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Editorial
Provides a statistical rule of thumb (3/n) to estimate the maximum risk of adverse events when zero complications have been observed in a sample size n > 30.
The probability of adverse and undesirable events during and after operations that have not yet occurred in a finite number of patients (n) can be estimated with Hanley's simple formula, which gives the upper limit of the 95% confidence interval of the probability of such an event: upper limit of 95% confidence interval = maximum risk = 3/n (for n > 30). Doctors and surgeons should keep this simple rule in mind when complication rates of zero are reported in the literature and when they have not (yet) experienced a disastrous complication in a procedure.
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Eypasch et al. (1995) studied this question.