Welch V, Doull M, Yoganathan M, Jull J, Boscoe M, Coen S E, Marshall Z, Pardo J Pardo, Pederson A, Petkovic J, Puil L, Quinlan L, Shea B, Rader T, Runnels V, Tudiver S
1Bruyère Research Institute, Bruyère Continuing Care, 304b-85 Primrose Avenue, Ottawa, Ontario K1R 6 M1 Canada.
2University of Ottawa, Ontario, Canada.
Res Integr Peer Rev. 2017 Sep 1;2:15. doi: 10.1186/s41073-017-0039-6. eCollection 2017.
Accurate 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.
We 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.
The 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.
Findings 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.
在健康研究中准确报告性别信息对于确保健康干预措施的安全性和有效性至关重要。在加拿大及国际上，政府、研究机构、期刊编辑和卫生机构都呼吁开展更具包容性的研究，提供按性别分类的数据，并在整个研究过程中纳入性别分析。性别分析通常被定义为一种考虑不同亚人群（如不同性别、年龄和社会地位的人群）如何以及为何可能以不同或相似方式经历健康状况和干预措施的方法。本研究的目的是评估关于性别和/或性别的报告范围及性质，包括在一组涉及人类参与者的加拿大随机对照试验（RCT）样本中是否进行了性别分析（SGA）。
我们使用经过验证的确认识别随机对照试验的筛选器，并结合与加拿大相关的术语，检索了2013年1月1日至2014年7月23日期间的MEDLINE数据库。两名评审员筛选检索结果，以确定在试验出版物中被确定为由加拿大组织资助的前100项随机对照试验，或其第一作者或最后作者来自加拿大的试验。在初始培训期间，由两人独立从10%的随机对照试验中提取数据；一旦就该样本达成一致，其余数据提取工作由一人完成，并由另一人进行核实。
检索共获得1433条记录。我们筛选了256条记录，以确定100项符合我们纳入标准的随机对照试验。随机对照试验的样本量中位数为107名参与者（范围为12 - 6085）。虽然98%的研究按性别描述了参与者的人口统计学组成，但只有6%进行了跨性别的亚组分析，4%报告了按性别分类的数据。没有文章对“性别”和/或“性”进行定义。没有出版物进行全面的性别分析。
研究结果凸显了在加拿大随机对照试验背景下对性别因素的利用不足，并强调需要就性别分析提供更明确的指导，以改善证据报告、为政策制定提供信息并指导未来研究。
