Some Practical Issues Related to Univariate Regression Analysis Prior to Multivariate Regression Analysis in Randomized Controlled Clinical Trials

Often many variables have to be analyzed for their importance in terms of significant contribution and predictability in medical research. One of the possible analytical tools may be the Multiple Linear Regression Analysis. However, research papers usually report both univariate and multivariate regression analyses of the data. The biostatistician sometimes faces practical difficulties while selecting the independent variables for logical inclusion in the multivariate analysis. The selection criteria for inclusion of a variable in the multivariate regression is that the variable at the univariate level should have a regression coefficient with p 〈 0.20. However, there is a chance that an independent variable with p 〉 0.20 at univariate regression may become significant in the multivariate regression analysis and vice versa, provided the above criteria is not strictly adhered to. We undertook both univariate and multivariate linear regression analyses on data from two multi-centric clinical trials. We recommend that there is no need to restrict the p value of 〈= 0.20. Because of high speed computer and availability of statistical software, the desired results could be achieved by considering all relevant independent variables in multivariate regression analysis.