EDITORIAL
Enhancing CONSORT compliance for improved
reporting of randomized controlled trials
Nikolaos Pandis, Associate Editor of Statistics and Research Design, and David L. Turpin, Interim Editor-in-Chief
Bern, Switzerland, Corfu, Greece, and Seattle, Wash
W
hen one is making clinical decisions, the
evidence-based dentistry approach amal-
gamates the best available evidence, clinical
expertise, and patients' preferences and values. High-
quality randomized controlled trials (RCTs) are an inte-
gral part of evidence-based medicine and dentistry.
They are the bricks and mortar of systematic reviews,
which are important determinants of health care policy
and clinical practice.
Complete and transparent trial reporting facilitates
accurate assessment of the quality of the study and cor-
rect interpretation of its results. To standardize the re-
porting of RCTs and guide researchers in reporting
clinical trials, the CONSORT (CONsolidated Standards
of Reporting Trials) reporting guidelines have been
developed. The latest and main CONSORT document
consists of 25 items covering all key aspects of clinical
trials, setting standards on how to design, conduct,
analyze, and interpret such studies.1 Over 600 biomed-
ical journals, including the American Journal of Ortho-
dontics and Dentofacial Orthopedics (AJO-DO) in
2004, have adopted the CONSORT guidelines, and
many have also adopted extensions of the CONSORT
guidelines, such as those for abstract reporting.2
Despite the widespread acceptance of these recommen-
dations, the reporting of clinical trials remains poor.3
Empirical evidence has shown that reporting of RCTs
in medicine and dentistry remains suboptimal, compro-
mised by lack of publication and by incomplete, selec-
tive, and misleading reporting.1
CONSORT implementation is typically a relatively
uninvolved process with scope for more active and
comprehensive alignment of research studies by au-
thors, peer reviewers, and editors. In 2011, the AJO-
DO, recognizing that adoption does not guarantee
compliance with the CONSORT guidelines, imple-
mented a plan geared to improve compliance and the
Am J Orthod Dentofacial Orthop 2014;145:1
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Copyright Ó 2014 by the American Association of Orthodontists.
http://dx.doi.org/10.1016/j.ajodo.2013.11.005
accuracy of RCT reporting. This plan includes videos,
links to the CONSORT Web site, and active guidance
of authors submitting RCTs regarding manuscript re-
porting in accordance with CONSORT guidelines.
Recent RCTs published in AJO-DO have shown dra-
matic improvement in reporting quality3; this improve-
ment reflects successful interaction between the
editors, reviewers, and authors. However, it also is
hoped that initial submissions will display better re-
porting, limiting the need for editorial input to achieve
CONSORT compliance, thus expediting the review
process.
In an effort to further improve reporting and help
AJO-DO authors at the initial submission stage, we
have updated the RCT format to include new subheads.
The new format will promote complete reporting and, by
extension, allow more efficient data extraction during
the systematic review process. The traditional IMRaD
(Introduction, Methods, Results, and Discussion) format
will be expanded to include multiple second-level sub-
heads. We have prepared a sample article, annotated
with comments and instructions, to help authors better
understand the RCT requirements, including the new
subheads. You can download a copy of the annotated
sample from the Author Information section of the
AJO-DO Web site (www.ajodo.org). This sample article
is intended as a guide to help authors better understand
how to apply the CONSORT requirements to their articles
before submission to the AJO-DO.
REFERENCES
1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC,
Devereaux PJ, et al. CONSORT 2010 explanation and elaboration:
updated guidelines for reporting parallel group randomised trials.
BMJ 2010;340:c869.
2. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG,
et al., CONSORT group. CONSORT for reporting randomized
controlled trials in journal and conference abstracts: explanation
and elaboration. PLoS Med 2008;5:e20.
3. Pandis N, Shamseer L, Kokich V, Moher D. Implementation of
adherence to the CONSORT guidelines by the American Journal of
Orthodontics and Dentofacial Orthopedics (AJO-DO). Peer Review
Congress; Chicago, Ill; September 8-10, 2013.