Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/26843
Appears in Collections:Psychology Journal Articles
Peer Review Status: Refereed
Title: Randomized controlled trials in adult traumatic brain injury: A systematic review on the use and reporting of clinical outcome assessments
Author(s): Horton, Lindsay
Rhodes, Jonathan R
Wilson, J T Lindsay
Contact Email: lindsay.horton@stir.ac.uk
Keywords: clinical outcome assessments
systematic review
randomized controlled trials
traumatic brain injury
multidimensional outcomes
Issue Date: 30-Sep-2018
Citation: Horton L, Rhodes JR & Wilson JTL (2018) Randomized controlled trials in adult traumatic brain injury: A systematic review on the use and reporting of clinical outcome assessments. Journal of Neurotrauma, 35 (17), pp. 2005-2014. https://doi.org/10.1089/neu.2018.5648.
Collaborative European NeuroTrauma Effectiveness Research in TBI
Grant Agreement No 602150-2
Abstract: As part of efforts to improve study design, the use of outcome measures in randomized controlled trials (RCTs) in traumatic brain injury (TBI) is receiving increasing attention. This review aimed to assess how clinical outcome assessments (COAs) have been used and reported in RCTs in adult TBI. Systematic literature searches were conducted to identify medium to large (n ≥ 100) acute and post-acute TBI trials published since 2000. Data were extracted independently by two reviewers using a set of structured templates. Items from the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and CONSORT patient-reported outcomes (PRO) extension were used to evaluate reporting quality of COAs. Glasgow Outcome Scale/Extended (GOS/GOSE) data were extracted using a checklist developed specifically for the review. A total of 126 separate COAs were identified in 58 studies. The findings demonstrate heterogeneity in the use of TBI outcomes, limiting comparisons and meta-analyses of RCT findings. The GOS/GOSE was included in 39 studies, but implemented in a variety of ways, which may not be equivalent. Multidimensional outcomes were used in 30 studies, and these were relatively more common in rehabilitation settings. The use of PROs was limited, especially in acute study settings. Quality of reporting was variable, and key information concerning COAs was often omitted, making it difficult to know how precisely outcomes were assessed. Consistency across studies would be increased and future meta-analyses facilitated by (a) using common data elements recommendations for TBI outcomes and (b) following CONSORT guidelines when publishing RCTs.
DOI Link: 10.1089/neu.2018.5648
Rights: This item has been embargoed for a period. During the embargo please use the Request a Copy feature at the foot of the Repository record to request a copy directly from the author. You can only request a copy if you wish to use this work for your own research or private study. Final publication is available from Mary Ann Liebert, Inc., publishers https://doi.org/10.1089/neu.2018.5648

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