Transfusion Technology Assessment Group, Donor Medicine Research Department, Sanquin Research, Amsterdam, The Netherlands.
Division of Major Policy Issues, Paul-Ehrlich-Institut, Langen, Germany.
Transfusion. 2021 Feb;61(2):503-515. doi: 10.1111/trf.16231. Epub 2020 Dec 25.
Risk-based decision making is increasingly recognized as key to support national blood policy makers and blood operators concerning the implementation of safety interventions, especially to address emerging infectious threats and new technology opportunities. There is an urgent need for practical decision support tools, especially for low- and middle-income countries that may not have the financial or technical capability to develop risk models. WHO supported the development of such a tool for blood safety. The tool enables users to perform both a quantitative Multi-Criteria Decision Assessment and a novel step-by-step qualitative assessment.
This paper summarizes the content, functionalities, and added value of the new WHO tool. A fictitious case study of a safety intervention to reduce the risk of HIV transmission by transfusion was used to demonstrate the use and usefulness of the tool.
Application of the tool highlighted strengths and weaknesses of both the quantitative and qualitative approaches. The quantitative approach facilitates assessment of the robustness of the decision but lacks nuances and interpretability especially when multiple constraints are taken into consideration. Conversely, while unable to provide an assessment of robustness, the step-by-step qualitative approach helps structuring the thought process and argumentation for a preferred intervention in a systematic manner.
The relative strengths and weaknesses of the quantitative and step-by-step qualitative approach to risk-based decision making are complementary and mutually enhancing. A combination of the two approaches is therefore advisable to support the selection of appropriate blood safety interventions for a particular setting.
基于风险的决策越来越被认为是支持国家血液政策制定者和血液操作人员实施安全干预措施的关键，特别是针对新出现的传染病威胁和新技术机会。迫切需要实用的决策支持工具，特别是对于可能没有财力或技术能力开发风险模型的中低收入国家。世卫组织支持开发这样一种血液安全工具。该工具使用户能够执行定量多标准决策评估和新颖的逐步定性评估。
本文总结了新的世卫组织工具的内容、功能和附加值。使用一个虚构的安全干预案例研究来减少输血传播 HIV 的风险，以演示该工具的使用和有用性。
该工具的应用突出了定量和定性方法的优缺点。定量方法有助于评估决策的稳健性，但缺乏细微差别和可解释性，尤其是在考虑多个约束条件时。相反，虽然无法提供稳健性评估，但逐步定性方法有助于系统地帮助构建对首选干预措施的思维过程和论证。
基于风险的决策的定量和逐步定性方法的相对优缺点是互补的，相互增强的。因此，建议结合使用这两种方法，以支持为特定环境选择适当的血液安全干预措施。
