"Background: Genders´ biological differences are often overlooked in clinical trials, which may undermine their reliability and applicability. This oversight can skew results, compromising the effectiveness of healthcare interventions. Researchers and policymakers should prioritise the integration of gender-specific analyses in their work to enhance the integrity and relevance of scientific findings, ensure the appropriateness of health interventions to different population needs, and improve trustworthiness. Nevertheless, no formal assessment of gender bias has been conducted among RCTs in our local context.

Objective: To assess gender-bias by applying a modified version of the Sex and Gender Appraisal tool for Systematic Reviews-2 (SGAT-SR-2) on Chilean randomised controlled trials (RCTs).

Methods: We retrieved RCT with at least one Chilean author, between the years 2017-2022. We excluded RCT centred on gender-exclusive diseases or those analysing only one gender. We applied the SGAT-SR-2 to assess whether the authors considered and managed gender bias. Since the SGAT-SR-2 tool was initially created for systematic reviews, we only considered a subset of questions applicable to RCTs (figure 1)

Results: Among 239 total RCTs identified, we have preliminarily assessed a random sample of 54 RCTs. 45 (78%) RCTs detailed the gender of the participants, but only 22 (38%) planned to collect characteristics of participants by gender. 12 (21%) incorporated gender in their main outcome analyses (e.g., by doing subgroup analysis). Six (10%) considered sex or gender differences in the eligibility criteria. Less than 10% of the RCTs considered gender or sex differences within their background, limitations, and applicability considerations.

Conclusions: Gender consideration in locally conducted RCTs is insufficient and superficial, being usually limited to the report of the participants’ gender. Future RCTs should actively incorporate a gender perspective on their design and interpretation of findings."