Background and objectives: 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.
Methods: 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.
Results: 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.
Conclusion: A familiarity with causal inference methods can help risk managers empirically verify, from observed events, the true causes of adverse sentinel events.