Assessing the quality of random clinical anesthesiology trials published on the Brazilian Journal of Anesthesiology from 2005 to 2008.

BACKGROUND AND OBJECTIVES

A random clinical trial (RCT) is defined as a study involving intervention and control groups with random distribution of the participants. The objective of the present study was to assess the quality of RCT in anesthesiology published during a specific time.

DESIGN OF THE STUDY

descriptive.

METHODS

A manual search of the articles published by the Brazilian Journal of Anesthesiology between January 2005 and February 2008 was undertaken to identify studies with characteristics of RCTs. The quality of RCTs was the primary parameter; secondary parameters included: approval by the Ethics on Research Committee (ERC), use of the informed consent (IC), description of the source of the grant, the sample size was calculated, number of authors, place of origin, statistical tests used, level of significance adopted, and classification of the type of study. The quality scale, descriptive statistics, and calculation of the 95% confidence interval were used to evaluate the quality of the RCTs.

RESULTS

Out of 114 studies, 42 were identified as RCT. Only 3 (7.1%) of those were classified as having good methodological quality considering the random distribution, double blind, losses, and exclusions. One-hundred and seven out of 114 studies were submitted to the ERC, 67 used IC, none of them described the source of the grant, 17 calculated the size of the sample, the studies had a mean of 4.49 authors; 60 publications were from São Paulo; the Student t test was used more often (47.4%), a level of significance of 5% was adopted by 97 studies; and 42 were RCTs.

CONCLUSIONS

After the manual search, 7.1% of the random clinical assays were considered of good methodological quality.