title: A review of activity indices and end points for clinical trials in children with Crohn's disease.
abstract: The necessity to include children and adolescents in clinical trials is increasingly recognized. Two recent workshops provided the impetus for pediatric gastroenterologists to develop evidence-based recommendations concerning end points and outcome assessment in cases of pediatric Crohn's disease. The overall goal was to facilitate clinical trial design by standardizing the methodology. This article critically reviews the available assessment tools and provides consensus recommendations for the evaluation of linear growth, disease activity, and health-related quality of life in clinical trials in pediatric Crohn's disease.
authors.affiliation: Hospital for Sick Children, Toronto, Ontario, Canada. anne.griffiths@sickkids.ca
authors.forename: Anne M
authors.initials: AM
authors.lastname: Griffiths
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Otley
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hyams
authors.forename: Antonio R
authors.initials: AR
authors.lastname: Quiros
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Grand
authors.forename: Athos
authors.initials: A
authors.lastname: Bousvaros
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: George R
authors.initials: GR
authors.lastname: Ferry
mesh_terms: D000293:Adolescent; D002648:Child; D002657:Child Development; D002669:Child Welfare; D002986:Clinical Trials as Topic; D003424:Crohn Disease / Q000628:therapy*; D023381:Endpoint Determination; D005260:Female; D005762:Gastroenterology / Q000639:trends; D006801:Humans; D008297:Male; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index