Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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17 Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992
17 Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992
Pages 151-173
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From page 151... ...
at the National Institutes of Health in September 1990 "to develop special initiatives to acquire vitally needed research data on women by increasing the participation both of women as subjects in clinical trials research and of institutions and investigators in performing research related to the health of women" (ORWH, 1991:67~. Nevertheless, since the majority of medical studies which have an important bearing on clinical practice are not based on clinical Dials, a thorough examination of women's representation in medical research needs to include the range of medical studies.
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The FDA has altered its policy that excluded most women with "childbearing potential" from the earliest phases of clinical trials. In addition, the FDA will provide formal guidance to drug developers emphasizing the need for women to be appropriately represented in clinical studies.
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Thus, findings of no significant gender differences are also important to women's medical care. Published medical studies provide the most credible scientific basis by which clinicians learn to treat their patients.
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These categories correspond roughly to the stringency with which the articles incorporate gender information.2 (Hereafter, the term "outcome" refers broadly to the dependent variables in the studies examined.) Study design was coded as follows: randomized controlled trial (including both placebo controlled trials and crossover studies)
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Articles that did not fit primarily into one internal medicine category were classified as health services research if the article examined issues of access to care, quality of care, practice guidelines, resource use, effects of insurance type, small area variation in treatment, or outcomes for multiple types of diseases. For example, one article examined small area variation in coronary angiography, carotid endarterectomy, and upper gastrointestinal endoscopy.
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ANALYSIS First, to determine whether women have been excluded from medical studies, we examine the distribution of single-gender studies by whether or not the disease studied is gender-specific and, if not, the apparent rationale for using a single-gender population. Second, to evaluate the broader issue of whether women have been underrepresented in medical studies, we examine women's representation in studies of non-gender-specific diseases using turo definitions of "underrepresentation ofgendei': (1)
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Table 1. Distribution of Articles Examining Only One Gender Men N % Gender-specific diseasesa 12 26.1 Non-gender-specific 34 73.9 diseases Women N % 24 66.7 12 33.3 Total 46 100.0 36 100.0 tone of the studies categorized as male gender specific examined anal intraepithelial neoplasia and anal papillomivirus among male homosexuals with group IV HIV.
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Partial explanations for this imbalance were that 53 percent of all studies for which convenience was the primary basis examined the almost exclusively male veteran population and another 24 percent of these studies consisted of secondary analyses of single-gender studies which tended to be allmale. Table 2.
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For all three types of designs, about 50 percent of the studies had samples with women representing between one-third and two-thirds of the subjects. Women were excluded from 6.8 percent of the cross-sectional studies, 18.0 percent of the longitudinal studies, and 25.0 percent of the random controlled trials.
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Using We lenient definition of underrepresentation, this ratio was 2.5 for cross-sectional studies, 2.8 for longitudinal studies, and 3A for random controlled trials. Using either definition, Me women were most often underrepresented compared to men in randomized trials.
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Because only a few disease categories have sufficient articles from which to generalize, we focus on the general patterns for disease types with 10 or more articles. The largest discrepancy occurred in studies of cardiovascular disease.
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Distribution of Articles on Non-Gender-Specific Diseases by Disease Type and Women's Representation Percentage of Women in the Sample Disease Type 0 1-33 3~66 67-99 100 Total 1 Cardiovascular 11 13 Dependency/sub stance abused Endocrinology Health services research Hypertension Infectious diseases Metabolic disorders 4 0 Musculoskeletal disorders Neurology Oncology Ophthalmology Psychiatry Public health Pulmonary Renal Miscellaneous. Total 14 0 0 38 7 6 1 1 19 0 2 1 1 5 2 2 5 12 O O o o o 6 2 13 5 0 19 4 6 o 3 6 2 1 o o 6 2 1 6 2 0 O O o 0 1 2 1 6 0 6 5 101 17 3 2 1 0 34 43 8 46 12 o o o o o 12 o 9 9 3 10 10 7 7 207 Dependency disorders and substance abuse includes articles on tobacco use.
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reported no analysis by gender (see Table 8~. These articles did not report bivariate associations between gender and the outcome variables and did not report controlling for gender in the analysis.
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examined d~ for men and women separately. Thus, 27.3 percent of the articles reported testing whether the analyses found essentially the same results for men and women.8 By contrast, 37.9 percent of the articles either reported no analysis by gender or reported significant bivariate associations of outcomes with gender and reported no further analysis.
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Women's representation varied by study methodology: women were excluded from randomized clinical trials and longitudinal studies substantially more often than from cross-sectional studies (3.7 and 2.6 times, respectively)
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By companson, nearly half of the male-only studies of non-gender-specific diseases simply examined a sample of convenience. These findings suggest that one important reason for a tendency for male-only studies to predominate is Me differential opporhmity for men to be in positions where clinical studies are likely to be funded and carried out (for example, receiving treatment in a Veterans Administration medical center or as a member of the armed services or as a prisoner)
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In addition, many randomized clinical trials and case-controlled studies avoided examining the effect of gender, sbmif~ing their samples to obtain equal representation of women in the control and intervention groups. For example, in a controlled trial of buprenorphine treatment for opioid dependence, Johnson, Jaffe, and Fudala (1992:27523 specifically state: "Gender differences have been reported to influence retention in methadone maintenance and therapeutic community treatment programs.
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I also thank Ben Amick, Elizabeth Goodman, Kathy Lasch, Debra Leaner, Sol Levine, Ed Schor, Diana Chapman Walsh, Ed especially Ann Barry Flood for commenting on earlier draRs of this manuscript.
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170 Comparison of lab diagnostic techniques with no demographic data Prescription orders for hospitalized patients Lung cells Topic CHLOE E BIRD Factors influencing publication House officers' responses to hypothetical cases Reducing the number of uninsured by subsidizing employer-based insurance Factors that prompt families to file malpractice claims Pediatricians' reasons for not participating in Medicaid Comparison of assessments of quality of care Evaluation of malpractice insurance costs Survey of gun ownership Primary care physicians' responses to domestic violence Primary care physicians' attitudes toward corporeal punishment Residents' attitudes toward or of persons with AIDS Treatment of medical students Medical reimbursement accuracy Physician retention by the OHS Corps compared to other rural physicians Which medical schools produce rural physicians Hospital leaders' opinions of HCFA mortality data Effects of medical student indebtedness and repayment on residents' cash flow Understanding recent grown in Medicare physician expenditures Physician reporting of adverse drug effects Prevalence of reading disability in children Attitudes of internal medicine faculty toward drug representatives Status of women in an academic medical center REV testing policies at hospitals Method of Analysis Computer model of CHD primary prevention Decision analysis study using hypothetical cohorts of women with breast cancer Meta-analysis of randomized controlled trials for myocardial infarction Literature review on the exclusion of older women from controlled trials regarding acute myocardial infarction Reanalysis of three previous studies Meta-analysis on depression Review of four previous studies Computer simulation based on meta-analysis Projection of trends based on review of the literature
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Cal, and Jerry Avorn. "The Exclusion of the Elderly and Women from Clinical Trials in Acute Myocardial Infarction." Journal of the American Medical Association 268(11)
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1992. "Fetal Protection and Women's Access to Clinical Trials." Journal of Women's Health 1~2~:137-140.
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7. All ofthe non-gender-specif~c infectious disease studies that focused exclusively on one gender examined sexually transmitted diseases.
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