P064 SYSTEMATIC REVIEW OF PROPORTION OF FEMALES AND MALES RECRUITED IN BLOOD PRESSURE DEVICE VALIDATION STUDIES AND RELATIONSHIP WITH MEASUREMENT ACCURACY

Background and Objective: New to market automatic blood pressure (BP) devices should undergo clinical validation according to a scientifically recognised protocol to ensure accurate measurements. Some recent research suggests a reduced accuracy of automated cuff BP in females compared to males. Females have been underrepresented in many areas of clinical research, but it is unknown whether this is common among BP device validation studies and if it is a contributory factor to reduced accuracy in females. The aim of this study was to determine the proportion of females compared to males recruited to validation studies and whether there is any relationship with the accuracy of automated BP measurement. Methods: A systematic review of BP device validation studies published between 1987 and 2023 was conducted. Studies that tested automated, upper-arm devices compared to auscultatory BP in a general population, including children, were included. Descriptive statistics were used to determine the proportion of females and males recruited and weighted meta-regression analyses were used to assess the relationship between sex and measurement accuracy. Results: Out of 322 eligible validation studies, the proportion of females and males recruited was reported in 287 (89.1%) studies. Only six (2.1%) studies included <30% females or males, which is the current minimum requirement of international standards. An average of 50.8% females were recruited to validation studies, and this was consistent across different validation protocols and year of study publication. There was no relationship between sex and measurement accuracy (p>0.05), except for a negligible tendency of automated devices to overestimate manual measurements of diastolic BP among studies with a greater proportion of females (R2=0.017, p=0.027). Conclusion: Females are not underrepresented in BP device validation studies. There was no meaningful relationship between the proportion of females recruited and measurement accuracy. These findings indicate current protocols are adequate to ensure representation of females and males in validation studies.