Abstract
Objective
To describe the extent to which adherence to Consolidated Standards of Reporting Trials
(CONSORT) statement in randomized controlled trials (RCTs) in adult traumatic brain
injury (TBI) has improved over time.
Data Sources
MEDLINE, PsycINFO, and CINAHL databases were searched from inception to September 2013.
Study Selection
Primary report of RCTs in adult TBI. The quality of reporting on CONSORT checklist
items was examined and compared over time. Study selection was conducted by 2 researchers
independently. Any disagreements were solved by discussion.
Data Extraction
Two reviewers independently conducted data extraction based on a set of structured
data extraction forms. Data regarding the publication years, size, locations, participation
centers, intervention types, intervention groups, and CONSORT checklist items were
extracted from the including trials.
Data Synthesis
Of 105 trials reviewed, 38.1%, 5.7%, and 32.4% investigated drugs, surgical procedures,
and rehabilitations as the intervention of interest, respectively. Among reports published
between the 2 periods 2002 and 2010 (n=51) and 2011 and September 2013 (n=16), the
median sample sizes were 99 and 118; 39.2% and 37.5% of all reports detailed implementation
of the randomization process; 60.8% and 43.8% provided information on the method of
allocation concealment; 56.9% and 31.3% stated how blinding was achieved; 15.7% and
43.8% reported information regarding trial registration; and only 2.0% and 6.3% stated
where the full trial protocol could be accessed, all respectively.
Conclusions
Reporting of several important methodological aspects of RCTs conducted in adult TBI
populations improved over the years; however, the quality of reporting remains below
an acceptable level. The small sample sizes suggest that many RCTs are likely underpowered.
Further improvement is recommended in designing and reporting RCTs.
Keywords
List of abbreviations:
CI (confidence interval), CONSORT (Consolidated Standards of Reporting Trials), RCT (randomized controlled trial), RR (relative risk), TBI (traumatic brain injury)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: December 09, 2014
Footnotes
Supported by the National Center for Advancing Translational Sciences (Clinical and Translational Science Award no. UL1TR000058).
Disclosures: none.
Identification
Copyright
© 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
