore. A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary. Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists' proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management. Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.

THE ADDED VALUE OF INTEGRATE-HTA GUIDANCE IN THE WORK PROCESSES OF HEALTH TECHNOLOGY ASSESSMENT AGENCIES.

PubMed

van der Wilt, Gert Jan; Kievit, Wietske; Oortwijn, Wija

2017-01-01

A central idea underlying the INTEGRATE-HTA project is that many of the interventions that are being used in health care are quite complex. By this, we mean that the relation between the delivery of the intervention on the one hand, and the onset of (desired and undesired) changes may be less straightforward than hoped for. There may be all sorts of reasons for this, varying from a lack of resources, lack of skills, perverse incentives, organizational problems, etc. Not identifying such factors and their potential impact may seriously compromise the policy relevance of a health technology assessment (HTA) (1). However, current approaches and methods in HTA do not seem to be adequately geared to deal with this complexity.

HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS.

PubMed

Vukovic, Vladimir; Favaretti, Carlo; Ricciardi, Walter; de Waure, Chiara

2018-01-01

Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement. PubMed, ISI-WOS, and University of York - Centre for Reviews and Dissemination-electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model. Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects. E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

Drug delivery system innovation and Health Technology Assessment: Upgrading from Clinical to Technological Assessment.

PubMed

Panzitta, Michele; Bruno, Giorgio; Giovagnoli, Stefano; Mendicino, Francesca R; Ricci, Maurizio

2015-11-30

Health Technology Assessment (HTA) is a multidisciplinary health political instrument that evaluates the consequences, mainly clinical and economical, of a health care technology; the HTA aim is to produce and spread information on scientific and technological innovation for health political decision making process. Drug delivery systems (DDS), such as nanocarriers, are technologically complex but they have pivotal relevance in therapeutic innovation. The HTA process, as commonly applied to conventional drug evaluation, should upgrade to a full pharmaceutical assessment, considering the DDS complexity. This is useful to study more in depth the clinical outcome and to broaden its critical assessment toward pharmaceutical issues affecting the patient and not measured by the current clinical evidence approach. We draw out the expertise necessary to perform the pharmaceutical assessment and we propose a format to evaluate the DDS technological topics such as formulation and mechanism of action, physicochemical characteristics, manufacturing process. We integrated the above-mentioned three points in the Evidence Based Medicine approach, which is data source for any HTA process. In this regard, the introduction of a Pharmaceutics Expert figure in the HTA could be fundamental to grant a more detailed evaluation of medicine product characteristics and performances and to help optimizing DDS features to overcome R&D drawbacks. Some aspects of product development, such as manufacturing processes, should be part of the HTA as innovative manufacturing processes allow new products to reach more effectively patient bedside. HTA so upgraded may encourage resource allocating payers to invest in innovative technologies and providers to focus on innovative material properties and manufacturing processes, thus contributing to bring more medicines in therapy in a sustainable manner. Copyright © 2015 Elsevier B.V. All rights reserved.

The correlation between HTA recommendations and reimbursement status of orphan drugs in Europe.

PubMed

Kawalec, Paweł; Sagan, Anna; Pilc, Andrzej

2016-09-06

The aim of this study was to review and compare types of reimbursement recommendations for orphan drugs issued by eight European health technology assessment (HTA) agencies and the reimbursement status of these drugs in the corresponding countries. Separate calculations were also performed for three sub-groups: ultra-orphan drugs, oncology orphan drugs and other (non-ultra, non-oncology) orphan drugs. We reviewed drugs authorized by the European Medicine Agency (EMA) between 1 November 2002 and 30 September 2015. Among these, we identified 101 orphan drugs. Seventy-nine of them were assessed by eight European HTA agencies. The average rates of positive, conditional and negative reimbursement recommendations issued by these agencies were 55.7 %, 15.3 % and 29.0 %, respectively. On average, 21.2 % of EMA-authorized orphan drugs were reimbursed in the eight European countries studied: 49.0 % of those with positive, 53.6 % of those with conditional, and 16.0 % of those with negative reimbursement recommendations. In addition, 5.4 % of orphan drugs that had not been assessed by any of the eight HTA agencies were also reimbursed. The shares of oncology, ultra, and other orphan drugs that were assessed by HTA agencies were similar, with the lowest share observed in ultra-orphan drugs (72 %) and the highest in other orphan drugs (80 %). In terms of reimbursement, 20 % of oncology orphan drugs, 25 % of ultra-orphan drugs and 21 % of other orphan drugs were reimbursed. Reimbursement of orphan drugs does not always correspond to the type of HTA recommendation. While the highest rate of reimbursement is observed (unsurprisingly) among drugs with positive or conditional recommendation, a high rate of reimbursement (11 %) is also observed among ultra-orphan drugs that had never been assessed by any HTA agency.

Priority setting for health technology assessments: a systematic review of current practical approaches.

PubMed

Noorani, Hussein Z; Husereau, Donald R; Boudreau, Rhonda; Skidmore, Becky

2007-01-01

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

IMPLEMENTATION OF HEALTH TECHNOLOGY ASSESSMENT WORK IN A HOSPITAL IN KAZAKHSTAN.

PubMed

Kosherbayeva, Lyazzat; Hailey, David; Kurakbaev, Kural; Tsoy, Aleksey; Zhuzzhanov, Ormanbek; Donbay, Abilay; Kumar, Ainur; Nadyrov, Kamalzhan

2016-01-01

The aim of this study was to implement health technology assessment (HA) in the First General City Hospital in Astana, Kazakhstan. We organized trainings to familiarize hospital staff with the purpose and details of HTA. An HTA committee was established, with representation from hospital physicians and managers, and criteria for prioritization of health technologies determined. Clinical departments of the hospital were asked to prepare applications for new technologies for their services. The HTA committee reviewed five applications and selected a technology from one of these, on single incision laparoscopic surgery (SILS), for assessment. A short HTA report on SILS was prepared, covering its safety, clinical effectiveness, and cost effectiveness. The report was used to support a request to the Department of Health for additional funding to implement this technology within the hospital. This funding was approved and SILS was established in several hospital departments. This successful initial experience with HTA has paved the way for its routine use by the hospital for informing decisions on the procurement and use of new health technologies.

Adoption of trastuzumab for breast cancer in four emerging countries in the use of health technology assessment: a case study.

PubMed

Martín-Ruiz, Eva; Espín Balbino, Jaime; Lemgruber, Alexandre; Caro-Martínez, Araceli; Lessa, Fernanda; Olry-de-Labry-Lima, Antonio; Pérez-Velasco, Roman; García-Mochón, Leticia

2016-07-01

To describe processes for the adoption of trastuzumab in four countries in the use of health technology assessment (HTA): Poland, Albania, Brazil and Colombia. Mixed methods were used for collection and triangulation of data. Data were examined following a conceptual framework connecting HTA process steps and key principles. Trastuzumab was generally assessed following well-structured HTA processes. Nonetheless, areas of improvement were detected in terms of transparency and inclusiveness, as well as in methods used. The extent to which different criteria influenced decisions was unclear. This study covers an area in which information may not always be available, and sets the example for emerging countries interested in HTA. Further studies to gain a better understanding on decision-making across settings are warranted.

Analysis of strengths, weaknesses, opportunities, and threats in the development of a health technology assessment program in Turkey.

PubMed

Kahveci, Rabia; Meads, Catherine

2008-01-01

The Turkish healthcare system is currently undergoing reform, and efficient use of resources has become a key factor in determining the allocation of resources. The objective of this study was to analyze strengths, weaknesses, opportunities, and threats (SWOT) in the development of a health technology assessment (HTA) program in Turkey. A SWOT analysis was performed using a literature review and interviews with key people in the Turkish Ministry of Health and Ministry of Labor and Social Security. Regarding recent reforms in health care, investments for information network and databank are the strengths, but the traditional "expert-based" decision making, poor availability of data, and poor quality of data could be seen as some of the weaknesses. Another major weakness is lack of general awareness of HTA. Increasing demand for transparency in decision making, demand for evidence, and demand for credibility by decision makers are some of the opportunities, and current healthcare reforms, i.e., restructuring of healthcare and general health insurance, could also be seen as major opportunities. These opportunities unfortunately could be threatened by lack of funding, and resources are challenged by large, recent national investments. There is a good opportunity for Turkey to use the skills in HTA currently being developed through activities in Europe and the Americas to assist in the development of a much more cost-effective and transparent healthcare system in Turkey.

Nonradioactive heteroduplex tracking assay for the detection of minority-variant chloroquine-resistant Plasmodium falciparum in Madagascar

PubMed Central

Juliano, Jonathan J; Randrianarivelojosia, Milijaona; Ramarosandratana, Benjamin; Ariey, Frédéric; Mwapasa, Victor; Meshnick, Steven R

2009-01-01

Background Strains of Plasmodium falciparum genetically resistant to chloroquine (CQ) due to the presence of pfcrt 76T appear to have been recently introduced to the island of Madagascar. The prevalence of such resistant genotypes is reported to be low (< 3%) when evaluated by conventional PCR. However, these methods are insensitive to low levels of mutant parasites present in patients with polyclonal infections. Thus, the current estimates may be an under representation of the prevalence of the CQ-resistant P. falciparum isolates on the island. Previously, minority variant chloroquine resistant parasites were described in Malawian patients using an isotopic heteroduplex tracking assay (HTA), which can detect pfcrt 76T-bearing P. falciparum minority variants in individual patients that were undetectable by conventional PCR. However, as this assay required a radiolabeled probe, it could not be used in many resource-limited settings. Methods This study describes a digoxigenin (DIG)-labeled chemiluminescent heteroduplex tracking assay (DIG-HTA) to detect pfcrt 76T-bearing minority variant P. falciparum. This assay was compared to restriction fragment length polymorphism (RFLP) analysis and to the isotopic HTA for detection of genetically CQ-resistant parasites in clinical samples. Results Thirty one clinical P. falciparum isolates (15 primary isolates and 16 recurrent isolates) from 17 Malagasy children treated with CQ for uncomplicated malaria were genotyped for the pfcrt K76T mutation. Two (11.7%) of 17 patients harboured genetically CQ-resistant P. falciparum strains after therapy as detected by HTA. RFLP analysis failed to detect any pfcrt K76T-bearing isolates. Conclusion These findings indicate that genetically CQ-resistant P. falciparum are more common than previously thought in Madagascar even though the fitness of the minority variant pfcrt 76T parasites remains unclear. In addition, HTAs for malaria drug resistance alleles are promising tools for the surveillance of anti-malarial resistance. The use of a non-radioactive label allows for the use of HTAs in malaria endemic countries. PMID:19291288

Analysis of evidence supporting the Federation of Bosnia and Herzegovina reimbursement medicines lists: role of the WHO Essential Medicines List, Cochrane systematic reviews and technology assessment reports.

PubMed

Mahmić-Kaknjo, Mersiha; Marušić, Ana

2015-07-01

We compared recently introduced Basic Medicines Lists of the Federation of Bosnia and Herzegovina (BH) (FBH Basic Lists (FBLs)) with the World Health Organization (WHO) Essential Medicines List (EML) and the evidence supporting the inclusion of additional medicines on FBLs. The sources of data included the 18th edition of the EML and the following FBLs: 2013 Hospital List, 2013 A List in Outpatient Setting, and 2012 List financed by the Federal Solidarity Fund. For medicines found on FBLs but not on EML, we searched the Cochrane Database of Systematic Reviews (CSR) and public health technology assessment (HTA) reports for evidence. FBLs had 134 medicines and 17 combinations that were not on EML, as well as 9 medicines deleted and 4 rejected from EML. EML had 82 medicines and 10 combinations of medicines not included in FBLs. Out of 125 medicines on FBLs but not on EML, 52 (42%) had good CSR evidence supporting their inclusion (n = 38) or exclusion (n = 14). For the rest (n = 74), we found 24 favourable HTA reports. For the total of 89 medicines (27%) listed on FBLs, we found no evidence (EML, CSR, HTA reports) good enough to justify their inclusion in FBLs. In circumstances of scarce financial resources, greater reliance on well-established, proven list is crucial. Independent, unbiased, high-quality evidence such as WHO EML, CSR and HTA reports (national or international with local adaptations) should be used when deciding on medicine reimbursement.

PATIENT-REPORTED OUTCOMES IN RARE LYSOSOMAL STORAGE DISEASES: KEY INFORMANT INTERVIEWS AND A SYSTEMATIC REVIEW PROTOCOL.

PubMed

Miller, Patricia A; Mulla, Sohail M; Adams-Webber, Thomasin; Sivji, Yasmin; Guyatt, Gordon H; Johnston, Bradley C

2016-01-01

To investigate the use, challenges and opportunities associated with using patient-reported outcomes (PROs) in studies with patients with rare lysosomal storage diseases (LSDs), we conducted interviews with researchers and health technology assessment (HTA) experts, and developed the methods for a systematic review of the literature. The purpose of the review is to identify the psychometrically sound generic and disease-specific PROs used in studies with patients with five LSDs of interest: Fabry, Gaucher (Type I), Niemann-Pick (Type B) and Pompe diseases, and mucopolysaccharidosis (Types I and II). Researchers and HTA experts who responded to an email invitation participated in a telephone interview. We used qualitative content analysis to analyze the anonymized transcripts. We conducted a comprehensive literature search for studies that used PROs to investigate burden of disease or to assess the impact of interventions across the five LSDs of interest. Interviews with seven researchers and six HTA experts representing eight countries revealed five themes. These were: (i) the importance of using psychometrically sound PROs in studies with rare diseases, (ii) the paucity of disease-specific PROs, (iii) the importance of having PRO data for economic analyses, (iv) practical and psychometric limitations of existing PROs, and (v) suggestions for new PROs. The systematic review has been completed. The interviews highlight current challenges and opportunities experienced by researchers and HTA experts involved in work with rare LSDs. The ongoing systematic review will highlight the experience, opportunities, and limitations of PROs in LSDs and provide suggestions for future research.

Methodological approaches of health technology assessment.

PubMed

Goodman, C S; Ahn, R

1999-12-01

In this era of evolving health care systems throughout the world, technology remains the substance of health care. Medical informatics comprises a growing contribution to the technologies used in the delivery and management of health care. Diverse, evolving technologies include artificial neural networks, computer-assisted surgery, computer-based patient records, hospital information systems, and more. Decision-makers increasingly demand well-founded information to determine whether or how to develop these technologies, allow them on the market, acquire them, use them, pay for their use, and more. The development and wider use of health technology assessment (HTA) reflects this demand. While HTA offers systematic, well-founded approaches for determining the value of medical informatics technologies, HTA must continue to adapt and refine its methods in response to these evolving technologies. This paper provides a basic overview of HTA principles and methods.

STAKEHOLDER INVOLVEMENT THROUGHOUT HEALTH TECHNOLOGY ASSESSMENT: AN EXAMPLE FROM PALLIATIVE CARE.

PubMed

Brereton, Louise; Wahlster, Philip; Mozygemba, Kati; Lysdahl, Kristin Bakke; Burns, Jake; Polus, Stephanie; Tummers, Marcia; Refolo, Pietro; Sacchini, Dario; Leppert, Wojciech; Chilcott, James; Ingleton, Christine; Gardiner, Clare; Goyder, Elizabeth

2017-01-01

Internationally, funders require stakeholder involvement throughout health technology assessment (HTA). We report successes, challenges, and lessons learned from extensive stakeholder involvement throughout a palliative care case study that demonstrates new concepts and methods for HTA. A 5-step "INTEGRATE-HTA Model" developed within the INTEGRATE-HTA project guided the case study. Using convenience or purposive sampling or directly / indirectly identifying and approaching individuals / groups, stakeholders participated in qualitative research or consultation meetings. During scoping, 132 stakeholders, aged ≥ 18 years in seven countries (England, Italy, Germany, The Netherlands, Norway, Lithuania, and Poland), highlighted key issues in palliative care that assisted identification of the intervention and comparator. Subsequently stakeholders in four countries participated in face-face, telephone and / or video Skype meetings to inform evidence collection and / or review assessment results. An applicability assessment to identify contextual and implementation barriers and enablers for the case study findings involved twelve professionals in the three countries. Finally, thirteen stakeholders participated in a mock decision-making meeting in England. Views about the best methods of stakeholder involvement vary internationally. Stakeholders make valuable contributions in all stages of HTA; assisting decision making about interventions, comparators, research questions; providing evidence and insights into findings, gap analyses and applicability assessments. Key challenges exist regarding inclusivity, time, and resource use. Stakeholder involvement is feasible and worthwhile throughout HTA, sometimes providing unique insights. Various methods can be used to include stakeholders, although challenges exist. Recognition of stakeholder expertise and further guidance about stakeholder consultation methods is needed.

[Review of the health technology assessment on surgeries in Japan].

PubMed

Nishigori, Tatsuto; Kawakami, Koji; Goto, Rei; Hida, Koya; Sakai, Yoshiharu

2015-01-01

Health Technology Assessment (HTA) is the systematic evaluation to measure the value of new health technologies. It improves the quality of choices on hand for cost-effective health technologies that are considered valuable. Japan has built a society of longevity consisted of the institution of the universal health care system, which is financially unsustainable. In Japan, no independent HTA organization has been publicly established but the government is contemplating implementation of such system. To advance the usage of HTA into surgery, we need to establish methods for evaluating new surgical technologies with steep learning curves. The promotion of clinical researches is also essential, especially by taking advantage of observational studies from medical big data such as the Japanese nationwide database which has more than four million surgical cases registered. In addition, we need more clinical information regarding each surgical patient's quality of life and socioeconomic status. The countries already introduced HTA into their health care system have measures to solve the problems that arose and have developed necessary evaluating methods. To introduce and promote HTA in Japan without taking away the benefit of our current healthcare, it is required that surgeons collaborate with other specialists such as methodologists and health economists.

Value-Based Assessment of New Medical Technologies: Towards a Robust Methodological Framework for the Application of Multiple Criteria Decision Analysis in the Context of Health Technology Assessment.

PubMed

Angelis, Aris; Kanavos, Panos

2016-05-01

In recent years, multiple criteria decision analysis (MCDA) has emerged as a likely alternative to address shortcomings in health technology assessment (HTA) by offering a more holistic perspective to value assessment and acting as an alternative priority setting tool. In this paper, we argue that MCDA needs to subscribe to robust methodological processes related to the selection of objectives, criteria and attributes in order to be meaningful in the context of healthcare decision making and fulfil its role in value-based assessment (VBA). We propose a methodological process, based on multi-attribute value theory (MAVT) methods comprising five distinct phases, outline the stages involved in each phase and discuss their relevance in the HTA process. Importantly, criteria and attributes need to satisfy a set of desired properties, otherwise the outcome of the analysis can produce spurious results and misleading recommendations. Assuming the methodological process we propose is adhered to, the application of MCDA presents three very distinct advantages to decision makers in the context of HTA and VBA: first, it acts as an instrument for eliciting preferences on the performance of alternative options across a wider set of explicit criteria, leading to a more complete assessment of value; second, it allows the elicitation of preferences across the criteria themselves to reflect differences in their relative importance; and, third, the entire process of preference elicitation can be informed by direct stakeholder engagement, and can therefore reflect their own preferences. All features are fully transparent and facilitate decision making.

Nature and reporting characteristics of UK health technology assessment systematic reviews.

PubMed

Carroll, Christopher; Kaltenthaler, Eva

2018-05-08

A recent study by Page et al. (PLoS Med. 2016;13(5):e1002028) claimed that increasing numbers of reviews are being published and many are poorly-conducted and reported. The aim of the present study was to assess how well reporting standards of systematic reviews produced in a Health Technology Assessment (HTA) context compare with reporting in Cochrane and other 'non-Cochrane' systematic reviews from the same years (2004 and 2014), as reported by Page et al. (PLoS Med. 2016;13(5):e1002028). All relevant UK HTA programme systematic reviews published in 2004 and 2014 were identified. After piloting of the form, two reviewers each extracted relevant data on conduct and reporting from these reviews. These data were compared with data for Cochrane and "non-Cochrane" systematic reviews, as published by Page et al. (PLoS Med. 2016;13(5):e1002028). All data were tabulated and summarized. There were 30 UK HTA programme systematic reviews and 300 other systematic reviews, including Cochrane reviews (n = 45). The percentage of HTA reviews with required elements of conduct and reporting was frequently very similar to Cochrane and much higher than all other systematic reviews, e.g. availability of protocols (90, 98 and 16% respectively); the specification of study design criteria (100, 100, 79%); the reporting of outcomes (100, 100, 78%), quality assessment (100, 100, 70%); the searching of trial registries for unpublished data (70, 62, 19%); reporting of reasons for excluding studies (91, 91 and 70%) and reporting of authors' conflicts of interests (100, 100, 87%). HTA reviews only compared less favourably with Cochrane and other reviews in assessments of publication bias. UK HTA systematic reviews are often produced within a specific policy-making context. This context has implications for timelines, tools and resources. However, UK HTA systematic reviews still tend to present standards of conduct and reporting equivalent to "gold standard" Cochrane reviews and superior to systematic reviews more generally.

Multi-Criteria Decision Analysis for Assessment and Appraisal of Orphan Drugs.

PubMed

Iskrov, Georgi; Miteva-Katrandzhieva, Tsonka; Stefanov, Rumen

2016-01-01

Limited resources and expanding expectations push all countries and types of health systems to adopt new approaches in priority setting and resources allocation. Despite best efforts, it is difficult to reconcile all competing interests, and trade-offs are inevitable. This is why multi-criteria decision analysis (MCDA) has played a major role in recent uptake of value-based reimbursement. MCDA framework enables exploration of stakeholders' preferences, as well as explicit organization of broad range of criteria on which real-world decisions are made. Assessment and appraisal of orphan drugs tend to be one of the most complicated health technology assessment (HTA) tasks. Access to market approved orphan therapies remains an issue. Early constructive dialog among rare disease stakeholders and elaboration of orphan drug-tailored decision support tools could set the scene for ongoing accumulation of evidence, as well as for proper reimbursement decision-making. The objective of this study was to create an MCDA value measurement model to assess and appraise orphan drugs. This was achieved by exploring the preferences on decision criteria's weights and performance scores through a stakeholder-representative survey and a focus group discussion that were both organized in Bulgaria. Decision criteria that describe the health technology's characteristics were unanimously agreed as the most important group of reimbursement considerations. This outcome, combined with the high individual weight of disease severity and disease burden criteria, underlined some of the fundamental principles of health care - equity and fairness. Our study proved that strength of evidence may be a key criterion in orphan drug assessment and appraisal. Evidence is used not only to shape reimbursement decision-making but also to lend legitimacy to policies pursued. The need for real-world data on orphan drugs was largely stressed. Improved knowledge on MCDA feasibility and integration to HTA is of paramount importance, as progress in medicine and innovative health technologies should correspond to patient, health-care system, and societal values.

A PROCESS OF PRIORITIZING TOPICS FOR HEALTH TECHNOLOGY ASSESSMENT IN KAZAKHSTAN.

PubMed

Kosherbayeva, Lyazzat; Hailey, David; Kurakbaev, Kural; Tabarov, Adlet; Kumar, Ainur; Gutzskaya, Gulnara; Stepkina, Elena

2016-01-01

The aim of this study was to develop criteria for the prioritization of topics for health technology assessment (HTA) in the healthcare system of Kazakhstan. Initial proposals for criteria were suggested through consultation with Ministry of Health (MoH) policy areas. These were refined through a workshop attended by HTA department staff, persons from medical universities and research institutes, and MoH policy makers. The workshop included discussion on methods used in international HTA practice. Opinions of participants on selection of criteria from those specified in a review of prioritization processes were used to define a list for inclusion in an instrument for routine use. A scoring system was established in later discussion. Selected criteria for HTA prioritization were burden of disease, availability of alternative technology, clinical effectiveness, economic efficiency, budget impact, and ethical, legal, and/or psychosocial aspects. For each criterion, a health technology under consideration is given a score from 3 (High) to 1 (Low). The total score determines whether the technology is of high to medium priority or of low priority. Determination of priorities for assessment, using the instrument, should be carried out by an expert group appointed by the MoH. The process was applied in 2014 to a selection of topics, and three health technologies were chosen for full assessments. Criteria for prioritization have evolved with development of the HTA program in Kazakhstan. A method for HTA prioritization has been developed that is easy to apply, requires comparatively few resources, and is compatible with processes required by the MoH.

[Essential hypertension in young people--ambulatory versus hospital care].

PubMed

Mitu, F; Leon, Maria-Magdalena

2012-01-01

Cardiovascular disease is the leading cause of death in our country. The number of young people with hypertension grow up quickly, so a good control of dyslipidemia and blood pressure (BP) is essential in prevention of cardiovascular disease. To investigate the prevalence of HTA at young people and established the corelation with another risk factors like smoke, colesterol, obesity and heredity, few data are available on the blood pressure characteristics of young patients. It has been investigate 366 young people between 19-25 years old, in ambulatory system and 350 younger with the same age, in hospital. Blood pressure was measured according to standard procedures, and was considered well-controlled if it was < 140/90 mm Hg. From our ambulatory patients were 198 women (54.1%), 168 men (45.9%) and from hospital were 178 women (50.9%) and 172 men (41.9%). HTA was present at 37 patients (10.1%) in ambulatory system and 50 patients (14.3%) in hospital. Between the intensity of smoke, the number of cigarette and the prevalence of HTA is a direct relation. The heredity factor is very important, too. The prevalence grow more than 2.5 at this patients. The incidence of HTA is 1.9 bigger at women with big values of colesterol and 2.1 at men with big colesterol. The relation between HTA--obesity is proven in our study, the incidence of HTA is 2.6 bigger at the obeses patients. These arguments should also promote further research in primary care on the control and the therapeutic behavior of the physicians.

EVALUATION OF THE HTA CORE MODEL FOR NATIONAL HEALTH TECHNOLOGY ASSESSMENT REPORTS: COMPARATIVE STUDY AND EXPERIENCES FROM EUROPEAN COUNTRIES.

PubMed

Kõrge, Kristina; Berndt, Nadine; Hohmann, Juergen; Romano, Florence; Hiligsmann, Mickael

2017-01-01

The health technology assessment (HTA) Core Model® is a tool for defining and standardizing the elements of HTA analyses within several domains for producing structured reports. This study explored the parallels between the Core Model and a national HTA report. Experiences from various European HTA agencies were also investigated to determine the Core Model's adaptability to national reports. A comparison between a national report on Genetic Counseling, produced by the Cellule d'expertise médicale Luxembourg, and the Core Model was performed to identify parallels in terms of relevant and comparable assessment elements (AEs). Semi-structured interviews with five representatives from European HTA agencies were performed to assess their user experiences with the Core Model. The comparative study revealed that 50 percent of the total number (n = 144) of AEs in the Core Model were relevant for the national report. Of these 144 AEs from the Core Model, 34 (24 percent) were covered in the national report. Some AEs were covered only partly. The interviewees emphasized flexibility in using the Core Model and stated that the most important aspects to be evaluated include characteristics of the disease and technology, clinical effectiveness, economic aspects, and safety. In the present study, the national report covered an acceptable number of AEs of the Core Model. These results need to be interpreted with caution because only one comparison was performed. The Core Model can be used in a flexible manner, applying only those elements that are relevant from the perspective of the technology assessment and specific country context.

The role of surgeons in identifying emerging technologies for health technology assessment.

PubMed

Stafinski, Tania; Topfer, Leigh-Ann; Zakariasen, Ken; Menon, Devidas

2010-04-01

Health technology assessment (HTA) is a tool intended to help policy-makers decide which technologies to fund. However, given the proliferation of new technologies, it is not possible to undertake an HTA of each one before it becomes funded. Consequently, "horizon-scanning" processes have been developed to identify emerging technologies that are likely to have a substantial impact on clinical practice. Although the importance of physicians in the adoption of new technologies is well recognized, their role in horizon scanning in Canada has been limited. The purpose of this project was to pilot an approach to engage physicians, specifically surgeons, in provincial horizon-scanning activities. We invited 18 surgeons from Alberta's 2 medical schools to a horizon-scanning workshop to solicit their views on emerging technologies expected to impact surgical practice within the next 5 years and/or the importance of different attributes or characteristics of new technologies. Surgeons, regardless of specialty, identified developments designed to enhance existing minimally invasive surgical techniques, such as endoscopic, robotic and image-guided surgery. Several nonsurgical areas, including molecular genetics and nano technology, were also identified. Of the 13 technology attributes discussed, safety or risk, effectiveness and feasibility were rated as most important. Lastly, participating surgeons expressed an interest in becoming further involved in local HTA initiatives. Surgeons, as adopters and users of health technologies, represent an important and accessible information source for identifying emerging technologies for HTA. A more formal, ongoing relationship between the government, HTA and surgeons may help to optimize the use of HTA resources.

The role of surgeons in identifying emerging technologies for health technology assessment

PubMed Central

Stafinski, Tania; Topfer, Leigh-Ann; Zakariasen, Ken; Menon, Devidas

2010-01-01

Background Health technology assessment (HTA) is a tool intended to help policy-makers decide which technologies to fund. However, given the proliferation of new technologies, it is not possible to undertake an HTA of each one before it becomes funded. Consequently, “horizon-scanning” processes have been developed to identify emerging technologies that are likely to have a substantial impact on clinical practice. Although the importance of physicians in the adoption of new technologies is well recognized, their role in horizon scanning in Canada has been limited. The purpose of this project was to pilot an approach to engage physicians, specifically surgeons, in provincial horizon-scanning activities. Methods We invited 18 surgeons from Alberta’s 2 medical schools to a horizon-scanning workshop to solicit their views on emerging technologies expected to impact surgical practice within the next 5 years and/or the importance of different attributes or characteristics of new technologies. Results Surgeons, regardless of specialty, identified developments designed to enhance existing minimally invasive surgical techniques, such as endoscopic, robotic and image-guided surgery. Several nonsurgical areas, including molecular genetics and nanotechnology, were also identified. Of the 13 technology attributes discussed, safety or risk, effectiveness and feasibility were rated as most important. Lastly, participating surgeons expressed an interest in becoming further involved in local HTA initiatives. Conclusion Surgeons, as adopters and users of health technologies, represent an important and accessible information source for identifying emerging technologies for HTA. A more formal, ongoing relationship between the government, HTA and surgeons may help to optimize the use of HTA resources. PMID:20334740

Health technology assessment and primary data collection for reducing uncertainty in decision making.

PubMed

Goeree, Ron; Levin, Les; Chandra, Kiran; Bowen, James M; Blackhouse, Gord; Tarride, Jean-Eric; Burke, Natasha; Bischof, Matthias; Xie, Feng; O'Reilly, Daria

2009-05-01

Health care expenditures continue to escalate, and pressures for increased spending will continue. Health care decision makers from publicly financed systems, private insurance companies, or even from individual health care institutions, will continue to be faced with making difficult purchasing, access, and reimbursement decisions. As a result, decision makers are increasingly turning to evidence-based platforms to help control costs and make the most efficient use of existing resources. Most tools used to assist with evidence-based decision making focus on clinical outcomes. Health technology assessment (HTA) is increasing in popularity because it also considers other factors important for decision making, such as cost, social and ethical values, legal issues, and factors such as the feasibility of implementation. In some jurisdictions, HTAs have also been supplemented with primary data collection to help address uncertainty that may still exist after conducting a traditional HTA. The HTA process adopted in Ontario, Canada, is unique in that assessments are also made to determine what primary data research should be conducted and what should be collected in these studies. In this article, concerns with the traditional HTA process are discussed, followed by a description of the HTA process that has been established in Ontario, with a particular focus on the data collection program followed by the Programs for Assessment of Technology in Health Research Institute. An illustrative example is used to show how the Ontario HTA process works and the role value of information analyses plays in addressing decision uncertainty, determining research feasibility, and determining study data collection needs.

Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

PubMed

Niehaus, Ines; Dintsios, Charalabos-Markos

2018-06-01

The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment by contrasting the benefit-risk ratio of EMA and the benefit-harm balance of the HTA jurisdiction. Agreement between market authorization and early benefit assessment is examined by Cohen's kappa (k). 21 of 41 assessments were considered in the analysis. Market authorization is more confirmatory than early benefit assessment because it includes a higher proportion of primary endpoints. The latter implies a primary endpoint to be relevant for the benefit-harm balance in only 67% of cases (0.078). Explorative mortality endpoints reached the highest agreement regarding the mutual consideration for the risk-benefit ratio and the benefit-harm balance (0.000). For explorative morbidity endpoints (-0.600), quality of life (-0.600) and side effects (-0.949) no agreement is ascertainable. To warrant a broader confirmatory basis for decisions supported by HTA, closer inter-institutional cooperation of approval authorities and HTA jurisdictions by means of reliable joint advice for manufacturers regarding endpoint definition would be favorable. Copyright © 2018 Elsevier B.V. All rights reserved.

What influences the choice of assessment methods in health technology assessments? Statistical analysis of international health technology assessments from 1989 to 2002.

PubMed

Draborg, Eva; Andersen, Christian Kronborg

2006-01-01

Health technology assessment (HTA) has been used as input in decision making worldwide for more than 25 years. However, no uniform definition of HTA or agreement on assessment methods exists, leaving open the question of what influences the choice of assessment methods in HTAs. The objective of this study is to analyze statistically a possible relationship between methods of assessment used in practical HTAs, type of assessed technology, type of assessors, and year of publication. A sample of 433 HTAs published by eleven leading institutions or agencies in nine countries was reviewed and analyzed by multiple logistic regression. The study shows that outsourcing of HTA reports to external partners is associated with a higher likelihood of using assessment methods, such as meta-analysis, surveys, economic evaluations, and randomized controlled trials; and with a lower likelihood of using assessment methods, such as literature reviews and "other methods". The year of publication was statistically related to the inclusion of economic evaluations and shows a decreasing likelihood during the year span. The type of assessed technology was related to economic evaluations with a decreasing likelihood, to surveys, and to "other methods" with a decreasing likelihood when pharmaceuticals were the assessed type of technology. During the period from 1989 to 2002, no major developments in assessment methods used in practical HTAs were shown statistically in a sample of 433 HTAs worldwide. Outsourcing to external assessors has a statistically significant influence on choice of assessment methods.

Developing an evidence-based methodological framework to systematically compare HTA coverage decisions: A mixed methods study.

PubMed

Nicod, Elena; Kanavos, Panos

2016-01-01

Health Technology Assessment (HTA) often results in different coverage recommendations across countries for a same medicine despite similar methodological approaches. This paper develops and pilots a methodological framework that systematically identifies the reasons for these differences using an exploratory sequential mixed methods research design. The study countries were England, Scotland, Sweden and France. The methodological framework was built around three stages of the HTA process: (a) evidence, (b) its interpretation, and (c) its influence on the final recommendation; and was applied to two orphan medicinal products. The criteria accounted for at each stage were qualitatively analyzed through thematic analysis. Piloting the framework for two medicines, eight trials, 43 clinical endpoints and seven economic models were coded 155 times. Eighteen different uncertainties about this evidence were coded 28 times, 56% of which pertained to evidence commonly appraised and 44% to evidence considered by only some agencies. The poor agreement in interpreting this evidence (κ=0.183) was partly explained by stakeholder input (ns=48 times), or by agency-specific risk (nu=28 uncertainties) and value preferences (noc=62 "other considerations"), derived through correspondence analysis. Accounting for variability at each stage of the process can be achieved by codifying its existence and quantifying its impact through the application of this framework. The transferability of this framework to other disease areas, medicines and countries is ensured by its iterative and flexible nature, and detailed description. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Integrating health technology assessment requirements in the clinical development of medicines: the experience from NICE scientific advice.

PubMed

Maignen, François; Osipenko, Leeza; Pinilla-Dominguez, Pilar; Crowe, Emily

2017-03-01

The primary objective of the study was to analyse the proposed clinical development and economic evaluation plans for investigational medicinal products for which pharmaceutical companies have sought health technology assessment (HTA) scientific advice (SA). We have selected and analysed all the scientific advice procedures undertaken by National Institute for Health and Care Excellence (NICE) SA between 1 January 2009 and 3 December 2015 for investigational medicinal products. We have mapped the questions asked by the companies and the areas of advice highlighted in the advice reports to the sections of the NICE methods guide to the technology appraisals (2013). An overwhelming proportion of SA procedures have addressed questions related to the clinical development and specifically the main pivotal efficacy studies. Approximately a quarter of the questions relate to the approaches to economic evaluation. Questions raised in European Medicines Agency-HTA procedures generally focus on clinical efficacy issues whereas cost-effectiveness ones tend to dominate in NICE-only procedures. Our analysis shows that the issues mostly discussed in the HTA SA are the choice of comparator, the generalisability of the clinical trial evidence to the NHS practice and the impact of the clinical trial outcomes on quality of life and survival. Less disagreement with the developers' plans was seen in the choice of clinical endpoints, population definition, position of the technology in the treatment pathway and study design. Scientific advice is designed to improve the quality of evidence and approaches to evidence generation for future regulatory approval and HTA evaluation. Our experience to date suggests that payer requirements are inconsistently integrated in the clinical development programmes. More efforts should be dedicated to demonstrating the clinical value of new medicinal products to patients and key decision-makers.

Transparency in practice: Evidence from 'verification analyses' issued by the Polish Agency for Health Technology Assessment in 2012-2015.

PubMed

Ozierański, Piotr; Löblová, Olga; Nicholls, Natalia; Csanádi, Marcell; Kaló, Zoltán; McKee, Martin; King, Lawrence

2018-01-08

Transparency is recognised to be a key underpinning of the work of health technology assessment (HTA) agencies, yet it has only recently become a subject of systematic inquiry. We contribute to this research field by considering the Polish Agency for Health Technology Assessment (AHTAPol). We situate the AHTAPol in a broader context by comparing it with the National Institute for Health and Care Excellence (NICE) in England. To this end, we analyse all 332 assessment reports, called verification analyses, that the AHTAPol issued from 2012 to 2015, and a stratified sample of 22 Evidence Review Group reports published by NICE in the same period. Overall, by increasingly presenting its key conclusions in assessment reports, the AHTAPol has reached the transparency standards set out by NICE in transparency of HTA outputs. The AHTAPol is more transparent than NICE in certain aspects of the HTA process, such as providing rationales for redacting assessment reports and providing summaries of expert opinions. Nevertheless, it is less transparent in other areas of the HTA process, such as including information on expert conflicts of interest. Our findings have important implications for understanding HTA in Poland and more broadly. We use them to formulate recommendations for policymakers.

Ethical, legal, and social issues in health technology assessment for prenatal/preconceptional and newborn screening: a workshop report.

PubMed

Potter, B K; Avard, D; Entwistle, V; Kennedy, C; Chakraborty, P; McGuire, M; Wilson, B J

2009-01-01

Prenatal/preconceptional and newborn screening programs have been a focus of recent policy debates that have included attention to ethical, legal, and social issues (ELSIs). In parallel, there has been an ongoing discussion about whether and how ELSIs may be addressed in health technology assessment (HTA). We conducted a knowledge synthesis study to explore both guidance and current practice regarding the consideration of ELSIs in HTA for prenatal/preconceptional and newborn screening. As the concluding activity for this project, we held a Canadian workshop to discuss the issues with a diverse group of stakeholders. Based on key workshop themes integrated with our study results, we suggest that population-based genetic screening programs may present particular types of ELSIs and that a public health ethics perspective is potentially highly relevant when considering them. We also suggest that approaches to addressing ELSIs in HTA for prenatal/preconceptional and newborn screening may need to be flexible enough to respond to diversity in HTA organizations, cultural values, stakeholder communities, and contextual factors. Finally, we highlight a need for transparency in the way that HTA producers move from evidence to conclusions and the ways in which screening policy decisions are made. Copyright © 2008 S. Karger AG, Basel.

Ethical, Legal, and Social Issues in Health Technology Assessment for Prenatal/Preconceptional and Newborn Screening: A Workshop Report

PubMed Central

Potter, B.K.; Avard, D.; Entwistle, V.; Kennedy, C.; Chakraborty, P.; McGuire, M.; Wilson, B.J.

2008-01-01

Prenatal/preconceptional and newborn screening programs have been a focus of recent policy debates that have included attention to ethical, legal, and social issues (ELSIs). In parallel, there has been an ongoing discussion about whether and how ELSIs may be addressed in health technology assessment (HTA). We conducted a knowledge synthesis study to explore both guidance and current practice regarding the consideration of ELSIs in HTA for prenatal/preconceptional and newborn screening. As the concluding activity for this project, we held a Canadian workshop to discuss the issues with a diverse group of stakeholders. Based on key workshop themes integrated with our study results, we suggest that population-based genetic screening programs may present particular types of ELSIs and that a public health ethics perspective is potentially highly relevant when considering them. We also suggest that approaches to addressing ELSIs in HTA for prenatal/preconceptional and newborn screening may need to be flexible enough to respond to diversity in HTA organizations, cultural values, stakeholder communities, and contextual factors. Finally, we highlight a need for transparency in the way that HTA producers move from evidence to conclusions and the ways in which screening policy decisions are made. PMID:19023190

CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE.

PubMed

Kani, Chara; Kourafalos, Vasilios; Litsa, Panagiota

2017-01-01

The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Hospital managers' need for information in decision-making--An interview study in nine European countries.

PubMed

Kidholm, Kristian; Ølholm, Anne Mette; Birk-Olsen, Mette; Cicchetti, Americo; Fure, Brynjar; Halmesmäki, Esa; Kahveci, Rabia; Kiivet, Raul-Allan; Wasserfallen, Jean-Blaise; Wild, Claudia; Sampietro-Colom, Laura

2015-11-01

Assessments of new health technologies in Europe are often made at the hospital level. However, the guidelines for health technology assessment (HTA), e.g. the EUnetHTA Core Model, are produced by national HTA organizations and focus on decision-making at the national level. This paper describes the results of an interview study with European hospital managers about their need for information when deciding about investments in new treatments. The study is part of the AdHopHTA project. Face-to-face, structured interviews were conducted with 53 hospital managers from nine European countries. The hospital managers identified the clinical, economic, safety and organizational aspects of new treatments as being the most relevant for decision-making. With regard to economic aspects, the hospital managers typically had a narrower focus on budget impact and reimbursement. In addition to the information included in traditional HTAs, hospital managers sometimes needed information on the political and strategic aspects of new treatments, in particular the relationship between the treatment and the strategic goals of the hospital. If further studies are able to verify our results, guidelines for hospital-based HTA should be altered to reflect the information needs of hospital managers when deciding about investments in new treatments. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

The impact of diagnosis and trait anxiety on psychological distress in women with early stage breast cancer: a prospective study.

PubMed

Keyzer-Dekker, Claudia M G; de Vries, Jolanda; Mertens, Marlies C; Roukema, Jan A; van der Steeg, Alida F W

2014-11-01

High trait anxiety (HTA) determines depressive symptoms and state anxiety in women with breast cancer (BC) or benign breast disease (BBD). Before implementing screening for psychological counselling in these women, it is important to evaluate whether high state anxiety and depressive symptoms are determined by (the threat of) having BC or solely by HTA. Therefore, we compared women with a lump in the breast with women with gallstone disease (GD). Women diagnosed with BC (n = 152), BBD (n = 205), and GD (n = 128) were included in a prospective longitudinal study. Questionnaires concerning trait anxiety (baseline), state anxiety, and depressive symptoms were completed before diagnosis was known (BC and BBD) or the laparoscopic cholecystectomy and 6 months later. Pre-diagnosis BC patients scored higher on state anxiety (p = .001) and depressive symptoms (p < .001) compared with GD. At 6 months, scores on depressive symptoms in BC remained higher than GD (p = .005). In women with HTA, before being diagnosed with BC or BBD, scores on state anxiety were higher compared with HTA women with GD (p < .001, p = .040). State anxiety and depressive symptoms at 6 months were predicted by baseline depressive symptoms in women with BC. The severity of diagnosis (BC) in combination with HTA determined the level of state anxiety and depressive symptoms. Therefore, we recommend identifying women with HTA and offering them a tailor-made follow-up protocol during and after the diagnostic process for BBD or BC. What is already known on this subject? Women diagnosed with BC or BBD experience high levels of anxiety and distress during the diagnostic process. These adverse psychological effects are strengthened by the personality characteristic trait anxiety. Before implementing screening for psychological counselling in women with high trait anixety, it is important to evaluate whether high state anxiety and depressive symptoms are determined by (the threat of) having BC or solely by HTA. What does this study add? To our knowledge, this is the first study comparing women who are confronted with the possibility of having a life-threatening disease, that is, BC, with women who were not suspected of having a life-threatening disease, that is, GD. This study reveals that the severity of diagnosis (BC) in combination with HTA determined the level of state anxiety and depressive symptoms. Therefore, we recommend identifying women with HTA and offering them a tailor-made follow-up protocol during and after the diagnostic process for BC or BBD. © 2013 The British Psychological Society.

Economic Evaluation of Health IT.

PubMed

Luzi, Daniela; Pecoraro, Fabrizio; Tamburis, Oscar

2016-01-01

Economic evaluation in health care supports decision makers in prioritizing interventions and maximizing the available limited resources for social benefits. Health Information Technology (health IT) constitutes a promising strategy to improve the quality and delivery of health care. However, to determine whether the appropriate health IT solution has been selected in a specific health context, its impact on the clinical and organizational process, on costs, on user satisfaction as well as on patient outcomes, a rigorous and multidimensional evaluation analysis is necessary. Starting from the principles of evaluation introduced since the mid-1980s within the Health Technology Assessment (HTA) guidelines, this contribution provides an overview of the main challenging issues related to the complex task of performing an economic evaluation of health IT. A set of necessary key principles to deliver a proper design and implementation of a multidimensional economic evaluation study is described, focusing in particular on the classification of costs and outcomes as well as on the type of economic analysis to be performed. A case study is eventually described to show how the key principles introduced are applied.

Challenges in Research and Health Technology Assessment of Rare Disease Technologies: Report of the ISPOR Rare Disease Special Interest Group.

PubMed

Nestler-Parr, Sandra; Korchagina, Daria; Toumi, Mondher; Pashos, Chris L; Blanchette, Christopher; Molsen, Elizabeth; Morel, Thomas; Simoens, Steven; Kaló, Zoltán; Gatermann, Ruediger; Redekop, William

2018-05-01

Successful development of new treatments for rare diseases (RDs) and their sustainable patient access require overcoming a series of challenges related to research and health technology assessment (HTA). These impediments, which may be unique to RDs or also apply to common diseases but are particularly pertinent in RDs, are diverse and interrelated. To develop for the first time a catalog of primary impediments to RD research and HTA, and to describe the cause and effect of individual challenges. Challenges were identified by an international 22-person expert working group and qualitative outreach to colleagues with relevant expertise. A broad range of stakeholder perspectives is represented. Draft results were presented at annual European and North American International Society for Pharmacoeconomics and Outcomes Research (ISPOR) congresses, and written comments were received by the 385-strong ISPOR Rare Disease Review Group from two rounds of review. Findings were refined and confirmed via targeted literature search. Research-related challenges linked to the low prevalence of RDs were categorized into those pertaining to disease recognition and diagnosis, evaluation of treatment effect, and patient recruitment for clinical research. HTA-related challenges were classified into issues relating to the lack of a tailored HTA method for RD treatments and uncertainty for HTA agencies and health care payers. Identifying and highlighting diverse, but interrelated, key challenges in RD research and HTA is an essential first step toward developing implementable and sustainable solutions. A collaborative multistakeholder effort is required to enable faster and less costly development of safe, efficacious, and appropriate new RD therapies that offer value for money. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

An international survey of the public engagement practices of health technology assessment organizations.

PubMed

Whitty, Jennifer A

2013-01-01

Many jurisdictions are moving toward greater public involvement in health technology assessment (HTA) processes. This study aims to provide a broad, cross-sectional indication of the extent and methods of public engagement in HTA, with a focus on which public are engaged, by what mechanisms, and the purpose of public engagement. An international Web-based survey of 217 organizations involved in HTA was undertaken. Contact e-mail addresses for targeted organizations were identified from the Internet. Individuals from 39 (18%) of the contacted organizations completed a survey. The majority (67%) of responding HTA organizations undertake public engagement activities, predominantly involving lay representatives of organized groups (81%), and to a lesser extent individual patients/consumers (54%) or citizens/community members (54%). For organizations undertaking public engagement, mechanisms based on communication or consultation were the most common, although some organizations have used or intend to use participatory approaches, particularly the Citizens' Jury (8%) or Consensus Council (20%) methods. Respondents identified with a number of rationales and barriers for undertaking public engagement. This survey provides further insight into the public engagement approaches that are used by HTA organizations in practice. In particular, it suggests a limited adoption of participatory methods to date, and interest in the use of social media. Study findings require further confirmation, due to limitations related to survey response. There is considerable opportunity for further research into pragmatic, robust, and meaningful approaches to public engagement to strengthen HTA policy and decision-making frameworks. An agenda for future research evolving from the survey responses is proposed. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey.

PubMed

Hatz, Maximilian H M; Schreyögg, Jonas; Torbica, Aleksandra; Boriani, Giuseppe; Blankart, Carl R B

2017-02-01

Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of 'new' devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of 'old' devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Decision Making and Priority Setting: The Evolving Path Towards Universal Health Coverage.

PubMed

Paolucci, Francesco; Redekop, Ken; Fouda, Ayman; Fiorentini, Gianluca

2017-12-01

Health technology assessment (HTA) is widely viewed as an essential component in good universal health coverage (UHC) decision-making in any country. Various HTA tools and metrics have been developed and refined over the years, including systematic literature reviews (Cochrane), economic modelling, and cost-effectiveness ratios and acceptability curves. However, while the cost-effectiveness ratio is faithfully reported in most full economic evaluations, it is viewed by many as an insufficient basis for reimbursement decisions. Emotional debates about the reimbursement of cancer drugs, orphan drugs, and end-of-life treatments have revealed fundamental disagreements about what should and should not be considered in reimbursement decisions. Part of this disagreement seems related to the equity-efficiency tradeoff, which reflects fundamental differences in priorities. All in all, it is clear that countries aiming to improve UHC policies will have to go beyond the capacity building needed to utilize the available HTA toolbox. Multi-criteria decision analysis (MCDA) offers a more comprehensive tool for reimbursement decisions where different weights of different factors/attributes can give policymakers important insights to consider. Sooner or later, every country will have to develop their own way to carefully combine the results of those tools with their own priorities. In the end, all policymaking is based on a mix of facts and values.

Public preferences for engagement in Health Technology Assessment decision-making: protocol of a mixed methods study.

PubMed

Wortley, Sally; Tong, Allison; Lancsar, Emily; Salkeld, Glenn; Howard, Kirsten

2015-07-14

Much attention in recent years has been given to the topic of public engagement in health technology assessment (HTA) decision-making. HTA organizations spend substantial resources and time on undertaking public engagement, and numerous studies have examined challenges and barriers to engagement in the decision-making process however uncertainty remains as to optimal methods to incorporate the views of the public in HTA decision-making. Little research has been done to ascertain whether current engagement processes align with public preferences and to what extent their desire for engagement is dependent on the question being asked by decision-makers or the characteristics of the decision. This study will examine public preferences for engagement in Australian HTA decision-making using an exploratory mixed methods design. The aims of this study are to: 1) identify characteristics about HTA decisions that are important to the public in determining whether public engagement should be undertaken on a particular topic, 2) determine which decision characteristics influence public preferences for the extent, or type of public engagement, and 3) describe reasons underpinning these preferences. Focus group participants from the general community, aged 18-70 years, will be purposively sampled from the Australian population to ensure a wide range of demographic groups. Each focus group will include a general discussion on public engagement as well as a ranking exercise using a modified nominal group technique (NGT). The NGT will inform the design of a discrete choice study to quantitatively assess public preferences for engagement in HTA decision-making. The proposed research seeks to investigate under what circumstances and how the public would like their views and preferences to be considered in health technology assessments. HTA organizations regularly make decisions about when and how public engagement should occur but without consideration of the public's preferences on the method and extent of engagement. This information has the potential to assist decision-makers in tailoring engagement approaches, and may be particularly useful in decisions with potential for conflict where clarification of public values and preferences could strengthen the decision-making process.

Health technology assessment. Evaluation of biomedical innovative technologies.

PubMed

Turchetti, Giuseppe; Spadoni, Enza; Geisler, Eliezer Elie

2010-01-01

This article describes health technology assessment (HTA) as an evaluation tool that applies systematic methods of inquiry to the generation and use of health technologies and new products. The focus of this article is on the contributions of HTA to the management of the new product development effort in the biomedical organization. Critical success factors (CSFs) are listed, and their role in assessing success is defined and explained. One of the conclusions of this article is that HTA is a powerful tool for managers in the biomedical sector, allowing them to better manage their innovation effort in their continuing struggle for competitiveness and survival.

Apport de l'orientation clinique dans le diagnostic des hypertensions arterielles endocriniennes

PubMed Central

El Aziz, Siham; Chadli, Asma; Louda, Fatima; El Ghomari, Hassan; Farouqi, Ahmed

2014-01-01

L'hypertension artérielle d'origine endocrinienne représente une cause curable d'hypertension artérielle (HTA), ce qui en justifie le dépistage. Une orientation clinique est souhaitable afin de prescrire les bilans adéquats, notamment dans les pays en voie de développement. L'objectif de notre étude est décrire les aspects cliniques des patients ayant une HTA endocrinienne diagnostiquée au CHU de Casablanca. Méthodes: Il s'agit d'une étude descriptive rétrospective de 2004 à 2011, incluant tout patient ayant une HTA endocrinienne (en dehors des dysthyroïdies) admis en Endocrinologie. Les données concernant les facteurs cliniques, paracliniques et thérapeutiques ont été colligées. Au cours de la période étudiée, 53 cas d'HTA endocrinienne ont été admis, avec une age moyen au diagnostic de 39,3 ans et un sex-ratio F/H de 3,9. Trente patients (56.6%) ont un age ont un âge inférieur à 40 ans. On ne retrouve pas d'hérédité tensionelle chez 88.7% des patients. Les étiologies sont le Syndrome de cushing (41.5%), le phéochromocytome (32%), les adénomes somatotropes (15%) et les hyperaldostéronismes primaire (7.5%). L'HTA est essentiellement de grade un ou deux (69.8%), avec un retentissement cardio-vasculaire chez 11 patients (20.7%). Les patients ayant un SC avaient tous des signes cutanés spécifiques. Il s'agissait de sujets jeunes avec plusieurs facteurs de risque cardiovasculaire. Nous avons retrouvé un amaigrissement chez 37.5% des patients ayant un phéochromocytome avec un indice de masse corporel moyen de 20 kg/m2. L'HTA était permanente dans 5 cas de phéochromocytomes. Il n'existait pas d'hypokaliémie chez 50% des patients ayant un hyperaldostéronisme. Les signes cliniques des patients ayant une acromégalie étaient francs, avec un age moyen plus élevé de 50 ans. Nous avons noté une régression de l'HTA chez 59% de ces patients après guérison de l'endocrinopathie en cause. Plusieurs signes cliniques peuvent nous orienter vers une HTA endocrinienne, notamment chez l'adulte jeune, et devraient indiquer les bilans adéquats afin d’éviter une méconnaissance du diagnostic. PMID:25422689

Potentiometric titration of polyhexamethylene biguanide hydrochloride with potassium poly(vinyl sulfate) solution using a cationic surfactant-selective electrode.

PubMed

Masadome, Takashi; Yamagishi, Yuichi; Takano, Masaki; Hattori, Toshiaki

2008-03-01

A potentiometric titration method using a cationic surfactant as an indicator cation and a plasticized poly(vinyl chloride) membrane electrode sensitive to the cationic surfactant is proposed for the determination of polyhexamethylene biguanide hydrochloride (PHMB-HCl), which is a cationic polyelectrolyte. A sample solution of PHMB-HCl containing an indicator cation (hexadecyltrimethylammonium ion, HTA) was titrated with a standard solution of an anionic polyelectrolyte, potassium poly(vinyl sulfate) (PVSK). The end-point was detected as a sharp potential change due to an abrupt decrease in the concentration of the indicator cation, HTA, which is caused by its association with PVSK. The effects of the concentrations of HTA ion and coexisting electrolytes in the sample solution on the degree of the potential change at the end-point were examined. A linear relationship between the concentration of PHMB-HCl and the end-point volume of the titrant exists in the concentration range from 2.0 x 10(-5) to 4.0 x 10(-4) M in the case that the concentration of HTA is 1.0 x 10(-5) M, and that from 1.0 x 10(-6) to 1.2 x 10(-5) M in the case that the concentration of HTA is 5.0 x 10(-6) M, respectively. The proposed method was applied to the determination of PHMB-HCl in some contact-lens detergents.

The future of health technology assessment in healthcare decision making in Asia.

PubMed

Yang, Bong-Min

2009-01-01

Most countries have healthcare resource constraints and it is easy to identify new health technologies as an area in need of resource management, particularly given that new health technologies usually increase rather than save costs. Resource constraints are even more noticeable in Asia than in other regions, with a comparatively greater speed of population aging and the development of health security systems. The healthcare industry and policy makers in Asia generally understand that rationing in healthcare delivery is inevitable and have come to accept health technology assessment (HTA) as a policy option. The HTA policy framework is slowly penetrating Asia; South Korea was the first country to regulate the use of pharmacoeconomic evidence in drug reimbursement decision making. The South Korean HTA policy was initially a surprise in Asia in that the policy was suddenly introduced with a short period of preparation, but industry, researchers and policy makers both in- and outside of South Korea have come to accept it as necessary and logical. Thailand and Taiwan have also taken steps towards using pharmacoeconomic evidence in HTA, while other Asian countries are planning to implement such policies. However, it could be some time before a legitimate pharmacoeconomic-based HTA policy is actually implemented in each country, and the course of action will vary depending on the policy culture, healthcare system and public trust in bureaucracy of each country.

Gender in health technology assessment: pilot study on agency approaches.

PubMed

Panteli, Dimitra; Zentner, Annette; Storz-Pfennig, Philipp; Busse, Reinhard

2011-07-01

Gender as a social construct is a recognized health determinant. Because best practice in reporting health technology assessment (HTA) clearly specifies the need to appraise a technology's social impact within the target population, the extent to which gender issues are taken into account in HTA production is of interest, not only in light of equitable practices but also for reasons of effectiveness. The aim of this study is to provide a first assessment of the degree of gender sensitivity shown by HTA agencies around the world today. The Web sites of sixty HTA agencies were analyzed. The consideration of gender aspects was specifically looked for in each agency's general mission statement, its priority setting process, and its methodological approach. Additionally, specific gender-oriented initiatives not belonging to any of the aforementioned categories were identified. Of the sixty agencies, less than half mention a commitment to addressing the social implication of health technologies. Only fifteen institutions make information on their priority setting principles available on their Web sites and gender was an issue in two of those cases. Data on methodology were obtainable online from 18 agencies, two of which mentioned gender issues explicitly. Finally, gender-oriented initiatives were identified by thirteen agencies. A gender-sensitive approach is apparently rarely adopted in current HTA production. Exceptional practices and relevant tools do exist and could serve as examples to be promoted by international collaborative networks.

WHAT IS THE ROLE OF COMMUNITY PREFERENCE INFORMATION IN HEALTH TECHNOLOGY ASSESSMENT DECISION MAKING? A CASE STUDY OF COLORECTAL CANCER SCREENING.

PubMed

Wortley, Sally; Flitcroft, Kathy; Howard, Kirsten

2015-01-01

The aim of this study was to determine the role of community preference information from discrete choice studies of colorectal cancer (CRC) screening in health technology assessment (HTA) reports and subsequent policy decisions. We undertook a systematic review of discrete choice studies of CRC screening. Included studies were reviewed to assess the policy context of the research. For those studies that cited a recent or pending review of CRC screening, further searches were undertaken to determine the extent to which community preference information was incorporated into the HTA decision-making process. Eight discrete choice studies that evaluated preferences for CRC screening were identified. Four of these studies referred to a national or local review of CRC screening in three countries: Australia, Canada, and the Netherlands. Our review of subsequently released health policy documents showed that while consideration was given to community views on CRC, policy was not informed by discrete choice evidence. Preferences and values of patients are increasingly being considered "evidence" to be incorporated into HTA reports. Discrete choice methodology is a rigorous quantitative method for eliciting preferences and while as a methodology it is growing in profile, it would appear that the results of such research are not being systematically translated or integrated into HTA reports. A formalized approach is needed to incorporate preference literature into the HTA decision-making process.

HTA educational outreach program and change the equation participation

NASA Astrophysics Data System (ADS)

Gordon, Robert

2013-05-01

In this presentation, Hitachi High Technologies America (HTA) introduces its Educational Outreach Program and explains it's involvement with Change The Equation (CTEq), a nonprofit, nonpartisan, CEO-led initiative that is mobilizing the business community to improve the quality of science, technology, engineering and mathematics (STEM) learning in the United States.

Presentation of economic evaluation results.

PubMed

Chaikledkaew, Usa

2014-05-01

The first HTA guidelines for Thailand included a chapter outlining a set of guidelines on how best to report the findings of health economic evaluations, based on a review of best practice and existing guidelines on the presentation of economic evaluation results from around the world. In this second edition of HTA guidelines for Thailand, the recommendations build on the first edition by using a case study to illustrate how the guidelines can be applied in a real research context. The guidelines propose that all reporting include ten key elements: defining the scope of the study, selection of comparator(s), defining the type of economic evaluation, measurement of costs, measurement of clinical effects, handling time in economic evaluation studies, handling uncertainty and sensitivity analysis, presentation of the results, discussion of the results, and disclosure of funding and authors conflict of interest.

Health technology assessment process of a cardiovascular medical device in four different settings.

PubMed

Olry de Labry Lima, Antonio; Espín Balbino, Jaime; Lemgruber, Alexandre; Caro Martínez, Araceli; García-Mochón, Leticia; Martín Ruiz, Eva; Lessa, Fernanda

2017-10-01

Health technology assessment (HTA) is a tool to help the decision-making process. The aim is to describe methods and processes used in the reimbursement decision making for drug-eluting stents (DES) in four different settings. DES as a technology under study was selected according to different criteria, all of them agreed by a working group. A survey of key informants was designed. DES was evaluated following well-structured HTA processes. Nonetheless, scope for improvement was observed in relation to the data considered for the final decision, the transparency and inclusiveness of the process as well as in the methods employed. An attempt to describe the HTA processes of a well-known medical device.

IMPROVING THE EFFECTIVENESS AND EFFICIENCY OF EVIDENCE PRODUCTION FOR HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Facey, Karen; Henshall, Chris; Sampietro-Colom, Laura; Thomas, Sarah

2015-01-01

Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective technologies, expedited regulatory approaches, and the opportunities provided by collaborative real-world evaluation of technologies. The Health Technology Assessment International (HTAi) Policy Forum met to consider these issues and the implications for evidence production to inform HTA. This paper shares their discussion to stimulate further debate. A background paper, presentations, group discussions, and stakeholder role play at the 2015 HTAi Policy Forum meeting informed this paper. HTA has an important role to play in helping improve evidence production and ensuring that the health service is ready to adopt effective technologies. It needs to move from simply informing health system decisions to also working actively to align stakeholder expectations about realistic evidence requirements. Processes to support dialogue over the health technology life cycle need to be developed that are mindful of limited resources, operate across jurisdictions and learn from past processes. Collaborations between health technology developers and health systems in different countries should be encouraged to develop evidence that will inform decision making. New analytical techniques emerging for real-world data should be harnessed to support modeling for HTA. A paradigm shift (to "Health Innovation System 2.0") is suggested where HTA adopts a more central, proactive role to support alignment within and amongst stakeholders over the whole life cycle of the technology. This could help ensure that evidence production is better aligned with patient and health system needs and so is more effective and efficient.

COMPREHENSIVE ASSESSMENT OF COMPLEX TECHNOLOGIES: INTEGRATING VARIOUS ASPECTS IN HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Lysdahl, Kristin Bakke; Mozygemba, Kati; Burns, Jacob; Brönneke, Jan Benedikt; Chilcott, James B; Ward, Sue; Hofmann, Bjørn

2017-01-01

Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects. Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers. The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods' applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources. The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.

International comparison and review of a health technology assessment skills program.

PubMed

Wanke, Margaret I; Juzwishin, Don

2005-01-01

A review of the Alberta Heritage Foundation for Medical Research's (AHFMR) 6-month Health Technology Skills Development Program was undertaken within an international context with the purpose of describing and assessing the current program, further formalizing the program based on identified opportunities for improvement, and enhancing collaborative linkages with other agencies. The objectives of the review were to (i) compare the AHFMR program with similar programs in other health technology assessment (HTA) agencies internationally; (ii) assess the value of the program; (iii) identify program strengths and opportunities for improvement; and (iv) review, critique, and recommend enhancements to the program model and role description. The review involved a qualitative study design that included a survey of the Skills Development Program participants' experience and perceptions; semistructured interviews with program stakeholders, and a written survey of HTA agencies/programs in other Canadian and international jurisdictions. The review concluded that the program was successful and valued by participants, the Foundation, and stakeholders in the policy and research communities. Findings suggest participant products have a potential for broad influence, including impact on funding decisions related to technology diffusion, influence through publications and presentations, and knowledge transfer in the participants' disciplines and employment settings. The main opportunity for enhancement was to differentiate the program into two streams according to different needs of participants, specifically between those who desire to be HTA producers and/or make HTA their careers, and those who desire to apply HTA in their employment capacity as policy or clinical decision-makers.

Disturbance of mitochondrial functions provoked by the major long-chain 3-hydroxylated fatty acids accumulating in MTP and LCHAD deficiencies in skeletal muscle.

PubMed

Cecatto, Cristiane; Godoy, Kálita Dos Santos; da Silva, Janaína Camacho; Amaral, Alexandre Umpierrez; Wajner, Moacir

2016-10-01

The pathogenesis of the muscular symptoms and recurrent rhabdomyolysis that are commonly manifested in patients with mitochondrial trifunctional protein (MTP) and long-chain 3-hydroxy-acyl-CoA dehydrogenase (LCHAD) deficiencies is still unknown. In this study we investigated the effects of the major long-chain monocarboxylic 3-hydroxylated fatty acids (LCHFA) accumulating in these disorders, namely 3-hydroxytetradecanoic (3HTA) and 3-hydroxypalmitic (3HPA) acids, on important mitochondrial functions in rat skeletal muscle mitochondria. 3HTA and 3HPA markedly increased resting (state 4) and decreased ADP-stimulated (state 3) and CCCP-stimulated (uncoupled) respiration. 3HPA provoked similar effects in permeabilized skeletal muscle fibers, validating the results obtained in purified mitochondria. Furthermore, 3HTA and 3HPA markedly diminished mitochondrial membrane potential, NAD(P)H content and Ca(2+) retention capacity in Ca(2+)-loaded mitochondria. Mitochondrial permeability transition (mPT) induction probably underlie these effects since they were totally prevented by cyclosporin A and ADP. In contrast, the dicarboxylic analogue of 3HTA did not alter the tested parameters. Our data strongly indicate that 3HTA and 3HPA behave as metabolic inhibitors, uncouplers of oxidative phosphorylation and mPT inducers in skeletal muscle. It is proposed that these pathomechanisms disrupting mitochondrial homeostasis may be involved in the muscle alterations characteristic of MTP and LCHAD deficiencies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cloning and characterization of the major histone H2A genes completes the cloning and sequencing of known histone genes of Tetrahymena thermophila.

PubMed Central

Liu, X; Gorovsky, M A

1996-01-01

A truncated cDNA clone encoding Tetrahymena thermophila histone H2A2 was isolated using synthetic degenerate oligonucleotide probes derived from H2A protein sequences of Tetrahymena pyriformis. The cDNA clone was used as a homologous probe to isolate a truncated genomic clone encoding H2A1. The remaining regions of the genes for H2A1 (HTA1) and H2A2 (HTA2) were then isolated using inverse PCR on circularized genomic DNA fragments. These partial clones were assembled into intact HTA1 and HTA2 clones. Nucleotide sequences of the two genes were highly homologous within the coding region but not in the noncoding regions. Comparison of the deduced amino acid sequences with protein sequences of T. pyriformis H2As showed only two and three differences respectively, in a total of 137 amino acids for H2A1, and 132 amino acids for H2A2, indicating the two genes arose before the divergence of these two species. The HTA2 gene contains a TAA triplet within the coding region, encoding a glutamine residue. In contrast with the T. thermophila HHO and HTA3 genes, no introns were identified within the two genes. The 5'- and 3'-ends of the histone H2A mRNAs; were determined by RNase protection and by PCR mapping using RACE and RLM-RACE methods. Both genes encode polyadenylated mRNAs and are highly expressed in vegetatively growing cells but only weakly expressed in starved cultures. With the inclusion of these two genes, T. thermophila is the first organism whose entire complement of known core and linker histones, including replication-dependent and basal variants, has been cloned and sequenced. PMID:8760889

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group.

PubMed

Garfield, Susan; Polisena, Julie; S Spinner, Daryl; Postulka, Anne; Y Lu, Christine; Tiwana, Simrandeep K; Faulkner, Eric; Poulios, Nick; Zah, Vladimir; Longacre, Michael

2016-01-01

Health technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations. The International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices. MDx-specific HTA programs in Europe, Australia, and North America were characterized by methodology, evaluation framework, and impact. Published MDx HTAs were reviewed, and five representative case studies of test evaluations were developed: United Kingdom (National Institute for Health and Care Excellence's Diagnostics Assessment Programme, epidermal growth factor receptor tyrosine kinase mutation), United States (Palmetto's Molecular Diagnostic Services Program, OncotypeDx prostate cancer test), Germany (Institute for Quality and Efficiency in Healthcare, human papillomavirus testing), Australia (Medical Services Advisory Committee, anaplastic lymphoma kinase testing for non-small cell lung cancer), and Canada (Canadian Agency for Drugs and Technologies in Health, Rapid Response: Non-invasive Prenatal Testing). Overall, the few HTA programs that have MDx-specific methods do not provide clear parameters of acceptability related to clinical and analytic performance, clinical utility, and economic impact. The case studies highlight similarities and differences in evaluation approaches across HTAs in the performance metrics used (analytic and clinical validity, clinical utility), evidence requirements, and how value is measured. Not all HTAs are directly linked to reimbursement outcomes. To improve MDx HTAs, organizations should provide greater transparency, better communication and collaboration between industry and HTA stakeholders, clearer links between HTA and funding decisions, explicit recognition of and rationale for differential approaches to laboratory-developed versus regulatory-approved test, and clear evidence requirements. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Time to publication for NIHR HTA programme-funded research: a cohort study

PubMed Central

Chinnery, Fay; Young, Amanda; Goodman, Jennie; Ashton-Key, Martin; Milne, Ruairidh

2013-01-01

Objective To assess the time to publication of primary research and evidence syntheses funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme published as a monograph in Health Technology Assessment and as a journal article in the wider biomedical literature. Study design Retrospective cohort study. Setting Primary research and evidence synthesis projects funded by the HTA Programme were included in the cohort if they were registered in the NIHR research programmes database and was planned to submit the draft final report for publication in Health Technology Assessment on or before 9 December 2011. Main outcome measures The median time to publication and publication at 30 months in Health Technology Assessment and in an external journal were determined by searching the NIHR research programmes database and HTA Programme website. Results Of 458 included projects, 184 (40.2%) were primary research projects and 274 (59.8%) were evidence syntheses. A total of 155 primary research projects had a completion date; the median time to publication was 23 months (26.5 and 35.5 months to publish a monograph and to publish in an external journal, respectively) and 69% were published within 30 months. The median time to publication of HTA-funded trials (n=126) was 24 months and 67.5% were published within 30 months. Among the evidence syntheses with a protocol online date (n=223), the median time to publication was 25.5 months (28 months to publication as a monograph), but only 44.4% of evidence synthesis projects were published in an external journal. 65% of evidence synthesis studies had been published within 30.0 months. Conclusions Research funded by the HTA Programme publishes promptly. The importance of Health Technology Assessment was highlighted as the median time to publication was 9 months shorter for a monograph than an external journal article. PMID:24285634

Value added medicines: what value repurposed medicines might bring to society?

PubMed

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

Background & objectives : Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods : A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing ( healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results : Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as 'medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers'. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access; (2) to improve healthcare system efficiency; and (3) to contribute to sustainability of healthcare systems through economic advantages. Current HTA framework, generic stigma, and pricing rules, such as internal reference pricing or tendering processes in place in some countries, were reported as the current key hurdles preventing the full recognition of value added medicines' benefits, discouraging manufacturers from bringing such products to the market. Discussion & conclusions : There is currently a gap between increasing regulatory authority interest in capturing value added medicines' benefits and the resistance of HTA bodies/payers, who tend to ignore this important segment of the pharmaceutical field. This situation calls for policy changes to foster appropriate incentives to enhance value recognition of value added medicines and deliver the expected benefit to society. Policy changes from HTA perspective should include: absence of any legislative barriers preventing companies from pursuing HTA; HTA requirements proportionate to potential reward; HTA decision-making framework taking into account the specific characteristics of value added medicines; eligibility for early HTA dialogues; Policy changes from pricing perspective should encompass: tenders/procurement policies allowing differentiation from generic medicines; eligibility for early entry agreement; non-systematic implementation of external and internal reference pricing policies; recognition of indication-specific pricing. At the same time, the pharmaceutical industry should engage all the stakeholders (patients, healthcare providers, HTA bodies/payers) in early dialogues to identify their expectations and to ensure the developed value added medicines address their needs.

Value added medicines: what value repurposed medicines might bring to society?

PubMed Central

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

ABSTRACT Background & objectives: Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods: A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing (healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results: Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as ‘medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers’. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access; (2) to improve healthcare system efficiency; and (3) to contribute to sustainability of healthcare systems through economic advantages. Current HTA framework, generic stigma, and pricing rules, such as internal reference pricing or tendering processes in place in some countries, were reported as the current key hurdles preventing the full recognition of value added medicines’ benefits, discouraging manufacturers from bringing such products to the market. Discussion & conclusions: There is currently a gap between increasing regulatory authority interest in capturing value added medicines’ benefits and the resistance of HTA bodies/payers, who tend to ignore this important segment of the pharmaceutical field. This situation calls for policy changes to foster appropriate incentives to enhance value recognition of value added medicines and deliver the expected benefit to society. Policy changes from HTA perspective should include: absence of any legislative barriers preventing companies from pursuing HTA; HTA requirements proportionate to potential reward; HTA decision-making framework taking into account the specific characteristics of value added medicines; eligibility for early HTA dialogues; Policy changes from pricing perspective should encompass: tenders/procurement policies allowing differentiation from generic medicines; eligibility for early entry agreement; non-systematic implementation of external and internal reference pricing policies; recognition of indication-specific pricing. At the same time, the pharmaceutical industry should engage all the stakeholders (patients, healthcare providers, HTA bodies/payers) in early dialogues to identify their expectations and to ensure the developed value added medicines address their needs. PMID:28265347

Discrete Event Simulation-Based Resource Modelling in Health Technology Assessment.

PubMed

Salleh, Syed; Thokala, Praveen; Brennan, Alan; Hughes, Ruby; Dixon, Simon

2017-10-01

The objective of this article was to conduct a systematic review of published research on the use of discrete event simulation (DES) for resource modelling (RM) in health technology assessment (HTA). RM is broadly defined as incorporating and measuring effects of constraints on physical resources (e.g. beds, doctors, nurses) in HTA models. Systematic literature searches were conducted in academic databases (JSTOR, SAGE, SPRINGER, SCOPUS, IEEE, Science Direct, PubMed, EMBASE) and grey literature (Google Scholar, NHS journal library), enhanced by manual searchers (i.e. reference list checking, citation searching and hand-searching techniques). The search strategy yielded 4117 potentially relevant citations. Following the screening and manual searches, ten articles were included. Reviewing these articles provided insights into the applications of RM: firstly, different types of economic analyses, model settings, RM and cost-effectiveness analysis (CEA) outcomes were identified. Secondly, variation in the characteristics of the constraints such as types and nature of constraints and sources of data for the constraints were identified. Thirdly, it was found that including the effects of constraints caused the CEA results to change in these articles. The review found that DES proved to be an effective technique for RM but there were only a small number of studies applied in HTA. However, these studies showed the important consequences of modelling physical constraints and point to the need for a framework to be developed to guide future applications of this approach.

Models and applications for measuring the impact of health research: update of a systematic review for the Health Technology Assessment programme.

PubMed

Raftery, James; Hanney, Steve; Greenhalgh, Trish; Glover, Matthew; Blatch-Jones, Amanda

2016-10-01

This report reviews approaches and tools for measuring the impact of research programmes, building on, and extending, a 2007 review. (1) To identify the range of theoretical models and empirical approaches for measuring the impact of health research programmes; (2) to develop a taxonomy of models and approaches; (3) to summarise the evidence on the application and use of these models; and (4) to evaluate the different options for the Health Technology Assessment (HTA) programme. We searched databases including Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library from January 2005 to August 2014. This narrative systematic literature review comprised an update, extension and analysis/discussion. We systematically searched eight databases, supplemented by personal knowledge, in August 2014 through to March 2015. The literature on impact assessment has much expanded. The Payback Framework, with adaptations, remains the most widely used approach. It draws on different philosophical traditions, enhancing an underlying logic model with an interpretative case study element and attention to context. Besides the logic model, other ideal type approaches included constructionist, realist, critical and performative. Most models in practice drew pragmatically on elements of several ideal types. Monetisation of impact, an increasingly popular approach, shows a high return from research but relies heavily on assumptions about the extent to which health gains depend on research. Despite usually requiring systematic reviews before funding trials, the HTA programme does not routinely examine the impact of those trials on subsequent systematic reviews. The York/Patient-Centered Outcomes Research Institute and the Grading of Recommendations Assessment, Development and Evaluation toolkits provide ways of assessing such impact, but need to be evaluated. The literature, as reviewed here, provides very few instances of a randomised trial playing a major role in stopping the use of a new technology. The few trials funded by the HTA programme that may have played such a role were outliers. The findings of this review support the continued use of the Payback Framework by the HTA programme. Changes in the structure of the NHS, the development of NHS England and changes in the National Institute for Health and Care Excellence's remit pose new challenges for identifying and meeting current and future research needs. Future assessments of the impact of the HTA programme will have to take account of wider changes, especially as the Research Excellence Framework (REF), which assesses the quality of universities' research, seems likely to continue to rely on case studies to measure impact. The HTA programme should consider how the format and selection of case studies might be improved to aid more systematic assessment. The selection of case studies, such as in the REF, but also more generally, tends to be biased towards high-impact rather than low-impact stories. Experience for other industries indicate that much can be learnt from the latter. The adoption of researchfish ® (researchfish Ltd, Cambridge, UK) by most major UK research funders has implications for future assessments of impact. Although the routine capture of indexed research publications has merit, the degree to which researchfish will succeed in collecting other, non-indexed outputs and activities remains to be established. There were limitations in how far we could address challenges that faced us as we extended the focus beyond that of the 2007 review, and well beyond a narrow focus just on the HTA programme. Research funders can benefit from continuing to monitor and evaluate the impacts of the studies they fund. They should also review the contribution of case studies and expand work on linking trials to meta-analyses and to guidelines. The National Institute for Health Research HTA programme.

Preferences for engagement in health technology assessment decision-making: a nominal group technique with members of the public.

PubMed

Wortley, Sally; Tong, Allison; Howard, Kirsten

2016-02-01

To identify characteristics (factors) about health technology assessment (HTA) decisions that are important to the public in determining whether public engagement should be undertaken and the reasons for these choices. Focus groups using a nominal group technique to identify and rank factors relevant to public engagement in HTA decision-making. Thematic analysis was also undertaken to describe reasons underpinning participants' choices and rankings. Members of the Australian general public. 58 people, aged 19-71 years participated in 6 focus groups. 24 factors were identified by participants that were considered important in determining whether public engagement should be undertaken. These factors were individually ranked and grouped into 4 themes to interpret preferences for engagement. Members of the public were more likely to think public engagement was needed when trade-offs between benefits and costs were required to determine 'value', uncertainties in the evidence were present, and family members and/or carers were impacted. The role of public engagement was also seen as important if the existent system lacked transparency and did not provide a voice for patients, particularly for conditions less known in the community. Members of the public considered value, impact, uncertainty, equity and transparency in determining when engagement should be undertaken. This indicates that the public's preferences on when to undertake engagement relate to both the content of the HTA itself as well as the processes in place to support HTA decision-making. By understanding these preferences, decision-makers can work towards more effective, meaningful public engagement by involving the public in issues that are important to them and/or improving the processes around decision-making. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Current recommendations on the estimation of transition probabilities in Markov cohort models for use in health care decision-making: a targeted literature review.

PubMed

Olariu, Elena; Cadwell, Kevin K; Hancock, Elizabeth; Trueman, David; Chevrou-Severac, Helene

2017-01-01

Although Markov cohort models represent one of the most common forms of decision-analytic models used in health care decision-making, correct implementation of such models requires reliable estimation of transition probabilities. This study sought to identify consensus statements or guidelines that detail how such transition probability matrices should be estimated. A literature review was performed to identify relevant publications in the following databases: Medline, Embase, the Cochrane Library, and PubMed. Electronic searches were supplemented by manual-searches of health technology assessment (HTA) websites in Australia, Belgium, Canada, France, Germany, Ireland, Norway, Portugal, Sweden, and the UK. One reviewer assessed studies for eligibility. Of the 1,931 citations identified in the electronic searches, no studies met the inclusion criteria for full-text review, and no guidelines on transition probabilities in Markov models were identified. Manual-searching of the websites of HTA agencies identified ten guidelines on economic evaluations (Australia, Belgium, Canada, France, Germany, Ireland, Norway, Portugal, Sweden, and UK). All identified guidelines provided general guidance on how to develop economic models, but none provided guidance on the calculation of transition probabilities. One relevant publication was identified following review of the reference lists of HTA agency guidelines: the International Society for Pharmacoeconomics and Outcomes Research taskforce guidance. This provided limited guidance on the use of rates and probabilities. There is limited formal guidance available on the estimation of transition probabilities for use in decision-analytic models. Given the increasing importance of cost-effectiveness analysis in the decision-making processes of HTA bodies and other medical decision-makers, there is a need for additional guidance to inform a more consistent approach to decision-analytic modeling. Further research should be done to develop more detailed guidelines on the estimation of transition probabilities.

Eye-movement evidence of the time-course of attentional bias for threatening pictures in test-anxious students.

PubMed

Dong, Yunying; De Beuckelaer, Alain; Yu, Liang; Zhou, Renlai

2017-06-01

Protocols for measuring attentional bias to threat in test-anxiety, a special form of trait-anxiety, are rarely found in the literature. In our eye-tracking study, we introduced a new protocol, and studied the time-course of attention to test-related pictures with varying threat levels in 22 high test-anxious (HTA) and 22 low test-anxious (LTA) subjects. To determine whether attentional bias to test-related pictures is due to test-anxiety and not to state-anxiety, we also included a third group of 22 subjects with high state-anxiety but low test-anxiety (HSA). The subjects completed a free viewing task (FVT) in which high threat-neutral (HT-N) and low threat-neutral (LT-N) picture pairs were presented for 3 s. The results demonstrated that: (1) HTA subjects showed initial orienting to LT pictures, early attentional engagement with HT pictures later on and avoidance of HT pictures at the very end; (2) LTA subjects showed initial orienting to HT pictures and maintenance of attention on them later on; while (3) HSA subjects showed an initial orientation towards LT pictures and maintenance of attention on LT and HT pictures later on. These results suggest that, (high) test-anxiety is also prone to attentional bias towards test-related threat stimuli. Implications for future research are discussed.

Utilization of multiple-criteria decision analysis (MCDA) to support healthcare decision-making FIFARMA, 2016

PubMed Central

Drake, Julia I.; de Hart, Juan Carlos Trujillo; Monleón, Clara; Toro, Walter; Valentim, Joice

2017-01-01

ABSTRACT Background and objectives:   MCDA is a decision-making tool with increasing use in the healthcare sector, including HTA (Health Technology Assessment). By applying multiple criteria, including innovation, in a comprehensive, structured and explicit manner, MCDA fosters a transparent, participative, consistent decision-making process taking into consideration values of all stakeholders. This paper by FIFARMA (Latin American Federation of Pharmaceutical Industry) proposes the deliberative (partial) MCDA as a more pragmatic, agile approach, especially when newly implemented. Methods: Literature review including real-world examples of effective MCDA implementation in healthcare decision making in both the public and private sector worldwide and in LA. Results and conclusion: It is the view of FIFARMA that MCDA should strongly be considered as a tool to support HTA and broader healthcare decision making such as the contracts and tenders process in order to foster transparency, fairness, and collaboration amongst stakeholders. PMID:29081919

A comparison of HAS & NICE guidelines for the economic evaluation of health technologies in the context of their respective national health care systems and cultural environments

PubMed Central

Massetti, Marc; Aballéa, Samuel; Videau, Yann; Rémuzat, Cécile; Roïz, Julie; Toumi, Mondher

2015-01-01

Background Health technology assessment (HTA) has been reinforced in France, notably with the introduction of economic evaluation in the pricing process for the most innovative and expensive treatments. Similarly to the National Institute for Clinical Excellence (NICE) in England, the National Authority for Health (HAS), which is responsible for economic evaluation of new health technologies in France, has published recommendations on the methods of economic evaluation. Since economic assessment represents a major element of HTA in England, exploring the differences between these methodological guidelines might help to comprehend both the shape and the role economic assessment is intended to have in the French health care system. Methods Methodological guidelines for economic evaluation in France and England have been compared topic-by-topic in order to bring out key differences in the recommended methods for economic evaluation. Results The analysis of both guidelines has revealed multiple similarities between France and England, although a number of differences were also noted regarding the elected methodology of analysis, the comparison of studies’ outcomes with cost-effectiveness thresholds, the study population to consider, the quality of life valuation methods, the perspective on costs, the types of resources considered and their valuation, the discount rates to apply in order to reflect the present value of interventions, etc. To account for these differences, modifications will be required in order to adapt economic models from one country to the other. Conclusions Changes in HTA assessment methods occur in response to different challenges determined by the different philosophical and cultural considerations surrounding health and welfare as well as the political considerations regarding the role of public policies and the importance of their evaluation. PMID:27123190

Long-chain 3-hydroxy fatty acids accumulating in long-chain 3-hydroxyacyl-CoA dehydrogenase and mitochondrial trifunctional protein deficiencies uncouple oxidative phosphorylation in heart mitochondria.

PubMed

Tonin, Anelise M; Amaral, Alexandre U; Busanello, Estela N B; Grings, Mateus; Castilho, Roger F; Wajner, Moacir

2013-02-01

Cardiomyopathy is a common clinical feature of some inherited disorders of mitochondrial fatty acid β-oxidation including mitochondrial trifunctional protein (MTP) and isolated long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD) deficiencies. Since individuals affected by these disorders present tissue accumulation of various fatty acids, including long-chain 3-hydroxy fatty acids, in the present study we investigated the effect of 3-hydroxydecanoic (3 HDCA), 3-hydroxydodecanoic (3 HDDA), 3-hydroxytetradecanoic (3 HTA) and 3-hydroxypalmitic (3 HPA) acids on mitochondrial oxidative metabolism, estimated by oximetry, NAD(P)H content, hydrogen peroxide production, membrane potential (ΔΨ) and swelling in rat heart mitochondrial preparations. We observed that 3 HTA and 3 HPA increased resting respiration and diminished the respiratory control and ADP/O ratios using glutamate/malate or succinate as substrates. Furthermore, 3 HDDA, 3 HTA and 3 HPA decreased ΔΨ, the matrix NAD(P)H pool and hydrogen peroxide production. These data indicate that these fatty acids behave as uncouplers of oxidative phosphorylation. We also verified that 3 HTA-induced uncoupling-effect was not mediated by the adenine nucleotide translocator and that this fatty acid induced the mitochondrial permeability transition pore opening in calcium-loaded organelles since cyclosporin A prevented the reduction of mitochondrial ΔΨ and swelling provoked by 3 HTA. The present data indicate that major 3-hydroxylated fatty acids accumulating in MTP and LCHAD deficiencies behave as strong uncouplers of oxidative phosphorylation potentially impairing heart energy homeostasis.

Critical appraisal of nonrandomized studies-A review of recommended and commonly used tools.

PubMed

Quigley, Joan M; Thompson, Juliette C; Halfpenny, Nicholas J; Scott, David A

2018-02-27

When randomized controlled trial data are limited or unavailable, or to supplement randomized controlled trial evidence, health technology assessment (HTA) agencies may rely on systematic reviews of nonrandomized studies (NRSs) for evidence of the effectiveness of health care interventions. NRS designs may introduce considerable bias into systematic reviews, and several methodologies by which to evaluate this risk of bias are available. This study aimed to identify tools commonly used to assess bias in NRS and determine those recommended by HTA bodies. Appraisal tools used in NRS were identified through a targeted search of systematic reviews (January 2013-March 2017; MEDLINE and EMBASE [OVID SP]). Recommendations for the critical appraisal of NRS by expert review groups and HTA bodies were reviewed. From the 686 studies included in the narrative synthesis, 48 critical appraisal tools were identified. Commonly used tools included the Newcastle-Ottawa Scale, the methodological index for NRS, and bespoke appraisal tools. Neither the Cochrane Handbook nor the Centre for Reviews and Dissemination recommends a particular instrument for the assessment of risk of bias in NRS, although Cochrane has recently developed their own NRS critical appraisal tool. Among HTA bodies, only the Canadian Agency for Drugs and Technologies in Health recommends use of a specific critical appraisal tool-SIGN 50 (for cohort or case-control studies). Several criteria including reporting, external validity, confounding, and power were examined. There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review. © 2018 John Wiley & Sons, Ltd.

Mechanisms of attentional selection bias for threatening emotions of anger and disgust in individuals with high-trait anxiety.

PubMed

Xia, Luyao; Cui, Lixia; Zhang, Qin; Dong, Xiaofei; Shi, Guangyuan

2018-03-07

There are still some controversies that attentional bias to negative emotions in individuals with high-trait anxiety (HTA), as compare with those with low-trait anxiety (LTA), occurs in the engagement or disengagement facet of attentional selectivity and whether this attentional bias is affected by negative emotional types. In this study, we explored the different attentional selectivity mechanisms for threatening emotions of anger and disgust between individuals with HTA and LTA using the variant attentional-probe paradigm. The results showed that under the engagement condition, the HTA group's attentional bias index of the anger mood was negative and was significantly less than the disgusting mood (positive) and that the P1 was smaller with angry faces as compared with neutral faces, which was separate from the results of the disgusted faces, having a significant difference with neutral faces on P1 component. In the LTA group, under the disengagement condition, the attentional bias index of the disgusting mood was significantly bigger than the attentional bias index of the anger mood. Moreover, the P1 of the disgusted faces was significantly bigger than the P1 of the angry faces. The topographical maps were also made to reveal the different neural underpinnings. The results suggested that there were different mechanisms of selective attentional bias for threatening emotions of anger and disgust in individuals with HTA. HTA individuals were characterized by facilitated attentional engagement with angry faces and impaired attentional engagement with disgusted faces. LTA individuals had different neural underpinnings and had impaired attentional disengagement with disgusted faces.

What is the impact of disease prevalence upon health technology assessment?

PubMed

Rotily, Michel; Roze, Stéphane

2013-12-01

As national budgets for health care will remain under stress for the foreseeable future, health technology assessment (HTA) aimed at offering guidance to policy-making will have an increasing role to play in optimizing resources. The emergence of new treatment paradigms and health technologies, and the prevalence studies which determine when a disease is a current or future burden for patients and the community are in the roots of the HTA process. Analysing studies on screening test strategies and health care policy, this paper revisits two key concepts in epidemiology, prevalence and incidence, in order to show their major impact upon HTA. Utilization of the predictive values of screening tests that include prevalence in their calculations, and analysing all options for screening strategies are necessary in HTA. Cost-effectiveness analyses and statistical models should include potential externalities, especially the impact of prevention and treatment on infectious disease prevalence. Beyond estimates of cost-effectiveness ratios, decision makers also need to know by how much their annual health care budget is likely to increase or decrease in the years following the emergence of new technologies: hence the importance of incidence- or prevalence-based economic evaluations. As new paradigms are occurring, especially in the field of oncology, with treatments targeted to 'small' groups of patients identified through genetic testing, prevalence data are strongly needed. Precise estimates of disease prevalence, in general populations as well as in risk or targeted groups, will therefore be necessary to improve HTA process. Copyright © 2013 Elsevier Ltd. All rights reserved.

Methods, procedures, and contextual characteristics of health technology assessment and health policy decision making: comparison of health technology assessment agencies in Germany, United Kingdom, France, and Sweden.

PubMed

Schwarzer, Ruth; Siebert, Uwe

2009-07-01

The objectives of this study were (i) to develop a systematic framework for describing and comparing different features of health technology assessment (HTA) agencies, (ii) to identify and describe similarities and differences between the agencies, and (iii) to draw conclusions both for producers and users of HTA in research, policy, and practice. We performed a systematic literature search, added information from HTA agencies, and developed a conceptual framework comprising eight main domains: organization, scope, processes, methods, dissemination, decision, implementation, and impact. We grouped relevant items of these domains in an evidence table and chose five HTA agencies to test our framework: DAHTA@DIMDI, HAS, IQWiG, NICE, and SBU. Item and domain similarity was assessed using the percentage of identical characteristics in pairwise comparisons across agencies. RESULTS were interpreted across agencies by demonstrating similarities and differences. Based on 306 included documents, we identified 90 characteristics of eight main domains appropriate for our framework. After applying the framework to the five agencies, we were able to show 40 percent similarities in "dissemination," 38 percent in "scope," 35 percent in "organization," 29 percent in "methods," 26 percent in "processes," 23 percent in "impact," 19 percent in "decision," and 17 percent in "implementation." We found considerably more differences than similarities of HTA features across agencies and countries. Our framework and comparison provides insights and clarification into the need for harmonization. Our findings could serve as descriptive database facilitating communication between producers and users.

French Health Technology Assessment of Antineoplastic Drugs Indicated in the Treatment of Solid Tumours: Perspective for Future Trends.

PubMed

Chouaid, Christos; Borget, Isabelle; Braun, Eric; Bazil, Marie-Laure; Schaetz, Dominique; Rémuzat, Cécile; Toumi, Mondher

2016-08-01

France is one of the European countries that spend the most on oncology drugs. To keep pharmaceutical expenditure under control, Health Authorities highly scrutinize market access of costly medicines. To assess current and future trends in French health technology assessment (HTA) of antineoplastic drugs indicated in the treatment of solid tumours. A review of the SMR and ASMR drivers of the Transparency Committee (CT) opinions issued for antineoplastic drugs indicated in the treatment of solid tumours and approved between 2009 and 2014 was performed to assess current trends in French health technology assessment (HTA), complemented by an expert board consultation to capture the critical issues on the future of antineoplastic drugs HTA. Thirty-one drugs indicated for the treatment of solid tumours were identified (77 % targeted therapies). Initial CT assessments were available for 26 drugs. Four key items in the CT assessment were identified: 1) Clinical trial methodology; 2) Acceptance of progression-free survival (PFS) as a valuable endpoint; 3) Transferability of clinical trials in clinical practice; 4) Unpredictability of CT decisions. Experts raised the important development of personalised medicines in oncology and key challenges for oncology products to generate information expected from HTA perspective. The French system remains committed to its values and philosophy (access of all innovations for everybody) which are threatened by the increasing launch of innovative therapies and budget constraint. Both HTA decision framework evolution and revision of the current pricing process should be considered in France to cope with these new challenges.

HOW CAN HEALTH SYSTEMS PREPARE FOR NEW AND EMERGING HEALTH TECHNOLOGIES? THE ROLE OF HORIZON SCANNING REVISITED.

PubMed

Oortwijn, Wija; Sampietro-Colom, Laura; Habens, Fay; Trowman, Rebecca

2018-06-11

For many years, several health technology assessment (HTA) agencies scanned the horizon to identify health technologies that were safe, effective and offer value for money. However, there is limited evidence regarding its impact. The role of horizon scanning in preparing health systems for the uptake of new and emerging health technologies was discussed during the 2018 HTA International (HTAi) Global Policy Forum Meeting. Reflection of the discussion between seventy-two senior representatives from for-profit, not-for-profit organizations, and HTAi leadership. It was informed by a background paper, and presentations from four invited experts and seventeen Policy Forum members. Current horizon scanning systems (HSS) mainly identify health technologies in the late stage of development, aiming to inform topic selection for HTA. Areas for improvement included the need for a clearer definition of the end user(s), purpose, scope, and focus of HSS, the long-term full health system effects, including all relevant stakeholders as early as possible, and considering smart data systems and international collaboration to improve HSS's efficiency. The way in which HSS could be further optimized and better shaped to prepare health systems was also discussed and good practice examples were presented. HSS have not yet reached their full potential in preparing health systems. To improve the current situation, the HTA community could act as convenors, bringing together all relevant stakeholders and providing the information that decision makers need. This would require a new, more integrative approach to define and use HSS and HTA, and requires new skills.

RESPONSIVENESS, LANGUAGE, AND ALIGNMENT: REFLECTIONS ON SOME CHALLENGES FOR HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Dillon, Andrew

2015-01-01

Health systems around the world cope with the challenge of difficult economic times, and the value of health technology assessment (HTA) is increasing. Making the right choices, with limited resources, in the face of increasingly complex technologies requires decisions informed by data and analyses that help us to manage the risks involved. Those who undertake and use HTA can play a greater role in helping decision makers meet these challenges; they need to think how to define innovation and respond to it, how to communicate their analyses, and, critically, how to align their work with the ambitions of their health systems. HTA can become a key health system enabler without compromising its objectivity or independence. It can say that it is too early to determine the value of a new technology when the data simply will not support a safe decision. However, it can also be bold and recommend the managed introduction of new technologies, even when the when the data is immature, provided that the health system understands the risks and there is a plausible case for believing that further research will support the value proposition. The goal for HTA is to be able confidently to do both.

[Use of health technology assessment in decision-making processes by the Brazilian Ministry of Health on the incorporation of technologies in the Brazilian Unified National Health System].

PubMed

Novaes, Hillegonda Maria Dutilh; Elias, Flávia Tavares Silva

2013-11-01

Policies for scientific development and knowledge production in health have increased in recent decades. In Brazil, incentives for research, development, and innovation have been part of the National Health Act since 1990, and science and technology policies for health, including health technology assessment (HTA), have been implemented since 1994, as in many other countries. The emphasis is now on impact evaluation of HTA policies in the incorporation of technologies by health services and systems. The article presents a case study of HTA utilization in decision-making processes in the Brazilian Ministry of Health, analyzing participation by the Department of Science and Technology (DECIT), responsible for the production of assessments used in the Commission on Technology Incorporation (CITEC) of the Ministry of Health from 2008 to 2010. CITEC used 103 assessments in its decisions during this period, of which DECIT produced 80%. Nearly all were literature reviews on therapeutic technologies. An increase in knowledge production was observed. A methodological and political learning process appears to have occurred in the use of HTA, but its impact on Brazilian Unified National Health System remains unclear.

International comparison of comparative effectiveness research in five jurisdictions: insights for the US.

PubMed

Levy, Adrian R; Mitton, Craig; Johnston, Karissa M; Harrigan, Brian; Briggs, Andrew H

2010-01-01

Spurred by a desire to improve quality of care and to understand the relative value of medical treatments, there has been a recent surge of interest in publicly funded comparative effectiveness research (CER) in the US. As health technology assessment (HTA) shares some of the same goals as CER, and publicly funded HTA has been a feature within other industrialized countries for many years, a review of HTA activities in some of these countries can be a helpful source of information for the US debate. Informed by a literature review, and in two cases augmented by informant interviews, we reviewed the organization of HTA activities in five jurisdictions: Canada, Sweden, Scotland, the Netherlands and Australia. We provide a summary description of the healthcare system in each country as well as a description of the key features of their HTA bodies, with a particular focus on the processes of HTA for listing medications on public formularies. Four of the committees evaluating medications for formulary inclusion are funded by, but remain at arm's length from, the government (Canada, Australia, Sweden and Scotland), while the process is fully embedded within the government in the Netherlands. Each of these jurisdictions has a stated preference for comparative outcomes evidence from randomized controlled trials, but will, under certain circumstances, accept randomized evidence using surrogate markers, other comparators that are not directly relevant or non-randomized evidence. Health technology evaluation committees largely comprise health professionals, with public representatives included in the Canadian, Australian and Scottish committees. Scotland is the only one of the five jurisdictions reviewed to have industry representation on the evaluation committee. We identified seven characteristics that are shared across the jurisdictions reviewed and that potentially serve as insights for development of CER in the US: (i) the process must be responsive to stakeholders' interests, in that the turn-around time for assessments must be minimized, transparency must be maximized, the process must be considered fair using universally agreed standards and the process must be modifiable based on stakeholders' requirements; (ii) the assessment of medical technologies other than drugs may present different challenges and is managed separately in other HTA organizations; (iii) because of the link between HTA and reimbursement decisions, completion of the HTA process following regulatory approval can delay market access to new technologies, thus closer integration between regulatory approval and HTA processes is being explored internationally; (iv) there is a direct or indirect link to reimbursement in the jurisdictions explored - without this link the role of CER in the US will remain advisory; (v) each jurisdiction reviewed benefits from a single payer that is informed by the process - given the diverse multipayer environment in the US, CER in the US may usefully focus on generating comparative effectiveness evidence; (vi) a common metric for assessing intended and unintended effects of treatment allows comparison across different technologies; and (vii) one stated focus of CER is on therapeutic benefit among 'high-priority populations', including specific demographic groups (the elderly and children, racial and ethnic minorities) and individuals with disabilities, multiple chronic conditions and specific genomic factors. This will be difficult to achieve because epidemiological evidence of differences in therapeutic benefit among subgroups is detected through effect modification, or more specifically, statistical evidence of effect measure modification, typically on relative measures of effect. Few randomized trials have enough power to detect effect modification and these have been uncommon in the scientific literature. As consideration is given to the development of a publicly funded CER body in the US, much can be learned from the international experience. Nevertheless, there are some distinctive features of the US healthcare system that must be taken into account when assessing the transferability of these insights.

Community views and perspectives on public engagement in health technology assessment decision making.

PubMed

Wortley, Sally; Tong, Allison; Howard, Kirsten

2017-03-01

Objectives The aim of the present study was to describe community views and perspectives on public engagement processes in Australian health technology assessment (HTA) decision making. Methods Six focus groups were held in Sydney (NSW, Australia) as part of a broad program of work on public engagement and HTA. Eligible participants were aged ≥18 years and spoke English. Participants were asked about their views and perspectives of public engagement in the HTA decision-making process, with responses analysed using a public participation framework. Results Fifty-eight participants aged 19-71 years attended the focus groups. Responses from the public indicated that they wanted public engagement in HTA to include a diversity of individuals, be independent and transparent, involve individuals early in the process and ensure that public input is meaningful and useful to the process. This was consistent with the public participation framework. Perceived shortcomings of the current public engagement process were also identified, namely the lack of awareness of the HTA system in the general population and the need to acknowledge the role different groups of stakeholders or 'publics' can have in the process. Conclusions The public do see a role for themselves in the HTA decision-making process. This is distinct to the involvement of patients and carers. It is important that any future public engagement strategy in this field distinguishes between stakeholder groups and outline approaches that will involve members of the public in the decision-making process, especially if public expectations of involvement in healthcare decision-making continue to increase. What is known about this topic? The views and perspectives of patients and consumers are important in the HTA decision-making process. There is a move to involve the broader community, particularly as decisions become increasingly complex and resources more scarce. What does this paper add? It not been known to what extent, or at what points, the community would like to be engaged with the HTA decision-making process. The present study adds to the evidence base on this topic by identifying features of engagement that may be important in determining the extent of wider public involvement. It is clear that the community expects the system to be transparent, for patients to be involved early in specific processes and the wider community to be able to contribute to the broader vision of the healthcare system. What are the implications for practitioners? A formalised strategy is needed to include the public voice into health technology decisions. With the current level of reform in the healthcare sector and the focus on creating a sustainable healthcare system, there is a real opportunity to implement an approach that not only informs patients and the community of the challenges, but includes and incorporates their views into these decisions. This will assist in developing and adapting policy that is relevant and meets the needs of the population.

INTELLIGENCE AND TRANSPARENCY IN HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Richardson, Henry S

2016-01-01

Current thinking about the methodology of health technology assessment (HTA) seems to be dominated by two fundamental tensions: [1] between maintaining a tight focus on quality-adjusted life-years and broadening its concern out to pay attention to a broader range of factors, and [2] between thinking of the evaluative dimensions that matter as being objectively important factors or as ones that are ultimately of merely subjective importance. In this study, I will argue that health is a tremendously important all-purpose means to enjoying basic human capabilities, but a mere means, and not an end. The ends to which health is a means are manifold, requiring all those engaged in policy making to exercise intelligence in a continuing effort to identify them and to think through how they interrelate. Retreating to the subjective here would be at odds with the basic idea of HTA, which is to focus on certain objectively describable dimensions of what matters about health and to collect empirical evidence rigorously bearing on what produces improvements along those dimensions. To proceed intelligently in doing HTA, it is important to stay open to reframing and refashioning the ends we take to apply to that arena. The only way for that to happen, as an exercise of public, democratic policy making, is for the difficult value questions that arise when ends clash not to be buried in subjective preference information, but to be front-and-center in the analysis.

Using Real-World Data in Health Technology Assessment (HTA) Practice: A Comparative Study of Five HTA Agencies.

PubMed

Makady, Amr; van Veelen, Ard; Jonsson, Páll; Moseley, Owen; D'Andon, Anne; de Boer, Anthonius; Hillege, Hans; Klungel, Olaf; Goettsch, Wim

2018-03-01

Reimbursement decisions are conventionally based on evidence from randomised controlled trials (RCTs), which often have high internal validity but low external validity. Real-world data (RWD) may provide complimentary evidence for relative effectiveness assessments (REAs) and cost-effectiveness assessments (CEAs). This study examines whether RWD is incorporated in health technology assessment (HTA) of melanoma drugs by European HTA agencies, as well as differences in RWD use between agencies and across time. HTA reports published between 1 January 2011 and 31 December 2016 were retrieved from websites of agencies representing five jurisdictions: England [National Institute for Health and Care Excellence (NICE)], Scotland [Scottish Medicines Consortium (SMC)], France [Haute Autorité de santé (HAS)], Germany [Institute for Quality and Efficacy in Healthcare (IQWiG)] and The Netherlands [Zorginstituut Nederland (ZIN)]. A standardized data extraction form was used to extract information on RWD inclusion for both REAs and CEAs. Overall, 52 reports were retrieved, all of which contained REAs; CEAs were present in 25 of the reports. RWD was included in 28 of the 52 REAs (54%), mainly to estimate melanoma prevalence, and in 22 of the 25 (88%) CEAs, mainly to extrapolate long-term effectiveness and/or identify drug-related costs. Differences emerged between agencies regarding RWD use in REAs; the ZIN and IQWiG cited RWD for evidence on prevalence, whereas the NICE, SMC and HAS additionally cited RWD use for drug effectiveness. No visible trend for RWD use in REAs and CEAs over time was observed. In general, RWD inclusion was higher in CEAs than REAs, and was mostly used to estimate melanoma prevalence in REAs or to predict long-term effectiveness in CEAs. Differences emerged between agencies' use of RWD; however, no visible trends for RWD use over time were observed.

QUALITY OF HEALTH TECHNOLOGY ASSESSMENT REPORTS PREPARED FOR THE MEDICAL SERVICES ADVISORY COMMITTEE.

PubMed

Hua, Martin; Boonstra, Tristan; Kelly, Patrick J; Wilson, Andrew; Craig, Jonathan C; Webster, Angela C

2016-01-01

The Medical Services Advisory Committee (MSAC) makes recommendations to the Australian Government for funding health technologies under the Medicare Benefits Schedule (MBS). Differences in public, clinical, commercial, and political opinions on health expenditure emphasize the importance of defensible funding decisions. We aimed to evaluate the quality of health technology assessment (HTA) reports over time and among health technologies assessed for MSAC. A cohort study was performed of HTA reports prepared for MSAC between 1998 and 2013. We measured the quality of HTA reports using reporting guidelines proposed by the European Collaboration for Assessment of Health Interventions. Individual component scores across eleven domains were calculated, and summed for an overall aggregate score. We used linear regression to investigate any change in quality over time and among the types of technologies assessed. We included 110 HTA reports. The safety (80 percent), effectiveness (84 percent), economic (74 percent), and organizational (99 percent) domains were better reported than the psychological, social, and ethical considerations (34 percent). The basic (75 percent), methodological (62 percent), background (82 percent), contextual (46 percent), status quo (54 percent), and technical information (66 percent) that framed each assessment were inconsistently reported. On average, overall quality scores increased by 2 percent (p < 0.001) per year, from approximately 60 percent to 80 percent over the 15-year period, with no significant difference among surgical, diagnostic or other nonpharmaceutical health technologies (p = 0.22). HTA reports prepared for MSAC are a key tool in allocating scarce health resources. The overall quality of these reports has improved, but the reporting of specific domains and subthemes therein could be better addressed.

Health technology assessment in India: the potential for improved healthcare decision-making.

PubMed

Kumar, Mrityunjai; Ebrahim, Shah; Taylor, Fiona C; Chokshi, Maulik; Gabbay, John

2014-01-01

Health technology assessment (HTA) is a multidisciplinary approach that uses clinical effectiveness, cost-effectiveness, policy and ethical perspectives to provide evidence upon which rational decisions on the use of health technologies can be made. It can be used for a single stand-alone technology (e.g. a drug, a device), complex interventions (e.g. a rehabilitation service) and can also be applied to individual patient care and to public health. It is a tool for enabling the assessment and comparison of health technologies using the same metric of cost-effectiveness. This process benefits the patient, the health service, the healthcare payer and the technology producer as only technologies that are considered cost-effective are promoted for widespread use. This leads to greater use of effective technologies and greater health gain. The decision-making process in healthcare in India is complex owing to multiplicity of organizations with overlapping mandates. Often the decision-making is not evidence-based and there is no mechanism of bridging the gap between evidence and policy. Elsewhere, HTA is a frequently used tool in informing policy decisions in both resource-rich and resource-poor countries. Despite national organizations producing large volumes of research and clinical guidelines, India has not yet introduced a formal HTA programme. The incremental growth in healthcare products, services, innovation in affordable medical devices and a move towards universal healthcare, needs to be underpinned with an evidencebase which focuses on effectiveness, safety, affordability and acceptability to maximize the benefits that can be gained with a limited healthcare budget. Establishing HTA as a formal process in India, independent of healthcare providers, funders and technology producers, together with a framework for linking HTA to policy-making, would help ensure that the population gets better access to appropriate healthcare in the future. Copyright 2014, NMJI.

The burden of rheumatoid arthritis and access to treatment: determinants of access.

PubMed

Lundqvist, J; Kastäng, F; Kobelt, G; Jönsson, B

2008-01-01

As part of the study "The Burden of Rheumatoid Arthritis (RA) and Patient Access to Treatment", this paper reviews the impact on access to RA drugs of the approval processes, pricing and funding decisions and times to market (access) in different countries. In addition, an overview of health technology assessments (HTA) and the economic literature related to RA treatments is provided. The time from approval to market access ranged from immediate to over 500 days in the countries included in the study. A total of 55 HTA reports were identified, 40 of them in the period between 2002 and 2006; 29 were performed by European HTA agencies, 14 in Canada and 7 in the United States. A total of 239 economic evaluations related to RA were identified in a specialized health economic database (HEED).

New trends and challenges in the European regulation of innovative medicines.

PubMed

Enzmann, Harald

2016-10-01

Regulators' marketing authorizations for innovative medicines are linked into a complex process with successive crucial decisions. Objectives and decision criteria of the stakeholders in this process, e.g. health technology assessment (HTA) bodies, payers, physicians and patients, vary and may result not only in different but even mutually exclusive requirements. Reacting to changes in scientific, economic and social demands, European regulatory agencies alter content and format of their assessment procedures and their communication. New diagnostic options (e.g. genotyping and biomarkers) and pharmaceutical innovations (e.g. targeted medicines, nanomedicines) are the scientific drivers of this development. Social drivers are the price and reimbursement decisions by HTA bodies and payers, prerequisites for most patients' access to innovative medicines. The European Medicines Agency's adaptive licensing concept and priority medicines scheme foster the early authorization of innovative medicines. HTA builds on regulators' assessment, with additional requirements and economic components. An intensified exchange between all stakeholders, e.g. in multilateral scientific advice procedures has been initiated. Diminishing the differences in the requirements of regulators and HTA bodies is in the best interest of both patients and the pharmaceutical industry, avoiding duplication of work and accelerating patients' access by early decisions on price and reimbursement. Copyright © 2016 Elsevier Inc. All rights reserved.

Characterization of a thermophilic cellulase from Geobacillus sp. HTA426, an efficient cellulase-producer on alkali pretreated of lignocellulosic biomass.

PubMed

Potprommanee, Laddawan; Wang, Xiao-Qin; Han, Ye-Ju; Nyobe, Didonc; Peng, Yen-Ping; Huang, Qing; Liu, Jing-Yong; Liao, Yu-Ling; Chang, Ken-Lin

2017-01-01

A themophilic cellulase-producing bacterium was isolated from a hot spring district and identified as Geobacillus sp. HTA426. The cellulase enzyme produced by the Geobacillus sp. HTA426 was purified through ammonium sulfate precipitation and ion exchange chromatography, with the recovery yield and fold purification of 10.14% and 5.12, respectively. The purified cellulase has a molecular weight of 40 kDa. The optimum temperature and pH for carboxymethyl cellulase (CMCase) activity of the purified cellulase were 60°C and pH 7.0, respectively. The enzyme was also stable over a wide temperature range of 50°C to 70°C after 5 h of incubation. Moreover, the strain HTA426 was able to grow and produce cellulase on alkali-treated sugarcane bagasse, rice straw and water hyacinth as carbon sources. Enzymatic hydrolysis of sugarcane bagasse, which was regarded as the most effective carbon source for cellulase production (CMCase activity = 103.67 U/mL), followed by rice straw (74.70 U/mL) and water hyacinth (51.10 U/mL). This strain producing an efficient thermostable cellulose is a potential candidate for developing a more efficient and cost-effective process for converting lignocellulosic biomass into biofuel and other industrial process.

Characterization of a thermophilic cellulase from Geobacillus sp. HTA426, an efficient cellulase-producer on alkali pretreated of lignocellulosic biomass

PubMed Central

Potprommanee, Laddawan; Wang, Xiao-Qin; Han, Ye-Ju; Nyobe, Didonc; Peng, Yen-Ping; Huang, Qing; Liu, Jing-yong; Liao, Yu-Ling; Chang, Ken-Lin

2017-01-01

A themophilic cellulase-producing bacterium was isolated from a hot spring district and identified as Geobacillus sp. HTA426. The cellulase enzyme produced by the Geobacillus sp. HTA426 was purified through ammonium sulfate precipitation and ion exchange chromatography, with the recovery yield and fold purification of 10.14% and 5.12, respectively. The purified cellulase has a molecular weight of 40 kDa. The optimum temperature and pH for carboxymethyl cellulase (CMCase) activity of the purified cellulase were 60°C and pH 7.0, respectively. The enzyme was also stable over a wide temperature range of 50°C to 70°C after 5 h of incubation. Moreover, the strain HTA426 was able to grow and produce cellulase on alkali-treated sugarcane bagasse, rice straw and water hyacinth as carbon sources. Enzymatic hydrolysis of sugarcane bagasse, which was regarded as the most effective carbon source for cellulase production (CMCase activity = 103.67 U/mL), followed by rice straw (74.70 U/mL) and water hyacinth (51.10 U/mL). This strain producing an efficient thermostable cellulose is a potential candidate for developing a more efficient and cost-effective process for converting lignocellulosic biomass into biofuel and other industrial process. PMID:28406925

Oncology drug health technology assessment recommendations: Canadian versus UK experiences

PubMed Central

Chabot, Isabelle; Rocchi, Angela

2014-01-01

Background Canada has two health technology assessment (HTA) agencies responsible for oncology drug funding recommendations: the Institut National d’Excellence en Santé et Services Sociaux (INESSS) for the province of Québec and the pan-Canadian Oncology Drug Review for the rest of Canada. The objective of the research was to review and compare the recommendations of these two agencies alongside an international comparator – the National Institute for Health and Care Excellence (NICE) in the United Kingdom – with respect to their recommendations records and the influence of clinical and cost-effectiveness evidence on the recommendations. Methods Recommendations were identified from the three agencies from January 1, 2002 to June 1, 2013. Recommendations were limited to five cancer sites (lung, breast, colon, kidney, blood) and to metastatic/advanced settings. Descriptive analyses examined the frequency of positive recommendations and factors related to a positive recommendation. For each recommendation, only publicly available information posted on the agency website was used to abstract data. Results There was a wide variation in the rate of positive recommendations, ranging from 48% for NICE to 95% for Canada’s national process (among the 74% of its recommendations that were publicly posted). Interagency agreement was low, with full agreement for only six of the 14 drugs commonly reviewed by all three agencies. Evidence of a survival gain was not necessary for a positive recommendation; progression-free survival was acceptable. Different approaches were taken when addressing unacceptable cost-effectiveness. NICE was most likely to yield a negative recommendation on these grounds, whereas Canada’s national process was most likely to yield a positive recommendation with a required pricing arrangement. Conclusion In this analysis, the primary reason for the observed divergence between agency recommendations appeared to be the availability of mechanisms in each jurisdiction to address cost-effectiveness subsequent to the HTA assessment process. Furthermore, caution is needed when interpreting cross-agency comparisons between HTA agencies, as recommendations may not correspond directly to subsequent funding decisions and actual patient access. This may be a concern, given the high international profile of assessments conducted by the reviewed HTA agencies. PMID:25075196

Reimbursement of biosimilars in Poland: is there a link to health technology assessment?

PubMed

Neumann, Dominika; Jabłecka, Anna

2016-12-01

Due to their complex structures, biosimilars are not generics. The differences between them are considered during market authorization processes but remain unclear during reimbursement decision-making. We analyzed the reimbursement of biopharmaceuticals in Poland with an emphasis on biosimilars and compared the health technology assessment (HTA) process with that defined in other countries. Recommendations provided by the Polish HTA organization and those in other countries were included as source documents. The period of interest covered January 2012 to December 2014. The reimbursement process for biosimilars in Poland is the same as that for generics. In contrast to other countries, a HTA is not involved in decision-making in Poland. The short administrative procedure for reimbursement of biosimilars in Poland accelerates the decision-making process; therefore, therapies can be made available to patients more quickly. However, this procedure can potentially lead to underestimation of aspects concerning the effectiveness and safety of biosimilars.

Conceptual modeling for Prospective Health Technology Assessment.

PubMed

Gantner-Bär, Marion; Djanatliev, Anatoli; Prokosch, Hans-Ulrich; Sedlmayr, Martin

2012-01-01

Prospective Health Technology Assessment (ProHTA) is a new and innovative approach to analyze and assess new technologies, methods and procedures in health care. Simulation processes are used to model innovations before the cost-intensive design and development phase. Thus effects on patient care, the health care system as well as health economics aspects can be estimated. To generate simulation models a valid information base is necessary and therefore conceptual modeling is most suitable. Project-specifically improved methods and characteristics of simulation modeling are combined in the ProHTA Conceptual Modeling Process and initially implemented for acute ischemic stroke treatment in Germany. Additionally the project aims at simulation of other diseases and health care systems as well. ProHTA is an interdisciplinary research project within the Cluster of Excellence for Medical Technology - Medical Valley European Metropolitan Region Nuremberg (EMN), which is funded by the German Federal Ministry of Education and Research (BMBF), project grant No. 01EX1013B.

Reflections on the evolution of health technology assessment in Europe.

PubMed

Sorenson, Corinna; Chalkidou, Kalipso

2012-01-01

Health technology assessment (HTA) has assumed an increasing role in health systems in recent years, with many countries establishing agencies or programmes to evaluate health technology and other interventions to inform policy decisions and clinical practice. This paper reflects upon its development and evolution in Europe over the last decade, with a focus on England, France, Germany and Sweden. In particular, we explore how HTA has evolved over time as well as its impact on policy and practice. While countries share many of the same objectives, there are differences in the way HTA agencies and programmes are organised, operate, and influence decision making. Despite these differences, all systems are faced with opportunities and challenges related to stakeholder involvement and acceptance, the suitability and transparency of assessment requirements and methods, balancing evidence and values in decision making, and demonstrating impact. © Cambridge University Press 2012

EBM, HTA, and CER: clearing the confusion.

PubMed

Luce, Bryan R; Drummond, Michael; Jönsson, Bengt; Neumann, Peter J; Schwartz, J Sanford; Siebert, Uwe; Sullivan, Sean D

2010-06-01

The terms evidence-based medicine (EBM), health technology assessment (HTA), comparative effectiveness research (CER), and other related terms lack clarity and so could lead to miscommunication, confusion, and poor decision making. The objective of this article is to clarify their definitions and the relationships among key terms and concepts. This article used the relevant methods and policy literature as well as the websites of organizations engaged in evidence-based activities to develop a framework to explain the relationships among the terms EBM, HTA, and CER. This article proposes an organizing framework and presents a graphic demonstrating the differences and relationships among these terms and concepts. More specific terminology and concepts are necessary for an informed and clear public policy debate. They are even more important to inform decision making at all levels and to engender more accountability by the organizations and individuals responsible for these decisions.

History of the international societies in health technology assessment: International Society for Technology Assessment in Health Care and Health Technology Assessment International.

PubMed

Banta, David; Jonsson, Egon; Childs, Paul

2009-07-01

The International Society for Technology Assessment in Health Care (ISTAHC) was formed in 1985. It grew out of the increasing awareness of the international dimensions of health technology assessment (HTA) and the need for new communication methods at the international level. The main function of ISTAHC was to present an annual conference, which gradually grew in size, and also to generally improve in quality from to year. ISTAHC overextended itself financially early in the first decade of the 2000s and had to cease its existence. A new society, Health Technology Assessment international (HTAi), based on many of the same ideas and people, grew up beginning in the year 2003. The two societies have played a large role in making the field of HTA visible to people around the world and providing a forum for discussion on the methods and role of HTA.

Lean systems approaches to health technology assessment: a patient-focused alternative to cost-effectiveness analysis.

PubMed

Bridges, John F P

2006-12-01

Many countries now use health technology assessment (HTA) to review new and emerging technologies, especially with regard to reimbursement, pricing and/or clinical guidelines. One of the common, but not universal, features of these systems is the use of economic evaluation, normally cost-effectiveness analysis (CEA), to confirm that new technologies offer value for money. Many have criticised these systems as primarily being concerned with cost containment, rather than advancing the interests of patients or innovators. This paper calls into question the underlying principles of CEA by arguing that value in the healthcare system may in fact be unconstrained. It is suggested that 'lean management principles' can be used not only to trim waste from the health system, but as a method of creating real incentives for innovation and value creation. Following the lean paradigm, this value must be defined purely from the patients' perspective, and the entire health system needs to work towards the creation of such value. This paper offers as a practical example a lean approach to HTA, arguing that such an approach would lead to better incentives for innovation in health, as well as more patient-friendly outcomes in the long run.

Influence of translucence/opacity and shade in the flexural strength of lithium disilicate ceramics

PubMed Central

Santos, Mila Oliveira; do Amaral, Flávia Lucisano Botelho; França, Fabiana Mantovani Gomes; Basting, Roberta Tarkany

2015-01-01

Background: Lithium disilicate ceramic system consists of glass ceramic ingots with different grades of translucence which may influence its flexural strength. Aims: To assess the three-point flexural strength of the different lithium disilicate-based ceramic ingots (IPS e.max Press/Ivoclar Vivadent) with different levels of translucence and shade. Materials and Methods: Six groups of ceramic ingots were selected to represent different levels of translucence and shade (HTA1, HTBL2, LTA2, LTB2, MO2, and HO). They measured 25 mm × 5 mm × 2 mm (n = 10), according to ISO 6872 specifications, and tested on a universal test machine (EMIC). Statistical Analysis Used: A one-way analysis of variance (ANOVA) was used (α = 0.05). Results: The results (in MPa) were: HTA1 = 392.98; HTBL2 = 390.74; LTA2 = 390.46; LTB2 = 389.92; MO2 = 390.43; HO = 391.96. ANOVA showed no significant difference among groups (P = 0.1528). Conclusions: Different levels of translucence, opacity and shade of ingots did not affect their mechanical strength, and the use of these ceramics should be guided by the esthetic demands of each clinical situation. PMID:26430304

Stratégie de prise en charge de l'hypertension artérielle en hémodialyse chronique: un modèle appliqué d’éducation thérapeutique des patients (ETP)

PubMed Central

El Harraqui, Ryme; Naima, Abda; Yassamine, Bentata; Haddiya, Intissar

2014-01-01

Même après l'entrée en dialyse, la prévalence de l'hypertension artérielle (HTA) reste élevée. Elle est souvent greffée d'une forte morbi-mortalité, et altère la qualité de vie des patients hémodialysés chroniques. La « méthode du poids sec (PS) », établie par Scribner, présente un intérêt indéniable dans la gestion de l'HTA chez le patient hémodialysé. Le but de notre travail était de déterminer la prévalence et les facteurs de risque (FDR) de l'HTA chez nos hémodialysés chroniques et d'en tenter une réduction en nous basant sur une stratégie d’éducation thérapeutique basée sur les recommandations de Scribner. Nous avons mené une étude prospective interventionnelle en trois mois et en trois phases, auprès des 93 hémodialysés chroniques de l'Hôpital Al Farabi d'Oujda. En phase 1, nous avons déterminé la prévalence de l'HTA par la surveillance horaire de la tension artérielle (TA) durant la séance de dialyse pendant deux semaines, soit sur un total de 442 séances. Les patients ont également mesuré leur pression artérielle (PA) hors-centre de façon biquotidienne les jours de non-dialyse, soit un total de 1720 mesures hors-centre. L'HTA a été définie par une Pression Artérielle Systolique (PAS) supérieure ou égale à 140mmHg et/ou une Pression Artérielle Diastolique (PAD) supérieure ou égale à 90mmHg sur au moins 2 mesures. En phase 2, les patients hypertendus ont bénéficié d'une prise en charge basée sur les recommandations de Scribner et une éducation thérapeutique (ETP). En phase 3, nous évalué les retombées de notre prise en charge. Une HTA a été notée sur 231 séances chez 57 patients, soit une prévalence de 61,3%. La PAS moyenne était de 172,75±17,69 (145-220) mmHg. Les FDR retenus sont: l’âge, la PPID importante, le non respect des règles hygiéno-diététiques (RHD) et le rythme de 2 séances de dialyse/semaine. Au départ, 13 patients (22,8%) étaient dialysés trois fois par semaine; nous avons doublé ce taux. Nous avons également réduit le PS chez 48 patients, à raison de ½Kg tous les 15 jours. Les résultats en phase 3 montrent que 8 patients sont passés dans le groupe des patients «normotendus », la prévalence de l'HTA passant ainsi à 52,7%. Dans le nouveau groupe «HTA + » (n = 49), la PAS moyenne est passée à 166,12±17,05 (140-200) mmHg. La PPID a baissé de 0,98±0,425 (0,35-2,1) Kgs chez 46 patients. La prévalence de l'HTA dans notre population rejoint les données de la littérature, mais en appliquant les principes de l'ETP à la prise en charge de celle-ci, nous avons pu en baisser la prévalence. Ainsi, La « méthode du PS » peut permettre de corriger l'HTA en HD, mais ce succès ne doit se concevoir sans un effort pédagogique soutenu de la part de l'ensemble de l’équipe soignante, d'où l'intérêt de planifier une ETP PMID:25722759

SCIENTIFIC AND SOCIAL VALUE JUDGMENTS FOR ORPHAN DRUGS IN HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Nicod, Elena; Kanavos, Panos

2016-01-01

We explore how broader aspects of a treatment's value and the impact of the condition on patients not captured by routine health technology assessment (HTA) methods using clinical and economic evidence, defined as "other considerations," may influence HTA processes in different settings. Countries included were England, Scotland, Sweden, and France. Data sources were the publicly available reports on HTA recommendations. Ten drugs with European Medicines Agency orphan designation and appraised in England were selected. Qualitative thematic analysis was used to systematically identify and code all "other considerations" based on a previously developed methodological framework, which also coded whether it was provided by stakeholders, and how it influenced the decision. A classification framework of scientific and social value judgments was developed and used throughout the study. A total of 125 "other considerations" were identified and grouped into ten subcategories based on the information provided. Eighteen to 100 percent of these, depending on the agency, were put forward as one of the main reasons for the final decision potentially contributing to accepting a higher incremental cost-effectiveness ratio or uncertain evidence. Some of these were nonquantified or nonelicited and pertained to the assessor's judgment. A taxonomy of these value judgments was created to be used in future cases. Results also contributed to better defining the determinants of social value and improving accountability for reasonableness. The systematic identification of the scientific and social value judgments enables to better understanding the dimensions of value, which can be used to improve their transparency and consistent use across decisions and settings.

New technologies and surgical innovation: five years of a local health technology assessment program in a surgical department.

PubMed

Poulin, Paule; Austen, Lea; Kortbeek, John B; Lafrenière, René

2012-06-01

There is pressure for surgical departments to introduce new and innovative health technologies in an evidence-based manner while ensuring that they are safe and effective and can be managed with available resources. A local health technology assessment (HTA) program was developed to systematically integrate research evidence with local operational management information and to make recommendations for subsequent decision by the departmental executive committee about whether and under what conditions the technology will be used. The authors present a retrospective analysis of the outcomes of this program as used by the Department of Surgery & Surgical Services in the Calgary Health Region over a 5-year period from December 2005 to December 2010. Of the 68 technologies requested, 15 applications were incomplete and dropped, 12 were approved, 3 were approved for a single case on an urgent/emergent basis, 21 were approved for "clinical audit" for a restricted number of cases with outcomes review, 14 were approved for research use only, and 3 were referred to additional review bodies. Subsequent outcome reports resulted in at least 5 technologies being dropped for failure to perform. Decisions based on local HTA program recommendations were rarely "yes" or "no." Rather, many technologies were given restricted approval with full approval contingent on satisfying certain conditions such as clinical outcomes review, training protocol development, or funding. Thus, innovation could be supported while ensuring safety and effectiveness. This local HTA program can be adapted to a variety of settings and can help bridge the gap between evidence and practice.

[Quality of health care, accreditation, and health technology assessment in Croatia: role of agency for quality and accreditation in health].

PubMed

Mittermayer, Renato; Huić, Mirjana; Mestrović, Josipa

2010-12-01

Avedis Donabedian defined the quality of care as the kind of care, which is expected to maximize an inclusive measure of patient welfare, after taking into account the balance of expected gains and losses associated with the process of care in all its segments. According to the World Medical Assembly, physicians and health care institutions have an ethical and professional obligation to strive for continuous quality improvement of services and patient safety with the ultimate goal to improve both individual patient outcomes as well as population health. Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner, with the aim to formulate safe and effective health policies that are patient focused and seek to achieve the highest value. The Agency for Quality and Accreditation in Health was established in 2007 as a legal, public, independent, nonprofit institution under the Act on Quality of Health Care. The Agency has three departments: Department of Quality and Education, Department of Accreditation, and Department of Development, Research, and Health Technology Assessment. According to the Act, the Agency should provide the procedure of granting, renewal and cancellation of accreditation of healthcare providers; proposing to the Minister, in cooperation with professional associations, the plan and program for healthcare quality assurance, improvement, promotion and monitoring; proposing the healthcare quality standards as well as the accreditation standards to the Minister; keeping a register of accreditations and providing a database related to accreditation, healthcare quality improvement, and education; providing education in the field of healthcare quality assurance, improvement and promotion; providing the HTA procedure and HTA database, supervising the healthcare insurance standards, and providing other services in the field of healthcare quality assurance, improvement, promotion and monitoring, according to the Act. Formal activities of the Agency in the field of HTA actually began in summer 2009. In the field of quality and accreditation, the plan and program of healthcare quality assurance, improvement, promotion and monitoring was finished and published in October 2010; preparation of the healthcare quality standards as well as the accreditation standards is still in process, with the aim to start accreditation process at 10 hospitals in 2011. Education in the field of healthcare quality assurance, improvement and promotion has been established as a continuous process from the beginning. The Agency is member of the International Society for Quality in Health Care (ISQua) and participates in the work of the European Accreditation Network (EAN). In the field of HTA, the Agency has established international collaboration and support, which resulted in its appointment and participation in the European network for Health Technology Assessment (EUnetHTA) Joint Action Project as a EUnetHTA Partner, as well as its membership in the international society, HTAi. TAIEX project has been approved as a two-day workshop in December 2010. The Croatian HTA Guidelines have been issued with the aim to start the HTA process and reports that should serve as recommendations, as a support to policy-makers at the national level, in particular the Croatian Ministry of Health and Social Welfare, and Croatian Institute of Health Insurance, in making evidence-informed decisions on the strategic planning, investment, management and implementation of technologies in health care, on funding (reimbursement) and coverage of health technologies, and at hospital level on the request from hospital directors and policy teams. In conclusion, establishment of all these measures in Croatia is by no means an easy and quick process, however, we do believe that it is feasible through continuous and close collaboration of all those involved.

Kinetic study of hydroxytyrosol oxidation and its related compounds by Red Globe grape polyphenol oxidase.

PubMed

García-García, María Inmaculada; Hernández-García, Samanta; Sánchez-Ferrer, Álvaro; García-Carmona, Francisco

2013-06-26

Red Globe grape polyphenol oxidase, partially purified using phase partitioning with Triton-X114, was used to study the oxidation of hydroxytytosol (HT) and its related compounds tyrosol (TS), tyrosol acetate (TSA), and hydroxytyrosol acetate (HTA). The enzyme showed activity toward both monophenols (monophenolase activity) and o-diphenols (diphenolase activity) with a pH optimum (pH 6.5) that was independent of the phenol used. However, the optimal temperature for diphenolase activity was substrate-dependent, with a broad optimum of 25-65 °C for HT, compared with the maximum obtained for HTA (40 °C). Monophenolase activity showed the typical lag period, which was modulated by pH, substrate and enzyme concentrations, and the presence of catalytic amounts of o-diphenols. When the catalytic power (Vmax/K(M)) was determined for both activities, higher values were observed for o-diphenols than for monophenols: 9-fold higher for the HT/TS pair and 4-fold higher for HTA/TSA pair. Surprisingly, this ratio was equally higher for TSA (2.2-fold) compared with that of TS, whereas no such effect was observed for o-diphenols. This higher efficiency of TSA could be related to its greater hydrophobicity. Acetyl modification of these phenols not only changes the kinetic parameters of the enzyme but also affects their antioxidant activity (ORAC-FL assays), which is lower in HTA than in HT.

Information needs of health technology assessment units and agencies in Spain.

PubMed

Galnares-Cordero, Lorea; Gutiérrez-Ibarluzea, Iñaki

2010-10-01

The aim of this study was to analyze the information needs of Spanish health technology assessment (HTA) agencies and units to facilitate access to the resources they require to substantiate their reports. A questionnaire was designed and distributed among HTA bodies to ascertain the actual situation of subscriptions to information resources and what information specialists from these bodies considered would be the ideal subscription situation. Their information needs were then studied, and the resources that best met these needs were put forward. Following this definition, a subscriptions policy was adopted with suppliers and publishers. The survey showed that HTA bodies share a minimum of core subscriptions that includes open sources (MEDLINE, DARE) and sources that the government subscribes to for the health community (ISI Web of Science, Cochrane Library Plus). There was no common approach to determining which databases to subscribe to (UpToDate, EMBASE, Ovid EBMR, CINAHL, or ECRI). After identifying the information needs, a list of resources was proposed that would best cover these needs and, of these, subscription to the following was proposed: Scopus, Ovid EBMR, Clinical Evidence, DynaMed, ECRI, and Hayes. There are differences in the way that HTA agencies and units access the different resources of biomedical information. Combined subscription to several resources for documentation services was suggested as a way of resolving these differences.

IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN LITIGATION CONCERNING ACCESS TO HIGH-COST DRUGS.

PubMed

Aleman, Alicia; Perez Galan, Ana

2017-01-01

The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process. The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants. Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health. Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

[Health technology assessment in Ecuador's ministry of public health as a tool for drug purchasing from 2012 to 2015].

PubMed

Armijos, Luciana; Escalante, Santiago; Villacrés, Tatiana

2017-06-08

Learn how the Ministry of Public Health (MSP, the Spanish acronym) of Ecuador uses health technology assessment (HTA) in decision-making on the purchase of drugs that are not on the National List of Essential Medicines (NLEM). Information from databases of the Health Intelligence Directorate (DIS, the Spanish acronym) and the National Directorate of Drugs and Medical Devices (DNMDM, the Spanish acronym), was used to compare decisions made by both entities, to learn about the use and consistency of HTA reports in decisions on purchasing drugs not included in the NLEM. From 2012 to 2015, 227 reports were issued, of which 87 cover drugs; 36, devices; 29: medical procedures; 34: health programs; and 41: other medical technologies. The DNMDM requested 59 of the reports on drugs. There was 80% agreement in decisions made by the two directorates that participate in the process. The MSP, through the DIS, began using HTA in 2012. Given that the majority of reports evaluate drugs, it is essential that reports be prepared for other types of medical technologies and that they be prepared and used as widely as possible. Despite a high level of agreement in decisions, it is important to continue to improve the reports' scope and quality, and to monitor adoption and dissemination of authorized and funded technologies to learn the effectiveness and impact of HTA in Ecuador.

Strengthening cost-effectiveness analysis in Thailand through the establishment of the health intervention and technology assessment program.

PubMed

Tantivess, Sripen; Teerawattananon, Yot; Mills, Anne

2009-01-01

Capacity is limited in the developing world to conduct cost-effectiveness analysis (CEA) of health interventions. In Thailand, there have been concerted efforts to promote evidence-based policy making, including the introduction of economic appraisals within health technology assessment (HTA). This paper reviews the experience of this lower middle-income country, with an emphasis on the creation of the Health Intervention and Technology Assessment Program (HITAP), including its mission, management structures and activities. Over the past 3 decades, several HTA programmes were implemented in Thailand but not sustained or developed further into a national institute. As a response to increasing demands for HTA evidence including CEA information, the HITAP was created in 2007 as an affiliate unit of a semi-autonomous research arm of the Ministry of Public Health. An advantage of this HTA programme over previous initiatives was that it was hosted by a research institute with long-term experience in conducting health systems and policy research and capacity building of its research staff, and excellent research and policy networks. To deal with existing impediments to conducting health economics research, the main strategies of the HITAP were carefully devised to include not only capacity strengthening of its researchers and administrative staff, but also the development of essential elements for the country's health economic evaluation methodology. These included, for example, methodological guidelines, standard protocols and benchmarks for resource allocation, many of which have been adopted by national policy-making bodies including the three major public health insurance plans. Networks and collaborations with domestic and foreign institutes have been sought as a means of resource mobilization and exchange. Although the HITAP is well financed by a number of government agencies and international organizations, the programme is vulnerable to shortages of qualified research staff, as most staff work on a part-time or temporary basis. To enhance the utilization of its research findings by policy makers, practitioners and consumers, the HITAP has adopted the principles of technical excellence, policy relevance, transparency, effective communication and participation of key stakeholders. These principles have been translated into good practice at every step of HTA management. In 2007 and 2008, the HITAP carried out assessments of a wide range of health products, medical procedures and public health initiatives. Although CEA and other economic evaluation approaches were employed in these studies, the tools and underlying efficiency goal were considered inadequate to provide complete information for prioritization. As suggested by official stakeholders, some of the projects investigated broader issues of management, feasibility, performance and socio-political implications of interventions. As yet, it is unclear what role HITAP research and associated recommendations have played in policy decisions. It is hoped that the lessons drawn on the creation of the HITAP and its experience during the first 2 years, as well as information on its main strategies and management structures, may be helpful for other resource-constrained countries when considering how best to strengthen their capacity to conduct economic appraisals of health technologies and interventions.

An assessment of the impact of the NHS Health Technology Assessment Programme.

PubMed

Hanney, S; Buxton, M; Green, C; Coulson, D; Raftery, J

2007-12-01

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. 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. 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. 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. 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.

Publication rate for funded studies from a major UK health research funder: a cohort study

PubMed Central

Turner, S; Wright, D; Maeso, R; Cook, A; Milne, R

2013-01-01

Objectives This study aimed to investigate what percentage of National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme-funded projects have published their final reports in the programme's journal HTA and to explore reasons for non-publication. Design Retrospective cohort study. Setting Failure to publish findings from research is a significant area of research waste. It has previously been suggested that potentially over 50% of studies funded are never published. Participants All NIHR HTA projects with a planned submission date for their final report for publication in the journal series on or before 9 December 2011 were included. Primary and secondary outcome measures The projects were classified according to the type of research, whether they had been published or not; if not yet published, whether they would be published in the future or not. The reasons for non-publication were investigated. Results 628 projects were included: 582 (92.7%) had published a monograph; 19 (3%) were expected to publish a monograph; 13 (2.1%) were discontinued studies and would not publish; 12 (1.9%) submitted a report which did not lead to a publication as a monograph; and two (0.3%) did not submit a report. Overall, 95.7% of HTA studies either have published or will publish a monograph: 94% for those commissioned in 2002 or before and 98% for those commissioned after 2002. Of the 27 projects for which there will be no report, the majority (21) were commissioned in 2002 or before. Reasons why projects failed to complete included failure to recruit; issues concerning the organisation where the research was taking place; drug licensing issues; staffing issues; and access to data. Conclusions The percentage of HTA projects for which a monograph is published is high. The advantages of funding organisations requiring publication in their own journal include avoidance of publication bias and research waste. PMID:23645914

Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry.

PubMed

Frønsdal, Katrine; Pichler, Franz; Mardhani-Bayne, Logan; Henshall, Chris; Røttingen, John-Arne; Mørland, Berit; Klemp, Marianne

2012-10-01

There has been an increased focus on the relationship between health technology assessment (HTA) and regulatory assessments and how regulatory, HTA and coverage bodies, and industry can work better together to improve efficiency and alignment of processes. There is increasingly agreement across sectors that improved communication and coordination could contribute to facilitating timely patient access to effective, affordable treatments that offer value to the health system. Discussions on aspects of this relationship are being held in different forums and various forms of coordination and collaboration are being developed or piloted within several jurisdictions. It is therefore both timely and of value to stakeholders to describe and reflect on current initiatives intended to improve interactions between regulatory, HTA and coverage bodies, and industry. Drawing on 2011 meetings of the HTAi Policy Forum and the Center for Innovation in Regulatory Science (CIRS), this study aims to describe and compare initiatives, and point to success factors and challenges that are likely to inform future work and collaboration.

A web based health technology assessment in tele-echocardiography: the experience within an Italian project.

PubMed

Giansanti, Daniele; Morelli, Sandra; Maccioni, Giovanni; Guerriero, Lorenzo; Bedini, Remo; Pepe, Gennaro; Colombo, Cesare; Borghi, Gabriella; Macellari, Velio

2009-01-01

Due to major advances in the information technology, telemedicine applications are ready for a widespread use. Nonetheless, to allow their diffusion in National Health Care Systems (NHCSs) specific methodologies of health technology assessment (HTA) should be used to assess the standardization, the overall quality, the interoperability, the addressing to legal, economic and cost benefit aspects. One of the limits to the diffusion of the digital tele-echocardiography (T-E) applications in the NHCS lacking of a specific methodology for the HTA. In the present study, a solution offering a structured HTA of T-E products was designed. The methodology assured also the definition of standardized quality levels for the application. The first level represents the minimum level of acceptance; the other levels are accessory levels useful for a more accurate assessment of the product. The methodology showed to be useful to rationalize the process of standardization and has received a high degree of acceptance by the subjects involved in the study.

PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA.

PubMed

Benisheva-Dimitrova, Tatyana; Sidjimova, Dobriana; Cherneva, Daniela; Kralimarkov, Nikolay

2017-01-01

The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

Standardized reporting for rapid relative effectiveness assessments of pharmaceuticals.

PubMed

Kleijnen, Sarah; Pasternack, Iris; Van de Casteele, Marc; Rossi, Bernardette; Cangini, Agnese; Di Bidino, Rossella; Jelenc, Marjetka; Abrishami, Payam; Autti-Rämö, Ilona; Seyfried, Hans; Wildbacher, Ingrid; Goettsch, Wim G

2014-11-01

Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals. Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model. The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report. The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.

[Health research and health technology assessment in Chile].

PubMed

Espinoza, Manuel Antonio; Cabieses, Báltica; Paraje, Guillermo

2014-01-01

Health research is considered an essential element for the improvement of population health and it has been recommended that a share of the national health budget should be allocated to develop this field. Chile has undertaken efforts in the last decades in order to improve the governmental structure created to promote the development of health research, which has increased human resources and funding opportunities. On the other hand, the sustained economic growth of Chile in the last decades suggests that the health expenditure will maintain its increasing trend in the following years. This additional funding could be used to improve coverage of current activities performed in the health system, but also to address the incorporation of new strategies. More recently, health technology assessment (HTA) has been proposed as a process to support decisions about allocation of resources based on scientific evidence. This paper examines the relationship between the development of health research and the HTA process. First, it presents a brief diagnosis of the situation of health research in Chile. Second, it reviews the conceptual basis and the methods that account for the relationship between a HTA process and the development of health research. In particular, it emphasizes the relevance of identifying information gaps where funding additional research can be considered a good use of public resources. Finally, it discusses the challenges and possible courses of action that Chile could take in order to guarantee the continuous improvement of an articulated structure for health research and HTA.

Defining products for a new health technology assessment agency in Madrid, Spain: a survey of decision makers.

PubMed

Andradas, Elena; Blasco, Juan-Antonio; Valentín, Beatriz; López-Pedraza, María-José; Gracia, Francisco-Javier

2008-01-01

The aim of this study was to explore the needs and requirements of decision makers in our regional healthcare system for health technology assessment (HTA) products to support portfolio development planning for a new HTA agency in Madrid, Spain. A Delphi study was conducted during 2003. Questionnaires were developed based on a review of products and services offered by other agency members of the International Network of Agencies for Health Technology Assessment, and included preference and prioritization questions to evaluate twenty-two different products and services. The initial Delphi panel involved eighty-seven experts from twenty-one public hospitals, eleven primary healthcare centers, six private hospitals, and eight departments of the Regional Ministry of Health of the Community of Madrid. The global participation rate was 83.9 percent. Ten of the twenty-two possible products were rated of high interest by more than 80 percent of respondents. Important differences in preferences and priorities were detected across different settings. Public hospitals and primary healthcare centers shared a more "micro" perspective, preferring classic technology-centered HTA products, whereas private hospitals and Ministry representatives demanded more "macro" products and services such as organizational model and information system assessments. The high participation rate supports the representativeness of the results for our regional context. The strategic development of an HTA portfolio based on decision makers' needs and requirements as identified in this type of exercise should help achieve a better impact on policy development and decision making.

Are economic evaluations and health technology assessments increasingly demanded in times of rationing health services? The case of the Argentine financial crisis.

PubMed

Rubinstein, Adolfo; Belizán, María; Discacciati, Vilda

2007-01-01

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. 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. 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. 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.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Henschke, Cornelia; Panteli, Dimitra; Perleth, Matthias; Busse, Reinhard

2015-01-01

The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Health technology assessment in Iran: challenges and views

PubMed Central

Olyaeemanesh, Alireza; Doaee, Shila; Mobinizadeh, Mohammadreza; Nedjati, Mina; Aboee, Parisa; Emami-Razavi, Seyed Hassan

2014-01-01

Background: Various decisions have been made on technology application at all levels of the health system in different countries around the world. Health technology assessment is considered as one of the best scientific tools at the service of policy- makers. This study attempts to investigate the current challenges of Iran’s health technology assessment and provide appropriate strategies to establish and institutionalize this program. Methods: This study was carried out in two independent phases. In the first, electronic databases such as Medline (via Pub Med) and Scientific Information Database (SID) were searched to provide a list of challenges of Iran’s health technology assessment. The views and opinions of the experts and practitioners on HTA challenges were studied through a questionnaire in the second phase which was then analyzed by SPSS Software version 16. This has been an observational and analytical study with a thematic analysis. Results: In the first phase, seven papers were retrieved; from which, twenty- two HTA challenges in Iran were extracted by the researchers; and they were used as the base for designing a structured questionnaire of the second phase. The views of the experts on the challenges of health technology assessment were categorized as follows: organizational culture, stewardship, stakeholders, health system management, infrastructures and external pressures which were mentioned in more than 60% of the cases and were also common in the views. Conclusion: The identification and prioritization of HTA challenges which were approved by those experts involved in the strategic planning of the Department of Health Technology Assessment will be a step forward in the promotion of an evidence- based policy- making and in the production of comprehensive scientific evidence. PMID:25695015

Mental health economics: insights from Brazil.

PubMed

Cruz, Luciane; Lima, Ana Flavia Da Silva; Graeff-Martins, Ana; Maia, Carlos Renato Moreira; Ziegelmann, Patricia; Miguel, Sandoro; Fleck, Marcelo; Polanczyk, Carisi

2013-04-01

As the responsibility and demand on health care grows and resources do not increase at the same pace, the healthcare system has been forced to reconsider the benefits and costs of their actions, to ensure a rational and effective decision-making process regarding the adoption of interventions and allocation of resources. Cost-effectiveness (CE) studies represent one of the basic tools to achieve this goal. To present the current state of Health Technology Assessment (HTA) and health economics in mental health in Brazil and its importance to the decision-making process. Descriptive paper on HTA and health economics in Brazil. Databases from government and universities as well as some scientific databases to assess the information are presented. Economic analysis to evaluate interventions in mental health care is a relatively recent addition to the field of health economics; in Brazil, it is also considered a topic within Epidemiology research area. There have been an increased number of studies developed in high-income countries. However, there are fewer CE studies in low- and middle-income ones. Psychiatric disorders represent a significant burden in developing countries, where resources devoted to health care are even scarcer.

Pharmacological Treatment of Hypertension: Effects in Endothelial Function.

PubMed

Cobos-Segarra, Leonardo; Lopez-Jaramillo, Patricio; Ponte-Negretti Ci, Carlos; Villar, Raul; Penaherrera, Ernesto

2018-05-07

The vascular endothelium plays a crucial role to maintain the functional integrity of the cardiovascular system through the secretion of vasoactive substances such as prostacyclin and NO. Endothelial dysfunction participate in the genesis of HTA, but also hypertension produces endothelial damage. The mayor class of antihypertensive drugs have beneficial effects in the recuperation of the endothelial function, actions that are contributing to explain the impact of the adequate control of HTA in the reduction of CV events. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Health technology assessment (HTA) organizations: dimensions of the institutional and political framework.

PubMed

Novaes, Hillegonda Maria Dutilh; Soárez, Patrícia Coelho de

2016-11-03

Health technology assessment (HTA) is consolidated as a scientific and technological practice. The aim of this study is to identify HTA organizations from different settings and analyze their relevant dimensions in terms of effectiveness/impact, in order to address the challenges they face in Brazil. Narrative literature review based on data and websites of HTA organizations. There are well-established activity development processes in all organizations. These activities have specific features in their profile, in the process of technology assessment, decision and implementation of technologies that influence their potential impact on health systems. Agencies share in common the challenges of ranking the technologies to be assessed, and the implementation of their recommendations. Technical and political strengthening of the institutionalization of HTA in Brazil may foster scientific, technological and innovation policies, effectively impacting health policies. Resumo: A avaliação de tecnologias em saúde (ATS) está consolidada enquanto prática científica e tecnológica. O objetivo do estudo é identificar organizações de ATS de diferentes contextos e analisá-las de acordo com dimensões relevantes na avaliação de sua efetividade/impacto, buscando contribuir com os desafios enfrentados no contexto nacional. Revisão narrativa da literatura, realizada em bases de dados e web sites de organizações de ATS. Existem processos de desenvolvimento das atividades bem estabelecidos em todas as organizações. Elas apresentam particularidades no seu perfil, nos processos de avaliação, decisão e implementação das tecnologias que influenciam o seu impacto potencial sobre os sistemas de saúde. As agências compartilham os desafios de priorização das tecnologias a serem avaliadas e implementação das suas recomendações. O fortalecimento técnico e político do processo de institucionalização da ATS no contexto nacional poderá contribuir com as políticas científicas, tecnológicas e de inovação, impactando de forma efetiva as políticas de saúde.

(Very) Early technology assessment and translation of predictive biomarkers in breast cancer.

PubMed

Miquel-Cases, Anna; Schouten, Philip C; Steuten, Lotte M G; Retèl, Valesca P; Linn, Sabine C; van Harten, Wim H

2017-01-01

Predictive biomarkers can guide treatment decisions in breast cancer. Many studies are undertaken to discover and translate these biomarkers, yet few biomarkers make it to practice. Before use in clinical decision making, predictive biomarkers need to demonstrate analytical validity, clinical validity and clinical utility. While attaining analytical and clinical validity is relatively straightforward, by following methodological recommendations, the achievement of clinical utility is extremely challenging. It requires demonstrating three associations: the biomarker with the outcome (prognostic association), the effect of treatment independent of the biomarker, and the differential treatment effect between the prognostic and the predictive biomarker (predictive association). In addition, economical, ethical, regulatory, organizational and patient/doctor-related aspects are hampering the translational process. Traditionally, these aspects do not receive much attention until formal approval or reimbursement of a biomarker test (informed by Health Technology Assessment (HTA)) is at stake, at which point the clinical utility and sometimes price of the test can hardly be influenced anymore. When HTA analyses are performed earlier, during biomarker research and development, they may prevent further development of those biomarkers unlikely to ever provide sufficient added value to society, and rather facilitate translation of the promising ones. Early HTA is particularly relevant for the predictive biomarker field, as expensive medicines are under pressure and the need for biomarkers to guide their appropriate use is huge. Closer interaction between clinical researchers and HTA experts throughout the translational research process will ensure that available data and methodologies will be used most efficiently to facilitate biomarker translation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

The first step in using a robot in brain injury rehabilitation: patients' and health-care professionals' perspective.

PubMed

Boman, Inga-Lill; Bartfai, Aniko

2015-01-01

To evaluate the usability of a mobile telepresence robot (MTR) in a hospital training apartment (HTA). The MTR was manoeuvred remotely and was used for communication when assessing independent living skills, and for security monitoring of cognitively impaired patients. Occupational therapists (OTs) and nurses received training in how to use the MTR. The nurses completed a questionnaire regarding their expectations of using the MTR. OTs and patients staying in the HTA were interviewed about their experiences of the MTR. Interviews and questionnaires were analysed qualitatively. The HTA patients were very satisfied with the MTR. The OTs and nurses reported generally positive experiences. The OT's found that assessment via the MTR was more neutral than being physically present. However, the use of the MTR implied considerable difficulties for health-care professionals. The main obstacle for the nurses was the need for fast and easy access in emergency situations while protecting the patients' integrity. The results indicate that the MTR could be a useful tool to support daily living skills and safety monitoring of HTA patients. However, when designing technology for multiple users, such as health-care professionals, the needs of all users, their routines and support services involved, should also be considered. Implications for Rehabilitation A mobile telepresence robot (MTR) can be a useful tool for assessments and communication in rehabilitation. The design of the robot has to allow easy use by remote users, particularly in emergency situations. When designing MTRs the needs of ALL users have to be taken into consideration.

ARTHROSCOPIC SURGERY FOR KNEE OSTEOARTHRITIS: IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN GERMANY.

PubMed

Fujita-Rohwerder, Naomi; Rüther, Alric; Sauerland, Stefan

2017-01-01

This study aims to describe how a negative reimbursement decision-based on the health technology assessment (HTA) report of a nondrug intervention-affects healthcare providers in Germany. Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG). Here, we examine how the decision to revoke reimbursement for arthroscopy was perceived by the surgical community. Information was collected from official hospital statistics, the internet, and informal interviews with orthopedic surgeons. In 2015, a total of 37,920 arthroscopic procedures were performed for knee osteoarthritis in Germany. Several surgical societies were unhappy with the negative decision, which was issued as a directive in November 2015, and they challenged the decision-making process as well as the underlying scientific evidence. In March 2016, fifteen societies issued joint recommendations on how to differentiate osteoarthritis from other knee diseases and how to document other diseases in a way that inspections by representatives of health insurance funds would not detect any deficiencies. In informal interviews, orthopedic surgeons indicated that miscoding of the principal diagnosis (meniscal tear rather than knee osteoarthritis) is to be expected, especially in the hospital sector. HTA can have a significant impact on the provision of health services, but various loopholes allow physicians to undermine policy decisions. Therefore, it is important to involve all stakeholders in HTA and to convince them of the benefits of evidence-based medicine.

The Health Technology Assessment of companion diagnostics: experience of NICE.

PubMed

Byron, Sarah K; Crabb, Nick; George, Elisabeth; Marlow, Mirella; Newland, Adrian

2014-03-15

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UK HTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

Avoiding and identifying errors in health technology assessment models: qualitative study and methodological review.

PubMed

Chilcott, J; Tappenden, P; Rawdin, A; Johnson, M; Kaltenthaler, E; Paisley, S; Papaioannou, D; Shippam, A

2010-05-01

Health policy decisions must be relevant, evidence-based and transparent. Decision-analytic modelling supports this process but its role is reliant on its credibility. Errors in mathematical decision models or simulation exercises are unavoidable but little attention has been paid to processes in model development. Numerous error avoidance/identification strategies could be adopted but it is difficult to evaluate the merits of strategies for improving the credibility of models without first developing an understanding of error types and causes. The study aims to describe the current comprehension of errors in the HTA modelling community and generate a taxonomy of model errors. Four primary objectives are to: (1) describe the current understanding of errors in HTA modelling; (2) understand current processes applied by the technology assessment community for avoiding errors in development, debugging and critically appraising models for errors; (3) use HTA modellers' perceptions of model errors with the wider non-HTA literature to develop a taxonomy of model errors; and (4) explore potential methods and procedures to reduce the occurrence of errors in models. It also describes the model development process as perceived by practitioners working within the HTA community. A methodological review was undertaken using an iterative search methodology. Exploratory searches informed the scope of interviews; later searches focused on issues arising from the interviews. Searches were undertaken in February 2008 and January 2009. In-depth qualitative interviews were performed with 12 HTA modellers from academic and commercial modelling sectors. All qualitative data were analysed using the Framework approach. Descriptive and explanatory accounts were used to interrogate the data within and across themes and subthemes: organisation, roles and communication; the model development process; definition of error; types of model error; strategies for avoiding errors; strategies for identifying errors; and barriers and facilitators. There was no common language in the discussion of modelling errors and there was inconsistency in the perceived boundaries of what constitutes an error. Asked about the definition of model error, there was a tendency for interviewees to exclude matters of judgement from being errors and focus on 'slips' and 'lapses', but discussion of slips and lapses comprised less than 20% of the discussion on types of errors. Interviewees devoted 70% of the discussion to softer elements of the process of defining the decision question and conceptual modelling, mostly the realms of judgement, skills, experience and training. The original focus concerned model errors, but it may be more useful to refer to modelling risks. Several interviewees discussed concepts of validation and verification, with notable consistency in interpretation: verification meaning the process of ensuring that the computer model correctly implemented the intended model, whereas validation means the process of ensuring that a model is fit for purpose. Methodological literature on verification and validation of models makes reference to the Hermeneutic philosophical position, highlighting that the concept of model validation should not be externalized from the decision-makers and the decision-making process. Interviewees demonstrated examples of all major error types identified in the literature: errors in the description of the decision problem, in model structure, in use of evidence, in implementation of the model, in operation of the model, and in presentation and understanding of results. The HTA error classifications were compared against existing classifications of model errors in the literature. A range of techniques and processes are currently used to avoid errors in HTA models: engaging with clinical experts, clients and decision-makers to ensure mutual understanding, producing written documentation of the proposed model, explicit conceptual modelling, stepping through skeleton models with experts, ensuring transparency in reporting, adopting standard housekeeping techniques, and ensuring that those parties involved in the model development process have sufficient and relevant training. Clarity and mutual understanding were identified as key issues. However, their current implementation is not framed within an overall strategy for structuring complex problems. Some of the questioning may have biased interviewees responses but as all interviewees were represented in the analysis no rebalancing of the report was deemed necessary. A potential weakness of the literature review was its focus on spreadsheet and program development rather than specifically on model development. It should also be noted that the identified literature concerning programming errors was very narrow despite broad searches being undertaken. Published definitions of overall model validity comprising conceptual model validation, verification of the computer model, and operational validity of the use of the model in addressing the real-world problem are consistent with the views expressed by the HTA community and are therefore recommended as the basis for further discussions of model credibility. Such discussions should focus on risks, including errors of implementation, errors in matters of judgement and violations. Discussions of modelling risks should reflect the potentially complex network of cognitive breakdowns that lead to errors in models and existing research on the cognitive basis of human error should be included in an examination of modelling errors. There is a need to develop a better understanding of the skills requirements for the development, operation and use of HTA models. Interaction between modeller and client in developing mutual understanding of a model establishes that model's significance and its warranty. This highlights that model credibility is the central concern of decision-makers using models so it is crucial that the concept of model validation should not be externalized from the decision-makers and the decision-making process. Recommendations for future research would be studies of verification and validation; the model development process; and identification of modifications to the modelling process with the aim of preventing the occurrence of errors and improving the identification of errors in models.

Involvement of consumers in health technology assessment activities by Inahta agencies.

PubMed

Hailey, David; Werkö, Sophie; Bakri, Rugayah; Cameron, Alun; Göhlen, Britta; Myles, Susan; Pwu, Jasmine; Yothasamut, Jomkwan

2013-01-01

To obtain further information from members of the International Network of Agencies for Health Technology Assessment (INAHTA) on the involvement of consumers in their programs. A questionnaire for a survey was developed and sent to member agencies in November 2010. Survey responses were compared with those from an earlier survey conducted in 2005. Of the thirty-three agencies that provided responses, 67 percent involve consumers in some aspects of their health technology assessment (HTA) programs, compared with 57 percent in 2005. As in the earlier survey, most agencies reporting involvement have contact with consumer or patient organizations and a large minority also involve individual consumers. Summaries of HTA reports that are intended to be easily understood by consumers are prepared by 84 percent of the agencies, and 42 percent involve consumers in dissemination of HTA material. In both areas, there was some increase from the levels previously reported. The survey results suggest that there is a trend to increased involvement of consumers by the INAHTA agencies in their programs but that the level of involvement remains relatively limited. The manner of consumer participation varies between agencies.

Brazilian health technology assessment bulletin: editorial process, dissemination strategies, critical appraisal, and initial impact.

PubMed

Silva, Marcus Tolentino; de Almeida, Rosimary Terezinha; Gava, Cintia Maria; Galvão, Taís Freire; da Silva, Edina Mariko Koga; Santos, Vania Cristina Canuto; Ronchini, Misani Akiko Kanamota; de Mesquita, Aline Monte; Elias, Flávia Tavares Silva; d'Oliveira, Alexandre Lemgruber Portugal; Atallah, Alvaro Nagib

2012-01-01

This study reports on the Brazilian experience of developing a specialized bulletin, the Brazilian Health Technology Assessment Bulletin (BRATS), on health technology assessments (HTA). The editorial process, format, and dissemination strategy of the publication are presented. A critical appraisal of the available issues was made using the checklist for HTA reports of the International Network of Agencies for Health Technology Assessment. The initial impact was estimated based on a retrospective observational measurement of the types of publications that cite the bulletin as a source of information. The publications citing BRATS were identified using Google Scholar. Since June 2008, fourteen issues of the bulletin have been produced. BRATS has not presented any significant limitation that would compromise generalizations of its results within the Brazilian context. The initial impact of the bulletin, however, has been small, which may be due to its exclusively electronic dissemination format and technical language. We found nine publications citing BRATS in Google Scholar. It is hoped that the bulletin will promote the continuity of HTA actions among health-sector managers and professionals in Brazil.

Multiple Epstein-Barr virus strains in patients with infectious mononucleosis: comparison of ex vivo samples with in vitro isolates by use of heteroduplex tracking assays.

PubMed

Tierney, Rosemary J; Edwards, Rachel Hood; Sitki-Green, Diane; Croom-Carter, Deborah; Roy, Sushmita; Yao, Qing-Yun; Raab-Traub, Nancy; Rickinson, Alan B

2006-01-15

Recent work using a heteroduplex tracking assay (HTA) to identify resident viral sequences has suggested that patients with infectious mononucleosis (IM) who are undergoing primary Epstein-Barr virus (EBV) infection frequently harbor different EBV strains. Here, we examine samples from patients with IM by use of a new Epstein-Barr nuclear antigen 2 HTA alongside the established latent membrane protein 1 HTA. Coresident allelic sequences were detected in ex vivo blood and throat wash samples from 13 of 14 patients with IM; most patients carried 2 or more type 1 strains, 1 patient carried 2 type 2 strains, and 1 patient carried both virus types. In contrast, coresident strains were detected in only 2 of 14 patients by in vitro B cell transformation, despite screening >20 isolates/patient. We infer that coacquisition of multiple strains is common in patients with IM, although only 1 strain tends to be rescued in vitro; whether nonrescued strains are present in low abundance or are transformation defective remains to be determined.

The contribution of health technology assessment, health needs assessment, and health impact assessment to the assessment and translation of technologies in the field of public health genomics.

PubMed

Rosenkötter, N; Vondeling, H; Blancquaert, I; Mekel, O C L; Kristensen, F B; Brand, A

2011-01-01

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.

Surrogate outcomes: experiences at the Common Drug Review

PubMed Central

2013-01-01

Background Surrogate outcomes are a significant challenge in drug evaluation for health technology assessment (HTA) agencies. The research objectives were to: identify factors associated with surrogate use and acceptability in Canada’s Common Drug Review (CDR) recommendations, and compare the CDR with other HTA or regulatory agencies regarding surrogate concerns. Methods Final recommendations were identified from CDR inception (September 2003) to December 31, 2010. Recommendations were classified by type of outcome (surrogate, final, other) and acceptability of surrogates (determined by the presence/absence of statements of concern regarding surrogates). Descriptive and statistical analyses examined factors related to surrogate use and acceptability. For thirteen surrogate-based submissions, recommendations from international HTA and regulatory agencies were reviewed for statements about surrogate acceptability. Results Of 156 final recommendations, 68 (44%) involved surrogates. The overall ‘do not list’ (DNL) rate was 48%; the DNL rate for surrogates was 41% (p = 0.175). The DNL rate was 64% for non-accepted surrogates (n = 28) versus 25% for accepted surrogates (odds ratio 5.4, p = 0.002). Clinical uncertainty, use of economic evidence over price alone, and a premium price were significantly associated with non-accepted surrogates. Surrogates were used most commonly for HIV, diabetes, rare diseases, cardiovascular disease and cancer. For the subset of drugs studied, other HTA agencies did not express concerns for most recommendations, while regulatory agencies frequently stated surrogate acceptance. Conclusions The majority of surrogates were accepted at the CDR. Non-accepted surrogates were significantly associated with clinical uncertainty and a DNL recommendation. There was inconsistency of surrogate acceptability across several international agencies. Stakeholders should consider collaboratively establishing guidelines on the use, validation, and acceptability of surrogates. PMID:24341379

Introduction of new technologies and decision making processes: a framework to adapt a Local Health Technology Decision Support Program for other local settings.

PubMed

Poulin, Paule; Austen, Lea; Scott, Catherine M; Poulin, Michelle; Gall, Nadine; Seidel, Judy; Lafrenière, René

2013-01-01

Introducing new health technologies, including medical devices, into a local setting in a safe, effective, and transparent manner is a complex process, involving many disciplines and players within an organization. Decision making should be systematic, consistent, and transparent. It should involve translating and integrating scientific evidence, such as health technology assessment (HTA) reports, with context-sensitive evidence to develop recommendations on whether and under what conditions a new technology will be introduced. However, the development of a program to support such decision making can require considerable time and resources. An alternative is to adapt a preexisting program to the new setting. We describe a framework for adapting the Local HTA Decision Support Program, originally developed by the Department of Surgery and Surgical Services (Calgary, AB, Canada), for use by other departments. The framework consists of six steps: 1) development of a program review and adaptation manual, 2) education and readiness assessment of interested departments, 3) evaluation of the program by individual departments, 4) joint evaluation via retreats, 5) synthesis of feedback and program revision, and 6) evaluation of the adaptation process. Nine departments revised the Local HTA Decision Support Program and expressed strong satisfaction with the adaptation process. Key elements for success were identified. Adaptation of a preexisting program may reduce duplication of effort, save resources, raise the health care providers' awareness of HTA, and foster constructive stakeholder engagement, which enhances the legitimacy of evidence-informed recommendations for introducing new health technologies. We encourage others to use this framework for program adaptation and to report their experiences.

Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems.

PubMed

Winnette, Randall; Zárate, Victor; Machnicki, Gerardo; DeMuro, Carla; Gawlicki, Mary; Gnanasakthy, Ari

2015-12-01

Patient-reported outcomes (PROs) are increasingly used to demonstrate the value of interventions and support health technology assessment (HTA). The objective of this work was to analyze trends regarding PROs in Latin America (LatAm), highlight challenges in the application of PROs in this region, and suggest solutions. A team of researchers with expertise in PROs conducted a nonsystematic PubMed literature search pertaining to the use of PROs in LatAm. The experts also drew on their experience working with PROs to assess the application of PROs in LatAm. The literature search yielded more than 4000 publications, with an increasing publication rate in recent years. PROs are being used in LatAm in various study types: instrument validation, phase III international clinical trials, health service research. A large Inter-American Development Bank study demonstrates the growing importance of PROs in the region. The growth in local value sets for the EuroQol five-dimensional questionnaire in LatAm reflects the regional emergence of HTA systems. Operational challenges relate to ensuring the use of good-quality questionnaires that, at a minimum, have undergone appropriate cultural adaptation and ideally have established psychometric properties. PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Adoption of the HPV vaccine: a case study of three emerging countries.

PubMed

Caro Martínez, Araceli; Espín Balbino, Jaime; Lemgruber, Alexandre; Martín Ruiz, Eva; Olry de Labry Lima, Antonio; García-Mochón, Leticia; Lessa, Fernanda

2017-05-01

The human papillomavirus (HPV) vaccine has recently attracted considerable attention in emerging countries, due to its potential to reduce the impact of HPV-related diseases. This case study sheds new light about the variety of HTA arrangements, methods and processes involved in the adoption and use of HPV vaccines in a selected sample of central, eastern and southern Europe and Latin America and the Caribbean, all of them emerging in the use of HTA. A multi-country case study was designed. Mixed methods, document review, semi-structured surveys and personal communication with experts, were used for data collection and triangulation. This study shows that common elements of good practice exist in the processes and methods used, with all countries arriving at the same appraisal recommendations. However, the influence of socio-politico-economic factors appears to be determinant on the final decisions and restrictions to access made. This case study intends to draw useful lessons for policymakers in emerging settings interested in the adoption of the HPV vaccine supported by evidence-informed processes, such as those offered by institutionalized HTA. Future studies are also recommended to elucidate the specific roles that social values and uncertainties play in vaccine decision-making across different societies.

Health technology assessment and comparative effectiveness research: a pharmaceutical industry perspective.

PubMed

Hao, Yanni; Thomas, Adrian

2013-08-01

We briefly review the characteristics of several established health technology assessment (HTA) programs in industrialized societies including Germany, the UK and France. Special attention is paid on two issues: the position of HTA in coverage decision making and the role of economic assessment in evaluation processes. Although law makers in the USA have barred the use of NICE's cost/quality-adjusted life year or similar health economics approaches by public payers for coverage decision making, there are suggestions of prioritizing relative efficacy evaluation over economic assessment under a comparative effectiveness research (CER) framework to inform payment rates of public payers (an approach similar to German and French HTA processes). However, such an approach is unlikely to prove viable. It should also be noted that, if cost considerations are made explicit in US CER policy decisions, CER may become an unsustainable approach undermined by a conflicting emphasis on both cost containment and a demand for costly comparative evidence. On the other hand, properly designed CER initiatives can serve as a facilitator of more efficient research activities and drug development models. With these points in mind, the likely pathway of US CER is explored and the plausible impact on industry innovation is discussed.

Chirp echo Fourier transform EPR-detected NMR

NASA Astrophysics Data System (ADS)

Wili, Nino; Jeschke, Gunnar

2018-04-01

A new ultra-wide band (UWB) pulse EPR method is introduced for observing all nuclear frequencies of a paramagnetic center in a single shot. It is based on burning spectral holes with a high turning angle (HTA) pulse that excites forbidden transitions and subsequent detection of the hole pattern by a chirp echo. We term this method Chirp Echo Epr SpectroscopY (CHEESY)-detected NMR. The approach is a revival of FT EPR-detected NMR. It yields similar spectra and the same type of information as electron-electron double resonance (ELDOR)-detected NMR, but with a multiplex advantage. We apply CHEESY-detected NMR in Q band to nitroxides and correlate the hyperfine spectrum to the EPR spectrum by varying the frequency of the HTA pulse. Furthermore, a selective π pulse before the HTA pulse allows for detecting hyperfine sublevel correlations between transitions of one nucleus and for elucidating the coupling regime, the same information as revealed by the HYSCORE experiment. This is demonstrated on hexaaquamanganese(II). We expect that CHEESY-detected NMR is generally applicable to disordered systems and that our results further motivate the development of EPR spectrometers capable of coherent UWB excitation and detection, especially at higher fields and frequencies.

[Involving patients, the insured and the general public in healthcare decision making].

PubMed

Mühlbacher, Axel C; Juhnke, Christin

2016-01-01

No doubt, the public should be involved in healthcare decision making, especially when decision makers from politics and self-government agencies are faced with the difficult task of setting priorities. There is a general consensus on the need for a stronger patient centeredness, even in HTA processes, and internationally different ways of public participation are discussed and tested in decision making processes. This paper describes how the public can be involved in different decision situations, and it shows how preference measurement methods are currently being used in an international context to support decision making. It distinguishes between different levels of decision making on health technologies: approval, assessment, pricing, and finally utilization. The range of participation efforts extends from qualitative surveys of patients' needs (Citizen Councils of NICE in the UK) to science-based documentation of quantitative patient preferences, such as in the current pilot projects of the FDA in the US and the EMA at the European level. Possible approaches for the elicitation and documentation of preference structures and trade-offs in relation to alternate health technologies are decision aids, such as multi-criteria decision analysis (MCDA), that provide the necessary information for weighting and prioritizing decision criteria. Copyright © 2015. Published by Elsevier GmbH.

Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

PubMed Central

Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

2014-01-01

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols. PMID:25333349

Development of sustainable models for technology evaluation in hospital.

PubMed

Miniati, Roberto; Frosini, Francesco; Cecconi, Giulio; Dori, Fabrizio; Gentili, G Biffi

2014-01-01

This paper reports the development of standard techniques for technology evaluation in hospital carried out at the Florence Teaching Hospital Careggi (AOUC), where, as a complex system, the technological evaluation is a strategic and essential element for the maintenance of high-quality clinical activity and maximization of available resources. The aim of this paper has been the development of a system of economically sustainable models for the implementation of HTA and HS analyses in the hospital environment as well as presenting, in addition to a valid scientific resilience, the methodological and temporary flexibility to satisfy needs of hospital decision-makers. The evaluation models call for 3 main phases: an initial analysis of the in-hospital request, a collection of data, and finally a draft of a specific, easily usable set of reports. Three standardized and tested models of evaluation were developed, which, in relation to the objective of the request and schedule of the assignment, provide for the production of a speedy report (1-week), an intermediate report (1-month), or a extensive report typical of classical studies of hospital based HTA (1-year). It is then related to the evaluation model of the IORT (Intra-Operative Radiation Therapy) technology. The developed models have permitted the construction, using personnel and laboratories within the hospital, of an evaluation system reliable and responsive to the HOSPITAL's temporary needs based on the HS and HTA analyses in the hospital environment. Regarding the applicable case of IORT, this has shown how in-hospital requests have been satisfied in the preset time: although it establishes expected improvements on the social effect and weight of the illness and reveals a high territorial strategic relevance, the introduction of IORT in the hospital presents some criticalities on the impact on the healthcare organization and the necessity of specific training of medical technologist personnel.

Synthesis, Characterization, and Environmental Applications of Hybrid Materials Based on Humic Acid Obtained by the Sol-Gel Route.

PubMed

Oliveira, Lílian Karla de; Molina, Eduardo Ferreira; Moura, André L A; de Faria, Emerson Henrique; Ciuffi, Katia Jorge

2016-01-20

Humic acids (HAs) are ubiquitous macromolecules in the environment. Due to their high contents of oxygenated functional groups, they can interact with contaminants present in the natural environment and therefore influence the behavior of pollutants. However, a pH of 2 or lower is required to maintain HAs in the solid form. To increase the stability of HAs and their capacity to bind to contaminants, this work proposes the development of new hybrid materials based on alkoxysilanes and HAs for environmental applications such as dye adsorption. Three different materials with new functional groups were prepared by employing the following alkoxysilanes: tetraethyl orthosilicate, (3-aminopropyl)triethoxysilane, and N-[3-(trimethoxylsilyl)propyl]ethylenediamine. The final materials were denoted HWA, HOA, and HTA, respectively, and they were characterized by elemental analysis, diffuse reflectance Fourier-transform infrared spectroscopy (DRIFT), small-angle X-ray scattering (SAXS), scanning electron microscopy (SEM), and N2 gas-volumetric adsorption. The point of zero charge (pzc) and stability of these materials were also determined. Their selectivity was evaluated in adsorption experiments performed with two different charged dyes in aqueous medium, namely anionic rose bengal (RB) and cationic methylene blue (MB). The elemental, DRIFT, SAXS, SEM, and textural analyses confirmed the presence of a combination of the features of HAs and alkoxysilanes. The pzc results showed that the new materials displayed different characteristics and affinities. All the materials were stable in aqueous solution up to pH 10. For MB, the percentage removal values obtained by using HWA, HOA, and HTA were 98, 85, and 67%, respectively. As for RB, the percentage removal values were 19, 18, and 44% for HWA, HOA, and HTA, respectively. These hybrid materials have potential use as adsorbents for the removal of cationic or anionic species and could be viable alternatives to remove various substances present as contaminants in natural environments.

Including quality attributes in efficiency measures consistent with net benefit: creating incentives for evidence based medicine in practice.

PubMed

Eckermann, Simon; Coelli, Tim

2013-01-01

Evidence based medicine supports net benefit maximising therapies and strategies in processes of health technology assessment (HTA) for reimbursement and subsidy decisions internationally. However, translation of evidence based medicine to practice is impeded by efficiency measures such as cost per case-mix adjusted separation in hospitals, which ignore health effects of care. In this paper we identify a correspondence method that allows quality variables under control of providers to be incorporated in efficiency measures consistent with maximising net benefit. Including effects framed from a disutility bearing (utility reducing) perspective (e.g. mortality, morbidity or reduction in life years) as inputs and minimising quality inclusive costs on the cost-disutility plane is shown to enable efficiency measures consistent with maximising net benefit under a one to one correspondence. The method combines advantages of radial properties with an appropriate objective of maximising net benefit to overcome problems of inappropriate objectives implicit with alternative methods, whether specifying quality variables with utility bearing output (e.g. survival, reduction in morbidity or life years), hyperbolic or exogenous variables. This correspondence approach is illustrated in undertaking efficiency comparison at a clinical activity level for 45 Australian hospitals allowing for their costs and mortality rates per admission. Explicit coverage and comparability conditions of the underlying correspondence method are also shown to provide a robust framework for preventing cost-shifting and cream-skimming incentives, with appropriate qualification of analysis and support for data linkage and risk adjustment where these conditions are not satisfied. Comparison on the cost-disutility plane has previously been shown to have distinct advantages in comparing multiple strategies in HTA, which this paper naturally extends to a robust method and framework for comparing efficiency of health care providers in practice. Consequently, the proposed approach provides a missing link between HTA and practice, to allow active incentives for evidence based net benefit maximisation in practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

Current state of ethics literature synthesis: a systematic review of reviews.

PubMed

Mertz, Marcel; Kahrass, Hannes; Strech, Daniel

2016-10-03

Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

The principles of Health Technology Assessment in laboratory medicine.

PubMed

Liguori, Giorgio; Belfiore, Patrizia; D'Amora, Maurizio; Liguori, Renato; Plebani, Mario

2017-01-01

The Health Technology Assessment (HTA) is a multi-professional and multidisciplinary evaluation approach designed to assess health technology in the broadest sense of the term, from its instruments to the rearranging of its organizational structures. It is by now an established methodology at national and international levels that involves several medical disciplines thanks to its versatility. Laboratory medicine is one of these disciplines. Such specialization was subjected, in recent years, to deep changes even from an organizational standpoint, in order to meet the health needs of the population, making them as effective and cost-effective as possible. In this regard, HTA was the tool used to assess implications in different areas.

'HTA for Crisis': sharing experiences during the 7th EBHC Symposium.

PubMed

Wladysiuk, Magdalena; Tabor, Anna; Godman, Brian

2013-02-01

The Central and Eastern European Society of Technology Assessment in Health Care was founded in Krakow, Poland in 2003. On October 8th and 9th, the 7th symposium took place titled 'HTA for Crisis'. This meeting was attended by over 250 decision makers, evidence-based specialists, healthcare managers, commercial company personnel and experts. The symposium was principally divided into four main themes: insurance in times of crisis; importance of pricing of health services in times of crisis; managing welfare benefits in times of crisis and Health Technology Assessment in crisis-laden countries. The symposium finished by debating potential ways forward for healthcare systems in times of crisis.

Twenty-five-gauge vitrectomy versus 23-gauge vitrectomy in the management of macular diseases: a comparative analysis through a Health Technology Assessment model.

PubMed

Grosso, Andrea; Charrier, Lorena; Lovato, Emanuela; Panico, Claudio; Mariotti, Cesare; Dapavo, Giancarlo; Chiuminatto, Roberto; Siliquini, Roberta; Gianino, Maria Michela

2014-04-01

Small-gauge vitreoretinal techniques have been shown to be safe and effective in the management of a wide spectrum of vitreoretinal diseases. However, the costs of the new technologies may represent a critical issue for national health systems. The aim of the study is to plan a Health Technology Assessment (HTA) by performing a comparative analysis between the 23- and 25-gauge techniques in the management of macular diseases (epiretinal membranes, macular holes, vitreo-macular traction syndrome). In this prospective study, 45-80-year-old patients undergoing vitrectomy surgery for macular disease were enrolled at the Torino Eye Hospital. In the HTA model we assessed the safety, clinical effectiveness, and cost and financial evaluation of 23-gauge compared with 25-gauge vitrectomies. Fifty patients entered the study; 14 patients underwent 23-gauge vitrectomy and 36 underwent 25-gauge vitrectomy. There was no statistically significant difference in post-operative visual acuity at 1 year between the two groups. No cases of retinal detachment or endophtalmitis were registered at 1-year follow-up. The 23-gauge technique was slightly more expensive than the 25-gauge: the total surgical costs were EUR1217.70 versus EUR1164.84 (p = 0.351). We provide a financial comparison between new vitreoretinal procedures recently introduced in the market and reimbursed by the Italian National Health System and we also stimulate a critical debate about the expensive technocratic model of medicine.

Chirp echo Fourier transform EPR-detected NMR.

PubMed

Wili, Nino; Jeschke, Gunnar

2018-04-01

A new ultra-wide band (UWB) pulse EPR method is introduced for observing all nuclear frequencies of a paramagnetic center in a single shot. It is based on burning spectral holes with a high turning angle (HTA) pulse that excites forbidden transitions and subsequent detection of the hole pattern by a chirp echo. We term this method Chirp Echo Epr SpectroscopY (CHEESY)-detected NMR. The approach is a revival of FT EPR-detected NMR. It yields similar spectra and the same type of information as electron-electron double resonance (ELDOR)-detected NMR, but with a multiplex advantage. We apply CHEESY-detected NMR in Q band to nitroxides and correlate the hyperfine spectrum to the EPR spectrum by varying the frequency of the HTA pulse. Furthermore, a selective π pulse before the HTA pulse allows for detecting hyperfine sublevel correlations between transitions of one nucleus and for elucidating the coupling regime, the same information as revealed by the HYSCORE experiment. This is demonstrated on hexaaquamanganese(II). We expect that CHEESY-detected NMR is generally applicable to disordered systems and that our results further motivate the development of EPR spectrometers capable of coherent UWB excitation and detection, especially at higher fields and frequencies. Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.

A Test of Spielberger’s State-Trait Theory of Anger with Adolescents: Five Hypotheses

PubMed Central

Quinn, Colleen A.; Rollock, David; Vrana, Scott R.

2014-01-01

Spielberger’s state-trait theory of anger was investigated in adolescents (n = 201, ages 10–18, 53% African American, 47% European American, 48% female) using Deffenbacher’s five hypotheses formulated to test the theory in adults. Self-reported experience, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) responses to anger provoking imagery scripts found strong support for the application of this theory to adolescents. Compared to the low trait anger (LTA) group, adolescents with high trait anger (HTA) produced increased HR, SBP and DBP, and greater self-report of anger to anger imagery (intensity hypothesis) but not greater self-report or cardiovascular reactivity to fear or joy imagery (discrimination hypothesis). The HTA group also reported greater frequency and duration of anger episodes and had longer recovery of SBP response to anger (elicitation hypothesis). The HTA group was more likely to report negative health, social, and academic outcomes (consequence hypothesis). Adolescents with high hostility reported more maladaptive coping with anger, with higher anger-in and anger-out than adolescents with low hostility (negative expression hypothesis). The data on all five hypotheses supported the notion that trait anger is firmly entrenched by the period of adolescence, with few developmental differences noted from the adult literature. PMID:24040882

Lion king or Aslan: a tale from Narnia!

PubMed

Battista, Renaldo

2011-01-01

In the Chronicles of Narnia series by C.S. Lewis, Aslan the all-powerful but benevolent lion does not need to have his tail twisted; rather, he twists tails to create convergence and harmony in his dream world. In this issue's lead article, "Twisting the Lion's Tail: Collaborative Health Policy Making in British Columbia," the authors discuss the problems regarding better coordination of health services research, knowledge translation and policy making. The roles of academia, health authorities and government are presently unclear, with leadership differences, power discrepancies, conflicting agendas, lag times and systemic structural complexity. Exploring these issues in British Columbia, Lindstrom, MacLeod and Levy advocate a change in perspective from practice gaps to bridging knowledge boundaries. Recommendations include networking of academia, action research and strengthening of relationships between stakeholders. However, a key cohesive element seems missing. Health technology assessment (HTA) is a formidable, dynamic driving force. With over 20 years' experience in HTA, Canada has a number of world-class innovative agencies federally and provincially that actively involve academia to generate evidence for informed policy making. Increased use of evidence-based medicine in research and the clinic may be achieved by augmenting HTA's scientific capacity through the creation of pan-Canadian exchange forums and by boosting the demand for knowledge translation.

Vaccines are different: A systematic review of budget impact analyses of vaccines.

PubMed

Loze, Priscilla Magalhaes; Nasciben, Luciana Bertholim; Sartori, Ana Marli Christovam; Itria, Alexander; Novaes, Hillegonda Maria Dutilh; de Soárez, Patrícia Coelho

2017-05-15

Several countries require manufacturers to present a budget impact analysis (BIA), together with a cost-effectiveness analysis, to support national funding requests. However, guidelines for conducting BIA of vaccines are scarce. To analyze the methodological approaches used in published budget impact analysis (BIA) of vaccines, discussing specific methodological issues related to vaccines. This systematic review of the literature on BIA of vaccines was carried out in accordance with the Centre for Reviews and Dissemination - CRD guidelines. We searched multiple databases: MedLine, Embase, Biblioteca Virtual de Saúde (BVS), Cochrane Library, DARE Database, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination - CRD), and grey literature. Two researchers, working independently, selected the studies and extracted the data. The methodology quality of individual studies was assessed using the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. A qualitative narrative synthesis was conducted. Twenty-two studies were reviewed. The most frequently evaluated vaccines were pneumococcal (41%), influenza (23%) and rotavirus (18%). The target population was stated in 21 studies (95%) and the perspective was clear in 20 (91%). Only 36% reported the calculations used to complete the BIA, 27% informed the total and disaggregated costs for each time period, and 9% showed the change in resource use for each time period. More than half of the studies (55%, n=12) reported less than 50% of the items recommended in the checklist. The production of BIA of vaccines has increased from 2009. The report of the methodological steps was unsatisfactory, making it difficult to assess the validity of the results presented. Vaccines specific issues should be discussed in international guidelines for BIA of vaccines, to improve the quality of the studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

PubMed

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation). Copyright © 2017. Published by Elsevier GmbH.

Using systematic reviews to inform NIHR HTA trial planning and design: a retrospective cohort.

PubMed

Bhurke, Sheetal; Cook, Andrew; Tallant, Anna; Young, Amanda; Williams, Elaine; Raftery, James

2015-12-29

Chalmers and Glasziou's paper published in 2014 recommends research funding bodies should mandate that proposals for additional primary research are built on systematic reviews of existing evidence showing what is already known. Jones et al. identified 11 (23%) of 48 trials funded during 2006-8 by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme did not reference a systematic review. This study did not explore the reasons for trials not referencing a systematic review or consider trials using any other evidence in the absence of a systematic review. Referencing a systematic review may not be possible in certain circumstances, for instance if the systematic review does not address the question being proposed in the trial. The current study extended Jones' study by exploring the reasons for why trials did not reference a systematic review and included a more recent cohort of trials funded in 2013 to determine if there were any changes in the referencing or use of systematic reviews. Two cohorts of NIHR HTA randomised controlled trials were included. Cohort I included the same trials as Jones et al. (with the exception of one trial which was discontinued). Cohort II included NIHR HTA trials funded in 2013. Data extraction was undertaken independently by two reviewers using full applications and trial protocols. Descriptive statistics was used and no formal statistical analyses were conducted. Five (11%) trials of the 47 funded during 2006-2008 did not reference a systematic review. These 5 trials had warranted reasons for not referencing systematic reviews. All trials from Cohort II referenced a systematic review. A quarter of all those trials with a preceding systematic review used a different primary outcome than those stated in the reviews. The NIHR requires that proposals for new primary research are justified by existing evidence and the findings of this study confirm the adherence to this requirement with a high rate of applications using systematic reviews.

HTA decision support system for sustainable business continuity management in hospitals. The case of surgical activity at the University Hospital in Florence.

PubMed

Miniati, Roberto; Dori, Fabrizio; Cecconi, Giulio; Gusinu, Roberto; Niccolini, Fabrizio; Gentili, Guido Biffi

2013-01-01

A fundamental element of the social and safety function of a health structure is the need to guarantee continuity of clinical activity through the continuity of technology. This paper aims to design a Decision Support System (DSS) for medical technology evaluations based on the use of Key Performance Indicators (KPI) in order to provide a multi-disciplinary valuation of a technology in a health structure. The methodology used in planning the DSS followed the following key steps: the definition of relevant KPIs, the development of a database to calculate the KPIs, the calculation of the defined KPIs and the resulting study report. Finally, the clinical and economic validation of the system was conducted though a case study of Business Continuity applied in the operating department of the Florence University Hospital AOU Careggi in Italy. A web-based support system was designed for HTA in health structures. The case study enabled Business Continuity Management (BCM) to be implemented in a hospital department in relation to aspects of a single technology and the specific clinical process. Finally, an economic analysis of the procedure was carried out. The system is useful for decision makers in that it precisely defines which equipment to include in the BCM procedure, using a scale analysis of the specific clinical process in which the equipment is used. In addition, the economic analysis shows how the cost of the procedure is completely covered by the indirect costs which would result from the expenses incurred from a broken device, hence showing the complete auto-sustainability of the methodology.

Bibliometric trends of health economic evaluation in Sub-Saharan Africa.

PubMed

Hernandez-Villafuerte, Karla; Li, Ryan; Hofman, Karen J

2016-08-24

Collaboration between Sub-Saharan African researchers is important for the generation and transfer of health technology assessment (HTA) evidence, in order to support priority-setting in health. The objective of this analysis was to evaluate collaboration patterns between countries. We conducted a rapid evidence assessment that included a random sample of health economic evaluations carried out in 20 countries (Angola, Botswana, Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia, Zimbabwe, Ghana, Kenya, Nigeria, Ethiopia, Uganda). We conducted bibliometric network analysis based on all first authors with a Sub-Saharan African academic affiliation and their co-authored publications ("network-articles"). Then we produced a connection map of collaboration patterns among Sub-Saharan African researchers, reflecting the number of network-articles and the country of affiliation of the main co-authors. The sample of 119 economic evaluations mostly related to treatments of communicable diseases, in particular HIV/AIDS (42/119, 35.29 %) and malaria (26/119, 21.85 %). The 39 first authors from Sub-Saharan African institutions together co-authored 729 network-articles. The network analysis showed weak collaboration between health economic researchers in Sub-Saharan Africa, with researchers being more likely to collaborate with Europe and North America than with other African countries. South Africa stood out as producing the highest number of health economic evaluations and collaborations. The development and evaluation of HTA research networks in Sub-Saharan Africa should be supported, with South Africa central to any such efforts. Organizations and institutions from high income countries interested in supporting priority setting in Sub-Saharan Africa should include promoting collaboration as part of their agendas, in order to take advantage of the potential transferability of results and methods of the available health economic analyses in Africa and internationally.

Do health technology assessments comply with QUOROM diagram guidance? An empirical study.

PubMed

Hind, Daniel; Booth, Andrew

2007-11-20

The Quality of Reporting of Meta-analyses (QUOROM) statement provides guidance for improving the quality of reporting of systematic reviews and meta-analyses. To make the process of study selection transparent it recommends "a flow diagram providing information about the number of RCTs identified, included, and excluded and the reasons for excluding them". We undertook an empirical study to identify the extent of compliance in the UK Health Technology Assessment (HTA) programme. We searched Medline to retrieve all systematic reviews of therapeutic interventions in the HTA monograph series published from 2001 to 2005. Two researchers recorded whether each study contained a meta-analysis of controlled trials, whether a QUOROM flow diagram was presented and, if so, whether it expressed the relationship between the number of citations and the number of studies. We used Cohen's kappa to test inter-rater reliability. 87 systematic reviews were retrieved. There was good and excellent inter-rater reliability for, respectively, whether a review contained a meta-analysis and whether each diagram contained a citation-to-study relationship. 49% of systematic reviews used a study selection flow diagram. When only systematic reviews containing a meta-analysis were analysed, compliance was only 32%. Only 20 studies (23% of all systematic reviews; 43% of those having a study selection diagram) had a diagram which expressed the relationship between citations and studies. Compliance with the recommendations of the QUOROM statement is not universal in systematic reviews or meta-analyses. Flow diagrams make the conduct of study selection transparent only if the relationship between citations and studies is clearly expressed. Reviewers should understand what they are counting: citations, papers, studies and trials are fundamentally different concepts which should not be confused in a diagram.

Network meta-analyses performed by contracting companies and commissioned by industry.

PubMed

Schuit, Ewoud; Ioannidis, John Pa

2016-11-25

Industry commissions contracting companies to perform network meta-analysis for health technology assessment (HTA) and reimbursement submissions. Our objective was to estimate the number of network meta-analyses performed by consulting companies contracted by industry, to assess whether they were published, and to explore reasons for non-publication. We searched MEDLINE for network meta-analyses of randomized trials. Papers were included if they had authors affiliated with any contracting company. All identified contracting companies as well as additional ones from the list of the exhibitors at the International Society for Pharmacoeconomics and Outcomes Research, an annual meeting that representatives from many contracting companies attend and exhibit at, were surveyed regarding conduct and publication of network meta-analyses. In 162 of 822 (20%) network meta-analysis papers, authors were affiliated to 66 contracting companies. Another 36 contracting companies were identified by the exhibitors list. Three companies had no contact information and six merged with others, therefore 93 companies were contacted. Thirty seven out of ninety three (40%) companies responded, and 19 indicated that they had performed a total of 476 network meta-analyses, but only 102 (21%) papers were published. Thirteen companies that disclosed to have conducted 174 network meta-analyses (45 published) provided reasons for non-publication. Of the 129 still unpublished meta-analyses, for 40 there were plans for future publication, for 37 the sponsor did not allow publication, for 16 the contracting companies did not plan to publish the meta-analysis, for another 23 plans were unclear, and the remaining 13 were used as HTA submission. The protocol of the network meta-analysis was publically available from 11/162 (6.8%) network meta-analyses published by authors affiliated with contracting companies. There is a prolific sector of professional contracting companies that perform network meta-analyses. Industry commissions many network meta-analyses, but most are not registered before or published after analyses in the scientific literature. Mechanisms to improve publication rates of network meta-analysis commissioned by industry are warranted.

[Prevalence of chronic kidney disease in hypertensive persons attended in primary care from Spain determined by application of estimating equations].

PubMed

Gómez Navarro, Rafael

2009-01-01

To study the renal function (FR) of the hypertensive patients by means of estimating equations and serum creatinine (Crp). To calculate the percentage of patients with chronic kidney disease (ERC) that present normal values of Crp. To analyze which factors collaborate in the deterioration of the FR. Descriptive cross-sectional study of patients with HTA. Crp and arterial tension (TA) were determined. The glomerular filtration rate was calculated by means of Cockroft-Gault and MDRD's formula. The years of evolution of the HTA were registered. A descriptive study of the variables and the possible dependence among them was completed, using several times linear multiple regression. 52 patients were studied (57,7% women). Average age 72,4 +/- 10,8. 32,6% (Cockcroft-Gault) or 21,5% (MDRD) were fulfilling ERC criterion. The ERC was mainly diagnosed in females. 21,4% (Cockcroft-Gault) and 9,5 % patients (MDRD) with ERC had normal Crp values. We do not find linear dependence between the numbers of TA and the FR. The TA check-up objectives do not suppose less development of ERC. In males we find linear dependence within the FR (MDRD) and the years of evolution of the HTA. The ERC is a frequent pathology in the hypertense persons. The systematical utilization of estimating equations facilitates the detection of hidden ERC in patients with normal Crp.

IMPORTANCE OF CONTEXTUAL DATA IN PRODUCING HEALTH TECHNOLOGY ASSESSMENT RECOMMENDATIONS: A CASE STUDY.

PubMed

Poder, Thomas G; Bellemare, Christian A

2018-01-01

Contextual data and local expertise are important sources of data that cannot be ignored in hospital-based health technology assessment (HTA) processes. Despite a lack of or unconvincing evidence in the scientific literature, technology can be recommended in a given context. We illustrate this using a case study regarding biplane angiography for vascular neurointervention. A systematic literature review was conducted, along with an analysis of the context in our setting. The outcomes of interest were radiation doses, clinical complications, procedure times, purchase cost, impact on teaching program, the confidence of clinicians in the technology, quality of care, accessibility, and the volume of activity. A committee comprising managers, clinical experts, physicians, physicists and HTA experts was created to produce a recommendation regarding biplane technology acquisition to replace a monoplane device. The systematic literature review yielded nine eligible articles for analysis. Despite a very low level of evidence in the literature, the biplane system appears to reduce ionizing radiation and medical complications, as well as shorten procedure time. Contextual data indicated that the biplane system could improve operator confidence, which could translate into reduced risk, particularly for complex procedures. In addition, the biplane system can support our institution in its advanced procedures teaching program. Given the advantages provided by the biplane technology in our setting, the committee has recommended its acquisition. Contextual data were of utmost importance in this recommendation. Moreover, this technology should be implemented alongside a responsibility to collect outcome data to optimize clinical protocol in the doses of ionizing delivered.

TESTING MULTI-CRITERIA DECISION ANALYSIS FOR MORE TRANSPARENT RESOURCE-ALLOCATION DECISION MAKING IN COLOMBIA.

PubMed

Castro Jaramillo, Hector Eduardo; Goetghebeur, Mireille; Moreno-Mattar, Ornella

2016-01-01

In 2012, Colombia experienced an important institutional transformation after the establishment of the Health Technology Assessment Institute (IETS), the disbandment of the Regulatory Commission for Health and the reassignment of reimbursement decision-making powers to the Ministry of Health and Social Protection (MoHSP). These dynamic changes provided the opportunity to test Multi-Criteria Decision Analysis (MCDA) for systematic and more transparent resource-allocation decision-making. During 2012 and 2013, the MCDA framework Evidence and Value: Impact on Decision Making (EVIDEM) was tested in Colombia. This consisted of a preparatory stage in which the investigators conducted literature searches and produced HTA reports for four interventions of interest, followed by a panel session with decision makers. This method was contrasted with a current approach used in Colombia for updating the publicly financed benefits package (POS), where narrative health technology assessment (HTA) reports are presented alongside comprehensive budget impact analyses (BIAs). Disease severity, size of population, and efficacy ranked at the top among fifteen preselected relevant criteria. MCDA estimates of technologies of interest ranged between 71 to 90 percent of maximum value. The ranking of technologies was sensitive to the methods used. Participants considered that a two-step approach including an MCDA template, complemented by a detailed BIA would be the best approach to assist decision-making in this context. Participants agreed that systematic priority setting should take place in Colombia. This work may serve as the basis to the MoHSP on its interest of setting up a systematic and more transparent process for resource-allocation decision-making.

Characterization of organic/organic' and organic/inorganic heterojunctions and their light-absorbing and light-emitting properties

NASA Astrophysics Data System (ADS)

Anderson, Michele Lynn

Increasing the efficiency and durability of organic light-emitting diodes (OLEDs) has attracted attention recently due to their prospective wide-spread use as flat-panel displays. The performance and efficiency of OLEDs is understood to be critically dependent on the quality of the device heterojunctions, and on matching the ionization potentials (IP) and the electron affinities (EA) of the luminescent material (LM) with those of the hole (HTA) and electron (ETA) transport agents, respectively. The color and bandwidth of OLED emission color is thought to reflect the packing of the molecules in the luminescent layer. Finally, materials stability under OLED operating conditions is a significant concern. LM, HTA, and ETA thin films were grown in ultra-high vacuum using the molecular beam epitaxy technique. Thin film structure was determined in situ using reflection high energy electron diffraction (RHEED) and ex situ using UV-Vis spectroscopy. LM, HTA, and ETA occupied frontier orbitals (IP) were characterized by ultraviolet photoelectron spectroscopy (UPS), and their unoccupied frontier orbitals (EA) estimated from UV-Vis and fluorescence spectroscopies in combination with the UPS results. The stability of the molecules toward vacuum deposition was verified by compositional analysis of thin film X-ray photoelectron spectra. The stability of these materials toward redox processes was evaluated by cyclic voltammetry in nonaqueous media. Electrochemical data provide a more accurate estimation of the EA since the energetics for addition of an electron to a neutral molecule can be probed directly. The energetic barriers to charge injection into each layer of the device has been correlated to OLED turn-on voltage, indicating that these measurements may be used to screen potential combinations of materials for OLEDs. The chemical reversibility of LM voltammetry appears to limit the performance and lifetimes of solid-state OLEDs due to degradation of the organic layers. The role of oxygen as an electron trap in OLEDs has also been verified electrochemically. Finally, a more accurate determination of the offset of the occupied energy levels at the interface between two organic layers has been achieved via in situ monitoring of the UPS spectrum during heterojunction formation.

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

PubMed

Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R; Salek, Sam

2017-01-01

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.

Photoacoustic image reconstruction: a quantitative analysis

NASA Astrophysics Data System (ADS)

Sperl, Jonathan I.; Zell, Karin; Menzenbach, Peter; Haisch, Christoph; Ketzer, Stephan; Marquart, Markus; Koenig, Hartmut; Vogel, Mika W.

2007-07-01

Photoacoustic imaging is a promising new way to generate unprecedented contrast in ultrasound diagnostic imaging. It differs from other medical imaging approaches, in that it provides spatially resolved information about optical absorption of targeted tissue structures. Because the data acquisition process deviates from standard clinical ultrasound, choice of the proper image reconstruction method is crucial for successful application of the technique. In the literature, multiple approaches have been advocated, and the purpose of this paper is to compare four reconstruction techniques. Thereby, we focused on resolution limits, stability, reconstruction speed, and SNR. We generated experimental and simulated data and reconstructed images of the pressure distribution using four different methods: delay-and-sum (DnS), circular backprojection (CBP), generalized 2D Hough transform (HTA), and Fourier transform (FTA). All methods were able to depict the point sources properly. DnS and CBP produce blurred images containing typical superposition artifacts. The HTA provides excellent SNR and allows a good point source separation. The FTA is the fastest and shows the best FWHM. In our study, we found the FTA to show the best overall performance. It allows a very fast and theoretically exact reconstruction. Only a hardware-implemented DnS might be faster and enable real-time imaging. A commercial system may also perform several methods to fully utilize the new contrast mechanism and guarantee optimal resolution and fidelity.

Institutionalising health technology assessment: establishing the Medical Technology Assessment Board in India.

PubMed

Downey, Laura E; Mehndiratta, Abha; Grover, Ashoo; Gauba, Vijay; Sheikh, Kabir; Prinja, Shankar; Singh, Ravinder; Cluzeau, Francoise A; Dabak, Saudamini; Teerawattananon, Yot; Kumar, Sanjiv; Swaminathan, Soumya

2017-01-01

India is at crossroads with a commitment by the government to universal health coverage (UHC), driving efficiency and tackling waste across the public healthcare sector. Health technology assessment (HTA) is an important policy reform that can assist policy-makers to tackle inequities and inefficiencies by improving the way in which health resources are allocated towards cost-effective, appropriate and feasible interventions. The equitable and efficient distribution of health budget resources, as well as timely uptake of good value technologies, are critical to strengthen the Indian healthcare system. The government of India is set to establish a Medical Technology Assessment Board to evaluate existing and new health technologies in India, assist choices between comparable technologies for adoption by the healthcare system and improve the way in which priorities for health are set. This initiative aims to introduce a more transparent, inclusive, fair and evidence-based process by which decisions regarding the allocation of health resources are made in India towards the ultimate goal of UHC. In this analysis article, we report on plans and progress of the government of India for the institutionalisation of HTA in the country. Where India is home to one-sixth of the global population, improving the health services that the population receives will have a resounding impact not only for India but also for global health.

Institutionalising health technology assessment: establishing the Medical Technology Assessment Board in India

PubMed Central

Downey, Laura E; Mehndiratta, Abha; Grover, Ashoo; Gauba, Vijay; Sheikh, Kabir; Prinja, Shankar; Singh, Ravinder; Cluzeau, Francoise A; Dabak, Saudamini; Teerawattananon, Yot; Kumar, Sanjiv; Swaminathan, Soumya

2017-01-01

India is at crossroads with a commitment by the government to universal health coverage (UHC), driving efficiency and tackling waste across the public healthcare sector. Health technology assessment (HTA) is an important policy reform that can assist policy-makers to tackle inequities and inefficiencies by improving the way in which health resources are allocated towards cost-effective, appropriate and feasible interventions. The equitable and efficient distribution of health budget resources, as well as timely uptake of good value technologies, are critical to strengthen the Indian healthcare system. The government of India is set to establish a Medical Technology Assessment Board to evaluate existing and new health technologies in India, assist choices between comparable technologies for adoption by the healthcare system and improve the way in which priorities for health are set. This initiative aims to introduce a more transparent, inclusive, fair and evidence-based process by which decisions regarding the allocation of health resources are made in India towards the ultimate goal of UHC. In this analysis article, we report on plans and progress of the government of India for the institutionalisation of HTA in the country. Where India is home to one-sixth of the global population, improving the health services that the population receives will have a resounding impact not only for India but also for global health. PMID:29225927

The Role of Noncomparative Evidence in Health Technology Assessment Decisions.

PubMed

Griffiths, Elizabeth A; Macaulay, Richard; Vadlamudi, Nirma K; Uddin, Jasim; Samuels, Ebony R

2017-12-01

Many health technology assessment (HTA) agencies express a preference for randomized controlled trial evidence when appraising health technologies; nevertheless, it is not always feasible or ethical to conduct such comparative trials. To assess the role of noncomparative evidence in HTA decision making. The Web sites of the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) in Germany were searched for single HTA reports (published between January 2010 and December 2015). The product, indication, outcome, and clinical evidence presented (comparative/noncomparative) were double-extracted, with any discrepancies reconciled. A noncomparative study was defined as any study not presenting results against another treatment (including placebo or best supportive care), regardless of phase or setting, including dose-ranging studies. A total of 549 appraisals were extracted. Noncomparative evidence was considered in 38% (45 of 118) of NICE submissions, 13% (34 of 262) of CADTH submissions, and 12% (20 of 169) of IQWiG submissions. Evidence submissions based exclusively on noncomparative evidence were presented in only 4% (5 of 118) of NICE appraisals, 6% (16 of 262) of CADTH appraisals, and 4% (6 of 169) of IQWiG appraisals. Most drugs appraised solely on the basis of noncomparative evidence were indicated for cancer or hepatitis C. Positive outcome rates (encompassing recommended/restricted/added-benefit decisions) for submissions presenting only noncomparative evidence were similar to overall recommendation rates for CADTH (69% vs. 68%, respectively), but were numerically lower for NICE (60% vs. 84%, respectively) and IQWiG (17% vs. 38%, respectively) (P > 0.05 for all). Noncomparative studies can be viewed as acceptable clinical evidence by HTA agencies when these study designs are justifiable and when treatment effect can be convincingly demonstrated, but their use is currently limited. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review

PubMed Central

Kawalec, Paweł; Tesar, Tomas; Vostalova, Lenka; Draganic, Pero; Manova, Manoela; Savova, Alexandra; Petrova, Guenka; Rugaja, Zinta; Männik, Agnes; Sowada, Christoph; Stawowczyk, Ewa; Harsanyi, Andras; Inotai, Andras; Turcu-Stiolica, Adina; Gulbinovič, Jolanta; Pilc, Andrzej

2017-01-01

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries. Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017. Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application. Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries. PMID:29326583

HEALTH TECHNOLOGY ASSESSMENT OF PUBLIC HEALTH INTERVENTIONS: A SYNTHESIS OF METHODOLOGICAL GUIDANCE.

PubMed

Mathes, Tim; Antoine, Sunya-Lee; Prengel, Peggy; Bühn, Stefanie; Polus, Stephanie; Pieper, Dawid

2017-01-01

The evaluation of public health interventions poses some challenges. As a consequence, health technology assessment (HTA) methods for public health interventions (PHI) have to be adapted. This study aimed to summarize the available guidance on methods for HTA of PHI. We systematically searched for methodological guidance on HTA of PHIs. Our focus was on research synthesis methods to evaluate effectiveness. Relevant information was synthesized narratively in a standardized way. Only four guidance documents were identified specifically for HTAs of PHI. The approaches used for HTAs of PHIs are broader and more flexible than those for medical interventions. For this reason, there is a tendency to identify the intervention components and context factors that influence the effectiveness and transferability of an intervention rather than to assess its effectiveness in general. The details in the guidance vary without justification. Unjustified heterogeneity between the different guidance approaches is most pronounced for quality assessment, assessment of applicability, and methods to integrate qualitative and quantitative evidence. Descriptions for the assessment of integrity, heterogeneity, sustainability, context factors, and applicability are often vague. The heterogeneity in approaches indicates that there is currently no consensus on methods to deal with the challenges of the PHI evaluations. A possible explanation for this may be that the methods are not sufficiently developed, and advantages and disadvantages of a certain method in relation to the research question (e.g., broad/focused) have not yet been sufficiently evaluated.

Health technology assessment, value-based decision making, and innovation.

PubMed

Henshall, Chris; Schuller, Tara

2013-10-01

Identifying treatments that offer value and value for money is becoming increasingly important, with interest in how health technology assessment (HTA) and decision makers can take appropriate account of what is of value to patients and to society, and in the relationship between innovation and assessments of value. This study summarizes points from an Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations, discussions among attendees, and background papers. Various perspectives on value were considered; most place patient health at the core of value. Wider elements of value comprise other benefits for: patients; caregivers; the health and social care systems; and society. Most decision-making systems seek to take account of similar elements of value, although they are assessed and combined in different ways. Judgment in decisions remains important and cannot be replaced by mathematical approaches. There was discussion of the value of innovation and of the effects of value assessments on innovation. Discussion also included moving toward "progressive health system decision making," an ongoing process whereby evidence-based decisions on use would be made at various stages in the technology lifecycle. Five actions are identified: (i) development of a general framework for the definition and assessment of value; development by HTA/coverage bodies and regulators of (ii) disease-specific guidance and (iii) further joint scientific advice for industry on demonstrating value; (iv) development of a framework for progressive licensing, usage, and reimbursement; and (v) promoting work to better adapt HTA, coverage, and procurement approaches to medical devices.

Characterization of human glucocorticoid receptor complexes formed with DNA fragments containing or lacking glucocorticoid response elements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tully, D.B.; Cidlowski, J.A.

1989-03-07

Sucrose density gradient shift assays were used to study the interactions of human glucocorticoid receptors (GR) with small DNA fragments either containing or lacking glucocorticoid response element (GRE) DNA consensus sequences. When crude cytoplasmic extracts containing ({sup 3}H)triamcinolone acetonide (({sup 3}H)TA) labeled GR were incubated with unlabeled DNA under conditions of DNA excess, a GRE-containing DNA fragment obtained from the 5' long terminal repeat of mouse mammary tumor virus (MMTV LTR) formed a stable 12-16S complex with activated, but not nonactivated, ({sup 3}H)TA receptor. By contrast, if the cytosols were treated with calf thymus DNA-cellulose to deplete non-GR-DNA-binding proteins priormore » to heat activation, a smaller 7-10S complex was formed with the MMTV LTR DNA fragment. Activated ({sup 3}H)TA receptor from DNA-cellulose pretreated cytosols also interacted with two similarly sized fragments from pBR322 DNA. Stability of the complexes formed between GR and these three DNA fragments was strongly affected by even moderate alterations in either the salt concentration or the pH of the gradient buffer. Under all conditions tested, the complex formed with the MMTV LTR DNA fragment was more stable than the complexes formed with either of the pBR322 DNA fragments. Together these observations indicate that the formation of stable complexes between activated GR and isolated DNA fragments requires the presence of GRE consensus sequences in the DNA.« less

TECHNOLOGY ASSESSMENT IN HOSPITALS: LESSONS LEARNED FROM AN EMPIRICAL EXPERIMENT.

PubMed

Foglia, Emanuela; Lettieri, Emanuele; Ferrario, Lucrezia; Porazzi, Emanuele; Garagiola, Elisabetta; Pagani, Roberta; Bonfanti, Marzia; Lazzarotti, Valentina; Manzini, Raffaella; Masella, Cristina; Croce, Davide

2017-01-01

Hospital Based Health Technology Assessment (HBHTA) practices, to inform decision making at the hospital level, emerged as urgent priority for policy makers, hospital managers, and professionals. The present study crystallized the results achieved by the testing of an original framework for HBHTA, developed within Lombardy Region: the IMPlementation of A Quick hospital-based HTA (IMPAQHTA). The study tested: (i) the HBHTA framework efficiency, (ii) feasibility, (iii) the tool utility and completeness, considering dimensions and sub-dimensions. The IMPAQHTA framework deployed the Regional HTA program, activated in 2008 in Lombardy, at the hospital level. The relevance and feasibility of the framework were tested over a 3-year period through a large-scale empirical experiment, involving seventy-four healthcare professionals organized in different HBHTA teams for assessing thirty-two different technologies within twenty-two different hospitals. Semi-structured interviews and self-reported questionnaires were used to collect data regarding the relevance and feasibility of the IMPAQHTA framework. The proposed HBHTA framework proved to be suitable for application at the hospital level, in the Italian context, permitting a quick assessment (11 working days) and providing hospital decision makers with relevant and quantitative information. Performances in terms of feasibility, utility, completeness, and easiness proved to be satisfactory. The IMPAQHTA was considered to be a complete and feasible HBHTA framework, as well as being replicable to different technologies within any hospital settings, thus demonstrating the capability of a hospital to develop a complete HTA, if supported by adequate and well defined tools and quantitative metrics.

Clinical and cost implications of amyloid beta detection with amyloid beta positron emission tomography imaging in early Alzheimer's disease - the case of florbetapir.

PubMed

Hornberger, John; Bae, Jay; Watson, Ian; Johnston, Joe; Happich, Michael

2017-04-01

Amyloid beta (Aβ) positron emission tomography (PET) imaging helps estimate Aβ neuritic plaque density in patients with cognitive impairment who are under evaluation for Alzheimer's disease (AD). This study aims to evaluate the cost-effectiveness of the Aβ-PET scan as an adjunct to standard diagnostic assessment for diagnosis of AD in France, using florbetapir as an example. A state-transition probability analysis was developed adopting the French Health Technology Assessment (HTA) perspective per guidance. Parameters included test characteristics, rate of cognitive decline, treatment effect, costs, and quality of life. Additional scenarios assessed the validity of the analytical framework, including: (1) earlier evaluation/treatment; (2) cerebrospinal fluid (CSF) as a comparator; and (3) use of other diagnostic procedures. Outputs included differences in quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). All benefits and costs were discounted for time preferences. Sensitivity analyses were performed to assess the robustness of findings and key influencers of outcomes. Aβ-PET used as an adjunct to standard diagnostic assessment increased QALYs by 0.021 years and 10 year costs by €470 per patient. The ICER was €21,888 per QALY gained compared to standard diagnostic assessment alone. When compared with CSF, Aβ-PET costs €24,084 per QALY gained. In other scenarios, Aβ-PET was consistently cost-effective relative to the commonly used affordability threshold (€40,000 per QALY). Over 95% of simulations in the sensitivity analysis were cost-effective. Aβ-PET is projected to affordably increase QALYs from the French HTA perspective per guidance over a range of clinical scenarios, comparators, and input parameters.

Valuing inter-sectoral costs and benefits of interventions in the healthcare sector: methods for obtaining unit prices.

PubMed

Drost, Ruben M W A; Paulus, Aggie T G; Ruwaard, Dirk; Evers, Silvia M A A

2017-02-01

There is a lack of knowledge about methods for valuing health intervention-related costs and monetary benefits in the education and criminal justice sectors, also known as 'inter-sectoral costs and benefits' (ICBs). The objective of this study was to develop methods for obtaining unit prices for the valuation of ICBs. By conducting an exploratory literature study and expert interviews, several generic methods were developed. The methods' feasibility was assessed through application in the Netherlands. Results were validated in an expert meeting, which was attended by policy makers, public health experts, health economists and HTA-experts, and discussed at several international conferences and symposia. The study resulted in four methods, including the opportunity cost method (A) and valuation using available unit prices (B), self-constructed unit prices (C) or hourly labor costs (D). The methods developed can be used internationally and are valuable for the broad international field of HTA.

Measurement of health outcomes.

PubMed

Thavorncharoensap, Montarat

2014-05-01

Health outcomes are one of the most important components of health technology assessments (HTAs). All HTA outcomes should be measured from a relevant sample using a properly designed study and method. A number of recommendations on health outcome measurements are made in this second edition of Thailand's HTA guidelines. In particular the use of final outcomes, rather than surrogate outcomes, in HTAs is stressed. Where surrogate outcomes are used, strong justification and evidence must be provided. Effectiveness is preferred over efficacy. The relative treatment effect (the difference between health outcome that would be experienced by patients receiving the technology and that experienced by the same group were they to receive an alternative technology) should be derived from a systematic review of head-to-head RCTs. Mixed treatment comparison (MTC) should be used only to provide supplementary data that cannot be obtained from a head-to-head comparison. Where no direct comparison evidence exists, indirect comparison and observational study data can be used.

Organizational Impact of the Introduction of a New Portable Syringe Pump for Iloprost Therapy in Italian Hospital Settings

PubMed Central

Restelli, Umberto; Faggioli, Paola; Scolari, Francesca; Gussoni, Gualberto; Valerio, Antonella; Sciascera, Alba; Croce, Davide; Mazzone, Antonino

2015-01-01

Purpose: The study aims at assessing the organizational and economic impact related to the use of a new portable syringe pump (Pompa Infonde®, Italfarmaco S.p.A., Cinisello Balsamo, Italy) at a hospital level. Methodology: Based on the HTA approach, the analysis assessed the organizational and economic impact of the new device at hospital level, using the traditional methods of Iloprost infusion as comparator. After a pilot evaluation, the organizational impact was assessed within 24 Italian hospitals. Structured interviews were conducted with clinicians and nurses. According to the Hospital-Based HTA approach, a questionnaire assessed the impact on human resources, training activities, internal meetings, spaces needed, facilities, clinical practice implications. Using Activity Based Costing approach, the economic evaluation was performed within the pilot center “Ospedale Civile” of Legnano, Italy. Findings: The new device leads to a positive managerial impact, with a substantial reduction of time to monitor patients by nurses. This resulted in a better management of human resources and in a reduction in nursing cost. Although a mild negative impact on training time for personnel, the structured interviews allowed the identification of three main areas of positive impact: (i) efficiency of internal processes, (ii) clinical pathways, (iii) synergies between wards. Originality: The organizational impact of Pompa Infonde®, showed that it is an efficient alternative to traditional methods, with benefits in the management of patients administered with Iloprost.

Multi-criteria development and incorporation into decision tools for health technology adoption.

PubMed

Poulin, Paule; Austen, Lea; Scott, Catherine M; Waddell, Cameron D; Dixon, Elijah; Poulin, Michelle; Lafrenière, René

2013-01-01

When introducing new health technologies, decision makers must integrate research evidence with local operational management information to guide decisions about whether and under what conditions the technology will be used. Multi-criteria decision analysis can support the adoption or prioritization of health interventions by using criteria to explicitly articulate the health organization's needs, limitations, and values in addition to evaluating evidence for safety and effectiveness. This paper seeks to describe the development of a framework to create agreed-upon criteria and decision tools to enhance a pre-existing local health technology assessment (HTA) decision support program. The authors compiled a list of published criteria from the literature, consulted with experts to refine the criteria list, and used a modified Delphi process with a group of key stakeholders to review, modify, and validate each criterion. In a workshop setting, the criteria were used to create decision tools. A set of user-validated criteria for new health technology evaluation and adoption was developed and integrated into the local HTA decision support program. Technology evaluation and decision guideline tools were created using these criteria to ensure that the decision process is systematic, consistent, and transparent. This framework can be used by others to develop decision-making criteria and tools to enhance similar technology adoption programs. The development of clear, user-validated criteria for evaluating new technologies adds a critical element to improve decision-making on technology adoption, and the decision tools ensure consistency, transparency, and real-world relevance.

Hidden Treasures and Secret Pitfalls: Application of the Capability Approach to ParkinsonNet.

PubMed

Canoy, Marcel; Faber, Marjan J; Munneke, Marten; Oortwijn, Wija; Nijkrake, Maarten J; Bloem, Bastiaan R

2015-01-01

In the Netherlands, the largest health technology assessment (HTA) program funds mainly (cost-)effectiveness studies and implementation research. The cost-effectiveness studies are usually controlled clinical trials which simultaneously collect cost data. The success of a clinical trial typically depends on the effect size for the primary outcome, such as health gains or mortality rates. A drawback is that in case of a negative primary outcome, relevant other (and perhaps more implicit) benefits might be missed. Conversely, positive trials can contain adverse outcomes that may also remain hidden. The capability approach (developed by Nobel Prize winner and philosopher Sen) is an instrument that may reveal such "hidden treasures and secret pitfalls" that lie embedded within clinical trials, beyond the more traditional outcomes. Here, we exemplify the possible merits of the capability approach using a large clinical trial (funded by the HTA program in the Netherlands) that aimed to evaluate the ParkinsonNet concept, an innovative network approach for Parkinson patients. This trial showed no effects for the primary outcome, but the ParkinsonNet concept tested in this study was nevertheless met with great enthusiasm and was rapidly implemented throughout an entire country, and meanwhile also internationally. We applied the capability approach to the ParkinsonNet concept, and this analysis yielded additional benefits within several capability domains. These findings seems to substantiate the claim that richer policy debates may ensue by applying the capability approach to clinical trial data, in addition to traditional outcomes.

ASSESSMENT OF MAST IN EUROPEAN PATIENT-CENTERED TELEMEDICINE PILOTS.

PubMed

Ekeland, Anne Granstrøm; Grøttland, Astrid

2015-01-01

Model for ASsessment of Telemedicine Applications (MAST) is a health technology assessment (HTA) inspired framework for assessing the effectiveness and contribution to quality of telemedicine applications based on rigorous, scientific data. This study reports from a study of how it was used and perceived in twenty-one pilots of the European project RENEWING HEALTH (RH). The objectives of RH were to implement large-scale, real-life test beds for the validation and subsequent evaluation of innovative patient-centered telemedicine services. The study is a contribution to the appraisal of HTA methods. A questionnaire was administered for project leaders of the pilots. It included questions about use and usefulness of MAST for (i) preceding considerations, (ii) evaluation of outcomes within seven domains, and (iii) considerations of transferability. Free text spaces allowed for proposals of improvement. The responses covered all pilots. A quantitative summary of use and a qualitative analysis of usefulness were performed. MAST was used and considered useful for pilot evaluations. Challenges included problems to scientifically determine alternative service options and outcome within the seven domains. Proposals for improvement included process studies and adding domains of technological usability, responsible innovation, health literacy, behavior change, caregiver perspectives and motivational issues of professionals. MAST was used according to its structure. Its usefulness in patient centered pilots can be improved by adding new stakeholder groups. Interdependencies between scientific rigor, resources and timeliness should be addressed. Operational options for improvements include process studies, literature reviews and sequential mini-HTAs for identification of areas for more elaborate investigations.

The positioning of economic principles under the changing conditions of the novel drug developmental process in cancer.

PubMed

Wilking, Nils; Wilking, Ulla; Jönsson, Bengt

2014-06-01

Cancer is a major burden to the health care system, presently mainly in developed countries, but is rapidly becoming a problem of similar magnitude in developing countries. Cancer ranks number two or three measured in loss of "good years of life" in Europe. The direct cost of cancer are estimated to be around 50% of total health care costs and of these costs a major part is linked to cancer drugs. With the ongoing revolution in the understanding of cancer and the development of an increasing number of new, but often very costly drugs, the health care systems in all parts of the world need to have a systematic way of evaluating new cancer drugs. Health technology assessment (HTA) now plays a major role in many parts of Europe. HTA has its focus on determining the value of new innovations in order to balance allocation of health care resources in a fair and equal way. This paper reviews the HTA process in general and for cancer drugs specifically. The key findings are that cancer drugs must be evaluated in a similar way as other health care technologies. One must however take into account that cancer drugs are often approved with a high level of uncertainty. Thus, it is of key importance that not only clinical efficacy, i.e., effect in pivotal clinical trials, is taken into account, but that there is a great need for follow-up studies so that post regulatory approval is able to properly measure population based effects [clinical effectiveness (CLE)].

[Cardiovascular recovery during intermittent exercise in highly-adherent partic pants with hypertension and type 2 diabetes mellitus].

PubMed

Cano-Montoya, Johnattan; Álvarez, Cristian; Martínez, Cristian; Salas, Andrés; Sade, Farid; Ramírez-Campillo, Rodrigo

2016-09-01

Despite the evidence supporting metabolic benefits of high intensity interval exercise (HIIT), there is little information about the cardiovascular response to this type of exercise in patients with type 2 diabetes (T2D) and hypertension (HTA). To analyze the changes in heart rate at rest, at the onset and at the end of each interval of training, after twelve weeks of a HIIT program in T2D and HTA patients. Twenty-three participants with T2D and HTA (20 women) participated in a controlled HIIT program. Fourteen participants attended 90% of more session of exercise and were considered as adherent. Adherent and non-adherent participants had similar body mass index (BMI), and blood pressure. A “1x2x10” (work: rest-time: intervals) HIIT exercise protocol was used both as a test and as training method during twelve weeks. The initial and finishing heart rate (HR) of each of the ten intervals before and after the intervention were measured. After twelve weeks of HIIT intervention, adherent participants had a significant reduction in the heart rate at the onset of exercise, and during intervals 4, 5, 8 and 10. A reduction in the final heart rate was observed during intervals 8 and 10. In the same participants the greatest magnitude of reduction, at the onset or end of exercise was approximately 10 beats/min. No significant changes in BMI, resting heart rate and blood pressure were observed. A HIIT program reduces the cardiovascular effort to a given work-load and improves cardiovascular recovery after exercise.

Multiple roles for Saccharomyces cerevisiae histone H2A in telomere position effect, Spt phenotypes and double-strand-break repair.

PubMed Central

Wyatt, Holly R; Liaw, Hungjiun; Green, George R; Lustig, Arthur J

2003-01-01

Telomere position effects on transcription (TPE, or telomeric silencing) are nucleated by association of nonhistone silencing factors with the telomere and propagated in subtelomeric regions through association of silencing factors with the specifically modified histones H3 and H4. However, the function of histone H2A in TPE is unknown. We found that deletion of either the amino or the carboxyltails of H2A substantially reduces TPE. We identified four H2A modification sites necessary for wild-type efficiency of TPE. These "hta1tpe" alleles also act as suppressors of a delta insertion allele of LYS2, suggesting shared elements of chromatin structure at both loci. Interestingly, we observed combinatorial effects of allele pairs, suggesting both interdependent acetylation and deacetylation events in the amino-terminal tail and a regulatory circuit between multiple phosphorylated residues in the carboxyl-terminal tail. Decreases in silencing and viability are observed in most hta1tpe alleles after treatment with low and high concentrations, respectively, of bleomycin, which forms double-strand breaks (DSBs). In the absence of the DSB and telomere-binding protein yKu70, the bleomycin sensitivity of hta1tpe alleles is further enhanced. We also provide data suggesting the presence of a yKu-dependent histone H2A function in TPE. These data indicate that the amino- and carboxyl-terminal tails of H2A are essential for wild-type levels of yKu-mediated TPE and DSB repair. PMID:12750320

Cost-effectiveness of trastuzumab in metastatic breast cancer: mainly a matter of price in the EU?

PubMed

Garattini, Livio; van de Vooren, Katelijne; Curto, Alessandro

2015-02-01

Trastuzumab (TR), a monoclonal antibody approved by EMA in 2000 and one of the first examples of "targeted therapy", is indicated to treat human epidermal growth factor receptor 2 (HER2) positive breast cancer. TR, whose patent will expire in 2015 in Europe, has been judged positively for reimbursement by most public authorities in the EU. Here we critically review the existing evidence on TR in metastatic breast cancer (MBC), in line with the multidisciplinary health technology assessment (HTA) approach, to assess whether the existing evidence supports TR positive reimbursement decisions taken in MBC by EU health authorities. We did a literature search for the main HTA topics (efficacy, quality of life and ethics) on the PubMed international database (2000-2013). Then, we did a specific literature search to select the full economic evaluations (FEEs) conducted in EU countries focused on TR as first-line innovative therapy in MBC. We retrieved scant evidence in the literature to support TR reimbursement in MBC. We found only two clinical trials and their results were unclear because of the large proportion of patients who crossed over. Moreover, the quality of methods was poor in all four European FEEs selected. This example of HTA exercise on a mature monoclonal antibody in a specific indication casts doubts on how often the reimbursement decisions taken by EU health authorities in emotional pathologies like cancer are rational. These decisions should at least be reconsidered periodically on the basis of the latest evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

HOSPITAL MANAGERS' NEED FOR INFORMATION ON HEALTH TECHNOLOGY INVESTMENTS.

PubMed

Ølholm, Anne Mette; Kidholm, Kristian; Birk-Olsen, Mette; Christensen, Janne Buck

2015-01-01

There is growing interest in implementing hospital-based health technology assessment (HB-HTA) as a tool to facilitate decision making based on a systematic and multidisciplinary assessment of evidence. However, the decision-making process, including the informational needs of hospital decision makers, is not well described. The objective was to review empirical studies analysing the information that hospital decision makers need when deciding about health technology (HT) investments. A systematic review of empirical studies published in English or Danish from 2000 to 2012 was carried out. The literature was assessed by two reviewers working independently. The identified informational needs were assessed with regard to their agreement with the nine domains of EUnetHTA's Core Model. A total of 2,689 articles were identified and assessed. The review process resulted in 14 relevant studies containing 74 types of information that hospital decision makers found relevant. In addition to information covered by the Core Model, other types of information dealing with political and strategic aspects were identified. The most frequently mentioned types of information in the literature related to clinical, economic and political/strategic aspects. Legal, social, and ethical aspects were seldom considered most important. Hospital decision makers are able to describe their information needs when deciding on HT investments. The different types of information were not of equal importance to hospital decision makers, however, and full agreement between EUnetHTA's Core Model and the hospital decision-makers' informational needs was not observed. They also need information on political and strategic aspects not covered by the Core Model.

Similarities and differences between stakeholders' opinions on using Health Technology Assessment (HTA) information across five European countries: results from the EQUIPT survey.

PubMed

Vokó, Zoltan; Cheung, Kei Long; Józwiak-Hagymásy, Judit; Wolfenstetter, Silke; Jones, Teresa; Muñoz, Celia; Evers, Silvia M A A; Hiligsmann, Mickaël; de Vries, Hein; Pokhrel, Subhash

2016-05-26

The European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) project aimed to study transferability of economic evidence by co-creating the Tobacco Return On Investment (ROI) tool, previously developed in the United Kingdom, for four sample countries (Germany, Hungary, Spain and the Netherlands). The EQUIPT tool provides policymakers and stakeholders with customized information about the economic and wider returns on the investment in evidence-based tobacco control, including smoking cessation interventions. A Stakeholder Interview Survey was developed to engage with the stakeholders in early phases of the development and country adaptation of the ROI tool. The survey assessed stakeholders' information needs, awareness about underlying principles used in economic analyses, opinion about the importance, effectiveness and cost-effectiveness of tobacco control interventions, and willingness to use a Health Technology Assessment (HTA) tool such as the ROI tool. A cross sectional study using a mixed method approach was conducted among participating stakeholders in the sample countries and the United Kingdom. The individual questionnaire contained open-ended questions as well as single choice and 7- or 3-point Likert-scale questions. The results corresponding to the priority and needs assessment and to the awareness of stakeholders about underlying principles used in economic analysis are analysed by country and stakeholder categories. Stakeholders considered it important that the decisions on the investments in tobacco control interventions should be supported by scientific evidence, including prevalence of smoking, cost of smoking, quality of life, mortality due to smoking, and effectiveness, cost-effectiveness and budget impact of smoking cessation interventions. The proposed ROI tool was required to provide this granularity of information. The majority of the stakeholders were aware of the general principles of economic analyses used in decision making contexts but they did not appear to have in-depth knowledge about specific technical details. Generally, stakeholders' answers showed larger variability by country than by stakeholder category. Stakeholders across different European countries viewed the use of HTA evidence to be an important factor in their decision-making process. Further, they considered themselves to be capable of interpreting the results from a ROI tool and were highly motivated to use it.

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

PubMed Central

Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R.; Salek, Sam

2017-01-01

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability. PMID:28443022

A structured review of health utility measures and elicitation in advanced/metastatic breast cancer.

PubMed

Hao, Yanni; Wolfram, Verena; Cook, Jennifer

2016-01-01

Health utilities are increasingly incorporated in health economic evaluations. Different elicitation methods, direct and indirect, have been established in the past. This study examined the evidence on health utility elicitation previously reported in advanced/metastatic breast cancer and aimed to link these results to requirements of reimbursement bodies. Searches were conducted using a detailed search strategy across several electronic databases (MEDLINE, EMBASE, Cochrane Library, and EconLit databases), online sources (Cost-effectiveness Analysis Registry and the Health Economics Research Center), and web sites of health technology assessment (HTA) bodies. Publications were selected based on the search strategy and the overall study objectives. A total of 768 publications were identified in the searches, and 26 publications, comprising 18 journal articles and eight submissions to HTA bodies, were included in the evidence review. Most journal articles derived utilities from the European Quality of Life Five-Dimensions questionnaire (EQ-5D). Other utility measures, such as the direct methods standard gamble (SG), time trade-off (TTO), and visual analog scale (VAS), were less frequently used. Several studies described mapping algorithms to generate utilities from disease-specific health-related quality of life (HRQOL) instruments such as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer 23 (EORTC QLQ-BR23), Functional Assessment of Cancer Therapy - General questionnaire (FACT-G), and Utility-Based Questionnaire-Cancer (UBQ-C); most used EQ-5D as the reference. Sociodemographic factors that affect health utilities, such as age, sex, income, and education, as well as disease progression, choice of utility elicitation method, and country settings, were identified within the journal articles. Most submissions to HTA bodies obtained utility values from the literature rather than exploring the HRQOL data obtained during clinical development. This was critiqued by the National Institute for Health and Clinical Excellence (NICE). Furthermore, the impact of age on utilities was highlighted by NICE and it was suggested that an age match of the study population should be attempted. Health utilities are recorded across the globe to varying extents and using differing elicitation methods. Manufacturers seeking reimbursement need to be aware of the country-specific requirements for elicitation of health utilities.

A structured review of health utility measures and elicitation in advanced/metastatic breast cancer

PubMed Central

Hao, Yanni; Wolfram, Verena; Cook, Jennifer

2016-01-01

Background Health utilities are increasingly incorporated in health economic evaluations. Different elicitation methods, direct and indirect, have been established in the past. This study examined the evidence on health utility elicitation previously reported in advanced/metastatic breast cancer and aimed to link these results to requirements of reimbursement bodies. Methods Searches were conducted using a detailed search strategy across several electronic databases (MEDLINE, EMBASE, Cochrane Library, and EconLit databases), online sources (Cost-effectiveness Analysis Registry and the Health Economics Research Center), and web sites of health technology assessment (HTA) bodies. Publications were selected based on the search strategy and the overall study objectives. Results A total of 768 publications were identified in the searches, and 26 publications, comprising 18 journal articles and eight submissions to HTA bodies, were included in the evidence review. Most journal articles derived utilities from the European Quality of Life Five-Dimensions questionnaire (EQ-5D). Other utility measures, such as the direct methods standard gamble (SG), time trade-off (TTO), and visual analog scale (VAS), were less frequently used. Several studies described mapping algorithms to generate utilities from disease-specific health-related quality of life (HRQOL) instruments such as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Breast Cancer 23 (EORTC QLQ-BR23), Functional Assessment of Cancer Therapy – General questionnaire (FACT-G), and Utility-Based Questionnaire-Cancer (UBQ-C); most used EQ-5D as the reference. Sociodemographic factors that affect health utilities, such as age, sex, income, and education, as well as disease progression, choice of utility elicitation method, and country settings, were identified within the journal articles. Most submissions to HTA bodies obtained utility values from the literature rather than exploring the HRQOL data obtained during clinical development. This was critiqued by the National Institute for Health and Clinical Excellence (NICE). Furthermore, the impact of age on utilities was highlighted by NICE and it was suggested that an age match of the study population should be attempted. Conclusion Health utilities are recorded across the globe to varying extents and using differing elicitation methods. Manufacturers seeking reimbursement need to be aware of the country-specific requirements for elicitation of health utilities. PMID:27382319

Early assessment of medical technologies to inform product development and market access: a review of methods and applications.

PubMed

Ijzerman, Maarten J; Steuten, Lotte M G

2011-09-01

Worldwide, billions of dollars are invested in medical product development and there is an increasing pressure to maximize the revenues of these investments. That is, governments need to be informed about the benefits of spending public resources, companies need more information to manage their product development portfolios and even universities may need to direct their research programmes in order to maximize societal benefits. Assuming that all medical products need to be adopted by the heavily regulated healthcare market at one point in time, it is worthwhile to look at the logic behind healthcare decision making, specifically, decisions on the coverage of medical products and decisions on the use of these products under competing and uncertain conditions. With the growing tension between leveraging economic growth through R&D spending on the one hand and stricter control of healthcare budgets on the other, several attempts have been made to apply the health technology assessment (HTA) methodology to earlier stages of technology development and implementation. For instance, horizon scanning was introduced to systematically assess emerging technologies in order to inform health policy. Others have introduced iterative economic evaluation, e.g. economic evaluations in earlier stages of clinical research. However, most of these methods are primarily intended to support governments in making decisions regarding potentially expensive new medical products. They do not really inform biomedical product developers on the probability of return on investment, nor do they inform about the market needs and specific requirements of technologies in development. It is precisely this aspect that increasingly receives attention, i.e. is it possible to use HTA tools and methods to inform biomedical product development and to anticipate further development and market access. Several methods have been used in previous decades, but have never been compiled in a comprehensive review. The main objective of this article was to provide an overview of previous work and methods in the field of early HTA, and to put these approaches in perspective through a conceptual framework introduced in this paper. A particular goal of the review was to familiarize decision makers with available techniques that can be employed in early-stage decision making, and to identify opportunities for further methodological growth in this emerging field of HTA.

Diagnostiquer l’hypertension artérielle

PubMed Central

Gelfer, Mark; Dawes, Martin; Kaczorowski, Janusz; Padwal, Raj; Cloutier, Lyne

2015-01-01

Résumé Objectif Mettre en lumière les recommandations 2015 du Programme éducatif canadien sur l’hypertension (PECH) sur le diagnostic et l’évaluation de l’hypertension artérielle (HTA). Qualité des données Une recherche systématique remontant à août 2014 a été effectuée par un bibliothécaire de la Collaboration Cochrane dans les banques de données MEDLINE et PubMed. Les résultats de la recherche ont fait l’objet d’une évaluation critique par le sous-comité du PECH sur la mesure de la pression artérielle (PA) et le diagnostic d’HTA, et les recommandations fondées sur les données probantes ont été soumises au Comité central d’examen du PECH aux fins d’examen indépendant et de classement. Finalement, les résultats et recommandations ont été présentés au Groupe de travail sur les recommandations aux fins de discussion, de débat, d’approbation et de vote. Les principales recommandations reposent sur des données probantes de niveau II. Message principal Selon les données probantes les plus récentes, le PECH a formulé 4 nouvelles recommandations classées dans 2 vastes catégories pour améliorer la mesure de la PA et la façon dont l’HTA est diagnostiquée en 2015. Il est fortement recommandé de mesurer la PA à l’aide d’appareils électroniques en clinique plutôt que par auscultation. Chez les patients dont les mesures en clinique sont élevées, le PECH recommande de se tourner précocement vers les mesures ambulatoires, préférablement le monitorage ambulatoire de la PA, afin d’identifier rapidement les patients atteints du syndrome du sarrau blanc. Conclusion Il est crucial d’améliorer la justesse diagnostique afin d’optimiser la prise en charge de l’HTA au Canada. Les mises à jour annuelles du PECH veillent à ce que les praticiens disposent de renseignements fondés sur les données probantes à jour pour éclairer leur pratique.

Over-, under- and misuse of pain treatment in Germany.

PubMed

Dietl, Markus; Korczak, Dieter

2011-04-19

The HTA-report (Health Technology Assessment) deals with over- and undertreatment of pain therapy. Especially in Germany chronic pain is a common reason for the loss of working hours and early retirement. In addition to a reduction in quality of life for the affected persons, chronic pain is therefore also an enormous economic burden for society. Which diseases are in particular relevant regarding pain therapy?What is the social-medical care situation regarding pain facilities in Germany?What is the social-medical care situation in pain therapy when comparing on international level?Which effects, costs or cost-effects can be seen on the micro-, meso- and macro level with regard to pain therapy?Among which social-medical services in pain therapy is there is an over- or undertreatment with regard to the micro-, meso- and macro level?Which medical and organisational aspects that have an effect on the costs and/or cost-effectiveness have to be particularly taken into account with regard to pain treatment/chronic pain?What is the influence of the individual patient's needs (micro level) in different situations of pain (e. g. palliative situation) on the meso- and macro level?Which social-medical and ethical aspects for an adequate treatment of chronic pain on each level have to be specially taken into account?Is the consideration of these aspects appropriate to avoid over- or undertreatment?Are juridical questions included in every day care of chronic pain patients, mainly in palliative care?On which level can appropriate interventions prevent over- or undertreatment? A systematic literature research is done in 35 databases. In the HTA, reviews, epidemiological and clinical studies and economic evaluations are included which report about pain therapy and in particular palliative care in the years 2005 till 2010. 47 studies meet the inclusion criteria. An undertreatment of acupuncture, over- and misuse with regard to opiate prescription and an overuse regarding unspecific chest pain and chronic low back pain (LBP) can be observed. The results show the benefit and the cost-effectiveness of interdisciplinary as well as multi-professional approaches, multimodal pain therapy and cross-sectoral integrated medical care. Only rough values can be determined about the care situation regarding the supply of pain therapeutic and palliative medical facilities as the data are completely insufficient. Due to the broad research question the HTA-report contains inevitably different outcomes and study designs which partially differ qualitatively very strong from each other. In the field of palliative care hospices for in-patients and palliative wards as well as hospices for out-patients are becoming more and more important. Palliative care is a basic right of all terminally ill persons. Despite the relatively high number of studies in Germany the HTA-report shows a massive lack in health care research. Based on the studies a further expansion of out-patient pain and palliative care is recommended. Further training for all involved professional groups must be improved. An independent empirical analysis is necessary to determine over or undertreatment in pain care.

Health Technology Assessment report on the presurgical evaluation and surgical treatment of drug-resistant epilepsy.

PubMed

Marras, Carlo Efisio; Canevini, Maria Paola; Colicchio, Gabriella; Guerrini, Renzo; Rubboli, Guido; Scerrati, Massimo; Spreafico, Roberto; Tassi, Laura; LoRusso, Giorgio; Tinuper, Paolo

2013-10-01

Epilepsy is a neurologic disorder with major social impact. Surgery is a valuable option in patients who are not responding to antiepileptic drugs. The literature reports demonstrate that a proportion ranging from 40 to 100% of patients with epilepsy achieve seizure remission after surgery. A presurgical evaluation (clinical and instrumental) must be performed in all patients with drug-resistant epilepsy to assess their suitability for surgical intervention. Health Technology Assessment (HTA) represents a modern approach to the analysis of technologies used for health care. HTA could be considered a bridge between science that produces evidence and the decisions that can be taken on the basis of that evidence at different levels of the health care system. The aim of this study is the HTA of epilepsy surgery including clinical, ethical, social, and economic features. The present study includes an analysis of the diagnostic and surgical workup performed at the Italian centers for the diagnosis and treatment of drug-resistant epilepsy (DRE). The study includes the following issues: (1) social, ethical impact, and costs of the disease; (2) clinical results, efficacy, and safety of surgery; (3) ethics and quality of life after surgery; and (4) economic impact and productivity regained after surgery. The cost of managing a patient with DRE included in the presurgical study was estimated by the bottom-up microcosting technique that starts from a detailed collection of data on consumption of resources and full costing. The phases analyzed were (1) noninvasive diagnostic workup; (2) neurosurgical intervention; and (3) follow-up. The literature reports indicate epilepsy surgery as an effective treatment both on clinical results and on ethical, social, and quality of life aspects. The workup including the noninvasive presurgical study followed by surgery has a total cost of €20,827. Management of short-term follow-up increases the overhead to €22,291 at the first year, and then to €23,571 after 5 years. According to the estimates made in this survey, funding based on diagnosis-related group (DRG) tariff for the noninvasive diagnostic stage involving hospital admission is not remunerative in Italy either at regional or national levels. Effectively the difference between full cost and DRG has a delta of €3,402 and €2,537 respectively. The total cost of the presurgical, surgical, and follow-up evaluation is not remunerative for €10,554 (national data). Economic surveys in Italy have shown that surgery for DRE is an advantageous treatment from the standpoint of third-party payers and is cost-effective for society. DRE presurgical evaluation and surgery are not remunerative either at regional or national levels. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries.

PubMed

Angelis, Aris; Lange, Ansgar; Kanavos, Panos

2018-01-01

Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value. To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment. A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) 'Responsibilities and structure of HTA agencies'; (2) 'Evidence and evaluation criteria considered in HTAs'; (3) 'Methods and techniques applied in HTAs'; and (4) 'Outcomes and implementation of HTAs'. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts. All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional 'social value judgements' (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making. More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness.

Integration of tablet technologies in the e-laboratory of cytology: a health technology assessment.

PubMed

Giansanti, Daniele; Pochini, Marco; Giovagnoli, Maria Rosaria

2014-10-01

Although tablet systems are becoming a powerful technology, particularly useful in every application of medical imaging, to date no one has investigated the acceptance and performance of this technology in digital cytology. The specific aims of the work were (1) to design a health technology assessment (HTA) tool to assess, in terms of performance and acceptance, the introduction of tablet technologies (wearable, portable, and non portable) in the e-laboratories of cytology and (2) to test the tool in a first significant application of digital cytology. An HTA tool was proposed operating on a domain of five dimensions of investigation comprising the basic information of the product of digital cytology, the perceived subjective quality of images, the assessment of the virtual navigation on the e-slide, the assessment of the information and communication technologies features, and the diagnostic power. Six e-slides regarding studies of cervicovaginal cytology digitalized by means of an Aperio ( www.aperio.com ) scanner and uploaded onto the www.digitalslide.it Web site were used for testing the methodology on three different network connections. Three experts of cytology successfully tested the methodology on seven tablets found suitable for the study in their own standard configuration. Specific indexes furnished by the tool indicated both a high degree of performance and subjective acceptance of the investigated technology. The HTA tool thus could be useful to investigate new tablet technologies in digital cytology and furnish stakeholders with useful information that may help them make decisions involving the healthcare system. From a global point of view the study demonstrates the feasibility of using the tablet technology in digital cytology.

Why laparoscopists may opt for three-dimensional view: a summary of the full HTA report on 3D versus 2D laparoscopy by S.I.C.E. (Società Italiana di Chirurgia Endoscopica e Nuove Tecnologie).

PubMed

Vettoretto, Nereo; Foglia, Emanuela; Ferrario, Lucrezia; Arezzo, Alberto; Cirocchi, Roberto; Cocorullo, Gianfranco; Currò, Giuseppe; Marchi, Domenico; Portale, Giuseppe; Gerardi, Chiara; Nocco, Umberto; Tringali, Michele; Anania, Gabriele; Piccoli, Micaela; Silecchia, Gianfranco; Morino, Mario; Valeri, Andrea; Lettieri, Emauele

2018-06-01

Three-dimensional view in laparoscopic general, gynaecologic and urologic surgery is an efficient, safe and sustainable innovation. The present paper is an extract taken from a full health technology assessment report on three-dimensional vision technology compared with standard two-dimensional laparoscopic systems. A health technology assessment approach was implemented in order to investigate all the economic, social, ethical and organisational implications related to the adoption of the innovative three-dimensional view. With the support of a multi-disciplinary team, composed of eight experts working in Italian hospitals and Universities, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaire and self-reported interviews, applying a final MCDA quantitative approach, and considering the dimensions resulting from the EUnetHTA Core Model. From systematic search of literature, we retrieved the following studies: 9 on general surgery, 35 on gynaecology and urology, both concerning clinical setting. Considering simulated setting we included: 8 studies regarding pitfalls and drawbacks, 44 on teaching, 12 on surgeons' confidence and comfort and 34 on surgeons' performances. Three-dimensional laparoscopy was shown to have advantages for both the patients and the surgeons, and is confirmed to be a safe, efficacious and sustainable vision technology. The objective of the present paper, under the patronage of Italian Society of Endoscopic Surgery, was achieved in that there has now been produced a scientific report, based on a HTA approach, that may be placed in the hands of surgeons and used to support the decision-making process of the health providers.

Early scientific advice obtained simultaneously from regulators and payers: findings from a pilot study in Australia.

PubMed

Wonder, Michael; Backhouse, Martin E; Hornby, Edward

2013-01-01

There is scope for better interaction between regulators, payers/HTA agencies, and medicines developers in their common objective of getting new medicines to patients. This paper reports on a tripartite early scientific advice pilot conducted by a pharmaceutical company (developer), the Therapeutic Goods Administration (TGA: regulator) and the Pharmaceutical Benefit Advisory Committee (PBAC) Secretariat (HTA agency) in Australia. The objective was to explore the practicality, feasibility, and sustainability of means of obtaining simultaneous scientific advice from both a regulatory and reimbursement perspective. Advice was sought for two development compounds in different disease areas. The focus was on matters of common interest to the TGA and the PBAC (i.e. the clinical evidence). Briefing books were prepared by the developer and supplied eight weeks prior to the meeting and only verbal advice was provided. The pilot meeting took place in 2009. Each session lasted for approximately two hours and was structured around the questions in the briefing books. The representatives from the TGA and PBAC Secretariat provided well-informed, considered and careful advice for both compounds, which was predominantly actionable and practical. The sessions proved highly informative and permitted better alignment of the possible positioning of new medicines with the clinical evidence that regulators and HTA agencies might subsequently require for favorable assessment. The process provided early and clear signals to inform major development investments and the probability of successful market access. A number of challenges need to be addressed before tripartite scientific advice can be provided on continual basis. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions.

PubMed

Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y

2018-02-01

The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.

Systems integration and demonstration of advanced reusable structure for ALS

NASA Technical Reports Server (NTRS)

Gibbins, Martin N.

1991-01-01

The objective was to investigate the potential of advanced material to achieve life cycle cost (LCC) benefits for reusable structure on the advanced launch system. Three structural elements were investigated - all components of an Advanced Launch System reusable propulsion/avionics module. Leading aeroshell configurations included sandwich structure using titanium, graphite/polyimide (Gr/PI), or high-temperature aluminum (HTA) face sheets. Thrust structure truss concepts used titanium, graphite/epoxy, or silicon carbide/aluminum struts. Leading aft bulkhead concepts employed graphite epoxy and aluminum. The technical effort focused on the aeroshell because the greatest benefits were expected there. Thermal analyses show the structural temperature profiles during operation. Finite element analyses show stresses during splash-down. Weight statements and manufacturing cost estimates were prepared for calculation of LCC for each design. The Gr/PI aeroshell showed the lowest potential LCC, but the HTA aeroshell was judged to be lower risk. A technology development plan was prepared to validate the applicable structural technology.

Health technology assessment-based development of a Spanish breast cancer patient decision aid.

PubMed

Izquierdo, Fátima; Gracia, Javier; Guerra, Mercedes; Blasco, Juan Antonio; Andradas, Elena

2011-10-01

The aim of this study was to develop a breast cancer Patient Decision Aid (PDA), using a Health Technology Assessment (HTA) process, to assist patients in their choice of therapeutic options, and to promote shared decision making among patients, healthcare professionals, and other interested parties. A systematic review (SR) was conducted of existing breast cancer patient Decision Aids encountered in the main scientific journal databases and on institutional Web sites that create PDAs, together with a Qualitative Research (QR) study, using semi-structured interviews and focus group with stakeholders (patients, family members, and health professionals), with the aim of developing a PDA for breast cancer. The SR shows that PDAs in breast cancer not only increase patient knowledge of the illness, leading to more realistic expectations of treatment outcomes, but also reduce passivity in the decision-making process and facilitate the appropriate choice of treatment options in accordance with patient medical and personal preferences. The analysis of QR shows that both breast cancer patients and healthcare professionals agree that surgery, adjuvant treatments, and breast reconstruction represent the most important decisions to be made. Worry, anxiety, optimism, and trust in healthcare professionals were determined as factors that most affected patients subjective experiences of the illness. This HTA was used as the basis for developing a PDA software program. The SR and QR used in the development of this PDA for breast cancer allowed patients to access information, gain additional knowledge of their illness, make shared treatment decisions, and gave healthcare professionals a deeper insight into patient experiences of the disease.

SOCIO-ETHICAL ISSUES IN PERSONALIZED MEDICINE: A SYSTEMATIC REVIEW OF ENGLISH LANGUAGE HEALTH TECHNOLOGY ASSESSMENTS OF GENE EXPRESSION PROFILING TESTS FOR BREAST CANCER PROGNOSIS.

PubMed

Ali-Khan, Sarah E; Black, Lee; Palmour, Nicole; Hallett, Michael T; Avard, Denise

2015-01-01

There have been multiple calls for explicit integration of ethical, legal, and social issues (ELSI) in health technology assessment (HTA) and addressing ELSI has been highlighted as key in optimizing benefits in the Omics/Personalized Medicine field. This study examines HTAs of an early clinical example of Personalized Medicine (gene expression profile tests [GEP] for breast cancer prognosis) aiming to: (i) identify ELSI; (ii) assess whether ELSIs are implicitly or explicitly addressed; and (iii) report methodology used for ELSI integration. A systematic search for HTAs (January 2004 to September 2012), followed by descriptive and qualitative content analysis. Seventeen HTAs for GEP were retrieved. Only three (18%) explicitly presented ELSI, and only one reported methodology. However, all of the HTAs included implicit ELSI. Eight themes of implicit and explicit ELSI were identified. "Classical" ELSI including privacy, informed consent, and concerns about limited patient/clinician genetic literacy were always presented explicitly. Some ELSI, including the need to understand how individual patients' risk tolerances affect clinical decision-making after reception of GEP results, were presented both explicitly and implicitly in HTAs. Others, such as concern about evidentiary deficiencies for clinical utility of GEP tests, occurred only implicitly. Despite a wide variety of important ELSI raised, these were rarely explicitly addressed in HTAs. Explicit treatment would increase their accessibility to decision-makers, and may augment HTA efficiency maximizing their utility. This is particularly important where complex Personalized Medicine applications are rapidly expanding choices for patients, clinicians and healthcare systems.

Developmental onset of reproductive barriers and associated proteome changes in stigma/styles of Solanum pennellii

PubMed Central

Chalivendra, Subbaiah C.; Lopez-Casado, Gloria; Bedinger, Patricia A.

2013-01-01

Although self-incompatibility (SI) in plants has been studied extensively, far less is known about interspecific reproductive barriers. One interspecific barrier, known as unilateral incongruity or incompatibility (UI), occurs when species display unidirectional compatibility in interspecific crosses. In the wild tomato species Solanum pennellii, both SI and self-compatible (SC) populations express UI when crossed with domesticated tomato, offering a useful model system to dissect the molecular mechanisms involved in reproductive barriers. In this study, the timing of reproductive barrier establishment during pistil development was determined in SI and SC accessions of S. pennellii using a semi-in vivo system to track pollen-tube growth in developing styles. Both SI and UI barriers were absent in styles 5 days prior to flower opening, but were established by 2 days before flower opening, with partial barriers detected during a transition period 3–4 days before flower opening. The developmental expression dynamics of known SI factors, S-RNases and HT proteins, was also examined. The accumulation of HT-A protein coincided temporally and spatially with UI barriers in developing pistils. Proteomic analysis of stigma/styles from key developmental stages showed a switch in protein profiles from cell-division-associated proteins in immature stigma/styles to a set of proteins in mature stigma/styles that included S-RNases, HT-A protein and proteins associated with cell-wall loosening and defense responses, which could be involved in pollen–pistil interactions. Other prominent proteins in mature stigma/styles were those involved in lipid metabolism, consistent with the accumulation of lipid-rich material during pistil maturation. PMID:23166371

Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study.

PubMed

Turchetti, Giuseppe; Pierotti, Francesca; Palla, Ilaria; Manetti, Stefania; Freschi, Cinzia; Ferrari, Vincenzo; Cuschieri, Alfred

2017-02-01

Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA). The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches. The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p < 0.001). The study showed no significant difference in total costs between OS and DMLS. Total costs of general surgery RAS were significantly higher than those of OS (p < 0.001), but not against DMLS general surgery. Indirect costs were significantly lower in RAS compared to both DMLS general surgery and OS gynecological surgery due to the shorter length of hospital stay of RAS approach (p < 0.001). Additionally, in all specialties compared to OS, patients treated by RAS experienced a quicker recovery and significantly less pain during the hospitalization and after discharge. The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

PubMed Central

BERRETTINI, S.; ARSLAN, E.; BAGGIANI, A.; BURDO, S.; CASSANDRO, E.; CUDA, D.; FILIPO, R.; GIORGI ROSSI, P.; MANCINI, P.; MARTINI, A.; QUARANTA, A.; QUARANTA, N.; TURCHETTI, G.; FORLI, F.

2011-01-01

SUMMARY The aim of Health Technology Assessment (HTA) is to provide decision-makers, distributors and recipients with information on the effectiveness, cost and impact of health technologies. The present study constitutes a subproject within the wider project “Analysis of the impact of professional involvement in evidence generation for the HTA process”, which is part of the strategic programme “Transfer of the results of the research in clinical practice and organisation of healthcare services”, coordinated by Laziosanità – Agency of Public Healthcare of the Lazio Region and AgeNaS (National Agency for Regional Healthcare Services). The objectives of the present subproject (cochlear implants) are as follows: a) to produce a report regarding the health impact of cochlear implants (CI) on their recipients, through a systematic review of literature and extensive selection of relative studies, combining the outcomes with metanalytical techniques. Output: report on the indications of usage in the groups of population for which benefits are controversial; b) to create a registry of patients using cochlear implants. The registry should contain a selection of anagraphic and clinical information relative to patient follow-up in order to assess factors associated with safety and impact on cochlear implant users. This source of information is essential for future observational studies. This was divided into 4 phases: 1st phase: definition of key participants in the assessment process; 2nd phase: definition of methods and timing of “Aims” (definition of the objective); 3rd phase: definition of the methods and times of the “assessment process”, 4th phase: production of the final report. From the analysis of systematic reviews and italian and international guidelines, the Working Group members approved recommendations on the following topics: results after CI in children in relation to age at implantation, bilateral CI in children, CI in deaf children with associated disabilities, CI in adults with advanced age, bilateral CI in adults and CI in adults with pre-lingual deafness. These recommendations have also been evaluated by the Consulting Committee members and approved with minimal suggestions. PMID:22287819

Decision-Oriented Health Technology Assessment: One Step Forward in Supporting the Decision-Making Process in Hospitals.

PubMed

Ritrovato, Matteo; Faggiano, Francesco C; Tedesco, Giorgia; Derrico, Pietro

2015-06-01

This article outlines the Decision-Oriented Health Technology Assessment: a new implementation of the European network for Health Technology Assessment Core Model, integrating the multicriteria decision-making analysis by using the analytic hierarchy process to introduce a standardized methodological approach as a valued and shared tool to support health care decision making within a hospital. Following the Core Model as guidance (European network for Health Technology Assessment. HTA core model for medical and surgical interventions. Available from: http://www.eunethta.eu/outputs/hta-core-model-medical-and-surgical-interventions-10r. [Accessed May 27, 2014]), it is possible to apply the analytic hierarchy process to break down a problem into its constituent parts and identify priorities (i.e., assigning a weight to each part) in a hierarchical structure. Thus, it quantitatively compares the importance of multiple criteria in assessing health technologies and how the alternative technologies perform in satisfying these criteria. The verbal ratings are translated into a quantitative form by using the Saaty scale (Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci 2008;1:83-98). An eigenvectors analysis is used for deriving the weights' systems (i.e., local and global weights' system) that reflect the importance assigned to the criteria and the priorities related to the performance of the alternative technologies. Compared with the Core Model, this methodological approach supplies a more timely as well as contextualized evidence for a specific technology, making it possible to obtain data that are more relevant and easier to interpret, and therefore more useful for decision makers to make investment choices with greater awareness. We reached the conclusion that although there may be scope for improvement, this implementation is a step forward toward the goal of building a "solid bridge" between the scientific evidence and the final decision maker's choice. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The value of value of information: best informing research design and prioritization using current methods.

PubMed

Eckermann, Simon; Karnon, Jon; Willan, Andrew R

2010-01-01

Value of information (VOI) methods have been proposed as a systematic approach to inform optimal research design and prioritization. Four related questions arise that VOI methods could address. (i) Is further research for a health technology assessment (HTA) potentially worthwhile? (ii) Is the cost of a given research design less than its expected value? (iii) What is the optimal research design for an HTA? (iv) How can research funding be best prioritized across alternative HTAs? Following Occam's razor, we consider the usefulness of VOI methods in informing questions 1-4 relative to their simplicity of use. Expected value of perfect information (EVPI) with current information, while simple to calculate, is shown to provide neither a necessary nor a sufficient condition to address question 1, given that what EVPI needs to exceed varies with the cost of research design, which can vary from very large down to negligible. Hence, for any given HTA, EVPI does not discriminate, as it can be large and further research not worthwhile or small and further research worthwhile. In contrast, each of questions 1-4 are shown to be fully addressed (necessary and sufficient) where VOI methods are applied to maximize expected value of sample information (EVSI) minus expected costs across designs. In comparing complexity in use of VOI methods, applying the central limit theorem (CLT) simplifies analysis to enable easy estimation of EVSI and optimal overall research design, and has been shown to outperform bootstrapping, particularly with small samples. Consequently, VOI methods applying the CLT to inform optimal overall research design satisfy Occam's razor in both improving decision making and reducing complexity. Furthermore, they enable consideration of relevant decision contexts, including option value and opportunity cost of delay, time, imperfect implementation and optimal design across jurisdictions. More complex VOI methods such as bootstrapping of the expected value of partial EVPI may have potential value in refining overall research design. However, Occam's razor must be seriously considered in application of these VOI methods, given their increased complexity and current limitations in informing decision making, with restriction to EVPI rather than EVSI and not allowing for important decision-making contexts. Initial use of CLT methods to focus these more complex partial VOI methods towards where they may be useful in refining optimal overall trial design is suggested. Integrating CLT methods with such partial VOI methods to allow estimation of partial EVSI is suggested in future research to add value to the current VOI toolkit.

The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials.

PubMed

Jones, Ashley P; Conroy, Elizabeth; Williamson, Paula R; Clarke, Mike; Gamble, Carrol

2013-03-25

A systematic review, with or without a meta-analysis, should be undertaken to determine if the research question of interest has already been answered before a new trial begins. There has been limited research on how systematic reviews are used within the design of new trials, the aims of this study were to investigate how systematic reviews of earlier trials are used in the planning and design of new randomised trials. Documentation from the application process for all randomised trials funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) between 2006 and 2008 were obtained. This included the: commissioning brief (if appropriate), outline application, minutes of the Board meeting in which the outline application was discussed, full application, detailed project description, referee comments, investigator response to referee comments, Board minutes on the full application and the trial protocol. Data were extracted on references to systematic reviews and how any such reviews had been used in the planning and design of the trial. 50 randomised trials were funded by NIHR HTA during this period and documentation was available for 48 of these. The cohort was predominately individually randomised parallel trials aiming to detect superiority between two treatments for a single primary outcome. 37 trials (77.1%) referenced a systematic review within the application and 20 of these (i.e. 41.7% of the total) used information contained in the systematic review in the design or planning of the new trial. The main areas in which systematic reviews were used were in the selection or definition of an outcome to be measured in the trial (7 of 37, 18.9%), the sample size calculation (7, 18.9%), the duration of follow up (8, 21.6%) and the approach to describing adverse events (9, 24.3%). Boards did not comment on the presence/absence or use of systematic reviews in any application. Systematic reviews were referenced in most funded applications but just over half of these used the review to inform the design. There is an expectation from funders that applicants will use a systematic review to justify the need for a new trial but no expectation regarding further use of a systematic review to aid planning and design of the trial. Guidelines for applicants and funders should be developed to promote the use of systematic reviews in the design and planning of randomised trials, to optimise delivery of new studies informed by the most up-to-date evidence base and to minimise waste in research.

Reparación Endovascular para Aneurisma de Aorta: Revisión Panorámica sobre su evidencia en el mundo y su aplicación en Latinoamérica.

PubMed

Calderón, María; Brito, Viviana; Alcaraz, Andrea; Rey-Ares, Lucila; Augustovski, Federico; García-Martí, Sebastián; Bardach, Ariel; Ciapponi, Agustín; López, Analía; Pichón-Riviere, Andrés

2018-05-10

Aortic aneurysm (AA) is a pathology with high morbidity and mortality. The management can be expectant, surgical, or through endovascular repair (EVAR). In Latin America the incidence of AA has increased and the analysis of therapeutic options, especially if they are expensive, is fundamental. To analyze available evidence on the effectiveness, safety and coverage policies of the EVAR. Panoramic review in the main bibliographical bases (MEDLINE, LILACS, EMBASE, Cochrane Library, DARE) and generic internet searchers, main health technology assessment (HTA) agencies and health insurance companies. Systematic reviews (SR), clinical practice guidelines (CPG), HTA and coverage policies, followed by the identification of primary studies published after the SR search date were included. A search of studies published until November 2015 in English and Spanish was carried out. 311 references were recovered, from which seven SRs were selected, one clinical study and 15 CPGs, consensus or coverage policies and ETS. For abdominal AA, high quality evidence showed no differences inlong-term survival with the use of EVAR compared to conventional surgery, but lower early mortality was observed (OR = 0.33, 95% CI 0.20 -0.55). EVAR was associated with a greater need for re-intervention. In the case of other types of AA, further evidence is still required to establish the benefit of EVAR. The CPGs, consensus, HTAs and coverage policies identified, mostly consider open surgery as the treatment of choice, reserving the EVAR for patients with high surgical risk for conventional surgery in the presence of favorable anatomy. Copyright © 2018. Published by Elsevier Inc.

The impact of orthopaedic research evidence on health financing in Australia.

PubMed

Hua, Martin; Myers, Daniel; Host, Lachlan

2018-05-02

In Australia, approval by the Medical Services Advisory Committee (MSAC) is an important step in the implementation of new health technologies. The MSAC considers health technology assessments (HTA) when submitting a recommendation to the Minister of Health on a new technology's suitability for public funding. Despite being such a critical tool in formulating policy, there has been little scrutiny on the impact of limited evidence on the performance of a national HTA agency's mandate. We aim to determine the proportion of HTAs of orthopaedic technologies prepared for the MSAC that were supported by higher levels of evidence for effectiveness, and whether this affected the MSAC's ability to conclude on efficacy. We also investigated whether the availability of higher level evidence affected the performance of cost-effectiveness analyses. We performed a cohort study of all HTAs prepared for the MSAC from 1998 to 2017 with regards to new technologies in orthopaedic surgery. We identified seven HTAs encompassing nine orthopaedic technologies for inclusion. Higher levels of evidence were available for assessing the technology's effectiveness in six out of the nine technologies. The results did not show a statistically significant relationship between the availability of higher level evidence and MSAC's ability to make a clear conclusion on the assessment of effectiveness (P = 0.5). The proportion of HTAs where a cost-effectiveness analysis was performed was significantly higher (P < 0.05) when higher levels of evidence were available for the assessment of effectiveness. The results indicate that there is a paucity of high quality evidence in the formulation of health policy with regards to the implementation of new orthopaedic technologies in the public healthcare system. This represents an opportunity for strong leadership from surgeons to help develop the tools needed for effective clinical decision-making.

An Evidence Framework for Off-Patent Pharmaceutical Review (EFOR) for Health Technology Assessment in Emerging Markets.

PubMed

Brixner, Diana; Kaló, Zoltán; Maniadakis, Nikos; Kim, Kyoo; Wijaya, Kalman

2018-03-29

This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. A literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). The IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. Emerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials. Copyright © 2018. Published by Elsevier Inc.

The transformed glucocorticoid receptor has a lower steroid-binding affinity than the nontransformed receptor

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nemoto, Takayuki; Ohara-Nemoto, Yuko; Denis, M.

1990-02-20

High-salt treatment of cytosolic glucocorticoid receptor (GR) preparations reduces the steroid-binding ability of the receptor and induces the conversion of the receptor from a nontransformed (non-DNA-binding) 9S form to a transformed (DNA-binding) 4S entity. Therefore, the authors decided to investigate the possible relationship between these two phenomena. The binding of ({sup 3}H)triamcinolone acetonide (({sup 3}H)TA) to the 9S form was almost saturated at a concentration of 20 nM, whereas ({sup 3}H)TA was hardly bound to the 4S form at this concentration. The 4S form was efficiently labeled at 200 nM. Scatchard analysis of the GR showed the presence of twomore » types of binding sites. In the absence of molybdate, the ratio of the lower affinity site was increased, but the total number of binding sites was not modified. The GR with the low ({sup 3}H)TA-binding affinity bound to DNA-cellulose even in its unliganded state, whereas the form with the high affinity did not. These results indicate that the transformed GR has a reduced ({sup 3}H)TA-binding affinity as compared to the nontransformed GR. The steroid-binding domain (amino acids 477-777) and the DNA- and steroid-binding domains (amino acids 415-777) of the human GR were expressed in Escherichia coli as protein A fused proteins. Taken together, these results suggest that the component(s) associating with the nontransformed GR, possibly the heat shock protein hsp 90, play(s) an important role in stabilizing the GR in a high-affinity state for steroids.« less

Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment program.

PubMed

Ridyard, Colin H; Hughes, Dyfrig A

2010-12-01

The UK Health Technology Assessment (HTA) program funds trials that address issues of clinical and cost-effectiveness to meet the needs of the National Health Service (NHS). The objective of this review was to systematically assess the methods of resource use data collection and costing; and to produce a best practice guide for data capture within economic analyses alongside clinical trials. All 100 HTA-funded primary research papers published to June 2009 were reviewed for the health economic methods employed. Data were extracted and summarized by: health technology assessed, costing perspective adopted, evidence of planning and piloting, data collection method, frequency of data collection, and sources of unit cost data. Ninety-five studies were identified as having conducted an economic analysis, of which 85 recorded patient-level resource use. The review identified important differences in how data are collected. These included: a priori evidence of analysts having identified important cost drivers; the piloting and validation of patient-completed resource use questionnaires; choice of costing perspective; and frequency of data collection. Areas of commonality included: the extensive use of routine medical records and reliance on patient recall; and the use of standard sources of unit costs. Economic data collection is variable, even among a homogeneous selection of trials designed to meet the needs of a common organization (NHS). Areas for improvement have been identified, and based on our findings and related reviews and guidelines, a checklist is proposed for good practice relating to economic data collection within clinical trials. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Reviewing the evidence to inform the population of cost-effectiveness models within health technology assessments.

PubMed

Kaltenthaler, Eva; Tappenden, Paul; Paisley, Suzy

2013-01-01

Health technology assessments (HTAs) typically require the development of a cost-effectiveness model, which necessitates the identification, selection, and use of other types of information beyond clinical effectiveness evidence to populate the model parameters. The reviewing activity associated with model development should be transparent and reproducible but can result in a tension between being both timely and systematic. Little procedural guidance exists in this area. The purpose of this article was to provide guidance, informed by focus groups, on what might constitute a systematic and transparent approach to reviewing information to populate model parameters. A focus group series was held with HTA experts in the United Kingdom including systematic reviewers, information specialists, and health economic modelers to explore these issues. Framework analysis was used to analyze the qualitative data elicited during focus groups. Suggestions included the use of rapid reviewing methods and the need to consider the trade-off between relevance and quality. The need for transparency in the reporting of review methods was emphasized. It was suggested that additional attention should be given to the reporting of parameters deemed to be more important to the model or where the preferred decision regarding the choice of evidence is equivocal. These recommendations form part of a Technical Support Document produced for the National Institute for Health and Clinical Excellence Decision Support Unit in the United Kingdom. It is intended that these recommendations will help to ensure a more systematic, transparent, and reproducible process for the review of model parameters within HTA. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Methodological Approaches in Conducting Overviews: Current State in HTA Agencies

ERIC Educational Resources Information Center

Pieper, Dawid; Antoine, Sunya-Lee; Morfeld, Jana-Carina; Mathes, Tim; Eikermann, Michaela

2014-01-01

Objectives: Overviews search for reviews rather than for primary studies. They might have the potential to support decision making within a shorter time frame by reducing production time. We aimed to summarize available instructions for authors intending to conduct overviews as well as the currently applied methodology of overviews in…

Reimbursement of pharmaceuticals: reference pricing versus health technology assessment.

PubMed

Drummond, Michael; Jönsson, Bengt; Rutten, Frans; Stargardt, Tom

2011-06-01

Reference pricing and health technology assessment are policies commonly applied in order to obtain more value for money from pharmaceuticals. This study focussed on decisions about the initial price and reimbursement status of innovative drugs and discussed the consequences for market access and cost. Four countries were studied: Germany, The Netherlands, Sweden and the United Kingdom. These countries have operated one, or both, of the two policies at certain points in time, sometimes in parallel. Drugs in four groups were considered: cholesterol-lowering agents, insulin analogues, biologic drugs for rheumatoid arthritis and "atypical" drugs for schizophrenia. Compared with HTA, reference pricing is a relatively blunt instrument for obtaining value for money from pharmaceuticals. Thus, its role in making reimbursement decisions should be limited to drugs which are therapeutically equivalent. HTA is a superior strategy for obtaining value for money because it addresses not only price but also the appropriate indications for the use of the drug and the relation between additional value and additional costs. However, given the relatively higher costs of conducting HTAs, the most efficient approach might be a combination of both policies.

Innovative Medical Technology, Health Technology Assessment, and Health Policy: The Case of Remote Patient Monitoring of Cardiac Implantable Electronic Devices in South Korea.

PubMed

Lee, Sang-Soo; Salole, Eugene

2017-01-01

In many developed countries with universal coverage healthcare systems, payers require new medical technologies to be assessed as safe, effective, and cost-effective through health technology assessment (HTA) before approval for reimbursement coverage and market access. However, in some cases, HTA is not the sole criterion for decision-making and other factors override the evidence. Remote patient monitoring (RPM) for cardiac implantable electronic devices, a novel technology recognized as safe, effective, and cost-effective, and the standard of care in many countries, is prohibited in South Korea. This peculiar situation is apparently due to deficiencies in healthcare policy and the delivery system and also to poor engagement between stakeholders. We propose that a higher level of engagement and trust between stakeholders needs to be developed, and healthcare providers should be involved in the early development of health policy, so that unnecessary barriers to access to useful medical technology are corrected, thereby allowing Koreans to enjoy the benefits available in other developed countries.

Oncotyrol--Center for Personalized Cancer Medicine: Methods and Applications of Health Technology Assessment and Outcomes Research.

PubMed

Siebert, Uwe; Jahn, Beate; Rochau, Ursula; Schnell-Inderst, Petra; Kisser, Agnes; Hunger, Theresa; Sroczynski, Gaby; Mühlberger, Nikolai; Willenbacher, Wolfgang; Schnaiter, Simon; Endel, Gottfried; Huber, Lukas; Gastl, Guenther

2015-01-01

The Oncotyrol - Center for Personalized Cancer Medicine is an international and interdisciplinary alliance combining research and commercial competencies to accelerate the development, evaluation and translation of personalized healthcare strategies in cancer. The philosophy of Oncotyrol is to collaborate with relevant stakeholders and advance knowledge "from bench to bedside to population and back". Oncotyrol is funded through the COMET Excellence Program by the Austrian government via the national Austrian Research Promotion Agency (FFG). This article focuses on the role of health technology assessment (HTA) and outcomes research in personalized cancer medicine in the context of Oncotyrol. Oncotyrol, which currently comprises approximately 20 individual projects, has four research areas: Area 1: Biomarker and Drug Target Identification; Area 2: Assay Development and Drug Screening; Area 3: Innovative Therapies; Area 4: Health Technology Assessment and Bioinformatics. Area 4 translates the results from Areas 1 to 3 to populations and society and reports them back to Area 3 to inform clinical studies and guidelines, and to Areas 1 and 2 to guide further research and development. In a series of international expert workshops, the Oncotyrol International Expert Task Force for Personalized Cancer Medicine developed the Methodological Framework for Early Health Technology Assessment and Decision Modeling in Cancer and practical guidelines in this field. Further projects included applications in the fields of sequential treatment of patients with chronic myeloid leukemia (CML), benefit-harm and cost-effectiveness evaluation of prostate cancer screening, effectiveness and cost-effectiveness of multiple cervical cancer screening strategies, and benefits and cost-effectiveness of genomic test-based treatment strategies in breast cancer. An interdisciplinary setting as generated in Oncotyrol provides unique opportunities such as systematically coordinating lab and bench research, product development, clinical studies and decision science/HTA and transparent joint planning of research and development with a partnership of researchers, manufacturers and health policy decision makers. However, generating a joint research and legal framework with numerous partners from different sectors can be challenging, particularly in the starting period of such an endeavor. The journey to translational personalized medicine through multidisciplinary collaborations may still be long and difficult, but it is evident that it must be continued to turn vision into reality. Copyright © 2015. Published by Elsevier GmbH.

Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme.

PubMed

Walters, Stephen J; Bonacho Dos Anjos Henriques-Cadby, Inês; Bortolami, Oscar; Flight, Laura; Hind, Daniel; Jacques, Richard M; Knox, Christopher; Nadin, Ben; Rothwell, Joanne; Surtees, Michael; Julious, Steven A

2017-03-20

Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43-2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79-97%). There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme

PubMed Central

Bonacho dos Anjos Henriques-Cadby, Inês; Bortolami, Oscar; Flight, Laura; Hind, Daniel; Knox, Christopher; Nadin, Ben; Rothwell, Joanne; Surtees, Michael; Julious, Steven A

2017-01-01

Background Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. Objectives To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. Data sources and study selection HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. Data extraction Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. Main outcome measures Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). Results This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43–2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79–97%). Conclusions There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. PMID:28320800

The use of Long-Lived Tracer Observations to Examine Transport Characteristics in the Lower Stratosphere

NASA Astrophysics Data System (ADS)

Lingenfelser, Gretchen Scott

This thesis explores the problem of uniformly aligning Ferroelectric Liquid Crystals (FLCs) over large areas whilst retaining bistability. A novel high tilt alignment (HTA) is presented and its electro-optic performance is compared to the traditional surface stabilised (SS) alignment using three different devices; test cells, displays and all-fibre optic devices. Evidence is presented to show that the SS alignment has a small surface pretilt of the director which reduces the number of zig-zag defects in parallel aligned cells. This is related to the layer structure and a review of the latest proposed structures of SS devices is presented. The HTA device is shown to have many advantages over the SS device; no zig-zag defects, excellent bistability in up to 6 mum thick cells, good mechanical stability and excellent viewing characteristics when multiplexed. These properties are explored and culminate in the production of two FLC displays, one HTA and one SS aligned. The properties of these displays are compared. In order to improve the appearance and frame time of the displays, multiplexing schemes were investigated, including a novel two slot scheme that was successfully used to drive both displays. It was found that the SS display could be driven in a reverse contrast mode by taking advantage of the relaxation process. This decreased the line address time and produced a higher contrast display. A nematic LC all-fibre optic polariser was produced with excellent extinction ratio (45 dB) and low loss (0.2 dB) using evanescent field coupling. A nematic LC modulator was then demonstrated using a novel electrode arrangement. A modulation depth of 28 dB was achieved using low voltages ( 10V) but with 10 kHz but the modulation depth was poor (8.2 dB) because of the unsuitable refractive indices. The potential and uses of LC all-fibre optic devices are discussed.

Caractéristiques de l'association diabète type 2 et hypertension artérielle chez le sujet âgé de 65 ans et plus

PubMed Central

Diyane, Khadija; El Ansari, Nawal; El Mghari, Ghizlane; Anzid, Karim; Cherkaoui, Mohamed

2013-01-01

Introduction L'HTA du diabétique âgé est particulière par sa fréquence et sa gravité. Cette association HTA-diabète type 2 (DT2) est particulièrement fréquente chez la personne âgée, et responsable d'une majoration du risque cardiovasculaire et d'une accélération de l'atteinte dégénérative du diabète. Méthodes Etude descriptive, concernant 100 patients diabétiques de type 2 hypertendus âgés de 65 ans ou plus, suivis au service d'endocrinologie-diabétologie du CHU de Marrakech, du mois de Novembre 2010 au mois de Juillet 2011. Le logiciel SPSS version 18 a été utilisé pour l'analyse statistique. Résultats Le sex-ratio des patients étudiés était de 0,26, l’âge moyen était de 69,2 ±; 4,3 ans, l'ancienneté du diabète était de 9,3 ±; 6,7 ans. Le diagnostic du diabète précédait celui de l'HTA dans 67,7% des cas. Seulement 4,2% avaient une HbA1c ≤ 6,5%. 60% des patients avaient une HTA de grade I. L'IMC moyen était de 28,1 ±; 4,6 kg/m2. La dyslipidémie était présente chez 59,6% de nos patients avec essentiellement une hypoHDLémie (75,9%). La macroangiopathie était observée chez 40% des patients avec essentiellement une cardiopathie ischémique (29%). Elle était significativement plus fréquente chez les patients ayant une HbA1c supérieure à 9%, LDL-c ≥ 1 g/l et une hypoHDLémie. La microangiopathie présente dans 82% des cas était significativement en relation avec l'HbA1c, le DFG et le taux des triglycérides. Conclusion Une prise en charge complète du risque cardio-vasculaire chez les sujets âgés se heurte à des problèmes objectifs en pratique courante, en particulier, la polymédication, source d'une mauvaise compliance et donc de mauvais résultats. Mots clés: Complications dégénératives, Diabète type 2, Dyslipidémie, Hypertension artérielle, Sujet âgé. PMID:23717715

The Hegemonic Triumvirate--Ideologies, Discourses, and Habitus in Sport and Physical Education: Implications and Suggestions

ERIC Educational Resources Information Center

Fernandez-Balboa, Juan-Miguel; Muros, Beatriz

2006-01-01

In this paper, we introduce the concept of "the hegemonic triumvirate" (HT)--a powerful system of "reality" construction resulting from the interrelation of dominant ideologies, habitus, and discourses. Then, after analyzing HT's components and some of their interrelations within the contexts of sport and physical education (PE), we examine some…

Complete Genome Sequence of the Thermophilic Bacterium Geobacillus thermoleovorans CCB_US3_UF5

PubMed Central

Abdul Rahman, Ahmad Yamin; Saito, Jennifer A.; Hou, Shaobin

2012-01-01

Geobacillus thermoleovorans CCB_US3_UF5 is a thermophilic bacterium isolated from a hot spring in Malaysia. Here, we report the complete genome of G. thermoleovorans CCB_US3_UF5, which shows high similarity to the genome of Geobacillus kaustophilus HTA 426 in terms of synteny and orthologous genes. PMID:22328744

Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops.

PubMed

Craven, Michael P; Allsop, Matthew J; Morgan, Stephen P; Martin, Jennifer L

2012-09-03

With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one. This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE.

Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops

PubMed Central

2012-01-01

Background With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. Methods A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. Results The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one. Conclusion This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE. PMID:22943625

National Database for Autism Research (NDAR): Big Data Opportunities for Health Services Research and Health Technology Assessment.

PubMed

Payakachat, Nalin; Tilford, J Mick; Ungar, Wendy J

2016-02-01

The National Database for Autism Research (NDAR) is a US National Institutes of Health (NIH)-funded research data repository created by integrating heterogeneous datasets through data sharing agreements between autism researchers and the NIH. To date, NDAR is considered the largest neuroscience and genomic data repository for autism research. In addition to biomedical data, NDAR contains a large collection of clinical and behavioral assessments and health outcomes from novel interventions. Importantly, NDAR has a global unique patient identifier that can be linked to aggregated individual-level data for hypothesis generation and testing, and for replicating research findings. As such, NDAR promotes collaboration and maximizes public investment in the original data collection. As screening and diagnostic technologies as well as interventions for children with autism are expensive, health services research (HSR) and health technology assessment (HTA) are needed to generate more evidence to facilitate implementation when warranted. This article describes NDAR and explains its value to health services researchers and decision scientists interested in autism and other mental health conditions. We provide a description of the scope and structure of NDAR and illustrate how data are likely to grow over time and become available for HSR and HTA.

Optoelectronic devices incorporating fluoropolymer compositions for protection

DOEpatents

Chen, Xuming; Chum, Pak-Wing S.; Howard, Kevin E.; Lopez, Leonardo C.; Sumner, William C.; Wu, Shaofu

2015-12-22

The fluoropolymer compositions of the present invention generally incorporate ingredients comprising one or more fluoropolymers, an ultraviolet light protection component (hereinafter UV protection component), and optionally one or more additional ingredients if desired. The UV protection component includes a combination of at least one hindered tertiary amine (HTA) compound having a certain structure and a weight average molecular weight of at least 1000. This tertiary amine is used in combination with at least one organic, UV light absorbing compound (UVLA compound) having a weight average molecular weight greater than 500. When the HTA compound and the UVLA compound are selected according to principles of the present invention, the UV protection component provides fluoropolymer compositions with significantly improved weatherability characteristics for protecting underlying materials, features, structures, components, and/or the like. In particular, fluoropolymer compositions incorporating the UV protection component of the present invention have unexpectedly improved ability to resist blackening, coloration, or other de gradation that may be caused by UV exposure. As a consequence, devices protected by these compositions would be expected to have dramatically improved service life. The compositions have a wide range of uses but are particularly useful for forming protective layers in optoelectronic devices.

Hyperbranched-polymer dispersed nanocomposite volume gratings for holography and diffractive optics

NASA Astrophysics Data System (ADS)

Tomita, Yasuo; Takeuchi, Shinsuke; Oyaizu, Satoko; Urano, Hiroshi; Fukamizu, Taka-aki; Nishimura, Naoya; Odoi, Keisuke

2016-10-01

We review our experimental investigations of photopolymerizable nanoparticle-polymer composites (NPCs) for holography and diffractive optics. Various types of hyperbranched polymer (HBP) were systhesized and used as transporting organic nanoparticles. These HBPs include hyperbranched poly(ethyl methacrylate) (HPEMA), hyperbranched polystyrene (HPS) and hyperbranched triazine/aromatic polymer units (HTA) whose refractive indices are 1.51, 1.61 and 1.82, respectively. Each HBP was dispersed in (meth)acrylate monomer whose refractive index was so chosen that a refractive index difference between HBP and the formed polymer was large. Such monomer-HBP syrup was mixed with a titanocene photoinitiator for volume holographic recording in the green. We used a two-beam interference setup to write an unslanted transmission volume grating at grating spacing of 1 μm and at a wavelength of 532 nm. It is shown that NPC volume gratings with the saturated refractive index modulation amplitudes as large as 0.008, 0.004 and 0.02 can be recorded in NPCs incorporated with HPEMA, HPS and HTA at their optimum concentrations of 34, 34 and 25 vol.%, respectively. We show the usefulness of HBP-dispersed NPC volume gratings for holographic applications such as holographic data storage and diffractive optical devices.

Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain

PubMed Central

Kim, Jin Young; Kwag, Kwang Il

2016-01-01

[Purpose] The purpose of this study was to investigate clinical effects of deep cervical flexor (DCF) muscles exercise on pain, Neck Disability Index (NDI), and neck and shoulder postures in patients with chronic neck pain. [Subjects and Methods] Twenty-eight patients with chronic neck pain were randomly assigned into either the general strengthening exercise (GSE) group or the DCF activation group as control and experimental groups, respectively. All exercises were performed three times per week over 4 weeks. NDI and numeric rating scale (NRS) score for pain were determined and radiological assessment of neck-shoulder postures (head tilt angle [HTA], neck flexion angle [NFA], and forward shoulder angle [FSA]) was performed before (baseline), 4 weeks after, and 8 weeks after exercise in order to directly compare the exercise effects between the groups. [Results] In the DCF group, the NDI, NRS score, and neck-shoulder postures (analyzed by uisng HTA, NFA, and FSA) were significantly improved. [Conclusion] DCF activation exercise was effective to alleviate pain, recover functions, and correct forward head posture in the patients with neck pain. Hence, it might be recommended in the rehabilitation of patients with chronic neck pain. PMID:26957772

Introduction to health economics and decision-making: Is economics relevant for the frontline clinician?

PubMed

Goeree, Ron; Diaby, Vakaramoko

2013-12-01

In a climate of escalating demands for new health care services and significant constraints on new resources, the disciplines of health economics and health technology assessment (HTA) have increasingly been turned to as explicit evidence-based frameworks to help make tough health care access and reimbursement decisions. Health economics is the discipline of economics concerned with the efficient allocation of health care resources, essentially trying to maximize health benefits to society contingent upon available resources. HTA is a broader field drawing upon several disciplines, but which relies heavily upon the tools of health economics and economic evaluation. Traditionally, health economics and economic evaluation have been widely used at the political (macro) and local (meso) decision-making levels, and have progressively had an important role even at informing individual clinical decisions (micro level). The aim of this paper is to introduce readers to health economics and discuss its relevance to frontline clinicians. Particularly, the content of the paper will facilitate clinicians' understanding of the link between economics and their medical practice, and how clinical decision-making reflects on health care resource allocation. Copyright © 2013 Elsevier Ltd. All rights reserved.

Orienting and maintenance of attention to threatening facial expressions in anxiety--an eye movement study.

PubMed

Holas, Pawel; Krejtz, Izabela; Cypryanska, Marzena; Nezlek, John B

2014-12-15

Cognitive models posit that anxiety disorders stem in part from underlying attentional biases to threat. Consistent with this, studies have found that the attentional bias to threat-related stimuli is greater in high vs. low anxious individuals. Nevertheless, it is not clear if similar biases exist for different threatening emotions or for any facial emotional stimulus. In the present study, we used eye-tracking to measure orienting and maintenance of attention to faces displaying anger, fear and disgust as threats, and faces displaying happiness and sadness. Using a free viewing task, we examined differences between low and high trait anxious (HTA) individuals in the attention they paid to each of these emotional faces (paired with a neutral face). We found that initial orienting was faster for angry and happy faces, and high trait anxious participants were more vigilant to fearful and disgust faces. Our results for attentional maintenance were not consistent. The results of the present study suggest that attentional processes may be more emotion-specific than previously believed. Our results suggest that attentional processes for different threatening emotions may not be the same and that attentional processes for some negative and some positive emotions may be similar. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

[Graphic synopsis of implementation of German guideline clearing reports in national disease management guidelines].

PubMed

Thole, Henning

2011-01-01

While methods for the production of guidelines (evidence analysis, assessment, adaptation) have been continually refined throughout the past years, there is a lack of instruments for the production of easily understandable synopses. Definition of a methodological approach to encompass synopses by Spidernet diagrams. Tables of synopses can be generated with distinct information to bring down the main results in one Spidernet diagram. This is possible for both the entire synopsis and parts of it. Guideline comparisons require detailed analyses on the one hand and easily understandable presentations of their results on the other. Guideline synopses can be substantially supported by graphic presentation of the results of synopsis. Graphic synopsis is also helpful in other cases; it may be used, for example, to summarise HTA reports, systematic reviews or guidelines. Copyright © 2011. Published by Elsevier GmbH.

Aspects cliniques, électrocardiographiques et échocardiographiques de l’hypertendu âgé au Sénégal

PubMed Central

Sarr, Simon Antoine; Babaka, Kana; Mboup, Mouhamadou Cherif; Fall, Pape Diadie; Dia, Khadidiatou; Bodian, Malick; Ndiaye, Mouhamadou Bamba; Kane, Adama; Diao, Maboury; Ba, Serigne Abdou

2016-01-01

Introduction L’hypertension artérielle (HTA) du sujet âgé est un facteur indépendant de maladie cardio-vasculaire. Nos objectifs étaient de décrire les aspects cliniques, électrocardiographique et échocardiographiques de l’HTA du sujet âgé. Méthodes Nous avons mené une étude descriptive et transversale de Janvier à Septembre 2013. Etaient inclus les sujets hypertendus âgés d’au moins 60 ans suivis en ambulatoire au service de cardiologie de l’Hôpital Principal de Dakar. Les données statistiques étaient analysées par le logiciel Epi Info 7 et une valeur de p < 0,05 était retenue comme significative. Résultats Au total, 208 patients étaient inclus. L’âge moyen était de 69,9 ans avec une prédominance féminine (sex-ratio de 0,85). La pression artérielle moyenne était de 162/90mmHg. L’HTA était contrôlée dans 13% des cas. A l’électrocardiogramme, on notait un trouble du rythme (17,78%), une hypertrophie auriculaire gauche (45,19%), une hypertrophie ventriculaire gauche (28,85%) et 2 cas de bloc auriculo-ventriculaire complet. Le Holter ECG révélait 4 cas de tachycardie ventriculaire non soutenue (IVb de Lown), 6 cas de fibrillation atriale paroxystique et 1 cas de flutter atrial paroxystique. L’échocardiographie réalisée chez 140 patients retrouvait une HVG à prédominance concentrique chez 25 patients, plus fréquente chez les hommes (p=0,04) et une dilatation de l’oreillette gauche dans 56,42% des cas, plus fréquente chez les patients plus âgés (p= 0,01). Conclusion Les aspects électrocardiographiques et échocardiographiques dans la population hypertendue âgée sont caractérisés par l’hypertrophie ventriculaire gauche notamment concentrique, la fréquence des arythmies révélées quelques fois par l’enregistrement électrocardiographique de longue durée. PMID:28292040

Development, implementation and evaluation of an evidence-based program for introduction of new health technologies and clinical practices in a local healthcare setting.

PubMed

Harris, Claire; Garrubba, Marie; Allen, Kelly; King, Richard; Kelly, Cate; Thiagarajan, Malar; Castleman, Beverley; Ramsey, Wayne; Farjou, Dina

2015-12-28

This paper reports the process of establishing a transparent, accountable, evidence-based program for introduction of new technologies and clinical practices (TCPs) in a large Australian healthcare network. Many countries have robust evidence-based processes for assessment of new TCPs at national level. However many decisions are made by local health services where the resources and expertise to undertake health technology assessment (HTA) are limited and a lack of structure, process and transparency has been reported. An evidence-based model for process change was used to establish the program. Evidence from research and local data, experience of health service staff and consumer perspectives were incorporated at each of four steps: identifying the need for change, developing a proposal, implementation and evaluation. Checklists assessing characteristics of success, factors for sustainability and barriers and enablers were applied and implementation strategies were based on these findings. Quantitative and qualitative methods were used for process and outcome evaluation. An action research approach underpinned ongoing refinement to systems, processes and resources. A Best Practice Guide developed from the literature and stakeholder consultation identified seven program components: Governance, Decision-Making, Application Process, Monitoring and Reporting, Resources, Administration, and Evaluation and Quality Improvement. The aims of transparency and accountability were achieved. The processes are explicit, decisions published, outcomes recorded and activities reported. The aim of ascertaining rigorous evidence-based information for decision-making was not achieved in all cases. Applicants proposing new TCPs provided the evidence from research literature and local data however the information was often incorrect or inadequate, overestimating benefits and underestimating costs. Due to these limitations the initial application process was replaced by an Expression of Interest from applicants followed by a rigorous HTA by independent in-house experts. The program is generalisable to most health care organisations. With one exception, the components would be achievable with minimal additional resources; the lack of skills and resources required for HTA will limit effective application in many settings. A toolkit containing details of the processes and sample materials is provided to facilitate replication or local adaptation by those wishing to establish a similar program.

Methods applied in cost-effectiveness models for treatment strategies in type 2 diabetes mellitus and their use in Health Technology Assessments: a systematic review of the literature from 2008 to 2013.

PubMed

Charokopou, M; Sabater, F J; Townsend, R; Roudaut, M; McEwan, P; Verheggen, B G

2016-01-01

To identify and compare health-economic models that were developed to evaluate the cost-effectiveness of treatments for type 2 diabetes mellitus (T2DM), and their use within Health Technology Assessments (HTAs). In total, six commonly used databases were searched for articles published between October 2008 and January 2013, using a protocolized search strategy and inclusion criteria. The websites of HTA organizations in nine countries, and proceedings from five relevant conferences, were also reviewed. The identified new health-economic models were qualitatively assessed using six criteria that were developed based on technical components, and characteristics related to the disease or the treatments being assessed. Finally, the number of times the models were applied within HTA reports, published literature, and/or major conferences was determined. Thirteen new models were identified and reviewed in depth. Most of these were based on identical key data sources, and applied a similar model structure, either using Markov modeling or microsimulation techniques. The UKPDS equations and panel regressions were frequently used to estimate the occurrence of diabetes-related complications and the probability of developing risk factors in the long term. The qualitative assessment demonstrated that the CARDIFF, Sheffield T2DM and ECHO T2DM models seem technically equipped to appropriately assess the long-term health-economic consequences of chronic treatments for patients with T2DM. It was observed that the CORE model is the most widely described in literature and conferences, and the most often applied model within HTA submissions, followed by the CARDIFF and UKPDS models. This research provides an overview of T2DM models that were developed between 2008 and January 2013. The outcomes of the qualitative assessments, combined with frequent use in local reimbursement decisions, prove the applicability of the CORE, CARDIFF and UKPDS models to address decision problems related to the long-term clinical and economic consequences of new and existing T2DM treatments.

Horizon scanning of new and emerging medical technology in Australia: its relevance to Medical Services Advisory Committee health technology assessments and public funding.

PubMed

O'Malley, Sue P; Jordan, Ernest

2009-07-01

In 1998, a formal process using full health technology assessments (HTAs) was implemented to determine the suitability for public subsidy of new and emerging medical technologies in the Australian private healthcare sector. This process is overseen by the Medical Services Advisory Committee (MSAC). In 2004, horizon scanning was introduced in Australia with the stated objective of identifying new and emerging medical technologies into the public healthcare sector, with consideration to the publicly subsidized private healthcare sector. How well horizon scanning works in identifying new and emerging technologies suitable for government subsidized funding in the private healthcare sector is examined in this study. A descriptive evaluation of the impact of horizon scanning as an early alert and awareness system identifying new and emerging technologies before these technologies are submitted to MSAC for a full HTA. All MSAC HTAs commenced after the introduction of horizon scanning in 2004 were cross-checked with the list of Prioritizing Summaries or Horizon Scanning Reports to determine whether a prior Prioritizing Summary or Horizon Scanning Report had been carried out. Of the forty-three technologies that were the subject of a full MSAC HTAs in the time period examined, only eleven had been the subject of either a Prioritizing Summary or Horizon Scanning Report. As a result of a full MSAC HTA, twelve of the technologies that were not the subject of a Prioritizing Summary or Horizon Scanning Report were given positive recommendations for public funding. Horizon scanning was set up to scan the introduction of new and emerging medical technologies into the public healthcare sector, with consideration to the publicly subsidized private healthcare sector. Based on the number of new and emerging technologies that have been the subject of a full MSAC HTA without first being subjected to either a Prioritizing Summary or Horizon Scanning Report, horizon scanning in Australia does not function as an "early alert and awareness system" for funding in the publicly subsidized private healthcare sector in Australia.

Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries.

PubMed

Kleijnen, S; Lipska, I; Leonardo Alves, T; Meijboom, K; Elsada, A; Vervölgyi, V; d'Andon, A; Timoney, A; Leufkens, H G; De Boer, A; Goettsch, W G

2016-09-01

There is a debate on the added clinical value of new, expensive, anticancer treatments. Among European decision makers, the relevance of commonly used end points in trials, especially overall survival (OS), progression-free survival (PFS) and quality of life (QoL), varies, leading to the available evidence being valued differently. This research studies the extent to which the value of end points for cancer medicines differs among European decision makers. We compared guidelines and relative effectiveness assessments (REAs) of medicines for pricing or reimbursement decisions in England, France, Germany, The Netherlands, Poland, and Scotland. Anticancer medicines that received marketing authorization in Europe between 2011 and 2013 with at least four available national REAs were evaluated. A total of 79 REAs were included. Health technology assessment (HTA) guidelines indicate a preference for clinically and patient relevant end points such as OS and QoL above surrogate end points. Most guidelines do not specify whether PFS is considered a surrogate or patient-relevant end point. The number of REAs included per jurisdiction varied between 7 (The Netherlands) and 18 (Germany). OS data were included in all REAs and were the preferred end point by HTA agencies, but these data were not always mature or robust. QoL data are included in only 54% of the REAs, with a limited impact on the recommendations. PFS data are included in 70% of the REAs, but the extent to which HTA agencies find PFS relevant varies. European decision-making on relative effectiveness of anticancer medicines is affected by a gap in requested versus available clinical evidence, mainly because the regulator is willing to accept some degree of clinical uncertainty. A multi-stakeholder debate would be essential to align concrete robust evidence requirements in oncology and a collectively shared definition for relevant clinical benefit, which will benefit patients and society in general. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

[Prospective study of gluco-lipidic hormone and peptide levels in morbidly obese patients after sleeve gastrectomy].

PubMed

Bruna, Marcos; Gumbau, Verónica; Guaita, Marcos; Canelles, Enrique; Mulas, Claudia; Basés, Carla; Celma, Isabel; Puche, José; Marcaida, Goitzane; Oviedo, Miguel; Vázquez, Antonio

2014-03-01

Different hormones and peptides involved in lipid and carbohydrate metabolism have been studied in relation to morbid obesity and its variation after bariatric surgery. The aim of this study is toevaluate variations in different molecules related to glico-lipidic metabolism during the first year after sleeve gastrectomy in morbidly obese patients. Prospective study in patients undergoing sleeve gastrectomy between November 2009 and January 2011. We analyzed changes in different clinical, anthropometric and analytic parameters related with glico-lipidic metabolism in all patients in the preoperative period, first postoperative day, fifth day, one month, 6 months and one year after surgery. Statistical analysis was performed using SPSS 20.0. We included 20 patients, 60% were women with a median of age of 45 years. Median of body mass index (IMC) was 48,5 kg/m(2) and 70% had obstructive sleep apnea syndrome (SAOS), 65% arterial hypertension (HTA), 45% dyslipidemia and 40% diabetes mellitus. One year after surgery, the percentage of excess of BMI loss was 72% and the rate of cure or improvement of dyslipidemia was 100%, diabetes 87,5%, HTA 84,6% and SAOS 57,1%. At this time, glycemia levels decreased significantly (P<.001), and levels of IGF-1 and HDL-cholesterol increased significantly. Levels of adiponectine increased and leptine (P=.003), insulin (P=.004) and triglycerides (P=.016) decreased significantly one year after the surgery. ACTH levels (that decreased during first 6 months after surgery), glycosilated hemoglobin, total cholesterol and LDL-cholesterol had no changes one year after surgery. Sleeve gastrectomy is a surgical technique with good results of weight loss and cure of comorbidities. This procedure induces significant modifications in blood levels of glico-lipidic metabolism related peptides and hormones, such as glucose, IGF-1, insulin, leptin, triglycerides and HDL-cholesterol. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

Accuracy of LightCycler(R) SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis: a systematic review protocol.

PubMed

Dark, Paul; Wilson, Claire; Blackwood, Bronagh; McAuley, Danny F; Perkins, Gavin D; McMullan, Ronan; Gates, Simon; Warhurst, Geoffrey

2012-01-01

Background There is growing interest in the potential utility of molecular diagnostics in improving the detection of life-threatening infection (sepsis). LightCycler® SeptiFast is a multipathogen probe-based real-time PCR system targeting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here the protocol of the first systematic review of published clinical diagnostic accuracy studies of this technology when compared with blood culture in the setting of suspected sepsis. Methods/design Data sources: the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment Database (HTA), the NHS Economic Evaluation Database (NHSEED), The Cochrane Library, MEDLINE, EMBASE, ISI Web of Science, BIOSIS Previews, MEDION and the Aggressive Research Intelligence Facility Database (ARIF). diagnostic accuracy studies that compare the real-time PCR technology with standard culture results performed on a patient's blood sample during the management of sepsis. three reviewers, working independently, will determine the level of evidence, methodological quality and a standard data set relating to demographics and diagnostic accuracy metrics for each study. Statistical analysis/data synthesis: heterogeneity of studies will be investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in Receiver Operator Characteristic (ROC) space. Bivariate model method will be used to estimate summary sensitivity and specificity. The authors will investigate reporting biases using funnel plots based on effective sample size and regression tests of asymmetry. Subgroup analyses are planned for adults, children and infection setting (hospital vs community) if sufficient data are uncovered. Dissemination Recommendations will be made to the Department of Health (as part of an open-access HTA report) as to whether the real-time PCR technology has sufficient clinical diagnostic accuracy potential to move forward to efficacy testing during the provision of routine clinical care. Registration PROSPERO-NIHR Prospective Register of Systematic Reviews (CRD42011001289).

Social and ethical analysis in health technology assessment.

PubMed

Tantivess, Sripen

2014-05-01

This paper presents a review of the domestic and international literature on the assessment of the social and ethical implications of health technologies. It gives an overview of the key concepts, principles, and approaches that should be taken into account when conducting a social and ethical analysis within health technology assessment (HTA). Although there is growing consensus among healthcare experts that the social and ethical ramifications of a given technology should be examined before its adoption, the demand for this kind of analysis among policy-makers around the world, including in Thailand, has so far been lacking. Currently decision-makers mainly base technology adoption decisions using evidence on clinical effectiveness, value for money, and budget impact, while social and ethical aspects have been neglected. Despite the recognized importance of considering equity, justice, and social issues when making decisions regarding health resource allocation, the absence of internationally-accepted principles and methodologies, among other factors, hinders research in these areas. Given that developing internationally agreed standards takes time, it has been recommended that priority be given to defining processes that are justifiable, transparent, and contestable. A discussion of the current situation in Thailand concerning social and ethical analysis of health technologies is also presented.

If it ain't broke, don't price fix it: the OFT and the PPRS.

PubMed

Towse, Adrian

2007-07-01

The Office of Fair Trading (OFT) Report on the UK Pharmaceutical Price Regulation Scheme (PPRS) recommends that when the current five-year PPRS expires in 2010 it be replaced with 'value-based pricing' which involves pre-launch centralised government price setting based on a cost-per-QALY threshold plus periodic ex post reviews. I examine the validity of the OFTs criticisms of the existing PPRS, review its proposals and propose an alternative way forward. I conclude that PPRS has performed well as a procurement bargain between industry and the UK government. It does not, however, incentivise efficient relative prices. That is not its job. I identify a number of problems with the OFT proposals. I recommend that key elements of a reformed UK pharmaceutical environment for 2010 should include an expanded role for HTA but with companies retaining freedom to set prices at launch; HTA use targeted via a contingent value of information approach; a retained backstop PPRS, perhaps moving to an RPI-X type control; the use of risk sharing and non-linear pricing arrangements; measures to ensure more effective therapeutic switching at local level; and measures to improve the take up of cost-effective treatments. Copyright (c) 2007 John Wiley & Sons, Ltd.

Health state utility values in locally advanced and metastatic breast cancer by treatment line: a systematic review.

PubMed

Paracha, Noman; Thuresson, Per-Olof; Moreno, Santiago G; MacGilchrist, Katherine S

2016-10-01

For patients with late-stage (metastatic) breast cancer, the impact of treatment on health-related quality of life is a key factor in decision-making. A systematic review was conducted to identify health state utility values (HSUVs) for late-stage breast cancer, derived using methods preferred by health technology assessment (HTA) agencies, by treatment line. The aim was to generate a list of HSUVs, that could help to justify the values used to populate cost-utility models. Areas covered: Ten electronic databases, international congress websites and online HSUV databases were searched (January 1995-May 2014) for HSUVs for adults with late-stage breast cancer that had been derived from methods favoured by HTA agencies. Publications were included only if they reported studies that originated HSUVs. Expert commentary: Large numbers of HSUVs are available for late-stage breast cancer in the published literature. Contrary to expectations, the HSUVs reported in the literature vary greatly for some health states. As a result, the choice of HSUV can have considerable implications for the outcomes of economic evaluations. Standardization of HSUV methodology is expected to reduce variability; however, further research is recommended for assessing the sensitivity of generic preference-based measures in late-stage (metastatic) breast cancer.

Are adverse effects incorporated in economic models? An initial review of current practice.

PubMed

Craig, D; McDaid, C; Fonseca, T; Stock, C; Duffy, S; Woolacott, N

2009-12-01

To identify methodological research on the incorporation of adverse effects in economic models and to review current practice. Major electronic databases (Cochrane Methodology Register, Health Economic Evaluations Database, NHS Economic Evaluation Database, EconLit, EMBASE, Health Management Information Consortium, IDEAS, MEDLINE and Science Citation Index) were searched from inception to September 2007. Health technology assessment (HTA) reports commissioned by the National Institute for Health Research (NIHR) HTA programme and published between 2004 and 2007 were also reviewed. The reviews of methodological research on the inclusion of adverse effects in decision models and of current practice were carried out according to standard methods. Data were summarised in a narrative synthesis. Of the 719 potentially relevant references in the methodological research review, five met the inclusion criteria; however, they contained little information of direct relevance to the incorporation of adverse effects in models. Of the 194 HTA monographs published from 2004 to 2007, 80 were reviewed, covering a range of research and therapeutic areas. In total, 85% of the reports included adverse effects in the clinical effectiveness review and 54% of the decision models included adverse effects in the model; 49% included adverse effects in the clinical review and model. The link between adverse effects in the clinical review and model was generally weak; only 3/80 (< 4%) used the results of a meta-analysis from the systematic review of clinical effectiveness and none used only data from the review without further manipulation. Of the models including adverse effects, 67% used a clinical adverse effects parameter, 79% used a cost of adverse effects parameter, 86% used one of these and 60% used both. Most models (83%) used utilities, but only two (2.5%) used solely utilities to incorporate adverse effects and were explicit that the utility captured relevant adverse effects; 53% of those models that included utilities derived them from patients on treatment and could therefore be interpreted as capturing adverse effects. In total, 30% of the models that included adverse effects used withdrawals related to drug toxicity and therefore might be interpreted as using withdrawals to capture adverse effects, but this was explicitly stated in only three reports. Of the 37 models that did not include adverse effects, 18 provided justification for this omission, most commonly lack of data; 19 appeared to make no explicit consideration of adverse effects in the model. There is an implicit assumption within modelling guidance that adverse effects are very important but there is a lack of clarity regarding how they should be dealt with and considered in modelling. In many cases a lack of clear reporting in the HTAs made it extremely difficult to ascertain what had actually been carried out in consideration of adverse effects. The main recommendation is for much clearer and explicit reporting of adverse effects, or their exclusion, in decision models and for explicit recognition in future guidelines that 'all relevant outcomes' should include some consideration of adverse events.

Handling time in economic evaluation studies.

PubMed

Permsuwan, Unchalee; Guntawongwan, Kansinee; Buddhawongsa, Piyaluk

2014-05-01

The discount rates and time horizons used in a health technology assessment (HTA) can have a significant impact on the results, and thus the prioritization of technologies. Therefore, it is important that clear guidance be provided on the appropriate discount rates for cost and health effect and appropriate time horizons. In this paper we conduct a review of relevant case studies and guidelines and provide guidance for all researchers conducting economic evaluations of health technologies in the Thai context. A uniform discount rate of 3% is recommended for both costs and health effects in base case analyses. A sensitivity analysis should also be conducted, with a discount range of 0-6%. For technologies where the effects are likely to sustain for at least 30y ears, a rate of 4% for costs and 2% for health effects is recommended. The time horizon should be long enough to capture the full costs and effects of the programs.

1987 Annual Tropical Cyclone Report

DTIC Science & Technology

1987-01-01

Significant Tropical Weather Adviso~~ es : issued daily, these products describe all tropical disturbances and assess their potential for further...COA3fm communicati~ estimates ofcurnmf andfmecast intensity ahiveffj%m sateC & a!hta. In tlie a.yampk,the current ‘T-number’ is 3.$ fiut the cun-ent...DEVIATION : 111 = ES : 465 Figure 5-2B. Frequeney di.s~”buticnt of th 48-hourforecast emorsin 30 nm (56 ~m) increnwttsfor dsignif~ant tropicalyclk.s in

Use of the AHP methodology in system dynamics: Modelling and simulation for health technology assessments to determine the correct prosthesis choice for hernia diseases.

PubMed

Improta, Giovanni; Russo, Mario Alessandro; Triassi, Maria; Converso, Giuseppe; Murino, Teresa; Santillo, Liberatina Carmela

2018-05-01

Health technology assessments (HTAs) are often difficult to conduct because of the decisive procedures of the HTA algorithm, which are often complex and not easy to apply. Thus, their use is not always convenient or possible for the assessment of technical requests requiring a multidisciplinary approach. This paper aims to address this issue through a multi-criteria analysis focusing on the analytic hierarchy process (AHP). This methodology allows the decision maker to analyse and evaluate different alternatives and monitor their impact on different actors during the decision-making process. However, the multi-criteria analysis is implemented through a simulation model to overcome the limitations of the AHP methodology. Simulations help decision-makers to make an appropriate decision and avoid unnecessary and costly attempts. Finally, a decision problem regarding the evaluation of two health technologies, namely, the evaluation of two biological prostheses for incisional infected hernias, will be analysed to assess the effectiveness of the model. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Alcohol use and pregnancy consensus clinical guidelines.

PubMed

Carson, George; Cox, Lori Vitale; Crane, Joan; Croteau, Pascal; Graves, Lisa; Kluka, Sandra; Koren, Gideon; Martel, Marie-Jocelyne; Midmer, Deana; Nulman, Irena; Poole, Nancy; Senikas, Vyta; Wood, Rebecca

2010-08-01

to establish national standards of care for the screening and recording of alcohol use and counselling on alcohol use of women of child-bearing age and pregnant women based on the most up-to-date evidence. published literature was retrieved through searches of PubMed, CINAHL, and the Cochrane Library in May 2009 using appropriate controlled vocabulary (e.g., pregnancy complications, alcohol drinking, prenatal care) and key words (e.g., pregnancy, alcohol consumption, risk reduction). Results were restricted to literature published in the last five years with the following research designs: systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment (HTA) and HTA-related agencies, national and international medical specialty societies, clinical practice guideline collections, and clinical trial registries. Each article was screened for relevance and the full text acquired if determined to be relevant. The evidence obtained was reviewed and evaluated by the members of the Expert Workgroup established by the Society of Obstetricians and Gynaecologists of Canada. The quality of evidence was evaluated and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care. the quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table 1). the Public Health Agency of Canada and the Society of Obstetricians and Gynaecologists of Canada. these consensus guidelines have been endorsed by the Association of Obstetricians and Gynecologists of Quebec; the Canadian Association of Midwives; the Canadian Association of Perinatal, Women's Health and Neonatal Nurses (CAPWHN); the College of Family Physicians of Canada; the Federation of Medical Women of Canada; the Society of Rural Physicians of Canada; and Motherisk. SUMMARY STATEMENTS: 1. There is evidence that alcohol consumption in pregnancy can cause fetal harm. (II-2) There is insufficient evidence regarding fetal safety or harm at low levels of alcohol consumption in pregnancy. (III) 2. There is insufficient evidence to define any threshold for low-level drinking in pregnancy. (III) 3. Abstinence is the prudent choice for a woman who is or might become pregnant. (III) 4. Intensive culture-, gender-, and family-appropriate interventions need to be available and accessible for women with problematic drinking and/or alcohol dependence. (II-2). 1. Universal screening for alcohol consumption should be done periodically for all pregnant women and women of child-bearing age. Ideally, at-risk drinking could be identified before pregnancy, allowing for change. (II-2B) 2. Health care providers should create a safe environment for women to report alcohol consumption. (III-A) 3. The public should be informed that alcohol screening and support for women at risk is part of routine women's health care. (III-A) 4. Health care providers should be aware of the risk factors associated with alcohol use in women of reproductive age. (III-B) 5. Brief interventions are effective and should be provided by health care providers for women with at-risk drinking. (II-2B) 6. If a woman continues to use alcohol during pregnancy, harm reduction/treatment strategies should be encouraged. (II-2B) 7. Pregnant women should be given priority access to withdrawal management and treatment. (III-A) 8. Health care providers should advise women that low-level consumption of alcohol in early pregnancy is not an indication for termination of pregnancy. (II-2A).

Genome-wide identification of physically clustered genes suggests chromatin-level co-regulation in male reproductive development in Arabidopsis thaliana

PubMed Central

Reimegård, Johan; Kundu, Snehangshu; Pendle, Ali; Irish, Vivian F.; Shaw, Peter

2017-01-01

Abstract Co-expression of physically linked genes occurs surprisingly frequently in eukaryotes. Such chromosomal clustering may confer a selective advantage as it enables coordinated gene regulation at the chromatin level. We studied the chromosomal organization of genes involved in male reproductive development in Arabidopsis thaliana. We developed an in-silico tool to identify physical clusters of co-regulated genes from gene expression data. We identified 17 clusters (96 genes) involved in stamen development and acting downstream of the transcriptional activator MS1 (MALE STERILITY 1), which contains a PHD domain associated with chromatin re-organization. The clusters exhibited little gene homology or promoter element similarity, and largely overlapped with reported repressive histone marks. Experiments on a subset of the clusters suggested a link between expression activation and chromatin conformation: qRT-PCR and mRNA in situ hybridization showed that the clustered genes were up-regulated within 48 h after MS1 induction; out of 14 chromatin-remodeling mutants studied, expression of clustered genes was consistently down-regulated only in hta9/hta11, previously associated with metabolic cluster activation; DNA fluorescence in situ hybridization confirmed that transcriptional activation of the clustered genes was correlated with open chromatin conformation. Stamen development thus appears to involve transcriptional activation of physically clustered genes through chromatin de-condensation. PMID:28175342

Nanobarcode gene expression monitoring system for potential miniaturized space applications

NASA Astrophysics Data System (ADS)

Ruan, Weiming; Eastman, P. Scott; Cooke, Patrick A.; Park, Jennifer S.; Chu, Julia S. F.; Gray, Joe W.; Li, Song; Chen, Fanqing Frank

Manned mission to space has been threatened by various cosmos risks including radiation, mirogravity, vacuum, confinement, etc., which may cause genetic variations of astronauts and eventually lead to damages of their health. Thus, the development of small biomedical devices, which can monitor astronaut gene expression changes, is useful for future long-term space missions. Using magnetic microbeads packed with nanocrystal quantum dots at controlled ratios, we were able to generate highly multiplexed nanobarcodes, which can encode a flexible panel of genes. Also, by using a reporter quantum dot, this nanobarcode platform can monitor and quantify gene expression level with improved speed and sensitivity. As a comparison, we studied TGF-β1 induced transcription changes in human bone marrow mesenchymal stem cells with both the nanobarcode microbead system and the Affymetrix GeneChip ® HTA system, which is currently considered as the industrial standard. Though using only 1/20 of the sample RNA, the nanobarcode system showed sensitivity equivalent to Affymetrix GeneChip ® system. The coefficient of variation, dynamic range, and accuracy of the nanobarcodes measurement is equivalent to that of the GeneChip ® HTA system. Therefore, this newly invented nanobarcode microbead platform is thought to be sensitive, flexible, cost-effective and accurate in a level equivalent to the conventional methods. As an extension of the use of this new platform, spacecrafts may carry this miniaturized system as a diagnostic tool for the astronauts.

Isolation and structural characterisation of two antibacterial free fatty acids from the marine diatom, Phaeodactylum tricornutum.

PubMed

Desbois, Andrew P; Lebl, Tomas; Yan, Liming; Smith, Valerie J

2008-12-01

One solution to the global crisis of antibiotic resistance is the discovery of novel antimicrobial compounds for clinical application. Marine organisms are an attractive and, as yet, relatively untapped resource of new natural products. Cell extracts from the marine diatom, Phaeodactylum tricornutum, have antibacterial activity and the fatty acid, eicosapentaenoic acid (EPA), has been identified as one compound responsible for this activity. During the isolation of EPA, it became apparent that the extracts contained further antibacterial compounds. The present study was undertaken to isolate these additional antibacterial factors using silica column chromatography and reverse-phase high-performance liquid chromatography. Two antibacterial fractions, each containing a pure compound, were isolated and their chemical structures were investigated by mass spectrometry and nuclear magnetic resonance spectroscopy. The antibacterial compounds were identified as the monounsaturated fatty acid (9Z)-hexadecenoic acid (palmitoleic acid; C16:1 n-7) and the relatively unusual polyunsaturated fatty acid (6Z, 9Z, 12Z)-hexadecatrienoic acid (HTA; C16:3 n-4). Both are active against Gram-positive bacteria with HTA further inhibitory to the growth of the Gram-negative marine pathogen, Listonella anguillarum. Palmitoleic acid is active at micro-molar concentrations, kills bacteria rapidly, and is highly active against multidrug-resistant Staphylococcus aureus. These free fatty acids warrant further investigation as a new potential therapy for drug-resistant infections.

Health State Utility Values for Age-Related Macular Degeneration: Review and Advice.

PubMed

Butt, Thomas; Tufail, Adnan; Rubin, Gary

2017-02-01

Health state utility values are a major source of uncertainty in economic evaluations of interventions for age-related macular degeneration (AMD). This review identifies and critiques published utility values and methods for eliciting de novo utility values in AMD. We describe how utility values have been used in healthcare decision making and provide guidance on the choice of utility values for future economic evaluations for AMD. Literature was searched using PubMed, and health technology assessments (HTA) were searched using HTA agency websites to identify articles reporting utility values or approaches to derive utility values in AMD and articles applying utilities for use in healthcare decision making relating to treatments for AMD. A total of 70 studies qualified for data extraction, 22 of which were classified as containing utility values and/or elicitation methods, and 48 were classified as using utility values in decision making. A large number of studies have elicited utility values for AMD, although those applied to decision making have focused on a few of these. There is an appreciation of the challenges in the measurement and valuation of health states, with recent studies addressing challenges such as the insensitivity of generic health-related quality of life (HRQoL) questionnaires and utility in the worse-seeing eye. We would encourage careful consideration when choosing utility values in decision making and an explicit critique of their applicability to the decision problem.

The chemical composition of tertiary Indian coal ash and its combustion behaviour - a statistical approach: Part 2

NASA Astrophysics Data System (ADS)

Sharma, Arpita; Saikia, Ananya; Khare, Puja; Dutta, D. K.; Baruah, B. P.

2014-08-01

In Part 1 of the present investigation, 37 representative Eocene coal samples of Meghalaya, India were analyzed and their physico-chemical characteristics and the major oxides and minerals present in ash samples were studied for assessing the genesis of these coals. Various statistical tools were also applied to study their genesis. The datasets from Part 1 used in this investigation (Part 2) show the contribution of major oxides towards ash fusion temperatures (AFTs). The regression analysis of high temperature ash (HTA) composition and initial deformation temperature (IDT) show a definite increasing or decreasing trend, which has been used to determine the predictive indices for slagging, fouling, and abrasion propensities during combustion practices. The increase or decrease of IDT is influenced by the increase of Fe2O3, Al2O3, SiO2, and CaO, respectively. Detrital-authigenic index (DAI) calculated from the ash composition and its relation with AFT indicates Sialoferric nature of these coals. The correlation analysis, Principal Component Analysis (PCA), and Hierarchical Cluster Analysis (HCA) were used to study the possible fouling, slagging, and abrasion potentials in boilers during the coal combustion processes. A positive relationship between slagging and heating values of the coal has been found in this study.

[How it should be enabled network cooperation on healthcare services. Towards an HispaNICE?

PubMed

Abellán Perpiñán, José María; Martínez Pérez, Jorge Eduardo

2016-11-01

Although the Spanish Network of Health Technology Assessment was founded in 2012, it is true that its actual influence on the rationalization of the National Health System's healthcare basket is scarce. The main argument of this article is that the Spanish Network of HTA should work "as if" it was an HispaNICE. That is to say, transferring the NICE's advantages to Spanish context. Copyright © 2016. Publicado por Elsevier España, S.L.U.

Influence of initial heating during final high temperature annealing on the offset of primary and secondary recrystallization in Cu-bearing grain oriented electrical steels

NASA Astrophysics Data System (ADS)

Rodriguez-Calvillo, P.; Leunis, E.; Van De Putte, T.; Jacobs, S.; Zacek, O.; Saikaly, W.

2018-04-01

The industrial production route of Grain Oriented Electrical Steels (GOES) is complex and fine-tuned for each grade. Its metallurgical process requires in all cases the abnormal grain growth (AGG) of the Goss orientation during the final high temperature annealing (HTA). The exact mechanism of AGG is not yet fully understood, but is controlled by the different inhibition systems, namely MnS, AlN and CuxS, their size and distribution, and the initial primary recrystallized grain size. Therefore, among other parameters, the initial heating stage during the HTA is crucial for the proper development of primary and secondary recrystallized microstructures. Cold rolled 0.3 mm Cu-bearing Grain Oriented Electrical Steel has been submitted to interrupted annealing experiments in a lab tubular furnace. Two different annealing cycles were applied:• Constant heating at 30°C/h up to 1000°C. Two step cycle with initial heating at 100°C/h up to 600°C, followed by 18 h soaking at 600°C and then heating at 30°C/h up to 1050°C. The materials are analyzed in terms of their magnetic properties, grain size, texture and precipitates. The characteristic magnetic properties are analyzed for the different extraction temperatures and Cycles. As the annealing was progressing, the coercivity values (Hc 1.7T [A/m]) decreased, showing two abrupt drops, which can be associated to the on-set of primary and secondary recrystallization. The primary recrystallized grain sizes and recrystallized fractions are fitted to a model using a non-isothermal approach. This analysis shows that, although the resulting grain sizes were similar, the kinetics for the two step annealing were faster due to the lower recovery. The on-set of secondary recrystallization was also shifted to higher temperatures in the case of the continuous heating cycle, which might end in different final grain sizes and final magnetic properties. In both samples, nearly all the observed precipitates are Al-Si-Mn nitrides, ranging from pure AlN to Si4Mn-nitride.

Accuracy of LightCycler® SeptiFast for the detection and identification of pathogens in the blood of patients with suspected sepsis: a systematic review protocol

PubMed Central

Wilson, Claire; Blackwood, Bronagh; McAuley, Danny F; Perkins, Gavin D; McMullan, Ronan; Gates, Simon; Warhurst, Geoffrey

2012-01-01

Background There is growing interest in the potential utility of molecular diagnostics in improving the detection of life-threatening infection (sepsis). LightCycler® SeptiFast is a multipathogen probe-based real-time PCR system targeting DNA sequences of bacteria and fungi present in blood samples within a few hours. We report here the protocol of the first systematic review of published clinical diagnostic accuracy studies of this technology when compared with blood culture in the setting of suspected sepsis. Methods/design Data sources: the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment Database (HTA), the NHS Economic Evaluation Database (NHSEED), The Cochrane Library, MEDLINE, EMBASE, ISI Web of Science, BIOSIS Previews, MEDION and the Aggressive Research Intelligence Facility Database (ARIF). Study selection: diagnostic accuracy studies that compare the real-time PCR technology with standard culture results performed on a patient's blood sample during the management of sepsis. Data extraction: three reviewers, working independently, will determine the level of evidence, methodological quality and a standard data set relating to demographics and diagnostic accuracy metrics for each study. Statistical analysis/data synthesis: heterogeneity of studies will be investigated using a coupled forest plot of sensitivity and specificity and a scatter plot in Receiver Operator Characteristic (ROC) space. Bivariate model method will be used to estimate summary sensitivity and specificity. The authors will investigate reporting biases using funnel plots based on effective sample size and regression tests of asymmetry. Subgroup analyses are planned for adults, children and infection setting (hospital vs community) if sufficient data are uncovered. Dissemination Recommendations will be made to the Department of Health (as part of an open-access HTA report) as to whether the real-time PCR technology has sufficient clinical diagnostic accuracy potential to move forward to efficacy testing during the provision of routine clinical care. Registration PROSPERO—NIHR Prospective Register of Systematic Reviews (CRD42011001289). PMID:22240646

Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework.

PubMed

Pfadenhauer, Lisa M; Gerhardus, Ansgar; Mozygemba, Kati; Lysdahl, Kristin Bakke; Booth, Andrew; Hofmann, Bjørn; Wahlster, Philip; Polus, Stephanie; Burns, Jacob; Brereton, Louise; Rehfuess, Eva

2017-02-15

The effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions. The Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework. The CICI framework comprises three dimensions-context, implementation and setting-which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments. The CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders.

Gender Difference of Unconscious Attentional Bias in High Trait Anxiety Individuals

PubMed Central

Tan, Jieqing; Ma, Zheng; Gao, Xiaochao; Wu, Yanhong; Fang, Fang

2011-01-01

By combining binocular suppression technique and a probe detection paradigm, we investigated attentional bias to invisible stimuli and its gender difference in both high trait anxiety (HTA) and low trait anxiety (LTA) individuals. As an attentional cue, happy or fearful face pictures were presented to HTAs and LTAs for 800 ms either consciously or unconsciously (through binocular suppression). Participants were asked to judge the orientation of a gabor patch following the face pictures. Their performance was used to measure attentional effect induced by the cue. We found gender differences of attentional effect only in the unconscious condition with HTAs. Female HTAs exhibited difficulty in disengaging attention from the location where fearful faces were presented, while male HTAs showed attentional avoidance of it. Our results suggested that the failure to find attentional avoidance of threatening stimuli in many previous studies might be attributed to consciously presented stimuli and data analysis regardless of participants' gender. These findings also contributed to our understanding of gender difference in anxiety disorder. PMID:21647221

Gender difference of unconscious attentional bias in high trait anxiety individuals.

PubMed

Tan, Jieqing; Ma, Zheng; Gao, Xiaochao; Wu, Yanhong; Fang, Fang

2011-01-01

By combining binocular suppression technique and a probe detection paradigm, we investigated attentional bias to invisible stimuli and its gender difference in both high trait anxiety (HTA) and low trait anxiety (LTA) individuals. As an attentional cue, happy or fearful face pictures were presented to HTAs and LTAs for 800 ms either consciously or unconsciously (through binocular suppression). Participants were asked to judge the orientation of a gabor patch following the face pictures. Their performance was used to measure attentional effect induced by the cue. We found gender differences of attentional effect only in the unconscious condition with HTAs. Female HTAs exhibited difficulty in disengaging attention from the location where fearful faces were presented, while male HTAs showed attentional avoidance of it. Our results suggested that the failure to find attentional avoidance of threatening stimuli in many previous studies might be attributed to consciously presented stimuli and data analysis regardless of participants' gender. These findings also contributed to our understanding of gender difference in anxiety disorder.

[Authorization and reimbursement of orphan drugs in an international comparison].

PubMed

Roll, K; Stargardt, T; Schreyögg, J

2011-08-01

This paper analyses schemes to promote the authorisation of and reimbursement for orphan drugs. 8 countries - Australia, Canada, Germany, Great Britain, France, Netherlands, Switzerland, USA - were studied to compare specific regulations for orphan drugs regarding drug admission, health technology assessment (HTA), decision-making for reimbursement, and off-label and compassionate use. Information was obtained by reviewing published and grey literature. Expert interviews were also conducted. The comparison of orphan drug legislation reveals that the EU and the USA offer the greatest incentives for the development of orphan drugs, whereas there is a tendency for Australia and Switzerland to profit from incentives in other countries. Although not explicitly stated, economic evaluation of orphan drugs takes the special circumstances for orphan drugs into account. In addition to common reimbursement practices, special schemes or programmes for the reimbursement of high-priced orphan drugs exist in all countries that were analysed. Therefore access to orphan drugs seems to be warranted. However, due to co-payments of 5%, the USA may form an exception. On the one hand, the use of special criteria for drug admission, HTA, and reimbursement promotes R&D for orphan drugs. On the other hand, high opportunity costs arise, because huge efforts are made for a minority of patients. A solution for this moral dilemma may be the application of "rule of rescue" or of "no cure, no pay" programmes. © Georg Thieme Verlag KG Stuttgart · New York.

COMPARISON OF RECENTLY USED PHACOEMULSIFICATION SYSTEMS USING A HEALTH TECHNOLOGY ASSESSMENT METHOD.

PubMed

Huang, Jiannan; Wang, Qi; Zhao, Caimin; Ying, Xiaohua; Zou, Haidong

2017-01-01

To compare the recently used phacoemulsification systems using a health technology assessment (HTA) model. A self-administered questionnaire, which included questions to gauge on the opinions of the recently used phacoemulsification systems, was distributed to the chief cataract surgeons in the departments of ophthalmology of eighteen tertiary hospitals in Shanghai, China. A series of senile cataract patients undergoing phacoemulsification surgery were enrolled in the study. The surgical results and the average costs related to their surgeries were all recorded and compared for the recently used phacoemulsification systems. The four phacoemulsification systems currently used in Shanghai are the Infiniti Vision, Centurion Vision, WhiteStar Signature, and Stellaris Vision Enhancement systems. All of the doctors confirmed that the systems they used would help cataract patients recover vision. A total of 150 cataract patients who underwent phacoemulsification surgery were enrolled in the present study. A significant difference was found among the four groups in cumulative dissipated energy, with the lowest value found in the Centurion group. No serious complications were observed and a positive trend in visual acuity was found in all four groups after cataract surgery. The highest total cost of surgery was associated with procedures conducted using the Centurion Vision system, and significant differences between systems were mainly because of the cost of the consumables used in the different surgeries. This HTA comparison of four recently used phacoemulsification systems found that each of system offers a satisfactory vision recovery outcome, but differs in surgical efficacy and costs.

[Clinical, electrocardiographic and echocardiographic aspects in elderly hypertensive patients in Senegal].

PubMed

Sarr, Simon Antoine; Babaka, Kana; Mboup, Mouhamadou Cherif; Fall, Pape Diadie; Dia, Khadidiatou; Bodian, Malick; Ndiaye, Mouhamadou Bamba; Kane, Adama; Diao, Maboury; Ba, Serigne Abdou

2016-01-01

Arterial hypertension (HTA) in the elderly is an independent risk factor for cardiovascular disease. Our study aims to describe the clinical, electrocardiographic and echocardiographic aspects of Arterial hypertension in elderly patients. We conducted a descriptive, cross-sectional study from January to September 2013. Hypertensive patients =60 years treated in Outpatient Cardiology Department at the Principal Hospital in Dakar were included in the study. Statistical data were analyzed using Epi Info 7 software and a p-value < 0.05 was taken as significant. A total of 208 patients were enrolled in the study. The average age was 69.9 years with a female predominance (sex ratio 0.85). Average blood pressure was 162/90 mm Hg. HTA was under control in 13% of cases. The ECG showed evidence of rhythm disturbance (17.78%), left atrial enlargement (45.19%), left ventricular hypertrophy (28.85%) and complete atrioventricular block in 2 cases. Holter ECG revealed non-sustained ventricular tachycardia (Lown class IVb) in 4 cases, paroxysmal atrial fibrillation in 6 cases and paroxysmal atrial flutter in 1 case. Echocardiography performed in 140 patients showed mainly concentric left ventricular hypertrophy in 25 patients, occuring more frequently in males (p=0,04) and dilated left atrium in 56,42% of cases, occuring more frequently in elderly patients (p= 0,01). Electrocardiographic and echocardiographic aspects in elderly hypertensive population are characterized by concentric left ventricular hypertrophy and by the frequency of arrhythmias sometimes revealed by long-term continuous external electrocardiographic recording.

The option value of delay in health technology assessment.

PubMed

Eckermann, Simon; Willan, Andrew R

2008-01-01

Processes of health technology assessment (HTA) inform decisions under uncertainty about whether to invest in new technologies based on evidence of incremental effects, incremental cost, and incremental net benefit monetary (INMB). An option value to delaying such decisions to wait for further evidence is suggested in the usual case of interest, in which the prior distribution of INMB is positive but uncertain. of estimating the option value of delaying decisions to invest have previously been developed when investments are irreversible with an uncertain payoff over time and information is assumed fixed. However, in HTA decision uncertainty relates to information (evidence) on the distribution of INMB. This article demonstrates that the option value of delaying decisions to allow collection of further evidence can be estimated as the expected value of sample of information (EVSI). For irreversible decisions, delay and trial (DT) is demonstrated to be preferred to adopt and no trial (AN) when the EVSI exceeds expected costs of information, including expected opportunity costs of not treating patients with the new therapy. For reversible decisions, adopt and trial (AT) becomes a potentially optimal strategy, but costs of reversal are shown to reduce the EVSI of this strategy due to both a lower probability of reversal being optimal and lower payoffs when reversal is optimal. Hence, decision makers are generally shown to face joint research and reimbursement decisions (AN, DT and AT), with the optimal choice dependent on costs of reversal as well as opportunity costs of delay and the distribution of prior INMB.

Tracing a roadmap for vitamin B₁₂ testing using the health technology assessment approach.

PubMed

Ferraro, Simona; Mozzi, Roberta; Panteghini, Mauro

2014-06-01

In our hospital, we are currently working to manage the appropriateness of vitamin B₁₂ (B12) testing. Unfortunately, the classic evidence-based approach is unhelpful in this process and meta-analyzing data on the accuracy of this marker for cobalamin deficiency detection is misleading due to the lack of reference diagnostic methods. The approach currently proposed by the Health Technology Assessment (HTA) enables us to tackle the issue of B₁₂ requests as a "healthcare" problem by considering the position of stakeholders involved in ordering, performing, interpreting the test, and receiving its results. Clinical expectations, methodological issues, and ethical aspects concerning the performance of the test can aid us in providing more guidance on the use of this marker. By building such structured information, hemodialysis patients and pregnant women have emerged as those groups preferentially requiring B₁₂ testing, as it may potentially improve the clinical outcome. To avoid misinterpretation of B₁₂ results more care should be taken in considering its biochemical and biological features, as well as the analytical issues. Spurious values obtained by current automated immunoassays may reflect suboptimal pre-analytical steps as well as known interfering conditions. Furthermore, the harmonization of results by available methods is still a far-reaching goal and the approach to interpret an individual's results should be improved. Tracing a roadmap for B₁₂ testing by exploiting the HTA model to balance the stakeholders' claims and maximizing the patient's outcome may help to manage the marker demand.

PubMed Central

DAMONTI, A.; MORELLI, P.; MUSSI, M.; PATREGNANI, C.; GARAGIOLA, E.; FOGLIA, E.; PAGANI, R.; CARMINATI, R.; PORAZZI, E.

2015-01-01

Summary Introduction. The objective of this paper is the comparison between two different technologies used for the removal of a uterine myoma, a frequent benign tumor: the standard technology currently used, laparoscopy, and an innovative one, colpoceliotomy. It was considered relevant to evaluate the real and the potential effects of the two technologies implementation and, in addition, the consequences that the introduction or exclusion of the innovative technology would have for both the National Health System (NHS) and the entire community. Methods. The comparison between these two different technologies, the standard and the innovative one, was conducted using a Health Technology Assessment (HTA). In particular, in order to analyse their differences, a multi-dimensional approach was considered: effectiveness, costs and budget impact analysis data were collected, applying different instruments, such as the Activity Based Costing methodology (ABC), the Cost-Effectiveness Analysis (CEA) and the Budget Impact Analysis (BIA). Organisational, equity and social impact were also evaluated. Results. The results showed that the introduction of colpoceliotomy would provide significant economic savings to the Regional and National Health Service; in particular, a saving of € 453.27 for each surgical procedure. Discussion. The introduction of the innovative technology, colpoceliotomy, could be considered a valuable tool; one offering many advantages related to less invasiveness and a shorter surgical procedure than the standard technology currently used (laparoscopy). PMID:26900330

Skill components of task analysis

PubMed Central

Rogers, Wendy A.; Fisk, Arthur D.

2017-01-01

Some task analysis methods break down a task into a hierarchy of subgoals. Although an important tool of many fields of study, learning to create such a hierarchy (redescription) is not trivial. To further the understanding of what makes task analysis a skill, the present research examined novices’ problems with learning Hierarchical Task Analysis and captured practitioners’ performance. All participants received a task description and analyzed three cooking and three communication tasks by drawing on their knowledge of those tasks. Thirty six younger adults (18–28 years) in Study 1 analyzed one task before training and five afterwards. Training consisted of a general handout that all participants received and an additional handout that differed between three conditions: a list of steps, a flow-diagram, and concept map. In Study 2, eight experienced task analysts received the same task descriptions as in Study 1 and demonstrated their understanding of task analysis while thinking aloud. Novices’ initial task analysis scored low on all coding criteria. Performance improved on some criteria but was well below 100 % on others. Practitioners’ task analyses were 2–3 levels deep but also scored low on some criteria. A task analyst’s purpose of analysis may be the reason for higher specificity of analysis. This research furthers the understanding of Hierarchical Task Analysis and provides insights into the varying nature of task analyses as a function of experience. The derived skill components can inform training objectives. PMID:29075044

Accuracy and cost-effectiveness of dynamic contrast-enhanced CT in the characterisation of solitary pulmonary nodules—the SPUtNIk study

PubMed Central

Qureshi, N R; Rintoul, R C; Miles, K A; George, S; Harris, S; Madden, J; Cozens, K; Little, L A; Eichhorst, K; Jones, J; Moate, P; McClement, C; Pike, L; Sinclair, D; Wong, W L; Shekhdar, J; Eaton, R; Shah, A; Brindle, L; Peebles, C; Banerjee, A; Dizdarevic, S; Han, S; Poon, F W; Groves, A M; Kurban, L; Frew, A J; Callister, M E; Crosbie, P; Gleeson, F V; Karunasaagarar, K; Kankam, O; Gilbert, F J

2016-01-01

Introduction Solitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available in the UK currently. Methods and analysis The SPUtNIk study will assess the diagnostic accuracy, clinical utility and cost-effectiveness of DCE-CT, alongside the current CT and 18-flurodeoxyglucose-positron emission tomography) (18FDG-PET)-CT nodule characterisation strategies in the National Health Service (NHS). Image acquisition and data analysis for 18FDG-PET-CT and DCE-CT will follow a standardised protocol with central review of 10% to ensure quality assurance. Decision analytic modelling will assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs. Ethics and dissemination Approval has been granted by the South West Research Ethics Committee. Ethics reference number 12/SW/0206. The results of the trial will be presented at national and international meetings and published in an Health Technology Assessment (HTA) Monograph and in peer-reviewed journals. Trial registration number ISRCTN30784948; Pre-results. PMID:27843550

Prévalence et caractéristiques des effets indésirables des antihypertenseurs chez les patients suivis en ambulatoire au Centre Hospitalier Universitaire Yalgado Ouédraogo

PubMed Central

Millogo, Georges Rosario Christian; Zongo, Ragomzingba Frank Edgard; Benao, Anita; Youl, Estelle Noëla Hoho; Bassoleth, Blaise Alexandre Bazona; Ouédraogo, Moussa; Zabsonré, Patrice; Guissou, Innocent Pierre

2018-01-01

La prise en charge médicamenteuse de l'hypertension artérielle (HTA) entraine des effets indésirables qui peuvent être gênants et ainsi influencer l'observance du patient. Nous avons étudié ces effets indésirables dans le service de cardiologie du Centre hospitalier universitaire Yalgado Ouédraogo afin de déterminer leurs fréquences et leurs caractéristiques. Il s'agissait d'une étude transversale de juillet à septembre 2015 chez les patients suivis en ambulatoire pour HTA. Les données ont été obtenues à partir de l'interrogatoire, des carnets de suivi des patients et des fiches de consultations. Au total 278 patients ont été inclus. La population d'étude incluait 69,1% de femmes. L'âge moyen était de 52,2 ans avec des extrêmes de 23 et 86 ans. Quatre vingt et sept virgule huit pourcent (87,8%) vivaient en milieu urbain. Le tabagisme, la dyslipidémie et les antécédents familiaux d'HTA représentaient respectivement 9%, 35,6% et 57,2%. Au plan thérapeutique, 43,2% étaient sous monothérapie, 35,6% sous bithérapie à l'initiation du traitement. Les inhibiteurs calciques (59,7%) étaient la classe thérapeutique la plus utilisée. La prévalence globale des effets indésirables était de 60,1%. Les inhibiteurs calciques étaient impliqués dans 53,6% suivis des diurétiques (48,6%) dans la survenue de l'effet indésirable. La prévalence spécifique par molécule était 28,1% pour l'amlodipine et 24,5% pour l'hydrochlorothiazide. La diurèse excessive (13,7%), la toux (12,9%) et les vertiges (11,5%) étaient les effets indésirables les plus fréquemment évoqués par les patients. Le système nerveux central et périphérique et le système ostéo-musculaire étaient les systèmes les plus atteints. Les effets indésirables sont un déterminant majeur de l'adhésion aux traitements antihypertenseur, car leur impact sur la vie quotidienne des patients peut s'avérer significatif. PMID:29875965

Non-catalytic transfer hydrogenation in supercritical CO2 for coal liquefaction

NASA Astrophysics Data System (ADS)

Elhussien, Hussien

This thesis presents the results of the investigation on developing and evaluating a low temperature (<150°C) non - catalytic process using a hydrogen transfer agent (instead of molecu-lar hydrogen) for coal dissolution in supercritical CO2. The main idea behind the thesis was that one hydrogen atom from water and one hydrogen atom from the hydrogen transfer agent (HTA) were used to hydrogenate the coal. The products of coal dissolution were non-polar and polar while the supercritical CO2, which enhanced the rates of hydrogenation and dissolution of the non-polar molecules and removal from the reaction site, was non-polar. The polar modifier (PM) for CO2 was added to the freed to aid in the dissolution and removal of the polar components. The addition of a phase transfer agent (PTA) allowed a seamless transport of the ions and by-product between the aqueous and organic phases. DDAB, used as the PTA, is an effective phase transfer catalyst and showed enhancement to the coal dissolution process. COAL + DH- +H 2O → COAL.H2 + DHO-- This process has a great feature due to the fact that the chemicals were obtained without requir-ing to first convert coal to CO and H2 units as in indirect coal liquefaction. The experiments were conducted in a unique reactor set up that can be connected through two lines. one line to feed the reactor with supercritical CO 2 and the other connected to gas chromatograph. The use of the supercritical CO2 enhanced the solvent option due to the chemical extraction, in addition to the low environmental impact and energy cost. In this thesis the experiment were conducted at five different temperatures from atmos-pheric to 140°C, 3000 - 6000 psi with five component of feed mixture, namely water, HTA, PTA, coal, and PM in semi batch vessels reactor system with a volume of 100 mL. The results show that the chemicals were obtained without requiring to first convert coal to CO and H2 units as in indirect coal liquefaction. The results show that the conversion was found to be 91.8% at opti-mum feed mixtures values of 3, 1.0 and 5.4 for water: PM, HTA: coal, water: coal respectively. With the oil price increase and growing in energy demand, the coal liquefaction remain affordable and available energy alternative.

Methods for Conducting Cognitive Task Analysis for a Decision Making Task.

DTIC Science & Technology

1996-01-01

Cognitive task analysis (CTA) improves traditional task analysis procedures by analyzing the thought processes of performers while they complete a...for using these methods to conduct a CTA for domains which involve critical decision making tasks in naturalistic settings. The cognitive task analysis methods

Validating Human Behavioral Models for Combat Simulations Using Techniques for the Evaluation of Human Performance

DTIC Science & Technology

2004-01-01

Cognitive Task Analysis Abstract As Department of Defense (DoD) leaders rely more on modeling and simulation to provide information on which to base...capabilities and intent. Cognitive Task Analysis (CTA) Cognitive Task Analysis (CTA) is an extensive/detailed look at tasks and subtasks performed by a...Domain Analysis and Task Analysis: A Difference That Matters. In Cognitive Task Analysis , edited by J. M. Schraagen, S.

Cognitive task analysis: harmonizing tasks to human capacities.

PubMed

Neerincx, M A; Griffioen, E

1996-04-01

This paper presents the development of a cognitive task analysis that assesses the task load of jobs and provides indicators for the redesign of jobs. General principles of human task performance were selected and, subsequently, integrated into current task modelling techniques. The resulting cognitive task analysis centres around four aspects of task load: the number of actions in a period, the ratio between knowledge- and rule-based actions, lengthy uninterrupted actions, and momentary overloading. The method consists of three stages: (1) construction of a hierarchical task model, (2) a time-line analysis and task load assessment, and (3), if necessary, adjustment of the task model. An application of the cognitive task analysis in railway traffic control showed its benefits over the 'old' task load analysis of the Netherlands Railways. It provided a provisional standard for traffic control jobs, conveyed two load risks -- momentary overloading and underloading -- and resulted in proposals to satisfy the standard and to diminish the two load risk.

Automating a Detailed Cognitive Task Analysis for Structuring Curriculum

DTIC Science & Technology

1991-06-01

Cognitive Task Analysis For... cognitive task analysis o3 0 chniques. A rather substantial literature has been amassed relative to _ - cutonqed knowledge acquisition but only seven...references have been found in LO V*r data base seaci of literature specifically addressing cognitive task analysis . - A variety of forms of cognitive task analysis

Automating a Detailed Cognitive Task Analysis for Structuring Curriculum

DTIC Science & Technology

1991-08-01

1991-- ] Aleeo/i ISM’-19# l Title: Automating a Detailed Cognitive Task Analysis for Structuring Curriculum Activities: To date we have completed task...The Institute for Management Sciences. Although the particular application of the modified GOMS cognitive task analysis technique under development is...Laboratories 91 9 23 074 Automnating a Detailed Cognitive Task Analysis For Stucuring Curriculum Research Plan Year 1 Task 1.0 Design Task 1.1 Conduct body

Using a Knowledge Representations Approach to Cognitive Task Analysis.

ERIC Educational Resources Information Center

Black, John B.; And Others

Task analyses have traditionally been framed in terms of overt behaviors performed in accomplishing tasks and goals. Pioneering work at the Learning Research and Development Center looked at what contribution a cognitive analysis might make to current task analysis procedures, since traditional task analysis methods neither elicit nor capture…

Quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 1: Individual participant data meta-analysis and health economic analysis

PubMed Central

Wotherspoon, Lisa M; Boyd, Kathleen A; Morris, Rachel K; Jackson, Lesley; Chandiramani, Manju; David, Anna L; Khalil, Asma; Shennan, Andrew; Hodgetts Morton, Victoria; Lavender, Tina; Khan, Khalid; Harper-Clarke, Susan; Mol, Ben W; Riley, Richard D; Norrie, John; Norman, Jane E

2018-01-01

Introduction The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (qfFN) concentration, in combination with clinical risk factors. Methods and analysis The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts) which quantifies fFN in a vaginal swab. In part 1 of the study, we will develop and internally validate a prognostic model using an individual participant data (IPD) meta-analysis of existing studies containing women with symptoms of preterm labour alongside fFN measurements and pregnancy outcome. An economic analysis will be undertaken to assess potential cost-effectiveness of the qfFN prognostic model. The primary endpoint will be the ability of the prognostic model to rule out spontaneous preterm birth within 7 days. Six eligible studies were identified by systematic review of the literature and five agreed to provide their IPD (n=5 studies, 1783 women and 139 events of preterm delivery within 7 days of testing). Ethics and dissemination The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14/32/01). It has been approved by the West of Scotland Research Ethics Committee (16/WS/0068). PROSPERO registration number CRD42015027590. Version Protocol version 2, date 1 November 2016. PMID:29627817

Comparative Cognitive Task Analysis

DTIC Science & Technology

2007-01-01

is to perform a task analyses to determine how people operate in a specific domain on a specific task. Cognitive Task Analysis (CTA) is a set of...accomplish a task. In this chapter, we build on CTA methods by suggesting that comparative cognitive task analysis (C2TA) can help solve the aforementioned

ATTITUDES OF ORTHOPEDIC SPECIALISTS TOWARD EFFECTS OF MEDICAL DEVICE PURCHASING.

PubMed

Lingg, Myriam; Merida-Herrera, Everth; Wyss, Kaspar; Durán-Arenas, Luis

2017-01-01

The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes. We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico. We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments. To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement.

[Evaluation of cardiac complications among chronic hemodialysis in Dakar].

PubMed

Moustapha, Cissé Mouhamadou; Tall, Lemrabott Ahmed; Maria, Faye; Khodia, Fall; Moustapha, Faye; Fary, Ka El Hadji; Abdou, Niang; Boucar, Diouf

2016-01-01

Hemodialysis is the first extrarenal treatment method that allowed supporting patients in terminal chronic failure in Senegal since 1997. 25 years later, we conducted this study to determine the type and the prevalence of different cardiovascular complications and identify the main cardiovascular risk factors. It is a retrospective study of 4 years. 38 patients treated at least 6 months in hemodialysis and cardiovascular explorations with a front chest x-ray, electrocardiogram and cardiac ultrasound. All patients who have not started hemodialysis, treated less than 6 months in hemodialysis, treaties in peritoneal dialysis or having raised cardiovascular explorations were excluded. For each selected patient, we collected data epidemiological, clinical, paraclinical and evolutionary aspects of cardiovascular complications. 38 patients were included in this study. The average age was 52 years ± 12.85 and the sex ratio H/F of 1.53. Initial nephropathy was dominated by the néphroangiosclérose followed by diabetic nephropathy. Clinically the signs of appeal are marked by the effort dyspnea palpitations, chest pain and physically by the HTA, anemia. Cardiovascular complications were dominated by hypertrophy (LVH) left ventricular, rhythm type of arrhythmia disorders valvular leakage (mitral and tricuspid) and cerebral vascular accident (stroke). The average impact of LVH according the HTA is 81%, by sex of 78.26% for men and 60% for women. At the end of the study, 27 patients were pursuing hemodialysis and 11 had died 6 (54%) of cardiovascular cause. Hemodialysis is a common purification technique in Senegal and its complications remain especially dominated by abuses cardiovascular.

IS THE LINK BETWEEN HEALTH AND WEALTH CONSIDERED IN DECISION MAKING? RESULTS FROM A QUALITATIVE STUDY.

PubMed

Garau, Martina; Shah, Koonal Kirit; Sharma, Priya; Towse, Adrian

2015-01-01

The aim of this study was to explore whether wealth effects of health interventions, including productivity gains and savings in other sectors, are considered in resource allocations by health technology assessment (HTA) agencies and government departments. To analyze reasons for including, or not including, wealth effects. Semi-structured interviews with decision makers and academic experts in eight countries (Australia, France, Germany, Italy, Poland, South Korea, Sweden, and the United Kingdom). There is evidence suggesting that health interventions can produce economic gains for patients and national economies. However, we found that the link between health and wealth does not influence decision making in any country with the exception of Sweden. This is due to a combination of factors, including system fragmentation, methodological issues, and the economic recession forcing national governments to focus on short-term measures. In countries with established HTA processes and methods allowing, in principle, the inclusion of wider effects in exceptional cases or secondary analyses, it might be possible to overcome the methodological and practical barriers and see a more systematic consideration of wealth effect in decision making. This would be consistent with principles of efficient priority setting. Barriers for the consideration of wealth effects in government decision making are more fundamental, due to an enduring separation of budgets within the public sector and current financial pressures. However, governments should consider all relevant effects from public investments, including healthcare, even when benefits can only be captured in the medium- and long-term. This will ensure that resources are allocated where they bring the best returns.

ENVIRONMENTAL IMPACT ASSESSMENT OF A HEALTH TECHNOLOGY: A SCOPING REVIEW.

PubMed

Polisena, Julie; De Angelis, Gino; Kaunelis, David; Gutierrez-Ibarluzea, Iñaki

2018-06-13

The Health Technology Expert Review Panel is an advisory body to Canadian Agency for Drugs and Technologies in Health (CADTH) that develops recommendations on health technology assessments (HTAs) for nondrug health technologies using a deliberative framework. The framework spans several domains, including the environmental impact of the health technology(ies). Our research objective was to identify articles on frameworks, methods or case studies on the environmental impact assessment of health technologies. A literature search in major databases and a focused gray literature search were conducted. The main search concepts were HTA and environmental impact/sustainability. Eligible articles were those that described a conceptual framework or methods used to conduct an environmental assessment of health technologies, and case studies on the application of an environmental assessment. From the 1,710 citations identified, thirteen publications were included. Two articles presented a framework to incorporate environmental assessment in HTAs. Other approaches described weight of evidence practices and comprehensive and integrated environmental impact assessments. Central themes derived include transparency and repeatability, integration of components in a framework or of evidence into a single outcome, data availability to ensure the accuracy of findings, and familiarity with the approach used. Each framework and methods presented have different foci related to the ecosystem, health economics, or engineering practices. Their descriptions suggested transparency, repeatability, and the integration of components or of evidence into a single outcome as their main strengths. Our review is an initial step of a larger initiative by CADTH to develop the methods and processes to address the environmental impact question in an HTA.

Appropriate evidence sources for populating decision analytic models within health technology assessment (HTA): a systematic review of HTA manuals and health economic guidelines.

PubMed

Zechmeister-Koss, Ingrid; Schnell-Inderst, Petra; Zauner, Günther

2014-04-01

An increasing number of evidence sources are relevant for populating decision analytic models. What is needed is detailed methodological advice on which type of data is to be used for what type of model parameter. We aim to identify standards in health technology assessment manuals and economic (modeling) guidelines on appropriate evidence sources and on the role different types of data play within a model. Documents were identified via a call among members of the International Network of Agencies for Health Technology Assessment and by hand search. We included documents from Europe, the United States, Canada, Australia, and New Zealand as well as transnational guidelines written in English or German. We systematically summarized in a narrative manner information on appropriate evidence sources for model parameters, their advantages and limitations, data identification methods, and data quality issues. A large variety of evidence sources for populating models are mentioned in the 28 documents included. They comprise research- and non-research-based sources. Valid and less appropriate sources are identified for informing different types of model parameters, such as clinical effect size, natural history of disease, resource use, unit costs, and health state utility values. Guidelines do not provide structured and detailed advice on this issue. The article does not include information from guidelines in languages other than English or German, and the information is not tailored to specific modeling techniques. The usability of guidelines and manuals for modeling could be improved by addressing the issue of evidence sources in a more structured and comprehensive format.

Environmental impacts of a large-scale incinerator with mixed MSW of high water content from a LCA perspective.

PubMed

Lou, Ziyang; Bilitewski, Bernd; Zhu, Nanwen; Chai, Xiaoli; Li, Bing; Zhao, Youcai

2015-04-01

Large-scale incinerators are applied widely as a result of the heavy burden of municipal solid waste (MSW) generated, while strong opposition is arising from the public living nearby. A large-scale working incineration plant of 1500 ton/day was chosen for evaluation using life cycle assessment. It was found that the corresponding human toxicity impacts via soil (HTs), human toxicity impacts via water (HTw) and human toxicity impacts via air (HTa) categories are 0.213, 2.171, and 0.012 personal equivalents (PE), and global warming (GW100) and nutrient enrichment (NE) impacts are 0.002 and 0.001 PE per ton of waste burned for this plant. Heavy metals in flue gas, such as Hg and Pb, are the two dominant contributors to the toxicity impact categories, and energy recovery could reduce the GW100 and NE greatly. The corresponding HTs, HTw and HTa decrease to 0.087, 0.911 and 0.008 PE, and GW100 turns into savings of -0.007 PE due to the increase of the heating value from 3935 to 5811 kJ/kg, if a trommel screener of 40 mm mesh size is used to pre-separate MSW. MSW sorting and the reduction of water content by physical pressure might be two promising pre-treatment methods to improve the combustion performance, and the application of stricter standards for leachate discharge and the flue gas purification process are two critical factors for improvement of the environmental profile identified in this work. Copyright © 2015. Published by Elsevier B.V.

EXPLORING VALUES OF HEALTH TECHNOLOGY ASSESSMENT AGENCIES USING REFLECTIVE MULTICRITERIA AND RARE DISEASE CASE.

PubMed

Goetghebeur, Mireille M; Wagner, Monika; Samaha, Dima; O'Neil, William; Badgley, Danielle; Castro-Jaramillo, Hector; Abrishami, Payam; Sarria-Santamera, Antonio; Cleemput, Irina; Tringali, Michele

2017-01-01

Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease. Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise. Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions' values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of "alleviating or preventing patient suffering," "serving the whole population equitably," "upholding healthcare system sustainability," and "making decisions informed by evidence and context" but may help share the ethical reasoning behind decisions. Incorporating "Priorities" (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives. Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

Thermoadaptation-Directed Enzyme Evolution in an Error-Prone Thermophile Derived from Geobacillus kaustophilus HTA426

PubMed Central

Kobayashi, Jyumpei; Wada, Keisuke; Furukawa, Megumi; Doi, Katsumi

2014-01-01

Thermostability is an important property of enzymes utilized for practical applications because it allows long-term storage and use as catalysts. In this study, we constructed an error-prone strain of the thermophile Geobacillus kaustophilus HTA426 and investigated thermoadaptation-directed enzyme evolution using the strain. A mutation frequency assay using the antibiotics rifampin and streptomycin revealed that G. kaustophilus had substantially higher mutability than Escherichia coli and Bacillus subtilis. The predominant mutations in G. kaustophilus were A · T→G · C and C · G→T · A transitions, implying that the high mutability of G. kaustophilus was attributable in part to high-temperature-associated DNA damage during growth. Among the genes that may be involved in DNA repair in G. kaustophilus, deletions of the mutSL, mutY, ung, and mfd genes markedly enhanced mutability. These genes were subsequently deleted to construct an error-prone thermophile that showed much higher (700- to 9,000-fold) mutability than the parent strain. The error-prone strain was auxotrophic for uracil owing to the fact that the strain was deficient in the intrinsic pyrF gene. Although the strain harboring Bacillus subtilis pyrF was also essentially auxotrophic, cells became prototrophic after 2 days of culture under uracil starvation, generating B. subtilis PyrF variants with an enhanced half-denaturation temperature of >10°C. These data suggest that this error-prone strain is a promising host for thermoadaptation-directed evolution to generate thermostable variants from thermolabile enzymes. PMID:25326311

Thermoadaptation-directed enzyme evolution in an error-prone thermophile derived from Geobacillus kaustophilus HTA426.

PubMed

Suzuki, Hirokazu; Kobayashi, Jyumpei; Wada, Keisuke; Furukawa, Megumi; Doi, Katsumi

2015-01-01

Thermostability is an important property of enzymes utilized for practical applications because it allows long-term storage and use as catalysts. In this study, we constructed an error-prone strain of the thermophile Geobacillus kaustophilus HTA426 and investigated thermoadaptation-directed enzyme evolution using the strain. A mutation frequency assay using the antibiotics rifampin and streptomycin revealed that G. kaustophilus had substantially higher mutability than Escherichia coli and Bacillus subtilis. The predominant mutations in G. kaustophilus were A · T→G · C and C · G→T · A transitions, implying that the high mutability of G. kaustophilus was attributable in part to high-temperature-associated DNA damage during growth. Among the genes that may be involved in DNA repair in G. kaustophilus, deletions of the mutSL, mutY, ung, and mfd genes markedly enhanced mutability. These genes were subsequently deleted to construct an error-prone thermophile that showed much higher (700- to 9,000-fold) mutability than the parent strain. The error-prone strain was auxotrophic for uracil owing to the fact that the strain was deficient in the intrinsic pyrF gene. Although the strain harboring Bacillus subtilis pyrF was also essentially auxotrophic, cells became prototrophic after 2 days of culture under uracil starvation, generating B. subtilis PyrF variants with an enhanced half-denaturation temperature of >10°C. These data suggest that this error-prone strain is a promising host for thermoadaptation-directed evolution to generate thermostable variants from thermolabile enzymes. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

EM structure of a helicase-loader complex depicting a 6:2 binding sub-stoichiometry from Geobacillus kaustophilus HTA426

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lin, Yen-Chen; Naveen, Vankadari; Molecular Cell Biology, Taiwan International Graduate Program, Institute of Molecular Biology, Academia Sinica, and Graduate Institute of Life Sciences, National Defense Medical Center, Taipei, Taiwan

During DNA replication, bacterial helicase is recruited as a complex in association with loader proteins to unwind the parental duplex. Previous structural studies have reported saturated 6:6 helicase-loader complexes with different conformations. However, structural information on the sub-stoichiometric conformations of these previously-documented helicase-loader complexes remains elusive. Here, with the aid of single particle electron-microscopy (EM) image reconstruction, we present the Geobacillus kaustophilus HTA426 helicase-loader (DnaC-DnaI) complex with a 6:2 binding stoichiometry in the presence of ATPγS. In the 19 Å resolution EM map, the undistorted and unopened helicase ring holds a robust loader density above the C-terminal RecA-like domain. Meanwhile, themore » path of the central DNA binding channel appears to be obstructed by the reconstructed loader density, implying its potential role as a checkpoint conformation to prevent the loading of immature complex onto DNA. Our data also reveals that the bound nucleotides and the consequently induced conformational changes in the helicase hexamer are essential for active association with loader proteins. These observations provide fundamental insights into the formation of the helicase-loader complex in bacteria that regulates the DNA replication process. - Highlights: • Helicase-loader complex structure with 6:2 sub-stoichiometry is resolved by EM. • Helicase hexamer in 6:2 sub-stoichiometry is constricted and un-opened. • 6:2 binding ratio of helicase-loader complex could act as a DNA loading checkpoint. • Nucleotides stabilize helicase-loader complex at low protein concentrations.« less

[Post-authorization research, registries, and drug development].

PubMed

Patarnello, Francesca; Recchia, Giuseppe

2013-06-01

In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices.

Improving population health or the population itself? Health technology assessment and our genetic future.

PubMed

Bassett, Ken; Lee, Patricia M; Green, Carolyn J; Mitchell, Lisa; Kazanjian, Arminée

2004-01-01

The province of British Columbia (BC), Canada is developing its first population-wide prenatal genetic screening program, known as triple-marker screening (TMS). TMS, initiated with a simple blood test, is most commonly used to screen for fetuses with the chromosomal abnormality known as Down syndrome or neural tube disorders. Women testing TMS-positive are offered diagnostic amniocentesis and, if the diagnosis is confirmed, selective second-trimester abortion. The project described in this study was initiated to address the broad range of issues arising from this testing technology and provides an example of the new type of health technology assessment (HTA) contribution emerging (and likely to become increasing necessary) in health policy development. With the advent of prenatal genetic screening programs, would-be parents gain the promise of identifying target conditions and, hence, the option of selective abortion of affected fetuses. There is considerable awareness that these developments pose challenges in every dimension (ethical, political, economic, and clinical) of the health-care environment. In the effort to construct an appropriate prenatal screening policy, therefore, administrators have understandably sought guidance from within the field of HTA. The report authors concluded that, within the restricted path open to it, the role of government is relatively clear. It has the responsibility to maintain equal access to prenatal testing, as to any other health service. It should also require maintenance of medical standards and evaluation of program performance. At the same time, policy-makers need actively to support those individuals born with disabilities and their families.

Robotics/Automated Systems Task Analysis and Description of Required Job Competencies Report. Task Analysis and Description of Required Job Competencies of Robotics/Automated Systems Technicians.

ERIC Educational Resources Information Center

Hull, Daniel M.; Lovett, James E.

This task analysis report for the Robotics/Automated Systems Technician (RAST) curriculum project first provides a RAST job description. It then discusses the task analysis, including the identification of tasks, the grouping of tasks according to major areas of specialty, and the comparison of the competencies to existing or new courses to…

Applying Cognitive Work Analysis to Time Critical Targeting Functionality

DTIC Science & Technology

2004-10-01

Cognitive Task Analysis , CTA, Cognitive Task Analysis , Human Factors, GUI, Graphical User Interface, Heuristic Evaluation... Cognitive Task Analysis MITRE Briefing January 2000 Dynamic Battle Management Functional Architecture 3-1 Section 3 Human Factors...clear distinction between Cognitive Work Analysis (CWA) and Cognitive Task Analysis (CTA), therefore this document will refer to these

Evaluating a Computerized Aid for Conducting a Cognitive Task Analysis

DTIC Science & Technology

2000-01-01

in conducting a cognitive task analysis . The conduct of a cognitive task analysis is costly and labor intensive. As a result, a few computerized aids...evaluation of a computerized aid, specifically CAT-HCI (Cognitive Analysis Tool - Human Computer Interface), for the conduct of a detailed cognitive task analysis . A

An audit of parents'/guardians' wishes recorded after coronial autopsies in cases of sudden unexpected death in infancy: issues raised and future directions.

PubMed

Cohen, M C; Blakey, S; Donn, T; McGovern, S; Parry, L

2009-07-01

In the U.K., cases of sudden unexpected death in infancy are under the jurisdiction of the Coroner and consent for a post-mortem is not required. Prior to the Human Tissue Act 2006 (HTA) there was also no requirement to request retention of tissue (blocks and slides). The HTA stipulates that parental/ guardian consent is mandatory to retain or dispose of all tissues after the Coroners' purposes have been fulfilled. In 2007, in order to avoid confusion with the consent needed for hospital post-mortems, a new form was introduced by Sheffield Children's Hospital NHS Foundation Trust (SCH) called Record of parents'/guardians'wishes regarding samples taken at a Coroner's post mortem. This version specifically asks if blocks and slides may be retained as part of the medical record, or are to be disposed of, and for parental agreement (or not) for the frozen tissue, blocks and slides to be used for education, audit, quality control and medical research. One hundred and nineteen Coroners' postmortems covering the years 2006-2007 were reviewed. All parents/guardians (P/G) were contacted and the outcomes of P/G wishes recorded by SCH staff, Coroners' Officers (CO) and Police Family Liaison Officers (PFLO) were analysed and compared (44% from CO were outstanding at the time of audit). Any delay in recording P/G wishes by these three groups was also compared. In 2006, parental agreement to the use of blocks and slides for education, audit, quality control and medical research was 94%, 77% and 75% for SCH, CO and PFLO, respectively. In 2007 it was 84%, 37% and 100% for the same groups. Permission for the retention of frozen tissue given to SCH, CO and PFLO was 90%, 62% and 100% in 2006 and 90%, 44% and 100% in 2007, respectively. Cases where parents did not wish for the retention or use of tissue (including blocks and slides) were 3%, 15% and 0% in 2006 for SCH, CO and PFLO respectively, and 0% for all groups in 2007. Training of staff in all aspects of post-mortem and bereavement care is essential for ascertaining parental wishes. Families should be provided with the knowledge that allows them to make informed choices. The analysis of the results of the audit supports this view.

Challenges to decision-making processes in the national HTA agency in Brazil: operational procedures, evidence use and recommendations.

PubMed

Yuba, Tania Yuka; Novaes, Hillegonda Maria Dutilh; de Soárez, Patrícia Coelho

2018-05-11

The quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures. This is a descriptive study based on CONITEC official reports from July 2012 through December 2016. Data were collected with a specific extraction form and analysed using descriptive statistics. We evaluated 199 CONITEC recommendation reports. The annual number of reports increased during the study period. The absolute annual number of new technologies incorporated in 2013 (n = 24) was similar to that observed for 2014 (n = 24) and 2015 (n = 22), decreasing in 2016 (n = 13). The type of technology most frequently evaluated was 'drugs' (68.3%), followed by 'procedures' (20.1%). Overall, 117 (58.8%) reports were internal demands, 75 (37.7%) were external demands and 7 (3.5%) were mixed demands. There were differences between internal and external demands in terms of the evidence used in the reports and the decision regarding the recommendation to incorporate the technologies. Among the internal demands, the recommendation to incorporate the new technology was made for 70.9% of the reports, only 9.6% of which included full HTAs. Among the external demands, the incorporation of the new technology was recommended for 17.3% of the reports, 76.9% of which included full HTAs. Of the 101 reports in which incorporation of the new technology was recommended, 88 (87.1%) did not include a full health economic evaluation and ICER calculation. There are compliance difficulties with the recommendations in the CONITEC internal regulations regarding the type and quality of evidence considered in the analysis of recommendation reports. The characteristics of the evidence used in recommendation reports and those considered to be mandatory were very different, indicating problems in decision-making processes. There is a need to study, with a broader perspective, the factors that influence the type of evidence used in decision-making processes in order to contribute to the development of better practices and policies.

Cognitive task analysis: Techniques applied to airborne weapons training

DOE Office of Scientific and Technical Information (OSTI.GOV)

Terranova, M.; Seamster, T.L.; Snyder, C.E.

1989-01-01

This is an introduction to cognitive task analysis as it may be used in Naval Air Systems Command (NAVAIR) training development. The focus of a cognitive task analysis is human knowledge, and its methods of analysis are those developed by cognitive psychologists. This paper explains the role that cognitive task analysis and presents the findings from a preliminary cognitive task analysis of airborne weapons operators. Cognitive task analysis is a collection of powerful techniques that are quantitative, computational, and rigorous. The techniques are currently not in wide use in the training community, so examples of this methodology are presented alongmore » with the results. 6 refs., 2 figs., 4 tabs.« less

A Method for Cognitive Task Analysis

DTIC Science & Technology

1992-07-01

A method for cognitive task analysis is described based on the notion of ’generic tasks’. The method distinguishes three layers of analysis. At the...model for applied areas such as the development of knowledge-based systems and training, are discussed. Problem solving, Cognitive Task Analysis , Knowledge, Strategies.

Prise en charge des hypertendus dans la ville de Cotonou (Bénin) en 2011: connaissances attitudes et pratiques des médecins généralistes

PubMed Central

Houenassi, Martin Dèdonougbo; David, Dokoui; Codjo, Léopold Houétondji; Attinsounon, Angelo Cossi; Alassani, Adebayo; Ahoui, Séraphin; Dovonou, Albert Comlan; Adoukonou, Thierry Armel; Dohou, Serge Hugues Mahougnon; Wanvoegbe, Armand; Agbodande, Anthelme

2016-01-01

Summary But: Ce travail vise à évaluer les connaissances, attitudes et pratiques des médecins généralistes sur la prise en charge de l’hypertension artérielle à Cotonou. Méthodes: L’étude était transversale et descriptive basée sur une enquête multicentrique du 1er Mai 2011 au 31 Juillet 2011. Un recrutement de tous les médecins généralistes, volontaires exerçant dans les centres de santé privés, publics et confessionnels de la ville de Cotonou, ayant autorisé l’étude, a été fait. Le 7ème rapport de Joint National Committee (JNC7) a été utilisé comme référentiel pour l’évaluation de la prise en charge des hypertendus. Un auto-questionnaire adressé aux généralistes, testé et validé, a été utilisé pour recueillir ces données. Résultats: Au total, 41 médecins généralistes dans huit établissements sanitaires ont été inclus. Près de la moitié des généralistes (48.8%) ne connaissaient pas la définition de l’HTA. Seulement 25 généralistes (61.0%) pouvaient décrire les conditions de mesure de la pression artérielle. Dix généralistes (24.4%) étaient incapables de lister la moitié des examens du bilan minimum de l’hypertension artérielle (HTA). La majorité (92.7%) ne connaissait pas la notion de risque cardiovasculaire global. L’objectif tensionnel (TA ≤ 140/90 mmHg) n’était connu que par 18 (43.9%) médecins. Les mesures hygiéno-diététiques seules (82.9%) et la monothérapie seule (70.7%) étaient les modalités thérapeutiques les plus prescrites. Les classes pharmacologiques antihypertensives prescrites étaient surtout les inhibiteurs calciques (82.9%), les inhibiteurs de l’enzyme de conversion (53.7%) et les diurétiques (36.6%). Les généralistes référaient les hypertendus aux cardiologues principalement pour non-maitrise du chiffres tensionnels (63,4%) et l’apparition de complications aigues (56.1%). Conclusion: Les connaissances des généralistes sur la prise en charge de l’HTA étaient insuffisantes et leurs attitudes et pratiques ne respectaient pas les recommandations internationales. PMID:27841915

Drug-class-specific changes in the volume and cost of antidiabetic medications in Poland between 2012 and 2015.

PubMed

Śliwczyński, Andrzej; Brzozowska, Melania; Jacyna, Andrzej; Iltchev, Petre; Iwańczuk, Tymoteusz; Wierzba, Waldemar; Marczak, Michał; Orlewska, Katarzyna; Szymański, Piotr; Orlewska, Ewa

2017-01-01

to investigate the drug-class-specific changes in the volume and cost of antidiabetic medications in Poland in 2012-2015. This retrospective analysis was conducted based on the National Health Fund database covering an entire Polish population. The volume of antidiabetic medications is reported according to ATC/DDD methodology, costs-in current international dollars, based on purchasing power parity. During a 4-year observational period the number of patients, consumption of antidiabetic drugs and costs increased by 17%, 21% and 20%, respectively. Biguanides are the basic diabetes medication with a 39% market share. The insulin market is still dominated by human insulins, new antidiabetics (incretins, thiazolidinediones) are practically absent. Insulins had the largest share in diabetes medications expenditures (67% in 2015). The increase in antidiabetic medications costs over the analysed period of time was mainly caused by the increased use of insulin analogues. The observed tendencies correspond to the evidence-based HTA recommendations. The reimbursement status, the ratio of cost to clinical outcomes and data on the long-term safety have a deciding impact on how a drug is used.

Accuracy and cost-effectiveness of dynamic contrast-enhanced CT in the characterisation of solitary pulmonary nodules-the SPUtNIk study.

PubMed

Qureshi, N R; Rintoul, R C; Miles, K A; George, S; Harris, S; Madden, J; Cozens, K; Little, L A; Eichhorst, K; Jones, J; Moate, P; McClement, C; Pike, L; Sinclair, D; Wong, W L; Shekhdar, J; Eaton, R; Shah, A; Brindle, L; Peebles, C; Banerjee, A; Dizdarevic, S; Han, S; Poon, F W; Groves, A M; Kurban, L; Frew, A J; Callister, M E; Crosbie, P; Gleeson, F V; Karunasaagarar, K; Kankam, O; Gilbert, F J

2016-01-01

Solitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available in the UK currently. The SPUtNIk study will assess the diagnostic accuracy, clinical utility and cost-effectiveness of DCE-CT, alongside the current CT and 18-flurodeoxyglucose-positron emission tomography) ( 18 FDG-PET)-CT nodule characterisation strategies in the National Health Service (NHS). Image acquisition and data analysis for 18 FDG-PET-CT and DCE-CT will follow a standardised protocol with central review of 10% to ensure quality assurance. Decision analytic modelling will assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs. Approval has been granted by the South West Research Ethics Committee. Ethics reference number 12/SW/0206. The results of the trial will be presented at national and international meetings and published in an Health Technology Assessment (HTA) Monograph and in peer-reviewed journals. ISRCTN30784948; Pre-results.

[Arterial sequelae of pregnancy hypertension. Detection by carotid piezogram].

PubMed

Meyer-Heine, A; Asquer, J C; Lagrue, G

1989-01-01

High blood pressure (HTA) is characterized by elevation of pression, but also by modifications of arterial pulse wave. Carotid piezograms were used to evaluate arterial pulse wave. Diastolic blood pressure is significantly correlated with dicrotic notch pressure. The duration of dicrotic notch is negatively correlated with arterial wall elasticity. Thus by carotid piezogram analysis one can determine the respective participation of arterial wall elasticity, peripheral resistance and cardiac factors in blood pressure elevation. Carotid piezograms were measured in 97 women (mean age 27, 8 y), with previous hypertensive pregnancy and apparently cured (mean blood pressure 122-74 mmHg at time of examination). 25 women only had normal piezogram drawing. Abnormalities similar to that of permanent hypertensive disease were observed in most cases. Dicrotic notch duration was significantly reduced and dicrotic notch pressure enhanced; in 34 women both of these abnormalities were present. In conclusion, among women previously hypertensive during pregnancy, even when blood pressure is returned to normal, abnormalities of arterial pulse wave may be present, suggesting that these women are prone to subsequent permanent hypertension.

Using Cognitive Task Analysis and Eye Tracking to Understand Imagery Analysis

DTIC Science & Technology

2006-01-01

Using Cognitive Task Analysis and Eye Tracking to Understand Imagery Analysis Laura Kurland, Abigail Gertner, Tom Bartee, Michael Chisholm and...have used these to study the analysts search behavior in detail. 2 EXPERIMENT Using a Cognitive Task Analysis (CTA) framework for knowledge...TITLE AND SUBTITLE Using Cognitive Task Analysis and Eye Tracking to Understand Imagery Analysis 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM

The impact of Clostridum difficile on surgical rate among ulcerative colitis patients: A systemic review and meta-analysis.

PubMed

Peng, Jiang-Chen; Shen, Jun; Zhu, Qi; Ran, Zhi-Hua

2015-01-01

There is growing recognition of the impact of Clostridum difficile infection (CDI) on patients with inflammatory bowel disease. Clostridium difficile infection causes greater morbidity and mortality. This study aimed to evaluate the impact of C. difficile on surgical risk among ulcerative colitis (UC) patients. We searched the following databases: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, ACP Journal Club, DARE, CMR, and HTA. Studies were included if fulfilled the following criteria: (1) Cohort or case-control studies, which involved a comparison group that lacked CDI, (2) Patients were given a primary diagnosis of UC, (3) Comorbidity of CDI was evaluated by enzyme immunoassay of stool for C. difficile toxin A and B or C. difficile stool culture, (4) Studies evaluated surgical rate, and (5) Studies reported an estimate of odds ratio, accompanied by a corresponding measure of uncertainty. Five studies with 2380 patients fulfilled the inclusion criteria. Overall, meta-analysis showed that UC with CDI patients had a significant higher surgical rate than patients with UC alone. (OR=1.76, 95% CI=1.36-2.28). C. difficile infection increased the surgical rate in UC patients. However, results should be interpreted with caution, given the limitations of this stud.

The prevention of postmenopausal osteoporotic fractures: results of the Health Technology Assessment of a new antiosteoporotic drug.

PubMed

de Waure, Chiara; Specchia, Maria Lucia; Cadeddu, Chiara; Capizzi, Silvio; Capri, Stefano; Di Pietro, Maria Luisa; Veneziano, Maria Assunta; Gualano, Maria Rosaria; Kheiraoui, Flavia; La Torre, Giuseppe; Nicolotti, Nicola; Sferrazza, Antonella; Ricciardi, Walter

2014-01-01

The Health Technology Assessment (HTA) approach was applied to denosumab in the prevention of osteoporotic fractures in postmenopausal women. Epidemiological, clinical, technical, economic, organizational, and ethical aspects were considered. Medical electronic databases were accessed to evaluate osteoporosis epidemiology and therapeutical approaches. A budget impact and a cost-effectiveness analyses were performed to assess economic implications. Clinical benefits and patient needs were considered with respect to organizational and ethical evaluation. In Italy around four millions women are affected by osteoporosis and have a higher risk for fractures with 70,000 women being hospitalized every year. Bisphosphonates and strontium ranelate are recommended as first line treatment for the prevention of osteoporotic fractures. Denosumab is effective in reducing vertebral, nonvertebral, and hip/femoral fractures with an advantage of being administered subcutaneously every six months. The budget impact analysis estimated a reduction in costs for the National Health Service with the introduction of denosumab. Furthermore, the economic analysis demonstrated that denosumab is cost-effective in comparison to oral bisphosphonates and strontium ranelate. Denosumab can be administered in outpatients by involving General Practitioners in the management. Ethical evaluation is positive because of its efficacy and compliance. Denosumab could add value in the prevention of osteoporotic fractures.

Integrating Cognitive Task Analysis into Instructional Systems Development.

ERIC Educational Resources Information Center

Ryder, Joan M.; Redding, Richard E.

1993-01-01

Discussion of instructional systems development (ISD) focuses on recent developments in cognitive task analysis and describes the Integrated Task Analysis Model, a framework for integrating cognitive and behavioral task analysis methods within the ISD model. Three components of expertise are analyzed: skills, knowledge, and mental models. (96…

Distinguishing response conflict and task conflict in the Stroop task: evidence from ex-Gaussian distribution analysis.

PubMed

Steinhauser, Marco; Hübner, Ronald

2009-10-01

It has been suggested that performance in the Stroop task is influenced by response conflict as well as task conflict. The present study investigated the idea that both conflict types can be isolated by applying ex-Gaussian distribution analysis which decomposes response time into a Gaussian and an exponential component. Two experiments were conducted in which manual versions of a standard Stroop task (Experiment 1) and a separated Stroop task (Experiment 2) were performed under task-switching conditions. Effects of response congruency and stimulus bivalency were used to measure response conflict and task conflict, respectively. Ex-Gaussian analysis revealed that response conflict was mainly observed in the Gaussian component, whereas task conflict was stronger in the exponential component. Moreover, task conflict in the exponential component was selectively enhanced under task-switching conditions. The results suggest that ex-Gaussian analysis can be used as a tool to isolate different conflict types in the Stroop task. PsycINFO Database Record (c) 2009 APA, all rights reserved.

Linking Task Analysis with Student Learning.

ERIC Educational Resources Information Center

Sherman, Thomas M.; Wildman, Terry M.

An examination of task analysis from several perspectives in order to identify some of its purposes and advantages reveals that, as the interest in learning theory has shifted from a predominately behavioral perspective to a more cognitive orientation, the purpose of task analysis has also shifted. Formerly the purpose of task analysis was to aid…

Task Analysis of Shuttle Entry and Landing Activities

NASA Technical Reports Server (NTRS)

Holland, Albert W.; Vanderark, Stephen T.

1993-01-01

The Task Analysis of Shuttle Entry and Landing (E/L) Activities documents all tasks required to land the Orbiter following an STS mission. In addition to analysis of tasks performed, task conditions are described, including estimated time for completion, altitude, relative velocity, normal and lateral acceleration, location of controls operated or monitored, and level of g's experienced. This analysis precedes further investigations into potential effects of zero g on piloting capabilities for landing the Orbiter following long-duration missions. This includes, but is not limited to, researching the effects of extended duration missions on piloting capabilities. Four primary constraints of the analysis must be clarified: (1) the analysis depicts E/L in a static manner--the actual process is dynamic; (2) the task analysis was limited to a paper analysis, since it was not feasible to conduct research in the actual setting (i.e., observing or filming duration an actual E/L); (3) the tasks included are those required for E/L during nominal, daylight conditions; and (4) certain E/L tasks will vary according to the flying style of each commander.

Three Techniques for Task Analysis: Examples from the Nuclear Utilities.

ERIC Educational Resources Information Center

Carlisle, Kenneth E.

1984-01-01

Discusses three task analysis techniques utilized at the Palo Verde Nuclear Generating Station to review training programs: analysis of (1) job positions, (2) procedures, and (3) instructional presentations. All of these include task breakdown, relationship determination, and task restructuring. (MBR)

Student Task Analysis for the Development of E-Learning Lectural System in Basic Chemistry Courses in FKIP UMMY Solok

NASA Astrophysics Data System (ADS)

Afrahamiryano, A.; Ariani, D.

2018-04-01

The student task analysis is one part of the define stage in development research using the 4-D development model. Analysis of this task is useful to determine the level of understanding of students on lecture materials that have been given. The results of this task analysis serve as a measuring tool to determine the level of success of learning and as a basis in the development of lecture system. Analysis of this task is done by the method of observation and documentation study of the tasks undertaken by students. The results of this analysis are then described and after that triangulation are done to draw conclusions. The results of the analysis indicate that the students' level of understanding is high for theoretical and low material for counting material. Based on the results of this task analysis, it can be concluded that e-learning lecture system developed should be able to increase students' understanding on basic chemicals that are calculated.

Complex systematic review - Perioperative antibiotics in conjunction with dental implant placement.

PubMed

Lund, Bodil; Hultin, Margareta; Tranaeus, Sofia; Naimi-Akbar, Aron; Klinge, Björn

2015-09-01

The aim of this study was to revisit the available scientific literature regarding perioperative antibiotics in conjunction with implant placement by combining the recommended methods for systematic reviews and complex systematic reviews. A search of Medline (OVID), The Cochrane Library (Wiley), EMBASE, PubMed and Health technology assessment (HTA) organizations was performed, in addition to a complementary hand-search. Selected systematic reviews and primary studies were assessed using GRADE and AMSTAR, respectively. A meta-analysis was performed. The literature search identified 846 papers of which 10 primary studies and seven systematic reviews were included. Quality assessment of the systematic reviews revealed two studies of moderate risk of bias and five with high risk of bias. The two systematic reviews of moderate risk of bias stated divergent numbers needed to treat (NNT) to prevent one patient from implant failure. Four of the primary studies comparing antibiotic prophylaxis with placebo were estimated to be of low, or moderate, risk of bias and subjected to meta-analysis. The NNT was 50 (pooled RR 0.39, 95% CI 0.18, 0.84; P = 0.02). None of these four studies individually show a statistical significant benefit of antibiotic prophylaxis. Furthermore, narrative analysis of the studies eligible for meta-analysis reveals clinical heterogeneity regarding intervention and smoking. Antibiotic prophylaxis in conjunction with implant placement reduced the risk for implant loss by 2%. However, the sub-analysis of the primary studies suggests that there is no benefit of antibiotic prophylaxis in uncomplicated implant surgery in healthy patient. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Gene Expression Profiling of Acute Lymphoblastic Leukemia in Children with Very Early Relapse.

PubMed

Núñez-Enríquez, Juan Carlos; Bárcenas-López, Diego Alberto; Hidalgo-Miranda, Alfredo; Jiménez-Hernández, Elva; Bekker-Méndez, Vilma Carolina; Flores-Lujano, Janet; Solis-Labastida, Karina Anastacia; Martínez-Morales, Gabriela Bibiana; Sánchez-Muñoz, Fausto; Espinoza-Hernández, Laura Eugenia; Velázquez-Aviña, Martha Margarita; Merino-Pasaye, Laura Elizabeth; García Velázquez, Alejandra Jimena; Pérez-Saldívar, María Luisa; Mojica-Espinoza, Raúl; Ramírez-Bello, Julián; Jiménez-Morales, Silvia; Mejía-Aranguré, Juan Manuel

2016-11-01

Acute lymphoblastic leukemia (ALL) is the most common childhood cancer worldwide. Mexican patients have high mortality rates, low frequency of good prognosis biomarkers (i.e., ETV6-RUNX1) and a high proportion is classified at the time of diagnosis with a high risk to relapse according to clinical features. In addition, very early relapses are more frequently observed than in other populations. The aim of the study was to identify new potential biomarkers associated with very early relapse in Mexican ALL children through transcriptome analysis. Microarray gene expression profiling on bone marrow samples of 54 pediatric ALL patients, collected at time of diagnosis and/or at relapse, was performed. Eleven patients presented relapse within the first 18 months after diagnosis. Affymetrix Human Transcriptome Array 2.0 (HTA 2.0) was used to perform gene expression analysis. Annotation and functional enrichment analyses were carried out using Gene Ontology, KEGG pathway analysis and Ingenuity Pathway Analysis tools. BLVRB, ZCCHC7, PAX5, EBF1, TMOD1 and BLNK were differentially expressed (fold-change >2.0 and p value <0.01) between relapsed and non-relapsed patients. Functional analysis of abnormally expressed genes revealed their important role in cellular processes related to the development of hematological diseases, cancer, cell death and survival and in cell-to-cell signaling interaction. Our data support previous findings showing the relevance of PAX5, EBF1 and ZCCHC7 as potential biomarkers to identify a subgroup of ALL children in high risk to relapse. Copyright © 2016 IMSS. Published by Elsevier Inc. All rights reserved.

Losartan improves resistance artery lesions and prevents CTGF and TGF-beta production in mild hypertensive patients.

PubMed

Gómez-Garre, D; Martín-Ventura, J L; Granados, R; Sancho, T; Torres, R; Ruano, M; García-Puig, J; Egido, J

2006-04-01

Although structural and functional changes of resistance arteries have been proposed to participate in arterial hypertension (HTA) outcome, not all therapies may correct these alterations, even if they normalize the blood pressure (BP). The aim of this study was to investigate the mechanisms of the protection afforded by the angiotensin receptor antagonist losartan in resistance arteries from patients with essential HTA. In all, 22 untreated hypertensive patients were randomized to receive losartan or amlodipine for 1 year and the morphological characteristics of resistance vessels from subcutaneous biopsies were evaluated. Protein expression of connective tissue growth factor (CTGF), transforming growth factor beta (TGF-beta), and collagens III and IV was detected by immunohistochemistry. In comparison with normotensive subjects, resistance arteries from hypertensive patients showed a significant media:lumen (M/L) ratio increment and a higher protein expression of CTGF, TGF-beta, and collagens. After 1 year of treatment, both losartan and amlodipine similarly controlled BP. However, M/L only decreased in patients under losartan treatment, whereas in the amlodipine-treated group this ratio continued to increase significantly. The administration of losartan prevented significant increments in CTGF, TGF-beta, and collagens in resistance arteries. By contrast, amlodipine-treated patients showed a higher vascular CTGF, TGF-beta, and collagen IV staining than before treatment. Our results show that the administration of losartan, but not amlodipine, to hypertensive patients improves structural abnormalities and prevents the production of CTGF and TGF-beta in small arteries, despite similar BP lowering. These data may explain the molecular mechanisms of the better vascular protection afforded by drugs interfering with the renin-angiotensin system.

Features of successful bids for funding of applied health research: a cohort study.

PubMed

Turner, Sheila; Davidson, Peter; Stanton, Louise; Cawdeary, Victoria

2014-09-22

The literature suggests that research funding decisions may be influenced by criteria such as gender or institution of the principal investigator (PI). The aim of this study was to investigate the association between characteristics of funding applications and success when considered by a research funding board. We selected a retrospective cohort of 296 outline applications for primary research (mainly pragmatic clinical trials) submitted to the commissioning board of the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme between January 1st 2006 and December 31st 2009. We selected proposals submitted to the commissioned NIHR HTA work stream as they addressed issues which the programme already deemed to be important, hence the priority of the research question was not considered as one of the selection criteria for success or failure. Main outcome measures were success or failure at short-listing and in obtaining research funding. The characteristics of applications associated with success at shortlisting and funding were multi-disciplinarity of the team (OR 19.94 [5.13, 77.50], P < 0.0001), particularly inclusion of a statistician (OR 3.76 [2.21, 6.37], P < 0.0001), and the completion of a pilot/feasibility study (OR 4.11 [1.24, 13.62], P = 0.0209). The gender of the PI was not associated with success or failure at either stage. The PI's affiliation institution was not associated with success or failure at shortlisting. The gender of the PI was not associated with success or failure. The characteristics of research applications most strongly associated with success were related to the range of expertise in the team and the completion of a pilot or feasibility study.

Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?

PubMed

Boudard, Aurélie; Martelli, Nicolas; Prognon, Patrice; Pineau, Judith

2013-08-01

Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA. We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5-point level-of-evidence scale. We screened and classified 217 studies: 215 clinical trials and 2 cost-effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high-level clinical evidence (levels 1-2); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high-quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow-up period and the mean follow-up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device. Our findings confirm that only a few studies of innovative medical devices provide high-level clinical evidence. Nevertheless, RCT may be the 'gold standard' for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations. © 2013 John Wiley & Sons Ltd.

Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia.

PubMed

Fischer, Katharina Elisabeth; Heisser, Thomas; Stargardt, Tom

2016-10-01

Little is known on the performance of the newly introduced health benefit assessment process, AMNOG, in Germany compared to other health technology assessment agencies. We analysed whether decisions of the German Federal Joint Committee (FJC) deviate from decisions of the UK National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the Australian Pharmaceutical Benefits Advisory Committee (PBAC). We analysed decisions made for comparable patient subgroups by the four agencies between 2011 and 2014. First, decisions were compared (a) by their final outcome, i.e. whether a health benefit was identified, and (b) by the agencies' judgement on comparative effectiveness. Subsequently, we partially explored reasons for differences between HTA agencies. From the 192 FJC decisions, we identified 55 that overlapped with NICE, 166 with SMC and 119 with PBAC. FJC agreed with NICE in 40% in final outcome (Cohen's Kappa=-0.13). Similar results were obtained for FJC and SMC (47.6%, kappa=0.03) and FJC and PBAC (48.7%, kappa=0.07). Agreement increased when comparing judgements based on comparative effectiveness only. However, the FJC's final decision was positive only in 43.6%, 39.2% and 44.5% of the patient subgroups, as opposed to 74.5% (NICE), 68.7% (SMC), and 68.9% (PBAC), respectively. We show that the FJC - an agency relatively new in structurally assessing the health benefit of pharmaceuticals - deviates considerably in decisions compared to other HTA agencies. Our study also reveals that the FJC tends to appraise stricter than NICE. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Validation of the underlying assumptions of the quality-adjusted life-years outcome: results from the ECHOUTCOME European project.

PubMed

Beresniak, Ariel; Medina-Lara, Antonieta; Auray, Jean Paul; De Wever, Alain; Praet, Jean-Claude; Tarricone, Rosanna; Torbica, Aleksandra; Dupont, Danielle; Lamure, Michel; Duru, Gerard

2015-01-01

Quality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as 'cost-effectiveness analyses'. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity. The main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making. An experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula. Observed and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions. This European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.