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A quality assessment of randomized controlled trial reports in endodontics
Author(s) -
Lucena C.,
Souza E. M.,
Voinea G. C.,
Pulgar R.,
Valderrama M. J.,
DeDeus G.
Publication year - 2017
Publication title -
international endodontic journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.988
H-Index - 119
eISSN - 1365-2591
pISSN - 0143-2885
DOI - 10.1111/iej.12626
Subject(s) - randomized controlled trial , consolidated standards of reporting trials , medicine , jadad scale , checklist , descriptive statistics , protocol (science) , sample size determination , test (biology) , endodontics , medical physics , statistics , dentistry , mathematics , psychology , surgery , alternative medicine , pathology , paleontology , biology , cognitive psychology , cochrane library
Abstract Aim To assess the quality of the randomized clinical trial ( RCT ) reports published in Endodontics between 1997 and 2012. Methodology Retrieval of RCT s 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 RCT s 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 RCT s 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 RCT s, 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), RCT s 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 RCT s in Endodontics.