Starting in the latter half of the nineteenth century, hormone transplants and injectable or oral hormone preparations were widely believed to be capable of restoring health and prolonging life. A public fascination with hormone treatments inspired early drug manufacturers in the United States (US) and Europe to synthesize sex hormones, and sales of hormone products enabled a number of these companies to experience tremendous growth during the 1930s despite the economic depression that hindered most other types of manufacturing during this period (Rothman & Rothman, 2003; Watkins, 2007).
Starting with the early period of hormone manufacturing, systemic menopausal hormone therapy (HT) was promoted to physicians for relief of hot flashes and vaginal dryness, prevention of chronic disease, stabilization of mood, cosmetic benefits, and extending or restoring youthful vigor. Ayerst, a hormone manufacturer that, by the late 1960s, spent a million dollars annually on advertising, secretly paid Robert Wilson, MD, to write “Feminine Forever” (1966). This best-selling book helped cement the connection between HT and healthy aging of women in the American consciousness (Rothman & Rothman, 2003; Watkins, 2007). According to Wilson’s writings, menopause is an estrogen deficiency degenerative disease that requires treatment of all women who are otherwise “castrates.” He claimed that HT prevented cancer, and he denied evidence that suggested estrogen was carcinogenic (Neel, 2002). “Feminine Forever” helped create a discourse that: (a) sold the concept and the product known as “hormone replacement therapy,” (b) pathologized and medicalized menopause, (c) contributed to a fear of menopause and aging and a belief that HT could slow the aging process, and (d) conceptually related hormone levels to the value (and self-esteem) of women.
After Wyeth Laboratories, a division of American Home Products, acquired Ayerst in the late 1980s, it continued aggressive marketing including overseeing the publication of ghost-written professional journal articles claiming HT could improve facial skin and prevent disease in women (Fugh-Berman, 2010). In the 1980s through the first half of 2002, print and television advertisements used glamorous celebrities to market Premarin® unopposed estrogen therapy and Prempro® estrogen-progestogen therapy directly to women. In the late 1990s, Premarin® and Prempro® sales comprised almost 70% of the menopausal HT market in the US, and by 2001, the two products generated $2 billion in sales annually (Petersen, 2002). The prevalence of HT use among women 50-74 years of age in the US was then well over 30% based on insurance claims made for filled prescriptions (Ettinger et al., 2012).
Despite feminist critique and changes in education, policy, and law that have taken place since Feminine Forever was published, it is possible that women who are now over 60 years of age have perceptions of HT that reflect exposure to past marketing efforts. Moreover, the growing field of “anti-aging” medicine, ever- increasing options for and uptake of cosmetic procedures, as well as other promising medical innovations, may contribute to unrealistic perceptions of HT benefits. The finding that hormone use is most prevalent among college-educated White women and low in most other races and socioeconomic groups (Brown et al., 1999; Keating, Cleary, Rossi, Zaslavsky, & Ayanian, 1999; Krishna, 2002; Lock, 1998) may reflect exposure to hormone marketing as well as access to a gynecology specialist.
Provider’s Role in HT Decision Making: Marketing HT to Gynecology Specialists
Gynecology specialists (both doctors and nurse practitioners), aggressively targeted by pharmaceutical marketing campaigns, remain skeptical of the science that informs prescribing guidelines (Brett, Carney, & McKeown, 2005; Fugh-Berman & Scialli, 2006; Power, Schulkin, & Rossouw, 2007; Steinkellner et al., 2012). Steinkellner et al. (2012) described prescribing patterns between 2002 and 2009, noting that HT prescribing among gynecologists increased while prescribing by internists declined. The authors cited survey studies (Brett et al., 2005; Power, Anderson, & Shulkin, 2009) that suggested gynecologists were less critical of the Women’s Health Initiative (WHI) estrogen-only trial than they were of the estrogen-progesterone trial, and they resisted changing their established prescribing practices.
The marketing of HT to providers includes direct contact by drug representatives, the provision of samples, authoring and sponsoring continuing education courses, and orchestrating the publication of professional journal articles with a promotional message (Fugh-Burman, 2010). Literature authored by gynecology specialists generally minimizes risks of HT compared with articles written by other medical specialists or generalists (Fugh-Berman & Scialli, 2006, Fugh-Berman, McDonald, Bell, Bethards, & Scialli, 2011). Fugh-Berman et al. (2011) examined articles that comprised reviews, editorials, comments, or letters on HT prescribing published between 2002 and 2006. Their findings indicated that articles with a promotional tone were more than twice as likely to be authored by physicians with ties to hormone manufacturers. Fugh-Berman et al. (2011) found five themes in the articles they reviewed: (a) the risks of HT have been exaggerated, (b) randomized clinical trials are not better than observational studies for determining the risks of HT, (c) the study populations used in the WHI were inappropriate for determining risks, (d) ongoing studies are expected to demonstrate protective effects from HT, and (e) different formulations and doses have different risk/benefit profiles, so HT tailored to an individual woman based on her unique attributes may be beneficial and have minimal risk. Articles authored by different “thought leaders” (with ties to the pharmaceutical industry) contained text repeated word-for-word, suggesting ghostwriting (Fugh-Berman et al., 2011).
Themes identified by Fugh-Berman et al. (2011) are similar to themes in the 2012 Hormone Therapy Position Statement of the North American Menopause Society (NAMS). Many individuals on the Advisory Panel for the Position Statement reported relationships with hormone manufacturers, particularly with Pfizer, the company that now owns Wyeth (NAMS, 2012). The NAMS website addresses the needs of patients, clinicians, and sponsors, and it hosts a decision tool to help women make decisions about HT use based on the impact of menopausal symptoms on “quality of life” (NAMS, 2015).
UpToDate® point-of-care clinical guidelines are used by 90% of academic medical centers in the US (UpToDate, 2015). The recommendations of UpToDate® regarding long-term use of HT are subtly but substantially different from the NAMS Position Statement. For example, in UpToDate® there is no suggestion that the risks of HT beyond five years (even when estrogen is used alone) can be counterbalanced by “quality of life” benefits as is argued in the Position Statement (NAMS, 2012). Because of risks to health associated with menopausal HT, UpToDate® guidelines suggest that prescription of systemic estrogen is not recommended (with rare exceptions, such as for osteoporosis that cannot be treated with bisphosphonates) beyond 3 to 5 years after the last menstrual period (Martin & Barbieri, 2015). By specifically providing data to guide decision making on the risks and benefits of HT for a period of up to five years in women 50 to 59 years of age (and not for longer periods of therapy), the authors emphasize this point. Unlike NAMS, UpToDate accepts no funding from pharmaceutical companies, medical device manufacturers, or any other commercial entity, and its more cautious recommendations do not reflect industry bias. It could be argued that the NAMS Position Statement is essentially HT promotion. A flow diagram depicting the influence of hormone marketing on perceptions of menopause, aging, and HT is presented on page 8 as Figure 1.
Using Hormone Therapy Involves Taking Risks
Estrogen is effective for treating menopausal hot flashes and vaginal dryness, and some women believe they need HT to maintain youthful bodies and lead active lives beyond menopause. HT was previously promoted for disease prevention until the Heart and Estrogen/Progestin Replacement Study (HERS) and WHI randomized clinical trials determined that it causes the diseases it was supposed to prevent (Hulley et al., 2002; WHI, 2002, 2004).
Increasing age and duration of HT are associated with increased breast cancer risk (Beral et al., 2011; CDC, 2015; Chlebowski & Anderson, 2012). Estrogen-receptor positive breast cancer is most strongly associated with the use of HT (Farhat, Walker, Buist, Onega, & Kerlikowske, 2010; Suhrke, Maelen, & Jahl, 2012). About 40,000 women in the US die from breast cancer each year (ACS, 2015), and it is a major cause of morbidity and mortality among older women. The mean age at diagnosis is 61 years, and approximately 66% of breast cancers are diagnosed in women over 55 years of age (NCI, 2014).
There is ongoing controversy about the risk of breast cancer from unopposed estrogen. The unopposed estrogen therapy arm of the WHI showed no increased risk (WHI, 2004), while the Million Women Study (MWS) showed increased risk (Beral et al., 2011). A reanalysis of original data from 51 epidemiologic studies comprising 52,705 women with and 108,411 women without breast cancer found that for each year a woman uses HT, the risk of breast cancer increases by 2.3%. These authors found that the relative risk of developing breast cancer was 1.35 (CI 1.21-1.49; p = 0.00001) in women currently using HT who had used it for five years or more compared with never users. Information on type of HT used was only available for 4,460 women, among whom 80% “mostly” used unopposed estrogen. The authors found no differences in breast cancer incidence between the estrogen-progestogen therapy and unopposed estrogen therapy users (Collaborative Group on Hormonal Factors in Breast Cancer, 1997).
Breast cancer is not the only significant health risk associated with HT. The incidence rates of ovarian cancer, coronary heart disease, ischemic stroke, deep vein thromboembolism, dementia, gallbladder disease, pancreatitis, and urinary incontinence are all increased in HT users (Chen, 2015; Collaborative Group on Epidemiological Studies of Ovarian Cancer, 2015; Manson et al., 2013; Nabel, 2013; Oskarsson, Orsini, Sadr-Azodi, & Wolk, 2014). Some of these risks may be lower with non-oral preparations that avoid first-pass metabolism, and there is a need for ongoing research to determine the true risks of HT. Research to address these questions is not the focus of my scientific inquiry. Rather, reasons for prescribing HT outside of treatment guidelines is the focus of my research.
HT Guidelines and Prescribing Practice
Because risks for breast cancer and other diseases increase with length of use, prescribing guidelines advise that HT be prescribed at the lowest effective dose for the shortest duration possible, for no longer than three to five years (Martin & Barbieri, 2015; NAMS, 2012). (As noted previously, the NAMS Position Statement equivocates regarding the use of HT beyond five years, suggesting that women may decide that HT risks are counterbalanced by “quality of life” benefits.) Despite these guidelines, more than 25% of all HT prescriptions in the US are written for women over the age of 60 (Hersh, Steffanick, & Stafford, 2004; Steinkellner et al., 2012). In 2009, the last year for which these data are available, the prevalence of use in the US ranged from 13% in women between 61-65 years of age, to 4% in women over 75 years of age (Steinkellner et al., 2012). Although there is a trend toward prescription of lower doses, Corbelli & Hess (2012) observed that there is no evidence to support the intuitive hypothesis that lower doses are associated with lower risk for cancer, and only 25% of all HT prescriptions were written for low-dose therapy through 2009 (Ettinger et al., 2012). Standard or high dose oral formulations remained the most common regimens observed through 2009, and the average length of use had steadily increased from 2002 to 2009.
Why do women over age 60 continue to use HT despite the risks? Literature that pertains to this question includes studies on: (1) women’s perceptions of menopause, aging, and HT; (2) women’s beliefs about the risks and benefits of HT and the ways they use this information for making HT decisions; and (3) providers’ roles in HT decision making. This review of the literature critically evaluates this body of literature, focusing on qualitative studies of midlife women, and it identifies areas where more research is needed.
Figure 1. Flow diagram depicting the influence of hormone marketing on patient and provider perceptions of menopause, aging, and HT.
When I began to formally develop this study as a doctoral student, I was enrolled in N269, Foundations of Human Health and Nursing Systems. One of the first assignments was to conduct a search in PubMed related to our “phenomenon.” Using the phrase “women’s beliefs about estrogen therapy” yielded 11 articles. “Prescribing estrogen AND older women” yielded 9 articles. Tellingly, the largest number of articles retrieved, 103, resulted from a search using the phrase “menopause hormone therapy AND health benefits.”
Additional searches were done to identify relevant articles on the topics of estrogen and cosmetic benefits, HT and depression, HT and sexual function, measurement of hot flashes, as well as other related areas. Filters for “published in the last 10 years, humans, and aged 65+ years” were utilized for many of these searches. (No filter on PubMed allowed me to restrict the age to 60 plus years; however, the 65+ year filter proved useful.) No single author was identified as an expert in any of the search areas. Restricting publication dates to 10 years approximated the interval since WHI study reports (2002, 2004) changed the landscape regarding menopause hormone therapy prescribing. I produced summary tables for the 15 qualitative studies deemed most relevant to my topic. I ultimately decided to include studies completed before 2002 that contributed valuable insight into HT decision making and the process of studying it.
Using the PubMed, CINAHL, Web of Science, and other databases available in the UCSF library, I routinely search for articles to update a comprehensive body of literature related to HT decision making. I have found that automatic retrieval systems in medical literature search engines capture only a fraction of new publications using the same search terms used in manual searches. I have also found that Google sometimes locates articles that other databases miss.
General Description of Literature Related to HT Decision Making
Various research approaches, both quantitative and qualitative, have been used to study HT decision making. Data-gathering methods have included surveys and questionnaires, on-line forums, focus groups, and interviews. A systematic review and meta-synthesis on HT knowledge and perception based on issues raised in 11 qualitative studies conducted after 2002 was published by Tao, Teng, Shao, Wu, & Mills (2011). This meta-synthesis, although innovative in design, added little to what had been reported in the literature. The two key findings were: (1) a large percentage of women received information on HT from the Internet and popular media, and (2) the women taking part in these studies evidenced a low level of concern regarding the risks of HT.
Although quantitative methods were used in some studies to produce descriptive statistics or to associate demographic characteristics with particular findings, the research evaluated in this review of the literature is primarily qualitative because of the type of research question I am attempting to answer. These qualitative studies were typical of either (a) social science or (b) medical practice literature with an emphasis on education and counseling. Articles in the social science literature included qualitative descriptive studies, ethnography, and grounded theory research. Some articles included discussion of social theory (such as feminism), nursing theory (e.g., Orem’s theory of self care and Meleis’s transitions theory) or contributed to theory generation (Im & Lipson, 1996; Kolip, Hoefling-Engles, & Schmacke, 2009; Stephens, Budge, & Carryer, 2002; Quinn, 1991). Some studies adopted an international perspective, included recent immigrants, or were conducted outside the US (Deeks, Zoungas, & Teede, 2008; Erol, 2011; Fauconnier, Ringa, Delanoe, Falissard, & Breart, 2000; Fisher, Sand, Lewis, & Boroditsky, 2000; Hunter & Liao, 1994; Hunter, O’Dea, & Britten, 1997; Im & Lipson, 1997; Krishna, 2002; Lock, 1998; Marmoreo, Brown, Batty, Cummings, & Powell, 1997). The purpose of many studies published prior to 2002 was to gain information that could improve adherence to HT, which the researchers clearly assumed to be safe and effective (Fisher et al., 2000; Krishna, 2002; Limousin-Lamothe, 1996; Marmoreo et al., 1998; Phelan et al., 2001). O’Connor et al. (1998) published a study on a decision aid structured to encourage women to use HT for cardiovascular disease and osteoporosis prevention (providing a woman’s medical history did not suggest a greater-than-average risk for breast cancer). Women with an absolute contraindication to HT were not included in the study, nor were women who had stopped using HT due to side effects. The self-administered decision aid used an audiotape to guide women through an illustrated booklet that included detailed information about HT risks and benefits. The decision aid included illustrated icons to represent certain concepts. These icons were used in weigh scale profiles of women choosing whether or not to use HT. Weigh scale profiles typical of the three possible HT decisions are included as Figure 2 on page 12.
A limitation noted by many of the authors of these studies is that White and well-educated women comprised the majority of study participants. This reflects the fact that some studies selected for participants who were HT users or were patients in gynecology specialty clinics, however, it does not explain the lack of diversity in other studies dealing with attitudes about menopause. Another limitation is that very few women over age 60 who used HT were included in any studies, and the few instances in which older women comprised part of a study population, age was not associated with individual quotes or themes.
A critique of the six qualitative studies that best address my research question follows. These published papers are alphabetically ordered and critiqued using the criteria of both Sandalowski (1993) and Beck (2009). I agree with Sandalowski’s opinion that rigor is less about
Figure 2. Relationship between women’s values and their decisions to take HRT
(O’Connor et al., 1998).
adherence to abstract and universal rules than it is about fidelity to the spirit of qualitative work. She noted that systematically validated findings may not always be truthful, and she also argued that efforts to establish reliability are often unwarranted and may actually weaken claims to validity. “What is forgotten is that in the naturalistic/interpretive paradigm, reality is assumed to be multiple and constructed rather than singular and tangible” (p. 3). This perspective addresses the issue of whether member checking constitutes a worthwhile practice for assuring validity, particularly when study results include abstractions reflecting the realities of multiple participants who may expect to be able to recognize their own experiences in analyses. Sandalowski wrote that the trustworthiness of a study is established when a scientist makes research practices visible and auditable. The criteria for assuring rigor cited by the authors of these six studies are those emphasized by Beck (2009), namely: credibility, dependability, confirmability, transferability, and authenticity. Following this critique is a synthesis of information from these six studies and additional research literature.
Critique of Six Salient Qualitative Studies Related to HT Decision Making
In 1997, Hunter, O’Dea, and Britten published their “thematic discourse analysis” describing how women in the UK accounted for their decisions about HT use. Forty-five women aged 49-51 (seven using HT), were interviewed in depth by a health psychologist who used a semi-structured format that broadly addressed menopause in terms of health and lifestyle. The study sought to describe the extent to which women use medical models in discussions of HT decision making, and the authors concluded that most women in this study did not. Although participants were recruited from gynecology specialty practices and interviews took place in a medical setting, most of these women described menopause as a natural process that did not require therapy unless specific symptoms required treatment, such as severe hot flashes. Some women expected that HT could improve mood and appearance, while other women were skeptical of such claims. Many women believed that HT was not natural, and they felt that having HT-induced periods was unnatural as well.
Hunter and colleagues (1997) concluded that beliefs about HT are contextual, and enabling women to voice their own opinions and make HT decisions that are consistent with their values is not often recognized as a necessary part of providing HT decision support. A strength of the study report is the insightful discussion section that cites related literature addressing the importance of empowering women. Issues raised included stigma, power and gender relationships, and the need to take into account variation in racial, ethnic, and other social backgrounds. A weakness of the study is its abbreviated data analysis, which consisted of dividing quotes into two sections: (1) perceived advantages and disadvantages of HT, and (2) reasons given for decisions to take or not to take HT. Response examples were reported in a straightforward manner without further thematic analysis, and this represents a missed opportunity for finding additional meaning in interview data. Although the findings of Hunter et al. are intuitively credible and likely to reflect the experiences of participants, there was no mention of peer review, reflexive memo writing, field notes, or validation by participants. Study methods were not fully described, and auditability (confirmability) was not addressed. Because research findings were essentially transcribed interview data selected for inclusion in one of two categories, not being able to fully assess rigor in analysis may not actually be a weakness.
Kolip et al. (2009) used a grounded theory approach to describe how postmenopausal women in Germany view HT. They interviewed 31 women in 2005, and used grounded theory methods for data collection and analysis. The study included three women over 60 who were current users of HT, however, the authors did not associate specific themes or quotes with individual participants or participant categories (such as age or HT use), and the issue of using HT outside of treatment guidelines was not addressed. The study sought to assess women’s “subjective logic” for using HT, to explore their motives, and to learn how individual women weigh the risks and benefits of HT. Their analysis resulted in five prototype user attitudes: integrity-preserving (preserve self-image, physical well-being); performance-oriented (slow the aging process, function as before); searching (doubt a HT decision); faith in medicine (trust and please one’s provider by using HT); and benefit-generalizing (hold anti-aging beliefs, attribute good health and non-menopausal symptom relief to HT). The authors suggested that women’s attitudes fall into overlapping patterns that are subject to change over time.
The strengths of this study included its rich descriptions and well-chosen quotes. The authors expressed surprise that menopausal symptoms as motives to use HT were minimized in interview data, and they observed that some participants attributed positive effects to HT that are not supported by scientific evidence (such as stress relief, fewer wrinkles, and improvement in chronic ailments, such as rheumatism). They acknowledged that interviews did not fully explore “benefit-generalizing,” and this approach could comprise a focus for future research. Although they reported that a need for control was a characteristic of the “integrity-preserving user,” they did not fully develop this concept in their analysis. It would be useful to explore these concepts among a sample of women who have used HT longer than five years. The study report included comprehensive descriptions of methods used to conduct interviews and analyze transcribed data. Efforts to enhance credibility included use of a reconstructive analytical procedure and peer review, however, there was no mention of member checking.
Marmoreo et al. (1998) addressed the topic of HT decision making using a modified grounded theory approach. Fifty-six Canadian menopausal or postmenopausal participants responded to a newspaper ads or poster advertising a study on HT decision making. Participants were purposively selected for assignment to one of eight heterogeneous focus groups consisting of never users, former or off-and-on users, and current users, with the objective of fostering “open and spontaneous discussion.” The numbers and ages of women in each category were not provided, nor was it stated whether using HT included both systemic and vaginal estrogen. Two of the eight focus groups were excluded because data on use of HT were missing), 25% of participants were continuous HT users, indicating a sample of 10 or 11 HT users. The mean age of participants was 56 with a range of 44-73, and this suggests that few of these 10 or 11 HT users were over the age of 60. Themes developed from analysis of focus group data were not associated with women in a particular use or age category.
Focus groups were facilitated by a family physician and a psychologist, and two broad questions were used to start discussions: “What are your ideas and perceptions about HRT?” and “What has been helpful in terms of your decision to take or not to take HRT?” The study report described the approach to analysis in detail, including efforts to ensure credibility. Analysis resulted in four themes called “spheres of influence”: a woman’s internal influence, or “the interface between her perceptions and feelings”; interpersonal relationships; ongoing external or societal influences; and the consequences resulting from the HT decision. The authors describe a “dynamic interplay” between the spheres of influence, and they hypothesized that an especially positive or negative sphere of influence, termed a “weighted influence,” could alter the decision-making process. Quotes were selected to illustrate weighted influences.
The physician’s role was not explicated in terms of its place within the spheres of influence, but one might assume that physicians are part of external influence, and their advice relates to the sphere of consequence. A weakness of the conceptual model is the lack of clarity regarding the physician’s role, especially in light of the authors’ suggestion that the relationship between a woman and her physician could comprise a “weighted influence.” Although the study reflected little of the bias toward use of HT for disease prevention in currency in the 1990s, the authors their motivation to learn how to help women appreciate HT’s benefits. The primary practice implication was that physicians should listen to patients to learn how to best address their concerns.
The authors observed that the concept of “control” of “the condition” was addressed by all study participants, however, this concept was not specifically addressed in focus group discussions or developed fully in analysis. Future studies might explore this concept, as it appears to be a theme in this body of literature. Techniques used to enhance credibility included a thorough description of the sample including composition of focus groups, the use of reflexivity in analysis, and the use of observation of focus groups (with the writing of field notes, one assumes). Additional efforts to ensure auditability were not explicit other than mention of verbatim transcription of focus group recordings.
In a qualitative study conducted in New Zealand, Stephens, Budge, and Carryer (2002) focused on the meaning of HT in relation to various discursive constructions of the meaning of menopause. The study sample consisted of 48 women aged 45-60 who were selected randomly from election rolls and sent letters inviting them to participate. Additional women were recruited with newspaper advertisements. Focus groups were purposively formed based on HT use: never, formerly, and current. Nineteen of the 48 women used HT currently. Major “interpretive repertoires” identified were: threatening change, natural, biomedical, and drug. HT was characterized within these interpretive repertoires as: a beauty product (threatening change); a poison (natural), a medicine (biomedical); and a drug of dependence (drug). The authors suggested that providers become familiar with these discourses in order to improve collaborative HT decision making.
The strengths of this study include its clear description of study methods and well-chosen quotes. A limitation of the design recognized by the researchers was the fact that some women’s voices were overwhelmed by more vocal focus group participants. The study’s thematic analysis of the discursive construction of menopause represents a Foucauldian post-modern philosophical perspective. Analysis of focus group data, in which quotes were placed within larger conversations, reflected a constructivist view of analysis. Efforts to ensure credibility, integrity, and auditability included complete descriptions of the sample, data collection methods, and analysis. Analysis incorporated a recursive process and peer review, and the final product reflected creativity and an artfulness that did not detract from the credibility of the study.
Theroux (2010) conducted a qualitative study in the US on HT decision making. Data gathering comprised 21 interviews (face-to-face except for two telephone interviews) of seven women aged 48-58. Initial interviews were followed by additional interviews at 6 and 12 months, giving this study a unique longitudinal aspect. The author, a women’s health nurse practitioner with a PhD, stated her intent to develop a decision support model. As the author stated, she did not move far from the data with analysis when she identified four major themes: experiencing changes, searching for answers, making the decision, and women’s needs. Theroux concluded that making a decision about HT is a non-linear process, and that women change their minds. She also concluded that unrealistic fears about HT interfered with decision making, that shared decision making is improved when nurse practitioners are prepared as coaches, and she suggested that the North American Menopause Society is a good resource for gaining this expertise.
Although Theroux (2010) did not use a grounded theory methodology, she suggested that future studies would benefit from such an approach. Limitations of the study are its low number of participants, simplistic thematic analysis, and bias toward a pharmaceutical industry-associated educational resource. Theroux reported using field notes taken from telephone conversations to document the tones of conversations, however, she made no mention of reflexive memoing. At the conclusion of the study, Theroux conducted additional interviews with six participants who had read a preliminary summary of the findings. In addition to member checking, the author listed prolonged engagement with participants, maintenance of an audit trail, and review of findings with other nurse practitioners and nurse researchers as methods used to ensure trustworthiness.
Walter and Britten (2002) conducted a qualitative study using focus groups and interviews to explore patients’ understandings of HT risk in the UK. Like the Marmoreo et al. (1998) study, the lead author of this study was a physician. The study was part of a larger body of research to identify effective ways of framing risks in clinical encounters. The sample was comprised of women 50-55 who were never-, ex-, and current-users of HT recruited from two gynecology practices. Major findings were: there is interplay between knowledge and core beliefs; patients prefer to form their own conclusions about risk likelihood; there is a tradeoff between risk likelihood and suffering; and family history influences understanding of risk. The authors suggested that the meanings of particular risks are modified by age, experience, and emotion. Imagery of danger, for example, appeared to modify perception of risk, the weighing of risk versus benefit, and subsequent behavior. The authors hypothesized that there is an emotional (non-cognitive) component to risk perception, and emotions that result from a synthesis of risk knowledge and core beliefs act as a “filter” to prevent contamination of core beliefs by risk information.
Although Walter and Britten (2002) did not use the term “grounded theory,” this study is an example of a modified grounded theory approach, and the resulting hypothesis resembles a grounded theory. Their analysis employed the “framework” method, and examples of thematic codes included references to beliefs about womanhood, fatalism, control, and choice. The concept of control was explored in terms of controlling risk, rather than controlling a “condition” as in other studies. In terms of applicability to my inquiry, this study’s limitations are its narrow focus on the framing of risk information and the fact that the sample consisted of younger women than my population of interest. Its primary value from my perspective is the hypothesis pointing to an emotional component in decision making. The role of emotion posited is similar to the role of emotion in “affect heuristic” decision theory, a theory that may have relevance to my inquiry. The report included informative details on the background and purpose of the study, the sample used, data collection methods, and a brief summary of data analysis using the framework method. The findings are believable, they reflect creativity, and they are likely to be transferrable to other situations involving decision making.
Synthesis of Information on HT Decision Making
Menopause Is a Salient Theme for Older Women on HT
Menopause is often the first obvious sign of aging, and most women who start HT initiate it close to menopause. Menopause and aging are linked conceptually, and both tend to have negative connotations in English-speaking countries and Western Europe (Lock, 1998; Krishna, 2002). Some women in midlife discover that aging brings a recognition of competency and a welcome change of focus from parental responsibility to self care (Beyene, Gilliss, & Lee, 2007). Premenopausal women in the Beyene et al. study did not anticipate needing HT for menopausal complaints, and many of them were engaged in activities and practices they expected would help them maintain youthfulness.
The majority of studies in this critical review of the literature were comprised of women approaching menopause or in the peri-menopause transition, however, some included women over the age of 60 (Deeks et al., 2008; French, Smith, Holtrop, & Holmes-Rovner, 2006; Kolip et al., 2009; Phelan et al., 2001). Findings from these studies confirmed that menopause continues to be a salient issue for older women. In a grounded theory study, Kolip et al. (2009) reported that interviews were initiated by asking all participants to provide a narrative recalling the first signs of menopause. They found that starting with this narrative helped reveal a woman’s motives and internal logic regarding the HT decision.
For her dissertation, UCSF nursing doctoral student Linda Crocket McKeever (1988) conducted an interpretive study of the menopause experience. McKeever wrote that, because the dominant culture in the US fails to formally recognize a positive change in status with menopause, women are motivated to postpone menopause by using HT. Controlling menopause symptoms and slowing the aging process are both powerful motivations for using HT, and some women believe that by doing so they delay or avoid menopause and aging (Fauconnier et al., 2000; Fisher et al., 2000; French et al., 2006; Hunter & Liao, 1994; Hunter et al., 1997; Kolip et al., 2009; Limouzin-Lamothe, 1996; Stephens et al., 2002; Sveinsdottir & Olafsson, 2006).
Along with intention to slow the aging process, factors associated with intent to use HT among premenopausal women include poor self-esteem and depressed mood (Fauconnier et al., 2000; Fisher et al., 2000; French et al., 2006; Hunter & Liao, 1993; Hunter et al.,1997; Marmoreo et al., 1998; Limouzin-Lamothe, 1996; Rolnick, Kopher, DeFor, & Kelley, 2005; Stephens et al., 2002). For some women, menopause presents emotional and physical difficulties related to changes in self-image, and interview data suggest that many women believe that depression, anxiety, and emotional lability are caused by menopause (Bauld & Brown, 2008; French et al., 2006; Kolip et al., 2009 Nosek et al., 2010). Bauld and Brown (2009) and Krishna (2002) reported that women who hold more negative beliefs about menopause and aging experience more physical and psychological symptoms with menopause. Controlling emotional lability is frequently cited as a reason for using HT (Fisher et al., 2000; Kolip et al., 2009; Limouzin-Lamothe, 1996; Theroux, 2010) and some women adjust dosing based on their emotional states (Kolip et al., 2009).
Perception of Benefit—Symptom Control and Fear of Non-Use
Controlling symptoms. In a multi-ethnic study in the US using an on-line forum, Im et al. (2010) concluded that the need to control menopausal symptoms is a characteristic of well-educated White women, the primary users of HT. One of the primary predictors of HT use is severe hot flashes; the primary perceived benefit of HT is control of hot flashes; and the major predictor for restarting HT after trying to quit is resumption of hot flashes (French et al., 2006; Grady, Ettinger, Tosteson, Pressman, & Macer, 2003; Hunter et al., 1997). Controlling hot flashes is one of the most frequently cited benefits deemed to outweigh HT risks (French et al., 2006; Hunter et al., 1997; Limouzin-Lamothe, 1996; Rolnick et al., 2005).
Kolip et al. (2009) noted that HT users in their study minimized symptoms such as hot flashes and vaginal dryness and instead expressed appreciation for various perceived benefits unrelated to menopausal symptoms. These benefits, mentioned in many studies (Deeks et al., 2008; French et al., 2006; Hunter & Liao, 1993; Hunter et al., 1997; Kolip et al., 2009; Limouzin-Lamothe, 1996; Marmoreo et al.,1997; Stephens et al.; 2002), include improvement in mood, weight control, lowering of fluid retention, stress reduction, and delayed aging, which includes better skin texture and tone, increased energy, and greater sex drive. In addition to these perceived benefits commonly attributed to HT, participants in the Kolip et al. (2009) study attributed improvement in chronic ailments, such as rheumatic pain, to HT; they reported adjusting dosages based on the perceived effect. The authors characterized the phenomenon of widespread attribution of benefits to HT as “benefit generalizing.”
Fear of not using HT. Avoiding risk is a perceived benefit of HT. Women in many studies spoke of the risk of not using HT for prevention of disease, for prevention of menopausal symptoms, for prevention of emotional lability, or for slowing the aging process. Understandably, disease prevention as a benefit of HT was a more frequent theme in studies completed before 2002 (Marmoreo et al., 1998; Stephens et al., 2002). Risks of not slowing the aging process, not preventing diminished sex drive, and not preventing emotional lability were sometimes mentioned in the context of a perceived need to avoid endangering one’s relationship with an intimate partner (Marmoreo et al., 1998; Stephens et al., 2002).
Prevention of disease is infrequently mentioned as a primary motivator to use HT in this body of literature (Deeks et al., 2008; Hunter et al., 1997; Limouzin-Lamothe, 1996; Stephens et al., 2002). Osteoporosis prevention was the primary focus of a study in which Turkish women were interviewed about their perceptions of osteoporosis risk and their perceived benefit of HT for prevention (Erol, 2011). The study took place following a media campaign on osteoporosis prevention using HT that was initiated by pharmaceutical interests. The campaign linked the risk for osteoporosis to the covering of women’s bodies (which is mandated by culture, religion, and law) preventing sun exposure. The campaign was seen by the authors as appropriation of cultural practices and fears in order to sell a product. The Erol (2011) study was unique in that it employed situational analysis theory and methods to explore the cultural meanings of HT as well as contextual aspects of HT decision making.
Perception of Risk—Conflict and Confusion
Most of the studies in this critical review of the literature examined HT risk perception, which is a dominant theme in studies published after 2002. In response to publicity surrounding the WHI finding that HT caused breast cancer, many women quit HT entirely, some later restarted it, some lowered or skipped doses, and some changed type of hormone preparation (French et al., 2006; Grady et al., 2003; Rolnick et al., 2005). Risks for breast and other cancers and general uncertainty about health risks have remained the dominant themes related to risk perception. Women in many studies, including studies done earlier than 2002, expressed confusion about risk, citing conflicting information in the media (French et al., 2006; Hunter et al., 1997; Krishna, 2002; Rolnick et al., 2005; Stephens et al., 2002; Theroux, 2010).
One aspect of risk is the risk of experiencing various disadvantages of HT that are less consequential than disease. Disadvantages of HT mentioned in several studies include having periods or spotting, headaches, weight gain, and bloating (French et al., 2006; Hunter et al., 1997; Stephens et al., 2002). Women also expressed concern about possible symptoms of HT withdrawal, especially symptoms they associated with the menopause experience (French et al., 2006; Hunter et al., 1997).
A Reassuring Provider—The Most Significant Predictor of HT Use
McKeever (1988) noted that society gives doctors great authority, and this influences many women to accept a medicalized interpretation of menopause and to follow a doctor’s advice to use HT. Having a reassuring and informative provider was found to be the most significant predictor of HT use, and decision support was identified as a perceived need in a number of studies (French et al., 2006; Kolip et al., 2009, Marmoreo et al., 1997; Phelan et al., 2001; Sveinsdottir & Olafsson, 2006; Theroux, 2010). Phelan et al. (2001) found that a visit with a gynecology specialist within the previous two years was a predictor of a positive attitude toward HT. Conversely, they also found that women who indicated that friends were an important source of information were likely to have negative attitudes toward HT.
Kolip et al. (2009) noted that a belief that HT is protective (held by both the provider and the patient) is partially responsible for prescription of HT to women over 60 years old. This finding is not surprising, in that claims of disease prevention appear regularly in popular media and on the Internet. An example of this phenomenon is the Kronos Early Estrogen Prevention Study (KEEPS) trial that was designed to determine whether estrogen, when taken early in menopause, could prevent cardiovascular disease (CVD) and/or cognitive decline (Kronos Longevity Research Institute, 2012). The KEEPS study, which began in 2005 and ended in 2012, was largely conducted to test the “timing” hypotheses, which suggested that the WHI report of more CVD and dementia after use of HT were findings associated with starting HT well after menopause, rather than early in menopause, as is normally the case.
At the 2012 annual meeting of NAMS, the authors of the KEEPS study announced that they had preliminary findings showing that HT was protective against CVD and dementia when started early in menopause. Press releases and related articles appeared widely in the popular media such as USA Today and WebMD, giving the public the impression that there was evidence to support these conclusions. However, the assertions made in 2012 were not supported by study data, and it was not until 2014 that results on CVD outcomes showing no protection were published in a peer-reviewed journal (Harmon et al., 2014). Results on cognition effects have yet to be published in a peer-reviewed journal, suggesting the KEEPS data showed no benefit. A 2012 document claiming that KEEPS data showed that CVD and dementia had been prevented by HT remains on the NAMS website where it is prominently featured (NAMS, 2015).
Kolip et al. (2009) also reported that some women agreed to use HT primarily to please their doctors, considering it a breach of faith to argue against this advice. When they felt comfortable with HT, they expressed appreciation for being relieved of the burden of making the decision. Other women in this study provided narratives about questioning the advice of doctors, and some told of being “threatened” by warnings of mental and physical consequences if they declined prescription of HT. The authors concluded that seeking gynecologic care at menopause almost inevitably resulted in prescription of HT, and that women lacked other sources of information and support for menopause-related concerns.
Conclusions: What is Missing from the Literature?
Few Older Women Took Part in Previous Studies
The majority of studies cited in this review included few women over 60 years of age. A primary reason for the younger research population is that many of these studies focused on the decision to begin HT prior to or during menopause. The purpose of many studies was to increase uptake of HT and improve adherence. When older women were quoted in the few studies that included them, the age of the speaker was not provided, and the ages of participants were almost never associated with themes or other findings. Although some surveys and questionnaires were completed by women over the age of 60 (Deeks et al., 2008; French et al., 2006; Phelan et al., 2001; Rolnick et al., 2005), characteristics of older women were not expressly identified, with rare exceptions. The Phelan et al. study (2001) found that older age was associated with more negative attitudes about HT in nonusers. Deeks et al. (2008) found that post-menopausal women had more positive attitudes about aging than younger women.
Factors influencing HT decisions may be different for older women compared to younger women. Older women may perceive the risks and benefits of HT differently due to age- or cohort-specific medical or personal histories, and they may also be weighing alternate priorities or conflicting beliefs about HT. There are numerous unanswered questions. Are older women confused about HT risks, or do they not care about risk information? Are they fatalistic? Has using HT become more of a practice than a decision? What role does the concept of “control” have in this practice? Are prescribers trying to get older patients to stop HT?
The authors of several studies suggested that psychological drug dependence, or fear of non-use, is one explanation for long-term use (Hunter et al., 1997; Marmoreo et al, 1998; Stephens et al., 2002). An article in The Lancet introduced the issue of HT drug dependence by suggesting that both physical and psychological dependence can be caused by estrogen (Bewley & Bewley, 1992). These authors mentioned the possibility of “rebound” symptoms as well as the psychological pain of giving up perceived anti-aging benefits. This suggests that fear of non-use may be a major driver of long-term use.
Much of the existing literature deals with expectations for HT benefits, and positive benefits associated with HT may be somewhat different for older women compared to women approaching menopause. A related un-explored question is whether original expectations for HT have been met, and whether these evolved into different expectations or attributions of benefit. As noted in the section on perceived benefits above, some women appear to benefit from a treatment (placebo) effect (Kolip et al., 2009). Older women, who are more likely to experience symptoms from chronic conditions (such as pain), may attribute symptom improvement to HT. This possible motivation for long-term use has not been addressed elsewhere in the literature, and it may help explain some long-term HT use. No previous studies focused on perceived benefits that may be unique to older women.
New Information and Policy Changes May Influence HT Decision Making
Some women in previous studies expressed cynicism about the interpretation of menopause as a disease (Marmero et al., 1997; Stephens et al., 2002). Others expressed anger about being given misinformation; however, these women did not appear to suspect corporate deception (French et al., 2006). Increasingly, information is published about the practice of ghostwriting, about large monetary awards made to women who developed breast cancer while taking Prempro®, and the related fact that Wyeth knew about breast cancer risk while publicly denying it (Bloomberg.com, 2012). Women using HT may respond to such information by becoming angry, and this emotional response might alter their assessment of risk versus benefit.
As noted above, the literature shows that having a prescriber who questions research findings and perceives HT to be safe and effective is a powerful predictor of use among younger menopausal women. It is not clear whether HT use in older women who are long-term users is as strongly associated with prescriber belief and behavior, and older women may be the principal drivers of the prescribing process. At least one managed care organization is taking steps to decrease the use of HT in older women (A. Huang, personal communication). Receiving a letter from an HMO about the risks of long-term HT, and being required to have one’s physician process an appeal to overrule a denial of drug coverage, may affect the decision making process.
What Sample and Study Design Would Best Address HT Decision Making Now?
No studies of the HT decision making processes of women over the age of 60 were found in the literature. Because women over the age of 60 are most likely to be harmed by long-term use of HT, it is important to learn about their motivations, and findings from earlier studies using samples of younger women cannot be generalized to this population. The type of study that would be most useful is one that involves intensive interviewing, that has a sample size large enough to capture a wide range of experience, and that takes analysis beyond mere categorizing.
Such a study would fully explore older women’s perceptions of menopause, aging, and hormone therapy, concepts that are defined in the following theory paper. This second paper begins with a section on the epistemological perspective of scientific realism and its relationship to theory development in nursing. It also addresses the implications of societal stigma related to gender and aging and the value of a feminist philosophical perspective. The paper explores symbolic interactionism and situational analysis as broad conceptual frameworks that could be used to guide the research. Because the research question involves decision making, the paper also addresses the emotional aspect of decision making with a brief discussion of decision theory.
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