Low rate of sex-specific result reporting in cardiovascular trials

Lori A. Blauwet; Sharonne N. Hayes; David Mcmanus; Rita F. Redberg; Mary Norine Walsh

doi:10.4065/82.2.166

Low rate of sex-specific result reporting in cardiovascular trials

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

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

68 Scopus citations

Abstract

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 optimise 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.

Original language	English (US)
Pages (from-to)	166-170
Number of pages	5
Journal	Mayo Clinic proceedings
Volume	82
Issue number	2
DOIs	https://doi.org/10.4065/82.2.166
State	Published - Feb 2007

ASJC Scopus subject areas

Medicine(all)

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10.4065/82.2.166

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@article{7581dcfd92a14050af85d4d3478a930a,

title = "Low rate of sex-specific result reporting in cardiovascular trials",

abstract = "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 optimise 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.",

author = "Blauwet, {Lori A.} and Hayes, {Sharonne N.} and David Mcmanus and Redberg, {Rita F.} and Walsh, {Mary Norine}",

note = "Funding Information: Sixty-one of the analyzed trials reported having received at least partial funding support from the NIH or the National Heart, Lung, and Blood Institute. Among such federally sponsored research, 31 (51%) of 61 trials provided sex-specific analysis compared with only 125 (22%) of 567 non-NIH-sponsored trials ( P <.001). A full 75% of the trials reviewed in the general medical journals were federally funded, which may account for the differences seen in SSR reporting between the general medical and cardiovascular journals. ",

year = "2007",

month = feb,

doi = "10.4065/82.2.166",

language = "English (US)",

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pages = "166--170",

journal = "Mayo Clinic Proceedings",

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T1 - Low rate of sex-specific result reporting in cardiovascular trials

AU - Blauwet, Lori A.

AU - Hayes, Sharonne N.

AU - Mcmanus, David

AU - Redberg, Rita F.

AU - Walsh, Mary Norine

N1 - Funding Information: Sixty-one of the analyzed trials reported having received at least partial funding support from the NIH or the National Heart, Lung, and Blood Institute. Among such federally sponsored research, 31 (51%) of 61 trials provided sex-specific analysis compared with only 125 (22%) of 567 non-NIH-sponsored trials ( P <.001). A full 75% of the trials reviewed in the general medical journals were federally funded, which may account for the differences seen in SSR reporting between the general medical and cardiovascular journals.

PY - 2007/2

Y1 - 2007/2

N2 - 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 optimise 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.

AB - 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 optimise 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.

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JO - Mayo Clinic Proceedings

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Low rate of sex-specific result reporting in cardiovascular trials

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