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

2017 ◽  
Vol 33 (5) ◽  
pp. 570-576 ◽  
Author(s):  
Kristin Bakke Lysdahl ◽  
Kati Mozygemba ◽  
Jacob Burns ◽  
Jan Benedikt Brönneke ◽  
James B. Chilcott ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Stakeholder Involvement ◽  
Complex Interventions ◽  
Health Technology ◽  
Legal Aspects ◽  
Added Value ◽  
Health Technologies ◽  
Stakeholder Perspectives ◽  
Wide Range

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

OP101 Do We Need To Extend Health Technology Assessment To Health Enhancement Assessment?

2017 ◽  
Vol 33 (S1) ◽  
pp. 46-46
Author(s):  
Bjørn Hofmann
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cognitive Abilities ◽  
Literature Search ◽  
Ethical Issues ◽  
Health Technology ◽  
Health Technologies ◽  
Health And Wellbeing ◽  
Wide Range

INTRODUCTION:Several health technologies used for therapy can also be used for health enhancement. Drugs stimulating cognitive abilities are but one example. Health Technology Assessment (HTA) has not been developed for assessing enhancements. This raises the question of how HTA should address the blurred distinction between therapy and enhancement. Should we (i) carve out a distinction between therapy and enhancement and limit HTA to therapy, (ii) use HTA for both therapy and enhancement (with some modifications), or (iii) should we develop a separate health enhancement assessment (HEA)?METHODS:A literature search of the medical, philosophical, and bioethical literature was conducted for debates, arguments, and suggested solutions to the issue of therapy versus enhancement.RESULTS:The same improvement in health may be therapeutic in one patient, but an enhancement in another. Moreover, both therapy and enhancement share the same goal: increased health and wellbeing. A wide range of arguments try to establish a difference between therapy and enhancement. They refer to naturalness, rehabilitation, normality, species-typical functioning/potential, disease, sustainability, and responsibility. On closer scrutiny few of these arguments do the job in bolstering the therapy-enhancement distinction. We already use a wide range of means to extend human abilities. Moreover, the therapy-enhancement distinction raises a wide range of ethical issues that are relevant for the assessment of a number of emerging health technologies.CONCLUSIONS:Existing HTA methodology can address a wide range of non-therapeutic health enhancements. However, a series of broader issues related to the goal of health care and responsibility for altering human evolution may not be addressed within traditional HTA frameworks. Specific HEAs may therefore be helpful.

PP136 How To Apply Health Technology Assessment To Large Scale e-Health Processes

2019 ◽  
Vol 35 (S1) ◽  
pp. 63-64
Author(s):  
Gro-Hilde Severinsen ◽  
Line Silsand ◽  
Anne Ekeland
Keyword(s):  
Health Technology Assessment ◽  
Information And Communication Technologies ◽  
Clinical Data ◽  
Technology Assessment ◽  
Large Scale ◽  
New Technologies ◽  
Health Technology ◽  
Added Value ◽  
Health Region ◽  
Wide Range

IntroductionThere are enormous expectations for e-health solutions to support high quality healthcare services, with accessibility, and effectiveness as key goals. E-health encompasses a wide range of information and communication technologies applied to health care, and focuses on combining clinical activity, technical development, and political requirements. Hence, e-health solutions must be evaluated in relation to the desired goals, to justify the high costs of such solutions.MethodsHealth technology assessment (HTA) aims to produce rational decisions for purchasing new technologies and evaluating healthcare investments, like drugs and medical equipment, by measuring added value in relation to clinical effectiveness, safety, and cost effectiveness. It is desired to also apply HTA assessment on large scale e-health solutions, but traditional quantitative HTA methodology may not be applicable to complex e-health systems developed and implemented as ongoing processes over years. Systematic reviews and meta-analyses of these processes risk being outdated when published, therefore action research designed to work with complex, large scale programs may be a more suitable approach.ResultsIn the project, we followed the development of a new process-oriented electronic patient record system (EPR) in northern Norway. Part of the process was structuring clinical data to be used in electronic forms within the system. This was the first time a health region structured the clinical data and designed the forms; receiving feedback alongside the process was very important. The goal was to use structured forms as a basis for reusing EPR data within and between systems, and to enable clinical decision support.DiscussionAfter designing a prototype of a structured form, we wrote an assessment report focusing on designing a methodology for such development, which stakeholders to include, and how to divide the work between the health region and the system vendor. The answers to such questions will have both practical and economic consequences for designing the next phase of the process.

Health Technology Assessment in Health Economics

2011 ◽  
pp. 69-86
Author(s):  
Steven Simoens
Keyword(s):  
Health Economics ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Expenditure ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Healthcare Sector ◽  
Scarce Resources ◽  
Health Technologies

This chapter introduces health technology assessment and health economics as tools for decision makers to allocate scarce resources in the healthcare sector. It argues that information about the safety, efficacy and effectiveness, organizational implications, social and ethical consequences, legal considerations, and health economic aspects of the application of a health technology needs to be taken into account with a view to informing decisions about the registration and reimbursement of a health technology. Also, the author hopes that understanding the methodology and use of health technology assessment and health economics will persuade the reader of the added value of such studies and promote the application of health technologies that support further health improvements, whilst containing health expenditure.

scholarly journals How innovation can be defined, evaluated and rewarded in health technology assessment

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Juan Carlos Rejon-Parrilla ◽  
Jaime Espin ◽  
David Epstein
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Unmet Need ◽  
Health Technology ◽  
Evidence Base ◽  
Added Value ◽  
Future Research ◽  
Health Technologies ◽  
Assessment Systems ◽  
Degree Of Innovation

Abstract Background What constitutes innovation in health technologies can be defined and measured in a number of ways and it has been widely researched and published about. However, while many countries mention it as a criterion for pricing or reimbursement of health technologies, countries differ widely in how they define and operationalise it. Methods We performed a literature review, using a snowballing search. In this paper, we explore how innovation has been defined in the literature in relation to health technology assessment. We also describe how a selection of countries (England, France, Italy, Spain and Japan) take account of innovation in their health technology assessment frameworks and explore the key methodologies that can capture it as a dimension of value in a new health technology. We propose a way of coming to, and incorporating into health technology assessment systems, a definition of innovation for health technologies that is independent of other dimensions of value that they already account for in their systems, such as clinical benefit. We use Spain as an illustrative example of how innovation might be operationalised as a criterion for decision making in health technology assessment. Results The countries analysed here can be divided into 2 groups with respect to how they define innovation. France, Japan and Italy use features such as severity, unmet need and therapeutic added value as indicators of the degree of innovation of a health technology, while England, Spain consider the degree of innovation as a separate and additional criterion from others. In the case of Spain, a notion of innovation might be constructed around concepts of `step-change’, `convenience’, `strength of evidence base’ and `impact on future research & development’. Conclusions If innovation is to be used as operational criteria for adoption, pricing and reimbursement of health technologies, the concept must be clearly defined, and it ought to be independent from other value dimensions already captured in their health technology assessment systems.

Health Technology Assessment in Health Economics

2011 ◽  
pp. 297-314 ◽  
Author(s):  
Steven Simoens
Keyword(s):  
Health Economics ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Expenditure ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Healthcare Sector ◽  
Scarce Resources ◽  
Health Technologies

This chapter introduces health technology assessment and health economics as tools for decision makers to allocate scarce resources in the healthcare sector. It argues that information about the safety, efficacy and effectiveness, organizational implications, social and ethical consequences, legal considerations, and health economic aspects of the application of a health technology needs to be taken into account with a view to informing decisions about the registration and reimbursement of a health technology. Also, the author hopes that understanding the methodology and use of health technology assessment and health economics will persuade the reader of the added value of such studies and promote the application of health technologies that support further health improvements, whilst containing health expenditure.

HARMONIZATION OF ETHICS IN HEALTH TECHNOLOGY ASSESSMENT: A REVISION OF THE SOCRATIC APPROACH

2014 ◽  
Vol 30 (1) ◽  
pp. 3-9 ◽  
Author(s):  
Bjørn Hofmann ◽  
Sigrid Droste ◽  
Wija Oortwijn ◽  
Irina Cleemput ◽  
Dario Sacchini
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Ethical Issues ◽  
Expert Panel ◽  
Health Technology ◽  
Joint Effort ◽  
Face To Face ◽  
Health Technologies ◽  
Wide Range ◽  
E Mail

Background: 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.Methods: 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.Results: 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.Conclusion: 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.

scholarly journals Development of a checklist to guide equity considerations in health technology assessment

2021 ◽  
Vol 37 ◽  
Author(s):  
Maria Benkhalti ◽  
Manuel Espinoza ◽  
Richard Cookson ◽  
Vivian Welch ◽  
Peter Tugwell ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Literature Search ◽  
Health Inequities ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Pilot Test

Abstract Objectives Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. Methods A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. Results ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. Conclusions ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

scholarly journals Estimating an EQ-5D-3L Value Set for Romania Using Time Trade-Off

2021 ◽  
Vol 18 (14) ◽  
pp. 7415
Author(s):  
Marian Sorin Paveliu ◽  
Elena Olariu ◽  
Raluca Caplescu ◽  
Yemi Oluboyede ◽  
Ileana-Gabriela Niculescu-Aron ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Assessment Process ◽  
Computer Assisted ◽  
Health State ◽  
Health States ◽  
Value Set ◽  
Health Technologies ◽  
Related Quality

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.

scholarly journals Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements

2021 ◽  
Vol 37 ◽  
Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Practical Experience ◽  
Added Value ◽  
Real World Data ◽  
Conflicting Demands ◽  
Real World Evidence ◽  
Semistructured Interviews

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

Designing an interactive model of factors affecting the health technology assessment (HTA) in Iran

2018 ◽  
Vol 23 (4) ◽  
pp. 301-311 ◽  
Author(s):  
Mohammadkarim Bahadori ◽  
Ramin Ravangard ◽  
Mahya Tohidi Nezhad ◽  
Naeimeh Pourtaheri ◽  
Sayyed Morteza Hosseini-Shokouh
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Social Dimension ◽  
Ethical Dimension ◽  
Policy Makers ◽  
Content Type ◽  
Factors Affecting ◽  
Health Technologies ◽  
Interactive Model

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.

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