Cognitive and behavioural assessments in clinical trials: what type of measure?

This paper provides an overview of the types of neuropsychological and beha vioural measures used in randomised controlled trials (RCTS) of antiepilept ic drugs (AEDs) in patients with epilepsy. The results of previous systemat ic reviews are reported in respect of the methods used in clinical trials t o assess cognitive and behavioural effects of AED treatment. There were 46 trials incorporating behavioural measures and 40 trials incorporating neuro psychological measures. The evidence supporting the choice of test, and the ir reliability, validity, and sensitivity to change was minimal. It is conc luded that poor reporting of methods and a plethora of both neuropsychologi cal and behavioural measures make it difficult to provide any meaningful co mments about the effects of AED treatment. A much more standardised approac h to assessing these effects is necessary. (C) 2001 Elsevier Science B.V. A ll rights reserved.