The Role of Cryoablation in Breast Cancer Beyond the Oncologic Control: COST and Breast-Q Patient-Reported Outcomes.

BACKGROUND: Cryoablation has been established as a minimally invasive alternative to resection of early-stage breast cancer; however, there are no data on the cost and impact on patients' financial, psychosocial, sexual, physical, and cosmetic outcomes utilizing this approach. This study compares cost-effectiveness and patient-reported quality-of-life factors in cryoablation versus resection. METHODS: Women with early-stage, low-risk infiltrating ductal carcinomas ≤ 1.5 cm underwent cryoablation or resection. Adjuvant therapy was provided according to tumor board recommendations. Direct and indirect costs were tracked for both groups. Financial toxicity and well-being outcome were measured by administering the Comprehensive Score of Financial Toxicity (COST) and BREAST-Q surveys, respectively, at 6-month follow-up. RESULTS: Of the 34 eligible patients, 14 (41.1%) consented for cryoablation and 20 (58.8%) underwent resection. The median (centile) (range) follow-up was 35.0 (21.3) (15-50) months for cryoablation vs. 25 (20.8) (17-50) months for resection [p = 0.6479]. Mean (standard deviation) cost of care for cryoablation versus resection was $2221.70 (615.70) versus $16,896.50 (1332.40) [p < 0.0001], and median financial well-being scores for the cryoablation versus resection groups were 38.0 (34.5, 40.0) versus 10 (5.3, 14.0) [p < 0.0001]. Poor financial well-being was directly correlated with the cost of care [p < 0.0001]. Median psychosocial well-being scores were similar across both groups, however the cryoablation group had higher scores for physical [100 (100, 100) vs. 89 (79, 100); p = 0.0141], sexual [100 (91, 100) vs. 91 (87.5, 91); p = 0.0079], and cosmetic [100 (100, 100) vs. 88 (88, 100); p = 0.0171] outcomes. CONCLUSION: Cryoablation offers a cost-effective and quality-of-life advantage compared with resection for early-stage, low-risk breast cancer.

The Association of Nursing Home Characteristics and Quality with Adverse Events After a Hospitalization.

BACKGROUND/OBJECTIVES: We previously found high rates of adverse events (AEs) for long-stay nursing home residents who return to the facility after a hospitalization. Further evidence about the association of AEs with aspects of the facilities and their quality may support quality improvement efforts directed at reducing risk. DESIGN: Prospective cohort analysis. SETTING AND PARTICIPANTS: 32 nursing homes in the New England states. A total of 555 long-stay residents contributed 762 returns from hospitalizations. METHODS: We measured the association between AEs developing in the 45 days following discharge back to long-term care and characteristics of the nursing homes including bed size, ownership, 5-star quality ratings, registered nurse and nursing assistant hours, and the individual Centers for Medicare & Medicaid Services (CMS) quality indicators. We constructed Cox proportional hazards models controlling for individual resident characteristics that were previously found associated with AEs. RESULTS: We found no association of AEs with most nursing home characteristics, including 5-star quality ratings and the composite quality score. Associations with individual quality indicators were inconsistent and frequently not monotonic. Several individual quality indicators were associated with AEs; the highest tertile of percentage of residents with depression (4%-25%) had a hazard ratio (HR) of 1.65 [95% confidence interval (CI) 1.16, 2.35] and the highest tertile of the percentage taking antipsychotic medications (18%-35%) had an HR of 1.58 (CI 1.13, 2.21). The percentage of residents needing increased assistance with activities of daily living was statistically significant but not monotonic; the middle tertile (13% to <20%) had an HR of 1.69 (CI 1.16, 2.47). CONCLUSIONS AND IMPLICATIONS: AEs occurring during transitions between nursing homes and hospitals are not explained by the characteristics of the facilities or summary quality scores. Development of risk reduction approaches requires assessment of processes and quality beyond the current quality measures.

SUPPORT-AF IV: Supporting use of AC through provider prompting about oral anticoagulation therapy for AF clinical trial study protocol.

Background: Six million Americans suffer from atrial fibrillation (AF), a heart rhythm abnormality that significantly increases the risk of stroke. AF is responsible for 15% of ischemic strokes, which lead to permanent disability in 60% of cases and death in up to 20%. Anticoagulation (AC) is the mainstay for stroke prevention in patients with AF. Despite guidelines recommending AC for patients, up to half of eligible patients are not on AC. Clinical decision support tools in the electronic health record (EHR) can help bridge the disparity in AC prescription for patients with AF. Objective: To enhance and assess the effectiveness of our previous rule-based alert on AC initiation and persistence in a diverse patient population from UMass-Memorial Medical Center and University of Florida at Jacksonville. Methods/Results: Using the EHR, we will track AC initiation and persistence. We will interview both patients and providers to determine a measure of satisfaction with AC management. We will track digital crumbs to better understand the alert's mechanism of effect and further add enhancements. These enhancements will be used to refine the alert and aid in developing an implementation toolkit to facilitate use of the alert at other health systems. Conclusion: If the number of AC starts, the likelihood of persisting on AC, and the frequency alert use are found to be higher among intervention vs control providers, we believe such findings will confirm our hypothesis on the effectiveness of our alert.

Psychosocial and health-related risk factors for depressive symptom trajectories among midlife women over 15 years: Study of Women's Health Across the Nation (SWAN).

BACKGROUND: Psychosocial and health-related risk factors for depressive symptoms are known. It is unclear if these are associated with depressive symptom patterns over time. We identified trajectories of depressive symptoms and their risk factors among midlife women followed over 15 years. METHODS: Participants were 3300 multiracial/ethnic women enrolled in a multisite longitudinal menopause and aging study, Study of Women's Health Across the Nation. Biological, psychosocial, and depressive symptom data were collected approximately annually. Group-based trajectory modeling identified women with similar longitudinal patterns of depressive symptoms. Trajectory groups were compared on time-invariant and varying characteristics using multivariable multinomial analyses and pairwise comparisons. RESULTS: Five symptom trajectories were compared (50% very low; 29% low; 5% increasing; 11% decreasing; 5% high). Relative to whites, blacks were less likely to be in the increasing trajectory and more likely to be in the decreasing symptom trajectory and Hispanics were more likely to have a high symptom trajectory than an increasing trajectory. Psychosocial/health factors varied between groups. A rise in sleep problems was associated with higher odds of having an increasing trajectory and a rise in social support was associated with lower odds. Women with low role functioning for 50% or more visits had three times the odds of being in the increasing symptom group. CONCLUSIONS: Changes in psychosocial and health characteristics were related to changing depressive symptom trajectories. Health care providers need to evaluate women's sleep quality, social support, life events, and role functioning repeatedly during midlife to monitor changes in these and depressive symptoms.

Vasomotor Symptoms Across the Menopause Transition: Differences Among Women.

Vasomotor symptoms (VMS) are the primary menopausal symptoms, occurring in up 80% of women and peaking around the final menstrual period. The average duration is 10 years, longer in women with an earlier onset. Compared with non-Hispanic white women, black and Hispanic women are more likely and Asian women are less likely to report VMS. Risk factors include greater body composition (in the early stage of menopausal transition), smoking, anxiety, depression, sensitivity to symptoms, premenstrual syndrome, lower education, and medical treatments, such as hysterectomy, oophorectomy, and breast cancer-related therapies. VMS patterns over time and within higher-risk subgroups are heterogeneous across women.

Experiences of Racism and Breastfeeding Initiation and Duration Among First-Time Mothers of the Black Women's Health Study.

BACKGROUND: Breastfeeding rates are lower for black women in the USA compared with other groups. Breastfeeding and lactation are sensitive time points in the life course, centering breastfeeding as a health equity issue. In the USA, experiences of racism have been linked to poor health outcomes but racism relative to breastfeeding has not been extensively investigated. AIMS: This study aims to investigate the association between experiences of racism, neighborhood segregation, and nativity with breastfeeding initiation and duration. METHODS: This is a prospective secondary analysis of the Black Women's Health Study, based on data collected from 1995 through 2005. Daily and institutional (job, housing, police) racism, nativity, and neighborhood segregation in relation to breastfeeding were examined. Odds ratios and 95% confidence intervals were calculated using binomial logistic regression for the initiation outcomes (N = 2705) and multinomial logistic regression for the duration outcomes (N = 2172). RESULTS: Racism in the job setting was associated with lower odds of breastfeeding duration at 3-5 months. Racism with the police was associated with higher odds of breastfeeding initiation and duration at 3-5 and 6 months. Being born in the USA or having a parent born in the USA predicted lower odds of breastfeeding initiation and duration. Living in a segregated neighborhood (primarily black residents) as a child was associated with decreased breastfeeding initiation and duration relative to growing up in a predominantly white neighborhood. CONCLUSION: Experiences of institutionalized racism influenced breastfeeding initiation and duration. Structural-level interventions are critical to close the gap of racial inequity in breastfeeding rates in the USA.

Political Efficacy and Participation of Nurse Practitioners.

Twenty-eight states have laws and regulations limiting the ability of nurse practitioners (NPs) to practice to the full extent of their education and training, thereby preventing patients from fully accessing NP services. Revisions to state laws and regulations require NPs to engage in the political process. Understanding the political engagement of NPs may facilitate the efforts of nurse leaders and nursing organizations to promote change in state rules and regulations. The purpose of this study was to describe the political efficacy and political participation of U.S. NPs and gain insight into factors associated with political interest and engagement. In the fall of 2015, we mailed a survey to 2,020 NPs randomly chosen from the American Academy of Nurse Practitioners' database and 632 responded (31% response rate). Participants completed the Trust in Government (external political efficacy) and the Political Efficacy (internal political efficacy) scales, and a demographic form. Overall, NPs have low political efficacy. Older age ( p≤.001), health policy mentoring ( p≤.001), and specific education on health policy ( p≤.001) were all positively associated with internal political efficacy and political participation. External political efficacy was not significantly associated with any of the study variables. Political activities of NPs are largely limited to voting and contacting legislators. Identifying factors that engage NPs in grassroots political activities and the broader political arena is warranted, particularly with current initiatives to make changes to state laws and regulations that limit their practice.

Persistence of depression in African American and Caucasian women at midlife: findings from the Study of Women Across the Nation (SWAN).

This study prospectively examined the course of depression in African American and Caucasian midlife women over an 11-year period. Racial differences in lifetime history of depression, severity of depressive symptoms and rates of depressive disorders at baseline, and persistence or recurrence of depression over an 11 year period were examined. Predictors of persistence/recurrence of depression were also examined. The sample was comprised of 423 midlife women enrolled in the Study of Women Across the Nation (SWAN) Mental Health Study (MHS). All participants completed baseline and annual assessments, which included self-reported measures of health, functioning, and psychosocial factors, and clinician administered assessments of psychiatric disorders. Logistic regression analyses were used to examine predictors of depression persistence/recurrence. Findings indicated that African American and Caucasian women did not differ significantly in rates of lifetime and baseline depressive disorders, or severity of depressive symptoms. Annual assessments revealed no significant differences between the groups in rates of persistent/recurrent depression. While African American and Caucasian women do not differ in recurrence of depression at midlife, factors associated with depression differed by race.

Weighted staffing plans for better prediction of staffing needs.

OBJECTIVE: The aim of this study was to examine the effect of patient turnover and acuity on worked hours per patient day (WHPPD). BACKGROUND: An examination of staffing plans publically posted by Massachusetts hospitals with more than 300 beds revealed that less than 40% were within 5% of their planned versus actual WHPPD. METHODS: Three years of WHPPD data collected from 14 adult acute care units were correlated with patient turnover and acuity data. A weight factor was retrospectively added to 8 paired units' planned WHPPD where correlations were identified. RESULTS: Twelve units (86%) showed significant correlations between WHPPD and patient turnover. Correlations between patient acuity and WHPPD were significant only at the aggregate level. After weighting WHPPD, the 8 paired units demonstrated a decreased variance between planned and actual WHPPD. CONCLUSION: Using a weight factor added to WHPPD to right size acute care medical-surgical units may be useful for accurate staff planning and budgeting.

Factors related to age at natural menopause: longitudinal analyses from SWAN.

Early age at the natural final menstrual period (FMP) or menopause has been associated with numerous health outcomes and might be a marker of future ill health. However, potentially modifiable factors affecting age at menopause have not been examined longitudinally in large, diverse populations. The Study of Women's Health Across the Nation (SWAN) followed 3,302 initially premenopausal and early perimenopausal women from 7 US sites and 5 racial/ethnic groups, using annual data (1996-2007) and Cox proportional hazards models to assess the relation of time-invariant and time-varying sociodemographic, lifestyle, and health factors to age at natural FMP. Median age at the FMP was 52.54 years (n = 1,483 observed natural FMPs). Controlling for sociodemographic, lifestyle, and health factors, we found that racial/ethnic groups did not differ in age at the FMP. Higher educational level, prior oral contraceptive use, and higher weight at baseline, as well as being employed, not smoking, consuming alcohol, having less physical activity, and having better self-rated health over follow-up, were significantly associated with later age at the FMP. These results suggest that age at the natural FMP reflects a complex interrelation of health and socioeconomic factors, which could partially explain the relation of late age at FMP to reduced morbidity and mortality.

Religion and healthy lifestyle behaviors among postmenopausal women: the women's health initiative.

Worship attendance has been associated with longer survival in prospective cohort studies. A possible explanation is that religious involvement may promote healthier lifestyle choices. Therefore, we examined whether attendance is associated with healthy behaviors, i.e. use of preventive medicine services, non-smoking, moderate drinking, exercising regularly, and with healthy dietary habits. The population included 71,689 post-menopausal women enrolled in the Women's Health Initiative observational study free of chronic diseases at baseline. Attendance and lifestyle behaviors information was collected at baseline using self-administered questionnaires. Healthy behaviors were modeled as a function of attendance using logistic regression. After adjustment for confounders, worship attendance (less than weekly, weekly, and more than weekly vs. never) was positively associated with use of preventive services [OR for mammograms: 1.34 (1.19, 1.51), 1.41 (1.26, 1.57), 1.33 (1.17, 1.52); breast self exams: 1.14 (1.02, 1.27), 1.33 (1.21, 1.48), 1.25 (1.1, 1.43); PAP smears: 1.22 (1.01, 1.47-weekly vs. none)]; non-smoking: [1.41 (1.35, 1.48), 1.76 (1.69, 1.84), 2.27 (2.15, 2.39)]; moderate drinking [1.35 (1.27, 1.45), 1.60 (1.52, 1.7), 2.19 (2.0, 2.4)]; and fiber intake [1.08 (1.03, 1.14), 1.16 (1.11, 1.22), 1.31 (1.23, 1.39), respectively], but not with regular exercise or with lower saturated fat and caloric intake. These findings suggest that worship attendance is associated with certain, but not all, healthy behaviors. Further research is needed to get a deeper understanding of the relationship between religious involvement and healthy lifestyle behaviors and of the inconsistent patterns in this association.

The ReSTAGE Collaboration: defining optimal bleeding criteria for onset of early menopausal transition.

OBJECTIVE: Criteria for staging the menopausal transition are not established. This article evaluates five bleeding criteria for defining early transition and provides empirically based guidance regarding optimal criteria. DESIGN/SETTING: Prospective menstrual calendar data from four population-based cohorts: TREMIN, Melbourne Women's Midlife Health Project (MWMHP), Seattle Midlife Women's Health Study (SMWHS), and Study of Women's Health Across the Nation (SWAN) with annual serum FSH from MWMHP and SWAN. PARTICIPANTS: 735 TREMIN, 279 SMWHS, 216 MWMHP, and 2270 SWAN women aged 35-57 at baseline who maintained menstrual calendars. MAIN OUTCOME MEASURE(S): Age at and time to menopause for: standard deviation >6 and >8 days, persistent difference in consecutive segments >6 days, irregularity, and >or=45 day segment. Serum FSH concentration. RESULT(S): Most women experienced each of the bleeding criteria. Except for a persistent >6 day difference that occurs earlier, the criteria occur at a similar age and at approximately the same age as late transition in a large proportion of women. FSH was associated with all proposed markers. CONCLUSION(S): The early transition may be best described by ovarian activity consistent with the persistent >6 day difference, but further study is needed, as other proposed criterion are consistent with later menstrual changes.

Helping midlife women predict the onset of the final menses: SWAN, the Study of Women's Health Across the Nation.

OBJECTIVE: Women approaching menopause often ask their doctors, "When are my periods going to end?" The objective of this study was to predict time to the final menstrual period (FMP). DESIGN: This multiethnic, observational cohort study, the Study of Women's Health Across the Nation, has been ongoing since 1996. Data collected from seven annual study visits were used. The community-based cohort from seven national sites included 3,302 white, African American, Hispanic, Chinese, and Japanese women aged 42 to 52 years at baseline with a uterus and at least one ovary, who were not pregnant or taking reproductive hormones, and had at least one menstrual period within the past 3 months at baseline. The time to the FMP was defined retrospectively after 12 months of amenorrhea. Uni- and multivariable Cox proportional hazard models, hazard ratios (HRs), and 95% CIs were computed for variables of interest. RESULTS: A total of 2,662 women, of whom 706 had an observed FMP, were included. Age, menstrual cycles that had become farther apart (HR = 2.56, 95% CI = 1.94-3.39) or more variable (HR = 1.79, 95% CI = 1.45-2.21), and current smoking (HR = 1.68, 95% CI = 1.35-2.08) were all associated with shorter time to the FMP. Higher (log) follicle-stimulating hormone (HR = 2.32, 95% CI = 2.02-2.67) was related to a shorter time to the FMP, but the highest estradiol category (>or=100 pg/mL [367 pmol/L]) was associated with an earlier onset of the FMP (HR = 2.16, 95% CI = 1.63-2.89). The number of vasomotor symptoms was related to an earlier FMP, whereas higher physical activity and educational levels were associated with a later FMP. CONCLUSIONS: Age, menstrual cycle recall, smoking status, and hormone measurements can be used to estimate when the FMP will occur, allowing for more precise estimates for older midlife women: in the most extreme cases, ie, age 54, high estradiol level, current smoking, and high follicle-stimulating hormone level, the FMP can be estimated to within 1 year.

Lifestyle and demographic factors in relation to vasomotor symptoms: baseline results from the Study of Women's Health Across the Nation.

Results of recent trials highlight the risks of hormone therapy, increasing the importance of identifying preventive lifestyle factors related to menopausal symptoms. The authors examined the relation of such factors to vasomotor symptoms in the multiethnic sample of 3,302 women, aged 42-52 years at baseline (1995-1997), in the Study of Women's Health Across the Nation (SWAN). All lifestyle factors and symptoms were self-reported. Serum hormone and gonadotropin concentrations were measured once in days 2-7 of the menstrual cycle. After adjustment for covariates using multiple logistic regression, significantly more African-American and Hispanic and fewer Chinese and Japanese than Caucasian women reported vasomotor symptoms. Fewer women with postgraduate education reported vasomotor symptoms. Passive exposure to smoke, but not active smoking, higher body mass index, premenstrual symptoms, perceived stress, and age were also significantly associated with vasomotor symptoms, although a dose-response relation with hours of smoke exposure was not observed. No dietary nutrients were significantly associated with vasomotor symptoms. These cross-sectional findings require further longitudinal exploration to identify lifestyle changes for women that may help prevent vasomotor symptoms.

Utilization of services by chronically ill people in managed care and indemnity plans: implications for quality.

Because incentives for managed care organizations favor cost containment, concerns have been raised that quality of care has suffered, especially for chronically ill people. This study compares utilization rates of managed care and indemnity patients with three chronic conditions, using five years of claims records (1993-97) from private plans and Medicare in one market. Findings show that for all three conditions, managed care patients were more likely to see both primary care physicians and specialists within a year, but less likely to use a hospital emergency department or to be an inpatient. Assuming that patients with these illnesses should see a physician annually and that good primary care reduces the need for emergency and inpatient services, it appears that the patterns of care used by chronically ill managed care patients in this market do not reflect lower quality than that received by similar indemnity patients.

Chronic disease medication use in managed care and indemnity insurance plans.

OBJECTIVE: To evaluate the impact of managed care on the use of chronic disease medications. DATA SOURCE: Claims data from 1997 from two indemnity and three independent practice association (IPA) model managed care insurance plans. RESEARCH DESIGN: Cross-sectional analysis of claims data. DATA COLLECTION: Adult patients with diabetes mellitus (DM, n = 26,444), congestive heart failure (CHF, n = 7,978), and asthma (n = 9,850) were identified by ICD-9 codes. Chronic disease medication use was defined through pharmacy claims for patients receiving one or more prescriptions for drugs used in treating these conditions. Using multiple logistic regression we adjusted for patient case mix and the number of primary care visits. PRINCIPAL FINDINGS: With few exceptions, managed care patients were more likely to use chronic disease medications than indemnity patients. In DM, managed care patients were more likely to use sulfonylureas (43 percent versus 39 percent for indemnity), metformin (26 percent versus 18 percent), and troglitazone (8.8 percent versus 6.4 percent), but not insulin. For CHF patients, managed care patients were more likely to use loop diuretics (45 percent versus 41 percent), ACE inhibitors or angiotensin receptor blockers (50 percent versus 41 percent), and beta-blockers (23 percent versus 16 percent), but we found no differences in digoxin use. In asthma, managed care patients were more likely to use inhaled corticosteroids (34 percent versus 30 percent), systemic corticosteroids (18 percent versus 16 percent), short-acting beta-agonists (42 percent versus 33 percent), long-acting beta-agonists (9.9 percent versus 8.6 percent), and leukotriene modifiers (5.4 percent versus 4.1 percent), but not cromolyn or methylxanthines. Statistically significant differences remained after multivariate analysis that controlled for age, gender, and severity. CONCLUSIONS: Chronic disease patients in these managed care plans are more likely to receive both inexpensive and expensive medications. Exceptions included older medications partly supplanted by newer therapies. Differences may be explained by the fact that patients in indemnity plans face higher out-of-pocket costs and managed care plans promote more aggressive medication use. The relatively low likelihood of condition-specific medications in both plan types is a matter of concern, however.

Assessment of digit preference in self-reported year at menopause: choice of an appropriate reference distribution.

Estimated associations between self-reported age at menopause and health may be attenuated if self-report is inaccurate. In a cross-sectional study, it is not possible to assess validity or reproducibility. Instead, one can examine digit preference, e.g., overreporting of numbers ending in zero or five. Typically, analyses use equal proportions-10% probability for each digit-as the reference distribution. Depending on the age distribution of the sample and on the underlying distribution of age at the event, however, an alternative reference distribution may be more appropriate. As an illustration, the authors examined digit preference in the self-reported calendar year at the final menstrual period in cross-sectional data from 2,151 naturally postmenopausal women in the Study of Women's Health Across the Nation (1995-1997), a multisite, multiethnic study of women aged 40-55 years. With chi-square tests, the distribution of terminal digit for self-reported year at the final menstrual period was compared with several reference distributions. The observed distribution was much closer to a reference distribution based on previously published data than it was to equal proportions. Future assessments of digit preference in cross-sectional studies should consider alternatives to equal proportions, particularly for samples with small age ranges and events with a restricted underlying age distribution.