Abstract
Background:
Patient–provider communication surrounding menopause symptoms and treatment is often limited. We developed and evaluated a health literacy-appropriate discussion guide to support patient education.
Materials and Methods:
A cross-sectional randomized study was conducted among 100 English-speaking women, aged 45–60 years, in Chicago, IL, and Durham, NC. Participants were randomly assigned to review either the discussion guide or a standard education material (n = 50 per arm) and to complete an open book knowledge questionnaire; they then rated the appearance and quality of both materials. Bivariate analyses examined knowledge and satisfaction by study arm and across sociodemographic characteristics. Multivariable models tested the effectiveness of the discussion guide to improve knowledge compared with the standard material.
Results:
Women receiving the discussion guide demonstrated significantly higher knowledge scores compared with those who reviewed the standard material (mean [M] = 20.0, standard deviation [SD] = 2.7, vs. M = 18.1, SD = 2.6; p < 0.001); 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material (p < 0.001). In multivariable analyses, participants receiving the discussion guide displayed significantly greater knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score (∝ = 1.9, 95% confidence interval [CI]: 0.9–2.9, p < 0.001) or 85% threshold (odds ratio: 5.7, 95% CI: 2.0–16.2, p < 0.001). More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content.
Conclusions:
The discussion guide improved understanding of menopause symptoms and treatment options in comparison with a current standard and was well received by a diverse audience.
Introduction
Menopause is a stage of life characterized by changes in production of reproductive hormones and the absence of a menstrual cycle for 12 months. While a natural process, menopause is associated with a number of physical and emotional symptoms, ranging from moderate to severe, which may impact women's health and quality of life. Most commonly, nearly 80% of postmenopausal women experience vasomotor symptoms, such as hot flashes or night sweating, and up to 50% of postmenopausal women have genitourinary symptoms such as vulvovaginal atrophy, incontinence, and urgency. 1,2 About 39% of women also experience depression during or postmenopause 3 ; increases in anxiety, disturbed sleep, and sexual problems have been reported. 4 –6
Despite the prevalence and potential severity of symptoms, patient–provider communication surrounding menopause and symptom management is often limited. Evidence suggests that one-third to one-half of symptomatic women do not have a discussion about menopause symptoms with their provider. 7,8 There are several reasons for this; many women have difficulty linking the symptoms they experience to menopause, others believe symptoms must be tolerated as part of the aging process, and some find it embarrassing to disclose vulvovaginal symptoms to a provider. 7,9,10 Yet, studies have shown that having a provider initiate dialog on menopause symptoms could greatly increase rates of communication. In the EMPOWER study, 72% of women reported a reluctance to initiate discussions on menopause symptoms themselves, yet 87% were willing to talk to their provider about specific vulvar or vaginal symptoms if the provider introduced the topic. 11 However, only 10%–15% of patient–provider communication on vulvovaginal atrophy is initiated by a provider. 7
A number of clinical guidelines and professional organizations endorse routine evaluation of menopause symptoms and an individualized approach to menopause treatment. 12 –14 Yet, many barriers exist in clinical practice to initiating conversations on menopause symptoms and their management. A study by Vesco et al. reported that many providers lack the knowledge and confidence needed to effectively counsel women on menopause symptoms and treatment, which may be partially due to insufficient training. 15,16 Providers in this study identified that the most common barriers to counseling were lack of time during the clinic visit (71%), limited access to patient education materials (44%), and patient discomfort discussing menopause symptoms (40%). This study and others also highlight provider concerns about the safety and efficacy of available therapies as deterrents to routine evaluation and treatment of menopause symptoms. 9,10,15
In this study, we sought to address many of the barriers to effective patient–provider communication on menopause through creation and evaluation of a tangible, patient-friendly Menopause Discussion Guide and Glossary of Terms. These materials were designed using health literacy best practices to educate, motivate, and empower women and providers to discuss menopause symptoms, symptom management, and treatment options during time-limited clinic visits. The objective of this study was to evaluate whether women who were exposed to the discussion guide and glossary would exhibit greater knowledge of menopause symptoms and treatment options compared with women who received a standard patient education material. We also assessed women's impressions of the discussion guide, both independently and in comparison with a standard material.
Materials and Methods
We conducted a two-arm, cross-sectional randomized study among women from community-based settings in metropolitan Chicago, IL, and Durham, NC, from August to September 2019. An independent Institutional Review Board (IRB) approved all study procedures.
Study participants
To be eligible for the study, participants had to be (1) aged 45–60 years during the study period, (2) English speaking, (3) female, (4) currently experiencing perimenopause symptoms or told by a doctor that they may be transitioning into menopause, and (5) with no severe hearing or visual impairment. Online advertisements and flyers were utilized to describe the study and ask interested individuals to call the research team to learn more about the opportunity. Interested participants were screened for eligibility via phone and an in-person interview scheduled at a community location.
Randomization
Before initiating the in-person interview, participants were engaged in the informed consent process and then randomized 1:1 via a random number table to receive either (1) a standard patient education material published by the American College of Obstetricians and Gynecologists (ACOG) or (2) a newly created Menopause Discussion Guide and Glossary.
Study materials
The standard, ACOG, patient education material was a three-page document describing “The Menopause Years.” It was written in a frequently asked questions (FAQ) format and included a short glossary of terms. 17 It is available online as an educational aid for patients.
The Menopause Discussion Guide and Glossary were created by the study team through an extensive review of the scientific literature, clinical guidelines, and currently available patient education materials. It consisted of a symptom checklist, developed by our team, to help women report the impact of common menopause symptoms on daily life; this was followed by educational content on menopause characteristics and symptom management. We sought to differentiate the guide from other tools by making it interactive in nature instead of purely informational. We also utilized health literacy best practices and plain language to support comprehension and use. 18,19
A Scientific Advisory Board, which consisted of two obstetrician/gynecologists, two behavioral medicine specialists, a pharmacist, and a nurse practitioner, provided clinical input on the guide and helped to determine its salience and accuracy. The guide and glossary were then pretested among the target audience in an iterative review process. Specifically, 15 racially diverse English-speaking women, aged 45–60 years, were recruited via convenience sampling from community settings in greater Chicago, IL, and Durham, NC. Each participant was asked to review the discussion guide during a cognitive interview and answer a series of open-ended questions about its appearance, organization, format, and content. Participant suggestions were used to guide revisions to the materials before additional testing. A final version of the guide and glossary is provided in Supplementary Appendix SA1.
Data collection and procedures
During an in-person interview, participants were asked to review their assigned educational material in depth and to rate its appearance, quality, and content. They then completed a brief knowledge questionnaire using the assigned material as a reference. Finally, they were asked about their sociodemographic and health characteristics. After completing this questionnaire, participants were shown the alternate educational material and asked to rate its appearance, quality, and content. In this manner, participants provided their impressions of both materials, although in different order. Finally, participants were asked which of the two materials they preferred.
Measurement
The primary outcome for this study was menopause knowledge, which was measured using a 13-item close-ended questionnaire designed to assess women's understanding of the causes, characteristics, and potential treatment options for menopause. This questionnaire was developed by the study team and included basic content that could be answered correctly with information provided in either patient education material. Items assessed understanding of a broad range of content presented in patient materials; questions utilized easy-to-understand language and consistent formats to support participant completion. Similar approaches to reverse engineering knowledge assessments from materials that are under evaluation are commonly used in health literacy research by our team and others. 20 –22 The knowledge assessment was open book and participants were encouraged to look at their assigned material while answering items. All of the items utilized a multiple-choice response format; nine items had a single correct response, while four had multiple correct answers. For these four items, participants were instructed to check all that apply for a final, summed knowledge score ranging from 0 to 22. The percentage of correct responses was then calculated as well as a binary knowledge outcome measure with a set a priori threshold of having achieved ≥85% correct responses. This threshold has been viewed by the FDA and other Health and Human Service agencies as a target comprehension goal. 23
Secondary outcomes for this study focused on women's overall impression and satisfaction with the material. Participants were asked to rate, on a scale of 1 to 10, how easy the material was to read and understand, how likely they would be to read the material, how likely they would be to change how they currently manage symptoms based upon its content, and their satisfaction with the amount of information provided. They were also asked to rate the overall appearance and quality of materials using five-point Likert scale response options (excellent to poor).
Participants also completed items assessing sociodemographic and health characteristics and history (e.g., health status, frequency/severity of menopause symptoms, and prior discussion with a provider about menopause). Finally, the newest vital sign (NVS) was administered to participants by a trained member of the research team to assess health literacy. The NVS is a commonly used tool that asks patients to read and interpret information provided on a nutrition facts label to assess their health literacy skills. 24
Analysis plan
Simple descriptive statistics were calculated for variables measuring participants' sociodemographic and health characteristics. NVS scores were categorized according to published criteria; participants were classified as having either adequate or limited (low/marginal) health literacy skills. 24 Bivariate analyses, utilizing chi square, t tests, or analysis of variance as appropriate, were then conducted to examine women's menopause knowledge, impressions, and satisfaction with the reviewed material first by study arm and then across sociodemographic characteristics. Multivariable linear and logistic regression models were then performed to test the effectiveness of the discussion guide to improve knowledge scores and achieve ≥85% comprehension compared with receiving the standard material while accounting for women's age, race, health literacy, having previously talked with a doctor about menopause symptoms, and site. Interaction terms for study arm and health literacy and study arm and age were also generated and entered into the models to determine whether any effect of the discussion guide on menopause knowledge varied by these characteristics. All analyses were performed using STATA, v15 (College Station, TX).
Results
A total of 100 women participated in the study (n = 50 per site). Table 1 summarizes participants' characteristics, both overall and stratified by study arm. Women were an average of 49.9 years old (standard deviation [SD] = 3.7), two-thirds were White (67.1%), and nearly a third were Black (29.0%). Most (69.0%) had a college education or more and 27.0% had limited health literacy according to the NVS. Two-thirds of participants self-reported very good or excellent health (69.0%) and having experienced menopause symptoms on a daily or weekly basis (67.0%). In all, 72.0% had discussed menopause symptoms previously with their provider. There were no statistically significant differences between study arms with regard to any measured participant characteristics.
Characteristics of Study Sample; Overall and by Randomized First Patient Material Exposure
There were no statistically significant differences between study arms at p < 0.05.
M, mean; SD, standard deviation.
Menopause knowledge
Women who were randomized to receive the discussion guide first demonstrated significantly higher knowledge scores compared with those who reviewed the standard material (M = 20.0, SD = 2.7, vs. M = 18.1, SD = 2.6; p < 0.001; Table 2). In terms of achieving a standard threshold level of comprehension, 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material (p < 0.001).
Study Outcomes, Overall and by First Randomized Patient Material Exposure
p < 0.001; bolded values are statistically significant (p < 0.05).
When investigated further, knowledge (by both score and threshold) was highest among those with adequate health literacy who received the discussion guide, followed by those with limited health literacy who reviewed the discussion guide. The difference in knowledge scores between these two groups was not statistically significant (p = 0.09; Table 3). However, those with adequate health literacy exposed to the discussion guide performed significantly better than those receiving the standard material regardless of their health literacy level (adequate: p = 0.006, limited: p = 0.003). Significant differences in knowledge between these groups were also found when knowledge was categorized by the ≥85% threshold.
Participant Knowledge and Preferred Patient Material, by Study Arm and Literacy Level
p < 0.001.
In multivariable analyses controlling for relevant covariates, participants who received the discussion guide and glossary displayed significantly greater menopause knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score (∝ = 1.9, 95% confidence interval [CI]: 0.9–2.9, p < 0.001; Table 4) or threshold (odds ratio: 5.7, 95% CI: 2.0–16.2, p < 0.001; Table 4). Limited health literacy was not found to be independently associated with knowledge using either metric under analysis. When interaction terms for either health literacy and study arm or age and study arm were entered into models, neither were found to be significant.
Multivariable Analysis of Participant Knowledge
Models also included age, race, previously having talked to a doctor about menopause symptoms, and site.
Satisfaction with the material
Overall, impressions of the discussion guide were positive. While not statistically significant, 84.0% of women who reviewed the discussion guide first rated its overall appearance as very good or excellent compared with 70.0% of women who viewed the standard material first (p = 0.10; Table 2). Yet, when women were given the alternative material to consider, 84.0% of those who viewed the standard material first subsequently rated the discussion guide as very good or excellent compared with only 42.0% of women who first viewed the discussion guide and glossary and then similarly rated the overall appearance of the standard material (p < 0.001).
Women were also more likely to score the discussion guide and glossary higher with regard to how easy they were to understand regardless of arm assignment (M = 9.9, SD = 0.4, vs. M = 9.3, SD = 1.1; p < 0.001). When comparing participants' perceived likelihood of reading the material in the doctor's office, the discussion guide was rated higher on average compared with the standard patient education, although this relationship was not significant (M = 8.8, SD = 1.5, vs. M = 8.1, SD = 2.5; p = 0.12). However, further analyses revealed that the discussion guide was rated significantly higher in terms of likelihood of being read among women who viewed the discussion guide first (M = 8.8, SD = 1.5, vs. M = 7.0, SD = 2.8; p = 0.04) and among all women after both materials had been reviewed (M = 8.5, SD = 2.3, vs. M = 7.0, SD = 2.8; p < 0.001). Similarly, those randomized to review the discussion guide first were more likely to rate the guide significantly higher than the standard in terms of likelihood of changing menopause care (M = 7.5, SD = 2.3, vs. M = 6.3, SD = 2.8; p ≤ 0.001) and their satisfaction with the amount of information provided (M = 9.1, SD = 1.3, vs. M = 8.3, SD = 2.2; p ≤ 0.001). More than two-thirds of women (68%) preferred the discussion guide to the standard. No differences were found in preference by health literacy level or participant sociodemographic characteristics.
Discussion
Findings suggest that the discussion guide and glossary can enhance women's understanding of menopause symptoms and treatment options regardless of one's health literacy skills. While there were relatively small differences between study arms in knowledge scores when measured continuously, analyses using thresholds revealed critical distinctions. Additional research in actual use settings will be needed to determine whether such differences are clinically meaningful and whether use of the guide can improve patient outcomes. Beyond knowledge, results also highlight the positive impression most women had for the discussion guide. It was consistently rated higher in every metric related to appearance, quality, and ease of use than the standard material, although differences in these ratings were not always statistically significant.
The menopause transition is often marked by moderate to severe menopause symptoms that can adversely affect a woman's health and quality of life. Despite the prevalence of these symptoms, women often do not receive the support needed to learn about this stage of life and to effectively manage symptoms. The discussion guide and glossary were developed to educate, motivate, and empower women and providers to discuss menopause symptoms, symptom management, and treatment options during time-limited clinic visits. This interactive guide differs from other available educational materials and was designed for diverse audiences, including women with low health literacy skills.
Our application of evidence-based, health literacy best practices in the design of the discussion guide translated to women's health literacy skills not being an independent predictor of acquired menopause knowledge. In fact, mean knowledge scores among women with limited health literacy receiving the discussion guide were higher, although not statistically significant, than women with adequate or limited health literacy who received the standard material. Despite a sizable body of literature investigating interventions to reduce health literacy disparities, these findings are novel in demonstrating such an improvement in information access. Surprisingly, only half of women with limited health literacy who first reviewed the discussion guide preferred it to the standard material. While the reason for this is unclear, a prior study by Yom-Tov et al. found that individuals with limited health literacy were more likely to seek out health information written at a higher reading grade level from more official sources. 25 That the standard material was endorsed by ACOG could have influenced women's preferences, despite the demonstrated ease of use of the discussion guide.
This project has a number of strengths. The discussion guide was designed to be interactive and informative; it was written in plain language and pretested among its target audience. Through the unique design of our cross-sectional randomized study, we not only evaluated the impact of the discussion guide and glossary on women's menopause knowledge but also assessed women's impression of the guide, both independently and in comparison with a standard material. In terms of limitations, this comprehension trial was conducted among a smaller convenience sample of English-speaking women, many of whom had spoken to a provider about menopause. It could therefore be subject to selection bias and may not be generalizable to all women in the United States. However, our sample was recruited from two geographically distinct locations and was diverse in terms of race, urban/suburban/rural residence, and sociodemographic characteristics; previous familiarity with menopause symptoms and treatment from provider discussions would likely have inflated knowledge scores and biased results toward the null. Finally, all testing was performed in a controlled interview environment; it is possible that results could differ in actual use settings.
Additional research will be needed to determine the efficacy of the guide when delivered in a health care setting among actual patients and to determine whether its use can have a clinically meaningful impact on patient outcomes. Future work will also be needed to determine how best to implement the discussion guide into routine clinical practice. One possibility is to utilize electronic health record (EHR) technology to generate a print version of the guide upon check-in for a clinic visit; the EHR could also be programmed to prompt providers to review the tool with patients. Our team has utilized similar approaches for other studies and found that such a design is feasible, with minimal clinic disruption. 26,27 However, research will be needed to examine this functionality for the specific context of menopause and to determine its utility across a variety of practice settings and patient populations. In particular, it will be essential to assess how the discussion guide performs among women with low health literacy skills and whether it can enhance patient–provider discussions among these more vulnerable patients.
Conclusions
Through this project, our team developed and evaluated a complementary discussion guide and glossary to help women identify menopause symptoms, make healthy lifestyle choices, and learn about potential symptom management and treatment options. While additional research is needed, results from this comprehension study indicate that the discussion guide can improve knowledge of menopause symptoms and treatment options and is well received by women regardless of health literacy skills.
Footnotes
Acknowledgments
The authors would like to acknowledge and thank Sheryl Kingsberg, PhD; Rebecca Thurston, PhD; Mary Beth Peterson, MD; Mary Jane Minkin, MD, FACOG, NCMP; Autumn Stewart-Lynch, PharmD, BCACP, CTTS; and Shelagh Larson, DNP, RNS, WHNP, NCMP, for serving as members of the Scientific Advisory Board for this project and for providing their invaluable expertise and assistance in developing and revising the Menopause Discussion Guide and Glossary.
Author Disclosure Statement
S.C.B. and M.S.W. served as consultants to Pfizer, Inc., for the research reported in this article as well as on other, unrelated research projects. Additionally, S.C.B. has served as a consultant to Merck Sharp & Dohme Corp., Northwestern University/Gordon and Betty Moore Foundation, and Luto LLC for work unrelated to this article. She has also received funding support via her institution from Pfizer, Merck Sharp & Dohme Corp., and Eli Lilly and Company. M.S.W. has served as a consultant to Merck Sharp & Dohme Corp., AbbVie, Vivus, Inc., Luto LLC, Anheuser–Busch InBev, Denver Health, and Teva Pharmaceuticals for work unrelated to this article. He also has received funding support via his institution from Pfizer, Merck Sharp & Dohme Corp., Eli Lilly and Company, AbbVie, and UnitedHealthcare. E.N.A. is an employee and shareholder of Pfizer, Inc. C.C.H. provided project management support to Pfizer for this research project. Additionally, she has provided consultancy support for work unrelated to this article to Pfizer, Inc., Takeda Pharmaceuticals, AstraZeneca, MSD, Lundbeck, Medtronic, and Shire. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the article. Employees of Pfizer, Inc., were involved in the study design and reporting of findings and are included as authors.
Funding Information
This study was funded by Pfizer, Inc.
Supplementary Material
Supplementary Appendix SA1
References
Supplementary Material
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