title: A quality assessment of randomized controlled trial reports in endodontics.
abstract: OBJECTIVE
  To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012.
  
  
  METHODS
  Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05).
  
  
  RESULTS
  A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000).
  
  
  CONCLUSIONS
  The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics.
authors.affiliation: Department of Conservative Dentistry, School of Dentistry, University of Granada, Granada, Spain.
authors.forename: C
authors.identifier: http://orcid.org/0000-0002-7987-8822
authors.initials: C
authors.lastname: Lucena
authors.affiliation: Department of Dentistry II, Federal University of Maranhão UFMA, São Luis, Brazil.
authors.forename: E M
authors.initials: EM
authors.lastname: Souza
authors.affiliation: University of Granada, Granada, Spain.
authors.forename: G C
authors.initials: GC
authors.lastname: Voinea
authors.affiliation: Department of Conservative Dentistry, School of Dentistry, University of Granada, Granada, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Pulgar
authors.affiliation: Department of Statistics and Operations Research, Faculty of Pharmacy, University of Granada, Granada, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Valderrama
authors.affiliation: Department of Endodontics, Grande Rio University (UNIGRANRIO), School of Dentistry, Rio de Janeiro, Brazil.
authors.forename: G
authors.initials: G
authors.lastname: De-Deus
mesh_terms: D004708:Endodontics; D006801:Humans; D010506:Periodicals as Topic; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000592:standards*
keywords: endodontics; quality assessment; randomized clinical trial; systematic review