Compliance of Randomized Clinical Trials in Noncarious Cervical Lesions With the CONSORT Statement: A Systematic Review of Methodology

Alessandra Reis · Juliana Larocca de Geus · Letícia Maíra Wambier · Marcos Schroeder · Alessandro Dourado Loguércio

35 citations0/0 files storedOperative Dentistry

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Meta-analysis and systematic reviews Dental materials and restorations Clinical practice guidelines implementation

Abstract

The literature was reviewed to evaluate the compliance of randomized clinical trials (RCTs) with the CONsolidated Standards of Reporting Trials (CONSORT ) and the risk of bias of these studies through the Cochrane Collaboration risk of bias tool (CCRT). RCTs were searched at Cochrane Library, PubMed, and other electronic databases to find studies about adhesive systems for cervical lesions. The compliance of the articles with CONSORT was evaluated using the following scale: 0 = no description, 1 = poor description, and 2 = adequate description. Descriptive analyses about the number of studies by journal, follow-up period, country, and quality assessments were performed with CCRT for assessing risk of bias in RCTs. One hundred thirty-eight RCTs were left for assessment. More than 30% of the studies received scores of 0 or 1. Flow chart, effect size, allocation concealment, and sample size were more critical items, with 80% receiving a score of 0. The overall CONSORT score for the included studies was 15.0 ± 4.8 points, which represents 46.9% of the maximum CONSORT score. A significant difference among countries was observed ( p<0.001), as well as range of year ( p<0.001). Only 4.3% of the studies were judged as at low risk; 36.2% were classified as having unclear risk and 59.4% as having high risk of bias. The adherence of RCTs evaluating adhesive systems to the CONSORT is low with unclear/high risk of bias.

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2011The Cochrane Collaboration's tool for assessing risk of bias in randomised trials 2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 2010CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials 1995Empirical Evidence of Bias 1995Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials 1998Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?1996Improving the quality of reporting of randomized controlled trials. The CONSORT statement

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