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Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations

Diane B. Stoy

Recruiting and retaining subjects in clinical studies are challenging tasks that are critical to the success of any study. Recent federal regulations regarding the inclusion of women in clinical studies have sparked new interest in (1) defining gender differences relevant to the recruitment and retention of subjects in clinical studies, and (2) developing gender-specific recruitment and retention strategies. This paper presents an overview of relevant differences between men and women, the implications of these differences for recruitment and retention, and some practical considerations for researchers conducting studies with female subjects.

THE DYNAMICS OF RECRUITMENT AND RETENTION

In clinical studies, the assessment of recruitment and retention is typically reported with quantitative measures such as the number of subjects screened for a study, the yield from specific recruitment sources, the subjects' adherence to a schedule of clinic visits, and the subjects' adherence to a regimen with an investigational medication. In reality, such quantitative measures reflect a social process of interaction between researchers and their subjects. Any discussion of recruitment or retention, therefore, must begin with the broad social context in which researchers and subjects develop their unique relationship.

The interaction begins with the first contact between a potential subject and the researchers. This contact may be sparked by the subject's attraction to the



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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations Diane B. Stoy Recruiting and retaining subjects in clinical studies are challenging tasks that are critical to the success of any study. Recent federal regulations regarding the inclusion of women in clinical studies have sparked new interest in (1) defining gender differences relevant to the recruitment and retention of subjects in clinical studies, and (2) developing gender-specific recruitment and retention strategies. This paper presents an overview of relevant differences between men and women, the implications of these differences for recruitment and retention, and some practical considerations for researchers conducting studies with female subjects. THE DYNAMICS OF RECRUITMENT AND RETENTION In clinical studies, the assessment of recruitment and retention is typically reported with quantitative measures such as the number of subjects screened for a study, the yield from specific recruitment sources, the subjects' adherence to a schedule of clinic visits, and the subjects' adherence to a regimen with an investigational medication. In reality, such quantitative measures reflect a social process of interaction between researchers and their subjects. Any discussion of recruitment or retention, therefore, must begin with the broad social context in which researchers and subjects develop their unique relationship. The interaction begins with the first contact between a potential subject and the researchers. This contact may be sparked by the subject's attraction to the

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers potential personal benefits derived from participating in a study and/or a study's appeal to the subject's altruism or affiliation needs. The interaction between researcher and participant then continues with the informed consent process in which the study design, risks, benefits, alternatives, researcher's responsibilities, and extent of the participant commitment are reviewed. Throughout the study's data collection phase, subjects fulfill their commitment to the researchers and the study protocol by performing a variety of specified behavioral tasks such as visiting the clinical center regularly for health assessments, completing health questionnaires, following a diet, or taking medication. Thus, the processes of recruitment and retention involve the mutual participation of researchers and study subjects in the implementation of a study protocol; an agreement between the researchers and the subjects about the behaviors required for that implementation; and the performance of those behaviors within the social context of the subjects' lives. Are there gender differences that affect the way in which women versus men perceive participation in clinical studies? Experience in clinical research suggests that there are differences, and that these differences are not only grounded in biology but also profoundly shaped by culture and patterns of human development. CROSS-CULTURAL DIFFERENCES: MEN VS. WOMEN Since the days of Freud, the differences between men and women have been the subject of great debate, the full extent of which is beyond the scope of this paper. It is safe to say that until recently, analytic approaches in the social sciences have relied on the male model as the gold standard, and have not been told from a feminine perspective. Despite this bias toward men, there is a general recognition across social science disciplines of distinct differences between men and women that extend beyond biology. According to Williams (1987), "the values and interests of females collectively are different in important, measurable ways from those of males in this society" (p. 190). These differences stem from the fact that men and women are socialized differently into two distinct cultures: manhood and womanhood. Although considerable geographic, generational, economic, religious, and ethnic variations exist, there is a constellation of gender-specific values, beliefs, and cultural imperatives. These values, beliefs, and imperatives—in conjunction with biological differences—represent the intersection of culture and biology, and have implications for the recruitment and retention of female subjects. According to psychologists (Williams, 1987; Miller, 1986; Johnson and Ferguson, 1990) the lives of contemporary women, like those of generations before them—are organized around "giving" to and serving others, and it is from

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers this dynamic that women derive a major part of their self-worth. As the bearers and primary caretakers of children, women typically submerge their own personality and subjugate their own needs to those of their families. Miller (1986) suggests that many of contemporary women's activities are undertaken in pursuit not of their own goals, but of the goals of others such as their spouse and children. Women's sense of self is also organized around being able to maintain affiliations and relationships with others. Activities directed at achieving personal goals, says Miller, can "easily be fraught with conflict and can contribute to diminishing a woman's self-image" (p. 54). The role conflict of contemporary women, i.e., the balancing of career and family needs, can result in "being pulled in all directions" (Williams, 1987, p. 299) and in the superwoman syndrome, in which women suffer exhaustion as they struggle to satisfy their family, career, and personal needs. In contrast, Miller (1986) suggests that men's lives—with their focus on "doing"—are psychologically organized against the principle of giving to others. Men's images revolve around selfseeking achievement and competition, the hallmarks that characterize the male culture. According to Miller, serving others is a "luxury a man desires or can afford only after he has fulfilled the primary requirements of manhood. Once he has become a man by other standards, he may choose to serve others" (p. 70). In his pivotal work on human development, Erickson (1968) used the male experience as the model for his eight progressive stages of the development of "man." These stages, said Erickson, are those that individuals must pass through on the path to maturity. Erickson postulated that, for women, intimacy preceded identity, and that a woman was expected to subjugate her aspirations to those of her husband and to the care of him and their children. Erickson also insisted that female psychology was driven by biology, and that a woman's identity was derived from her reproductive role. Erickson has been criticized (Johnson and Ferguson, 1990) for failing to recognize the developmental impact of sex roles and the limitations that role expectations placed on women's equal participation in society. The work of Erickson (1968) as well as that of Levinson (1978) and Vaillant (1978) extended the study of human development past adolescence to the entire life span. The concept that psychological growth and development continued from birth until death was later popularized by Sheehy in her book Passages, although Sheehy and her colleagues in human development have been criticized for extrapolating the data from the study of men to women. Contemporary views of life span theory suggest that the sequence and intensity of the predictable life stages of adults are truly different in men and women, even in today's society in which women have gained fuller participation. These differences arise from the impact of childbearing and parenting, which remain female functions, and social changes, such as improved occupational mobility, which arose from the woman's movement. Although there is always

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers individual variation within cultural groups, these differences can generally be seen in the life patterns of men and women today. The life development pattern for men in early and middle adulthood is primarily focused on career achievement, with parenting generally relegated to a secondary role. After the attainment of career goals in mid-life, men's primary focus is thought to shift away from career issues and toward the enrichment of relationships with family and community. Conversely, in early adulthood, the lives of women revolve primarily around their parenting responsibilities, which often take precedence over their career aspirations. Contrary to popular belief, studies of women with an "empty nest" suggest that women experience mid-life differently than men. Free from the parenting responsibilities of small children, women at mid-life are finally free to satisfy their individual needs for achievement by focusing their energies on their own career aspirations. Thus, the life pattern of women and men at early and middle adulthood appears to be remarkably different. GENDER DIFFERENCES: IMPLICATIONS FOR RESEARCH Scientific evidence and clinical experience suggest that there may be significant differences in the recruitment and retention of male and female subjects. For example, as the primary caretaker of children, a young woman with a family may be hesitant to enroll in a study that presents potential risks to her safety and livelihood, and ultimately that of her children. A working mother may also be hesitant to participate because she may be unable to incorporate the behavioral requirements of the study into her daily schedule in which she already experiences stress from conflicting role demands. For example, a young mother may wish to reserve her annual or sick leave for the days when her children are ill, rather than a half or whole day of study-related health assessments. Women who agree to participate in a study may also experience some life crises in her family, such as a serious illness of a child, that may limit her short- and long-term ability to conform to the requirements of a study protocol. There are also generational differences among women that are important to acknowledge. For example, women over the age of 65—who did not grow up in the era of self-help, preventive medicine, or communal exercise such as aerobic dancing—may be less willing to participate in studies that conflict with their prevailing beliefs about health. These beliefs may include such ideas as not taking hormone replacement because they feel well and believe that "if it's not broken, don't fix it"; or not participating in a study involving group exercise because they feel uncomfortable undressing and exercising with strangers. Women in this age group also may be unwilling to agree to participate in a study without discussing the study with their spouse or family.

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers There are also special considerations for older women related to aging, social roles, and cultural biases. For example, one recruitment campaign for a clinical study of postmenopausal estrogen replacement was a dismal failure in metropolitan Washington, D.C., when it was advertised by the media as a ''menopause'' study. Focus groups later revealed that the failure of the recruitment was directly related to the use of the word "menopause" in the advertising. In the youth-oriented American society, menopause is synonymous with aging, which has negative connotations for women. Thus, women were hesitant to be associated with a study of aging women. The same type of study, however, later enjoyed an enormously successful recruitment campaign when the study's recruitment director eliminated the word menopause from its publicity materials and instead used "Women have hearts, too!" as the study's theme. Another consideration is the difference between men and women in the age of onset of disease. Studies of women with heart disease, for example, involve women who are generally 10 to 20 years older than their male peers with heart disease. These older women are often less independent and less mobile. This lack of independence can be a considerable barrier to participation in a study that involves regular visits to a clinical center. Even in an urban area such as metropolitan Washington, D.C., many older women do not have a driver's license or are unwilling to drive into the city. In addition, once enrolled in a study, older women such as these with a variety of medical problems are often unwilling to travel to the center in inclement weather. For example, on a recent rainy Friday afternoon in Washington, D.C., all five women who were scheduled to visit the clinical center for an introductory visit did not keep their appointments as scheduled. Although concerns about mobility are evidenced in older men and women, the fact that heart disease manifests itself at a later age in women increases the recruitment and retention difficulties inherent in heart disease studies in women. METHODOLOGICAL CONSIDERATIONS FOR RESEARCHERS What actions can researchers take to assure the full participation of women in clinical studies? The starting point, I believe, is to acknowledge that there are distinct differences between men and women. Although there are always variations within and across groups, there are distinct biological, cultural, and developmental differences between men and women that can directly and indirectly affect women's participation in clinical research. Given these differences, researchers who are conducting studies with women may consider the following: Providing young women with children and older women with very

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers specific and clear information about the behavioral requirements of the study. Since a selective recruitment process can enhance long-term retention, researchers should make every effort during the consent process to clarify the behavioral requirements of the study. Although this information must be reviewed as part of the informed consent, it often becomes lost among the myriad of details in the consent form. Therefore, it is helpful to provide participants with a separate document that clearly outlines the study's visit schedule, the procedures required at each visit, and the time required for each. This document should also specify what time of day the clinic visits must occur (early/late morning, afternoons or evenings), the locations to which the subjects must report, and how flexible the scheduling can be. For example, in one multicenter study of postmenopausal hormone replacement, the subjects were required to spend one full day and one half day a year undergoing health assessments such as blood- clotting studies, endometrial biopsies, and mammography. Other studies may involve regular blood testing or urine collection throughout the work day, or admission to a metabolic unit in a hospital. Offering flexible scheduling and child care. Women with young children may be willing to participate in clinical studies if they can complete their clinic visits during school hours, or if the clinical center will provide short-term child care. Some interested women may be willing to participate if the clinical center offers evening and Saturday appointments. Flexible scheduling is also important for women who are faced with a family crisis that they must handle in addition to their other roles. Researchers may be able to obtain administrative leave for their study subjects by writing a letter to the subject's supervisor. Offering assistance with transportation. Both older and younger women who do not drive may require assistance with local transportation. Some universities provide door-to-door van transportation, while others provide reimbursement for taxicabs, bus transportation, or local parking. Allowing extra time to carefully review the study's risks and benefits with female subjects. Although women are socialized into a giving role, they may be hesitant to participate in a study in which there are considerable risks. Adequate time should be spent discussing the risks and benefits with the woman, and if desired, with her significant other. Sending the study materials home in advance of the clinic visit is helpful because it gives a woman time to review the materials in the privacy of her home before returning to the clinical center. Designing the recruitment materials for the study in a way that is sensitive to women. This means careful wording of references to age, sexuality, fertility, menopausal symptoms, etc. It is helpful to enlist the services of public relations professionals with experience in women's health. In addition, the use of focus groups is a cost effective method for test marketing preliminary recruitment materials and identifying potential problems with recruitment materials.

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers Making every effort to recognize the women's contribution to the research effort. The multiple and often conflicting roles of contemporary women leave women with little spare time. Women who participate in clinical studies, who have given their time and energy, should be recognized for their contribution. This may be done with special study-sponsored events, certificates of appreciation, study-related memorabilia, etc. REFERENCES Erickson, E. (1968) Identity: Youth and Crisis. New York: W. W. Norton & Company, Inc. Levinson, D. J. (1978) The Season's of a Man's Life. New York: Ballantine. Miller, J. B. (1986) Toward a New Psychology of Women. Boston: Beacon Press. Johnson, K., and T. Ferguson. (1990) Trusting Ourselves: The Sourcebook on Psychology for Women. New York: Atlantic Monthly Press. Vaillant, G. E. (1978) Adaptation to Life. Boston: Little, Brown. Williams, J. H. (1987) Psychology of Women: Behavior in a Biosocial Context. New York: W. W. Norton & Company, Inc.