The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan [version 1; peer review: 2 approved]
Beverley-Ann Biggs,
Mohammad Saiful Alam Bhuiyan,
Sant-Rayn Pasricha,
Sabine Braat,
Julie A. Simpson,
Leila Larson,
Jena Derakhshani Hamadani,
Mohammed Imrul Hasan,
Shamima Shiraji,
Sheikh Jamal Hossain
Affiliations
Beverley-Ann Biggs
Department of Medicine and Victorian Infectious Diseases Service (Royal Melbourne Hospital), Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
Mohammad Saiful Alam Bhuiyan
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
Sant-Rayn Pasricha
Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, Australia
Centre for Epidemiology and Biostatistics, University of Melbourne, Melbourne, Australia
Julie A. Simpson
Centre for Epidemiology and Biostatistics, University of Melbourne, Melbourne, Australia
Leila Larson
Department of Medicine and Victorian Infectious Diseases Service (Royal Melbourne Hospital), Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
Jena Derakhshani Hamadani
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
Mohammed Imrul Hasan
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
Shamima Shiraji
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
Sheikh Jamal Hossain
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database. Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.
