Adherence to the CONSORT statement of randomized clinical trials on ART restorations in children: current status and reporting characteristics

Abstract

Appropriate research reports are important to facilitate the evaluation of studies and the decision-making by dentists and policymakers. This meta-research study assessed the conformity of randomized clinical trials (RCTs) on atraumatic restorative treatment (ART) restorations with the CONSORT recommendations and their risk of bias (RoB). Cochrane Library, MEDLINE, BBO, LILACS, Scopus, and Web of Science databases were searched from April 2019 to June 2021 for RCTs that assessed the longevity of ART restorations in children. A specific tool was used to assess adherence to the CONSORT recommendations; RoB was evaluated with the Cochrane risk-of-bias tool. Descriptive analyses included the number of studies by journal, follow-up period, country, and quality assessments. A total of 2,181 papers were retrieved and 36 of them were analyzed qualitatively. The overall CONSORT mean score (CONms) was 22.52 ± 6.17 out of 32 points. The best described items were intervention and outcomes, whereas allocation concealment was described in only 22% of the papers. Significant differences in CONms were detected in the analysis by country and publication dates. High CONms were observed in recently published papers (26.7 ± 3.1) when compared to first ART studies (18.1 ± 4.6; p < 0.001). RoB was low in four studies, unclear in 11, and high in 21. Adherence of the papers to the CONSORT recommendations was not fully achieved and most of the papers had unclear and high RoB (PROSPERO registration #CRD42020201460).

Reporting health and medical research

“…Despite the potential for reporting guidelines to improve the completeness and transparency of health and medical research publications, the evidence base is limited and focused primarily on the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline for clinical trials 22. Trials commonly fail to report CONSORT items related to study design (ie, randomisation and allocation procedures) and blinding,23–26 all critical items for assessing risk of bias. Journal endorsement of reporting guidelines increases reporting of these items,19 although not in all instances,27 with insufficient evidence for many guidelines 22.…”