Citation

Meeuws S, Yue JK, Huijben JA, Nair N, Lingsma HF, Bell MJ, Manley GT, Maas A. J. Neurotrauma 2020; ePub(ePub): ePub.

Affiliation

Netherlands; Andrew.Maas@uza.be.

Copyright

(Copyright © 2020, Mary Ann Liebert Publishers)

DOI

10.1089/neu.2019.6867

PMID

32000562

Abstract

Standardization and harmonization of data collection in studies on traumatic brain injury (TBI) is of paramount importance for meta-analyses. Nearly ten years ago, the Common Data Elements for TBI (TBI-CDEs v1) were promulgated to achieve these goals. The TBI-CDEs v2, developed in 2012, broadened the approach to all injury severities and phases of recovery. We aimed to quantify harmonization of these data elements in three large, prospective studies conducted within the International Initiative for TBI Research (InTBIR). Data variables of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI), Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) and Approaches and Decisions in Acute Pediatric TBI (ADAPT) studies were indexed and matched to the second version of the TBI CDEs (TBI-CDE v2). We focused on the CDE sub-categories of "Acute Hospitalized "(AH) and "Moderate/Severe TBI: Rehabilitation"(Rehab). Following reduction and merging of related elements, 21 Core, 46 Basic AH and 50 Basic Rehab elements were deemed harmonizable across studies. Agreements of Core and Basic study CDEs for the AH domain with the TBI CDEs were respectively 81% and 91% for CENTER-TBI, 76% and 93% for TRACK-TBI, and 85% in ADAPT for both domains. For the domain Rehab, agreement with Basic TBI CDEs was 84% for CENTER-TBI, 94% for TRACK-TBI and 71% for ADAPT. Non-harmonization was largely caused by absence of the elements in the studies. For elements present, the compatibility of coding with TBI CDEs was 90-99%. Gaps in global applicability were identified. The high degree of harmonization demonstrates the utility of common data elements in TBI research, and confirms the potential for meta-analysis. However, the global applicability of TBI-CDEs needs to be improved. CENTER-TBI, TRACK-TBI, ADAPT, and other InTBIR studies provide a platform to inform further refinement and internationalization of the TBI-CDEs.

Language: en

Keywords

CLINICAL TRIAL; PROSPECTIVE STUDY; TRAUMATIC BRAIN INJURY