title: Interrater reliability issues in multicenter trials, Part I: Theoretical concepts and operational procedures used in Department of Veterans Affairs Cooperative Study #394.
abstract: This article describes a standardized method for establishing and maintaining desired levels of interrater reliability (IRR) in multicenter trials. The procedure involves six steps: distribution of procedural guides, distribution of an introduction tape, initial distribution of patient interviews to rate, training at the study kickoff meeting, ongoing IRR monitoring, and group training throughout the study. This method is being used in a national Veterans Affairs Cooperative Study (CS #394), involving nine sites to examine the treatment effects of vitamin E on tardive dyskinesia. The six-step standardized process allowed for early detection of areas of concern in assessment administration. When comparing intraclass correlation coefficients (ICCs) at different points in the initial training, the Barnes Akathisia Scale and Anchored Brief Psychiatric Rating Scale reliability improved from 0.68 to 0.74 and from 0.54 to 0.87, respectively. After analyzing the ratings collected prior to the start of CS #394, data were collected to conduct the first check on Abnormal Involuntary Movement Scale (AIMS) IRR during enrollment; the estimated ICC for the AIMS had decreased from 0.87 to 0.60. Raters were instructed to re-assess the subjects from the first videotape on the AIMS and received additional training. The re-rating indicated very good reliability, 0.84, IRR was measured once for the Global Assessment of Functioning Scale resulting in an ICC of 0.90. The companion article (Part II: Edson et al. 1997, page 59 of this issue) describes the statistical procedures used to measure IRR.
authors.affiliation: Psychiatry Service, VA Medical Center/NYU School of Medicine, NY 10010, USA.
authors.forename: K
authors.initials: K
authors.lastname: Tracy
authors.forename: L A
authors.initials: LA
authors.lastname: Adler
authors.forename: J
authors.initials: J
authors.lastname: Rotrosen
authors.forename: R
authors.initials: R
authors.lastname: Edson
authors.forename: P
authors.initials: P
authors.lastname: Lavori
mesh_terms: D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*; D015588:Observer Variation; D012107:Research Design; D014481:United States; D014493:United States Department of Veterans Affairs