Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study.
Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study.
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DOI：
10.1186/s41073-017-0039-6
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发表时间：
2017
影响因子：
6.1
通讯作者：
Tudiver S
中科院分区：
文献类型：
--
作者：
Welch V;Doull M;Yoganathan M;Jull J;Boscoe M;Coen SE;Marshall Z;Pardo JP;Pederson A;Petkovic J;Puil L;Quinlan L;Shea B;Rader T;Runnels V;Tudiver S
准确报告卫生研究中的性和性别问题是确保卫生干预措施安全有效的一个组成部分。在加拿大和国际上，政府、研究组织、期刊编辑和卫生机构呼吁进行更具包容性的研究，提供按性别分列的数据，并在整个研究过程中纳入性别和性别分析。性和性别分析通常被定义为一种考虑不同亚群（例如，不同性别、年龄和社会地位的人）可能会以不同或相似的方式经历健康状况和干预。本研究的目的是评估性别和/或性别报告的程度和性质，包括是否在加拿大随机对照试验（RCT）样本中进行了性别和性别分析（SGA）。我们使用经验证的筛选器检索了MEDLINE，检索时间为2013年1月1日至2014年7月23日，以识别RCT，并结合与加拿大相关的术语。两名评审员筛选了检索结果，以确定试验出版物中确定的前100个RCT，这些RCT由加拿大组织资助，或者第一作者或最后一位作者位于加拿大。在初始培训期间，由两人从10%的RCT中独立提取数据;一旦就该样本达成一致，其余的数据提取由一人完成，并由第二人进行验证。共检索到1433条记录。我们筛选了256份记录，以确定100项符合我们资格标准的RCT。随机对照试验的中位样本量为107例受试者（范围12-6085）。虽然98%的研究按性别描述了参与者的人口构成，但只有6%的研究进行了跨性别的亚组分析，4%的研究报告了按性别分列的数据。没有条款对“性别”和/或“性别”作出定义。没有出版物进行全面的性和性别分析。调查结果突出了加拿大随机对照试验中对性和性别因素的认识不足，并强调需要更好地阐述性和性别分析指导，以改善证据报告，为政策制定提供信息，并指导未来的研究。本文的在线版本（doi：10.1186/s41073-017-0039-6）包含补充材料，可供授权用户使用。
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. The online version of this article (doi:10.1186/s41073-017-0039-6) contains supplementary material, which is available to authorized users.