Optimization of sample size design in TCM clinical research / 中华中医药杂志

ABSTRACT

Sample size design is to determine the minimum number of observed cases in the case of ensuring the reliability of research conclusions.The reliability of sample size estimation mainly related to the reliability of the basis of sample size calculation.Some things are essential,such as the emphasis on pre-test quality,extensive collection of relevant literature and research materials and accurate analysis.Estimation of sample size is first to determine the value of ?,?,or 1-? and effect indicators and their types,the effect indicators predictive value of each comparison group,the emphasis on sources and requirements of the effect indicators predictive value(the basis of calculation),besides,should pay close attention to study design and comparison of types,each group allocation ratio,the expected rate of lost to follow,the level of expected treatment compliance,the choice of some main effect indicators in outcome evaluation.An introduction and explaining with examples to estimation method and estimation of sample size formula,such as design of randomized controlled trials,cohort studies and case-control study commonly used in the clinical validation study of TCM,and study design commonly used in the clinical exploratory study of TCM,case analysis and so on.