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dc.contributor.authorWilson, J T Lindsay-
dc.contributor.authorSlieker, Frans-
dc.contributor.authorLegrand, Valerie-
dc.contributor.authorMurray, Gordon-
dc.contributor.authorStocchetti, Nino-
dc.contributor.authorMaas, Andrew I R-
dc.description.abstractOBJECTIVE: Accurate and consistent outcome assessment is essential to randomized clinical trials. We aimed to explore observer variation in the assessment of outcome in a recently completed trial of dexanabinol in head injury and to consider steps to reduce such variation. METHODS: Eight hundred sixty-one patients with severe traumatic brain injury who were admitted to 86 centers were included in a multicenter, placebo-controlled, Phase III trial. Outcome was assessed at 3 and 6 months postinjury using the extended Glasgow Outcome Scale; standardized assessment was facilitated by the use of a structured interview. Before initiation of trial centers, outcome ratings were obtained for sample cases to establish initial levels of agreement. Training sessions in outcome assessment were held, and problems in assigning outcome were investigated. During the trial, a process of central review was established to monitor performance. Interobserver variation was analyzed using the κ statistic. RESULTS: Substantial observer variation was found in the rating of sample cases (weighted κ, 0.72; confidence interval, 0.68–0.75) and in assigning outcome based on completed structured interviews (weighted κ, 0.61; confidence interval, 0.57–0.64). In the early stages of the trial, a relatively large number of discrepancies (29–37%) were identified on central review. This number declined as the trial progressed and coincided with investigator training and feedback from central review. Centers with higher enrollment rates showed better performance. CONCLUSION: Observer variation in outcome assessment is a significant problem for head injury trials. Consistency can be improved by standardizing procedures, training assessors, and monitoring the quality of assessments and providing feedback to inteen_UK
dc.publisherLippincott, Williams & Wilkins-
dc.relationWilson JTL, Slieker F, Legrand V, Murray G, Stocchetti N & Maas AIR (2007) Observer Variation in the Assessment of Outcome in Traumatic Brain Injury: Experience From A Multicenter, International Randomized Clinical Trial, Neurosurgery, 61 (1), pp. 123-129.-
dc.rightsThe publisher does not allow this work to be made publicly available in this Repository. Please use the Request a Copy feature at the foot of the Repository record to request a copy directly from the author; you can only request a copy if you wish to use this work for your own research or private study.-
dc.subjectClinical trialsen_UK
dc.subjectObserver variationen_UK
dc.subjectTraumatic brain injuryen_UK
dc.subject.lcshHead Wounds and injuries-
dc.subject.lcshBrain Wounds and injuries-
dc.subject.lcshMagnetic resonance imaging-
dc.titleObserver Variation in the Assessment of Outcome in Traumatic Brain Injury: Experience From A Multicenter, International Randomized Clinical Trialen_UK
dc.typeJournal Articleen_UK
dc.rights.embargoreasonThe publisher does not allow this work to be made publicly available in this Repository therefore there is an embargo on the full text of the work.-
dc.type.statusPublisher version (final published refereed version)-
dc.contributor.affiliationErasmus MC Rotterdam-
dc.contributor.affiliationUniversity of Edinburgh-
dc.contributor.affiliationUniversity of Milan-
dc.contributor.affiliationErasmus MC Rotterdam-
Appears in Collections:Psychology Journal Articles

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