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Selective Outcome Reporting Bias in Randomized Controlled Trials on Dental Caries in Children and Adolescents: A
Livia da Rosa Oliveira1, Rokaia Ahmed Elagami1, Thais Marchezini Reis1
1School of Dentistry, Division of Pediatric Dentistry, University of São Paulo, Department of Orthodontics and Pediatric Dentistry, São Paulo, Brazil.
Introduction:
Selective outcome reporting (SOR) is a bias that can occur in randomized controlled trials (RCTs), defined as the alteration or omission of primary outcome in the publication compared to the original protocol. Researchers may modify outcomes to highlight statistically significant results. This study aimed to assess the prevalence of SOR in RCTs related to dental caries in children and adolescents.
Methods:
We conducted a search on
Results:
A total of 175 protocols and their corresponding publications were included. SOR was identified in 58.9% (n = 103) of the studies, with 41.1% (n = 72) showing discrepancies in the primary outcome's time frame. Retrospective registrations accounted for 73.7% of the studies. SOR was significantly associated with discrepancies in the follow-up period (p < 0.001) and with study design type (parallel assignment, split-mouth, cluster RCT, and no information) (p = 0.048).
Conclusions:
The high prevalence of SOR in dental caries RCTs in pediatric dentistry highlights the need for attention to this issue. Ensuring transparency in the research process requires implementing an appropriate pre-registered protocol, disclosing deviations from it, and enabling stakeholders to compare the protocol with the published outcomes which can help reduce research waste.
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