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Low Rate of Sex-Specific Result Reporting in Cardiovascular Trials

2007; Elsevier BV; Volume: 82; Issue: 2 Linguagem: Inglês

10.1016/s0025-6196(11)60993-2

1942-5546

Lori A. Blauwet, Sharonne N. Hayes, David D. McManus, Rita F. Redberg, Mary Norine Walsh,

Health and Medical Research Impacts

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<.001). CONCLUSION 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. To explore the extent to which sex-specific result (SSR) reporting appears in recently published cardiovascular studies. 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. 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<.001). 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.