In the March, 2014, issue of the Journal of Evidence-Based Dental Practice, Kiriakou et al,1 assessed the completeness of the abstract reporting of randomized clinical trials (aka, randomized controlled trials [RCTs]) in six leading journals of oral implantology. Journal of Oral Implantology (JOI) was included in the study. Assessment tools were based upon the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) Group's 2010 recommendations (http://www.consort-statement.org). It was concluded that reporting quality in RCT abstracts in oral implantology journals needs to be improved. It was further concluded that to achieve optimal quality in abstract reporting, editors and authors for dental implant journals should be encouraged to endorse the CONSORT.1
Empirical evidence indicates that bias is present in controlled trials when insufficient methodological approaches are utilized. This is especially true if there is inadequate allocation concealment and a lack of sufficient randomization.2–4 Therefore in 1993, 30 experts met to debate methods of improving and standardizing the reporting of randomized trials. Through an evolution that joined US- and Canadian-based groups, the CONSORT Group was formed.
Today, the CONSORT Group includes medical journal editors, clinical trial designers, epidemiologists, and methodologists. The current 2010 CONSORT guidelines include a 25-item checklist with focus on trial design, analysis, and interpretation. There is also a participant flow diagram that displays the progress of all participants through the trial. These international guidelines provide a standard protocol for authors to use when preparing manuscripts reporting trial findings. The protocol facilitates complete and transparent reporting, reducing the influence of bias, and aiding critical appraisal and interpretation.
The core CONSORT statement is based on the “standard” two-group parallel design. However, the CONSORT Group has extended and modified the core CONSORT statement for application in intervention reports, patient data analysis, plus other randomized trial designs (ie, cluster trials, noninferiority and equivalence trials, and pragmatic trials). The extensions and modifications are a constant work in progress.
Over 600 journals and editorial groups worldwide that include The Lancet, BMJ, The Journal of the American Medical Association, The New England Journal of Medicine, World Association of Medical Editors, and the International Committee of Medical Journal Editors, now endorse the CONSORT statement. JOI has begun the endorsement process. Beginning with this issue of JOI, new Clinical Research and Dental Implant Research submissions will be required to follow the CONSORT 2010 statement. Instructions and a link to the CONSORT Group website will be included in the Instructions for Authors section of the PeerTrack JOI electronic submission portal (http://www.editorialmanager.com/aaid-joi/).
Randomized clinical trials, the most rigorous of clinical trials, minimize the risk of confounding factors influencing the results.3–6 JOI has a history of publishing RCTs.7–10 Following the CONSORT 2010 statement will improve JOI's ability to provide unbiased information that meets the demand for improved treatment strategies with the goal of optimal patient care.