Evaluation of the Application Effect of Simple Tool for Online Sample Size Calculation in Randomized Controlled Trial
Objectives To evaluate the accuracy of the calculation results of the simple online sample size calculation tool,and explore its advantages and application value in the clinical research environment.Methods We developed a Chinese online tool for sample size calculation,and compared the results with PASS software.Randomized Controlled Trial(RCT)was used as the design type.Different parameters were tested.Consistency between the online tool and PASS was evaluated by absolute difference,bland-Altman curve,and Intraclass Correlation Coefficient(ICC).Results The study calculated the parameters based on the sample size of 3 real clinical research projects.By adjusting one parameter at a time,different parameter combinations were formed,finally,60 and 80 parameter combination data were obtained from qualitative data and quantitative data,respectively,and were included in the sample size calculation.For the equivalence test and non-inferiority test of qualitative data,the differences in sample size calculated by the two tools ranged between 0 and 6.For quantitative data,the differences in sample size calculated by the two tools always remained between 0 and 4.At the same time,the ICC values of the sample sizes calculated by the two tools were close to 1,which is statistically significant.Conclusions The online sample size calculation tool had good accuracy and stability,and was easy to use.It was suitable for assisting clinical medical staff in scientific research.
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