scholarly journals Testing the HTA Core Model: Experiences from two pilot projects

2009 ◽  
Vol 25 (S2) ◽  
pp. 21-27 ◽  
Author(s):  
Iris Pasternack ◽  
Heidi Anttila ◽  
Marjukka Mäkelä ◽  
Tuija Ikonen ◽  
Pirjo Räsänen ◽  
...  

Objectives: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development.Methods: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA).Results: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work.Conclusions: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA reports.

2018 ◽  
Vol 34 (S1) ◽  
pp. 16-17
Author(s):  
Martina Andellini ◽  
Francesco Faggiano ◽  
Roxana di Mauro ◽  
Pietro Derrico ◽  
Matteo Ritrovato

Introduction:The purpose of this study is to gather evidence on safety and overall effectiveness of three alternative technologies for gait rehabilitation in diplegic children with Cerebral Palsy: robotic, conventional and joint conventional and robotic gait training.Methods:A new methodology, decision-oriented health technology assessment (DoHTA), was applied to assess the technology on clinical, technical, organizational, economic, social and ethical, legal and safety domains. This method, conceived as a hospital-based HTA tool for supporting the introduction of innovative technologies, has been implemented merging the EUnetHTA Core Model® with the Multi-Criteria Decision Analysis. In particular, the general items of the EUnetHTA Core Model® are re-formulated as performance indicators and re-placed along a decision tree structure that, from the one hand, respects the original top-down design of the EUnetHTA model (growing level of detail from domains to issues) and, from the other hand, allows obtaining a quantitative evaluation of each identified performance indicator.Results:The multiple indicators, which have been identified for the seven domains, play important and different roles in the alternative technologies evaluation. DoHTA results showed that robotic system offers the possibility to control more accurately the exerted forces and movement trajectories than the traditional therapy. It gives the possibility to measure the task performances parameters and to receive the patient feedback simultaneously. To carry out robotic gait rehabilitation fewer therapists are required compared with the conventional therapy, resulting in lower therapists’ physical workload.Conclusions:Despite the great perspectives that robotics offer to motor rehabilitation, it seems that robotic gait training could not provide greater benefits in terms of motor and functional recovery compared to the conventional therapy. Preliminary results, supported by most recent literature evidence, lead to the hypothesis that joint use of robotic and conventional therapy can produce better clinical outcomes than the separate use of the two rehabilitation techniques.


Author(s):  
Vladimir Vukovic ◽  
Carlo Favaretti ◽  
Walter Ricciardi ◽  
Chiara de Waure

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.


2021 ◽  
Vol 20 (2) ◽  
pp. 38-41
Author(s):  
Péter Szegner

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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Elvira ◽  
Mercè Obach ◽  
Caridad Pontes

Abstract Background Heterogeneity in drug access throughout Europe may be influenced by differences in drug-assessment strategies. The EUnetHTA’s assessment core model (EUnetHTA-core) and the EVIDEM’s multicriteria framework are reference methodologies in this context, the latter including a wider compromise between non-contextual and contextual criteria. Compliance of 37 European Health Technology Assessment bodies (HTAb) with EUnetHTA-core has been reported, but the use of EVIDEM by this HTAb is still unknown. Methods To describe the uptake and use of multicriteria approaches to evaluate drug value by European HTAb using EVIDEM as reference framework, a multicriteria framework was obtained based on EVIDEM model. The criteria used for drug appraisal by HTAb was extracted from the EUnetHTA report, and completed through search of websites, publications and HTAb reports. Use of EVIDEM assessment model in 37 European HTAb has been described semi-quantitatively and summarized using an alignment heatmap. Results Aligned, medium or misaligned profiles were seen for 24,3%, 51,4% and 24,3% of HTAb when matching to EVIDEM dimensions and criteria was considered. HTAb with explicit responsibilities in providing specific advice on reimbursement showed more aligned profiles on contextual and non-contextual dimensions. Conclusions EUnetHTA’s core model is limited in assessing medicines while EVIDEM’s framework provides contextual dimension used by some HTAb in Europe that can be escalated to other agencies. Most of the 37 European HTAb have room to broaden their contextual assessment tools, especially when social and medical perception of need requires to be explicit to support payer’s decision on reimbursement.


2019 ◽  
Vol 35 (4) ◽  
pp. 273-279
Author(s):  
Perihan Elif Ekmekci ◽  
Müberra Devrim Güner

AbstractObjectivesEthics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®.MethodsThe study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis.ResultsThe results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process.ConclusionsThe HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.


2018 ◽  
Vol 34 (4) ◽  
pp. 368-377 ◽  
Author(s):  
Alexandre Barna ◽  
Teresita M Cruz-Sanchez ◽  
Karen Berg Brigham ◽  
Cong-Tri Thuong ◽  
Finn Boerlum Kristensen ◽  
...  

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


2017 ◽  
Vol 33 (6) ◽  
pp. 644-653 ◽  
Author(s):  
Kristina Kõrge ◽  
Nadine Berndt ◽  
Juergen Hohmann ◽  
Florence Romano ◽  
Mickael Hiligsmann

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


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
C de Waure ◽  
I Giacchetta ◽  
S Violi ◽  
C Martini ◽  
C Favaretti

Abstract Background In the last years, many health apps have been developed to support citizens' and patients' health management. Nevertheless, a thorough evaluation is necessary to support the decision to incorporate them into healthcare systems. Health technology assessment (HTA) could be considered a valid evaluation tool allowing considering different stakeholders' perspectives. This research aimed to look for studies that applied HTA to health apps and to analyze feasibility and limits of HTA in this field. Methods A systematic review was performed considering three databases, namely PubMed, Web of Science (WoS) and University of York-Centre for Reviews and Dissemination database. Being the topic of health app assessment new, articles were considered eligible if they assessed at least two of the domains of the HTA core model suggested by the European network for Health Technology Assessment (EUnetHTA). Furthermore, only articles published in English in the last 5 years were considered. Results A total of 850 articles were found: 383 articles from PubMed, 462 from WoS and 5 from York. After removing duplicates, 708 articles remained and 43 were eventually included after the screening process. Seven articles were focused on apps used by healthcare professionals, while 36 dealt with apps aimed to support patients. None of the papers explicitly mentioned HTA as assessment tool. Indeed, not all the domains of the HTA core model were assessed in any article. Apps' technical description, clinical effectiveness and social aspects were the domains considered more often. On the contrary, costs and economic evaluation was clearly faced by one article only. Conclusions Even though the scientific literature on health apps is growing, the adoption of standardized methods for their evaluation, such as HTA, is still scant. This might be due to peculiarities of health apps and points out the importance of adapting existing methods in order to let a thorough assessment possible.


2017 ◽  
Vol 33 (S1) ◽  
pp. 161-162
Author(s):  
Vladimir Vukovic ◽  
Carlo Favaretti ◽  
Chiara de Waure

INTRODUCTION:Evaluation is crucial for integration of e-Health/m-Health applications into healthcare systems and their further sustainability. However, evaluation of these technologies is often challenged by poor quality of research design, lack of common outcome indicators and no consensus on appropriate methodology. Health Technology Assessment (HTA) could offer a sound methodological basis for these evaluations (1). The aim of this study was to look for HTA reports on e-Health/m-Health technologies and to describe their characteristics and analyze transparency, consistency and thoroughness, with the goal to detect fields for improvements.METHODS:A literature search was performed on PubMed, ISI WOS and University of York – Centre for Reviews and Dissemination (CRD) electronic databases, in order to identify reports that had evaluated e-Health/m-Health technologies, published until 1 April 2016. We used the International Network of Agencies for Health Technology Assessment (INAHTA) checklist (2) to evaluate transparency and consistency of included reports. We also assessed thoroughness of reports by checking the presence of the domains suggested by European Network for HTA (EUnetHTA) HTA Core Model (3).RESULTS:Twenty-eight reports published between 1999 and 2015 were included. Most of reports (71.4 percent) were delivered by non-European countries and only 35.7 percent were classified as full reports. E-Health/m-Health technologies from several fields of medicine, mostly cardiology (21.4 percent) and psychiatry (17.9 percent) were evaluated. Policy question was clearly defined in 32.1 percent of reports, whereas ethical (21.4 percent) and legal implications (3.6 percent) were domains with the least presence. 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 around 40 percent organizational and social aspects. Remaining domains were evaluated in very few reports.CONCLUSIONS:E-Health/m-Health technologies are increasingly present in the field of HTA. Our work identified a number of elements not being included in the available reports. Several reports missed to respond to relevant assessment elements especially ethical, social and organizational implications. There is a need for strengthening and standardizing methods used for the evaluation of these technologies.


Author(s):  
Tiziana Franchin ◽  
Francesco Faggiano ◽  
Mario Plebani ◽  
Maurizio Muraca ◽  
Liliana De Vivo ◽  
...  

AbstractPoint-of-care testing (POCT) is a successful methodology for meeting clinical expectations of rapid and accurate results. Scientific literature has moreover highlighted and confirmed the necessity of individuating the best technological solution, in accordance with clinical requirements and contextualized to the whole health organization, where it will be implemented. Health Technology Assessment (HTA) can assist in reaching an appropriate and contextualized decision on a health technology. The aim of this study is to adapt a HTA core model for improving the evaluation of a POCT technology: blood gas analyzers.The European Network for Health Technology Assessment (EUnetHTA) core model for diagnostic technologies was applied for evaluating globally marketed blood gas analyzers. Evaluation elements were defined according to available literature and validated using the Delphi method.A HTA model of 71 issues, subdivided into 26 topics and 10 domains, was obtained by interviewing 11 healthcare experts over two rounds of Delphi questionnaires. Ten context parameters were identified in order to define the initial scenario from which the technology assessment was to begin.The model presented offers a systematic and objective structure for the evaluation of blood gas analyzers, which may play a guidance role for healthcare operators approaching the evaluation of such technologies thus improving, in a contextualized fashion, the appropriateness of purchasing.


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