Estimating risk when zero events have been observed

Quigley, John and Revie, Matthew and Dawson, Jesse (2013) Estimating risk when zero events have been observed. BMJ Quality and Safety, 22 (12). pp. 1042-1043. (https://doi.org/10.1136/bmjqs-2013-002246)

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Abstract

Assessing the risk of complications or adverse events following an intervention presents challenges when they have not yet occurred. Suppose, for instance, a chronic shortage of cardiac telemetry beds has prompted a hospital to implement a new policy that places low-risk patients admitted to ‘rule out myocardial infarction’ in regular ward beds (ie, with no telemetry). After 6 months and the admission of 100 such patients, no cardiac arrests or other untoward events have occurred. This absence of harm (ie, zero adverse events) indicates a low risk, but clearly we cannot infer a risk of zero on the basis of only 100 patients. But, what can we say about the true underlying risk?

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