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Literature & Humanities
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jalali
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2012
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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
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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