Sex and Gender Subgroup Analyses of Randomized Trials The Need to Proceed With Caution

INTRODUCTION AND BACKGROUND: Subgroup analyses by sex or gender can raise potential differences in response to medical interventions which require further investigation. However, sex/gender-based SGA have the potential to be misleading if their results are overinterpreted and may incorrectly influence medical management. OBJECTIVES: We sought to assess the frequency of subgroup analysis (SGA) by sex/gender in randomized controlled trials (RCTs) …