Introduction: Female participation is lower than males in both acute stroke and stroke rehabilitation trials. However, less is known about how female participation differs across countries and regions.
Objective: To systematically assess the percentage of female participants in RCTs of post stroke rehabilitation of upper extremity (UE) motor disorders in low-middle-income (LMICs) and high-income countries (HICs) as well as different HIC world regions.
Materials & methods: CINAHL, Embase, PubMed, Scopus and Web of Science were searched from 1960 to April 1, 2021. Studies were eligible for inclusion if they: (1) were RCTs or crossovers published in English; (2) ≥50% of participants were diagnosed with stroke; 3) included adults ≥18 years old; and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. Countries were divided into HICs and LMICs based on their growth national incomes. The HICs were further divided into the three regions of North America, Europe, and Asia & Pacific. Data analysis was performed using SPSS and RStudio v.4.3.1.
Results: 1,276 RCTs met inclusion criteria. 298 RCTs were in LMICs and 978 were in HICs. The percentage of female participants was significantly higher in HICs (39.5%) than LMICs (36.9%). Comparing HIC regions, there was a significant difference in the overall female percentages in favour of RCTs in HIC-Europe compared to LMICs but not HIC-North America or HIC-Asia & Pacific. There was no significant change in the percentage of female participants in all countries and regions over the last two decades, with no differences in trends between the groups.
Conclusions: Sufficient female representation in clinical trials is required for the generalizability of results. Despite differences in overall percentage of female participation between countries and regions, females have been underrepresented in both HICs and LMICs with no considerable change over two decades.
S. Karger AG, Basel.