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

Abstract

ObjectiveTo 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.Data SourcesCINAHL, 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 (EBRSR).Study SelectionStudies 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.Data ExtractionTwo investigators independently screened the title and abstracts, and the duplicates were removed. A full text review was done for studies which met all inclusion criteria. Data was extracted using a custom data extraction template in Covidence and 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).Data synthesis1,276 RCTs met inclusion criteria, and of these, 5.2% did not report results on sex accounting for 5.6% of participants. Females have been underrepresented in stroke RCTs, accounting for 38.8% of participants. Female participation was greater in acute post-stroke phase than chronic and subacute phases. Over almost five decades, there has been a small decrease in the proportion of female participants in these trials.ConclusionsEvidence-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. 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 (EBRSR). 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 the duplicates were removed. A full text review was done for studies which met all inclusion criteria. Data was extracted using a custom data extraction template in Covidence and 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). 1,276 RCTs met inclusion criteria, and of these, 5.2% did not report results on sex accounting for 5.6% of participants. Females have been underrepresented in stroke RCTs, accounting for 38.8% of participants. Female participation was greater in acute post-stroke phase than chronic and subacute phases. Over almost five 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.

Topics & Concepts