Reporting guidance considerations from a statistical perspective: Overview of tools to enhance the rigour of reporting of randomised trials and systematic reviews

Abstract

Objective Research waste has received considerable attention from the biomedical community. One noteworthy contributor is incomplete reporting in research publications. When detailing statistical methods and results, ensuring analytic methods and findings are completely documented improves transparency. For publications describing randomised trials and systematic reviews, guidelines have been developed to facilitate complete reporting. This overview summarises aspects of statistical reporting in trials and systematic reviews of health interventions. Methods A narrative approach to summarise features regarding statistical methods and findings from reporting guidelines for trials and reviews was taken. We aim to enhance familiarity of statistical details that should be reported in biomedical research among statisticians and their collaborators. Results We summarise statistical reporting considerations for trials and systematic reviews from guidance documents including the Consolidated Standards of Reporting Trials (CONSORT) Statement for reporting of trials, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement for trial protocols, the Statistical Analyses and Methods in the Published Literature (SAMPL) Guidelines for statistical reporting principles, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement for systematic reviews and PRISMA for Protocols (PRISMA-P). Considerations regarding sharing of study data and statistical code are also addressed. Conclusions Reporting guidelines provide researchers with minimum criteria for reporting. If followed, they can enhance research transparency and contribute improve quality of biomedical publications. Authors should employ these tools for planning and reporting of their research.