Limitations of the incidence density ratio as approximation of the hazard ratio

Background Incidence density ratios (IDRs) are frequently used to account for varying follow-up times when comparing the risks of adverse events in two treatment groups. The validity of the IDR as approximation of the hazard ratio (HR) is unknown in the situation of differential average follow up by treatment group and non-constant hazard functions. Thus, the use of the IDR when individual patient data are not available might be questionable.