When one is making clinical decisions, the evidence-based dentistry approach amalgamates the best available evidence, clinical expertise, and patients’ preferences and values. High-quality randomized controlled trials (RCTs) are an integral 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 correct interpretation of its results. To standardize the reporting 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. Over 600 biomedical journals, including the American Journal of Orthodontics 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. Despite the widespread acceptance of these recommendations, the reporting of clinical trials remains poor. Empirical evidence has shown that reporting of RCTs in medicine and dentistry remains suboptimal, compromised by lack of publication and by incomplete, selective, and misleading reporting.
CONSORT implementation is typically a relatively uninvolved process with scope for more active and comprehensive alignment of research studies by authors, peer reviewers, and editors. In 2011, the AJO-DO , recognizing that adoption does not guarantee compliance with the CONSORT guidelines, implemented a plan geared to improve compliance and the accuracy of RCT reporting. This plan includes videos, links to the CONSORT Web site, and active guidance of authors submitting RCTs regarding manuscript reporting in accordance with CONSORT guidelines. Recent RCTs published in AJO-DO have shown dramatic improvement in reporting quality ; this improvement reflects successful interaction between the editors, reviewers, and authors. However, it also is hoped that initial submissions will display better reporting, 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 subheads. 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 .