scholarly journals Time to Align: A Call for Consensus on the Assessment of Genetic Testing

2021 ◽  
Vol 9 ◽  
Author(s):  
Erica Pitini ◽  
Valentina Baccolini ◽  
Giuseppe Migliara ◽  
Claudia Isonne ◽  
Alessandro Sindoni ◽  
...  

In this paper, we updated our 2018 systematic review aimed to identify and compare ad hoc designed frameworks for genetic testing evaluation. Overall, we identified 30 frameworks (29 in the first systematic review and one in the update): they were mainly based on the ACCE model, whereas a minority were adjustments of the more traditional Health Technology Assessment (HTA) approach. After discussing the strengths and weaknesses of the retrieved frameworks, this perspective calls for consensus on the assessment of genetic testing. In line with the recent European recommendations that encouraged the generation of comparable evidence across Member States, we believe that the time has come to align all the ideas that have emerged over the last few decades and find a sustainable and sharable tool for the evaluation of genetic and genomic applications. Therefore, we suggest stopping the evaluation of such technologies using ad hoc strategies–affected by validation, implementation, and adoption issues–and we propose to use a general HTA approach, particularly the European reference tool for the assessment of health technologies, the EUnetHTA HTA core model, that is built on solid theoretical and methodological principles and provides a comprehensive assessment of the technologies value.

Author(s):  
Marie-Pierre Gagnon ◽  
Marie Desmartis ◽  
Dolorès Lepage-Savary ◽  
Johanne Gagnon ◽  
Michèle St-Pierre ◽  
...  

Objectives:The aim of this study was to review international experiences of patient or public involvement in the field of health technology assessment (HTA).Methods:A systematic review of the scientific literature was conducted. A literature search was performed across nine databases. Other literature was identified through citation tracking, government websites (HTA agencies), and Internet search engines. Characteristics of the studies, description of the activities related to patient or public involvement, impact of these activities on the HTA process, and factors facilitating or limiting involvement were abstracted independently by two reviewers.Results:A total of 1,441 potentially relevant papers were identified by the main search strategy. Among these, seventeen papers met the inclusion criteria; other search strategies identified seven additional documents. The findings reveal that patient or public involvement in HTA activities was reported in two domains, research and HTA process. In the research domain, patients are consulted to gather evidence about their perspectives, experiences, or preferences about a health technology. These perspectives could add key dimensions to the evaluation of health technologies that might otherwise be overlooked. In the domain of the HTA process, patients or public representatives participate in different stages of this process: prioritization, evidence assessment, or dissemination of findings.Conclusions:There are few published examples of experiences involving patients and the public in HTA. These examples show that patients' or the public's perspectives could add important dimensions to the evaluation of health technologies. However, there is a need to develop more systematic approaches to considering patients' and the public's perspectives in HTA.


Author(s):  
Marian Sorin Paveliu ◽  
Elena Olariu ◽  
Raluca Caplescu ◽  
Yemi Oluboyede ◽  
Ileana-Gabriela Niculescu-Aron ◽  
...  

Objective: To provide health-related quality of life (HRQoL) data to support health technology assessment (HTA) and reimbursement decisions in Romania, by developing a country-specific value set for the EQ-5D-3L questionnaire. Methods: We used the cTTO method to elicit health state values using a computer-assisted personal interviewing approach. Interviews were standardized following the most recent version of the EQ-VT protocol developed by the EuroQoL Foundation. Thirty EQ-5D-3L health states were randomly assigned to respondents in blocks of three. Econometric modeling was used to estimate values for all 243 states described by the EQ-5D-3L. Results: Data from 1556 non-institutionalized adults aged 18 years and older, selected from a national representative sample, were used to build the value set. All tested models were logically consistent; the final model chosen to generate the value set was an interval regression model. The predicted EQ-5D-3L values ranged from 0.969 to 0.399, and the relative importance of EQ-5D-3L dimensions was in the following order: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. Conclusions: These results can support reimbursement decisions and allow regional cross-country comparisons between health technologies. This study lays a stepping stone in the development of a health technology assessment process more driven by locally relevant data in Romania.


2018 ◽  
Vol 34 (5) ◽  
pp. 447-457 ◽  
Author(s):  
Christian A. Bellemare ◽  
Pierre Dagenais ◽  
Suzanne K.-Bédard ◽  
Jean-Pierre Béland ◽  
Louise Bernier ◽  
...  

Objectives:Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.Methods:Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.Results:A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.Conclusions:Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.


2017 ◽  
Vol 33 (S1) ◽  
pp. 30-31
Author(s):  
Tuija Ikonen ◽  
Heli Lähteenmäki

INTRODUCTION:Hospital mangers need information for decision making (1). Hospital-based health technology assessment (HTA) methods were tested out to support the budget planning of investments for a new building to be constructed for diagnostic and teaching units at a publicly funded tertiary care university hospital. The hospital board nominated an ad hoc working group to reassess all investment proposals for devices, equipment and furniture for the diagnostic or teaching units that intended to move into the new building. The need for assessment was obliged when the submitted proposals of the units exceeded two-fold the initially allocated investment budget.METHODS:Depending on the level of expenditure, all proposals were assessed by one of the following processes: (i) Proposals over EUR250,000 were evaluated by three to five person expert groups using multi-domain assessment adapting Hospital-based HTA-principles; (ii) Proposals between EUR50,000 and EUR250,000 were returned to the units for miniHTA-assessments by clinicians who submitted the initial proposals and (iii) All proposals below EUR50,000 were prioritized by the units to cut the expenditure by at least 25 percent, with a special emphasis on synergistic use of devices and equipment among the units.RESULTS:The expert groups suggested significant reductions to the proposals, including the withdrawal of a Magnetic Resonance Imaging (MRI)-unit considered to be suboptimally located. Furthermore, the need for a new scanner was declined by promoting adherence to evidence-based diagnostic guidelines and more efficient utilization of existing scanners. Self-assessed MiniHTAs revealed proposals that were unnecessary or the specifications for devices needed re-adjustments. Prioritization revealed excess numbers of devices, for instance the number of cold storage appliances could be reduced. Altogether, the investment proposals were cut by over EUR3.8 million to reach the initial budgetary allocation.CONCLUSIONS:Innovative and flexible usage of hospital-based HTA methodology can be applied to budget planning and evaluation of investment proposals to support decision making. Based on encouraging results, hospital-based HTA was accepted to become a part of hospital strategy as a tool for the annual investment planning.


2018 ◽  
Vol 23 (4) ◽  
pp. 301-311 ◽  
Author(s):  
Mohammadkarim Bahadori ◽  
Ramin Ravangard ◽  
Mahya Tohidi Nezhad ◽  
Naeimeh Pourtaheri ◽  
Sayyed Morteza Hosseini-Shokouh

PurposeAccording to the great importance of community health as well as the ever-increasing development of health technologies, the importance of designing an interactive model of factors affecting health technology assessment (HTA) can be highlighted. The purpose of designing and implementing the framework of health information system assessment is to ensure that the required accurate data which are necessary to measure the main health indicators are available. The purpose of this paper is to design an interactive model of factors affecting HTA.Design/methodology/approachThis is a cross-sectional, descriptive-analytic study conducted in the Iran Ministry of Health and Medical Education in the second half of 2017. A sample of 60 experts and professionals working in the field of health technologies are selected using purposive and snowball sampling methods. Two researcher-made questionnaires are used to collect the required data. The collected data are analyzed using decision-making trial and evaluation laboratory (DEMATEL) and MATLAB R2013a.FindingsThe results showed that “Legal dimension,” “safety,” “Effectiveness” and “Social dimension” were the affecting factors and net causes, and “Current application,” “Knowledge of technology,” “Ethical dimension,” “Costs” and “Organizational dimension” were the affected factors and net effects in the interactive model. Furthermore, “Legal dimension” with the coordinates C: [1.88, 1.27] and “Ethical dimension” with the coordinates C: [1.75, −75] were known as the most affecting and most affected factors in the interactive model, respectively.Originality/valueThe DEMATEL model is an appropriate tool for managers and policy makers to structure and prioritize factors influencing the HTA. Policy makers and decision makers can use this model for identifying relationships among factors and prioritize them. Because health policy makers and managers have a major role in formulating the regulations and guidelines related to the HTA, they should pay more attention to the legal considerations in their decisions and use the management tools to move the available resources toward implementing and enforcing rules and guidelines related to the HTA.


2019 ◽  
Vol 11 (4) ◽  
Author(s):  
Jari Haverinen ◽  
Niina Keränen ◽  
Petra Falkenbach ◽  
Anna Maijala ◽  
Timo Kolehmainen ◽  
...  

Health technology assessment (HTA) refers to the systematic evaluation of the properties, effects, and/or impacts of health technology. The main purpose of the assessment is to inform decisionmakers in order to better support the introduction of new health technologies. New digital healthcare solutions like mHealth, artificial intelligence (AI), and robotics have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as that of other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified. The first objective of this study was to describe the state-of-the-art HTA methods for mHealth, AI, and robotics. The second objective of this study was to evaluate the domains needed in the assessment. The final aim was to develop an HTA framework for digital healthcare services to support the introduction of novel technologies into Finnish healthcare. In this study, the state-of-the-art HTA methods were evaluated using a literature review and interviews. It was noted that some good practices already existed, but the overall picture showed that further development is still needed, especially in the AI and robotics fields. With the cooperation of professionals, key aspects and domains that should be taken into account to make fast but comprehensive assessments were identified. Based on this information, we created a new framework which supports the HTA process for digital healthcare services. The framework was named Digi-HTA.


Author(s):  
Mehmet Akif Erişen ◽  
Fatma Özlem Yılmaz

INTRODUCTION: In this study, it was aimed to evaluate the views and opinions of the health administrators, who are working in the private hospitals in Konya province centre about health technology assessment and applications. METHODS: Qualitative research methods have been used in research, and phenomologic method is preferred. The research was conducted using face-to-face interviews with health administrators working in private hospitals serving in the centre of Konya and accepting to participate in the research. A semi-structured interview form was used as a data collection tool in the survey. RESULTS: As a result of the analysis, sub-themes were created under the headings of health technologies, health technology assessment, health technology assessment applications in Turkey, health technology assessment approach of private hospitals, establishment of health technology assessment department, health technology assessment applications of the respondents’ hospitals and future position of health technology assessment. And the findings under the created themes are interpreted. DISCUSSION AND CONCLUSION: The managers had various information about health technology assessment applications however it was limited. In this respect, it would be beneficial to provide a general education about health technology assessment in order to increase awareness and application of health technology assessment practices.


Author(s):  
V. V. Omelyanovsky ◽  
V. K. Fedyaeva ◽  
N. Z. Musina

In the article, we analyze the current version of Government Regulation No. 871 where the principles of health technologies assessment (HTA) and the reimbursement strategies in Russia have been put forward. We conclude that the HTA methodology in Russia is consistent with the multi-criteria decision analysis. Recommendations on the improvement of the assessment methodology in Regulation No. 871 are provided.


2009 ◽  
Vol 25 (S1) ◽  
pp. 163-173 ◽  
Author(s):  
Laura Sampietro-Colom ◽  
Jose Asua ◽  
Eduardo Briones ◽  
Jordi Gol ◽  

Objectives: The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain.Methods: A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain.Results: 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.Conclusions: 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.


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