scholarly journals Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European network for Health Technology Assessment, EUnetHTA

2009 ◽  
Vol 25 (S2) ◽  
pp. 1-8 ◽  
Author(s):  
Finn Børlum Kristensen ◽  
Kristian Lampe ◽  
Deborah L. Chase ◽  
Sun Hae Lee-Robin ◽  
Claudia Wild ◽  
...  
Keyword(s):  
Health Policy ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Good Practice ◽  
Health Technology ◽  
Public Consultation ◽  
Consensus Methods ◽  
European Network ◽  
Structured Information

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

PP14 Development Of The European Network For Health Technology Assessment Standards Tool For Registries In Health Technology Assessment

2018 ◽  
Vol 34 (S1) ◽  
pp. 70-70
Author(s):  
Emmanuel Gimenez Garcia ◽  
Mireia Espallargues ◽  
Jae Long ◽  
Maja Valentic ◽  
Irena Guzina ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Good Practice ◽  
Health Technology ◽  
Registry Data ◽  
European Network ◽  
Real World Data ◽  
The Third ◽  
Evidence Quality ◽  
Evidence Generation

Introduction:Bridging gaps between registry-holders, Health Technology Assessment (HTA) producers and users is one of the aims of the European Network for HTA (EUnetHTA) Joint Action 3. In this context, a post-launch evidence generation tool is being developed, including a quality standards tool for registries in HTA. The standards tool for registries in HTA will enable, among others, registry owners to consistently collect high quality registry data, and HTA agencies to use proper registry data collected by others as evidence for their assessments. The objective is to present the first draft version of the tool structure, which is going to be piloted during the forthcoming months.Methods:A review and description of the currently available first version (November 2017) sections, items and criteria for HTA studies.Results:The tool is divided in three sections; “Methodological Information”, “Essential Standards” and “Additional Requirements”. The first section enables users to analyze not only the ability of the registry to answer to research questions but also to check the registry transparency. The second section encloses the essential elements of good practice and evidence quality (therefore all of them must be met before an HTA report can use the registry data). Finally, the third section includes elements of good practice and evidence quality useful to consider in planning and evaluating registries for specific purposes. Although suggestions are defined, the third section item requirements could depend on the individual HTA agency perspectives and needs.Conclusions:There is a clear growing availability and requirement for real world data for health technology assessment. A piloted and robust registry standards tool for HTA can provide a relevant basis to improve both the evidence generation but also to make more trustful and excellent evaluations.

scholarly journals Developing a quality management system for the European Network for Health Technology Assessment (EUnetHTA): toward European HTA collaboration

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Miriam Luhnen ◽  
Sari Susanna Ormstad ◽  
Anne Willemsen ◽  
Chaienna Schreuder-Morel ◽  
Catharina Helmink ◽  
...  
Keyword(s):  
Quality Management ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Management System ◽  
Quality Management System ◽  
Health Technology ◽  
European Network ◽  
Joint Work ◽  
Working Groups ◽  
Assessment Reports

Abstract Objectives The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation. Methods Several working groups defined processes and methods to support assessment teams in creating high-quality assessment reports. Existing guidelines, templates, and tools were refined and missing parts were newly created and integrated into the new QMS framework. EUnetHTA has contributed to Health Technology Assessment (HTA) capacity building through training and knowledge sharing. Continuous evaluation helped to identify gaps and shortcomings in processes and structures. Results Based on a common quality management concept and defined development and revision procedures, twenty-seven partner organizations jointly developed and maintained around forty standard operating procedures and other components of the QMS. All outputs were incorporated into a web-based platform, the EUnetHTA Companion Guide, which was launched in May 2018. Concerted efforts of working groups were required to ensure consistency and avoid duplication. Conclusions With the establishment of a QMS for jointly produced assessment reports, EUnetHTA has taken a significant step toward a sustainable model for scientific and technical collaboration within European HTA. However, the definition of processes and methods meeting the numerous requirements of healthcare systems across Europe remains an ongoing and challenging task.

Hospital-based health technology assessment in Brazil: current experiences and challenges

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Patricia Coelho de Soárez ◽  
Vera Lúcia Edais Pepe ◽  
Hillegonda Maria Dutilh Novaes
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Regulatory System ◽  
Health Technology ◽  
Regulation System ◽  
Hospital Policy ◽  
National Network ◽  
Unified Health System ◽  
Use Of Resources

Abstract In Brazil, there is no consensus on the concept of hospital-based health technology assessment (HB-HTA). There is great variability in the existing models and difficulty in evaluating their results—whether in respect of clinical decisions, quality of care, and hospital policy and management or in respect of optimizing the use of resources. This study aims to discuss the experiences of HB-HTA, its integration into the regulatory system for the adoption of new technologies into the Brazilian public (SUS) (Unified Health System), and its main challenges. During a workshop, a panel of specialists in HTA and/or HB-HTA was formed, representative of four different perspectives: (i) Health services and health technology assessment units, (ii) Academia, (iii) Secretary of State for Health, and (iv) the Federal SUS sector. This was followed by discussion, a preliminary consensus, contributions from the audience, a plenary session, and a final consensus. HB-HTA is not institutionalized, nor is it part of the regulation system for the adoption of new technologies in the SUS. The main challenges are the difficulties in creating qualified teams, financial support, and sustainability. The work of these bodies in respect of the evaluation of new technologies deserves further studies analyzing the relationship between the pressure for adoption from the hospital team and industry professionals and legal rulings. It is necessary to strengthen HB-HTA culture and implement this policy in hospital management, making assessment bodies a part of managerial and decision-making processes in hospitals, and develop regional collaborative networks and a national network of HTA.

VP165 Landscape Assessment: Patient Engagement In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 224-225
Author(s):  
Elisabeth Oehrlein ◽  
Jason Harris ◽  
Nicole Labkoff ◽  
Eleanor Perfetto ◽  
Manal Ziadeh ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Public Involvement ◽  
Web Search ◽  
Health Technology ◽  
Public Consultation ◽  
Patient Questionnaire ◽  
Draft Guidance ◽  
Stakeholder Consultation

INTRODUCTION:Understanding the current landscape of patient engagement across value decision-making bodies internationally is a critical first step toward improving the patient centricity of Health Technology Assessment (HTA). This study assessed: (i) Terms and definitions used; (ii) Patient engagement opportunities; (iii) Evidence of patient engagement.METHODS:A sample of country-specific HTA's (HTA; n = 6), professional organizations (PO; n = 4), and collaborations/independent organizations (CO; n = 3) was selected for representativeness. Information was gathered through: (i) targeted web search and (ii) emailing organizations directly. Definitions, HTA methods documents, and the three most recent evaluations were identified, abstracted, and compared. Data were collected between September-October 2016.RESULTS:Numerous terms are used to describe patient engagement: patient input (HTA = 1, PO = 1), patient-group submitted information (HTA = 1), cooperation with patients/users (HTA = 1), public consultation (HTA = 1), patient perspectives (HTA = 1, PO = 1), involvement of people affected (HTA = 1), patient involvement (HTA = 2), patient and public involvement (HTA = 1), lay involvement (HTA = 1), inclusion of patient representative (PO = 3), patient reports (PO = 1), patient preference (PO = 2), public consultation (CO = 1), stakeholder consultation (CO = 1), open input (CO = 1), stakeholder engagement (CO = 1), and patient participation (CO = 1). Opportunities for patient engagement were described as: patient questionnaire (HTA = 2); comment period (HTA = 1; CO = 1); committee participation (HTA = 3; PO = 3); propose topics (HTA = 1); draft guidance (HTA = 1); general stakeholder forum (CO = 1). While organizations outline opportunities for patient engagement, not all organizations have clear evidence the practices are used or have impact. Recent evaluations demonstrate clear evidence of engagement (HTA = 2); Unclear or mixed evidence (HTA = 1; PO = 1; CO = 2); No evidence (HTA = 3; PO = 3; CO = 1).CONCLUSIONS:There is substantial heterogeneity in the terms used to describe patient engagement activities across organizations. While a variety of opportunities for patient engagement are described, lack of clear evidence to how patient engagement practices are consistently used may contribute to the perception that engagement by HTAs.

The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomes

2020 ◽  
Vol 36 (3) ◽  
pp. 191-196 ◽  
Author(s):  
Giovanni Tafuri ◽  
Chantal Bélorgey ◽  
Carlo Favaretti ◽  
Edith Frénoy ◽  
Flora Giorgio ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Healthcare Professionals ◽  
Health Technology ◽  
Joint Production ◽  
European Network ◽  
Fourth Edition ◽  
Patient Organizations ◽  
Medical Need ◽  
To Receive

The European Network for Health Technology Assessment (EUnetHTA) organizes an annual Forum with stakeholders to receive feedback on its activities, processes, and outputs produced. The fourth edition of the EUnetHTA Forum brought together representatives of HTA bodies, patient organizations, healthcare professionals (HCPs), academia, payers, regulators, and industry. The aim of this paper is to provide an overview of the highlights presented at the 2019 EUnetHTA Forum, reporting the main items and themes discussed in the plenary panel and breakout sessions. The leading topic was the concept of unmet medical need seen from different stakeholders' perspectives. Breakout sessions covered the joint production of assessment reports and engagement with payers, patients, and HCPs. Synergies, pragmatism, and inclusiveness across Member States and stakeholders were emphasized as leading factors to put in place a collaboration that serves the interest of patients and public health in a truly European spirit.

scholarly journals COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Rossella Tomaiuolo ◽  
Pietro Derrico ◽  
Matteo Ritrovato ◽  
Massimo Locatelli ◽  
Frida Milella ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Evaluation Method ◽  
New Technologies ◽  
Health Management ◽  
Health Technology ◽  
Innovative Technology ◽  
Serological Tests ◽  
Antibody Tests

Abstract Objective In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. Methods The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. Results The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: the selection of the tests to be evaluated; the research and collection of information to support the adoption and appropriateness of the technology; and the preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. Conclusions The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management.

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

2018 ◽  
Vol 34 (1) ◽  
pp. 87-96 ◽  
Author(s):  
Vladimir Vukovic ◽  
Carlo Favaretti ◽  
Walter Ricciardi ◽  
Chiara de Waure
Keyword(s):  
Economic Evaluation ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Healthcare Systems ◽  
Core Model ◽  
Social Aspects ◽  
European Network ◽  
Health Technologies ◽  
Research Questions

Objectives: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.Methods: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.Results: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.Conclusions: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.

Az egészségügyi technológiaértékelés múltja, jelene és jövője – nemzetközi perspektívából

2021 ◽  
Vol 20 (2) ◽  
pp. 38-41
Author(s):  
Péter Szegner
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Core Model ◽  
European Network

Az egészségügy finanszírozása és fenntarthatósága kapcsán kiemelt fontosságú a bizonyítékokon alapuló döntéshozatal. Napjaink diszruptív trendjei – például a digitalizáció, az adatvezérelt rendszerek, és természetesen a COVID-19 járvány – illetve az egészségügyi rendszerek átalakulása következtében kiemelt szerep juthat a multidiszciplináris egészségügyi technológiaértékelés (Health Technology Assessment, HTA) területének. Magyar országon 2004 óta működik a HTA-val kapcsolatos feladatokat ellátó, társadalombiztosítási befogadási folyamatban döntéstámogató szereppel bíró Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet Technológia-értékelő Főosztálya (TÉF). Európai szinten a European Network for Health Technology Assessment (EUnetHTA) tekinthető az egyik legnagyobb volumenű nemzetközi kezdeményezésnek a területen, mely 2021-ben 29 országból 81 szervezetet ölelt fel. Az EUnetHTA számos eszköze és közös értékelése segíti a tagállamokat, ennek keretében jött létre a HTA Core Model, a gyártókkal folytatott korai tudományos konzultációk, vagy a befogadást követő tudományos bizonyítékok előállítását célzó pilotok. A jövőt illetően kiemelendő, hogy 2021 második felét követően jelentős átalakulás veszi kezdetét az európai technológiaértékelésben – így az EUnetHTA hálózat évtizedes együttműködése nem folytatódik tovább jelen formájában. Az átalakulás egyik fő hajtóereje az Európai Parlament és az Európai Unió Tanácsa által 2021 júniusában elfogadott HTA szabályozás. Az EUnetHTA által kidolgozott jövőbeli HTA együttműködés modellje (FMC) és az elmúlt 15 év nemzetközi tapasztalatai alapján állítható, hogy az ellátórendszerben megjelenő számos lehetőségre és kihívásra megfelelő választ tud majd adni az európai HTA közösség. A végső cél pedig továbbra is a betegek számára hozzáférhető és fenntartható egészségügyi szolgáltatások biztosítása, illetve a társadalom egészségi állapotának javítása lesz.

OP316 Patients’ Testimonials In The National Committee For Health Technology Incorporation In Brazilian Public Health System (Conitec) Meetings

2021 ◽  
Vol 37 (S1) ◽  
pp. 12-13
Author(s):  
Clarice Portugal ◽  
Adriana Prates ◽  
Luiza Losco ◽  
Fabiana Floriano ◽  
Odete da Silva ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Patient Participation ◽  
Technology Assessment ◽  
Selection Process ◽  
Health Technology ◽  
Public Consultation ◽  
National Committee ◽  
The Public ◽  
Construction Of Knowledge ◽  
Main Representative

IntroductionThe Department of Management and Incorporation of Technologies and Innovation in Health (DGITIS) acts as Conitec's Executive Secretariat. Among its attributions, it promotes the public/patient involvement in the health technology assessment (HTA) process. Recently, Conitec has been working on the inclusion of patient's testimonials about their illness experience in the plenary sessions, that is, the monthly meeting where technologies are assessed.MethodsTo support the action of including patient reporting in Conitec's HTA process, DGITIS developed research on HTA agencies websites worldwide. The main criteria was the inclusion of patients’ reports in their Committee meetings. DGITIS contacted some of these agencies and requested a listserv question to the International Network of Agencies for Health Technology Assessment (INAHTA) members. These findings supported the DGITIS for the inclusion of patient participation in Conitec's meetings, from the selection process to the actual participation.ResultsFor the Conitec's HTA process, the patients’ participation should occur in the prior session to the public consultation, guaranteeing the inclusion of their perspective since the recommendation process beginning. Hence, every demand for incorporation to be discussed at Conitec's meeting should be preceded by a public call for patients with the clinical condition. The DGITIS will also hold preparatory meetings, which will serve as moments for shared construction of knowledge and literacy.ConclusionsThe nomination process, so far, has been grounded as a consensus among the patients. Thus, Conitec acts as a mediator, connecting the involved stakeholders, in a way that they can autonomously organize themselves and indicate the main representative and an alternate one. With the inclusion of the patient's perspective in the Conitec's meeting, another form of patient participation was opened in the HTA process. Therefore, the consolidation of this participation space is feasible and contributes to enrich the Brazilian HTA process.

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