Helen Barraclough, MSc, Ramaswamy Govindan, MD

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Biostatistics Primer: What a Clinician Ought to Know: Subgroup Analyses Helen Barraclough, MSc, Ramaswamy Govindan, MD Journal of Thoracic Oncology Volume 5, Issue 5, Pages 741-746 (May 2010) DOI: 10.1097/JTO.0b013e3181d9009e Copyright © 2010 Terms and Conditions

FIGURE 1 What is an interaction test? In this hypothetical example, there are two treatment (Tx) arms in the clinical trial: A and B. There are also two levels of the subgroup of patients defined by the baseline characteristic of gender: males and females. The regression lines linking the circles and squares represent the efficacy of treatment A and B, respectively, for overall survival (as estimated by the log hazard from the Cox Proportional Hazards Model). The log hazard estimates the log risk of death. Hence, the higher the regression line, the higher the risk of death. The treatment effect is illustrated by an arrow in each level of the subgroup (which in this example is the log HR[Tx A vs Tx B]). If the regression lines are parallel, there is no interaction between treatment and gender (A). Hence, the treatment effect in males is the same as in females. However, if the regression lines are not parallel (B and C), there is a statistically significant interaction between treatment and gender. Thus, the treatment effect in males is significantly different to that observed in females. Journal of Thoracic Oncology 2010 5, 741-746DOI: (10.1097/JTO.0b013e3181d9009e) Copyright © 2010 Terms and Conditions

FIGURE 2 Forest plot. Forest plot are commonly used to graphically present subgroup analyses results. Above is a hypothetical result corresponding to the qualitative interaction example described in Figure 1C. The diamond represents the point estimate of the HR(Tx A vs Tx B) and the horizontal lines the 95% confidence intervals. Journal of Thoracic Oncology 2010 5, 741-746DOI: (10.1097/JTO.0b013e3181d9009e) Copyright © 2010 Terms and Conditions

Journal of Thoracic Oncology 2010 5, 741-746DOI: (10. 1097/JTO Journal of Thoracic Oncology 2010 5, 741-746DOI: (10.1097/JTO.0b013e3181d9009e) Copyright © 2010 Terms and Conditions

Journal of Thoracic Oncology 2010 5, 741-746DOI: (10. 1097/JTO Journal of Thoracic Oncology 2010 5, 741-746DOI: (10.1097/JTO.0b013e3181d9009e) Copyright © 2010 Terms and Conditions