title: Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains.
abstract: The OMERACT module on systemic lupus erythematosus (SLE) dealt with the definition of preliminary core sets of outcome domains for randomized clinical trials (RCT) and longitudinal observational studies (LOS). After lectures introducing the problems and addressing the key issues, 6 discussion groups, 3 each for LOS and RCT, discussed and weighted more than a dozen possible items for use as outcome domains. The means of the respective 3 groups were calculated. For both RCT and LOS the same outcome domains received more than 10 of a total maximum of 100 points: disease activity, health related quality of life (HRQOL), damage, and toxicity/adverse events. However, the weights for HRQOL and damage were different for LOS and RCT. A final vote led to the acceptance of these 4 variables as a preliminary core set for outcome in SLE by more than 80% of the participants. This core set will allow for improved design, performance, and evaluation of future studies in SLE. However, a number of domains not included in the core set were regarded as important for further analysis and research.
authors.affiliation: University of Vienna, Austria.
authors.forename: J S
authors.initials: JS
authors.lastname: Smolen
authors.forename: V
authors.initials: V
authors.lastname: Strand
authors.forename: M
authors.initials: M
authors.lastname: Cardiel
authors.forename: S
authors.initials: S
authors.lastname: Edworthy
authors.forename: D
authors.initials: D
authors.lastname: Furst
authors.forename: D
authors.initials: D
authors.lastname: Gladman
authors.forename: C
authors.initials: C
authors.lastname: Gordon
authors.forename: D A
authors.initials: DA
authors.lastname: Isenberg
authors.forename: J H
authors.initials: JH
authors.lastname: Klippel
authors.forename: M
authors.initials: M
authors.lastname: Petri
authors.forename: L
authors.initials: L
authors.lastname: Simon
authors.forename: P
authors.initials: P
authors.lastname: Tugwell
authors.forename: F
authors.initials: F
authors.lastname: Wolfe
mesh_terms: D003657:Decision Making; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008180:Lupus Erythematosus, Systemic / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome