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Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study Welch, V.; Doull, M.; Yoganathan, M.; Jull, J.; Boscoe, M.; Coen, S. E; Marshall, Z.; Pardo, J. P; Pederson, A.; Petkovic, J.; Puil, L.; Quinlan, L.; Shea, B.; Rader, T.; Runnels, V.; Tudiver, S. Sep 1, 2017

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RESEARCH Open AccessReporting of sex and gender in randomizedcontrolled trials in Canada: a cross-sectionalmethods studyV. Welch1,2* , M. Doull3, M. Yoganathan1, J. Jull4, M. Boscoe5, S. E. Coen6, Z. Marshall7, J. Pardo Pardo8,A. Pederson9, J. Petkovic1,2, L. Puil10, L. Quinlan1, B. Shea1,2, T. Rader11, V. Runnels12 and S. Tudiver13AbstractBackground: Accurate reporting on sex and gender in health research is integral to ensuring that healthinterventions are safe and effective. In Canada and internationally, governments, research organizations, journaleditors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and theintegration of sex and gender analysis throughout the research process. Sex and gender analysis is generallydefined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, andsocial 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, includingwhether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs)with human participants.Methods: We searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification ofRCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first orlast author based in Canada. Data were independently extracted by two people from 10% of the RCTs during aninitial training period; once agreement was reached on this sample, the remainder of the data extraction wascompleted by one person and verified by a second.Results: The search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibilitycriteria. The median sample size of the RCTs was 107 participants (range 12–6085). While 98% of studies describedthe demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and4% reported sex-disaggregated data. No article defined “sex” and/or “gender.” No publication carried out acomprehensive sex and gender analysis.Conclusions: Findings highlight poor uptake of sex and gender considerations in the Canadian RCT context andunderscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence,inform policy development, and guide future research.Keywords: Sex/gender analysis, Gender, Randomized controlled trials as a topic, Canada, Quality* Correspondence: Vivian.Welch@uottawa.ca1Bruyère Research Institute, Bruyère Continuing Care, 304b-85 PrimroseAvenue, Ottawa, Ontario K1R 6 M1, Canada2University of Ottawa, Ontario, CanadaFull list of author information is available at the end of the articleResearch Integrity and           Peer Review© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Welch et al. Research Integrity and Peer Review  (2017) 2:15 DOI 10.1186/s41073-017-0039-6BackgroundOver the past several decades, there has been increasingawareness within the community of health researchers, fun-ders, and knowledge users (e.g., policy-makers, practi-tioners, and patients) of the need to understand how sexand gender influence health outcomes [1, 2]. “Sex” is com-monly used to refer to genetic, biological, and physiologicalprocesses; whereas “gender” is commonly used to refer tothe roles, relationships, behaviors, relative power, and othertraits that societies ascribe to women, men, and people ofdiverse gender identities [3]. Sex and gender interact witheach other and other characteristics to influence health out-comes [4–9]. For example, research indicates there are sig-nificant physiological differences in cardiac functionbetween males and females such as susceptibility to QTinterval prolongation and serious heart arrhythmias as wellas gender differences in how men and women who haveheart disease are diagnosed and treated [10–12]. Failure totake these differences into account, not just between menand women, but also across other characteristics such asage and socioeconomic status, can have serious, even life-threatening, consequences for individual patients.As used in this paper, sex and gender analysis is an ap-proach and framework for considering fundamentalquestions about how and why different subpopulations(e.g., of diverse genders, ages, and social locations) mayexperience health conditions and interventions in differ-ent or similar ways. These fundamental questions aresystematically applied to all stages of the researchprocess, starting with the formulation of the initial re-search question, followed by the development of meth-odology, conduct of the analysis, and interpretation ofresults and reflecting on their implications [13–16].Policies and guidance increasingly mandate or recom-mend routine collection, reporting and analysis of the influ-ence of sex and gender in scientific research. However,uptake of sex and gender analysis, and its impacts onreporting and on health outcomes remain unclear [2, 17,18]. For example, funding policies of the U.S. National In-stitutes of Health (Revitalization Act 1993) [19], mandatingthe appropriate inclusion of women and minorities in clin-ical trials have resulted in increased inclusion of diversepopulations in some areas of health research [20, 21] butnot all [22]. Furthermore, sex and gender analysis to assesssimilarities or differences in health outcomes remains lim-ited [23]. In the Canadian federal context, neither HealthCanada’s 1997 Guidance Document on Inclusion ofWomen in Clinical Trials nor the more detailed May 2013document that replaced it, “Considerations for Inclusion ofWomen in Clinical Trials and Analysis of Sex Differences”[24], provide mechanisms to track implementation of thisguidance by researchers and sponsors of clinical trials inCanada to identify outcomes in relation to sex and genderconsiderations. In 2011, the Canadian Institutes of HealthResearch (CIHR) implemented a requirement that all re-search grant applicants indicate whether their researchproposal addresses sex and gender and to provide justifi-cation for their response [25, 26]. The preliminary resultsassessing the implementation of this policy indicate in-creased consideration of sex and gender in most categor-ies of research proposals [26], but the impact of the policyon the conduct and reporting of research, including ran-domized controlled trials (RCTs), has yet to be examined.The objective of this study was to provide a prelimin-ary assessment of the extent and nature of reportingabout sex and/or gender, including whether sex and gen-der analysis was carried out, in a sample of recently pub-lished Canadian RCTs with human participants.MethodsA collaborative research team (all authors on this paper)engaged in a deliberative, consensus building processand team meetings conducted to plan, develop, and con-duct a cross-sectional study to meet our objective.Consensus was reached on a data extraction form andmethods for the study. Our working definitions of sex andgender were adapted from the Canadian Institutes ofHealth Research, Canada’s health research funding agency,which recognizes sex and gender as analytically distinctbut interdependent concepts and which also acknowledgesthe nuances of sex and gender beyond the binary [27].For the purposes of our search, Canadian trials were de-fined as those that were either identified in the publicationas funded by a Canada-based funder and/or had a first orlast author with affiliation based in Canada. To accountfor the diverse nature of Canadian trials, which can in-volve cross-border and inter-sectoral collaborations, weincluded multi-centre trials, as well as trials funded jointlyby Canadian and international sources. We did not restrictinclusion on the basis of age (e.g., children, adolescents)or whether the trial focused on specific populations (in-cluding across sex and/or gender). We chose a sample sizeof 100 RCTs based on the sample size of other similarmethodological studies [23, 28, 29]. This sample size of100 trials will detect a proportion of 25% with a 95% con-fidence interval of ±8.5%.A search strategy was developed in consultation with alibrarian scientist (TR) to identify Canadian RCTs con-ducted with human participants. This strategy compriseda MEDLINE search using the OVID interface with thespecific filter (randomized controlled trial.pt OR random-ized controlled trial.mp) combined with Canadian prov-inces/territories (Quebec or Ontario or “Prince EdwardIsland” or New Brunswick or Nunavut or “NorthwestTerritories” or Nova Scotia or Newfoundland or Labradoror Yukon or British Columbia or Manitoba or Alberta orSaskatchewan).in OR (Canadian or Canada).in) from 01January 2013 to 23 July 2014. We chose to searchWelch et al. Research Integrity and Peer Review  (2017) 2:15 Page 2 of 11MEDLINE up to 1 year prior to data collection becausemost articles would be indexed according to Medical Sub-ject Headings by this time, allowing the use of the specificfilter for randomized trials.Two authors screened records independently (duplicatescreening) in order of date of publication, starting with themost recent, to identify those RCTs meeting eligibilitycriteria.A data extraction form was developed and pre-tested tocapture data on the type of intervention, study design(cluster or individually randomized trial), sample size, andfunding sources. We assessed whether sex and genderanalysis was conducted, what was done and how this wasreported, drawing from items in the PRISMA-Equity ex-tension [30] and the European Association of ScienceEditors (EASE) guidance [31]. Details on whether sex orgender were mentioned and in what context were col-lected from the title/abstract, introduction, methods, eligi-bility criteria, population characteristics, results, subgroupanalysis, interpretation of applicability, and discussion. Wealso collected data on reporting of social determinants ofhealth (e.g., socioeconomic status, occupation, place ofresidence) which will be reported in a separate paper(contact first author for details) (see Additional file 1:Appendix 1 for complete list of data extraction items).Data were independently extracted by two people from10% of the RCTs as a training exercise: once agreementwas reached on this sample [32] the remainder of the dataextraction was completed by one person (one of TB, LQ,and MY) and was verified by a second (one of JJ, VW).We included both primary publications of RCTs as wellas secondary publications (i.e., secondary analyses on RCTsthat had already been published). For 13 secondary publica-tions, we identified the primary RCT publication and usedthat as the basis for the data extraction, and supplementedwith information from the secondary publication. Second-ary publications were included because subgroup analysesare sometimes reported in secondary, follow-up publica-tions rather than in the primary trial report.ResultsSearch resultsThe search identified 1433 records. We screened 256 re-cords from the most recent to the oldest to identify thefirst 100 eligible RCTs. Of the ineligible records, 120were excluded because they were not RCTs or involvednon-human subjects. We also excluded 36 RCTs thatdid not have a Canadian funder or a first or last authorbased in Canada (Fig. 1).Description of the sampleInclusion criteriaCanadian funding was reported in 68/100 of the RCTs(68%), while the remaining 32 trials were eligible forinclusion in the sample on the basis of having a first or lastauthor based in Canada. Of these 32 trials, 13 were fundedby non-Canadian sources and 19 did not report on anysources of funding. Of the 81 RCTs that did report on fund-ing sources, 37 identified non-profit sources of funding; 22identified government sources (e.g., Canadian Institutes ofHealth Research, Health Canada); 10 indicated they weresolely funded by industry; while 8 RCTs identified a com-bination of non-profit and government sources; 2 identifiednon-profit and industry funding and 2 identified govern-ment and industry sources of funding (Additional file 2:Appendix 2).PopulationWe classified trials as “single-sex” and “mixed-sex”, basedon the terminology used by Gendered Innovations [33].Twelve RCTs were classified as single-sex studies becausethey had eligibility criteria that restricted participation towomen, one RCT enrolled girls and one RCT enrolledboys. The remainder of RCTs were classified as mixed-sexbecause they enrolled male and female participants.Eighty-five out of 88 mixed-sex RCTs reported the num-ber of enrolled male and female participants. For these,the median number of male participants was 45 (range 3–3843) and the median number of female participants was53 (range 1–1712). As shown in Table 1, the median sam-ple size of the 100 RCTs was 103 (range 20–1466) for sin-gle sex studies and 107 participants (range 12–6085) forFig. 1 Study flow chartWelch et al. Research Integrity and Peer Review  (2017) 2:15 Page 3 of 11Table1CharacteristicsofRCTs(n=100)StudycharacteristicsSingle-sexRCTs(n=12)Mixed-sexRCTs(n=88)Total(100)N(%)unlessotherwisespecifiedN(%)unlessotherwisespecifiedN(%)unlessotherwisespecifiedFirstauthorCanadian118899(99%)LastauthorCanadian128193(93%)Samplesize(randomized)103(median)Range(20–1466)107(median)Range(12–6085)107(median)range(12–6085)Reportsrecruitmentmethods7(58%)43(49%)50(50%)ClusterRCTs1(8%)8(9%)9(9%)TypeofinterventionPharmacological5(42%)32(36%)37(37%)Non-pharmacological7(58%)45(51%)52(52%)Surgical0(0%)6(7%)6(6%)Organizational0(0%)5(6%)5(5%)Multi-siteWithinCanada3(25%)24(27%)27(27%)OutsideofCanada(includesCanada)0(0%)13(15%)13(13%)OutsideofCanada(notincludingCanada)0(0%)1(1%)1(1%)RegionNRa0(0%)1(1%)1(1%)Single-siteWithinCanada8(67%)47(53%)55(55%)OutsideofCanada1(8%)1(1%)2(2%)RegionNR0(0%)1(1%)1(1%)CanadianfundingYes9(75%)59(67%)68(68%)No0(0%)13(15%)13(13%)NR3(25%)16(18%)19(19%)TypeoffundingNon-profit3(25%)34(39%)37(37%)Government4(33%)18(20%)22(22%)Industry0(0%)10(11%)10(10%)Non-profit+government2(17%)6(7%)8(8%)Non-profit+industry0(0%)2(2%)2(2%)Government+industry0(0%)2(2%)2(2%)Notreported3(25%)16(18%)19(19%)a NRnotreported.NoinformationwasprovidedWelch et al. Research Integrity and Peer Review  (2017) 2:15 Page 4 of 11mixed-sex studies. As noted, we did not restrict inclusionon the basis of age or focus on specific populations. Twotrials did not provide any information about the sex of thepopulation, referring to the population as patients ornurses/care aides.Multi- and single siteOf the 100 RCTs, 42 were reported as multi-site and 58were single-site RCTs. Not all trials provided informa-tion on the study site(s) (Table 1). In the subset ofmulti-site trials that did report information on site loca-tion, 27/42 (64%) were conducted entirely within Canadaand only one out of the remaining 15 included no siteswithin Canada. In single-site RCTs reporting location,the majority (55/58 or 95%) were conducted in Canada,2 RCTs were conducted in other countries but hadCanadian first or last authors and one RCT did not de-scribe site location.Types of interventionsThe interventions included in the sample of 100RCTs were highly diverse. These included 52 non-pharmacological interventions, such as rehabilitationtechniques, food supplements (e.g., canola oil andginseng), and cognitive behavior interventions; 37pharmacological interventions, (e.g., the use of simva-statin in hypertension); 6 surgical interventions, (e.g.,coronary artery bypass grafting); and 5 organizationalinterventions (e.g., simulation-based training for lap-aroscopic inguinal repair) (see complete list of in-cluded studies in Additional file 3: Appendix 3).Reporting of sex/gender in RCTsSex and gender terminology in RCTsThe terminology used by authors to describe the partici-pant demographic composition by “sex or gender” var-ied. For example, some trials used the term gender andsome used sex. No RCT provided or referenced a defin-ition of sex or gender or of sex and gender analysis. Nostudies reported on inclusion of gender diverse partici-pants (e.g., transgender, gender non-binary, or othergender identities). Similarly, no studies used the termcisgender or transgender to describe the populations.For this reason, reference to males and females in thisreview and in the source references is assumed to referto cisgender females and males according to Schilt andWestbrook’s (2009) definition of cisgender referring to“individuals who have a match between the gender theywere assigned at birth, their bodies, and their personalidentity” (p. 461) [34]. Because the RCTs varied in theuse of terms related to sex and gender, we use the ex-pression sex or gender to report the results.Reporting of sex or gender in the sample of RCTsNone of the RCT authors stated that they intended toconduct sex and gender analysis, nor did any do so.The extent to which sex or gender was reported acrossvarious sections of RCT publications varied consider-ably, as shown in Fig. 2. We provide examples of report-ing to illustrate each section.Title/abstract of RCTsIn the title or abstract, 19 (19%) RCTs reported on someaspect of sex or gender.Fig. 2 Reporting of sex and/or gender in RCTsWelch et al. Research Integrity and Peer Review  (2017) 2:15 Page 5 of 11Single-sex studies In the title or abstract, 11 out of 12(92%) single-sex RCTs reported some aspect of sex or gen-der. For four of these, the population was defined in thetitle. For example, “Effect of a Novel Movement Strategyin Decreasing ACL Risk Factors in Female AdolescentSoccer Players: A Randomized Controlled Trial” [35].Mixed-sex studies Eight out of 88 (9%) RCTs reportedon some aspect of sex or gender, and this was men-tioned only in the abstract.Background/rationale of RCTsIn the rationale or background section, sex or genderwas only mentioned in 11 (11%) of the RCTs. Single-sexstudies: 5 out of 12 single-sex RCTs (42%) reported onsex or gender in the background section. Three of theRCTs reported information on prevalence or importanceof a condition in subpopulations. Two of these studiesreported a rationale related to sex or gender.Mixed-sex studies Six out of 88 mixed-sex RCTs (7%)reported sex or gender information in the backgroundsection. One RCT reported information on prevalenceacross sex or gender. For example, one RCT stated that“…symptomatic knee OA (ed: osteoarthritis) occurs in10% of men and 13% of women ages 59 years(pg.1837)” [36]. Five RCTs reported a rationale related towhy the intervention might work differently across sexor gender or provided background evidence about differ-ential effects. For example, one study of compressiontechnologies for leg ulcer care stated in the backgroundthat, “women did more poorly according to one study,but two other studies found no significant effect of gen-der (pg. 1834)” [37]. Of these six studies, none reportanalyzing the effect of sex or gender but three RCTs dis-cuss applicability of results with regards to sex orgender.Eligibility criteria of RCTsSingle-sex studies All 12 single-sex RCTS described anexclusion based on sex or gender. Two of these 12 RCTs(1 with pharmacological intervention and 1 with non-pharmacological intervention) excluded pregnant/breast-feeding women.Mixed-sex studies Twenty-one of the 88 mixed-sex RCTs(24%) described exclusion criteria based on sex or gender.Twelve RCTs excluded pregnant/breastfeeding women, 1excluded women of child-bearing age, and 4 RCTs excludedboth pregnant women and women of childbearing age.Thirteen of these 17 RCTs evaluated pharmacological inter-ventions. For example, one pharmacological interventionusing “low (50 mg/day) or high (200 mg/day) dose ofLosartan” excluded “pregnant and lactating women”(pg.590) [38] and another using a “supplement with a high-dose micronutrient, mineral and antioxidant preparation(K-PAX UltraH) or an identically appearing 100% RDApreparation of multivitamins and minerals” had exclusioncriteria that included “HIV-2 infection alone, pregnancy ornot willing to practice barrier method of birth control” (pg.3) [39]. Of the remaining four RCTs that excluded preg-nant/breastfeeding women or women of child-bearing age,two RCTs were non-pharmacological interventions, onesurgical, and one organizational intervention. No studiesdiscuss the rationale or risk considerations for excluding onthe basis of pregnancy.Intervention description in RCTsOnly one mixed-sex RCT took sex or gender into ac-count when describing the characteristics of how anintervention was implemented. In that study, authors re-ported using a “male and female team” to present educa-tional sessions on managing side effects of androgendeprivation therapy (ADT) and the impact on couples[40]. The rationale provided was: “so that attendeeswould understand that the program was meant to serveequally the concerns of the male patient and the femalepartner (in heterosexual couples) (pg. 228)” [40].Description of participants in RCTsAlmost all RCTs (98%) reported demographic character-istics by sex or gender by identifying number of male/fe-male participants in text or as part of their demographictable describing baseline characteristics.Single-sex studies Six of the 12 single-sex RCTsused terms related to gender (men, women, boys) to re-port the population studied and the other six RCTs usethe terms male and/or female.Mixed-sex studies Fifteen of 88 RCTs used the termgender to describe the population and 16 RCTs used theterms ‘men/women’ to report the population demo-graphics. Eighty-six RCTs reported the populationdemographics according to sex or gender. As notedabove, two RCTs did not provide any description ofpopulation by sex but instead referred to participants as“patients” (n = 1) [41] or “nurses/care aides” (n = 1) [42].Statistical analysis of RCTs across sex or genderMixed-sex studies Twenty of the 88 RCTs (23%) re-ported analyses related to sex or gender in the methodssection, but none included a comprehensive sex andgender analysis across stages of the research process [6].These statistical methods included randomization strati-fied by sex or gender (3 RCTs) [43–45], adjusting for sexWelch et al. Research Integrity and Peer Review  (2017) 2:15 Page 6 of 11or gender as a covariate (11 RCTs) [37, 46–55] and sub-group analysis across sex or gender (6 RCTs) [56–61].The three trials which stratified randomization by sex orgender did not report subgroup analyses across sex or gen-der [43–45]. All 11 RCTs that described an intention toadjust for sex or gender as a variable, adjusted for or in-cluded sex or gender as a covariate in their analysis model.For the six RCTs that reported results of subgroup ana-lyses across sex or gender mentioned above, five RCTspre-specified the intention to conduct subgroup analysisby sex or gender in the methods section. Only four studiesprovided sex-disaggregated data across intervention andcomparator arms [51, 58, 60, 62]. For example, a studylooking at effects of Korean red ginseng provides themean and standard deviation of the outcome for eachintervention arm and control arm disaggregated for maleand female (pg. 166) [51]. Only one of the six studies thatconducted subgroup analyses discussed the treatment in-teractions by sex in their discussion of results [60].Discussion/conclusions of RCTsSingle-sex studies Seven of 12 RCTs reported on sex orgender in their discussion regarding applicability andimplications. For example, one study examining the ef-fect of zinc supplementation on copper status in boys re-ported that “… the results of this study are expected tobe generalizable to girls (pg. 288)” [63].Mixed-sex studies Eleven of the 88 RCTs reported onsex or gender implications of their findings. For example,one study stated that: “…although differences did not at-tain statistical significance, women were overrepresentedin the SBI (ed: spiritually based intervention) and the ex-tent to which findings can be fully extended to men is notclear (pg.504)” [64]. A study on colorectal cancer screen-ing concluded: “Our results confirm those reported in thatFOBT (ed: fecal occult blood test) uptake tends to increasewith age among men and women (pg.9)” [65].DiscussionWe found no examples of sex and gender analysis in a sam-ple of 100 Canadian-led or funded RCTs [24, 27, 66].Where sex and gender were considered, these consider-ations were often limited and mainly focused on biomedicalanalysis of differences across sex. For example, no studiesconsidered the influence of gender. Only 6% (six studies) ofour sample reported subgroup analyses across sex or gen-der. This was despite the fact that over 50% of our sampleof RCTs evaluated non-pharmacologic interventions suchas decision aids, cognitive therapy, self-help education tools,and community-based interventions where gender may playan important role in how the intervention is delivered (bywhom and in what context) and received. Furthermore, ofthe six RCTs with subgroup analysis, only one commentedin any depth on the methodological challenges of conduct-ing sub-group analysis or on the significance of their find-ings and implications for clinical practice. We also notedinconsistent use of terminology in some RCTs, with sex andgender being used without definition and sometimes inter-changeably. In RCTs, information on eligibility and recruit-ment forms is usually collected as “male/female”, and theuse of the term “gender” may be inaccurate. These findingsare consistent with those of recent studies looking at sex-related reporting in randomized trials published in majormedical journals [23, 67]. Clarity in the application of theconceptual constructs of sex and gender and of sex andgender analysis is an important component of scientificrigor and contributes to the growing understanding of theways that sex-based biological factors and gendered socialfactors are intertwined and interact with other social fac-tors, shaping health behavior, opportunities, and outcomes[5, 24, 68–70].The credibility and clinical importance of sex-basedsubgroup analyses must be carefully scrutinized sincethere is a risk of spurious findings due to under-poweredtests and multiple testing. A recent meta-synthesis foundthat statistically significant effects of sex on treatment re-sponse in randomized trials were rarely reported, andwhen they were, they were rarely confirmed in subsequenttrials or in meta-analyses, and very rarely led to a recom-mendation for differential treatment [71]. However, exam-ples where differential treatment has been recommended(e.g., weight management for men by Public HealthEngland [72], statin management [71], and differentialdosage recommendations based on a differential risk-benefit ratio for Ambien (Zolpidem) [73], justify the needfor sex and gender analysis in trials. The lack of data andanalysis about women and coronary heart disease (due toexclusion of women from some clinical trials) is postu-lated as one of the reasons for under-treatment of womenwith symptoms of ischaemic heart disease [74]. There is aneed for an improved evidence-base and for robust meth-odologies to determine differences and similarities of ef-fects across sex and gender [6].A variety of initiatives are attempting to address incon-sistent terminology and the lack of robust sex and genderanalysis in health research. For example, the Canadian In-stitutes of Health Research has published a casebook [66]and a tool for peer reviewers of grants and/or papers [27],a major advancement in promoting appropriate sex andgender analysis in research [75]. The SAGER (Sex andGender Equity in Research) guidelines were developed bythe Gender Policy Committee of the European Associ-ation of Science Editors (EASE) for reporting sex and gen-der in all types of science publications [31]. At the sametime, academic journals are putting in place editorial pol-icies that require sex-specific or gender-specific reportingWelch et al. Research Integrity and Peer Review  (2017) 2:15 Page 7 of 11[76]. Members of our team have recently developedreporting guidelines for health equity relevant RCTs, as anextension of the CONSORT statement (ConsolidatedReporting of Randomized Trials) [77] and briefing notesto improve the consideration of sex and gender in system-atic reviews [3]. All of these tools can be used by authorsof RCTs to improve reporting of sex and gender.More initiatives are needed to implement these andother tools and encourage their use to address the lackof sex and gender analysis in trials. Different strategiesmay be needed to tailor these initiatives for specific au-diences such as trialists, funders, journal editors, pa-tients/public, and policy-makers [78].Furthermore, in our study, there were no RCTs thatmentioned gender diverse populations. As knowledge ofsex and gender analysis develops, approaches to studydesign and analysis need to keep current with clear andconsistent terminology to support gender-sensitivedecision-making [6].This study examined reporting of sex, gender, and sexand gender analysis in a sample of Canadian RCTs, wheresectors of the funding environment are actively promotinginclusion of sex and gender analysis in all research [26].Although our study reviewed only a small cross-section ofCanadian RCTs, our findings suggest that despite policiesto encourage sex and gender analysis we are not yet seeingimpacts in terms of sex and gender reporting in RCTs anduptake of sex and gender analysis. Reporting sex and gen-der considerations in peer-reviewed publications is a keyindicator of whether policy efforts to mandate and en-courage sex and gender analysis are effective. Thus, it willbe important to continue to monitor changes in reportingover time to determine whether policy interventions aredelivering their intended outcomes and develop new ap-proaches for increasing skill level in the research andknowledge user communities.This preliminary study has a number of limitations. Thisstudy is limited to what is reported in the included RCTs.It is possible that the effects of sex and/or gender on re-sponse were tested in more studies but not reported. Also,this sample of RCTs includes relatively small RCTs (with amedian of 100 participants) and many of the studieswould be underpowered to detect differences in responseacross sex or gender. In the six RCTs which did conduct asubgroup analysis across sex or gender, we did not assessthe power for this analysis, nor the quality of these ana-lyses because we expected there to be too few studies withthese analyses to be generalizable to other situations. An-other limitation is that our definition of “Canadian” trialsmay have missed or under-selected multi-national trials.We did not collect whether the flow of participants wasreported according to gender (e.g., recruited, enrolled,completed), and this information would be important forconducting a sex and gender-based analysis. We also didnot contact authors to obtain any additional details aboutsex and gender analysis, methods, or results. As well, thefindings in this study may not be extrapolated to RCTsconducted primarily in other countries, due to the focuson Canadian RCTs, although some studies included mul-tiple non-Canadian sites [23, 79].ConclusionsThis survey of a sample of Canadian RCTs reveals very lit-tle analysis of differences or similarities in health out-comes across sex and/or gender, and no clear attempts onthe part of researchers to integrate elements of sex andgender analysis. Furthermore, there was no mention of in-clusion or exclusion of gender diverse people. This studyprovides a baseline and methodological approach to com-pare and assess changes in reporting about sex and genderand in the application of sex and gender analysis in futureCanadian RCTs, and adds to global and Canadian effortsto make the case for integrating sex and gender analysis inhealth research. This study demonstrates a need for con-tinued efforts to improve appropriate consideration andreporting of sex and gender and the integration of sex andgender analysis in randomized trials so that ultimatelyhealth services and policies address the needs of diversepopulations and improve health outcomes for all.Additional filesAdditional file 1: List of Data Extraction Items. (DOCX 19 kb)Additional file 2: List of Funding Sources. (DOCX 21 kb)Additional file 3: Table of Included Studies. (DOCX 49 kb)AbbreviationsCIHR: Canadian Institutes of Health Research; EASE: European Association ofScience Editors; NIH: National Institute of Health; PRISMA-Equity: PreferredReporting Items for Systematic Reviews and Meta-Analyses for equity-focused systematic reviews; RCT: Randomized controlled trialsAcknowledgementsWe would like to thank our funders and Theo Ambie who assisted with datacollection.FundingInstitute of Gender and Health, Canadian Institutes of Health Research,Planning Grant (#328296).Availability of data and materialsThe datasets generated during and/or analyzed during the current study areavailable from the corresponding author on reasonable request.Authors’ contributionsVW, MD, SEC, VR, ST, LP, BS, and MB conceptualized the cross-sectionalmethod study. MY, JJ, LQ, and TB extracted the data. TR contributed to thesearch strategy. MY, VW, JJ, and JP interpreted the data and wrote the initialmanuscript. All co-authors contributed to the planning and interpretation ofthe data through revisions of the manuscript. All authors read and approvedthe final manuscript.Ethics approval and consent to participateNot applicable.Welch et al. Research Integrity and Peer Review  (2017) 2:15 Page 8 of 11Consent for publicationNot applicable.Competing interestsThe authors declare that they have no competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Author details1Bruyère Research Institute, Bruyère Continuing Care, 304b-85 PrimroseAvenue, Ottawa, Ontario K1R 6 M1, Canada. 2University of Ottawa, Ontario,Canada. 3School of Nursing, University of British Columbia, T223-2211Wesbrook Mall, Vancouver, British Columbia V6T 2B5, Canada. 4OttawaHospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.5Research Sex/gender, Health Equity, Primary Care Consultant, 906 BowronCourt, North Vancouver, BC V7H 2S7, Canada. 6Department of Geographyand Planning, Queen’s University, Mackintosh-Corry Hall, Kingston, OntarioK7L 3 N6, Canada. 7Renison University College, University of Waterloo, 240Westmount Road North, Waterloo, Ontario N2L 3G4, Canada. 8CochraneMusculoskeletal, University of Ottawa, Ottawa Hospital Research Institute, TheOttawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON K1H 8L6,Canada. 9B.C. Women’s Hospital + Health Centre, E305, 4500 Oak Street,Vancouver, BC V6H 3E1, Canada. 10Department of Anesthesiology,Pharmacology & Therapeutics, Faculty of Medicine, University of BritishColumbia, 2176 Health Sciences Mall, Vancouver, BC V6T 1Z3, Canada.11Canadian Agency for Drugs and Technology in Health, 865 Carling Ave,Ottawa, Ontario, Canada. 12Globalization and Health Equity Research Unit,School of Epidemiology, Public Health and Preventive Medicine, University ofOttawa, 850 Peter Morand Crescent, Ottawa, Ontario K1G 5Z3, Canada.13Gender and Health Consultant, 161 Northwestern Avenue, Ottawa, OntarioK1Y 0 M1, Canada.Received: 29 March 2017 Accepted: 26 June 2017References1. Clayton JA, Collins FS. Policy: NIH to balance sex in cell and animal studies.Nature. 2014;509:282–3.2. Johnson JL, Beaudet A. Sex and gender reporting in health research: whyCanada should be a leader. Can J Public Health. 2013;104(1):e80–1.3. 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