title: Ethical analysis in HTA of complex health interventions.
abstract: BACKGROUND
  In 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.
  
  
  METHODS
  Six 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: Centre for Medical Ethics, University of Oslo, Oslo, Norway. kristin.bakke-lysdahl@hioa.no.
authors.forename: Kristin Bakke
authors.initials: KB
authors.lastname: Lysdahl
authors.affiliation: ECORYS Netherlands BV, Rotterdam, The Netherlands.
authors.forename: Wija
authors.initials: W
authors.lastname: Oortwijn
authors.affiliation: Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Centre, Nijmegen, The Netherlands.|Athena Institute for Innovation in the Health and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: Gert Jan
authors.initials: GJ
authors.lastname: van der Wilt
authors.affiliation: Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Refolo
authors.affiliation: Institute of Bioethics, "A. Gemelli" School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Sacchini
authors.affiliation: Department of Health Services Research, Institute of Public Health and Nursing Research, and Health Sciences, University of Bremen, Bremen, Germany.|Health Sciences Bremen, Bremen, Germany.
authors.forename: Kati
authors.initials: K
authors.lastname: Mozygemba
authors.affiliation: Department of Health Services Research, Institute of Public Health and Nursing Research, and Health Sciences, University of Bremen, Bremen, Germany.|Health Sciences Bremen, Bremen, Germany.
authors.forename: Ansgar
authors.initials: A
authors.lastname: Gerhardus
authors.affiliation: ScHARR, University of Sheffield, Sheffield, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Brereton
authors.affiliation: Centre for Medical Ethics, University of Oslo, Oslo, Norway.|The Norwegian University for Science and Technology, Gjøvik, Norway.
authors.forename: Bjørn
authors.initials: B
authors.lastname: Hofmann
mesh_terms: D026689:Ethical Analysis / Q000379:methods*; D026690:Ethics, Clinical; D006801:Humans; D013673:Technology Assessment, Biomedical / Q000941:ethics*
keywords: Health technology assessment; bioethics; complex health intervention