Article type
Year
Abstract
Introduction/Objective: To assess the reporting of data on women in recently published trials of drug therapy for myocardial infarction (MI) including those funded by agencies with a gender-related policy.
Methods: Data Sources and Study Selection: All randomized control trials (RCTs), including meta-analyses, of drug therapies for MI published in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, The Annals of Internal Medicine, The British Medical Journal from 1992 through 1996. A total of 102 abstracts appeared to meet our inclusion criteria and these were obtained and reviewed in further detail. After further review, 59 were excluded. Data Extraction: Two reviewers independently extracted information about gender from the 43 articles. Discrepancies were resolved in a consensus conference. Data synthesis: Sixteen percent (n=7) of the articles summarised the findings of studies funded by an agency with a gender-related policy which was the U.S. National Institutes of Health.
Results: Overall, women represented 0 to 48% of the trial participants (average 24.1%) compared to 16.8% of participants in articles funded by agencies with a gender-related policy. Only 14 of 43 (32.5%) articles provided gender-related results, 2 of which were secondary analyses where gender was the major outcome of interest. Excluding these 2 secondary analyses, 12 articles presented subgroup analyses of which 7 (16.3%) conducted an interaction analysis to determine if women responded differently than men with regard to the major outcomes. Only 5 articles made any mention of gender in the discussion, 2 of which were reporting on secondary analyses with gender as the main focus.
Discussion: Our findings suggest that RCTs published in leading general medical journals poorly represent women irrespective of whether the trial was funded by an agency with a gender-related policy. Structured reporting of gender-related information of clinical trials may improve the quality of information available on therapies to treat women.
Methods: Data Sources and Study Selection: All randomized control trials (RCTs), including meta-analyses, of drug therapies for MI published in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, The Annals of Internal Medicine, The British Medical Journal from 1992 through 1996. A total of 102 abstracts appeared to meet our inclusion criteria and these were obtained and reviewed in further detail. After further review, 59 were excluded. Data Extraction: Two reviewers independently extracted information about gender from the 43 articles. Discrepancies were resolved in a consensus conference. Data synthesis: Sixteen percent (n=7) of the articles summarised the findings of studies funded by an agency with a gender-related policy which was the U.S. National Institutes of Health.
Results: Overall, women represented 0 to 48% of the trial participants (average 24.1%) compared to 16.8% of participants in articles funded by agencies with a gender-related policy. Only 14 of 43 (32.5%) articles provided gender-related results, 2 of which were secondary analyses where gender was the major outcome of interest. Excluding these 2 secondary analyses, 12 articles presented subgroup analyses of which 7 (16.3%) conducted an interaction analysis to determine if women responded differently than men with regard to the major outcomes. Only 5 articles made any mention of gender in the discussion, 2 of which were reporting on secondary analyses with gender as the main focus.
Discussion: Our findings suggest that RCTs published in leading general medical journals poorly represent women irrespective of whether the trial was funded by an agency with a gender-related policy. Structured reporting of gender-related information of clinical trials may improve the quality of information available on therapies to treat women.