Female Enrollment in Rehabilitation Trials: A Systematic Review of Reporting Sex and Female Participation in Randomized Controlled Trials of Poststroke Upper Extremity Rehabilitation Over 50 Years

• Published in: Archives of physical medicine and rehabilitation Vol. 105; no. 7; pp. 1399 - 1406
• Main Authors: Mehrabi, Sarvenaz, Harnett, Amber, Saikaley, Marcus, Fleet, Jamie L., Eng, Janice J., Bayley, Mark, Teasell, Robert
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.07.2024
• Subjects: Differences; Female; Gender equity; Patient participation; Rehabilitation; Sex; Stroke; Upper extremity; UE; Stroke; RCT; Gender equity; Patient participation; Sex; Female; Rehabilitation; PEDro; Upper extremity; Differences
• ISSN: 0003-9993; 1532-821X; 1532-821X
• DOI: 10.1016/j.apmr.2024.01.026

To systematically assess the reporting of sex and the percentage of female participants in randomized controlled trials (RCTs) examining interventions for the post-stroke rehabilitation of upper extremity (UE) motor disorders. CINAHL, Embase, PubMed, Scopus and Web of Science were searched from 1960 to April 1, 2021. Additional articles were identified using the Evidence-Based Review of Stroke Rehabilitation. Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English, (2) ≥50% of participants were diagnosed and affected by stroke, (3) included adults ≥18 years old, and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. Two investigators independently screened the title and abstracts, and duplicates were removed. A full-text review was done for studies that met all inclusion criteria. Data were extracted using a custom data extraction template in Covidence and were transferred to online Excel (V16) for data management. Study characteristics and extracted variables were summarized using standard descriptive statistics. Data analyses were performed using SPSS (V29.0). A total of 1276 RCTs met inclusion criteria, and of these, 5.2% did not report results on sex, accounting for 5.6% of participants. Women have been underrepresented in stroke RCTs, accounting for 38.8% of participants. Female participation was greater in the acute poststroke phase than in the chronic and subacute phases. Over almost 5 decades, there has been a small decrease in the proportion of female participants in these trials. Evidence-based medicine for the treatment and prevention of stroke is guided by results from RCTs. Generalizability depends on sufficient representation in clinical trials. Stakeholders, such as funders and journal editors, play a key role in encouraging researchers to enroll enough of both sexes and to report the presence or absence of sex differences in RCTs.