Returning genomic results in a Federally Qualified Health Center: the intersection of precision medicine and social determinants of health.

PURPOSE: This report describes the return of sequencing results to low-income Latino participants recruited through a Federally Qualified Health Center (FQHC). We describe challenges in returning research results secondary to social determinants of health and present lessons learned to guide future genomic medicine implementation studies in low-resource settings. METHODS: Five hundred Latino adults (76% women) consented to research sequencing for a predetermined panel of actionable genes. Providers and staff from the FQHC were engaged to align processes with the practice and a community advisory board grounded the project in the local community. RESULTS: A pathogenic/likely pathogenic variant was present in 10 participants (2%). Challenges in return of results included the time lag (582 ± 53 days) between enrollment and returning actionable results, difficulty reaching participants, missed appointments, low health literacy, lack of health insurance, and reconciling results with limited information on family history. Return of one actionable result was deferred due to acute emotional distress secondary to recent traumatic life events. CONCLUSION: The social determinants of health influence the implementation of genomic medicine in low-income populations in low-resource settings. Considering nonbiological factors that contribute to disparities will be necessary to better appreciate how genomic medicine may fit within the context of health equity.

Racial Disparities in Breast Cancer Outcomes in the Metropolitan Atlanta Area: New Insights and Approaches for Health Equity.

BACKGROUND: Racial disparities in breast cancer (BC) outcomes persist where non-Hispanic black (NHB) women are more likely to die from BC than non-Hispanic white (NHW) women, and the extent of this disparity varies geographically. We evaluated tumor, treatment, and patient characteristics that contribute to racial differences in BC mortality in Atlanta, Georgia, where the disparity was previously characterized as especially large. METHODS: We identified 4943 NHW and 3580 NHB women in the Georgia Cancer Registry with stage I-IV BC diagnoses in Atlanta (2010-2014). We used Cox proportional hazard regression to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) comparing NHB vs NHW BC mortality by tumor, treatment, and patient characteristics on the additive and multiplicative scales. We additionally estimated the mediating effects of these characteristics on the association between race and BC mortality. RESULTS: At diagnosis, NHB women were younger-with higher stage, node-positive, and triple-negative tumors relative to NHW women. In age-adjusted models, NHB women with luminal A disease had a 2.43 times higher rate of BC mortality compared to their NHW counterparts (95% CI = 1.99 to 2.97). High socioeconomic status (SES) NHB women had more than twice the mortality rates than their white counterparts (HR = 2.67, 95% CI = 1.65 to 4.33). Racial disparities among women without insurance, in the lowest SES index, or diagnosed with triple-negative BC were less pronounced. CONCLUSIONS: In Atlanta, the largest racial disparities are observed in luminal tumors and most pronounced among women of high SES. More research is needed to understand drivers of disparities within these treatable features.

Prevalent Health Concerns Among African American Women Belonging to a National Volunteer Service Organization (The Links, Incorporated).

OBJECTIVE: African American women bear a disproportionate burden of cardiovascular disease (CVD) and cancer. The purpose of this study was to identify prevalent health concerns among African American women who are members of The Links, Incorporated (Links), a large national service organization with health programming for communities of color. METHODS: Survey data (n = 391) were collected during the 2012 Links National Assembly. Twenty-six health issues were presented within five groups: cancer, CVD, pulmonary disease, chronic conditions, and behavioral health. For each issue, women indicated if it was a concern for "you/your family" or "the African American community" via check-boxes. Differences in the proportions for "you/your family" and "the African American community" were evaluated using the McNemar test. RESULTS: Hypertension was the most frequently endorsed concern for you/your family (79 %); 73 % indicated this was a concern for the African American community. Sickle cell anemia was the most frequently endorsed concern for the African American community (77 %). Melanoma was the least endorsed health issue overall (15 % you/your family, 55 % community). Breast was the most frequently endorsed cancer concern, while lung was among the least. For 23 out of 26 health issues, the proportion concerned was greater for the "African American community" than for "you/your family" (all p < 0.05). CONCLUSION: CVD and breast cancer were salient concerns; both are topics for which national awareness campaigns and Links health programming exist. Comparatively lower concern was observed for melanoma, a cancer with known survival disparities, and for lung cancer, a leading cause of death in women.

Adaptation of an Acculturation Scale for African Refugee Women.

Newly-arrived African refugees are a vulnerable group of immigrants for whom no validated acculturation measures exist. A valid measurement tool is essential to understand how acculturative processes impact health and health disparities. We adapted the Bicultural Involvement Questionnaire (BIQ) to characterize its reliability among ethnic Somali women residing in Minnesota, and Somali, Somali Bantu, and Burundian women in Arizona. Surveys were administered to 164 adult women. Analyses were conducted along socio-demographic variables of ethnicity, geographic residence, age, and length of time in the United States through t tests and one-way analysis of variance. Exploratory factor analysis was conducted on the modified BIQ. Exploratory factor analyses yielded five subscales: "Speak Native Language", "Speak English Language", "Enjoy Native Activities", "Enjoy American Activities", and "Desired Ideal Culture". The subscales of the modified BIQ possessed Cronbach's α ranging from 0.68 to 0.92, suggestive that all subscales had acceptable to excellent internal consistency. The modified BIQ maintained its psychometric properties across geographic regions of resettled Central and East African refugees.

The feasibility and educational value of Hear My Voice, a chaplain-led spiritual life review process for patients with brain cancers and progressive neurologic conditions.

Research continues to establish the importance of spirituality for many persons with medical illnesses. This paper describes a pilot study titled, "Hear My Voice," designed to provide an opportunity for persons with progressive neurologic illnesses, including brain tumors and other neurodegenerative diseases, to review and discuss their spirituality with a board-certified chaplain, and to prepare a spiritual legacy document (SLD). First, we provide background information that underscores the importance of such a project for this patient population that is particularly vulnerable to cognitive impairment and communication difficulties. Second, we provide detailed methodology, including the semi-structured interview format used, the development of the SLD, and an overview of responses from participants and investigators. We also describe the quantitative and qualitative approaches to analysis taken with the aim of developing scientific validation in support of the Hear My Voice project.

Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial.

OBJECTIVE: To evaluate the effect of a theory-based, culturally targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test. METHOD: 5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to one of three groups to receive their results: Intervention (I): culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; Active Control (AC): nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; or Standard Care Only (SCO). The primary outcome was attendance at the initial follow-up appointment. Secondary outcomes included delay in care, completion of care at 18 months, state anxiety (STAI Y-6), depressive symptoms (CES-D), and distress (CDDQ). Anxiety was assessed at enrollment, notification of results, and 7-14 days later with the CDDQ and CES-D. RESULTS: 299 women were included in intent-to-treat analyses. Adherence rates were 60% (I), 54% (AC), and 58% (SCO), p = .73. Completion rates were 39% (I) and 35% in the AC and SCO groups, p = .77. Delay in care (in days) was (M ± SD): 58 ± 75 (I), 69 ± 72 (AC), and 54 ± 75 (SCO), p = .75. Adherence was associated with higher anxiety at notification, p < .01 and delay < 90 days (vs. 90+) was associated with greater perceived personal responsibility, p < .05. Women not completing their care (vs. those who did) had higher CES-D scores at enrollment, p < .05. CONCLUSIONS: A theory-based, culturally targeted message was not more effective than a nontargeted message or standard care in improving behavior.

Primary care utilization and mental health diagnoses among adult patients requiring interpreters: a retrospective cohort study.

BACKGROUND: Patients requiring interpreters may utilize the health care system differently or more frequently than patients not requiring interpreters; those with mental health issues may be particularly difficult to diagnose. OBJECTIVE: To determine whether adult patients requiring interpreters exhibit different health care utilization patterns and rates of mental health diagnoses than their counterparts. DESIGN: Retrospective cohort study examining patient visits to primary care (PC), express care (EC), or the emergency department (ED) of a large group practice within 1 year. PATIENTS: Adult outpatients (n = 63,525) with at least one visit within the study interval and information regarding interpreter need. MAIN MEASURES: Mean visit counts, counts of mental disorders, and somatic symptom diagnoses between patients requiring interpreters (IS patients) and not requiring interpreters (non-IS patients). KEY RESULTS: IS patients (n = 1,566) had a higher mean number of visits overall (3.10 vs. 2.52), in PC (2.54 vs. 1.95), and in ED (0.53 vs. 0.44) than non-IS patients (all p < 0.01). IS patients had a lower mean number of visits in EC than non-IS patients (0.03 vs. 0.13; p < 0.01). Interpreter need remained a significant predictor of visit count in multivariate analyses including age, sex, insurance, and clinical complexity. A greater proportion of IS patients were high utilizers (10+ visits) than non-IS patients (3.6 % vs. 1.7 %; p < 0.01). IS patients had a lower frequency of mental health diagnoses (13.9 % vs. 16.7 %), but a higher frequency of diagnoses recognized as potential somatic symptoms including diseases of the nervous (29.3 % vs. 24.2 %), digestive (22.6 % vs. 14.5 %), and musculoskeletal systems (43.2 % vs. 34.5 %), and ill-defined conditions (61 % vs. 49.9 %), all p < 0.01. CONCLUSIONS: IS patients visited PC more often than their counterparts and were more often high utilizers of care. Two sources of high utilization, mental health diagnoses and somatic symptoms, differed appreciably between our populations and may be contributing factors.

Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial.

OBJECTIVE: Colposcopy has been used to detect epithelial damage with vaginal microbicides. In animal models, optical coherence tomography provided increased sensitivity over colposcopy in detecting epithelial injury. This randomized, double-blinded, clinical study compared optical coherence tomography to colposcopy for the evaluation of epithelial injury in women using placebo or nonoxynol-9. METHODS: Thirty women aged 18-45 were randomized to use hydroxyethyl cellulose placebo or nonoxynol-9 vaginal gel twice daily for 5.5 days. Imaging with colposcopy and optical coherence tomography was performed before product use, after the last dose, and 1 week later. Colposcopy was graded using standard criteria. Optical coherence tomography images were scored for epithelial integrity based on a published scoring system and were measured for epithelial thickness. RESULTS: Colposcopy findings, optical coherence tomography scores, and epithelial thicknesses were similar between treatment groups at baseline. After treatment, there were significant differences between the nonoxynol-9 (1.37) and control group (1.15) optical coherence tomography scores (P<.001), indicating epithelial injury, and there was epithelial thinning in the nonoxynol-9 group (237 micrometers) compared with the control group (292 micrometers; P=.008). There were no significant posttreatment colposcopic differences in epithelial disruption between treatment groups, with only increased erythema noted after nonoxynol-9 use (P=.02). CONCLUSION: Optical coherence tomography detected epithelial disruption and thinning not identified by colposcopy. Vaginal epithelial thickness, a measure previously available only through biopsy, decreased after nonoxynol-9 use, a finding that may contribute to increased susceptibility to human immunodeficiency virus after frequent use. Optical coherence tomography shows promise for the noninvasive clinical assessment of vaginal epithelial damage. CLINICAL TRIAL REGISTRATION: UMIN Clinical Trials Registry, www.umin.ac.jp/ctr/index.htm, R000006186. LEVEL OF EVIDENCE: I.

Perceptions of reimbursement for clinical trial participation.

A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women's perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women's completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22-45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation.

Is Spanish language a barrier to domestic violence assessment?

BACKGROUND: Domestic violence is the leading cause of injury to premenopausal women and fatal in over 1000 women annually, but few healthcare providers ask about it, citing numerous barriers, including language. This study tested the hypothesis that language does, in fact, pose a barrier to screening and that Spanish-speaking women report lower lifetime screening rates. METHODS: This study was part of an ongoing, multiclinic site, cervical cancer prevention trial in which patients completed a baseline survey, available in both Spanish and English, with the question: "Has a doctor or other healthcare provider ever asked you about domestic violence?" as well as other questions. RESULTS: Of 2591 women, 1017 (39%) chose to complete the survey in Spanish and 1574 (61%) in English. Within the entire group, 1137 (44%) reported having been asked about domestic violence. Among those completing the Spanish survey, this rate was 47% (lifetime assessment), and among English-language respondents, it was surprisingly lower at 42% (p=0.011). In multivariate analyses, however, this language effect was reduced to nonsignificance. Instead, age (particularly the 28-34-year quartile), having been pregnant, clinic site, and type of medical visit (postpartum) were positively associated with lifetime assessment. CONCLUSIONS: This study found a Spanish language preference is not a barrier to domestic violence assessment.

Attitudes, beliefs and behaviors surrounding organ donation among Hispanic women.

PURPOSE OF REVIEW: Hispanic individuals are disproportionately in need of donor organs and are less likely to consent to donation than their non-Hispanic counterparts. This review addresses psychological constructs that include the attitudes and beliefs that surround organ donation within Hispanic communities and highlights the importance of women in the domain of organ donation. RECENT FINDINGS: Attitudes toward living and posthumous donation are favorable. Mistrust of the medical profession, concerns about religious acceptance of donation, perceptions of inequity in the distribution of donated organs, and the context in which donation requests typically are made all serve as barriers to consent. Women are more likely to consent to donation than are men. SUMMARY: Hispanic-American groups are heterogeneous. Culturally sensitive approaches to communicating a donation request must consider ethnic origin and language preference. Family discussion of donation should be encouraged by the medical community as part of healthcare decision-making (independent of death or crisis); women may serve as an excellent bridge between healthcare providers and families in this regard.

The Body Image Concern Inventory: validation in a multiethnic sample and initial development of a Spanish language version.

Dysmorphic appearance concern encompasses preoccupation with a perceived appearance defect, defect checking and camouflaging, and social avoidance. The current study sought to evaluate the internal consistency, factor structure, and convergent validity of a measure of dysmorphic appearance concern, the Body Image Concern Inventory, as well as evaluate the psychometric properties of a Spanish version of the instrument. Women recruited as part of a reproductive clinic-based clinical trial completed the BICI and other self-report measures of distress. A total of 1043 women completed the measures in English (M=29 years, range=18-55 years) and 573 women completed the measures in Spanish (M=32 years, range=18-55 years). Both the English and Spanish BICI were internally consistent and correlated moderately with measures of current psychological distress (STAI-S, CES-D). Confirmatory factor analyses replicated the measure's proposed factor structure. Applications of the BICI for future research are discussed.

Demographic, behavioral, and physical correlates of body esteem among low-income female adolescents.

PURPOSE: To examine demographic, behavioral, and physical correlates of body esteem among female adolescents of lower socioeconomic background. METHODS: Data were collected in a women's health clinic in southeast Texas as part of a larger investigation. A total of 271 female individuals aged 16-21 years completed the Body Esteem Scale (BES), which yields scores for total body esteem, sexual attractiveness, weight concern, and physical condition. Participants answered questions regarding smoking and the presence of acne. Height and weight were measured by a nurse using standard instrumentation and technique. Of the participants, 35% were African-American, 31% white, and 34% Hispanic; and 48% reported an annual household income less than $20,000. The mean body mass index (BMI) was 26.1 (SD = 6.5). RESULTS: Race/ethnicity was associated with total body esteem, sexual attractiveness, weight esteem, and physical condition (all p < .01). African-American participants demonstrated greater body esteem on all scales relative to white participants. Adolescents reporting annual household incomes less than $20,000 (vs. greater) demonstrated higher overall body esteem, sexual attractiveness, and physical condition (all p < .01). Current smokers (vs. non-smokers) reported lower physical condition (p < .01), lower weight concern (p < .05), and lower overall body esteem (p < .02). BMI was associated with weight concern (p < .001) and total body esteem (p = .05). Adolescents reporting acne (vs. not) reported lower scores for total body esteem, sexual attractiveness, and weight concern (all p < .05). CONCLUSIONS: Body esteem among adolescent females is affected by demographic, physical, and behavioral variables. Results highlight the importance of measuring multiple dimensions of body esteem.

An evaluation of health care providers' sexual violence screening practices.

OBJECTIVE: To evaluate whether health care providers (HCPs) screen women and provide them with information about sexual violence and how women receive this information. STUDY DESIGN: A multiethnic sample of 945 low-income women recruited from family planning clinics responded to an anonymous survey regarding their discussions with HCPs about sexual violence. RESULTS: Forty-eight percent of women reported that they had been screened or given information about sexual violence by a HCP. Only 6% of women expressed discomfort with being screened, and more than 95% found the information given to them by HCPs to be helpful. Latina, less educated, and monolingual Spanish-speaking women were less likely to have been screened or provided information. CONCLUSION: Women find discussions of sexual violence by their HCPs to be helpful and nonintrusive. Educational, linguistic, and cultural factors appear to affect the likelihood that HCPs discuss sexual violence with their patients.

A qualitative examination of the needs of families faced with the option of organ donation.

Fewer than half of families approached about organ donation provide consent. Identifying specific support needs of family members in these situations is critical to help them cope and for improving consent rates. This focus group study retrospectively investigated donor and non-donor family members' perceived social support needs while facing the death of their loved one. Implications for nursing care and other interventions are discussed for interested healthcare providers.

Psychological and sociocultural perspectives on follow-up of abnormal Papanicolaou results.

OBJECTIVE: To understand women's motivation to attend follow-up of an abnormal Papanicolaou (Pap) test by applying a general theoretical framework for voluntary behavior. METHODS: Semistructured, face-to-face interviews were conducted among 120 low-income, African-American, Caucasian, or Hispanic outpatients, aged 25-50 years, who presented for routine gynecologic care. Interview questions assessed social, cognitive, environmental, and emotional factors surrounding follow-up for an abnormal Pap test. Content analysis was performed. RESULTS: The majority of women (74%) described their attitude toward returning for a follow-up visit as favorable. Overall, knowledge regarding the significance of an abnormal result was poor, and misconceptions were common. Perceived barriers, consequences, and social influences associated with attending follow-up were qualitatively different across the 3 racial/ethnic groups. For example, African-American and Hispanic women expressed embarrassment more frequently than Caucasian women and were less likely to anticipate obstacles to attending follow-up. Furthermore, African-American women were the least likely to be influenced by others' opinions and to perceive difficulty in adhering to follow-up recommendations. For nearly all women, adequate communication with their provider was a key component of anticipated adherence. CONCLUSION: Clinicians may exert a positive influence on adherence among patients who experience an abnormal Pap test by engaging patients in a dialogue that accommodates the patient's sociocultural environment, explores concerns regarding the partner's reaction, emphasizes the importance of follow-up, provides a clear understanding of the process and timeline surrounding follow-up recommendations, and encourages the patient to anticipate obstacles to adherence and assists with solutions.