Women's Health Issues
Volume 17, Issue 6 , Pages 342-350 , November 2007

Sex and Gender Subgroup Analyses of Randomized Trials: The Need to Proceed With Caution

  • Amandev K. Aulakh, BHSc

      Affiliations

    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
    • Amandev Aulakh is a Masters Student in Health Research Methodology at McMaster University and is supported by a CIHR-HSFO CARING Network Masters Studentship.
    • ,
  • Sonia S. Anand, MD, PhD, FRCPc

      Affiliations

    • Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
    • Department of Medicine, McMaster University, Hamilton, Ontario, Canada
    • Doctor Sonia Anand is a recipient of a Canadian Institutes of Health Research (CIHR) Clinician-Scientist Award (Phase 2) and is the Eli Lilly May Cohen Chair in Women’s Health at McMaster University.
    • Corresponding Author InformationCorrespondence to: Dr. Sonia Anand, The CARING Network, MDCL Rm. 3500, McMaster University, 1200 Main Street West, Hamilton, Ontario, Canada L8N 3Z5. Phone: 905-527-4322, ext 44557; fax: 905-577-1490.

Received 20 July 2006 ,Accepted 16 April 2007.

References 

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  9. Kapral MK, Wang H, Austin PC, Fang J, Kucey D, Bowyer B, et al. Sex differences in carotid endarterectomy outcomes: Results from the Ontario carotid endarterectomy registry. Stroke. 2003;34:1120–1125
  10. Lippman A. The inclusion of women in clinical trials: Are we asking the right questions? (Women and Health Protection). 2006;Available: www.whp-apsf.ca/pdf/clinicalTrialsEN.pdf. Retrieved January 12, 2007
  11. Mattos MA, Sumner DS, Bohannon WT, Parra J, McLafferty RB, Karch LA, et al. Carotid endarterectomy in women: Challenging the results from ACAS and NASCET. Annals of Surgery. 2001;234:438–446
  12. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. 1994;Available: http://grants.nih.gov. Retrieved March 10, 2006
  13. Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. The New England Journal of Medicine. 2005;352:1293–1304
  14. The Canadian Cooperative Study Group. A randomized trial of aspirin and sulfinpyrazone in threatened stroke. The New England Journal of Medicine. 1978;299:53–59
  15. World Health Organization. What do we mean by “sex” and “gender”?. 2006;Available: www.who.int/gender/whatisgender/en/. Retrieved May 9, 2006
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PII: S1049-3867(07)00060-6

doi: 10.1016/j.whi.2007.04.002

Women's Health Issues
Volume 17, Issue 6 , Pages 342-350 , November 2007

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