The Promise and Potential Perils of Big Data for Advancing Symptom Management Research in Populations at Risk for Health Disparities.

Symptom management research is a core area of nursing science and one of the priorities for the National Institute of Nursing Research, which specifically focuses on understanding the biological and behavioral aspects of symptoms such as pain and fatigue, with the goal of developing new knowledge and new strategies for improving patient health and quality of life. The types and volume of data related to the symptom experience, symptom management strategies, and outcomes are increasingly accessible for research. Traditional data streams are now complemented by consumer-generated (i.e., quantified self) and "omic" data streams. Thus, the data available for symptom science can be considered big data. The purposes of this chapter are to (a) briefly summarize the current drivers for the use of big data in research; (b) describe the promise of big data and associated data science methods for advancing symptom management research; (c) explicate the potential perils of big data and data science from the perspective of the ethical principles of autonomy, beneficence, and justice; and (d) illustrate strategies for balancing the promise and the perils of big data through a case study of a community at high risk for health disparities. Big data and associated data science methods offer the promise of multidimensional data sources and new methods to address significant research gaps in symptom management. If nurse scientists wish to apply big data and data science methods to advance symptom management research and promote health equity, they must carefully consider both the promise and perils.

Phenotype and Adverse Quality of Life in Boys with Klinefelter Syndrome.

OBJECTIVES: To characterize associations among psychosocial well-being, physical phenotype, and sex hormones in a sample of youth with Klinefelter syndrome (KS). We hypothesized that KS physical traits (phenotype) are associated with adverse psychosocial health measures and that testosterone levels are associated with adverse psychosocial health. STUDY DESIGN: Forty-three boys with KS (ages 8-18 years) participated in a cross-sectional study. Participants underwent physical examination, hormone analyses, and psychosocial health questionnaires. RESULTS: Using an investigator-developed Klinefelter Phenotype Index Scale, the number of KS physical traits ranged from 1-13 (mean 5.1 ± 1.9). Pubertal boys presented with more KS traits compared with prepubertal boys (5.6 vs 4.2, P = .01). Boys diagnosed prenatally had a milder phenotype compared with those diagnosed postnatally. Gonadotropins were elevated without androgen deficiency in 45%. Psychosocial health scores indicated adverse quality of life (QOL) (67%), low self-esteem (38%), poor self-concept (26%), and risk for depression (16%) without a difference between pubertal groups. Linear regression showed that 22% of the variance in QOL (P = .0001) was explained by phenotype. Testosterone level was not associated with psychosocial health measures. CONCLUSIONS: Depending on the degree of phenotypic abnormality, boys with KS may be at risk for impaired QOL. Testosterone levels were not shown to influence psychosocial health. The Klinefelter Phenotype Index Scale may be a useful tool to characterize KS features in boys.

From maca to marijuana: cultural influences on joint pain symptoms and management in urban perimenopausal and early postmenopausal Latinas.

OBJECTIVE: The purpose of this qualitative study was to explore the symptom experience and coping strategies for managing joint pain during the menopause transition in urban Latina women. METHODS: We conducted focus groups with 13 English-speaking peri and early postmenopausal Latinas living in Upper Manhattan in New York City in 2014. Eligible participants were self-identified Latinas aged 45 to 60 years with new onset or worsening joint pain and spontaneous amenorrhea, recruited through flyers and snowball sampling. Focus group interviews conducted in English were audiotaped, transcribed, and analyzed by a bilingual research team, using NVivo software (QSR International) to organize and code themes. RESULTS: On average, participants were aged 51.7 ± 4.8 years and overweight (body mass index of 29.3 ± 6.7 kg/m 2 ); 10 (76.9%) were Puerto Rican, and the last menstrual period was 1 month to 5 years ago. The following four themes emerged: 1) menopause and joint pain are an alarming package; 2) pain disrupts life and livelihood; 3) medical management is unsatisfactory and raises worries about addiction; and 4) home remedies for coping with pain-from maca to marijuana. Despite access to a world-class medical facility in their neighborhood, women seeking pain relief preferred to self-manage joint pain with exercise, over-the-counter products, and other culturally valued home remedies. Many suffered through it. CONCLUSIONS: For midlife Latinas, joint pain symptoms may emerge or worsen unexpectedly as part of the menopause transition and carry distressing consequences for daily activities and quality of life. There is a need to develop more culturally specific approaches for menopause-related pain management in this underserved population.

Using information technology and social networking for recruitment of research participants: experience from an exploratory study of pediatric Klinefelter syndrome.

BACKGROUND: Recruiting pediatric samples for research may be challenging due to parental mistrust of the research process, privacy concerns, and family time constraints. Recruitment of children with chronic and genetic conditions may further complicate the enrollment process. OBJECTIVE: In this paper, we describe the methodological challenges of recruiting children for research and provide an exemplar of how the use of information technology (IT) strategies with social networking may improve access to difficult-to-reach pediatric research participants. METHODS: We conducted a cross-sectional descriptive study of boys between the ages of 8 and 18 years with Klinefelter syndrome. This study presented unique challenges for recruitment of pediatric participants. These challenges are illustrated by the report of recruitment activities developed for the study. We reviewed the literature to explore the issues of recruiting children for research using conventional and IT approaches. Success rates of conventional recruitment approaches, such as brochures, flyers in medical offices, and physician referrals, are compared with IT-based outreach. The IT approaches included teleconferencing via a Klinefelter syndrome support group, services of a Web-based commercial recruitment-matching company, and the development of a university-affiliated research recruitment website with the use of paid advertising on a social networking website (Facebook). RESULTS: Over a 3-month period, dissemination of over 150 recruitment brochures and flyers placed in a large urban hospital and hospital-affiliated clinical offices, with 850 letters to physicians and patients were not successful. Within the same period, face-to-face recruitment in the clinical setting yielded 4 (9%) participants. Using Web-based and social networking approaches, 39 (91%) agreed to participate in the study. With these approaches, 5 (12%) were recruited from the national Klinefelter syndrome advocacy group, 8 (19%) from local and teleconference support groups, 10 (23%) from a Web-based research recruitment program, and 16 (37%) from the university-affiliated recruitment website. For the initial 6 months, the university website was viewed approximately 2 to 3 times per day on average. An advertisement placed on a social networking site for 1 week increased website viewing to approximately 63 visits per day. Out of 112 families approached using all of these methods, 43 (38%) agreed to participate. Families who declined cited either travel distance to the study site (15, 22%) or unwillingness to disclose the Klinefelter syndrome diagnosis to their sons (54, 78%) as the reasons for nonparticipation. CONCLUSIONS: Use of Web-based technologies enhances the recruitment of difficult-to-reach populations. Of the many approaches employed in this study, the university-affiliated recruitment website supported by a Facebook advertisement appeared to be the most successful. Research grant budgets should include expenses for website registration and maintenance fees as well as online advertisements on social networking websites. Tracking of recruitment referral sources may be helpful in planning future recruitment campaigns.

Using social network analysis to examine collaborative relationships among PhD and DNP students and faculty in a research-intensive university school of nursing.

The nursing profession has seen a dramatic rise in the number of schools offering both DNP and PhD nursing programs. Information is limited on the impact of this parallel approach in doctoral education on the quality and scope of scholarly interactions or institutional culture.The authors studied collaboration characteristics across the DNP and PhD programs of a research-intensive university school of nursing, before and after programmatic enhancements. An IRB-approved online survey was delivered to faculty and students of both programs at baseline and one year after curricular changes. Response rates were 70% and 74%, respectively. The responses were analyzed by using social network analysis and descriptive statistics to characterize the number and strength of connections between and within student groups, and between students and faculty. At baseline, the flow of communication was centralized primarily through faculty. At Time 2, density of links between students increased and network centralization decreased, suggesting more distributed communication. This nonlinear quantitative approach may be a useful addition to the evaluation strategies for doctoral education initiatives.

Do correlates of white matter features differ between older men and women living with human immunodeficiency virus?

OBJECTIVE: Given estrogen's role in human immunodeficiency virus (HIV) disease progression and the higher rates of neurocognitive decline in affected women, the purpose of this study was to assess whether the relationship of white matter features and reproductive hormone levels differed between men versus women (sex as a moderator), controlling for selected cardiometabolic risk factors, HIV-related health indicators, and demographics in an aging population of persons living with HIV (PLWH). METHODS: Older PLWH (50 y and older; 44 women and 35 men; mean ± SD age, 59.8 ± 0.6 y; 55.7% women; 72.2% non-Hispanic Black) participated in a cross-sectional study involving a fasting blood draw and a demographic survey (visit 1) and a magnetic resonance imaging scan (visit 2) to determine white matter volume and white matter hyperintensity (WMH) volume. Associations between reproductive hormones (follicle-stimulating hormone [FSH], estradiol, testosterone, dehydroepiandrosterone sulfate [DHEA-S]) and white matter features were assessed in linear regression models. Covariates were age, body mass index, hypertension, diabetes, dyslipidemia, current smoking status, CD4 count, and cranial size. RESULTS: For white matter volume, a sexually dimorphic interaction was seen for DHEA-S (B = 21.23; P = 0.012) and observed for FSH (B = -22.97, P = 0.08) with a trend for significance after controlling for risk factors. In women, higher white matter volume was associated with higher DHEA-S (B = 13.89, P = 0.017) and lower FSH (B = 23.58, P = 0.01). No hormone associations were shown in men for white matter volume. For WMH volume, no significant interaction effects between sex and reproductive hormones were identified. For WMH, sex did not predict associations with reproductive hormones after controlling for risk factors. CONCLUSIONS: Although sexually dimorphic interactions of reproductive hormones and total white matter volume were demonstrated, our study findings do not support a role for sex-based differences in reproductive hormones as predictive correlates of WMH in a small sample of older PLWH.

Association Between HIV Symptom Burden and Inflammatory Cytokines: An Analysis by Sex and Menopause Stage.

Introduction: There is a growing body of knowledge characterizing the menopause experience in those with HIV. The primary goal of this study was to assess inflammatory cytokine associations with symptoms and sex-specific differences, and the secondary focus was to assess differences among women by menopause status. Materials and Methods: One hundred persons living with HIV (PLWH) (25 men and 75 women recruited by menopause stage) completed a blood draw for hormones and cytokines and study questions on demographics, height and weight, reproductive health status, HIV symptoms, PROMIS-29 measures, and most recent viral load; study visits were synchronized to the early follicular phase in women with regular cycles. Results: In both sexes, the most burdensome HIV symptoms were muscle aches/joint pain, difficulty falling asleep, fatigue, and neuropathy. Three of the five symptoms where burden scores differed by menopause stage were related to pain with highest scores in the premenopause group; the postmenopause group also demonstrated a similar burden for muscle aches/joint pain while scores for men and perimenopause women were lowest. Pain intensity scores on the PROMIS-29 also varied significantly by groups. After controlling for sex, menopause stage and body mass index, significant differences were noted in C-reactive protein (CRP), interleukin (IL)-6, and IL-8 for PLWH who reported muscle aches/joint pain. Conclusions: Our findings suggest enhanced burden for HIV-related symptoms in women in the early follicular phase, possibly owing to menstruation. This supports the need for more targeted investigations in younger cycling women with HIV at multiple phases across the menstrual cycle. Muscle aches/pain are strongly associated with decreased CRP and IL-8 levels and increased IL-6 levels suggesting the need for further investigation of the biological pathways contributing to pain in PLWH. Finally, there is evidence to support that in PLWH, systemic inflammation is heightened above recommended clinical guidelines even when viral load is undetectable supporting the need for further study of the effects of persistent elevated inflammation on health outcomes.

Ecological momentary assessment of HIV versus reproductive health symptoms in women of differing reproductive stages living with HIV.

OBJECTIVE: To what extent menopause is related to symptom burden in women living with HIV (WLWH) is unclear, as a specific reproductive health analysis has seldom been undertaken, in part due to an inadequate assessment of reproductive status. The purpose of this study was to document and compare symptom frequency and attribution over 46 days and examine differences by reproductive status with a sample of 75 WLWH. METHODS: We conducted an ecological momentary assessment using text messaging to follow 75 women confirmed for menopause stage with hormone profiles for 46 days. Participants were asked to respond to the following open-ended questions via a text message 3× weekly: (1) Did you have your period today? (Yes/No) (2) What were your top three menstrual/menopausal symptoms today? (3) What were your top three HIV-related symptoms today? RESULTS: A total of 73 women (mean± SD age = 51 ±â€Š8 y, range= 24-67 y) completed the study (10 pre-, 20 peri-, and 43 postmenopause). The majority of volunteers were black non-Hispanic (74%), nonsmokers (61%), with some high school (68%) and reporting <$20,000 annual income. After controlling for cofactors, HIV symptom profiles differed by menopause stage: postmenopause predicted more fatigue, muscle aches and pains, nausea/vomiting, and diarrhea (vs peri- or premenopause). HIV-related depression was predicted by the peristage. For reproductive symptoms, women endorsed fatigue (58%), hot flashes (52%), depression (49%), and muscle aches and pains (44%) as most common, but of these, only muscle aches and pains demonstrated group differences in period prevalence (post = 35%; peri = 45%; pre = 80%, P= 0.03) Surprisingly, hot flash frequency was similar, but fever/chills/sweats varied across menopause stage (period prevalence: post=42%; peri=15%; pre=0%, P=0.01). Reporting "a period today" predicted the profile of reproductive symptoms, but was not related to HIV symptoms. CONCLUSIONS: Although fatigue, muscle aches/pains and depression are perceived as common attributes of both HIV infection and reproductive status in WLWH, they distinguish condition-specific symptom profiles that are dependent on menopause stage.

In people living with HIV (PLWH), menopause (natural or surgical) contributes to the greater symptom burden in women: results from an online US survey.

OBJECTIVE: The majority of people living with HIV in the United States are now over the age of 50, but symptom burden research has seldom included older women or the potential role of menopause. The aim of the study was to examine the influence of menopause as part of sex differences in HIV symptom burden. METHODS: A cross-sectional study was conducted that included both a sex-based analysis of previously reported HIV symptom characteristics of 1,342 respondents to an online survey (males, n = 957; female, n = 385) and a follow-up online survey of menstrual bleeding patterns (inferred menopause) in eligible females (n = 242) from the respondent pool. Using linear mixed models, we identified predictors of symptom burden scores in female respondents. RESULTS: For the most troublesome symptoms assessed in the sex-based analysis, depression scores were similar (P > 0.05), but higher (worse) burden scores for fatigue (P = 0.013) and muscle aches/pains (P = 0.004) were exclusively observed in females after adjusting for covariates. Respondents to the female survey (n = 222) were predominantly Black, heterosexual, nonsmokers, and obese, with an HIV diagnosis of approximately 16 years and at least one comorbid condition. Burden scores were higher in women reporting amenorrhea due to natural menopause or hysterectomy (n = 104) versus the menstruating group (n = 118) for muscle aches/pains (P = 0.05), fatigue (P = 0.03), and difficulty falling asleep (P = 0.04), independent of age, HIV duration, and number of HIV-associated non-AIDS conditions. CONCLUSIONS: Two of the most common symptoms in people living with HIV-fatigue and muscle aches/joint pains-invoke additional burden in women. Independent of aging, symptom burden may be exacerbated after menopause, supporting a shifting paradigm for HIV care management.

Postmenopausal hormone treatment alters neural pathways but does not improve verbal cognitive function.

OBJECTIVE: Cognitive outcomes in trials of postmenopausal hormone treatment have been inconsistent. Differing outcomes may be attributed to hormone formulation, treatment duration and timing, and differential cognitive domain effects. We previously demonstrated treatment benefits on visual cognitive function. In the present study, we describe the effects of hormone treatment on verbal outcomes in the same women, seeking to understand the effects of prior versus current hormone treatment on verbal function. METHODS: This is a cross-sectional evaluation of 57 women (38 hormone users [25 prior long-term users and 13 current users] and 19 never-users). Hormone users took identical formulations of estrogen or estrogen + progestin (0.625 mg/d conjugated equine estrogens with or without medroxyprogesterone acetate) for at least 10 years, beginning within 2 years of menopause. Women were evaluated with tests of verbal function and functional magnetic resonance imaging (fMRI) of a verbal discrimination task. RESULTS: All women scored similarly on assessments of verbal function (Hopkins Verbal Learning Test and a verbal discrimination task performed during the fMRI scanning session); however, women ever treated with hormones had more left inferior frontal (T = 3.72; P < 0.001) and right prefrontal cortex (T = 3.53; P < 0.001) activation during the verbal task. Hormone-treated women performed slightly worse on the verbal discrimination task (mean accuracy 81.72 ±â€Š11.57 ever-treated, 85.30 ±â€Š5.87 never-treated, P = 0.14), took longer to respond (mean reaction time 1.10 ±â€Š0.17 s ever-treated, 1.02 ±â€Š0.11 never-treated, P = 0.03), and remembered fewer previously viewed words (mean accuracy 62.21 ±â€Š8.73 ever-treated, 65.45 ±â€Š7.49 never-treated, P = 0.18). Increased posterior cingulate activity was associated with longer response times (R = 0.323, P = 0.015) and worse delayed verbal recall (R = -0.328, P = 0.048), suggesting that increased activation was associated with less efficient cognitive processing. We did not detect between group differences in activation in the left prefrontal cortex, superior frontal cortex, thalamus, or occipital/parietal junction. CONCLUSIONS: Although current and past hormone treatment was associated with differences in neural pathways used during verbal discrimination, verbal function was not higher than never-users.

Cardiovascular Risk in HIV-Infected and Uninfected Postmenopausal Minority Women: Use of the Framingham Risk Score.

OBJECTIVE: To characterize and compare cardiovascular disease (CVD) risk in HIV-infected and uninfected postmenopausal minority women using the Framingham Risk Score (FRS) as an assessment measure. METHODS: A cross-sectional analysis was performed in 152 (109 HIV+, 43 HIV-) subjects from an existing study cohort of postmenopausal Hispanic and African American women. Data necessary to calculate FRS and menopause features were retrieved by retrospective chart review. Bivariate statistics was used to compare CVD risk factors. Multivariable linear regression was used to determine factors associated with FRS in HIV-infected women. RESULTS: The HIV-infected group was younger, less obese, and with lower rates of diabetes versus controls. In a subset of age-matched participants, median FRS did not differ between groups (14.6 [IQR = 9.1, 21.6] vs. 15.5 [IQR = 12.3, 22.1]; p = 0.73). Fourteen percent of HIV-infected women meeting criteria for the low-risk FRS category (<10%) had a history of CVD, a similar rate as controls. HIV-infected women at intermediate/high CVD risk had higher rates of surgical menopause. According to 2013 clinical guidelines, more than half of HIV-infected women not prescribed statin therapy (52%) were eligible for treatment; however, statin therapy was similarly under-prescribed in uninfected women. CONCLUSIONS: In this study, CVD risk as assessed by the FRS was not significantly different by HIV status. Performance of the FRS may be compromised in postmenopausal HIV-infected minority women. HIV-infected and uninfected women may be undertreated with statin therapy. Large longitudinal cohorts and inclusion of subclinical measures of CVD are necessary to better characterize risk.

Differential associations for menopause and age in measures of vitamin K, osteocalcin, and bone density: a cross-sectional exploratory study in healthy volunteers.

OBJECTIVE: To distinguish the effects of midlife aging from early postmenopause on vitamin K measures, bone formation biomarkers, and bone density. DESIGN: Cycling older volunteers (CO; 40-52 years, n = 19) were compared to cycling young (CY; 20-30 years, n = 21) and untreated, age-matched women in the early postmenopause years (EPM; 40-52 years, mean years PM = 2.8 +/- 0.5, n = 19). We assessed sex steroids, vitamin status (phylloquinone, 25-hydroxyvitamin D, retinol), osteocalcin (OC), percentage of undercarboxylated osteocalcin (%ucOC), and bone mineral density (BMD) at the spine and hip with dual-energy x-ray absorptiometry. RESULTS: CO women had similar estradiol and vitamin status as CY women, but lower OC (0.64 +/- 0.04 vs 0.97 +/- 0.08 nmol/L, P = 0.01) and BMD at the total hip (1.0038 +/- 0.032 vs 1.1126 +/- 0.030 g/cm2, P = 0.02). In the two older groups, BMD was similar at all sites, but OC was elevated in the EPM women (1.10 +/- 0.10 vs 0.64 +/- 0.04 nmol/L, EPM vs CO, P = 0.001). Although phylloquinone was highest in the EPM women, %ucOC was also higher when compared with all cycling women (21.9 +/- 1.7% vs 17.4 +/- 0.9%, n = 40; P = 0.02). CONCLUSIONS: Premenopausal women show reduced BMD despite normal estrogen profiles. %ucOC may be a specific bone marker of the early postmenopause in healthy women.

Use of a standardized menopause symptom rating scale in a sample of women with physical disabilities.

OBJECTIVE: To determine the psychometric properties of a menopause symptom rating scale developed on nondisabled women in a sample of women polio survivors with physical disabilities. DESIGN: The 25-item Menopause Symptom List (MSL) was administered to 190 women between ages 40 and 65 not taking hormone or estrogen therapy. Factor analysis, bivariate correlation, and analysis of variance were performed to determine the scale's underlying structure, construct validity, and association with menopausal status. RESULTS: Factor analysis revealed four factors: (1) psychological, (2) somatic-sensory, (3) somatic-sleep, and (4) vasomotor. Factors 1 and 3 were associated with postpolio sequelae, self-rated health, positive and negative affect, life satisfaction, and perceived stress. Factor 2 was associated with postpolio sequelae, basic activities of daily living, self-rated health, negative affect, life satisfaction, and perceived stress. Factor 4 was associated with postpolio sequelae, self-rated health, negative affect, and perceived stress. Comparison by menopause status found Factors 1 and 3 significantly differed between groups (F(2,181) = 6.68 and 4.17, respectively; P = 0.02). Contrary to expectations, vasomotor factor severity was not distinguished by menopause status. CONCLUSIONS: Menopause symptom scales standardized on nondisabled women should be used cautiously with women with physical disabilities. Associations between construct validity measures and menopause symptomatology suggest a complex relationship between physical disability and menopause.

Creating a new structure for research on health care effectiveness.

Effectiveness research (a term we use in preference to the more confining and difficult health services or outcomes research) evaluates the clinical setting and the health care system on which it depends. It uses a variety of health care assessment techniques and the practical clinical trial to inform clinical practice, quality interventions, and health policy decisions. Effectiveness research had not had sufficient public or private funding to produce the information needed to facilitate evidence-based health care improvement. However, recent trends, such as the likelihood for continued substantial increases in health care costs and concern regarding the quality and safety of the US health care system, are among the important arguments for increasing its funding and capacity. We propose a new entity, a public-private consortium to expand and offer new capability and resources in this area. The consortium would consist of all relevant public and private entities. It would be organized into an executive committee, which would identify research priorities and panels to design requests for proposals. Competitive peer-reviewed proposals, transparency and balance of forces in choice of topics, conduct of research, and interpretation of results would be important features. Metrics for success would be use of the data derived from consortium projects in medical decision making and benefit design. The consortium would provide balance and potential mediation of conflicting or competing interests in which all stakeholders will be present to establish the rules. Broad representation of all interests would serve to avoid the economic, policy, and political issues that have bedeviled past efforts. Models for the consortium include the Health Effectiveness Institute, the Centers for Education and Research on Therapeutics, and the Transportation Research Board.

Health-related quality of life issues in women with polycystic ovary syndrome.

OBJECTIVE: To evaluate the influence of obesity, fertility status, and androgenism scores on health-related quality of life in women with polycystic ovary syndrome (PCOS). DESIGN: Cross-sectional, correlational. SETTING: Private reproductive endocrinology practice in two southeast U.S. cities. PARTICIPANTS: Convenience sample of 128 women with PCOS, half of whom were attempting to conceive in addition to being treated for PCOS. Most were White (97%), married (78%), with a mean age of 30.4 years (SD +/- 5.5). MAIN OUTCOME MEASURES: The Health-Related Quality of Life Questionnaire (PCOSQ) for women with polycystic ovary syndrome. A laboratory panel and clinical measures, including body mass index, waist-to-hip ratio, and degree of hirsutism. RESULTS: The most common health-related quality of life concern reported by women with PCOS was weight, followed in descending order by menstrual problems, infertility, emotions, and body hair. CONCLUSIONS: The psychological implications of PCOS are easily underestimated and have been largely ignored. Nursing has a pivotal role in recognizing these concerns and implementing therapy to improve quality of life in women with PCOS.