CONSORT adherence and risk of bias in Randomised Controlled Trials reports on deep caries management

Abstract

Abstract Background Recently, trials supported changes in deep caries management. However, reporting might lack details, affecting interpretation and implementation. Thus, we aimed to evaluate the adherence to the CONSORT statement and the risk of bias of Randomized Controlled Trials (RCTs) on deep caries management published in paediatric dental journals. Methods We searched PubMed for RCTs in six paediatric dental journals between 2010 to 2022, focusing on deep caries lesion management. Adherence to CONSORT guideline and risk of bias were assessed using a modified tool with 19 items scored from 0 to 2 (maximum 38 points) and assessed using Cochrane RoB 2. We performed descriptive and regression analyses (α = 5%). Results We analysed 127 RCTs. The mean (Standard Deviation) CONSORT adherence score was 21.1 (6.7). Notably, 96.1% of the studies received a score of 2 for the "intervention" item, whereas 83.5% scored 0 for "estimated effect size”. Risk of bias assessment revealed 40.1% with high risk, 59.1% with some concerns, and 0.8% with low risk. RCTs with a high risk of bias had lower CONSORT scores (p<0.001) than those with low or some concerns. RCTs published in journals without the endorsement of the CONSORT statement show lower scores than those in journals endorsing the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) show significantly lower CONSORT statement compliance than trials published recently within 5 years. Conclusion Among investigated RCTs, adherence to CONSORT is relatively low. Moreover, a lower adherence to CONSORT was associated with a higher risk of bias. Registration: This study protocol was prospectively registered on Open Science Framework - DOI (10.17605/OSF.IO/V6SYZ).