Ethical analysis in HTA of complex health interventions

Abstract

BackgroundIn the field of health technology assessment (HTA), there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the potential methodological challenges for ethical analysis are as yet unknown.MethodsSix of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches.ResultsThe Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach.ConclusionThis study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general.

Ethical Evaluation in Health Technology Assessment: A Challenge for Applied Philosophy

“…Coherence Analysis (CA) and Wide Reflective Equilibrium (WRE) are viewed by some authors as indistinguishable, since WRE is by definition a coherentist model (Lysdahl et al, 2016). While we acknowledge that this claim is valid at the foundational level, since both approaches cope with the absence of truth in morals by a "test of consistency" (Saarni et al, 2008), it is not so at the ethical-evaluation level.…”

“…The six approaches with philosophy as their foundational discipline have one common denominator: their denial of the possibility of finding a universal moral truth. The way Lysdahl et al characterize the coherentist dimension of WRE is transferable to all the other five approaches: "Coherentist, here, is used in contrast to foundational approaches, which assume that there are certain undisputable basic principles from which moral judgments can be derived" (Lysdahl et al, 2016). The absence of a universal moral truth means that ethical analysis cannot be grounded on one -universally shared -world view.…”

“…Legault et al lenge to tackle in philosophical analysis in order to overcome the fundamental barrier for the integration of ethics in HTA. Articles by Assasi et al (Assasi et al, 2014, 2016 have identified and summarized a number of other barriers, two of which originate from the very nature of ethical analysis itself. The first is the diversity in the kinds of ethical analysis proposed and their complexity; the second is in the difficulty of applying ethical analysis in such a way as to obtain tangible results (Assasi et al, 2015).…”

HTA for pharmaceuticals in Europe: will the mountain deliver a mouse?

“…For instance, the contribution of ethical aspects has always been relevant in theory and scant in practice [2,[17][18][19], with articles on methods often overwhelming those on applications in the literature [20]. The most likely reason is that it is problematic (even impossible) to test ethical implications of single technologies empirically as ethics reports to more general issues [21], e.g., ubiquitous conflicts of interest raised in medicine [22]. Although much less analyzed in the literature, roughly the same holds for legal aspects [19], with the indication not to conduct HTAs on pharmaceuticals close to patent expiry protection as a good example of very general (though not trivial) recommendation [23].…”

Evaluación de Tecnologías Sanitarias (ETESA) una Visión Global del Concepto y de sus Alcances

“…Por otro lado, ETESA es la forma integral de investigar las consecuencias técnicas, legales, económicas, éticas y sociales que ocurren a lo largo del tiempo, así como los efectos directos o indirectos, deseados e indeseados, que se derivan del uso de una TS (Kuhn-Barrientos, 2014; Gagnon, 2014;Lysdahl et al, 2016;OPS, 2017).…”