Reproductive characteristics, menopausal status, race and ethnicity, and risk of breast cancer subtypes defined by ER, PR and HER2 status: the Breast Cancer Etiology in Minorities study.

BACKGROUND: Associations between reproductive factors and risk of breast cancer differ by subtype defined by joint estrogen receptor (ER), progesterone receptor (PR), and HER2 expression status. Racial and ethnic differences in the incidence of breast cancer subtypes suggest etiologic heterogeneity, yet data are limited because most studies have included non-Hispanic White women only. METHODS: We analyzed harmonized data for 2,794 breast cancer cases and 4,579 controls, of whom 90% self-identified as African American, Asian American or Hispanic. Questionnaire data were pooled from three population-based studies conducted in California and data on tumor characteristics were obtained from the California Cancer Registry. The study sample included 1,530 luminal A (ER-positive and/or PR-positive, HER2-negative), 442 luminal B (ER-positive and/or PR-positive, HER2-positive), 578 triple-negative (TN; ER-negative, PR-negative, HER2-negative), and 244 HER2-enriched (ER-negative, PR-negative, HER2-positive) cases. We used multivariable unconditional logistic regression models to estimate subtype-specific ORs and 95% confidence intervals associated with parity, breast-feeding, and other reproductive characteristics by menopausal status and race and ethnicity. RESULTS: Subtype-specific associations with reproductive factors revealed some notable differences by menopausal status and race and ethnicity. Specifically, higher parity without breast-feeding was associated with higher risk of luminal A and TN subtypes among premenopausal African American women. In contrast, among Asian American and Hispanic women, regardless of menopausal status, higher parity with a breast-feeding history was associated with lower risk of luminal A subtype. Among premenopausal women only, luminal A subtype was associated with older age at first full-term pregnancy (FTP), longer interval between menarche and first FTP, and shorter interval since last FTP, with similar OR estimates across the three racial and ethnic groups. CONCLUSIONS: Subtype-specific associations with reproductive factors overall and by menopausal status, and race and ethnicity, showed some differences, underscoring that understanding etiologic heterogeneity in racially and ethnically diverse study samples is essential. Breast-feeding is likely the only reproductive factor that is potentially modifiable. Targeted efforts to promote and facilitate breast-feeding could help mitigate the adverse effects of higher parity among premenopausal African American women.

Persistence to Basal Insulin: Association With Health Outcomes in a Population With Type 2 Diabetes.

This study examined the association between persistence to basal insulin and clinical and economic health outcomes. The question of whether a persistence measure for basal insulin could be leveraged in quality measurement was also explored. Using the IBM-Truven MarketScan Commercial and Medicare Supplemental Databases from 1 January 2011 to 31 December 2015, a total of 14,126 subjects were included in the analyses, wherein 9,898 (70.1%) were categorized as persistent with basal insulin therapy. Basal insulin persistence was associated with lower A1C, fewer hospitalizations and emergency department visits, and lower health care expenditures. Quality measures based on prescription drug claims for basal insulin are feasible and should be considered for guiding quality improvement efforts.

It is time for a new comprehensive medication review quality measure.

Medication therapy management (MTM) services include comprehensive medication reviews (CMRs), which have been completed with millions of patients since their inception in the United States. The current MTM quality measure focuses on whether CMRs were completed (ie, the CMR completion rate). However, this process measure does not assess quality of care, or patient-reported or other outcomes of CMRs, and, therefore, does not reward MTM providers for improving health outcomes. In this viewpoint article, we present 3 reasons that shape our argument for new MTM quality measures and offer recommendations on next steps to achieve this. DISCLOSURES: Dr Vaffis is an employee of Clinical Outcomes Solutions and discloses this was work was completed previously during her employment at the University of Arizona. Dr Dhatt is an employee of Janssen and discloses this was work was completed previously during her employment at the University of Arizona. Dr Anderson is an employee of The Freedom Fund and discloses this was work was completed previously during her employment at the University of Arizona. Dr Black is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Campbell received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx and discloses this work was completed previously during his employment at the University of Arizona. Dr Kolobova is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Hines is an employee of Pharmacy Quality Alliance. Dr Castora-Binkley is an employee of Pharmacy Quality Alliance. Dr Nelson is an employee of Pharmacy Quality Alliance. Dr Axon received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx. Dr Warholak received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx and discloses this was work was completed previously during her employment at the University of Arizona.

Changes in Breast Cancer Risk and Risk Factor Profiles among U.S.-Born and Immigrant Asian American Women Residing in the San Francisco Bay Area.

BACKGROUND: Breast cancer incidence rates in women of Asian descent have been increasing in the United States and Asia. METHODS: In a case-control study of Asian American women from the San Francisco Bay Area, we assessed associations with birthplace and migration-related characteristics and compared risk factors between Asian American and non-Hispanic White women by birthplace and birth cohort. RESULTS: Birthplace and migration-related characteristics were associated with breast cancer risk only among women in the younger birth cohort (1951-1984) that comprised 355 cases diagnosed at age ≤55 years and 276 sister and population controls. Breast cancer risk was marginally increased among foreign-born women [OR = 1.40; 95% confidence interval (CI), 0.97-2.03] and two-fold among foreign-born Chinese women (OR = 2.16; 95% CI, 1.21-3.88). Two-fold increased risks were associated with migration at age ≥40 years and longer U.S. residence (≥30 years or ≥75% of life). The education level was high among both cases and controls. Differences in the prevalence of risk factors by birthplace and birth cohort suggest temporal changes in reproductive and lifestyle-related factors. The prevalence in risk factors was similar between foreign-born and U.S.-born women in the younger birth cohort, and did not fully explain the observed associations with birthplace and other migration characteristics. CONCLUSIONS: In contrast to studies from earlier decades, younger foreign-born Asian American women had a higher risk of breast cancer than U.S.-born Asian American women. IMPACT: It is important and urgent to understand what factors drive the increasing burden of breast cancer in women of Asian descent and implement effective prevention programs.

Variability in Opioid-Related Drug Overdoses, Social Distancing, and Area-Level Deprivation during the COVID-19 Pandemic: a Bayesian Spatiotemporal Analysis.

Monitoring the spatial and temporal course of opioid-related drug overdose mortality is a key public health determinant. Despite previous studies exploring the evolution of drug-related fatalities following the stay-at-home mandates during the COVID-19 pandemic, little is known about the spatiotemporal dynamics that mitigation efforts had on overdose deaths. The purpose of this study was to describe the spatial and temporal dynamics of overdose death relative risk using a 4-week interval over a span of 5 months following the implementation of the COVID-19 lockdown in the city of Chicago, IL. A Bayesian space-time model was used to produce posterior risk estimates and exceedance probabilities of opioid-related overdose deaths controlling for measures of area-level deprivation and stay-at-home mandates. We found that area-level temporal risk and inequalities in drug overdose mortality increased significantly in the initial months of the pandemic. We further found that a change in the area-level deprivation from the first to the fourth quintile increased the relative risk of a drug overdose risk by 44.5%. The social distancing index measuring the proportion of persons who stayed at home in each census block group was not associated with drug overdose mortality. We conclude by highlighting the importance of contextualizing the spatial and temporal risk in overdose mortality for implementing effective and safe harm reduction strategies during a global pandemic.

Overall survival is the lowest among young women with postpartum breast cancer.

BACKGROUND: Women diagnosed with breast cancer prior to age 45 years (<45y) and within the first 5 years postpartum (postpartum breast cancer, PPBC) have the greatest risk for distal metastatic recurrence. METHODS: Pooling data from the Colorado Young Women Breast Cancer cohort and the Breast Cancer Health Disparities Study (N = 2519 cases), we examined the association of parity, age, and clinical factors with overall survival (OS) of breast cancer over 15 years of follow-up. RESULTS: Women with PPBC diagnosed at <45y had the lowest OS (p < 0.0001), while OS of nulliparous cases diagnosed at <45y did not differ from OS of cases diagnosed at 45-65y regardless of parity status. After adjustment for study site, race/ethnicity, clinical stage, year of diagnosis and stratification for oestrogen receptor status, PPBC remained an independent factor associated with poor OS. Among cases diagnosed at <45y, nulliparous cases had 1.6 times better OS (hazard ratio (HR) = 0.61, 95%CI 0.42-0.87) compared to those with PPBC, with a more pronounced survival difference among stage I breast cancers (HR = 0.30, 95%CI 0.11-0.79). Among very young women diagnosed at age ≤35y, nulliparous cases had 2.3 times better OS (HR = 0.44, 95%CI 0.23-0.84) compared to PPBC. CONCLUSION: Our results suggest that postpartum status is the main driver of poor prognosis in young women with breast cancer, with the strongest association in patients diagnosed at age ≤35y and in those with stage I disease.

Energy homeostasis genes modify the association between serum concentrations of IGF-1 and IGFBP-3 and breast cancer risk.

Breast cancer is a multifactorial disease in which the interplay among multiple risk factors remains unclear. Energy homeostasis genes play an important role in carcinogenesis and their interactions with the serum concentrations of IGF-1 and IGFBP-3 on the risk of breast cancer have not yet been investigated. The aim of this study was to assess the modifying effect of the genetic variation in some energy homeostasis genes on the association of serum concentrations of IGF-1 and IGFBP-3 with breast cancer risk. We analyzed 78 SNPs from 10 energy homeostasis genes in premenopausal women from the 4-Corner's Breast Cancer Study (61 cases and 155 controls) and the Mexico Breast Cancer Study (204 cases and 282 controls). After data harmonization, 71 SNPs in HWE were included for interaction analysis. Two SNPs in two genes (MBOAT rs13272159 and NPY rs16131) showed an effect modification on the association between IGF-1 serum concentration and breast cancer risk (Pinteraction < 0.05, adjusted Pinteraction < 0.20). In addition, five SNPs in three genes (ADIPOQ rs182052, rs822391 and rs7649121, CARTPT rs3846659, and LEPR rs12059300) had an effect modification on the association between IGFBP-3 serum concentration and breast cancer risk (Pinteraction < 0.05, adjusted Pinteraction < 0.20). Our findings showed that variants of energy homeostasis genes modified the association between the IGF-1 or IGFBP-3 serum concentration and breast cancer risk in premenopausal women. These findings contribute to a better understanding of this multifactorial pathology.

Cumulative menstrual months and breast cancer risk by hormone receptor status and ethnicity: The Breast Cancer Etiology in Minorities Study.

Reproductive and hormonal factors may influence breast cancer risk via endogenous estrogen exposure. Cumulative menstrual months (CMM) can be used as a surrogate measure of this exposure. Using harmonized data from four population-based breast cancer studies (7284 cases and 7242 controls), we examined ethnicity-specific associations between CMM and breast cancer risk using logistic regression, adjusting for menopausal status and other risk factors. Higher CMM was associated with increased breast cancer risk in non-Hispanic Whites, Hispanics and Asian Americans regardless of menopausal status (all FDR adjusted P trends = .0004), but not in African Americans. In premenopausal African Americans, there was a suggestive trend of lower risk with higher CMM. Stratification by body mass index (BMI) among premenopausal African American women showed a nonsignificant positive association with CMM in nonobese (BMI <30 kg/m2 ) women and a significant inverse association in obese women (OR per 50 CMM = 0.56, 95% CI 0.37-0.87, Ptrend  = .03). Risk patterns were similar for hormone receptor positive (HR+; ER+ or PR+) breast cancer; a positive association was found in all premenopausal and postmenopausal ethnic groups except in African Americans. HR- (ER- and PR-) breast cancer was not associated with CMM in all groups combined, except for a suggestive positive association among premenopausal Asian Americans (OR per 50 CMM = 1.33, P = .07). In summary, these results add to the accumulating evidence that established reproductive and hormonal factors impact breast cancer risk differently in African American women compared to other ethnic groups, and also differently for HR- breast cancer than HR+ breast cancer.

A 12-Year Retrospective Study of the Prevalence of Anticholinergic Polypharmacy and Associated Outcomes Among Medicare Patients with Overactive Bladder in the USA.

BACKGROUND AND OBJECTIVE: Antimuscarinics, drugs with anticholinergic properties, are frequently prescribed for overactive bladder, and anticholinergic burden is associated with adverse events. The "Polypharmacy: Use of Multiple Anticholinergic Medications in Older Adults" (Poly-ACH) measure was developed by the Pharmacy Quality Alliance and is used by the Centers for Medicare and Medicaid Services. Using the Poly-ACH measure, we assessed the prevalence of anticholinergic polypharmacy among Medicare patients in the USA with overactive bladder and determined associations between polypharmacy and medical conditions, care, and spending. METHODS: This was a retrospective cohort study of Medicare beneficiaries with overactive bladder (coverage period: 2006-2017). Anticholinergic polypharmacy, measured by the Poly-ACH, was defined as concurrent use of two or more anticholinergics, each with two or more prescription claims on different dates of service for ≥ 30 cumulative days. Change in annual frequency of anticholinergic polypharmacy was assessed using logistic regression. Associations between anticholinergic polypharmacy over 3 years and falls, fractures, mental status, and medical care spending were assessed with longitudinal regression models. RESULTS: In total, 226,712 patients contributed 940,201 person-years of follow-up after overactive bladder diagnosis. The share of patients meeting the Poly-ACH definition was 3.3% in 2006 and 1.7% in 2017. Women and nursing home residents had higher risks of anticholinergic polypharmacy. Having 1 year or more of positive Poly-ACH status in the 3 years prior was associated with higher rates of all outcomes. CONCLUSIONS: Anticholinergic polypharmacy was uncommon among older adults with overactive bladder. Prevalence was higher among women and nursing home residents, and it was associated with negative outcomes, highlighting potential longitudinal implications of anticholinergic burden.

Factors associated with medication nonadherence among Medicare low-income subsidy beneficiaries with diabetes, hypertension, and/or heart failure.

BACKGROUND: Previous studies have documented factors influencing medication nonadherence among the Medicare population, but few studies have examined medication nonadherence among the Medicare low-income subsidy (LIS) population. Furthermore, little is known about the factors associated with nonadherence among this population, especially those with prevalent chronic conditions such as type 2 diabetes, hypertension, or heart failure. OBJECTIVE: To examine factors associated with the likelihood of medication nonadherence among Medicare LIS recipients with type 2 diabetes, hypertension, or heart failure. METHODS: This was a retrospective analysis of 2012-2013 Medicare Parts A, B, and D claims (most recent available for this research) linked to the Area Health Resources Files. Beneficiaries aged 65 years or older with continuous Medicare coverage and receiving any LIS were included. Individuals were categorized into full LIS or partial LIS groups. Nonadherence was determined by the proportion of days covered less than 80% for specified oral type 2 diabetes, hypertension, and heart failure medications, as defined by the Pharmacy Quality Alliance. A multivariate logistic regression was used to determine and compare individual-level and community-level characteristics associated with nonadherence among the entire study sample, the full LIS group, and the partial LIS group. RESULTS: The study sample included 505,771 Medicare beneficiaries, with 448,509 (88.7%) receiving full LIS and 57,262 (11.3%) receiving partial LIS. The proportion of individuals nonadherent was higher among the full LIS population (33.2%) than that of the partial LIS population (30.8%). Among the entire population, younger age was associated with nonadherence (OR = 0.98; 95% CI = 0.98-0.99). Men were more likely to be nonadherent than women (OR = 1.12; 95% CI = 1.11-1.14). Compared with non-Hispanic Whites, racial/ethnic minorities had higher nonadherence. Compared with beneficiaries who were non-Hispanic White, the ORs for those who were Black, Hispanic, Asian, and other were 1.41 (95% CI = 1.38-1.43), 1.58 (95% CI = 1.55-1.61), 1.08 (95% CI = 1.05-1.11), and 1.63 (95% CI = 1.56-1.70), respectively. There were higher nonadherence rates among patients living in communities with lower socioeconomic characteristics, such as a metropolitan statistical area (MSA vs non-MSA; OR = 1.05, 95% CI = 1.04-1.07). A higher risk adjustment summary score, indicating worse health status, was associated with an increased likelihood of medication nonadherence (OR = 1.21; 95% CI = 1.20-1.22). These patterns were similar among the full and partial LIS groups. CONCLUSIONS: Individual- and community-level characteristics were associated with the likelihood of medication nonadherence among Medicare LIS recipients with type 2 diabetes, hypertension, or heart failure. These characteristics included younger age, male sex, racial/ethnic minorities, living in lower socioeconomic communities, and a higher risk adjustment summary score. This study provided insight into medication nonadherence within the Medicare LIS population and identified the need to consider these factors when developing future policies to improve medication adherence. DISCLOSURES: This study was funded by the Pharmaceutical Research & Manufacturers of America (PhRMA), which was involved in the preparation and revision of the manuscript. Dougherty is employed by PhRMA. Todor was a PQA-CVS Health Foundation Scholar who was funded to work on this study. Hines is employed by Pharmacy Quality Alliance. Wang reports grants from AbbVie, Curo, Bristol Myers Squibb, and Pfizer, during the time of this study, and fees from the PhRMA Foundation for work on its Heath Outcomes Research Advisor Committee. The other authors have nothing to disclose. This study was presented as a poster at the online 2020 PQA Annual Meeting, May 7, 2020.

Effects of the Medicare Part D comprehensive medication review on medication adherence among patients with Alzheimer's disease.

OBJECTIVE: Older patients with Alzheimer's disease (AD) are challenged with adhering to complex medication regimens. We examined effects of Comprehensive Medication Review (CMR), a required Medicare Part D Medication Therapy Management (MTM) program component, on medication adherence among AD patients. METHODS: This retrospective study analyzed 100% of 2016-2017 Medicare claims covering the entire United States, linked to Area Health Resources Files. Medicare beneficiaries aged ≥65 years were included. Propensity score matching identified comparable intervention and comparison groups with the intervention defined as receiving a CMR in 2017. A difference-in-differences analysis included in multivariate logistic regressions an interaction term between CMR receipt and year 2017. The outcome measured was nonadherence to diabetes, hypertension and hyperlipidemia medications, with nonadherence defined as proportion of days covered <80% for study medications. RESULTS: Unadjusted comparisons indicated the proportion of nonadherence for intervention group members decreased from 2016 to 2017 but increased for the comparison group. In adjusted analyses, reduction in medication nonadherence among the intervention group remained higher: odds ratios for the interaction term were 0.62 (95% confidence interval [CI] = 0.54-0.71), 0.54 (95% CI = 0.50-0.58) and 0.50 (95% CI = 0.47-0.53) respectively for diabetes, hypertension and hyperlipidemia medications. This suggests that the likelihood of nonadherence in the intervention group was respectively reduced by 38%, 46% and 50% more than the comparison group. CONCLUSIONS: CMR was found to reduce nonadherence to diabetes, hypertension and hyperlipidemia medications among older Medicare beneficiaries with AD. This provides evidence that the MTM program is effective for a population with unique medication compliance challenges.

Randomized Trial Evaluating Clinical Impact of RAPid IDentification and Susceptibility Testing for Gram-negative Bacteremia: RAPIDS-GN.

BACKGROUND: Rapid blood culture diagnostics are of unclear benefit for patients with gram-negative bacilli (GNB) bloodstream infections (BSIs). We conducted a multicenter, randomized, controlled trial comparing outcomes of patients with GNB BSIs who had blood culture testing with standard-of-care (SOC) culture and antimicrobial susceptibility testing (AST) vs rapid organism identification (ID) and phenotypic AST using the Accelerate Pheno System (RAPID). METHODS: Patients with positive blood cultures with Gram stains showing GNB were randomized to SOC testing with antimicrobial stewardship (AS) review or RAPID with AS. The primary outcome was time to first antibiotic modification within 72 hours of randomization. RESULTS: Of 500 randomized patients, 448 were included (226 SOC, 222 RAPID). Mean (standard deviation) time to results was faster for RAPID than SOC for organism ID (2.7 [1.2] vs 11.7 [10.5] hours; P < .001) and AST (13.5 [56] vs 44.9 [12.1] hours; P < .001). Median (interquartile range [IQR]) time to first antibiotic modification was faster in the RAPID arm vs the SOC arm for overall antibiotics (8.6 [2.6-27.6] vs 14.9 [3.3-41.1] hours; P = .02) and gram-negative antibiotics (17.3 [4.9-72] vs 42.1 [10.1-72] hours; P < .001). Median (IQR) time to antibiotic escalation was faster in the RAPID arm vs the SOC arm for antimicrobial-resistant BSIs (18.4 [5.8-72] vs 61.7 [30.4-72] hours; P = .01). There were no differences between the arms in patient outcomes. CONCLUSIONS: Rapid organism ID and phenotypic AST led to faster changes in antibiotic therapy for gram-negative BSIs. CLINICAL TRIALS REGISTRATION: NCT03218397.

Effects of the Medicare Part D Comprehensive Medication Review on Racial and Ethnic Disparities in Medication Adherence.

Background: Substantial research has documented inequalities between US minorities and whites in meeting the eligibility criteria for the Medicare Part D medication therapy management (MTM) program. Even though the Centers for Medicare & Medicaid Services attempted to relax the eligibility criteria, a critical barrier to effective MTM reform is a lack of stronger evidence about the effects of MTM on minorities' health outcomes. Objective: To examine the effects of comprehensive medication review (CMR), an MTM core component, on racial and ethnic disparities in adherence to diabetes, hypertension, and hyperlipidemia medications among Medicare beneficiaries aged ≥65 years. Methods: This study used full-year 2017 Medicare Parts A, B, and D claims data, including MTM data, linked to the Area Health Resources Files. Racial and ethnic disparities in nonadherence to diabetes, hypertension, and hyperlipidemia medications were compared between CMR recipients and nonrecipients matched by their propensity scores. To determine the changes in racial and ethnic disparities after receiving CMR, a difference-in-differences framework was applied, by including in logistic regression analyses interaction terms between dummy variables for CMR receipt and each racial or ethnic minority group. Results: Compared with CMR nonrecipients, CMR recipients had significantly lower racial and ethnic disparities across the 3 outcome measures, with the exception of the difference between whites and blacks in nonadherence to diabetes medications. For example, compared with CMR nonrecipients, among CMR recipients the differences in the odds of nonadherence to hypertension medications were reduced, respectively, by 8% (95% confidence interval [CI], 0.88-0.96) between whites and blacks; by 18% (95% CI, 0.78-0.86) between whites and Hispanics; by 16% (95% CI, 0.77-0.91) between whites and Asians; and by 9% (95% CI, 0.85-0.98) between whites and other racial and ethnic groups. Conclusion: Receiving a CMR reduced the racial and ethnic disparities in adherence to diabetes, hypertension, and hyperlipidemia medications among Medicare beneficiaries aged ≥65 years. These findings provide critical empirical evidence that may inform the future design of the Medicare Part D MTM program, which is valuable for improving pharmacotherapy outcomes and could further realize its potential when additional people from racial and ethnic minorities are enrolled.

Exploring Racial and Ethnic Disparities in Medication Adherence Among Medicare Comprehensive Medication Review Recipients.

Background: There has been a lack of evidence on whether there are racial and ethnic disparities in medication nonadherence among individuals receiving comprehensive medication review (CMR), a required component of the Medicare Part D medication therapy management (MTM) services. Objectives: To explore racial/ethnic disparities in medication nonadherence among older MTM enrollees who received a CMR and to determine how much the identified disparities can be explained by observed characteristics. Methods: The retrospective study used 100% of the 2017 Medicare claims, including MTM data. Linked Area Health Resources Files provided community characteristics. Nonadherence was defined as proportion of days covered <80%, and was measured for diabetes, hypertension, and hyperlipidemia medications. Racial/ethnic disparities were examined by logistic regressions that included racial/ethnic minority dummy variables. A nonlinear Blinder-Oaxaca decomposition method was applied to decompose the identified disparities. Results: Compared with non-Hispanic Whites (Whites), Blacks were respectively 39% (odds ratio [OR] = 1.39, 95% confidence interval [CI] = 1.33-1.45), 27% (OR = 1.27, 95% CI = 1.22-1.32), and 43% (OR = 1.43, 95% CI = 1.39-1.47) more likely to be nonadherent to diabetes, hypertension, and hyperlipidemia medications; Hispanics were 20% (OR = 1.20, 95% CI = 1.14-1.27) more likely to be nonadherent to hyperlipidemia medications. The total portion of disparity explained was 13.42%, 7.66%, 14.87%, and 10.69% respectively for disparities in Black-White (B-W) diabetes, B-W hypertension, B-W hyperlipidemia, and Hispanic-White hyperlipidemia. The top three contributors were the proportion of married-couple families, census region, and male gender. Conclusions: A lower level of community affluence and social support, regional variations, and a lower proportion of males in Blacks and Hispanics may contribute to the disparities in medication nonadherence. The large unexplained portion of the disparity attests that nonadherence is a complex issue. The Medicare MTM program needs to implement measures to reduce disparities in medication adherence.

Racial/ethnic disparities in measure calculations for Part D Star Ratings among Medicare beneficiaries with diabetes, hypertension, and/or hyperlipidemia.

BACKGROUND: Previous literature reported racial/ethnic disparities in the measure assessment of diabetes medication adherence in the Medicare Part D Star Ratings program. OBJECTIVE: This study examined the likelihood of inclusion in measure calculation across racial/ethnic groups for adherence metrics in Part D Star Ratings among individuals with diabetes, hypertension, and/or hyperlipidemia. METHODS: This was a retrospective cross sectional analysis of a 10% random sample of 2017 Medicare claims linked to Area Health Resources Files. Inclusion in measure calculation was determined based on inclusion/exclusion criteria in adherence metrics for adherence medications for diabetes, hypertension, and hyperlipidemia in Part D Star Ratings developed by the Pharmacy Quality Alliance. Logistic regression and multinomial logistic regression were used to adjust for patient/community characteristics. RESULTS: The study sample size was 2 707 216. Compared to Non-Hispanic White (White) beneficiaries, minorities were more likely to be excluded from measure calculation among individuals with 1 condition. For example, among individuals with hypertension, compared to White individuals, the adjusted odds ratios for exclusion for Black, Hispanic, Asian/Pacific Islander and other individuals were 1.46 (95% confidence interval, or CI = 1.42-1.50), 1.38 (95% CI = 1.33-1.43), 1.28 (95% CI = 1.21-1.35), and 1.08 (95% CI = 1.02-1.15), respectively. Among individuals with more than 1 chronic condition, minorities were more likely to be included in fewer calculations for medication adherence measures. For example, among individuals with all 3 conditions, the adjusted relative risk ratios for Black, compared to White, beneficiaries for being included in 0, 1, and 2 measures, versus all 3 measures, were 2.14 (95% CI = 1.99-2.30), 1.49 (95% CI = 1.41-1.56), 1.20 (95% CI = 1.18-1.23), respectively. CONCLUSIONS: Compared to White beneficiaries, racial/ethnic minorities are more likely to be excluded from the calculation for adherence measures among individuals with diabetes, hypertension, and/or hyperlipidemia. Future studies should examine whether such disparities exacerbate existing racial/ethnic disparities in health outcomes and devise solutions for these disparities.

Association Between Medication Adherence and Healthcare Costs Among Patients Receiving the Low-Income Subsidy.

OBJECTIVES: Significant literature exists on the effects of medication adherence on reducing healthcare costs, but less is known about the effect of medication adherence among Medicare low-income subsidy (LIS) recipients. This study examined the effects of medication adherence on healthcare costs among LIS recipients with diabetes, hypertension, and/or heart failure. METHODS: This retrospective study analyzed Medicare claims data (2012-2013) linked to the Area Health Resources Files. Using measures developed by the Pharmacy Quality Alliance, adherence to 11 medication classes was studied among patients with 7 possible combinations of the diseases mentioned. Adherence was measured in 8 categories of proportion of days covered (PDC): ≥95%, 90% to <95%, 85% to <90%, 80% to <85%, 75% to <80%, 50% to <75%, 25% to <50%, and <25%. Annual Medicare costs were compared across adherence categories. A generalized linear model was used to control for patient/community characteristics. RESULTS: Among patients with only one disease, such as diabetes, patients with the lowest adherence (PDC < 25%) had $3152/year higher Medicare costs than patients with the highest adherence (PDC ≥ 95%; $11 101 vs $7949; P < .05). The adjusted costs among patients with PDC < 25% was $1893 higher than patients with PDC ≥ 95% ($9919 vs $8026; P < .05). Among patients with multiple chronic conditions, patients' adherence to medications for fewer diseases had higher costs. CONCLUSIONS: Greater medication adherence is associated with lower Medicare costs in the Medicare LIS population. Future policy affecting the LIS program should encourage better medication adherence among patients with chronic diseases.

Menstrual and reproductive characteristics and breast cancer risk by hormone receptor status and ethnicity: The Breast Cancer Etiology in Minorities study.

We pooled multiethnic data from four population-based studies and examined associations of menstrual and reproductive characteristics with breast cancer (BC) risk by tumor hormone receptor (HR) status [defined by estrogen receptor (ER) and progesterone receptor (PR)]. We estimated odds ratios and 95% confidence intervals using multivariable logistic regression, stratified by age (<50, ≥50 years) and ethnicity, for 5,186 HR+ (ER+ or PR+) cases, 1,365 HR- (ER- and PR-) cases and 7,480 controls. For HR+ BC, later menarche and earlier menopause were associated with lower risk in non-Hispanic whites (NHWs) and Hispanics, and higher parity and longer breast-feeding were associated with lower risk in Hispanics and Asian Americans, and suggestively in NHWs. Positive associations with later first full-term pregnancy (FTP), longer interval between menarche and first FTP and shorter time since last FTP were limited to younger Hispanics and Asian Americans. Except for nulliparity, reproductive characteristics were not associated with risk in African Americans. For HR- BC, lower risk was associated with later menarche, except in African Americans and older Asian Americans and with longer breast-feeding in Hispanics and Asian Americans only. In younger African Americans, HR- BC risk associated with higher parity (≥3 vs. 1 FTP) was increased fourfold in women who never breast-fed, but not in those with a breast-feeding history, suggesting that breast-feeding may mitigate the adverse effect of higher parity in younger African American women. Further work needs to evaluate why menstrual and reproductive risk factors vary in importance according to age and ethnicity.

Testing the face validity and inter-rater agreement of a simple approach to drug-drug interaction evidence assessment.

Low concordance between drug-drug interaction (DDI) knowledge bases is a well-documented concern. One potential cause of inconsistency is variability between drug experts in approach to assessing evidence about potential DDIs. In this study, we examined the face validity and inter-rater reliability of a novel DDI evidence evaluation instrument designed to be simple and easy to use. METHODS: A convenience sample of participants with professional experience evaluating DDI evidence was recruited. Participants independently evaluated pre-selected evidence items for 5 drug pairs using the new instrument. For each drug pair, participants labeled each evidence item as sufficient or insufficient to establish the existence of a DDI based on the evidence categories provided by the instrument. Participants also decided if the overall body of evidence supported a DDI involving the drug pair. Agreement was computed both at the evidence item and drug pair levels. A cut-off of ≥ 70% was chosen as the agreement threshold for percent agreement, while a coefficient > 0.6 was used as the cut-off for chance-corrected agreement. Open ended comments were collected and coded to identify themes related to the participants' experience using the novel approach. RESULTS: The face validity of the new instrument was established by two rounds of evaluation involving a total of 6 experts. Fifteen experts agreed to participate in the reliability assessment, and 14 completed the study. Participant agreement on the sufficiency of 22 of the 34 evidence items (65%) did not exceed the a priori agreement threshold. Similarly, agreement on the sufficiency of evidence for 3 of the 5 drug pairs (60%) was poor. Chance-corrected agreement at the drug pair level further confirmed the poor interrater reliability of the instrument (Gwet's AC1 = 0.24, Conger's Kappa = 0.24). Participant comments suggested several possible reasons for the disagreements including unaddressed subjectivity in assessing an evidence item's type and study design, an infeasible separation of evidence evaluation from the consideration of clinical relevance, and potential issues related to the evaluation of DDI case reports. CONCLUSIONS: Even though the key findings were negative, the study's results shed light on how experts approach DDI evidence assessment, including the importance situating evidence assessment within the context of consideration of clinical relevance. Analysis of participant comments within the context of the negative findings identified several promising future research directions including: novel computer-based support for evidence assessment; formal evaluation of a more comprehensive evidence assessment approach that requires consideration of specific, explicitly stated, clinical consequences; and more formal investigation of DDI case report assessment instruments.

One Early Course-Based Undergraduate Research Experience Produces Sustainable Knowledge Gains, but only Transient Perception Gains.

Universities have been called upon to integrate research experiences into early, introductory courses to better prepare our STEM workforce. This call is primarily based on short-term studies that link research experiences with knowledge and perception gains. However, the influence of pre-existing student characteristics has not been fully disentangled from the research experience, and the long-term stability of these gains is uncertain. To address these issues, we integrated a course-based undergraduate research experience (CURE) into randomly assigned sections of a required freshman-level biology laboratory course. We previously reported that this CURE resulted in immediate targeted knowledge and perception gains. Here, we evaluate the stability of these gains as students progressed through a biology degree program. At sophomore year, the impact of the CURE on student perception was still apparent. When compared to controls, students who participated in the CURE perceived a greater understanding of what researchers do and an increased interest in pursuing a research career. However, by senior year, these positive perceptions had fallen to levels shared by control groups. Targeted knowledge gains persisted throughout this study. Our results support CURE logic models predicting that multiple CUREs will be required to sustain perception gains.