Reporting of clinical trials in the orthodontic literature from 2008 to 2012: observational study of published reports in four major journals.

Abstract

The aim of this study is to provide an update as to whether authors in the orthodontic field of research currently report randomized clinical trials (RCTs) adequately as defined by the Consolidated Standards of Reporting Trials (CONSORT) statement. The American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Journal of Orthodontics (JO), European Journal of Orthodontics (EJO) and Angle Orthodontist (AO) were reviewed to identify all articles that reported RCTs published between January 2008 and June 2012.Reports were scored using the CONSORT 37 item checklist. A 10% random sample of the papers was scored by a second examiner to assess inter-examiner reliability of the CONSORT score. Another 10% random sample of the papers was scored a second time by the first examiner 3 months after initial data collection to test intra-examiner reliability. A total of 151 clinical trial reports have been identified out of 3335 articles in the four journals from January 2008 to June 2012.Mean CONSORT score of the four journals was 51.7%. Journal of Orthodontics achieved the highest score of 73.6% and the lowest score was achieved by AO with a score of 44.5%. Overall compliance with CONSORT increased from 47.8 to 56.3% between 2008 and 2012. Clinical trials reports represented < 5% of articles in the four main orthodontic journals between 2008 and 2012. • CONSORT mean score ranged from 44.5 to 73.6% between journals. • CONSORT mean score increased through the period of investigation.