Reporting quality of randomized controlled trials in orthodontics - What affects it and did it improve over the last 10 years?

Abstract

Summary Introduction: Objectives were to investigate the factors affecting the overall reporting quality and the reporting quality trend of each item over the last 10 years for orthodontic randomized controlled trials (RCTs). Material and Methods: MEDLINE, The Cochrane Library, and EMBASE databases were searched (2003-12) to retrieve studies. Four major orthodontic journals and reference list of included articles were hand searched to identify additional RCTs. The overall reporting quality for all included RCTs (2003-12) was assessed using CONSORT, 2001 (ORQs 2001, score 0-20). In addition, CONSORT, 2010 (ORQs 2010, score 0-27), was used for RCTs published after 2010. Generalized estimated equations (GEEs) model was used for analysis (ORQs 2001 and ORQs 2010). Cochran-Armitage trend test was used to evaluate the reporting quality trend of each individual item based on the CONSORT, 2001. Results: Totally 309 relevant studies were identified, out of which 86 were published after 2010. The median for total ORQs 2001 and ORQs 2010 was 9 (interquartile range 7-12) and 12 (interquartile range 9-15), respectively. Year and journal of publication were significant predictors for both ORQs 2001 and ORQs 2010. Location, sample size, and multicentre trials were significant predictors only for ORQs 2001, and not for ORQs 2010. Trend test showed that reporting quality of four items, namely identification of trial as randomized, sample size, blinding, and randomization has improved significantly with time. Conclusion: There is an improvement in the reporting quality. However, it is still suboptimal. To improve the reporting quality, the CONSORT guidelines should be followed strictly.