CONSORT statement adherence and risk of bias in randomized controlled trials on deep caries management: a meta-research

被引:0
|
作者
Elagami, Rokaia Ahmed [1 ,3 ]
Reis, Thais Marchezini [1 ]
Hassan, Mohamed Ahmed [2 ]
Tedesco, Tamara Kerber [1 ]
Braga, Mariana Minatel [1 ]
Mendes, Fausto Medeiros [1 ,3 ]
Cenci, Maximiliano Sergio [3 ]
Huysmans, Marie-Charlotte [3 ]
Raggio, Daniela Procida [1 ]
机构
[1] Univ Sao Paulo, Fac Dent, Dept Orthodont & Pediat Dent, Sao Paulo, Brazil
[2] Univ Sao Paulo, Dept Stomatol, Fac Dent, Sao Paulo, Brazil
[3] Radboud Univ Nijmegen, Res Inst Med Innovat, Dept Dent, Med Ctr, Nijmegen, Netherlands
来源
BMC ORAL HEALTH | 2024年 / 24卷 / 01期
关键词
RoB; 2; tool; Randomized clinical controlled trials; Dental caries management; CONSORT adherence; Pediatric dentistry; CLINICAL-TRIALS; REPORTING QUALITY; DESIGN; WASTE;
D O I
10.1186/s12903-024-04417-0
中图分类号
R78 [口腔科学];
学科分类号
1003 ;
摘要
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 (alpha = 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.
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页数:12
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