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Equal is Not the Same

Professor at Pace presents historic and current challenges when including women in research studies

Monday August 25, 2008
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There was a time in the not-too-distant past when premenopausal women were thought to be completely protected from cardiac disease by their hormones. If a man presented with pain in the chest area, for example, he would be routinely assessed for cardiac problems.

A 30-something woman with a complaint of epigastric pain in the ED might be given an antacid or an anti-anxiety medication and be sent home, although in women, as we know now, such symptoms are often associated with cardiac problems.

The problem arose because women were routinely excluded from studies of cardiac disease. The implications of such a bias are obvious; however, not as obvious are other effects resulting from their exclusion from research studies. For example, the safety and efficacy of medications were tested only on men, so the effects on women were simply unknown.

In 1985, the U.S. Public Health Task Force on Women's Health issued a report saying that this historic prejudice against women's health issues deprived women of proper health care and health information. As a response to the report, the National Institutes of Health (NIH) established a policy to include women in clinical research.

If nothing changes, nothing changes

The new policy would have been a boon to women's health care had it been enforced, but it was not until almost five years later; in 1990, that the Government Accounting Office (GAO) issued a report evaluating the implementation of the NIH policy. The disapproval in the GAO report about the fact that women and minorities were underrepresented in study populations sparked a new national conversation. Partly in response to the criticism, the NIH created the Office of Research on Women's Health (ORWH). Because the scientific community had recognized the importance of treating women differently, females began to be included in populations selected for research studies. This did not completely solve the problem, however.

"Women are included in the populations studied now, but the study designs often are not focused specifically on gender differences," says Joanne Singleton, PhD, RN, FNP-BC, professor and family nurse practitioner and director of Nursing Practice Program, Pace University, New York, New York. This gender-blindness design sometimes makes it impossible to discern the different responses men and women have to the medication or treatment studied.

Signals about smoking

Singleton was one of the investigators in a study of smoking cessation treatments. Women and men respond to nicotine differently, and the level of cotinine, a metabolite of nicotine, is different in men than it is in women. She also notes that the psychological aspects of nicotine addiction are different for men than for women. In women, she says, the initial drive to smoke seems to be rooted socially, whereas in men, the drive is more likely associated with the physical addiction to the nicotine and the nicotine metabolite, cotinine.

When the investigators began to look at previous studies, they found that although women were included in the study, no findings were reported that related to gender or ethnicity. This has implications for treatment, since tobacco treatment is complicated by physiological and psychological factors. The Surgeon General's guidelines for treating tobacco use do not specifically address the differences between men and women, except to say that it is important to be aware of gender and ethnic differences (http://www.surgeongeneral.gov/tobacco/tobaqrg.htm).

Different genders, different reactions

Getting women to participate in studies is no more problematic than getting men to participate, says Singleton. The problem is that a study that may last months or even years has a high attrition rate for both sexes. People — men and women — drop out for any number of reasons. It is important for the investigators to design the study so that data can be retrieved and looked at to reveal gender differences.

It makes sense that men and women respond to medications and treatments in various ways, because they have unique biologies. Knowing the differences is potentially life-saving. Consider our 30-something woman in the ED with epigastric pain. Research during the past 10 years has addressed the way that women respond to cardiac insult. Knowing that women do not usually complain of the constricting, squeezing pain so commonly reported by men has changed the way they are assessed in the ED — and has probably saved women's lives.

The original NIH guidelines mandating that women be included in studied populations recognized that women and ethnic groups should be included so that information about treatment could be equally available. Equal, however, is not the same.

In 2001, the guidelines were amended by statute and the language regarding the inclusion of women and minority subjects was strengthened. As a way to address the recruitment differences and outreach involved in including a population never before specifically tapped to participate, the NIH is mandated to support and conduct outreach programs to recruit female and minority study participants. The cost of including women and minorities is not an acceptable reason for exclusion. The policy governing any research funded by the NIH requires that the design of the study include a description of the proposed study population in terms of gender and race/ethnic group (http://grants.nih.gov/grants/funding/wom en_min/guidelines_amended_10_2001.htm).

Women are properly excluded from many studies if they become pregnant. Singleton notes that every study will have specific issues regarding pregnancy, first and foremost being whether or not drugs are used and whether they could damage the fetus. How pregnancy is dealt with is usually determined by the person who designs the study and is monitored by the peer review panel, which oversees the process.

Treatments and medications are designed to help the body cope with some kind of insult or disease. When researchers look at the complex and dynamic interactions that keep our bodies and souls together, it is essential that they recognize that female and male reactions may be different. Designing studies that can reveal how they are unique may make the difference between successful recovery and death.

Marylisa Kinsley, RN, BSN, is a contributing writer for Nursing Spectrum. To comment on this story, e-mail editorNJ@nursingspectrum.com.