Selective Outcome Reporting Bias in Randomized Controlled Trials on Dental Caries in Children and Adolescents: A Meta-Research Study

  • 0School of Dentistry, Division of Pediatric Dentistry, University of São Paulo, Department of Orthodontics and Pediatric Dentistry, São Paulo, Brazil.

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Summary

This summary is machine-generated.

Selective outcome reporting (SOR) bias is prevalent in pediatric dental caries randomized controlled trials (RCTs). Over half of studies showed discrepancies between protocols and publications, indicating a need for greater research transparency.

Area Of Science

  • Dentistry
  • Clinical Trials
  • Biostatistics

Background

  • Selective outcome reporting (SOR) is a bias in randomized controlled trials (RCTs) where outcomes are altered or omitted in publications versus the original protocol.
  • This bias can lead to the overemphasis of statistically significant findings.
  • This study investigates the prevalence of SOR in pediatric dental caries RCTs.

Purpose Of The Study

  • To determine the prevalence of selective outcome reporting (SOR) in published randomized controlled trials (RCTs) concerning dental caries in children and adolescents.
  • To identify factors associated with SOR in this research area.

Main Methods

  • Searched ClinicalTrials.gov and ICTRP for pediatric dental caries RCTs published up to February 2023.
  • Included RCTs with at least two arms and a published article.
  • Extracted data on outcomes from protocols and publications for comparison.

Main Results

  • Selective outcome reporting (SOR) was identified in 58.9% of the 175 included studies.
  • Discrepancies in the primary outcome's time frame were observed in 41.1% of studies.
  • SOR was significantly associated with follow-up period discrepancies (p < 0.001) and study design type (p = 0.048).

Conclusions

  • A high prevalence of SOR exists in pediatric dental caries RCTs, necessitating increased attention.
  • Implementing pre-registered protocols and disclosing deviations are crucial for research transparency.
  • Comparing published outcomes with protocols helps reduce research waste and ensures reliable findings.

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