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The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan

Sabine Braat1, Leila Larson2,3, Julie A Simpson1

  • 1Centre for Epidemiology and Biostatistics, University of Melbourne, Melbourne, Australia.

F1000Research
|April 11, 2022
PubMed

Insights

This study details the statistical analysis plan for the Benefits and Risks of Iron interventionS in Children (BRISC) trial. It ensures transparent and reproducible evaluation of iron supplementation

Area of Science:

  • Pediatric Nutrition
  • Public Health Interventions
  • Clinical Trial Methodology

Background:

  • The Benefits and Risks of Iron interventionS in Children (BRISC) trial investigates iron supplementation's effects in rural Bangladeshi children.
  • Evaluates iron supplements versus multiple micronutrient powders (MNPs) against placebo.

Purpose of the Study:

  • To outline the statistical analysis plan for the BRISC trial.
  • To ensure transparency and reproducibility in analyzing trial data on child development, growth, and health outcomes.

Main Methods:

  • A multi-site, three-arm, double-dummy blinded, parallel group, randomized controlled superiority trial.
  • Involves 3300 children aged 8 months.
  • Statistical analysis plan developed by trial statisticians in consultation with committees.

Main Results:

  • This paper focuses on the statistical analysis plan, not preliminary results.
  • The plan details the methodology for analyzing data collected post-intervention and post-follow-up.

Conclusions:

  • The published statistical analysis plan supports transparent and reproducible reporting of BRISC trial findings.
  • Facilitates rigorous evaluation of iron interventions in child populations.

Keywords:
BangladeshBayley ScalesIronanaemiachild developmentcognitionrandomised control trialstatistical analysis plan

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