UBC Faculty Research and Publications

Gender-sensitive reporting in medical research Heidari, Shirin; Abdool Karim, Quarraisha; Auerbach, Judith D; Buitendijk, Simone E; Cahn, Pedro; Curno, Mirjam J; Hankins, Catherine; Katabira, Elly; Kippax, Susan; Marlink, Richard; Marsh, Joan; Marusic, Ana; Nass, Heidi M; Montaner, Julio; Pollitzer, Elizabeth; Ruiz-Cantero, Maria T; Sherr, Lorraine; Sow, Papa S; Squires, Kathleen; Wainberg, Mark A Mar 8, 2012

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COMMENTARY Open AccessGender-sensitive reporting in medical researchShirin Heidari1*, Quarraisha Abdool Karim2,3†, Judith D Auerbach4†, Simone E Buitendijk5†, Pedro Cahn6†,Mirjam J Curno1†, Catherine Hankins7†, Elly Katabira8†, Susan Kippax9†, Richard Marlink10,11†, Joan Marsh12†,Ana Marusic13†, Heidi M Nass14†, Julio Montaner15,16†, Elizabeth Pollitzer17†, Maria Teresa Ruiz-Cantero18†,Lorraine Sherr19†, Papa Salif Sow20†, Kathleen Squires21† and Mark A Wainberg22†AbstractSex and gender differences influence the health and wellbeing of men and women. Although studies have drawnattention to observed differences between women and men across diseases, remarkably little research has beenpursued to systematically investigate these underlying sex differences. Women continue to be underrepresented inclinical trials, and even in studies in which both men and women participate, systematic analysis of data to identifypotential sex-based differences is lacking. Standards for reporting of clinical trials have been established to ensureprovision of complete, transparent and critical information. An important step in addressing the gender imbalancewould be inclusion of a gender perspective in the next Consolidated Standards of Reporting Trials (CONSORT)guideline revision. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as a set of well-recognized and widely used guidelines for authors and biomedical journals, should similarly emphasize the ethicalobligation of authors to present data analyzed by gender as a matter of routine. Journal editors are also promotersof ethical research and adequate standards of reporting, and requirements for inclusion of gender analyses shouldbe integrated into editorial policies as a matter of urgency.Main textA person’s sex is an important health determinant. In avariety of instances, it has been shown that physiologicaldifferences between the sexes influence health outcomes.Genetic differences translate into distinct anatomy,result in variations in hormone production, and affectimmunological and inflammatory responses. Ultimately,these multiple factors influence the health and wellbeingof men and women, explaining the diverse demo-graphics and epidemiology of diseases, as well as distinc-tive responses to illness. In addition, there is a complexinterplay between innate physiological sex differencesand socioeconomic and behavioural gender differencesthat further affect health outcomes.Although studies have drawn attention to observeddifferences between women and men across diseases,few have been designed to specifically do so. Some ofthese patterns have been observed as early as duringfoetal development, where external influence isminimized. For example, female infants may be at a sub-stantially higher risk of acquiring HIV in utero thanmale infants, even after adjusting for confounders suchas mothers’ viral load and birth weight [1], and maleinfants seem more likely to be infected during breastfeeding [2].Similarly, women and men have been shown to dis-play disparate immunity and immunopathology inresponse to a series of microbial infections, indicating acomplex interaction between microbe-specific and gen-der-specific immune responses [3]. Autoimmune dis-eases, such as Systemic Lupus Erythematosus andrheumatoid arthritis, are more prevalent in women thanmen, and women more frequently reject allogeneicgrafts after cardiac transplantation, with higher post-operative mortality [4]. A set of gender differences hasalso been observed in chronic pain, with some condi-tions further influenced differentially by age [5].Remarkably little research has been pursued to sys-tematically investigate these underlying sex differences.For too long, medical research has turned a blind eye todifferences in disease prevalence, progression and clini-cal outcomes between women and men. Women* Correspondence: shirin.heidari@iasociety.org† Contributed equally1International AIDS Society, Geneva, SwitzerlandFull list of author information is available at the end of the articleHeidari et al. Journal of the International AIDS Society 2012, 15:11http://www.jiasociety.org/content/15/1/11© 2012 Heidari et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.continue to be underrepresented in clinical trials andare subject to medical practices based on data from apredominantly Caucasian male population [6]. Somewould even argue that medicine as it is practiced todayis less evidence-based for women than it is for men.Even in studies in which both men and women parti-cipate, systematic analysis of data to identify potentialsex-based differences is lacking. Similarly, editorial poli-cies in scientific journals requiring or encouraging gen-der analysis in reported research are more often theexception than the rule.Standards for reporting of clinical trials have beenestablished to ensure provision of complete and trans-parent critical information. The Consolidated Standardsof Reporting Trials (CONSORT) group came togetherin 1996 to provide uniform guidelines for accurate andadequate reporting of randomized clinical trials. Despitetwo revisions of the guidelines since its conception, theCONSORT statement fails to make any mention of sexand gender. Since the 2010 statement indicates that anaspiration of the group is to help improve design, con-duct and reporting of trials, an important step inaddressing the gender imbalance would be inclusion ofa gender perspective in the next CONSORT guidelinerevision [7,8]. Others including UNAIDS have alsorequested such an inclusion in the CONSORT state-ment revision [8].The International Committee of Medical Journal Edi-tors (ICMJE) defines standards for scientific reporting inits Uniform Requirements for Manuscripts Submitted toBiomedical Journals [9]. Fortunately, these do proposeanalyses of data by such variables as age and sex “wherescientifically appropriate”; this is an encouraging sugges-tion as the Uniform Requirements are a well-recognizedand widely used set of guidelines for authors and biome-dical journals. However, systematic provision of datadisaggregated by sex (and age) is not only desirable, butshould also be strongly recommended. ICMJE is cer-tainly in a position to emphasize the ethical obligationof authors to present data analyzed by sex as a matterof routine.Lately, there have been some positive developmentson gender inclusion in medical research, and a growingnumber of efforts recognize the gender gap in science.A recent European gender summit co-organized byGenSET network and the European Science Foundationand supported by the European Commission may beone of the most comprehensive gatherings to reviewgender inequality and its consequences for science todate [10,11]. Presentations at the meeting highlightedhow gender inequity becomes more pronounced as oneascends the academic career ladder, and how researchfalls short of ensuring that findings are relevant for sub-populations and will benefit both women and men. Datawere also presented on how gender diversification posi-tively stimulates innovation and productivity. The out-come of the summit was a manifesto signed by, amongothers, several science editors. The manifesto underlinesthat “the assertion that science is gender neutral is notthe case”, and calls for researchers, funding bodies,reviewers and journal editors to consider gender inresearch design, conduct and reporting [12].The Lancet took a positive step following the gendersummit in November 2011, when its editors introduceda very welcome policy, encouraging inclusion of sex andgender analysis in submitted manuscripts [13]. The Jour-nal of the International AIDS Society also has a policy tothis effect [14]. Our aspiration is that a similar policy beadopted across all scientific journals. Most importantly,however, we call on the ICMJE and CONSORT groupsto recognize the importance of systematic analysis andreporting of sex differences from trials and to ensurethat their guidelines introduce gender dimensions intheir checklists and flowcharts, and recommend inclu-sion of this parameter as a matter of routine in thereporting of clinical data on human subjects.Editors are often referred to as the gatekeepers ofscience, responsible for ensuring that what is publishedin scientific journals qualifies, both scientifically andethically, as contributions to the collective pool ofknowledge. Editors are also promoters of ethicalresearch and adequate standards of reporting. Require-ments for inclusion of gender analyses should not gounnoticed.Author details1International AIDS Society, Geneva, Switzerland. 2Centre for the AIDSProgramme of Research in South Africa, Nelson R Mandela School ofMedicine, University of KwaZulu-Natal, Durban, South Africa. 3Department ofEpidemiology, Columbia University, New York, NY, USA. 4IndependentScience and Policy Consultant, San Francisco, CA, USA. 5Leiden University,Leiden, The Netherlands. 6Fundación Huesped, Buenos Aires, Argentina.7Department of Infectious Disease Epidemiology, Faculty of Epidemiologyand Population Health, London School of Hygiene and Tropical Medicine,London, UK. 8Department of Research, Makerere Medical School, Kampala,Uganda. 9Social Policy Research Centre, University of New South Wales,Sydney, Australia. 10Harvard School of Public Health, Boston, MA, USA.11Elizabeth Glaser Pediatric AIDS Foundation, Los Angeles, CA, USA.12European Association of Science Editors; Wiley-Blackwell, InternationalHouse, London, UK. 13Department of Research in Biomedicine and Health,University of Split School of Medicine, Split, Croatia. 14Madison, WI, USA.15Division of AIDS, University of British Columbia, Vancouver, Canada. 16BCCentre for Excellence in HIV/AIDS, St. Paul’s Hospital, Providence Healthcare,Vancouver, Canada. 17Portia Ltd, London, UK. 18CIBERESP, University ofAlicante, Alicante, Spain. 19Department of Infection and Population Health,University College London, London, UK. 20Department of Infectious Diseases,University of Dakar, Dakar, Senegal. 21Jefferson Medical College of ThomasJefferson University, Philadelphia, USA. 22McGill University AIDS Centre,Jewish General Hospital, Montreal, QC, Canada.Authors’ contributionsSH wrote the first draft of the article. All other authors contributed equallyto the manuscript by providing comments on subsequent drafts. All authorshave read and approved the final version of this manuscript.Heidari et al. Journal of the International AIDS Society 2012, 15:11http://www.jiasociety.org/content/15/1/11Page 2 of 3Competing interestsSH is an employee of the International AIDS Society, and her salary isprovided partly by unrestricted educational grants from the followingpharmaceutical companies: Abbott, Boehringer Ingelheim, Gilead, Merck,Pfizer, Roche, Tibotec and ViiV Healthcare. PC has served as: Advisory BoardMember at Avexa, Gilead, GSK, Myriad, Merck, Pfizer, Pharmasset, ScheringPlough and Tibotec; Investigator at Avexa, Boehringer Ingelheim, Gilead,GSK, Roche, Merck, Pfizer, Pharmasset, Schering Plough, Tibotec, Abbott andBMS; Speaker (content and design performed by the speaker, no companycontrol) for Abbott, BMS, Boehringer Ingelheim, GSK, Merck, Pfizer andTibotec; and Scientific Advisor for Merck Sharp & Dohme, Pfizer, GSK, Avexaand Tibotec. He is not a shareholder in any pharmaceutical company, norhas he any commercial interest or investment in any pharmaceuticalcompany. RM has served as an advisor to the BMS Foundation and theMerck Company Foundation.JM is supported by the British Columbia Ministry of Health, through anAvant-Garde Award (No. 1DP1DA026182-01) from the National Institute ofDrug Abuse (NIDA), at the US National Institutes of Health, and through a KTAward from the Canadian Institutes of Health Research. He has also receivedfinancial support from the International AIDS Society, United Nations AIDSProgram, World Health Organization, National Institutes of Health Research-Office of AIDS Research, National Institute of Allergy & Infectious Diseases,the United States President’s Emergency Plan for AIDS Relief, the Bill &Melinda Gates Foundation, French National Agency for Research on AIDS &Viral Hepatitis, the Public Health Agency of Canada, the University of BritishColumbia, Simon Fraser University, Providence Health Care and VancouverCoastal Health Authority. He has received grants from Abbott, Biolytical,Boehringer-Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merckand ViiV Healthcare. QAK, JDA, SEB, MJC, CH, EK, SK, JM, AM, HMN, EP, MTR-C, LS, PSS, KS, MAW have no competing interests to declare.The opinions expressed in this article are those of the authors and do notnecessarily reflect those of their respective organizations.Received: 3 March 2012 Accepted: 8 March 2012Published: 8 March 2012References1. Taha TE, Nour S, Kumwenda NI, Broadhead RL, Fiscus SA, Kafulafula G,Nkhoma C, Chen S, Hoover DR: Gender differences in perinatal HIVacquisition among African infants. Pediatrics 2005, 115:e167-e172.2. Sherr L, Mueller J, Varrall J: Evidence-based gender findings for childrenaffected by HIV and AIDS - a systematic overview. AIDS Care 2009,21(S1):83-97.3. McClelland EE, Smith JM: Gender specific differences in the immuneresponse to infection. Arch Immunol Ther Exp 2011, 59(3):203-213.4. Shumway S: Transplant and ventricular assist devices: Gender differencesin application and implementation. J Thorac Cardiovasc Surg 2004,127(5):1253-1255.5. Greenspan JD, Craft RM, LeResche L, Arendt-Nielsen L, Berkley KJ,Fillingim RB, Gold MS, Holdcroft A, Lautenbacher S, Mayer EA, Mogil JS,Murhpy AZ, Traub RJ, the Consensus Working Group of the Sex, Gender,and PAIN SIG of the ISAP: Studying sex and gender differences in painand analgesia: A consensus report. Pain 2007, 132(S26).6. d’Arminio Monforte A, González L, Haberl A, Sherr L, Ssanyu-Sseruma W,Walmsley SL: Women for Positive Action. Better mind the gap:addressing the shortage of HIV-positive women in clinical trials. AIDS2010, 24(8):1091-1094.7. Schulz KF, Altman DG, Moher D, for the CONSORT Group: CONSORT 2010statement: updated guidelines for reporting parallel group randomisedtrials. PLoS Med 2010, 7(3):e1000251.8. Elisa Chilet- Rosell and Teresa Ruiz- Cantero, CONSORT Statement 2010:What about the gender perspective? [http://www.annals.org/content/152/11/726.full/reply#annintmed_el_124620].9. Uniform Requirements for Manuscripts Submitted to Biomedical Journals:Writing and Editing for Biomedical Publication 2010 [http://www.icmje.org/urm_full.pdf].10. Marsh J: Women in science - what’s the world missing? European ScienceEditing 2012, 38(1):2.11. Heidari S, Marsh J: Gender issues in science publications. European ScienceEditing 2012, 38(1):13.12. Gender manifesto: Manifesto for Integrated Action on the Gender Dimensionin Research and Innovation [http://www.gender-summit.eu/index.php].13. Taking sex into account in medicine. Lancet 2011, 378(9806):1826.14. Heidari S, Eckert MJ, Kippax S, Karim QA, Sow P, Wainberg MA: Time forgender mainstreaming in editorial policies. J Int AIDS Soc 2011, 14:11.doi:10.1186/1758-2652-15-11Cite this article as: Heidari et al.: Gender-sensitive reporting in medicalresearch. Journal of the International AIDS Society 2012 15:11.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitHeidari et al. Journal of the International AIDS Society 2012, 15:11http://www.jiasociety.org/content/15/1/11Page 3 of 3


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