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Q-SEA – a tool for quality assessment of ethics analyses conducted as part of health technology assessments

机译：Q-SEA –作为卫生技术评估的一部分进行的伦理分析质量评估的工具

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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.
机译：简介：道德问题评估是卫生技术评估（HTA）的重要组成部分。但是，就质量评估工具的存在而言，与HTA的其他领域（例如临床或成本效益）相比，HTA的伦理学在方法论上欠发达。目的：通过以下方法从方法上推进HTA伦理学：（1）提出并拟定Q-SEA，这是伦理学分析质量评估的第一个工具，以及（2）将Q-SEA应用于对HTA伦理学进行系统的样本审查，以便方法：为了制定Q-SEA工具的项目清单，我们系统地回顾了有关HTA道德方法论的文献，回顾了HTA组织的网站，并征求了32位该领域专家的意见。在两个为期两天的研讨会上探讨了HTA的道德规范。随后，我们通过将Q-SEA应用于对HTA进行的道德分析来完善其功能。结果：Q-SEA仪器包含两个域–过程域和输出域。过程域包含5个元素：研究问题，文献检索，纳入/排除标准，观点和道德框架。输出域包含5个元素：完整性，偏见，影响，概念澄清和价值观冲突。结论：Q-SEA是HTA中道德分析质量评估的第一个工具。仪器的进一步改进以增强其可用性仍在继续。

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