Abstract
BackgroundAccurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants.MethodsWe searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second.ResultsThe search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12–6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined “sex” and/or “gender.” No publication carried out a comprehensive sex and gender analysis.ConclusionsFindings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research.
Highlights
Accurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective
We excluded 36 Randomized controlled trials (RCT) that did not have a Canadian funder or a first or last author based in Canada (Fig. 1)
Description of the sample Inclusion criteria Canadian funding was reported in 68/100 of the RCTs (68%), while the remaining 32 trials were eligible for Population We classified trials as “single-sex” and “mixed-sex”, based on the terminology used by Gendered Innovations [33]
Summary
Accurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. Research indicates there are significant physiological differences in cardiac function between males and females such as susceptibility to QT interval prolongation and serious heart arrhythmias as well as gender differences in how men and women who have heart disease are diagnosed and treated [10,11,12] Failure to take these differences into account, not just between men and women, and across other characteristics such as age and socioeconomic status, can have serious, even lifethreatening, consequences for individual patients. These fundamental questions are systematically applied to all stages of the research process, starting with the formulation of the initial research question, followed by the development of methodology, conduct of the analysis, and interpretation of results and reflecting on their implications [13,14,15,16]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
