How to understand, critically appraise, and write the Statistical Methods section of a clinical research paper

The Statistical Methods section of a clinical research paper is frequently perceived as "daunting" and "intimidating" by clinicians not only to write but also to read and critically appraise. The Statistical Method section links the aims and objectives of the study to the primary outcome and details how the research question is to be answered. This is challenging as it requires a clear understanding of the clinical question, research methodologies, and statistical methods. As such, it is often poorly written which leads to the apprehension we described in readers. In this paper, we try to remove the angst by providing simple strategies to understand, critically appraise, and write a Statistical Methods section. We also look at why it is so difficult to write a Statistical Methods section and review the resources that have been developed to help clinicians apply statistical methods to their research. Finally, we emphasise the importance of collaboration with a statistician, not only in the writing of the Statistical Methods section but throughout the life of a clinical research study.