Use this URL to cite or link to this record in EThOS: http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.592772
Title: The reporting of ethical approval and informed consent for clinical trials in four major orthodontic journals
Author: Fitzgerald, Rhian
Awarding Body: University of Liverpool
Current Institution: University of Liverpool
Date of Award: 2012
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Abstract:
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<0.001), Random* in Title (p<0.001), Random* in Abstract not Title (p<0.001), Location of origin (p=0.001), Year of publication (p=0.003), The journal of publication (p=0.004) and Number of centres (p=0.008). A logistic regression analysis showed that the most significant indicators of ethical approval and informed consent having been reported were: Publication in the JO (p=0.018), 6 or more authors (p<0.001), Random* in the abstract not title (p=0.004) and Publication after 2004 (p=0.001). A comparison of handsearching with three commonly used electronic search methods showed that handsearching was more accurate. Ovid was significantly less sensitive than PubMed (OR 8.43, 95% CI 5.48, 12.97) missing 157 RCTs (72.0%), while PubMed missed 51 (23.4%). The free text PubMed search, using the terms orthodontic AND random*, was the most sensitive missing 45 RCTs (20.6%); though this was not statistically significant (OR 0.85, 95% CI 0.54, 1.34) Only 56 RCTs (25.7%) were found by all 3 electronic searches. However 37 RCTs (17%) were not identified by any of the electronic search strategies. Conclusions: The reporting of whether ethical approval and informed consent had been obtained are inadequately reported in papers reporting orthodontic RCTs and CCTs. RCTs published in the JO, those with 6 or more authors, with Random* in the abstract but not the title and those published after 2004, were most likely to have reported that ethical approval and informed consent had been obtained. Handsearching was more accurate than electronic searching and PubMed more sensitive than Ovid.
Supervisor: Harrison, Jayne E. Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID: uk.bl.ethos.592772  DOI: Not available
Keywords: RK Dentistry
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