Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/2386
Appears in Collections:Psychology Journal Articles
Peer Review Status: Refereed
Title: Observer Variation in the Assessment of Outcome in Traumatic Brain Injury: Experience From A Multicenter, International Randomized Clinical Trial
Authors: Wilson, J T Lindsay
Slieker, Frans
Legrand, Valerie
Murray, Gordon
Stocchetti, Nino
Maas, Andrew I R
Contact Email: jtlw1@stir.ac.uk
Keywords: Clinical trials
Observer variation
Outcome
Traumatic brain injury
Issue Date: Jul-2007
Publisher: Lippincott, Williams & Wilkins
Citation: Wilson 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.
Abstract: OBJECTIVE: 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 inte
Type: Journal Article
URI: http://hdl.handle.net/1893/2386
URL: http://www.neurosurgery-online.com
DOI Link: http://dx.doi.org/10.1227/01.neu.0000279732.21145.9e
Rights: The 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.
Affiliation: Psychology
Erasmus MC Rotterdam
Quintiles
University of Edinburgh
University of Milan
Erasmus MC Rotterdam

Files in This Item:
File Description SizeFormat 
Wilson2007_Observer variation in the assessment of outcome.pdf189.75 kBAdobe PDFUnder Embargo until 31/12/2999     Request a copy

Note: If any of the files in this item are currently embargoed, you can request a copy directly from the author by clicking the padlock icon above. However, this facility is dependant on the depositor still being contactable at their original email address.

This item is protected by original copyright



Items in the Repository are protected by copyright, with all rights reserved, unless otherwise indicated.

If you believe that any material held in STORRE infringes copyright, please contact library@stir.ac.uk providing details and we will remove the Work from public display in STORRE and investigate your claim.