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Table 1 Characteristics of complexity, short explanations and implications for ethics analysis

From: Ethical analysis in HTA of complex health interventions

Characteristic Short explanation Implications for ethical analysis in HTAa
Multiple and changing perspectives The variety of perspectives is caused by the many components (social, material, theoretical, and procedural [51]), actors, stakeholders, organisational levels involved. Additionally, these are interconnected and interacting. Address the variety of perspectives (typically the stakeholders’ interests and intentions), questions about normative implications of interconnectedness and interactions between actors/components, and moral questions related to control and decision making.
Indeterminate phenomena The interventions or health condition cannot be strictly defined or delimited due to characteristics like flexibility, tailoring, self-organization, adaptivity, and evolution over time. Identify moral challenges related to indeterminacy of the intervention and/or the target medical condition(s). E.g. identify possible contradictory interpretationsb and alternative use of the intervention, and the justifications of these.
Uncertain causality Factors like synergy between components, feedback loops, moderators and mediators of effect, context and the symbolic value of the intervention lead to uncertain causal pathways between intervention and outcome. Address morally relevant issues related to methodological choices in the HTA itself. The uncertainties call for transparency and openness about the grounds for the choices and an integrative approach.
Unpredictable outcomes The outcomes of the intervention may be many, variable, new, emerging and unexpected. Address ethical challenges of handling outcome uncertainties, regarding outcome type, size, for whom/at what level, and at what time.
Ethical complexity Interventions are especially ethically complex because of contradictions between basic ethical principles, or because fundamental moral or sociocultural values are at stake. Reveal underlying norms and values, and elucidate possible contradicting principles or values (resolvability).
Reveal potential fundamental ethical, social, cultural values at stake, and contribute to handling of conflicting concerns. Clarity of aim and scope of ethical analyses (conclusiveness and integration in HTA), and comprehensiveness and transparency of reporting are essential.
  1. aDescribing some obvious implications certainly does not exclude the possibility of other relevant implications
  2. bThe indeterminacy of complex interventions allows for interpretations in different, also contradictory, ways, (i.e. paradoxes need careful scrutiny and conciliation of interpretations to be resolved) [52]