title: The CONSORT Statement: Application within and adaptations for orthodontic trials.
abstract: High-quality randomized controlled trials (RCTs) are an integral part of evidence-based medicine. RCTs are the bricks and mortar of high-quality systematic reviews, which are important determinants of health care policy and clinical practice. For published research to be used most effectively, investigators and authors should follow the guidelines for accurate and transparent reporting of RCTs. The consolidated standards of reporting trials (CONSORT) statement and its extensions are among the most widely used reporting guidelines in biomedical research. CONSORT was adopted by the American Journal of Orthodontics and Dentofacial Orthopedics in 2004. Since 2011, this Journal has been actively implementing compliance with the CONSORT reporting guidelines. The objective of this explanatory article is to highlight the relevance and implications of the various CONSORT items to help authors to achieve CONSORT compliance in their research submissions of RCTs to this and other orthodontic journals.
authors.affiliation: Assistant professor, Department of Orthodontics and Dentofacial Orthopedics, Dental School, Medical Faculty, University of Bern, Bern, Switzerland; private practice, Corfu, Greece. Electronic address: npandis@yahoo.com.
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Pandis
authors.affiliation: Senior clinical lecturer and honorary consultant, Barts and the London School of Medicine and Dentistry, Queen Mary University, London, United Kingdom.
authors.forename: Padhraig S
authors.initials: PS
authors.lastname: Fleming
authors.affiliation: Senior research fellow, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, United Kingdom; senior scientist, Centre d'Epidémiologie Clinique, Université Paris Descartes, INSERM U1153, France.
authors.forename: Sally
authors.initials: S
authors.lastname: Hopewell
authors.affiliation: Professor, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, United Kingdom.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
mesh_terms: D000043:Abstracting and Indexing; D015982:Bias; D057189:Checklist; D018865:Dental Research / Q000592:standards; D055094:Evidence-Based Dentistry; D019983:Guideline Adherence; D006801:Humans; D009970:Orthodontics; D010352:Patient Dropouts; D063868:Patient Outcome Assessment; D018579:Patient Selection; D010506:Periodicals as Topic; D017410:Practice Guidelines as Topic; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012042:Registries; D058028:Research Report / Q000592:standards; D012109:Research Support as Topic; D012196:Review Literature as Topic; D018401:Sample Size