Female participation in Canadian stroke rehabilitation trials: Comparing trial participants to the inpatient rehabilitation population.

OBJECTIVES

1) to determine whether the sex distribution and other characteristics of Canadian stroke rehabilitation trial participants differ from the inpatient stroke rehabilitation population in Canada 2) to explore whether trial eligibility criteria may be impacting the proportion of females participating in stroke trials.

MATERIALS AND

METHODS

This was a cross-sectional study using Canadian inpatient stroke rehabilitation population and three stroke rehabilitation clinical trials data. Between-group differences in population and trial data were described and a participant to prevalence ratio for females was calculated. Trial eligibility criteria were examined in the context of the inpatient stroke rehabilitation population characteristics to explore whether eligibility criteria may be disproportionately excluding females.

RESULTS

There were 201 trial participants (29.4 % female) and 37,047 patients admitted to inpatient stroke rehabilitation (44.8 % female). The overall participant to prevalence ratio for females was 0.66. Females admitted to inpatient stroke rehabilitation were older than males (p<.001), with no sex difference in age in trial participants (p=.114). A significantly smaller proportion of female trial participants had a diagnosis of hypertension compared to females admitted to inpatient rehabilitation (41.4 % vs 66.2 %; p <.001). This difference was not observed for males. Compared to males, females admitted to inpatient rehabilitation more frequently had characteristics (mood disorder, living alone, discharged to long-term care), which may have resulted in their exclusion from ≥1 of the trials.

CONCLUSIONS

Females enrolled in stroke rehabilitation trials are underrepresented compared to inpatient rehabilitation. Trial eligibility criteria may result in the disproportionate exclusion of females compared to males.