Low rate of sex-specific result reporting in cardiovascular trials.
OBJECTIVE
To explore the extent to which sex-specific result (SSR) reporting appears in recently published cardiovascular studies.


METHODS
All original adult cardiovascular clinical trials published in Annals of Internal Medicine, Archives of Internal Medicine, Journal of the American Medical Association, The New England Journal of Medicine, Journal of the American College of Cardiology, The American Journal of Cardiology, and Circulation from July 1 through December 31, 2004, were reviewed. Sex-specific result reporting was defined as presenting primary outcomes for women in a format to allow the data to be abstracted for use in a meta-analysis.


RESULTS
Of the 645 studies reviewed, 17 were excluded because they were appropriately single-sex trials. Of the remaining 628 studies, only 153 (24%) provided SSRs. The percentage of studies reporting SSRs was 37% (23/62) for general medical journals and 23% (130/566) for cardiovascular journals (P = .10). Among National Institutes of Health (NIH)-sponsored research, 31 (51%) of 61 trials analyzed outcomes by sex compared with 125 (22%) of 567 trials not sponsored by the NIH (P < .01).


CONCLUSIONS
Only a few current cardiovascular trials provide sex-specific data. Sex differences remain poorly understood, and this deficiency limits our ability to optimize medical care for both sexes. The stipulation that SSRs be investigated has led to significantly more SSR reporting in NIH-funded research. A parallel mandate by journal editors that requires authors to provide sex-specific data and analysis may help to bridge this knowledge gap.
Blauwet
Lori A
LA
Division of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, Minn 55905, USA. blauwet.lori@mayo.edu
Hayes
Sharonne N
SN
McManus
David
D
Redberg
Rita F
RF
Walsh
Mary Norine
MN
D000328:Adult; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000628:therapy; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D035081:Editorial Policies; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D010506:Periodicals as Topic; D017410:Practice Guidelines as Topic; D012107:Research Design / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data*; D017678:Sex Distribution; D016896:Treatment Outcome