scholarly journals Different methods for ethical analysis in health technology assessment: An empirical study

2011 ◽  
Vol 27 (4) ◽  
pp. 305-312 ◽  
Author(s):  
Samuli I. Saarni ◽  
Annette Braunack-Mayer ◽  
Bjørn Hofmann ◽  
Gert Jan van der Wilt

Objectives: Ethical analysis can highlight important ethical issues related to implementing a technology, values inherent in the technology itself, and value-decisions underlying the health technology assessment (HTA) process. Ethical analysis is a well-acknowledged part of HTA, yet seldom included in practice. One reason for this is lack of knowledge about the properties and differences between the methods available. This study compares different methods for ethical analysis within HTA.Methods: Ethical issues related to bariatric (obesity) surgery were independently evaluated using axiological, casuist, principlist, and EUnetHTA models for ethical analysis within HTA. The methods and results are presented and compared.Results: Despite varying theoretical underpinnings and practical approaches, the four methods identified similar themes: personal responsibility, self-infliction, discrimination, justice, public funding, and stakeholder involvement. The axiological and EUnetHTA models identified a wider range of arguments, whereas casuistry and principlism concentrated more on analyzing a narrower set of arguments deemed more important.Conclusions: Different methods can be successfully used for conducting ethical analysis within HTA. Although our study does not show that different methods in ethics always produce similar results, it supports the view that different methods of ethics can yield relevantly similar results. This suggests that the key conclusions of ethical analyses within HTA can be transferable between methods and countries. The systematic and transparent use of some method of ethics appears more important than the choice of the exact method.

2012 ◽  
Vol 28 (2) ◽  
pp. 195-196
Author(s):  
Kathrin Dengler ◽  
Uta Bittner

In their article “Different methods for ethical analysis in health technology assessment: An empirical study” published inInternational Journal of Technology Assessment in Health Care, Volume 27 Number 4, Samuli I. Saarni, Annette Braunack-Mayer, Bjørn Hofmann, and Gert Jan van der Wilt present an empirical study about different methods for ethical analysis in health technology assessment (HTA). They claim that ethical analysis is an important issue which can highlight values inherent in a technology and value-decisions underlying a HTA process (4). Although their study is rich in detail; gives an interesting overview of casuistry, principlism, and axiological ethic frameworks; and make ethical evaluations within HTA more transparent, we suppose, one important point needs further serious discussion: the clarification of what is meant by “value.”


2011 ◽  
Vol 21 (9) ◽  
pp. 1469-1476 ◽  
Author(s):  
Samuli I. Saarni ◽  
Heidi Anttila ◽  
Suoma E. Saarni ◽  
Pertti Mustajoki ◽  
Vesa Koivukangas ◽  
...  

2020 ◽  
Vol 36 (6) ◽  
pp. 534-539
Author(s):  
Pietro Refolo ◽  
Kenneth Bond ◽  
Bart Bloemen ◽  
Ilona Autti-Rämö ◽  
Bjørn Hofmann ◽  
...  

AbstractObjectivesThere is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.MethodsBased on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.ResultsExpertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.ConclusionsThe competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.


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. 46-46
Author(s):  
Bjørn Hofmann

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.


2009 ◽  
Vol 25 (S2) ◽  
pp. 84-91 ◽  
Author(s):  
Camilla Palmhøj Nielsen ◽  
Sarah Wadmann Lauritsen ◽  
Finn Børlum Kristensen ◽  
Marie Louise Bistrup ◽  
Americo Cecchetti ◽  
...  

Objectives: This article explains how the issue of stakeholder involvement was addressed in the European network for Health Technology Assessment (EUnetHTA) Project and describes the structures of future stakeholder involvement in the EUnetHTA Collaboration.Methods: Initiatives led to a dialogue with stakeholders and exchanging views and expectations on health technology assessment (HTA) processes and the future development of EUnetHTA. The methods of involving different stakeholder groups in EUnetHTA included general information to stakeholders about EUnetHTA, targeted information on a Web site, analysis of stakeholder opinions on HTA and EUnetHTA, and development of a draft stakeholder policy.Results: First steps were taken to organize processes to consolidate the legitimacy of EUnetHTA and its products and encourage the representation of interests, thus contributing to promoting the utilization of HTA in national/regional policy making. A stakeholder Web site, analyses of stakeholder opinions on HTA and EUnetHTA in a discussion topic catalog, and a draft stakeholder policy resulted from the work.Conclusions: Stakeholder involvement in EUnetHTA is necessary to ensure the legitimacy and prospects for utilization of EUnetHTA and its products. The described activities and results create the foundation for a continued dialogue with, and involvement of, stakeholders. The EUnetHTA stakeholder meeting can be considered as a successful experience of dialogue between EUnetHTA and stakeholders, which should be continued. Our experience shows the challenge of obtaining balanced stakeholder representation across the identified stakeholder groups. Continued attention should be given to achieving balanced stakeholder representation.


2017 ◽  
Vol 33 (5) ◽  
pp. 570-576 ◽  
Author(s):  
Kristin Bakke Lysdahl ◽  
Kati Mozygemba ◽  
Jacob Burns ◽  
Jan Benedikt Brönneke ◽  
James B. Chilcott ◽  
...  

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.


2016 ◽  
Vol 32 (3) ◽  
pp. 181-189 ◽  
Author(s):  
Bahareh Yazdizadeh ◽  
Safoura Shahmoradi ◽  
Reza Majdzadeh ◽  
Shila Doaee ◽  
Mohammad Bazyar ◽  
...  

Objectives: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.Methods:The study was conducted in two stages, semi-structured interviews, and “policy dialogue” with stakeholders. The data were analyzed through the framework approach.Results: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.Conclusions: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.


2008 ◽  
Vol 24 (04) ◽  
pp. 423-429 ◽  
Author(s):  
Bjørn Morten Hofmann

From the heydays of HTA in the 1970s, it has been argued that ethics should be a part of HTA. Despite more than 30 years with repeated intentions, only few HTA reports include ethical analysis, and there is little agreement on methods for integrating ethics. This poses the question of why it is so important to integrate ethics in HTA? The article analyzes ten arguments for making ethics part of HTA. The validity of the arguments depend on what we mean by “integrating,” “ethics,” and “HTA.” Some of the counterarguments explain why it has taken so long to integrate ethics in HTA and why there are so many ethical approaches. Nevertheless, some of the arguments for making ethics part of HTA appear to be compelling. Health care is a moral endeavor, and the vast potential of technology poses complex moral challenges. A thorough assessment of technology would include reflection on these moral aspects. Ethics provides such a moral reflection. Health technology is a way to improve the life of human individuals. This involves questions of what “the good life” is, and hence ethical issues. Trying to ignore such questions may inflict with the moral foundation of health care: to help people. Additionally, HTA is anevaluation, and as such also a reflection on values. Hence, there is a profound affinity between HTA and ethics. Accordingly, ethics cannot be “integrated” in HTA as ethics is already a constitutive part of HTA. However, ethics can be acknowledged and emphasized.


2019 ◽  
Vol 35 (S1) ◽  
pp. 35-35
Author(s):  
María Sánchez González ◽  
Iñaki Imaz-Iglesia ◽  
Juan Pablo Chalco-Orrego

IntroductionAppropriate involvement of stakeholders is one of the founding principles of the European Cooperation on Health Technology Assessment. The European Network for Health Technology Assessment (EUnetHTA) produces Rapid Relative Effectiveness Assessments (REAs) to assess pharmaceutical (PT) or other technologies (OT). Stakeholders essentially participate in the scoping, the draft assessment phase, or both.MethodsAll REAs published since 2013 were reviewed. Stakeholder participation in scoping (project plan) and draft assessment was evaluated. We aggregated categories of stakeholders in four groups (Health Care Providers and Academia, Patients and Consumers, Manufacturers, and Regulators and Payers). Means of collaboration (meetings, comments to project plan and draft assessment, questionnaires, focus groups) are also analyzed. Data is continuously updated with new REAs.ResultsMore than 20 REAs have been published at the moment, with a higher number of OT. Health Care Providers and Academia acted as experts in both phases, participating in all REA of OT, and less of PT. Manufacturers participated in all REA in the scoping phase. Regulators and Payers, less involved, participated mainly in the scoping phase. The main methods are providing comments in a standardized form and meetings. Patients' contribution, similar in OT and PT, has increased over the years. Questionnaires or interviews were the main method of involvement, followed by participation in meetings and focus groups. Visibility and transparency have also improved, with a clearer reporting of the stakeholder contribution in the last assessments.ConclusionsThe stakeholder involvement in EUnetHTA REAs is steadily growing, with the different nature of stakeholders’ categories reflected in their contribution to the assessments. EUnetHTA is standardizing stakeholder involvement procedures taking into account the particularities of each group when generating guidance for stakeholder involvement.


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