Quality Assessment of Ethics Analyses for Health Technology Asssessment

Abstract

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. Keywords: Health technology assessment, Ethics analysis, Quality assessment, Methods ETHICS AND HTAThe aim of health technology assessment (HTA) is to provide decision makers with a sound evidence base for health policy decisions, including those on public reimbursement of-or disinvestment from-particular health technologies, screening programs, and changes in clinical guidelines (1-7). Toward that aim, HTA studies the "medical, economic, social, and ethical implications of the development, diffusion, and use of health technologies"-such as pharmaceuticals, medical devices, andThe authors thank Nazila Assasi and her co-authors for sharing the details of their search methodology, as well as the anonymous peer reviewers for their helpful comments and feedback. This study builds on the discussions held at the "Workshops on Methodology in Ethics for Health Technology Assessments," which were held in October 2013 in Edmonton and Cologne. The authors gratefully acknowledge the participation and contributions of all of the workshops' participants. The workshops attracted funding and in-kind contributions from:

Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments

“…As a result, a preliminary version of the Q-SEA instrument has previously been published [10]. However, in applying this instrument to a specific systematic review of ethics issues in HTA, modifications were necessary.…”

“…To generate the instrument, we adopted a rigorous, three-pronged process, which we have reported previously [10]. Briefly, first, we identified a recent systematic review of guidelines for integrating ethics issues into health technology assessments [18], and reviewed in full all of the included guidelines, searching for criteria for assessing the quality of ethics analyses.…”

“…Finally, we also convened two 2-day workshops of experts in methodology in ethics for HTA, which focused on the issue of quality assessment in ethics for HTA. The workshops yielded a preliminary list of elements for Q-SEA; the list subsequently underwent multiple rounds of refinements over email discussions – indeed, undergoing further refinements from the list of items initially proposed [10]. This, finally, resulted in the Q-SEA instrument presented below.…”

“…Nevertheless, one area of ethics for HTA that indeed is considerably underdeveloped in comparison to other areas of HTA is quality assessment of ethics analyses in HTA [10], [11]. …”

When complexity matters: a step-by-step guide to incorporating a complexity perspective in guideline development for public health and health system interventions

“…Some useful approaches have been developed outside of the frameworks for systematic reviewing and guideline development. For example, Quality Standards for Ethics Analyses (Q-SEA) can be used as a tool to assess the quality of ethics analyses conducted for a guideline [43].…”