fa Predictors of ethical approval and informed consent in orthodontic RCTs ارتودنسی Orthodontics پژوهشي Research <p> <strong>Objectives:</strong></p><p>  Determine the number of orthodontic randomized controlled trials (RCTs) published in four key orthodontic journals from 1 January 2001 to 31 December 2010, whether details about ethical approval (EA) and/or informed consent (IC) were reported and identify predictors for reporting EA and IC in orthodontic RCTs. </p><p> <strong>Design:</strong></p><p>  Retrospective observational study. </p><p> <strong>Setting:</strong></p><p>  American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) from 2001 to 2010. </p><p> <strong>Interventions:</strong></p><p>  AJODO, AO, EJO and JO were handsearched to identify all RCTs published from 1 January 2001 to 31 December 2010. </p><p> <strong>Main outcome measure:</strong> </p><p> The RCTs were assessed to identify: inclusion of details about EA and IC, publication journal, number of authors, number and location of centres involved, perceived statistician involvement, publication year and inclusion of random* in either the title, abstract or body of the text. <strong></strong></p><p> <strong>Results:</strong></p><p>  218 RCTs were published. 109 (48·6%) had reported both EA and IC, 59 (27·1%) neither and 53 (12·9%) either EA or IC. Factors associated with an RCT reporting obtaining EA and IC: number of authors (P<0·001), random* in title (P<0·001), random* in abstract but not title (P<0·001), location of origin (P = 0·001), publication year (P = 0·003), journal of publication (P = 0·004) and number of centres (P = 0·008). Logistic regression suggested the most significant indicators of reporting EA and IC were: publication in the JO (P = 0·018), >6 authors (P<0·001), random* in the abstract but not title (P = 0·004) and publication after 2004 (P = 0·001). </p><p> <strong>Conclusions:</strong></p><p>  RCTs were most likely to have reported EA and IC when published in the JO, after 2004 while having more than six authors and random* in the abstract but not title. </p><hr><p></p><p> <strong>Source: </strong>Journal of Orthodontics</p><p><a href="http://jorthod.maneyjournals.org/content/40/3/234.abstract" target="_blank"> <font color="#0000ff">Full Text</font></a></p> Ethical approval, informed consent, predictors, RCTs 0 0 http://idai.ir/browse.php?a_code=A-10-32-1902&slc_lang=fa&sid=1 Rhian C Fitzgerald rhian.fitzgerald@nhs.net 10031947532846008916 10031947532846008916 Yes Liverpool University Dental School and Hospital Liverpool, UK Girvan Burnside 10031947532846008917 10031947532846008917 No Jayne E Harrison 10031947532846008918 10031947532846008918 No