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Article: A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group

TitleA proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi group
Authors
Issue Date2004
PublisherWiley-Blackwell Publishing, Inc. The Journal's web site is located at http://www.epilepsia.com/
Citation
Epilepsia, 2004, v. 45 n. 11, p. 1416-1428 How to Cite?
AbstractPURPOSE: To reach a broad consensus on case definitions, outcomes, and outcome measures that will ease future study design and facilitate comparison of data from different studies of infantile spasms and West syndrome. METHODS: Persons who had recently presented or published first-author original research in this field were invited to participate in an e-mail Delphi process and to invite other investigators or clinicians who they thought might participate. RESULTS: The process consisted of six rounds, anonymous except to the facilitator. In total, responses were received from 46 participants. The final statement was approved by 31 participants from 15 countries. It concluded that the primary clinical outcome, cessation of spasms, should denote absence of witnessed spasms from within 14 days of commencement of treatment, and for > or =28 consecutive days from the last witnessed spasm. Primary electroclinical outcome denotes cessation of spasms with resolution of hypsarrhythmia. West syndrome should be a defined subset of the syndrome of infantile spasms. An infantile spasms single-spasm variant should be recognized. Ways are suggested of handling subtle spasms in the context of clinical studies. It proposes a standard for reporting modifying and atypical features of hypsarrhythmia, a minimal set of baseline characteristics and outcomes that should be reported in trials of infantile spasms, and suggests a standard definition of relapse. Consensus was not reached on a definition of hypsarrhythmia. CONCLUSIONS: We reached a clear consensus on many aspects of study design for the investigation of infantile spasms, although incomplete consensus was found on how to define EEG criteria.
Persistent Identifierhttp://hdl.handle.net/10722/143553
ISSN
2015 Impact Factor: 4.706
2015 SCImago Journal Rankings: 2.579
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorLux, ALen_US
dc.contributor.authorOsborne, JPen_US
dc.contributor.authorAvanzini, Gen_US
dc.contributor.authorGranata, Ten_US
dc.contributor.authorBaram, TZen_US
dc.contributor.authorCaraballo, Ren_US
dc.contributor.authorFarrell, Ken_US
dc.contributor.authorHancock, Een_US
dc.contributor.authorIto, Men_US
dc.contributor.authorKohyama,Jen_US
dc.contributor.authorKoul, Ren_US
dc.contributor.authorLee, WLen_US
dc.contributor.authorLiao, Jen_US
dc.contributor.authorLukban, MBen_US
dc.contributor.authorMendoza-Salonga, ARen_US
dc.contributor.authorMarson, AGen_US
dc.contributor.authorNeville, Ben_US
dc.contributor.authorNomayo, HOen_US
dc.contributor.authorOguni, Hen_US
dc.contributor.authorOhtahara, Sen_US
dc.contributor.authorOng, HTen_US
dc.contributor.authorLauzan, DPen_US
dc.contributor.authorRating, Den_US
dc.contributor.authorSchmitt, Ben_US
dc.contributor.authorThambyayah, MAen_US
dc.contributor.authorVigevano, Fen_US
dc.contributor.authorVisudtibhan, Aen_US
dc.contributor.authorWhitehouse, Wen_US
dc.contributor.authorWong, VCNen_US
dc.contributor.authorYoung, Cen_US
dc.contributor.authorZhou, Zen_US
dc.date.accessioned2011-12-12T03:51:50Z-
dc.date.available2011-12-12T03:51:50Z-
dc.date.issued2004en_US
dc.identifier.citationEpilepsia, 2004, v. 45 n. 11, p. 1416-1428en_US
dc.identifier.issn0013-9580en_US
dc.identifier.urihttp://hdl.handle.net/10722/143553-
dc.description.abstractPURPOSE: To reach a broad consensus on case definitions, outcomes, and outcome measures that will ease future study design and facilitate comparison of data from different studies of infantile spasms and West syndrome. METHODS: Persons who had recently presented or published first-author original research in this field were invited to participate in an e-mail Delphi process and to invite other investigators or clinicians who they thought might participate. RESULTS: The process consisted of six rounds, anonymous except to the facilitator. In total, responses were received from 46 participants. The final statement was approved by 31 participants from 15 countries. It concluded that the primary clinical outcome, cessation of spasms, should denote absence of witnessed spasms from within 14 days of commencement of treatment, and for > or =28 consecutive days from the last witnessed spasm. Primary electroclinical outcome denotes cessation of spasms with resolution of hypsarrhythmia. West syndrome should be a defined subset of the syndrome of infantile spasms. An infantile spasms single-spasm variant should be recognized. Ways are suggested of handling subtle spasms in the context of clinical studies. It proposes a standard for reporting modifying and atypical features of hypsarrhythmia, a minimal set of baseline characteristics and outcomes that should be reported in trials of infantile spasms, and suggests a standard definition of relapse. Consensus was not reached on a definition of hypsarrhythmia. CONCLUSIONS: We reached a clear consensus on many aspects of study design for the investigation of infantile spasms, although incomplete consensus was found on how to define EEG criteria.en_US
dc.languageengen_US
dc.publisherWiley-Blackwell Publishing, Inc. The Journal's web site is located at http://www.epilepsia.com/en_US
dc.relation.ispartofEpilepsiaen_US
dc.subject.meshChild, Preschoolen_US
dc.subject.meshDelphi Techniqueen_US
dc.subject.meshElectroencephalography/standards/statistics & numerical dataen_US
dc.subject.meshElectronic Mailen_US
dc.subject.meshHumansen_US
dc.subject.meshInfanten_US
dc.subject.meshOutcome Assessment (Health Care)en_US
dc.subject.meshSpasms, Infantile/*diagnosisen_US
dc.subject.meshTerminology as Topicen_US
dc.subject.meshTreatment Outcomeen_US
dc.titleA proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: consensus statement of the West Delphi groupen_US
dc.typeArticleen_US
dc.identifier.emailWong, VCN:vcnwong@hku.hken_US
dc.identifier.authorityWong, VCN=rp00334en_US
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1111/j.0013-9580.2004.02404.xen_US
dc.identifier.pmid15509243-
dc.identifier.scopuseid_2-s2.0-7944238270-
dc.identifier.hkuros104263-
dc.identifier.volume45en_US
dc.identifier.issue11en_US
dc.identifier.spage1416en_US
dc.identifier.epage1428en_US
dc.identifier.isiWOS:000224908700015-

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