Leach Bennett Judie, Devine Dana V
Canadian Blood Services, Ottawa, ON, Canada.
Centre for Blood Research, University of British Columbia, Vancouver, BC, Canada.
Vox Sang. 2018 Nov;113(8):737-749. doi: 10.1111/vox.12708. Epub 2018 Sep 19.
Formal processes to assess risk are well established in numerous areas of society including the environment, transportation, energy and food production sectors as well as some areas of health care such as new drugs or other therapeutic goods. However, these processes and their associated frameworks have only recently come to be used to make decisions in blood transfusion practice or in blood system policy development. This review describes the evolution of the use of risk-based decision making and discusses the elements that should be considered in its application to blood system issues. Following the identification and characterization of the risk, a structured process is undertaken to assess the magnitude of the risk and the level of risk reduction that can reasonably be achieved in the context of the complexity of the risk management action proposed and its cost. Inputs must be sought from appropriate subject matter experts, but also from those who can consider issues of ethics and social values. Engagement of the public is an essential step. Proposed interventions should be assessed for their likelihood of mitigating the risk and the proportional resource allocation in comparison with similar risks to the blood system or health system. Examples are provided of how a risk-based decision-making framework is used to address identified risks in the blood system.
在社会的众多领域，包括环境、交通、能源和食品生产部门以及医疗保健的某些领域（如新药或其他治疗用品），评估风险的正式流程已确立。然而，这些流程及其相关框架直到最近才被用于输血实践或血液系统政策制定的决策中。本综述描述了基于风险的决策制定的使用演变，并讨论了将其应用于血液系统问题时应考虑的因素。在识别和描述风险之后，要进行一个结构化的过程来评估风险的大小以及在所提议的风险管理行动的复杂性及其成本的背景下能够合理实现的风险降低水平。必须征求适当的主题专家的意见，同时也要征求那些能够考虑伦理和社会价值问题的人的意见。公众参与是必不可少的一步。应评估提议的干预措施减轻风险的可能性以及与血液系统或卫生系统的类似风险相比的资源分配比例。文中给出了基于风险的决策框架如何用于应对血液系统中已识别风险的示例。
