The 8-point extended Glasgow Outcome Scale (GOSE) is commonly used as the primary outcome in the traumatic brain injury (TBI) clinical trials. The outcome is conventionally collected through a structured interview with the patient alone or together with a caretaker. Despite the fact that using the structured interview questionnaires helps reach agreement in GOSE assessment between raters, significant variation remains among different raters. We introduce an alternate GOSE rating system as an aid in determining GOSE with the objective of reducing the inter-rater variation in the primary outcome assessment in TBI trials. Forty-five trauma centers were randomly assigned into three groups to assess GOSE on sample cases, using the alternative GOSE rating system coupled with central quality control (Group 1), the alternative system alone (Group 2), or conventional structured interviews (Group 3). The inter-rater variation between an expert and untrained raters was assessed and reported through raw agreement and the weighted kappa statistics. Groups 2 and 3 without central review yielded inter-rater agreements of 83% (weighted kappa, 0.81; 95% C.I., 0.69-0.92) and 83% (weighted kappa 0.76, 95% C.I., 0.63-0.89) respectively in GOS rating. In GOSE, the groups reached an agreement of 76% (weighted kappa, 0.79; 95% C.I., 0.69-0.89) and 63% (weighted kappa, 0.70; 95% C.I., 0.60-0.81) respectively. The group using the alternative rating system coupled with central monitoring yielded the highest inter-rater agreement among three group in rating GOS (97%; weighted kappa, 0.95; 95% C.I., 0.89 - 1.00) and GOSE (97%; weighted kappa, 0.97; 95% C.I., 0.91 - 1.00). We conclude that the alternate GOSE rating system couple with central monitoring is an improved method that reduces inter-rater variations providing for the first time, source documentation and structured narratives that allow a thorough central review of information. The data suggest that a collective effort can be made to minimize the inter-rater variation.
Language: en
", language="en", issn="0897-7151", doi="10.1089/neu.2010.1293", url="http://dx.doi.org/10.1089/neu.2010.1293" }