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CONSORT statement adherence and risk of bias in randomized controlled trials on deep caries management: a meta-research.
- Source :
- BMC Oral Health; 6/13/2024, Vol. 24 Issue 1, p1-12, 12p
- Publication Year :
- 2024
-
Abstract
- Background: Recently, trials have 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 pediatric dental journals. Methods: We searched PubMed for RCTs in six pediatric dental journals between 2010 and 2022, focusing on deep caries lesion management. Adherence to the CONSORT guideline and the risk of bias were assessed using a modified tool with 19 items; each scored from 0 to 2 (maximum of 38 points), and the Cochrane risk-of-bias (RoB 2) tool. We performed descriptive and regression analyses (α = 5%). Results: We analyzed 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 the "estimated effect size". The risk of bias assessment revealed that 40.2% of the RCTs were at high risk, 59% were at low risk, and 0.8% were at 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 had lower scores than those in journals with the endorsement of the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) showed significantly lower CONSORT statement compliance than trials published recently within 5 years. Conclusion: Adherence to the CONSORT was relatively low among the investigated RCTs. Moreover, lower adherence to the CONSORT was associated with a higher risk of bias. Trial Registration: This study protocol was prospectively registered on the Open Science Framework - DOI (10.17605/OSF.IO/V6SYZ). [ABSTRACT FROM AUTHOR]
- Subjects :
- TREATMENT of dental caries
MEDICAL protocols
RISK assessment
SERIAL publications
QUALITATIVE research
RESEARCH funding
MULTIPLE regression analysis
LOGISTIC regression analysis
RANDOMIZED controlled trials
META-analysis
DESCRIPTIVE statistics
QUANTITATIVE research
RESEARCH bias
PEDIATRIC dentistry
SYSTEMATIC reviews
MEDLINE
ODDS ratio
RESEARCH methodology
STATISTICS
RESEARCH
ONLINE information services
CONFIDENCE intervals
DATA analysis software
INTER-observer reliability
EVALUATION
STANDARDS
Subjects
Details
- Language :
- English
- ISSN :
- 14726831
- Volume :
- 24
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- BMC Oral Health
- Publication Type :
- Academic Journal
- Accession number :
- 177879064
- Full Text :
- https://doi.org/10.1186/s12903-024-04417-0