The use of tailored subheadings was successful in enhancing compliance with CONSORT in a dental journal

Despina Koletsi, Padhraig S. Fleming, Rolf G. Behrents, Christopher D. Lynch, Nikolaos Pandis

Efforts to enhance the reporting of clinical trials have intensified in recent years with automated strategies and editorial involvement showing promise in improving compliance with accepted guidelines. This study aimed to evaluate the effectiveness of a concerted approach to adherence to CONSORT (CONsolidated Standards Of Reporting Trials) guidelines in a dental journal. Following the publication of an exemplar clinical trial on the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) website and related changes to the author guidelines, trial submissions were required to follow a standard format incorporating subheadings mirroring the CONSORT guidelines. Compliance with CONSORT was assessed in initial submissions over a 30-month period. Reporting was compared to submissions of randomized controlled trials (RCTs) which did not include subheadings over the same period. Seventy-one RCTs were submitted to the AJO-DO from January 2014 to June 2016, 49 with subheadings and 22 without. Most CONSORT items (e.g. random sequence generation, allocation concealment and blinding) were more frequently adequately reported when RCTs were submitted with inclusion of subheadings. Overall, reporting quality of the submitted RCTs was 15.2% higher with use of the subheadings format (95%CI: 10.5, 20.0; p<0.001) with a mean overall score of 87.3%. Enhanced compliance of submitted RCTs was found with use of a bespoke approach to trial presentation utilizing CONSORT item subheadings. The improvement in initial submissions is particularly encouraging as this arose without input either from peer reviewers or journal editors. This simple approach may have wider applicability.