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Dichotomization is the transformation of a continuous outcome (response) to a binary outcome. This approach, while somewhat common, is harmful from the viewpoint of statistical estimation and hypothesis testing. We show that this leads to loss of information, which can be large. For normally distributed data, this loss in terms of Fisher's information is at least 1-2/pi (or 36%). In other words, 100 continuous observations are statistically equivalent to 158 dichotomized observations. The amount of information lost depends greatly on the prior choice of cut points, with the optimal cut point depending upon the unknown parameters. The loss of information leads to loss of power or conversely a sample size increase to maintain power. Only in certain cases, for instance, in estimating a value of the cumulative distribution function and when the assumed model is very different from the true model, can the use of dichotomized outcomes be considered a reasonable approach.

This paper is focused on statistical modelling, prediction and adaptive adjustment of patient recruitment in multicentre clinical trials. We consider a recruitment model, where patients arrive at different centres according to Poisson processes, with recruitment rates viewed as a sample from a gamma distribution. A statistical analysis of completed studies is provided and properties of a few types of parameter estimators are investigated analytically and using simulation. The model has been validated using many real completed trials. A statistical technique for predictive recruitment modelling for ongoing trials is developed. It allows the prediction of the remaining recruitment time together with confidence intervals using current enrolment information, and also provision of an adaptive adjustment of recruitment by calculating the number of additional centres required to accomplish a study up to a certain deadline with a pre-specified probability. Results are illustrated for different recruitment scenarios.