Abstract
Objective
To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence
strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics
(AJO-DO) and to report its impact on the completeness of reporting of published trials.
Study Design and Setting
The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment
of randomized clinical trial (RCT) reporting during the editorial process. The completeness
of reporting CONSORT items was compared between trials submitted and published during
the implementation period (July 2011 to September 2013) and trials published between
August 2007 and July 2009.
Results
Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication
and assessed for completeness of reporting, seven of which were eventually published.
For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%,
interquartile range = 60%). All published trials in 2011–2013, reported 33 of 37 CONSORT
(sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation
of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after
the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically
only reported when applicable.
Conclusion
Trials published following implementation of the AJO-DO CONSORT adherence strategy
completely reported more CONSORT items than those published or submitted previously.
Keywords
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Article info
Publication history
Published online: May 14, 2014
Accepted:
April 9,
2014
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.