Scott Anna Mae, Hofmann Björn, Gutiérrez-Ibarluzea Iñaki, Bakke Lysdahl Kristin, Sandman Lars, Bombard Yvonne
Centre for Research in Evidence-Based Practice (CREBP), Bond University, Gold Coast, Queensland, Australia.
Institute for the Health Sciences, Norwegian University for Science and Technology, Gjøvik, Norway; Centre of Medical Ethics, University of Oslo, Oslo, Norway.
GMS Health Technol Assess. 2017 Mar 15;13:Doc02. doi: 10.3205/hta000128. eCollection 2017.
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. 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. 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. 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. Q-SEA is the first instrument for quality assessment of ethics analyses in HTA. Further refinements to the instrument to enhance its usability continue.
伦理问题评估是卫生技术评估（HTA）的重要组成部分。然而，就质量评估工具的存在而言，与HTA的其他领域（如临床或成本效益）相比，HTA伦理在方法学上尚不完善。为了在方法学上推进HTA伦理：（1）提出并详细阐述Q-SEA，这是首个用于伦理分析质量评估的工具；（2）将Q-SEA应用于HTA伦理的样本系统评价，以说明并促进其使用。为了制定Q-SEA工具的项目清单，我们系统回顾了HTA伦理方法学的文献，查阅了HTA组织的网站，并在两次为期两天的研讨会上征求了32位HTA伦理领域专家的意见。随后，我们通过将其应用于为HTA进行的伦理分析对Q-SEA进行了完善。Q-SEA工具由两个领域组成——过程领域和结果领域。过程领域由5个要素组成：研究问题、文献检索、纳入/排除标准、视角和伦理框架。结果领域由5个要素组成：完整性、偏差、影响、概念澄清和价值冲突。Q-SEA是HTA中首个用于伦理分析质量评估的工具。对该工具的进一步完善以提高其可用性的工作仍在继续。
