title: Towards an international consensus on definitions and standardised outcome measures for therapeutic trials (and epidemiological studies) in West syndrome.
abstract: This paper argues for a standardized use of definitions and outcome measures in publications on West syndrome. Specific recommendations include the need for a validated definition of hypsarrhythmia, the use of the term non-symptomatic and abandoning the terms cryptogenic and idiopathic, talking about underlying disease association and not aetiology or cause and defining a clinical response to mean that no clinical evidence of a spasm has been seen 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 whenever possible. A consensus group will take these and other suggestions forward--please contact mail to: mpsjpo@bath.ac.uk if you are interested in taking part.
authors.affiliation: The Children's Centre, Royal United Hospital NHS Trust Bath, Combe Park, Bath, BA1 3NG, UK. mpsjpo@bath.ac.uk
authors.forename: J P
authors.initials: JP
authors.lastname: Osborne
authors.forename: A
authors.initials: A
authors.lastname: Lux
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D004569:Electroencephalography; D006801:Humans; D007223:Infant; D017063:Outcome Assessment, Health Care / Q000592:standards*; D013036:Spasms, Infantile / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy*