Centre for Medical Ethics,University of Oslo.
Department of Health Services Research,University of Bremen.
Int J Technol Assess Health Care. 2017 Jan;33(5):570-576. doi: 10.1017/S0266462317000678. Epub 2017 Aug 7.
Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects.
Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers.
The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods' applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources.
The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.
尽管健康技术评估（HTA）方法最近有所发展，但对于复杂医疗技术的评估仍存在方法上的差距。《综合 HTA 指南》针对有效性、经济、伦理、社会文化和法律方面的评估，涉及到评估复杂技术时所面临的挑战，例如异质的研究设计、多个利益相关者的观点以及不可预测的结果。本文的目的是概述该指南并描述整合这些评估方面的附加值。
不同的方法用于开发指南的各个部分，但都借鉴了现有已发表的知识，并得到了利益相关者的参与支持。在案例研究中应用并根据内部和外部审查员的反馈对指南进行了修改。
该指南由五个部分组成，涵盖 HTA 的五个核心方面，均根据评估的复杂性、背景和利益相关者的参与呈现逐步的方法。关于有效性、健康经济学和伦理学方面的指南侧重于帮助用户选择适当的或进一步开发现有的方法。这些建议是基于现有方法在处理复杂干预措施所带来的问题方面的适用性。该指南提供了识别社会文化和法律问题的新框架，以及相关方法和来源的概述。
《综合 HTA 指南》概述了广泛的方法，并促进了在这些方法之间进行适当的选择。该指南使人们能够理解复杂性对 HTA 的重要性，并将来自流行病学、经济学、伦理学、法律和社会理论等学科的评估结合在一起。这表明该指南适用于广泛的技术。
