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

Brain Dev. 2001 Nov;23(7):677-82. doi: 10.1016/s0387-7604(01)00282-0.

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: [email protected] if you are interested in taking part.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic / standards*
  • Electroencephalography
  • Humans
  • Infant
  • Outcome Assessment, Health Care / standards*
  • Spasms, Infantile / diagnosis
  • Spasms, Infantile / epidemiology*
  • Spasms, Infantile / therapy*