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. STUDY DESIGN: 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.
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. STUDY DESIGN: 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.
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