Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania.
Qual Manag Health Care. 2020 Oct/Dec;29(4):260-269. doi: 10.1097/QMH.0000000000000276.
Root cause analysis involves evaluation of causal relationships between exposures (or interventions) and adverse outcomes, such as identification of direct (eg, medication orders missed) and root causes (eg, clinician's fatigue and workload) of adverse rare events. To assess causality requires either randomization or sophisticated methods applied to carefully designed observational studies. In most cases, randomized trials are not feasible in the context of root cause analysis. Using observational data for causal inference, however, presents many challenges in both the design and analysis stages. Methods for observational causal inference often fall outside the toolbox of even well-trained statisticians, thus necessitating workforce training.
This article synthesizes the key concepts and statistical perspectives for causal inference, and describes available educational resources, with a focus on observational clinical data. The target audience for this review is clinical researchers with training in fundamental statistics or epidemiology, and statisticians collaborating with those researchers.
The available literature includes a number of textbooks and thousands of review articles. However, using this literature for independent study or clinical training programs is extremely challenging for numerous reasons. First, the published articles often assume an advanced technical background with different notations and terminology. Second, they may be written from any number of perspectives across statistics, epidemiology, computer science, or philosophy. Third, the methods are rapidly expanding and thus difficult to capture within traditional publications. Fourth, even the most fundamental aspects of causal inference (eg, framing the causal question as a target trial) often receive little or no coverage. This review presents an overview of (1) key concepts and frameworks for causal inference and (2) online documents that are publicly available for better assisting researchers to gain the necessary perspectives for functioning effectively within a multidisciplinary team.
A familiarity with causal inference methods can help risk managers empirically verify, from observed events, the true causes of adverse sentinel events.
根本原因分析涉及评估暴露(或干预)与不良结局之间的因果关系,例如确定不良罕见事件的直接原因(例如,遗漏医嘱)和根本原因(例如,临床医生的疲劳和工作量)。评估因果关系需要随机化或应用于精心设计的观察性研究的复杂方法。在大多数情况下,在根本原因分析的背景下进行随机试验是不可行的。然而,使用观察数据进行因果推断在设计和分析阶段都面临许多挑战。即使是受过良好训练的统计学家,用于观察性因果推断的方法也常常不在工具包中,因此需要进行劳动力培训。
本文综合了因果推断的关键概念和统计观点,并描述了可用的教育资源,重点是观察性临床数据。本文的目标读者是具有基础统计学或流行病学培训的临床研究人员以及与这些研究人员合作的统计学家。
现有的文献包括许多教科书和数千篇综述文章。然而,由于许多原因,使用这些文献进行独立学习或临床培训计划极具挑战性。首先,已发表的文章通常假设具有不同符号和术语的高级技术背景。其次,它们可能是从统计学、流行病学、计算机科学或哲学等多个角度撰写的。第三,方法正在迅速扩展,因此很难在传统出版物中捕捉到。第四,即使是因果推断的最基本方面(例如,将因果问题框定为目标试验)也很少或根本没有得到涵盖。本文综述了(1)因果推断的关键概念和框架,以及(2)在线文档,这些文档可供公开使用,以便更好地帮助研究人员获得在多学科团队中有效运作所需的观点。
熟悉因果推断方法可以帮助风险经理从观察到的事件中实证验证不良哨兵事件的真正原因。