Department of Health Services Research,University of Bremen.
ScHARR,University of Sheffield.
Int J Technol Assess Health Care. 2017 Jan;33(5):544-551. doi: 10.1017/S0266462317000484. Epub 2017 Jul 31.
Current health technology assessment (HTA) is not well equipped to assess complex technologies as insufficient attention is being paid to the diversity in patient characteristics and preferences, context, and implementation. Strategies to integrate these and several other aspects, such as ethical considerations, in a comprehensive assessment are missing. The aim of the European research project INTEGRATE-HTA was to develop a model for an integrated HTA of complex technologies.
A multi-method, four-stage approach guided the development of the INTEGRATE-HTA Model: (i) definition of the different dimensions of information to be integrated, (ii) literature review of existing methods for integration, (iii) adjustment of concepts and methods for assessing distinct aspects of complex technologies in the frame of an integrated process, and (iv) application of the model in a case study and subsequent revisions.
The INTEGRATE-HTA Model consists of five steps, each involving stakeholders: (i) definition of the technology and the objective of the HTA; (ii) development of a logic model to provide a structured overview of the technology and the system in which it is embedded; (iii) evidence assessment on effectiveness, economic, ethical, legal, and socio-cultural aspects, taking variability of participants, context, implementation issues, and their interactions into account; (iv) populating the logic model with the data generated in step 3; (v) structured process of decision-making.
The INTEGRATE-HTA Model provides a structured process for integrated HTAs of complex technologies. Stakeholder involvement in all steps is essential as a means of ensuring relevance and meaningful interpretation of the evidence.
当前的健康技术评估（HTA）在评估复杂技术方面做得不够好，因为对患者特征和偏好、背景和实施方面的多样性关注不足。综合评估中还缺乏整合这些方面以及其他一些方面的策略，如伦理考虑。欧洲研究项目 INTEGRATE-HTA 的目的是开发一种综合评估复杂技术的模型。
一种多方法、四阶段的方法指导了 INTEGRATE-HTA 模型的开发：（i）确定要整合的不同信息维度，（ii）综合评估现有整合方法的文献，（iii）调整评估复杂技术不同方面的概念和方法在综合过程框架内，以及（iv）在案例研究中应用该模型并进行后续修订。
INTEGRATE-HTA 模型由五个步骤组成，每个步骤都涉及利益相关者：（i）定义技术和 HTA 的目标；（ii）开发逻辑模型，提供技术和嵌入系统的结构化概述；（iii）评估有效性、经济、伦理、法律和社会文化方面的证据，同时考虑参与者的变异性、背景、实施问题及其相互作用；（iv）将第 3 步生成的数据填入逻辑模型；（v）进行结构化的决策过程。
INTEGRATE-HTA 模型为复杂技术的综合 HTA 提供了一个结构化的流程。利益相关者在所有步骤中的参与至关重要，这是确保证据的相关性和有意义解释的一种手段。
