Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study

doi:10.1186/s41073-017-0039-6

. 2017 Sep 1:2:15.

doi: 10.1186/s41073-017-0039-6. eCollection 2017.

Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study

V Welch^{1

2}, M Doull³, M Yoganathan¹, J Jull⁴, M Boscoe⁵, S E Coen⁶, Z Marshall⁷, J Pardo Pardo⁸, A Pederson⁹, J Petkovic^{1

2}, L Puil¹⁰, L Quinlan¹, B Shea^{1

2}, T Rader¹¹, V Runnels¹², S Tudiver¹³

Affiliations

¹ 1Bruyère Research Institute, Bruyère Continuing Care, 304b-85 Primrose Avenue, Ottawa, Ontario K1R 6 M1 Canada.
² 2University of Ottawa, Ontario, Canada.
³ 3School of Nursing, University of British Columbia, T223-2211 Wesbrook Mall, Vancouver, British Columbia V6T 2B5 Canada.
⁴ 4Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario Canada.
⁵ Research Sex/gender, Health Equity, Primary Care Consultant, 906 Bowron Court, North Vancouver, BC V7H 2S7 Canada.
⁶ 6Department of Geography and Planning, Queen's University, Mackintosh-Corry Hall, Kingston, Ontario K7L 3 N6 Canada.
⁷ 7Renison University College, University of Waterloo, 240 Westmount Road North, Waterloo, Ontario N2L 3G4 Canada.
⁸ Cochrane Musculoskeletal, University of Ottawa, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON K1H 8L6 Canada.
⁹ 9B.C. Women's Hospital + Health Centre, E305, 4500 Oak Street, Vancouver, BC V6H 3E1 Canada.
¹⁰ 10Department of Anesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, University of British Columbia, 2176 Health Sciences Mall, Vancouver, BC V6T 1Z3 Canada.
¹¹ Canadian Agency for Drugs and Technology in Health, 865 Carling Ave, Ottawa, Ontario Canada.
¹² 12Globalization and Health Equity Research Unit, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, 850 Peter Morand Crescent, Ottawa, Ontario K1G 5Z3 Canada.
¹³ Gender and Health Consultant, 161 Northwestern Avenue, Ottawa, Ontario K1Y 0 M1 Canada.

PMID: 29451565
PMCID: PMC5803639
DOI: 10.1186/s41073-017-0039-6

Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study

V Welch et al. Res Integr Peer Rev. 2017.

. 2017 Sep 1:2:15.

doi: 10.1186/s41073-017-0039-6. eCollection 2017.

Authors

Affiliations

¹ 1Bruyère Research Institute, Bruyère Continuing Care, 304b-85 Primrose Avenue, Ottawa, Ontario K1R 6 M1 Canada.
² 2University of Ottawa, Ontario, Canada.
³ 3School of Nursing, University of British Columbia, T223-2211 Wesbrook Mall, Vancouver, British Columbia V6T 2B5 Canada.
⁴ 4Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario Canada.
⁵ Research Sex/gender, Health Equity, Primary Care Consultant, 906 Bowron Court, North Vancouver, BC V7H 2S7 Canada.
⁶ 6Department of Geography and Planning, Queen's University, Mackintosh-Corry Hall, Kingston, Ontario K7L 3 N6 Canada.
⁷ 7Renison University College, University of Waterloo, 240 Westmount Road North, Waterloo, Ontario N2L 3G4 Canada.
⁸ Cochrane Musculoskeletal, University of Ottawa, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON K1H 8L6 Canada.
⁹ 9B.C. Women's Hospital + Health Centre, E305, 4500 Oak Street, Vancouver, BC V6H 3E1 Canada.
¹⁰ 10Department of Anesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, University of British Columbia, 2176 Health Sciences Mall, Vancouver, BC V6T 1Z3 Canada.
¹¹ Canadian Agency for Drugs and Technology in Health, 865 Carling Ave, Ottawa, Ontario Canada.
¹² 12Globalization and Health Equity Research Unit, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, 850 Peter Morand Crescent, Ottawa, Ontario K1G 5Z3 Canada.
¹³ Gender and Health Consultant, 161 Northwestern Avenue, Ottawa, Ontario K1Y 0 M1 Canada.

PMID: 29451565
PMCID: PMC5803639
DOI: 10.1186/s41073-017-0039-6

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Canada; Gender; Quality; Randomized controlled trials as a topic; Sex/gender analysis.

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Conflict of interest statement

Not applicable.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 2**
Reporting of sex and/or gender in RCTs

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[1] Clayton JA, Collins FS. Policy: NIH to balance sex in cell and animal studies. Nature. 2014;509:282–3. doi: 10.1038/509282a. - DOI - PMC - PubMed

[2] Clayton JA, Collins FS. Policy: NIH to balance sex in cell and animal studies. Nature. 2014;509:282–3. doi: 10.1038/509282a. - DOI - PMC - PubMed

[3] Johnson JL, Beaudet A. Sex and gender reporting in health research: why Canada should be a leader. Can J Public Health. 2013;104(1):e80–1. - PMC - PubMed

[4] Johnson JL, Beaudet A. Sex and gender reporting in health research: why Canada should be a leader. Can J Public Health. 2013;104(1):e80–1. - PMC - PubMed

[5] Doull M, Welch V, Puil L, Runnels V, Coen SE, Shea B, O'Neill J, Borkhoff C, Tudiver S, Boscoe M. Development and evaluation of ‘briefing notes’ as a novel knowledge translation tool to aid the implementation of sex/gender analysis in systematic reviews: a pilot study. PLoS One. 2014;9(11):e110786. doi: 10.1371/journal.pone.0110786. - DOI - PMC - PubMed

[6] Doull M, Welch V, Puil L, Runnels V, Coen SE, Shea B, O'Neill J, Borkhoff C, Tudiver S, Boscoe M. Development and evaluation of ‘briefing notes’ as a novel knowledge translation tool to aid the implementation of sex/gender analysis in systematic reviews: a pilot study. PLoS One. 2014;9(11):e110786. doi: 10.1371/journal.pone.0110786. - DOI - PMC - PubMed

[7] Krieger N. Genders, sexes, and health: what are the connections—and why does it matter? Int J Epidemiol. 2003;32(4):652–7. doi: 10.1093/ije/dyg156. - DOI - PubMed

[8] Krieger N. Genders, sexes, and health: what are the connections—and why does it matter? Int J Epidemiol. 2003;32(4):652–7. doi: 10.1093/ije/dyg156. - DOI - PubMed

[9] Springer KW, Mager Stellman J, Jordan-Young RM. Beyond a catalogue of differences: a theoretical frame and good practice guidelines for researching sex/gender in human health. Soc Sci Med. 2012;74(11):1817–1824. doi: 10.1016/j.socscimed.2011.05.033. - DOI - PubMed

[10] Springer KW, Mager Stellman J, Jordan-Young RM. Beyond a catalogue of differences: a theoretical frame and good practice guidelines for researching sex/gender in human health. Soc Sci Med. 2012;74(11):1817–1824. doi: 10.1016/j.socscimed.2011.05.033. - DOI - PubMed

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Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study

Affiliations

Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study

Authors

Affiliations

Abstract

Conflict of interest statement

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