Do Treatment Recommendations Reported in the Research Literature Consider Differences Between Women and Men?

This survey was designed to determine to what extent treatment recommendations reported in research studies published in major medical journals examine or acknowledge potential differences between women and men in response to treatment. Secondary goals were to define how often data analysis by gender was reported and how results compared from 1990 and 1994 publications. All original articles published in The New England Journal of Medicine, the Journal of the American Medical Association, and the Annals of Internal Medicine, January through June 1990 and 1994 (n = 721) were examined, and 106 intervention and treatment studies with >50 subjects were selected for review. Prospective treatment and intervention studies (including randomized clinical trials) with at least two experimental groups or a control group and intervention groups were included. Two independent reviewers reviewed article demographics, disease studied, number and gender of subjects, whether data were analyzed by gender, gender results discussed if data analyzed by gender, gender results discussed if data not analyzed by gender (yes/no), and treatment recommendations gender-neutral (always/sometimes/never). Descriptive statistics were used. Among studies with female and male subjects (1990, n = 31; 1994, n = 45), only 19% (n = 6) of the 1990 studies and 24% (n = 11) of the 1994 studies reported any data analysis by gender despite the fact that 40% of the subjects were female. If there was any evidence of data analysis by gender, there was a greater probability that gender would be discussed. No studies in 1990 and only one study in 1994 made treatment recommendations acknowledging any potential gender differences. When studies from 1990 and 1994 were compared, no significant differences on any of the measured variables were detected. Despite improvement in research design and federal requirements, which may ensure representative numbers of women within research studies, the differential responses of women and men to intervention and treatment protocols are still not routinely discussed in the recommendations of published research studies.