title: Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery.
abstract: BACKGROUND
  The randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities.
  
  
  METHODS
  All of the articles chosen for review reported on phase III randomized controlled gastrointestinal surgical trials were published in 12 international journals during 2006 and 2007. The eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. The methodological quality was evaluated using the Jadad scale, and the ethical quality was evaluated using the Berdeu score.
  
  
  RESULTS
  The mean Jadad score was 9.7 ± 1.78. The methodological quality was insufficient in 64 RCTs (37.4 %; Jadad score <9). The mean Berdeu score was 0.36 ± 0.08. The journal impact factor, number of randomized patients, and number of centers correlated with the outcome of the Jadad score, and the journal impact factor, industry funding, and year in which the trial began correlated with the outcome of the Berdeu score. Informed consent from patients was not obtained in 7 % (n = 12) of the RCTs, and research ethics committee approval was not mentioned in 14.6 % (n = 25) of the RCTs.
  
  
  CONCLUSIONS
  The reporting of gastrointestinal surgery RCTs is less than optimal. In our study, the trials of higher methodological quality were more likely to provide information about their ethical aspects. These results suggest the need for more attention to be paid to the conduct of clinical research and the reporting of ethical aspects. The appropriation of the ethical rules by surgeons involved in human clinical trials could improve the methodology and reporting of RCTs in gastrointestinal surgery.
authors: Department of Digestive Surgery, Rouen University Hospital, 1 rue Germont, 76031 Rouen Cedex, France.
authors: Valérie
authors: V
authors: Bridoux
authors: Grégoire
authors: G
authors: Moutel
authors: Horace
authors: H
authors: Roman
authors: Babak
authors: B
authors: Kianifard
authors: Francis
authors: F
authors: Michot
authors: Christian
authors: C
authors: Herve
authors: Jean-Jacques
authors: JJ
authors: Tuech
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000941:ethics* / Q000379:methods* / Q000592:standards; D013505:Digestive System Surgical Procedures; D006801:Humans; D055811:Journal Impact Factor; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods* / Q000592:standards