Domains, Trends, and Uptake of Common Data Elements in Intervention Studies Focused on Recovery of Consciousness in Severe Brain Injury From 1986 to 2020: A Scoping Review.

OBJECTIVE

To evaluate the range and typology of primary clinical outcome assessments used in intervention studies promoting recovery of consciousness for patients with disorders of consciousness. A secondary aim was to examine the extent to which the introduction of common data elements (CDE) has reduced the heterogeneity of primary clinical outcome assessments in studies that include participants with disorders of consciousness.

DATA SOURCES: We searched for articles across 5 databases including Cochrane, Embase, PsycInfo, PubMed, and Scopus.

STUDY SELECTION: We selected articles that focused on facilitating recovery of consciousness among adults with disorders of consciousness after severe traumatic brain injury.

DATA EXTRACTION: We extracted the study year, primary clinical outcome assessment, and funding source.

DATA SYNTHESIS: We classified the primary clinical outcome by International Classification of Functioning, Disability, and Health domain and CDE status. A total of 75 primary clinical outcome assessments were extracted from 306 included articles representing 307 studies; 45 primary clinical outcome assessments (60%) aligned with the International Classification of Functioning, Disability, and Health Body Function domain. The proportion of articles with US federal funding that reported a CDE as the clinical outcome assessment did not differ by year published.

CONCLUSIONS

Implementation of CDEs in 2010 did not substantively change the utilization of clinical outcome assessments that are CDEs because these were already more likely to be reported than non-CDEs. Overall, the wide variation in primary clinical outcome assessments used in intervention studies facilitating recovery of consciousness limits the ability to conduct meta-analyses, which are needed to increase the strength of evidence for disorders of consciousness interventions.