title: Randomized controlled trials in plastic surgery: a 20-year review of reporting standards, methodologic quality, and impact.
abstract: BACKGROUND
  Randomized controlled trials in plastic surgery have not been analyzed comprehensively. We analyzed plastic surgical randomized controlled trials with respect to reporting standards, methodologic quality, and impact on the specialty.
  
  
  METHODS
  Randomized controlled trials published from 1986 to 2006 in three major plastic surgery journals were scored for quality and impact using the Consolidated Standards of Reporting Trials checklist, the Jadad criteria, citation numbers, and other parameters. The associations between the quality scores and multiple independent parameters, including trial impact, were explored. The relative impact of randomized controlled trials in plastic surgery was compared with that in other specialties.
  
  
  RESULTS
  A total of 163 randomized controlled trials were evaluated. The average Consolidated Standards of Reporting Trials and Jadad scores were 49 percent and 2.3, respectively. There were deficiencies in the reporting of parameters that influence bias and statistical significance. Randomized controlled trials with high impact or high methodologic quality had higher reporting scores. However, the quality and impact scores did not correlate with the number of participants, subject category, country of origin, or year or journal of publication. Nonsurgical trials had significantly higher quality and impact than surgical trials. Randomized controlled trials in plastic surgery had relatively lower impact as compared with randomized controlled trials in other specialties.
  
  
  CONCLUSIONS
  The reporting and methodologic standards of randomized controlled trials in plastic surgery need improvement. Standards could be improved if well-accepted reporting and methodologic criteria are considered when designing and evaluating randomized controlled trials. Instituting higher standards may improve the impact of randomized controlled trials and make them more influential in plastic surgery.
authors.affiliation: Boston, Mass. From the Department of Plastic Surgery, Children's Hospital, Harvard Medical School, and the Division of Plastic Surgery, Massachusetts General Hospital, Harvard Medical School.
authors.forename: Amir H
authors.initials: AH
authors.lastname: Taghinia
authors.forename: Eric C
authors.initials: EC
authors.lastname: Liao
authors.forename: James W
authors.initials: JW
authors.lastname: May
mesh_terms: D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D013518:Surgery, Plastic / Q000592:standards*