Professional Documents
Culture Documents
EDITORIAL
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
EDITORIAL
active recruitment and enrollment of participants, and should explain why only subjects of certain ages were
women have been shown to have different, and frequently included or why women were excluded. The guiding prin-
more, barriers to participation in trials than men.6 Random- ciple should be clarity about how and why a study was done
ized clinical trials are considered the best type of scientific in a particular way.”8 Perhaps it is time for this recommen-
evidence, to which observational studies are an important dation to be made a mandate and for journal editors to
complement. After we have answered the experimental either require that manuscripts include sex-specific data to
question about the efficacy of a particular therapy or be considered for review or at least to make such data
procedure in the more idealized randomized trial setting, available online. The “author information” section of Cir-
observational data tell us about its benefit and effective- culation suggests providing “sex-specific and/or racial/
ness in the “real world.” To ensure high-quality evidence- ethnic-specific data when appropriate, in describing the
based health care, we must not only include adequate outcomes of epidemiologic analyses or clinical trials; or
numbers of men and women in research but report SSRs specifically state that no sex-based or racial/ethnic-based
also. This practice is especially important for large obser- differences were present.”9 The Journal of the American
vational studies, as results can help inform our clinical College of Cardiology uses nearly identical wording,10
practice. but substitutes “gender-specific” for “sex-specific.” How-
The data reported by Rogers and Ballantyne on the ever, this requirement is not emphasized to submitting
current state of sex-specific reporting show there is much authors or to journals’ peer reviewers and is not a consis-
room for improvement. Of the studies of men and women tent practice in recent publications, even when female
reviewed, 93% did not provide sex-specific analysis. It is participants are included in sufficient numbers to provide
disappointing to find that, as recently as 2006, sex-specific this reporting.9,10
reporting and rates of inclusion of women in clinical trials It is time to recognize that women are complex biologi-
were still appallingly low. In fact, in large trials involving cal creatures just as are men. All clinical studies should
the study of pharmaceuticals, the percentage of sex-spe- strive to include equal numbers of female and male partici-
cific reporting was a dismal zero. pants or to at least reflect the prevalence of the condition of
We observed the same phenomenon in a recent review interest by sex. In older populations, this could appropri-
of cardiology clinical trials where only 25% of all studies ately include a preponderance of women. A recent analysis
reported results by sex.7 As heart disease is the leading of clinical trials used for Medicare national coverage deci-
cause of death in women, it is dismaying that data from sions found that, although 58% of Medicare beneficiaries
cardiovascular clinical trials are so limited. Unexpected sex- are women, women make up only 25% of participants in
based differences have been found in the epidemiology the clinical trials reviewed.11 Until we are able to make this
of many diseases, such as lung cancer, other non–sex- leap, women will continue to be marginalized in clinical
specific cancers, degenerative joint disease, and depression trials of diseases that affect them in numbers equal to men.
and mental health disorders, leading us to conclude that We hope that this editorial and the work that has pre-
the lack of sex differences should not be assumed and ceded it serve as a clarion call to researchers, authors,
instead must be systematically studied. Further, we agree reviewers, and journal editors to include sex-specific re-
with Rogers and Ballantyne that, because of reporting that porting in all clinical trials that include more than 50 par-
is inconsistent or lacking, these types of analyses to as- ticipants. Analyzing data by sex for conditions or treat-
sess levels of SSRs are quite cumbersome and require ments affecting both men and women is the only way we
intensive literature review and data analysis when done will be able to begin to provide optimal care for all patients
after publication. and is a critical step toward the ultimate goal of “individu-
Heightened awareness among investigators, authors, re- alized medicine.”
viewers, and journal editors of the importance of enrolling
and reporting data for both men and women in clinical Sharonne N. Hayes, MD
trials will inform efforts to achieve optimal care of all Division of Cardiovascular Diseases
patients. The International Committee of Medical Journal Women’s Heart Clinic
Editors8 recommends that investigators describe their se- Mayo Clinic
lection of study participants, including controls, clearly Rochester, MN
(eg, eligibility, exclusion criteria, description of the source
population). The committee states, “Because the relevance Rita F. Redberg, MD, MSc
of such variables as age and sex to the object of research is Division of Cardiology
not always clear, authors should explain their use when Women’s Cardiovascular Services
they are included in a study report; for example, authors University of California, San Francisco
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
EDITORIAL
1. Public Health Service Task Force on Women’s Health Issues. Women’s 7. Blauwet LA, Hayes SN, McManus DN, Redberg RF, Walsh MN. Low
Health: Report of the Public Service Task Force on Women’s Health Issues. rate of sex-specific result reporting in cardiovascular trials. Mayo Clin Proc.
Public Health Rep. 1985;100(1):73-106. 2007;82(2):166-170.
2. US Department of Health and Human Services. NIH Guide for Grants 8. International Committee of Medical Journal Editors. Uniform Require-
and Contracts. Vol 19, No. 28; July 27, 1990. http://grants.nih.gov/grants ments for Manuscripts Submitted to Biomedical Journals: Writing and Edit-
/guide/historical/1990_07_27_Vol_19_No_28.pdf. Accessed March 31, 2008. ing for Biomedical Publication. http://www.icmje.org/. Accessed March 31,
3. US Department of Health and Human Services, National Institutes of 2008.
Health. NIH guidelines on the inclusion of women and minorities as subjects in 9. Kosiborod M, Inzucchi SE, Krumholz HM, et al. Glucometrics in pa-
clinical research. Federal Register. 1994;59:14508-14513. http://www.hhs tients hospitalized with acute myocardial infarction: defining the optimal out-
.gov/ohrp/humansubjects/guidance/59fr14508.htm. Accessed March 31, 2008. comes-based measure of risk. Circulation. 2008 Feb 26;117(8):1018-1027.
4. Institute of Medicine (US) Committee on Understanding the Biology of Epub 2008 Feb 11.
Sex and Gender Differences. Wizemann TM, Pardue M-L, eds. Exploring the 10. Lee SW, Park SW, Kim YH, et al. Drug-eluting stenting followed by
Biological Contributions to Human Health: Does Sex Matter? Washington, cilostazol treatment reduces late restenosis in patients with diabetes mellitus:
DC: National Academy Press; 2001. the DECLARE-DIABETES Trial (A Randomized Comparison of Triple Anti-
5. Rogers WA, Ballantyne AJ, Australian Gender Equity in Health Re- platelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent
search Group. Exclusion of women from clinical research: myth or reality? Implantation in Diabetic Patients). J Am Coll Cardiol. 2008;51(12):1181-
Mayo Clin Proc. 2008;83:536-542. 1187.
6. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers 11. Dhruva SS, Redberg RF. Variations between clinical trial participants
to participation in randomised controlled trials: a systematic review. J Clin and Medicare beneficiaries in evidence used for Medicare national coverage
Epidemiol. 1999;52(12):1143-1156. decisions. Arch Intern Med. 2008;168(2):136-140.
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.