Medical Student The George Washington University School of Medicine and Health Sciences Staten Island, New York
Abstract Text:
Background: Examining disorders of consciousness (DoC) intervention studies has been hampered by the heterogeneity in primary outcome assessments. In 2010, the National Institute of Neurological Disorders and Stroke (NINDS) generated common data elements (CDEs) for traumatic brain injury, including recovery of consciousness. Research that is federally funded recommends the use of CDEs as then findings from each study could by synthesized and compared to one another. (1) Therefore, our study aims to evaluate the primary outcome assessments utilized in intervention studies for persons in DoC and use of CDEs recommended for recovery of consciousness.
Methods: We evaluated DoC intervention studies between January 1, 1986 and December 31, 2020 in Cochrane, Embase, PsycInfo, PubMed, and Scopus databases. 12,381 distinct studies were identified for review. Title and abstracts were screened by 2 authors and then a full-text review was completed. Studies that met the inclusion criteria were intervention studies that had a primary outcome that centered on the recovery of consciousness. For included studies, we extracted the year of the study, primary outcome assessment, intervention, and funding status. We evaluated the primary outcome assessment for classification to the World Health Organization International Classification of Functioning, Disability, and Health (WHO ICF) domains (e.g., body function, body structure) and CDE status.
Results: 75 primary outcome measures were extracted from a total of 311 included studies. Most of these primary outcome measures can be categorized under the Body Function domain of the WHO ICF domains. One outcome measure had a classification that had not yet been included in the WHO ICF, “sufficient response to continue rehabilitation.” Hence, not all domains are captured by the WHO ICF. 53 primary outcomes (71%) were in alignment with the ICF Body Function domain and 54 (72%) were only used by a single study. 37 studies reported a US federal agency as a funding source: 17/37 prior to 2010 and 20/37 after 2010. Before 2010, 11/17 (71%) federally funded studies reported a CDE as the primary outcome, while 9/20 (45%) reported a CDE after 2010.
Conclusion: NINDS CDEs were implemented in 2010, yet there remains a lack of standardization of primary outcome assessments in DoC intervention studies funded in the United States. While it is possible that research conducted using CDEs remains unpublished (e.g., studies funded in 2019), it is clear that heterogeneity of outcomes for DoC intervention studies remains.
Reference: 1. Meeuws S, Yue JK, Huijben JA, Nair N, Lingsma HF, Bell MJ, Manley GT, Maas AIR. Common Data Elements: Critical Assessment of Harmonization between Current Multi-Center Traumatic Brain Injury Studies. J Neurotrauma. 2020 Jun 1;37(11):1283-1290. doi: 10.1089/neu.2019.6867. Epub 2020 Feb 25. PMID: 32000562; PMCID: PMC7249452.
Keywords: Disorders of Consciousness, Primary Outcome Assessments, Common Data Elements, WHO ICF, Recovery
