title: The reporting of ethical approval and informed consent for clinical trials in four major orthodontic journals
Creators: name: Fitzgerald, Rhian
Publisher: name: University of Liverpool Repository
Year: 2014

description: Background: All research involving human participants should have ethical approval and informed consent. There is no recent evidence on the incidence of reporting of compliance with these ethical criteria in orthodontic journals, nor is there evidence on which factors predict the compliance of Randomised Controlled Trials (RCTs) with ethical approval and informed consent. Aims: This study aimed to: • Assess the number of Randomised Controlled Trials and Controlled Clinical Trials (CCTs) published in the American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Orthodontic Journal and Journal of Orthodontics (formerly British Journal of Orthodontics) between 1st January 2001 and 31st December 2010. • Determine the number of these papers which recorded having obtained ethical approval and informed consent. • Determine the number of authors, number of centres, location, involvement of a statistician, year of publication and the presence of “random*” in either the title or abstract or body of the RCTs. • Determine whether the factors above influenced an RCT’s likelihood of having recorded ethical approval and informed consent. • Determine the sensitivity of identifying RCTs in the four journals under consideration using various electronic search methods, through a MEDLINE search via PubMed and Ovid, for publication type “RCT” and PubMed free text search for “random* AND orthodontic”. Compare results with previously published findings. • Compare the electronic search methods with handsearching as the gold standard. Design: Retrospective observational study. Data Sources: Articles published between 1st January 2001 and 31st December 2010 in the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), The Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) (formerly British Journal of Orthodontics). Sample: All CCTs and RCTs published in the AJODO, AO, EJO and JO between 1st January 2001 and 31st December 2010 were included. Method: • RF passed the Cochrane Oral Health Group Handsearching test. • A search of all CCTs and RCTs published in the AJODO, AO, EJO and JO between 1st January 2001 and 31st December 2010 was performed. • The RCTs and CCTs were assessed for a statement that the paper had obtained ethical approval and informed consent. • The RCTs were further analysed to determine the following criteria: publication journal, number of authors, number of centres, location of origin, involvement of a statistician, year of publication, and whether random* was in the title or abstract or body of the article. Results: Over the ten year period 4748 articles were identified, of which 218 reported RCTs and 89 CCTs. RCTs comprised 4.6% and CCTs 1.9% of all articles published over that time period. Of the CCTs, 36% had reported both ethical approval and informed consent and 39.3% had neither. Of the RCTs, 48.6% had reported both ethical approval and informed consent and 27.1% had neither. Factors associated with an RCT reporting that ethical approval and informed consent had been obtained were: Number of authors (p