Citation

Yamal JM, Hannay HJ, Gopinath SP, Aisiku I, Benoit JS, Robertson CS. J. Neurotrauma 2019; ePub(ePub): ePub.

Affiliation

Baylor College of Medicine, Neurosurgery , One Baylor Plaza , Houston, Texas, United States , 77030 ; claudiar@bcm.edu.

Copyright

(Copyright © 2019, Mary Ann Liebert Publishers)

DOI

10.1089/neu.2018.5939

PMID

30973053

Abstract

The original unstructured Glasgow Outcome Scale (uGOS) and the newer structured interviews GOS and GOSE have been used widely as outcomes in severe traumatic brain injury (TBI) trials. We compared outcome categories (ranging from dead to good recovery) for each measure in a randomized trial of transfusion threshold and the implications of measure choice and analysis methods for the results of the trial. We planned to explore patient symptomology possibly driving any discrepancies between the patient's uGOS and GOS scores. Category correspondence between uGOS and GOS scores occurred in 160 (88.4%) of the 181 analyzed cases. The GOSE and GOS instruments incorporated more behavioral/cognitive/social and other components, leading to a worse outcome in some cases than for the uGOS. Choice of outcome measure and analysis led to incongruous conclusions. Dichotomizing uGOS into favorable outcome (good recovery and moderate disability categories) versus unfavorable (severe disability, vegetative state, and dead categories), we observed a significant effect of transfusion threshold (odds ratio [OR]=0.51, p=0.03; adjusted OR=0.40, p=0.02). For the same dichotomization of GOS and GOSE, the effect was not statistically significant but the ORs were similar (ORs between 0.57 and 0.68, p>0.15 for all). An effect was not detected using ordinal logistic regression or sliding dichotomy method for all three measures. Differences in categorizations of subjects between moderate and severe disability among the scales impacted conclusions of the trial. In future studies, particular attention should be given to implementing GOS measures and describing the methodology for how outcomes were ascertained.

Language: en

Keywords

CLINICAL TRIAL; OUTCOME MEASURES; TRAUMATIC BRAIN INJURY