Journal
JOURNAL OF NEUROTRAUMA
Volume 38, Issue 17, Pages 2419-2434Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/neu.2020.7528
Keywords
central review; clinical outcome assessments; data curation; GOSE; traumatic brain injury
Funding
- NIH-NINDS - TRACKTBI [U01NS086090]
- United States Department of Defense - TBI Endpoints Development Initiative [W81XWH-14-2-0176]
- TRACK-TBI Precision Medicine [W81XWH-18-2-0042]
- TRACKTBI NETWORK [W81XWH-15-9-0001]
- NIH-NINDS - TRACK-TBI [U01NS086090]
- National Football League (NFL) Scientific Advisory Board - TRACK-TBI LONGITUDINAL
- United States Department of Energy
- One Mind
- NeuroTruama SciencesLLC
- Abbott Laboratories
- Department of Defense TBI Endpoints Development Initiative [W81XWH-14-2-0176]
- TRACK-TBI NETWORK [W81XWH-15-9-0001]
- CENTER-TBI (EU FP7 programme) [602150]
- NINDS [R01 NS110856]
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The Glasgow Outcome Scale (GOS) and its extended form (GOSE) are widely used in assessing global disability in traumatic brain injury research. Central review is crucial in improving consistency across sites and over time, and clear scoring criteria coupled with ongoing guidance and feedback to data collectors are essential in avoiding scoring errors.
The Glasgow Outcome Scale (GOS) in its original or extended (GOSE) form is the most widely used assessment of global disability in traumatic brain injury (TBI) research. Several publications have reported concerns about assessor scoring inconsistencies, but without documentation of contributing factors. We reviewed 6801 GOSE assessments collected longitudinally, across 18 sites in the 5-year, observational Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study. We recorded error rates (i.e., corrections to a section or an overall rating) based on site assessor documentation and categorized scoring issues, which then informed further training. In cohort 1 (n = 1261; February 2014 to May 2016), 24% of GOSEs had errors identified by central review. In cohort 2 (n = 1130; June 2016 to July 2018), acquired after curation of cohort 1 data, feedback, and further training of site assessors, the error rate was reduced to 10%. GOSE sections associated with the most frequent interpretation and scoring difficulties included whether current functioning represented a change from pre-injury (466 corrected ratings in cohort 1; 62 in cohort 2), defining dependency in the home and community (163 corrections in cohort 1; three in cohort 2) and return to work/school (72 corrections in cohort 1; 35 in cohort 2). These results highlight the importance of central review in improving consistency across sites and over time. Establishing clear scoring criteria, coupled with ongoing guidance and feedback to data collectors, is essential to avoid scoring errors and resultant misclassification, which carry potential to result in failure of clinical trials that rely on the GOSE as their primary outcome measure.
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