Repeated events and total time on test

We adopt the total time on test procedure to investigate monotone time trends in the intensity in a repeated event setting. The correct model is assumed to be a proportional hazards model, with a random effect to account for dependence within subjects. The method offers a simple routine for testing relevant hypotheses for recurrent event processes, without making distributional assumptions about the frailty. Such assumptions may severely affect conclusions concerning regression coefficients and cause bias in the estimated heterogeneity. The method is illustrated by re-analyzing Danish registry data and a long-term Swiss clinical study on recurrence in affective disorder. Copyright (c) 2008 John Wiley & Sons, Ltd.