Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery"

Ian Yuan; Vanessa A Olbrecht; Janell L Mensinger; Bingqing Zhang; Andrew J Davidson; Britta S von Ungern-Sternberg; Justin Skowno; QingQuan Lian; XingRong Song; Pin Zhao; JianMin Zhang; MaZhong Zhang; YunXia Zuo; Jurgen C de Graaff; Laszlo Vutskits; Peter Szmuk; Charles D Kurth

doi:10.1111/pan.13589

Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery"

Paediatr Anaesth. 2019 Mar;29(3):243-249. doi: 10.1111/pan.13589.

Authors

Ian Yuan¹, Vanessa A Olbrecht², Janell L Mensinger³, Bingqing Zhang¹, Andrew J Davidson⁴, Britta S von Ungern-Sternberg^{5

6}, Justin Skowno⁷, QingQuan Lian⁸, XingRong Song⁹, Pin Zhao¹⁰, JianMin Zhang¹¹, MaZhong Zhang¹², YunXia Zuo¹³, Jurgen C de Graaff¹⁴, Laszlo Vutskits¹⁵, Peter Szmuk¹⁶, Charles D Kurth¹

Affiliations

¹ Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania.
² Department of Anesthesiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
³ Department of Epidemiology and Biostatistics, Dornsife School of Public Health, Drexel University, Philadelphia, Pennsylvania.
⁴ Department of Anaesthesia and Pain Management, Royal Children's Hospital, Melbourne, VIC, Australia.
⁵ Department of Anaesthesia and Pain Management, Perth Children's Hospital, Perth, WA, Australia.
⁶ Medical School, The University of Western Australia, Perth, WA, Australia.
⁷ Department of Anaesthesia, Children's Hospital at Westmead, University of Sydney, Sydney, NSW, Australia.
⁸ Department of Anesthesiology, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
⁹ Department of Anesthesiology, Guangzhou Medical University Affiliated Women and Children Medical Center, Guangzhou, China.
¹⁰ Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, China.
¹¹ Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, Beijing, China.
¹² Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.
¹³ Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
¹⁴ Department of Anesthesiology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.
¹⁵ Department of Anesthesiology, Pharmacology, and Intensive Care, University Hospitals of Geneva, Geneva, Switzerland.
¹⁶ Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas.

PMID: 30664323
DOI: 10.1111/pan.13589

Abstract

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.

Keywords: EEG; SAP; SAP example; SAP template; Statistical Analysis Plan; isoelectric EEG.

Publication types

Multicenter Study
Observational Study

MeSH terms

Child, Preschool
Data Interpretation, Statistical*
Electroencephalography / statistics & numerical data*
Humans
Infant
Infant, Newborn
Multicenter Studies as Topic / statistics & numerical data
Prospective Studies
Statistics as Topic / standards*