Challenges and Opportunities for Deliberative Processes for Healthcare Decision-Making Comment on "Evidence-Informed Deliberative Processes for Health Benefit Package Design - Part II: A Practical Guide".

The second edition of the practical guide for evidence-informed deliberative processes (EDPs) is an important addition to the growing guidance on deliberative processes supporting priority setting in healthcare. While the practical guide draws on an extensive amount of information collected on established and developing processes within a range of countries, EDPs present health technology assessment (HTA) bodies with several challenges. (1) Basing recommendations on current processes that have not been well-evaluated and that have changed over time may lead to weaker legitimacy than desired. (2) The requirement for social learning among stakeholders may require increased resourcing and blur the boundary between moral deliberation and political negotiation. (3) Robust evaluation should be based on an explicit theory of change, and some process outcomes may be poor guides to overall improvement of EDPs. This comment clarifies and reinforces the recommendations provided in the practical guide.

Core competencies for ethics experts in health technology assessment.

OBJECTIVES: There 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. METHODS: Based 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. RESULTS: Expertise 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. CONCLUSIONS: The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

Principles for deliberative processes in health technology assessment.

Deliberative processes are a well-established part of health technology assessment (HTA) programs in a number of high- and middle-income countries, and serve to combine complex sets of evidence, perspectives, and values to support open, transparent, and accountable decision making. Nevertheless, there is little documentation and research to inform the development of effective and efficient deliberative processes, and to evaluate their quality. This article summarizes the 2020 HTAi Global Policy Forum (GPF) discussion on deliberative processes in HTA.Through a combination of small and large group discussion and successive rounds of polling, the GPF members reached strong agreement on three core principles for deliberative processes in HTA: transparency, inclusivity, and impartiality. In addition, discussions revealed other important principles, such as respect, reviewability, consistency, and reasonableness, that may supplement the core set. A number of associated supporting actions for each of the principles are also described in order to make each principle realizable in a given HTA setting. The relative importance of the principles and actions are context-sensitive and must be considered in light of the political, legislative, and operational factors that may influence the functioning of any particular HTA environment within which the deliberative process is situated. The paper ends with suggested concrete next steps that HTA agencies, researchers, and stakeholders might take to move the field forward. The proposed principles and actions, and the next steps, provide a springboard for further research and better documentation of important aspects of deliberation that have historically been infrequently studied.

Ethical Challenges Related to Patient Involvement in Health Technology Assessment.

Including information and values from patients in HTA has the potential to improve both the process and outcomes of health technology policy decisions. Accordingly, funding and structural incentives to include patients in HTA activities have increased over the past several years. Unfortunately, these incentives have not yet been accompanied by a corresponding increase in resources, time, or commitment to responsiveness. In this Perspectives piece, we reflect on our collective experiences participating in, conducting, and overseeing patient engagement activities within HTA to highlight the ethical challenges associated with this area of activity. While we remain committed to the idea that patient engagement activities strengthen the findings, relevance, and legitimacy of health technology policy, we are deeply concerned about the potential for these activities to do ethical harm. We use this analysis to call for action to introduce strong protections against ethical violations that may harm patients participating in HTA engagement activities.

Identifying the Need for Good Practices in Health Technology Assessment: Summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA.

The systematic use of evidence to inform healthcare decisions, particularly health technology assessment (HTA), has gained increased recognition. HTA has become a standard policy tool for informing decision makers who must manage the entry and use of pharmaceuticals, medical devices, and other technologies (including complex interventions) within health systems, for example, through reimbursement and pricing. Despite increasing attention to HTA activities, there has been no attempt to comprehensively synthesize good practices or emerging good practices to support population-based decision-making in recent years. After the identification of some good practices through the release of the ISPOR Guidelines Index in 2013, the ISPOR HTA Council identified a need to more thoroughly review existing guidance. The purpose of this effort was to create a basis for capacity building, education, and improved consistency in approaches to HTA-informed decision-making. Our findings suggest that although many good practices have been developed in areas of assessment and some other key aspects of defining HTA processes, there are also many areas where good practices are lacking. This includes good practices in defining the organizational aspects of HTA, the use of deliberative processes, and measuring the impact of HTA. The extent to which these good practices are used and applied by HTA bodies is beyond the scope of this report, but may be of interest to future researchers.

QUALITY ASSESSMENT OF ETHICS ANALYSES FOR HEALTH TECHNOLOGY ASSSESSMENT.

OBJECTIVES: Although consideration of ethical issues is recognized as a crucial part of health technology assessment, ethics analysis for HTA is generally perceived as methodologically underdeveloped in comparison to other HTA domains. The aim of our study is (i) to verify existing tools for quality assessment of ethics analyses for HTA, (ii) to consider some arguments for and against the need for quality assessment tools for ethics analyses for HTA, and (iii) to propose a preliminary set of criteria that could be used for assessing the quality of ethics analyses for HTA. METHODS: We systematically reviewed the literature, reviewed HTA organizations' Web sites, and solicited views from thirty-two experts in the field of ethics for HTA. RESULTS: The database and HTA agency Web site searches yielded 420 references (413 from databases, seven from HTA Web sites). No formal instruments for assessing the quality of ethics analyses for HTA purposes were identified. Thirty-two experts in the field of ethics for HTA from ten countries, who were brought together at two workshops held in Edmonton (Canada) and Cologne (Germany) confirmed the findings from the literature. CONCLUSIONS: Generating a quality assessment tool for ethics analyses in HTA would confer considerable benefits, including methodological alignment with other areas of HTA, increase in transparency and transferability of ethics analyses, and provision of common language between the various participants in the HTA process. We propose key characteristics of quality assessment tools for this purpose, which can be applied to ethics analyses for HTA purposes.

Ethics expertise for health technology assessment: a Canadian national survey.

OBJECTIVES: The aim of this study was to identify individuals with expertise in ethics analysis in Canada, who might contribute to health technology assessment (HTA); to gauge these individuals' familiarity with, and experience participating in, the production of HTA. METHODS: A contact list was developed using the Canadian Bioethics Society membership list and faculty listings of Canadian universities, bioethics centers, and health agencies. An eighteen-question email survey was distributed to potential respondents to collect data on demographic information, education and work experience in applied ethics, and involvement in HTA. RESULTS: The survey response rate was 52.8 percent (350/663). Respondents worked primarily in academic institutions (50.4 percent) or hospitals (15.4 percent). Many respondents (83.1 percent) had education, formal training, or work-related experience in practical ethics related to health care, with many having a doctorate (34.5 percent) or master's degree (19.0 percent). One quarter (24.5 percent; n = 87) of respondents indicated they had been involved in an analysis of ethical issues for HTA. Almost two-thirds (65.4 percent; n = 165) of those who had not previously participated in ethics analysis believed they might usefully contribute to an analysis of ethical issues in HTA. Experts who have conducted ethics analysis in HTA had more than twice the odds of having education and training in ethics and a PhD than those who might contribute to ethics analysis. CONCLUSION: Many people have contributed to ethics analysis in HTA in Canada, and more are willing to do so. Given the absence of a reliable credential for ethics expertise, HTA producers should exercise caution when enlisting ethics experts.

Revealing and acknowledging value judgments in health technology assessment.

BACKGROUND: Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. METHODS: A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. RESULTS: Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. CONCLUSIONS: HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

Improving ethics analysis in health technology assessment.

OBJECTIVES: The aim of this study was to critically examine the current guidance for conducting ethics analysis in health technology assessment (HTA) and to offer recommendations for how to improve this practice. METHODS: MEDLINE, Philosopher's Index, and Google Scholar were searched for articles and reports using the keywords "ethics" and "health technology assessment" and related terms. Bibliographies of all relevant articles were also examined for additional references. A philosophical analysis of the existing guidance was conducted. RESULTS: We offer three recommendations for improving ethics analysis in HTA. First, ethical and legal issues must be clearly separated so that all policy-relevant questions that the technology raises can be considered clearly and systematically. Second, analysts must make better use of ethics theory and discuss better how particular theoretical approaches and associated analytic tools are selected to make transparent which alternative approaches were considered and why they were rejected. Third, the necessity for philosophical expertise to adequately conduct ethics analysis needs to be acknowledged. CONCLUSIONS: To act on these recommendations for ethics analysis, we offer these three steps forward: acknowledge and use relevant expertise, further develop models for conducting and reporting ethics analyses, and make use of untapped resources in the literature.