The implementation of sex-and gender-based considerations in exercise-based randomized controlled trials in individuals with stroke: A cross-sectional study.

Abstract

Emerging evidence suggests that sex-and gender-based factors may influence responses to exercise post-stroke. The Sex and Gender Equity in Research (SAGER) guidelines (2016) published international standards for terminology and considerations for research design and trial reporting. The extent to which sex- and gender-based considerations have been implemented in stroke exercise trials is currently unknown. The objective of this cross-sectional study was to compare the proportion of studies that have implemented sex/gender considerations before and after the publication of the SAGER guidelines. We conducted a comprehensive search of the literature to identify exercise-based trials in individuals with stroke. Study titles, abstracts, introductions (hypothesis statements), methods, results and discussions were assessed for adherence to the SAGER guidelines. The proportion of studies adhering to SAGER guidelines published prior to and including December 31, 2016 and from 2017-March 2023 were compared. Of the 245 studies identified, 150 were published before December 31, 2016, of which 0 (0%) titles/abstracts, 0 (0%) introductions, 21 (14.0%) methods, 8 (5.3%) results, and 7 (4.7%) discussion sections adhered to the SAGER guidelines, and 35 (23.3%) reported proper sex and gender terminology. Of the 95 studies published between 2017-2023, 0 (0%) title/abstracts, 1 (1.0%) introduction, 16 (16.8%) methods, 5 (5.3%) results, and 10 (10.5%) discussion sections adhered to the guidelines, and 37 (38.9%) of studies included proper terminology. The implementation of sex- and gender-based considerations in stroke exercise trials is low, but positively the reporting of proper terminology has increased since the publication of standardized reporting guidelines. This study serves as a call to action for stroke rehabilitation researchers to incorporate sex- and gender-based considerations in all stages of research studies, to improve the rigour and generalizability of findings, and promote health equity.