Q-SEA - a tool for quality assessment of ethics analyses conducted as part of health technology assessments.
Introduction:Assessment of ethics issues is an important part of health technology assessments (HTA). However, in terms of existence of quality assessment tools, ethics for HTA is methodologically underdeveloped in comparison to other areas of HTA, such as clinical or cost effectiveness.Objective:To methodologically advance ethics for HTA by: (1) proposing and elaborating Q-SEA, the first instrument for quality assessment of ethics analyses, and (2) applying Q-SEA to a sample systematic review of ethics for HTA, in order to illustrate and facilitate its use.Methods:To develop a list of items for the Q-SEA instrument, we systematically reviewed the literature on methodology in ethics for HTA, reviewed HTA organizations' websites, and solicited views from 32 experts in the field of ethics for HTA at two 2-day workshops. We subsequently refined Q-SEA through its application to an ethics analysis conducted for HTA.Results:Q-SEA instrument consists of two domains - the process domain and the output domain. The process domain consists of 5 elements: research question, literature search, inclusion/exclusion criteria, perspective, and ethics framework. The output domain consists of 5 elements: completeness, bias, implications, conceptual clarification, and conflicting values.Conclusion:Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue.
Centre for Research in Evidence-Based Practice (CREBP), Bond University, Gold Coast, Queensland, Australia.
Anna Mae
AM
Scott
Institute for the Health Sciences, Norwegian University for Science and Technology, Gjøvik, Norway; Centre of Medical Ethics, University of Oslo, Oslo, Norway.
Björn
B
Hofmann
Dept. of Biochemistry, Nursing University School Vitoria-Gasteiz, Vitoria-Gasteiz, Basque Country, Spain; OSTEBA, Basque Office for HTA, Research and Innovation Directorate, Department for Health, Vitoria-Gasteiz, Basque Country, Spain.
Iñaki
I
Gutiérrez-Ibarluzea
Centre for Medical Ethics, University of Oslo, Oslo, Norway.
Kristin
K
Bakke Lysdahl
National Centre for Priority Setting in Health Care, Linköping University, Linköping, Sweden; University of Borås, Borås, Sweden.
Lars
L
Sandman
Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
Yvonne
Y
Bombard
ethics analysis; health technology assessment; methodology; quality assessment; systematic reviews