Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Sep 1;36(17):2484-2492.
doi: 10.1089/neu.2018.5939. Epub 2019 May 23.

Glasgow Outcome Scale Measures and Impact on Analysis and Results of a Randomized Clinical Trial of Severe Traumatic Brain Injury

Jose-Miguel Yamal  1 , H Julia Hannay  2   3 , Shankar Gopinath  4 , Imoigele P Aisiku  5 , Julia S Benoit  3   6 , Claudia S Robertson  4
Affiliations
Randomized Controlled Trial

Glasgow Outcome Scale Measures and Impact on Analysis and Results of a Randomized Clinical Trial of Severe Traumatic Brain Injury

Jose-Miguel Yamal et al. J Neurotrauma. .

Abstract

The original unstructured Glasgow Outcome Scale (uGOS) and the newer structured interviews GOS and the Extended GOS (GOS-E) have been used widely as outcomes in severe traumatic brain injury (TBI) trials. We compared outcome categories (ranging from dead [D] to good recovery [GR]) 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 GOS-E 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 (GR and moderate disability [MD] categories) versus unfavorable (severe disability [SD], vegetative state [VS], and D 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 GOS-E, 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.

Keywords: EPO; GOS; closed head injury; hemoglobin transfusion trigger; sliding dichotomy; traumatic brain injury.

PubMed Disclaimer

Conflict of interest statement

No competing financial interests exist.

References

    1. Bernard S.A., Nguyen V., Cameron P., Masci K., Fitzgerald M., Cooper D.J., Walker T., Std B.P., Myles P., Murray L., David Taylor, Smith K., Patrick I., Edington J., Bacon A., Rosenfeld J.V., and Judson R. (2010). Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury. Ann. Surg. 252, 959–965 - PubMed
    1. Bulger E.M., May S., Brasel K.J., Schreiber M., Kerby J.D., Tisherman S.A., Newgard C., Slutsky A., Coimbra R., Emerson S., Minei J.P., Bardarson B., Kudenchuk P., Baker A., Christenson J., Idris A., Davis D., Fabian T.C., Aufderheide T.P., Callaway C., Williams C., Banek J., Vaillancourt C., Heest R.V., Sopko G., Hata J.S., Hoyt D.B., and ROC Investigators. (2010). Out-of-hospital hypertonic resuscitation following severe traumatic brain injury. JAMA 304, 1455–1464 - PMC - PubMed
    1. Cooper D.J., Myles P.S., McDermott F.T., Murray L.J., Laidlaw J., Cooper G., Tremayne A.B., Bernard S.S., Ponsford J., and HTS Study Investigators. (2004). Prehospital hypertonic saline resuscitation of patients with hypotension and severe traumatic brain injury. JAMA 291, 1350–1357 - PubMed
    1. Maas A.I., Murray G.D., Roozenbeek B., Lingsma H.F., Butcher I., McHugh G.S., Weir J., Lu J., Steyerberg E.W., and International Mission on Prognosis Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT) Study Group. (2013). Advancing care for traumatic brain injury: findings from the IMPACT studies and perspectives on future research. Lancet Neurol. 12, 1200–1210 - PMC - PubMed
    1. Bodien Y.G., McCrea M., Dikmen S., Temkin N., Boase K., Machamer J., Taylor S.R., Sherer M., Levin H., Kramer J.H., Corrigan J.D., McAllister T.W., Whyte J., Manley G.T., Giacino J.T., and TRACK-TBI Investigators. (2018). Optimizing outcome assessment in multicenter TBI trials: perspectives from TRACK-TBI and the TBI Endpoints Development Initiative. J. Head Trauma Rehabil. 33, 147–157 - PMC - PubMed

Publication types