Recommendations for the Use of Common Outcome Measures in Pediatric Traumatic Brain Injury Research

Abstract

This article addresses the need for age-relevant outcome measures for traumatic brain injury (TBI) research and summarizes the recommendations by the inter-agency Pediatric TBI Outcomes Workgroup. The Pediatric Workgroup's recommendations address primary clinical research objectives including characterizing course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies. Consistent with other Common Data Elements (CDE) Workgroups, the Pediatric TBI Outcomes Workgroup adopted the standard three-tier system in its selection of measures. In the first tier, core measures included valid, robust, and widely applicable outcome measures with proven utility in pediatric TBI from each identified domain including academics, adaptive and daily living skills, family and environment, global outcome, health-related quality of life, infant and toddler measures, language and communication, neuropsychological impairment, physical functioning, psychiatric and psychological functioning, recovery of consciousness, social role participation and social competence, social cognition, and TBI-related symptoms. In the second tier, supplemental measures were recommended for consideration in TBI research focusing on specific topics or populations. In the third tier, emerging measures included important instruments currently under development, in the process of validation, or nearing the point of published findings that have significant potential to be superior to measures in the core and supplemental lists and may eventually replace them as evidence for their utility emerges.

Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury

“…Pediatric CDEs have subsequently been published, but have yet to be implemented and validated. [29][30][31][32] The timeline specified by the NIH Grand Opportunity grant did not permit the development of a complete set of best practices, computational tools to facilitate data quality management, and optimal strategies for TBI-CDE curation. Table 5 summarizes the status of important requirements and data quality components that we addressed in the TRACK-TBI Pilot and those that need to be addressed.…”

Therapy Development for Diffuse Axonal Injury

“…155 While significant work has been done (and is continuing) to gain consensus and recommend CDEs for outcome measures for use in clinical trials and other TBI-related research, limitations of existing outcome measures remain. 156,157 For example, the most widely used primary outcome measures in clinical trials have been the Glasgow Outcome Scale (GOS) and the GOS-Extended. Despite continued use as primary outcome measures, they remain problematic given the limited range of values and insensitivity in a number of contexts (e.g., changes in an acute or subacute or rehabilitation post-injury interval, mild TBI, etc.).…”

The Importance of Orientation in Evaluating Recovery in Pediatric Traumatic Brain Injury

“…The GSC-MC includes a Verbal Response Score that assesses orientation to self, place, and date [11]. According to Mc Cauley et al [12], these screening tests are limited in their ability to provide adequate assessment data for making treatment decisions for individuals with TBI. An additional but related question is whether information concerning orientation can be used as an indicator of cognitive readiness for the demands inherent to a return to school.…”