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Citation |
Lu J, Gary KW, Copolillo A, Ward J, Niemeier JP, Lapane KL. Arch. Phys. Med. Rehabil. 2014; 96(4): 702-714. |
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Affiliation |
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, U.S.A. |
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Copyright |
(Copyright © 2014, Elsevier Publishing) |
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DOI |
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PMID |
25497515 |
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Abstract |
OBJECTIVE: To describe 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 randomized controlled trials in adult traumatic brain injury. 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 2002-2010 (n=51) and 2011-September, 2013 (n=16), median sample size was 99 and 118; 39.2% and 37.5% detailed implementation of randomization process; 60.8% and 43.8% of all reports provided information on 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 full trial protocol could be accessed, respectively. Language: en |