Evidence map›Paper›PMID 38872165›Full record

ArticleBMC oral health2024

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

Rokaia Ahmed Elagami, Thais Marchezini Reis, Mohamed Ahmed Hassan, Tamara Kerber Tedesco, Mariana Minatel Braga, Fausto Medeiros Mendes, Maximiliano Sérgio Cenci, Marie-Charlotte Huysmans, Daniela Prócida Raggio

Abstract read
In one paragraph

Article in BMC oral health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Rokaia Ahmed ElagamiDepartment of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Thais Marchezini ReisDepartment of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Mohamed Ahmed HassanDepartment of Stomatology, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Tamara Kerber TedescoDepartment of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Mariana Minatel BragaDepartment of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Fausto Medeiros MendesDepartment of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil.
Maximiliano Sérgio CenciDepartment of Dentistry, Radboud University Medical Center, Research Institute for Medical Innovation, Nijmegen, The Netherlands.
Marie-Charlotte HuysmansDepartment of Dentistry, Radboud University Medical Center, Research Institute for Medical Innovation, Nijmegen, The Netherlands.
Daniela Prócida RaggioDepartment of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of São Paulo, São Paulo, Brazil. danielar@usp.br.

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 303230/2019-3Conselho Nacional de Desenvolvimento Científico e Tecnológico 310972/2021-3Conselho Nacional de Desenvolvimento Científico e Tecnológico 316974/2021-8Coordenação de Aperfeiçoamento de Pessoal de Nível Superior 001
6 · The paper itself

Abstract

backgroundRecently, 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.

methodsWe 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%).

resultsWe 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.

conclusionAdherence 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 registrationThis study protocol was prospectively registered on the Open Science Framework - DOI ( 10.17605/OSF.IO/V6SYZ ).

Indexed as

BiasDental CariesGuideline AdherenceHumansRandomized Controlled Trials as TopicCONSORT adherenceDental caries managementPediatric dentistryRandomized clinical controlled trialsRoB 2 tool

Identifiers

PMID38872165
PMCPMC11177528

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.