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Background: Regression to the mean (RTM) is a statistical phenomenon that can make natural variation in repeated data look like real change. It happens when unusually large or small measurements tend to be followed by measurements that are closer to the mean.

Methods: We give some examples of the phenomenon, and discuss methods to overcome it at the design and analysis stages of a study.

Results: The effect of RTM in a sample becomes more noticeable with increasing measurement error and when follow-up measurements are only examined on a sub-sample selected using a baseline value.

Conclusions: RTM is a ubiquitous phenomenon in repeated data and should always be considered as a possible cause of an observed change. Its effect can be alleviated through better study design and use of suitable statistical methods.

(C) International Epidemiological Association 2005. Published by Oxford University Press. All rights reserved.