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Published on: August 16, 2019
Recommendations for the use of common outcome measures in pediatric traumatic brain injury research
Stephen R McCauley1, Elisabeth A Wilde, Vicki A Anderson
1Department of Physical Medicine and Rehabilitation, Neurology, and Pediatrics, Baylor College of Medicine, and the Michael E. DeBakey Veterans Administration Medical Center, Houston, Texas 77030, USA. mccauley@bcm.edu
Insights
This article presents age-relevant outcome measures for pediatric traumatic brain injury (TBI) research. It details tiered recommendations for assessing recovery, treatment effects, and outcomes in children with TBI.
Area of Science:
- Pediatric Traumatic Brain Injury Research
- Outcome Measurement in Clinical Trials
Background:
- Standardized outcome measures are crucial for advancing pediatric traumatic brain injury (TBI) research.
- Existing measures may not adequately capture the nuances of recovery and long-term effects in children.
Purpose of the Study:
- To outline age-relevant outcome measures for pediatric TBI research.
- To summarize recommendations from the inter-agency Pediatric TBI Outcomes Workgroup.
- To guide the selection of appropriate measures for clinical research objectives.
Main Methods:
- The Pediatric TBI Outcomes Workgroup adopted a three-tier system for measure selection.
- Tier 1 includes core measures with proven utility across various domains.
- Tiers 2 and 3 include supplemental and emerging measures for specific research needs.
Main Results:
- Core measures cover academics, adaptive skills, quality of life, neuropsychological function, and TBI symptoms.
- Supplemental measures address specific pediatric TBI populations or research questions.
- Emerging measures represent instruments under development with future potential.
Conclusions:
- The recommended tiered system provides a framework for selecting validated outcome measures in pediatric TBI research.
- Standardized measures will enhance the characterization of recovery, treatment efficacy, and outcome prediction.
- These recommendations aim to improve the consistency and comparability of pediatric TBI studies.
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.
