Towards an international consensus on definitions and standardised outcomemeasures for therapeutic trials (and epidemiological studies) in West syndrome

This paper argues for a standardized use of definitions and outcome measure s in publications on West syndrome. Specific recommendations include the ne ed for a validated definition of hypsarrhythmia, the use of the term non-sy mptomatic and abandoning the terms cryptogenic and idiopathic, talking abou t underlying disease association and not aetiology or cause and defining a clinical response to mean that no clinical evidence of a spasm has been see n for a specified time - 48 h was suggested. Patients should be followed up to report development - perhaps at 12-15 months and again at 2 and 5 years . Disease free survival should be reported. Side effects need to be seen as adverse events producing risk modification. Outcomes should be blind whene ver possible. A consensus group will take these and other suggestions forwa rd - please contact mailto:mpsjpo@bath.ac.uk if you are interested in takin g part. (C) 2001 Elsevier Science B.V. All rights reserved.