Abstract
The number of patients who would need to be treated to prevent a given adverse outcome in one patient, called the number needed to treat, is often used in randomized trials and observational studies to provide a simple measure of the effect of a treatment. The computation of the number needed to treat can, however, be inaccurate and its interpretation misleading in trials with varying follow-up times. In this case, the cumulative incidence of an outcome cannot simply be calculated as a proportion of subjects but must instead be estimated over time by means of the Kaplan–Meier approach that accounts for varying follow-up times.

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