Braat Sabine, Larson Leila, Simpson Julie A, Hasan Mohammed Imrul, Hamadani Jena Derakhshani, Hossain Sheikh Jamal, Shiraji Shamima, Bhuiyan Mohammad Saiful Alam, Biggs Beverley-Ann, Pasricha Sant-Rayn
Centre for Epidemiology and Biostatistics, University of Melbourne, Melbourne, Australia.
Department of Medicine and Victorian Infectious Diseases Service (Royal Melbourne Hospital), Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
F1000Res. 2020 May 22;9:427. doi: 10.12688/f1000research.23383.1. eCollection 2020.
: 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. : 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. : 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. Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.
儿童铁干预的益处与风险（BRISC）试验将评估在孟加拉国农村地区，给8个月大的儿童补充铁剂或含铁多种微量营养素粉（MNP）与安慰剂相比，连续3个月普遍补充对儿童发育、生长、发病率、干预结束时及干预后9个月的贫血、缺铁和炎症实验室指标的影响。本文描述了统计分析计划。BRISC是一项针对3300名儿童的多中心、三臂、双模拟盲法、平行组随机对照优势试验。统计分析计划由试验统计学家根据方案、数据收集表以及盲态研究数据库中的研究结果，与试验指导委员会和试验管理委员会协商制定。这份在分配治疗方案揭盲前公布的详细统计分析计划，将支持BRISC试验揭盲后进行的统计分析和报告。它有助于统计分析和报告的透明度及可重复性。澳大利亚新西兰临床试验注册中心ACTRN12617000660381（于2017年5月8日注册）；世界卫生组织通用试验编号U1111 - 1196 - 1125。
