Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(8):development of statistical analysis strategies and key considerations
10.12173/j.issn.1005-0698.202508028
- VernacularTitle:《药物流行病学研究方法学指南(第2版)》及其系列解读(8):统计分析策略的制定与注意事项
- Author:
Qing WANG
1
;
Xinyan FENG
;
Dandan WANG
;
Zenan GU
;
Guangyun MAO
;
Yi WANG
Author Information
1. 温州医科大学公共卫生学院流行病与卫生统计学系(浙江温州 325035)
- Publication Type:Journal Article
- Keywords:
Pharmacoepidemiology;
Methodology;
Guildelines;
Statistical analysis strategies;
Bias control
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(9):993-1003
- CountryChina
- Language:Chinese
-
Abstract:
The establishment of standardized statistical analysis strategies is of great significance to ensuring scientific value and promoting high-quality development in pharmacoepidemiology research.Based on the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition),this article interprets the statistical analysis content within it section of the Guidelines.The first part outlines the importance and specific content of statistical analysis strategies in pharmacoepidemiology studies,introduces the variable definitions and sample size estimation and elaborates on data preprocessing and statistical methods.It also briefly discusses bias control and sensitivity analysis.The second part focuses on considerations for developing statistical analysis strategies,with further clarification on subgroup analysis,interim analysis,and the preparation of the statistical analysis reports.