Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery".
Ian YuanVanessa A OlbrechtJanell L MensingerBingqing ZhangAndrew J DavidsonBritta Sylvia von Ungern-SternbergJustin J SkownoQingQuan LianXingRong SongPin ZhaoJianMin ZhangMaZhong ZhangYunXia ZuoJurgen C de GraaffLaszlo VutskitsPeter SzmukCharles D KurthPublished in: Paediatric anaesthesia (2019)
This Statistical Analysis Plan details the statistical procedures to be applied for the analysis of data for the multicenter electroencephalography study. It consists of a basic description of the study in broad terms and separate sections that detail the methods of different aspects of the statistical analysis, summarized under the following headings (a) Background; (b) Definitions of protocol violations; (c) Definitions of objectives and other terms; (d) Variables for analyses; (e) Handling of missing data and study bias; (f) Statistical analysis of the primary and secondary study outcomes; (g) Reporting of study results; and (h) References. It serves as a template for researchers interested in writing a Statistical Analysis Plan.