Quality of randomized clinical trials published by plastic surgeons: a long-term follow-up study

Abstract

Introduction: In two previous studies, the quality of randomized clinical trials (RCTs) with the participation of at least one plastic surgeon was assessed in two periods: from 1966 to 2003 and from 2004 to 2008. The objective is to evaluate the evolution of the quality of RCTs published by plastic surgeons in the subsequent five-year period, from 2009 to 2013. Methods: RCTs published from 2009 to 2013, in English, with the participation of at least one plastic surgeon, were identified by an electronic search and classified according to allocation concealment by two independent evaluators. The quality of the studies with adequate allocation concealment was evaluated by two evaluators using the Delphi List and the Jadad Scale. Results: Of the 6,997 identified studies, 261 were classified according to allocation concealment. Of these, 43 (16.47%) had adequate allocation concealment. According to an assessment conducted using the Delphi List, there was an improvement in the items "most important characteristics of the prognosis" (p < 0.001), "use of an independent evaluator" (p = 0.0029), and "measures of variability and estimation of points for the primary variable" (p = 0.0057) compared to the 1966-2003 assessment ; there was no difference in the assessment of the same items from 2004-2008. Regarding the Jadad Scale, there was an increase in the scores from 2009 to 2013 compared to the 1996-2003 period (p < 0.0004); however, there was no significant difference in the 2004-2008 period. Conclusion: There was no difference in the quality of the RCTs published by plastic surgeons in the 2009-2013 period compared to the previous five-year period (2004 to 2008). However, both periods indicated higher quality compared to the 1966-2003 period.

Keywords

• randomized controlled trials as a subject
• evidencebased medicine
• statistical analysis
• random distribution
• plastic surgery