Publications by authors named "Aaron N Winn"

43 Publications

Financial burden and medication adherence among near-poor older adults in a pharmaceutical assistance program.

Res Social Adm Pharm 2021 Apr 29. Epub 2021 Apr 29.

Medical College of Wisconsin, Pharmacy School, 8701 Watertown Plank Rd., HRC H2600, Milwaukee, WI, 53226, USA. Electronic address:

Background: With increasing drug prices in the past decade, affordability and medication adherence are a growing concern for near-poor older adults, especially for those who are not receiving Low-Income Subsidy in Medicare Part D. SeniorCare is a pharmaceutical assistance program in Wisconsin for near-poor older adults, providing comprehensive prescription coverage with flat copayments.

Objectives: To evaluate five-year trends in financial hardship and medication adherence and to examine factors associated with these outcomes in SeniorCare members.

Methods: SeniorCare program enrollment and pharmacy claims data from 2014 to 2018 were used. The study population was near-poor older adults in SeniorCare with annual family income ≤200% of the federal poverty level. Financial burden was assessed using the proportion of total annual out-of-pocket costs to total annual income. Medication adherence was assessed by adapting the measures endorsed by the Pharmacy Quality Alliance and National Quality Forum. Descriptive statistics and independent t-tests were used to evaluate the trends, and multivariate logistic regressions were conducted to examine factors associated with financial burden and medication adherence.

Results: From 2014 to 2018, mean annual out-of-pocket costs per member declined by 3.7% (p < 0.001) for all drugs, while those for specialty drugs increased by 31.2% (p < 0.05). Around 3.3% spent more than 5% of their income for prescription drugs in 2014, which decreased to 2.4% in 2018 (p < 0.001). The proportions of adherent patients increased from 78.1% to 81.2% (p < 0.001) for diabetes medications (excluding insulins), from 77.3% to 79.5% (p < 0.001) for statins, and from 79.8% to 80.8% (p < 0.05) for RASA. Members subject to a $500 annual deductible were more likely to experience high financial burden (adjusted odds ratio (AOR) = 1.677, p < 0.001) and less likely to be adherent to diabetes medications (AOR = 0.484, p < 0.001).

Conclusions: The near-poor older adults enrolled in Wisconsin SeniorCare program had low financial burden and good medication adherence within the program.
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http://dx.doi.org/10.1016/j.sapharm.2021.04.016DOI Listing
April 2021

Personal Payments from Pharmaceutical Companies to Authors of Oncology Clinical Practice Guidelines.

Oncologist 2021 May 13. Epub 2021 May 13.

Health Outcomes Research Group, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Background: Oncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice guideline committees is associated with differences in the amounts of industry money received.

Materials And Methods: We conducted a nested case-control study from August 2013 to December 2018. We manually abstracted membership records of National Comprehensive Cancer Network (NCCN) Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee ("joiners") during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference-in-differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair.

Results: During the study period, 54 physicians joined an NCCN Guidelines committee. These physicians received more payments than matched controls in the year prior to joining ($11,259 vs. $3,427; p = .02); this difference did not increase in the year after joining (DiD = $731; p = .45).

Conclusion: Medical oncologists selected to NCCN Guidelines committees had greater financial ties to industry than their peers. The potential influence of industry in oncology clinical practice guidelines may be reduced through the selection of committee members with fewer ties to industry.

Implications For Practice: Oncologists who author clinical practice guidelines frequently have financial conflicts of interest with the pharmaceutical industry. This creates concern about the potential for industry influence on guidelines. However, it is unknown whether oncologists who author guidelines have greater industry relationships than their peers. This study compared medical oncologists who were newly selected to join a National Comprehensive Cancer Network (NCCN) Guidelines panel with medical oncologists at the same institutions and at similar career stages. At the time they joined, oncologists joining NCCN Guidelines panels had received more than three times the dollar value of industry payments than their peers. The potential for industry influence may be reduced by the selection of less-conflicted panel members.
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http://dx.doi.org/10.1002/onco.13823DOI Listing
May 2021

Clinician burnout during the COVID-19 pandemic before vaccine administration.

J Am Pharm Assoc (2003) 2021 Apr 20. Epub 2021 Apr 20.

Background: Coronavirus disease 2019 (COVID-19) has disrupted pharmacy practice. Little research has been done to assess how COVID-19 has affected pharmacists' employment, workload, and feelings of burnout.

Objectives: The objectives of this study were to characterize the impact of COVID-19 on pharmacists' employment status, workload, and feelings of burnout, as well as to examine emotional health concerns related to COVID-19.

Methods: Wisconsin pharmacists were surveyed using an online instrument between August 25, 2020, and September 22, 2020. The data analysis, performed in December 2020, examined employment status, 3 common burnout risk factors (workload, rewards, and social depersonalization), and emotional health concerns related to COVID-19.

Results: Of the 1300 pharmacists, 439 completed the survey (33.8%). The study analysis included pharmacists in community (n = 127) and hospital or health system (n = 107) settings. With regard to employment changes and workload, hospital pharmacists (36%) were more likely to have their hours reduced than community pharmacists (13%) (P < 0.01), and, conversely, community pharmacists (19%) were more likely to have their hours increased than hospital pharmacists (8%) (P = 0.01). For the burnout domain of workload, 45% of the pharmacists reported increased feelings of physical exhaustion at work, and 53% reported increased feelings of emotional exhaustion at work, with no difference between settings. Regarding the burnout domain of rewards, 6% of the hospital pharmacists and 1% of the community pharmacists experienced a reduction in hourly wages or salaries as a result of COVID-19. For the burnout domain of depersonalization, 25% of the pharmacists reported that their ability to connect with colleagues and patients decreased during the COVID-19 pandemic. Additional emotional health concerns reported by the pharmacists included 40% experiencing more anxiety and 25% experiencing more sadness or depression during the COVID-19 pandemic, with no difference between settings.

Conclusion: This study found that the burnout domains related to workload, rewards, and depersonalization were negatively affected by COVID-19. Pharmacy managers need to proactively combat burnout as well as be reactive when employees show signs of burnout to maintain their workforce and meet the COVID-19-associated challenges.
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http://dx.doi.org/10.1016/j.japh.2021.04.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056845PMC
April 2021

The Role of Physician Professional Networks in Physicians' Receipt of Pharmaceutical and Medical Device Industries' Payments.

J Gen Intern Med 2021 Apr 26. Epub 2021 Apr 26.

Gillings School of Global Public Health, Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Financial relationships between physicians and the pharmaceutical and medical device industries are common, but the factors associated with physicians receiving payments are unknown.

Objective: The objective of this study is to evaluate the influence of physicians' professional networks' characteristics on the receipt of payments among physicians.

Design: Network analysis of cross-sectional data PARTICIPANTS: US physicians who shared Medicare patients with other physicians in 2015 (N=357,813).

Exposure (intervention): Proportion of a physician's professional network that received industry payments and other network characteristics including number of physician connections, how central the physician is within the network, and the tightness of the referral network in which a physician is located.

Main Outcome Measures: Relative risk of receiving industry payments. We used modified Poisson regression to control for confounding by gender, time since graduation, practice size, and practice setting (teaching hospital vs. not). We included dummy variables for specialty and hospital referral region level.

Key Results: The proportion of a physician's peers in their professional network that received payments was strongly associated with receipt of pharmaceutical or device industry payments by the physician (top vs bottom quartile aRR=1.28, 95%CI=1.25-1.31). Physician's centrality within a network had a small positive effect on receiving payment (top vs bottom quartile aRR=1.02, 95%CI=1.01-1.04). Network density also had a small negative association with receipt of payment (top vs bottom quartile aRR=0.97, 95%CI=0.96-0.98).

Conclusions: Network characteristics, particularly the receipt of payments among physicians one shares patients with, are associated with whether a physician receives payments. This finding has implications for institutional regulation of industry payments to physicians and demonstrates how institutional policy may impact not only the physicians within the institution but also physicians outside of the institution.
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http://dx.doi.org/10.1007/s11606-021-06802-9DOI Listing
April 2021

An adapted two-step floating catchment area method accounting for urban-rural differences in spatial access to pharmacies.

J Pharm Health Serv Res 2021 Mar 16;12(1):69-77. Epub 2021 Jan 16.

Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, USA.

Objective: To adapt the two-step floating catchment area approach to account for urban-rural differences in pharmacy access in the United States.

Methods: The urban-rural two-step floating catchment area method was described mathematically. To calculate urban-rural-two-step floating catchment area measure, census tracts and pharmacies within the study area (Southeastern Wisconsin) were classified as urban, suburban or rural, and then different catchment area sizes (2, 5 and 15 miles) were applied, based on the Centers for Medicare & Medicaid Services (CMS)' criteria for Medicare Part D service access within urban, suburban and rural areas. The urban-rural-two-step floating catchment area measures were compared to traditional two-step floating catchment area measures computed using three fixed catchment area sizes (2, 5, and 15 miles) by visually examining their spatial distributions. Associations between the four pharmacy accessibility measures and selected socio-demographics are calculated using Spearman's rank-order correlation and further compared.

Key Findings: The urban-rural two-step floating catchment area measure outperforms all the fixed catchment size measures and has the strongest Spearman correlations with the selected census variables. It also reduces the number of census tracts characterized as 'no access' when compared to the original measures. The spatial distribution of urban-rural two-step floating catchment area pharmacy access exhibits a more granular variation across the study area.

Conclusions: The results support our hypothesis that spatial access to pharmacies should account for urbanicity/rurality patterns within a region.
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http://dx.doi.org/10.1093/jphsr/rmaa022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938828PMC
March 2021

The costs of treating and not treating patients with chronic myeloid leukemia with tyrosine kinase inhibitors among Medicare patients in the United States.

Cancer 2021 01 29;127(1):93-102. Epub 2020 Oct 29.

Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, Michigan.

Background: Patients with high cost-sharing of tyrosine kinase inhibitors (TKIs) experience delays in treatment for chronic myeloid leukemia (CML). To the authors' knowledge, the clinical outcomes among and costs for patients not receiving TKIs are not well defined.

Methods: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, the authors evaluated differences in TKI initiation, health care use, cost, and survival among patients with CML with continuous Medicare Parts A and B and Part D coverage who were diagnosed between 2007 and 2015.

Results: A total of 941 patients were included. Approximately 29% of all patients did not initiate treatment with TKIs within 6 months (non-TKI users), and had lower rates of BCR-ABL testing and more hospitalizations compared with TKI users. Approximately 21% were not found to have any TKI claims at any time. TKI initiation rates within 6 months of diagnosis increased for all patients over time (61% to 85%), with greater improvements observed in patients receiving subsidies (55% to 90%). Total Medicare costs were greater in patients treated with TKIs, with approximately 50% because of TKI costs. Non-TKI users had more inpatient costs compared with TKI users. Trends in cost remained significant when adjusting for age and comorbidities. The median overall survival was 40 months (95% confidence interval [95% CI], 34-48 months) compared with 86 months (95% CI, 73 months to not reached), respectively, for non-TKI users versus TKI users, a finding that remained consistent when adjusting for age, comorbidities, and subsidy status (hazard ratio, 2.23; 95% CI, 1.77-2.81).

Conclusions: Approximately 21% of all patients with CML did not receive TKIs at any time. Cost-sharing subsidies consistently are found to be associated with higher initiation rates. Non-TKI users had higher inpatient costs and poorer survival outcomes. Interventions to lower TKI costs for all patients are desirable.
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http://dx.doi.org/10.1002/cncr.33267DOI Listing
January 2021

Response to Strassels and Durham.

J Natl Cancer Inst 2020 12;112(12):1280

Department of Population Health and Department of Anesthesiology, University of Kansas Medical Center (KUMC), Kansas City, KS, USA.

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http://dx.doi.org/10.1093/jnci/djaa146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735774PMC
December 2020

Association of Current Opioid Use With Serious Adverse Events Among Older Adult Survivors of Breast Cancer.

JAMA Netw Open 2020 09 1;3(9):e2016858. Epub 2020 Sep 1.

Department of Population Health, University of Kansas Medical Center, Kansas City.

Importance: National efforts to improve safe opioid prescribing focus on preventing misuse, overdose, and opioid use disorder. This approach overlooks opportunities to better prevent other serious opioid-related harms in complex populations, such as older adult survivors of cancer. Little is known about the rates and risk factors for comprehensive opioid-related harms in this population.

Objective: To determine rates of multiple opioid-related adverse drug events among older adults who survived breast cancer and estimate the risk of these events associated with opioid use in the year after completing cancer treatment.

Design, Setting, And Participants: This retrospective cohort study used 2007 to 2016 Surveillance, Epidemiology and End Results-Medicare data from fee-for-service Medicare beneficiaries with first cancer diagnosis of stage 0 to III breast cancer at age 66 to 90 years from January 1, 2008, through December 31, 2015, who completed active breast cancer treatment. Data were analyzed from October 31, 2019, to June 10, 2020.

Exposures: Repeated daily measure indicating possession of any prescription opioid supply in Medicare Part D prescription claims.

Main Outcomes And Measures: Adjusted risk ratios (aRRs), estimated using modified Poisson generalized estimating equation models, for adverse drug events related to substance misuse (ie, diagnosed opioid abuse, dependence, or poisoning), other adverse drug events associated with opioid use (ie, gastrointestinal events, infections, falls and fractures, or cardiovascular events), and all-cause hospitalization associated with opioid supply the prior day, controlling for patient characteristics.

Results: Among 38 310 women included in the study (mean [SD] age, 74.3 [6.3] years), there were 0.010 (95% CI, 0.008-0.011) adverse drug events related to substance misuse per 1000 person-days, 0.237 (95% CI, 0.229-0.245) other adverse drug events associated with opioid use per 1000 person-days, and 0.675 (95% CI, 0.662-0.689) all-cause hospitalizations per 1000 person-days. Opioid use was associated with increased risk of adverse drug events related to substance misuse (aRR, 14.62; 95% CI, 9.69-22.05; P < .001), other adverse drug events related to opioid use (aRR, 2.50; 95% CI, 2.11-2.96; P < .001), and all-cause hospitalization (aRR, 2.77; 95% CI, 2.55-3.02; P < .001). In a dose-response effect, individuals with high daily opioid doses had consistently higher risks of all study outcomes compared with individuals who had low opioid doses. Compared with days with no opioid exposure, the risk of any adverse drug event related to substance misuse was 3.4-fold higher for individuals with a current opioid supply ≥50 mg morphine equivalent dose per day (aRR, 3.40; 95% CI, 2.47-4.68; P < .001), while the risk was 2.3-fold higher for individuals with 1 to 49 mg morphine equivalent dose per day (aRR, 2.29; 95% CI, 1.89-2.77; P < .001).

Conclusions And Relevance: These findings suggest that among older adults who survived breast cancer, continued prescription opioid use in the year after completing active cancer treatment was associated with an immediate increased risk of a broad range of serious adverse drug events related to substance misuse and other adverse drug events associated with opioid use. Clinicians should consider the comprehensive risks of managing cancer pain with long-term opioid therapy.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.16858DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492912PMC
September 2020

The impact of generic aromatase inhibitors on initiation, adherence, and persistence among women with breast cancer: Applying multi-state models to understand the dynamics of adherence.

Pharmacoepidemiol Drug Saf 2020 05 20;29(5):550-557. Epub 2020 Mar 20.

Cancer Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

Purpose: Clinical trials have clearly documented the survival benefit of aromatase inhibitors (AIs); however, many women fail to initiate (primary nonadherence) or remain adherent to AIs (secondary nonadherence). Prior studies have found that costs impact secondary nonadherence to medications but have failed to examine primary nonadherence. The purpose of this study is to examine primary and secondary adherence following the reduction in copays due to the introduction of generic AIs.

Methods: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified 50 054 women diagnosed with incident breast cancer between 2008 and 2013. We compare women whose copays would change and those whose would not, due to the receipt of cost-sharing subsidies before and after generics were introduced using a difference-in-difference (DinD) analysis. To examine primary and secondary nonadherence, we rely on a multistate model with four states (Not yet initiated, User, Not Using, and Death). We adjusted for baseline factors using inverse probability treatment weights and then simulated adherence for 36 months following diagnosis.

Results: The generic introduction of AIs resulted in patients initiating AIs faster (DinD = -4.7%, 95%CI = -7.0, -2.3; patients not yet initiating treatment at 6-months), being more adherent (DinD ranging in absolute increase of 8.1%-10.4%) and being less likely to not be using the therapy (DinD range in absolute decrease of 1.2% at 6 months to 8.8% at 24 months) for women that do not receive a subsidy after generics were available.

Conclusions: Introduction of generic alternatives to AIs significantly reduced primary and secondary nonadherence.
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http://dx.doi.org/10.1002/pds.4995DOI Listing
May 2020

Oral Oncology Parity Laws, Medication Use, and Out-of-Pocket Spending for Patients With Blood Cancers.

J Natl Cancer Inst 2020 10;112(10):1055-1062

Department of Health Care Policy, Harvard Medical School, Boston, MA, USA.

Background: In this study, we sought to estimate the association between oral oncology parity law adoption and anticancer medication use for patients with chronic myeloid leukemia or multiple myeloma.

Methods: This was an observational study of administrative claims from 2008 to 2017. Among individuals initiating tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia or immunomodulatory drugs for multiple myeloma, we compared out-of-pocket spending, adherence, and discontinuation before and after parity among individuals in fully insured plans (subject to parity) vs self-funded plans (exempt from parity) using propensity-score weighted difference-in-differences regression models.

Results: Among patients initiating TKIs (N = 2082) or immunomodulatory drugs (N = 3326) there were no statistically significant differences in adherence or discontinuation associated with parity. The proportion of patients with initial out-of-pocket payments of $0 increased in fully insured plans after parity from 5.7% to 46.1% for TKIs and from 10.9% to 48.8% for immunomodulatory drugs. Relative to changes in self-funded plans, those in fully insured plans were 4.27 (95% CI = 2.20 to 8.27) times as likely to pay nothing for TKIs and 1.96 (95% CI = 1.40 to 2.73) times as likely to pay nothing for immunomodulatory drugs after parity. Similarly, the proportion paying more than $100 decreased from 30.3% to 24.7% for TKIs and 30.6% to 27.5% for immunomodulatory drugs in fully insured plans after parity. Relative to changes in self-funded plans, those in fully insured plans were 0.74 (95% CI = 0.54 to 1.01) times as likely to pay more than $100 for TKIs and 0.85 (95% CI = 0.68 to 1.06) times as likely to pay more than $100 for immunomodulatory drugs after parity.

Conclusions: Among patients initiating TKIs or immunomodulatory drugs, parity was not associated with better adherence or less discontinuation of therapy but yielded decreased patient out-of-pocket payments for some patients.
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http://dx.doi.org/10.1093/jnci/djz243DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7566334PMC
October 2020

New-onset persistent opioid use following breast cancer treatment in older adult women.

Cancer 2020 02 17;126(4):814-822. Epub 2019 Dec 17.

Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, Wisconsin.

Background: Patients with cancer-related pain are underrepresented in the opioid literature despite high opioid exposure and numerous risk factors for adverse opioid outcomes, including unnecessary persistent opioid use. The objective of this study was to determine the extent, historical trends, and predictors of new-onset persistent opioid use among older adult women after active breast cancer treatment.

Methods: Using Surveillance, Epidemiology, and End Results-Medicare data for opioid-naive women diagnosed with stage 0 to III breast cancer at the age of 66 to 90 years between 2008 and 2013, this study estimated overall and quarterly adjusted probabilities of new-onset persistent opioid use, which was defined as receiving ≥90 days' supply of opioids in the year after active breast cancer treatment. Sensitivity analyses were conducted with an alternative definition of persistent opioid use: any opioid fill 90 to 180 days after active cancer treatment.

Results: Nearly two-thirds of the subjects received prescription opioid therapy during cancer treatment. Quarterly probabilities of new-onset persistent opioid use after active treatment ranged from 2% to 4%; in sensitivity analyses, the alternative outcome definition resulted in predicted probabilities ranging from 11.4% to 14.7%. Subjects with more advanced disease, a higher comorbidity burden, a low-income status, and greater opioid exposure during active cancer treatment were more likely to develop persistent opioid use.

Conclusions: Persistent opioid use was an infrequent occurrence among older adult patients with breast cancer completing cancer treatment between 2008 and 2013. This finding was encouraging because of the concerning opioid trends seen in noncancer populations. However, opportunities to further mitigate unsafe opioid use as a complication of cancer care, including standardization of persistent opioid use definitions, should be explored.
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http://dx.doi.org/10.1002/cncr.32593DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6994182PMC
February 2020

Concurrent Opioid and Benzodiazepine Prescriptions Among Older Women Diagnosed With Breast Cancer.

J Natl Cancer Inst 2020 07;112(7):765-768

Department of Population Health and Department of Anesthesiology, University of Kansas Medical Center (KUMC), KU Cancer Center, KUMC, Kansas City, KS.

Guidelines recommend using caution in co-prescribing opioids with benzodiazepines, yet, in practice, the extent of concurrent prescribing is poorly understood. Notably, no population-based studies, to our knowledge, have investigated concurrent prescribing among patients with cancer. We conducted a retrospective cohort study using data from the Surveillance, Epidemiology, and End Results (SEER) database linked with Medicare claims (2012-2016) for women diagnosed with breast cancer. We used modified Poisson regression to examine predictors of any concurrent prescriptions in the year post-diagnosis and Poisson regression to examine predictors of the number of overlapping days. We found that 13.0% of the 19 267 women in our sample had concurrent prescriptions. Women who underwent more extensive treatment and those with previous use of opioids or benzodiazepines were at increased risk for concurrent prescriptions (adjusted risk ratio of previous benzodiazepine use vs no previous use = 15.05, 95% confidence interval = 13.19 to 17.19). Among women with concurrent prescriptions, overlap was most pronounced among low-income, rural, and Hispanic women (adjusted incidence rate ratio of Hispanic vs non-Hispanic white = 1.25, 95% confidence interval = 1.20 to 1.30). Our results highlight opportunities to reduce patients' unnecessary exposure to this combination.
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http://dx.doi.org/10.1093/jnci/djz201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7357325PMC
July 2020

Clinician Encouragement and Online Health Record Usage.

J Gen Intern Med 2019 11;34(11):2345-2347

Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, USA.

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http://dx.doi.org/10.1007/s11606-019-05162-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848784PMC
November 2019

Assessing endometrial cancer risk among US women: long-term trends using hysterectomy-adjusted analysis.

Am J Obstet Gynecol 2019 10 22;221(4):318.e1-318.e9. Epub 2019 May 22.

School of Pharmacy, Medical College of Wisconsin, Milwaukee, WI; Cancer Center, Medical College of Wisconsin, Milwaukee, WI.

Background: Commonly reported incidence rates for endometrial cancer fail to take into account both the large number of hysterectomies performed each year and the dynamic change in hysterectomy rate over the past decade. Large racial differences in premenopausal hysterectomy rates between Black and White women in the United States likely affect calculation of race-based risk.

Objectives: The objectives of the study were to determine how the long-term trends in Black-White differences in endometrial cancer incidence and histology type have changed over time for women at risk.

Study Design: Using longitudinal Surveillance, Epidemiology, and End Results data from 1997 to 2014 and state-level hysterectomy prevalence from the Behavioral Risk Factor Surveillance System, we calculated hysterectomy-adjusted incidence rates of endometrial cancer and the proportion of high vs low-risk endometrial cancer, by race, over time.

Results: In women older than 50 years who have not had a hysterectomy, endometrial cancer incidence is 87 per 100,000 from 1997 to 2014. Among White women endometrial cancer incidence changed from 102 (1997-2001) to 86 (2012-2014) cases per 100,000, with a nonsignificant decreasing linear trend (adjusted risk ratio, 0.95; 95% confidence interval, 0.91-1.00; p=0.05). In contrast, incidence for Black women was 88 (1997-2001), 101 (2002-2006), 100 (2007-2011), and 102 (2012-2014) cases per 100,000 with no decreasing trend (adjusted risk ratio, 1.02; 95% confidence interval, 0.96-1.10, P = .449). High-risk histology increased among both groups (White: adjusted risk ratio, 1.06; 95% confidence interval, 1.01-1.11; P = .015; Black: adjusted risk ratio, 1.06; 95% confidence interval, 1.02-1.10, P = .007). Racial difference in the proportion of high-risk disease remained stable.

Conclusion: Updated hysterectomy-adjusted incidence demonstrates that endometrial cancer is the second most common cancer among women older than 50 years with a uterus and that endometrial cancer has been more common among Black women compared with White women in the United States since 2002. A clinical approach of proactive communication and routine screening for early symptoms in the perimenopausal and menopausal years, especially among Black women, is warranted. These findings can also inform equitable distribution of research funding for endometrial cancer and serve to promote public awareness of this common cancer.
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http://dx.doi.org/10.1016/j.ajog.2019.05.024DOI Listing
October 2019

Evaluating the Strength of the Association Between Industry Payments and Prescribing Practices in Oncology.

Oncologist 2019 05 6;24(5):632-639. Epub 2019 Feb 6.

Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

Background: Financial relationships between physicians and the pharmaceutical industry are common, but factors that may determine whether such relationships result in physician practice changes are unknown.

Materials And Methods: We evaluated physician use of orally administered cancer drugs for four cancers: prostate (abiraterone, enzalutamide), renal cell (axitinib, everolimus, pazopanib, sorafenib, sunitinib), lung (afatinib, erlotinib), and chronic myeloid leukemia (CML; dasatinib, imatinib, nilotinib). Separate physician cohorts were defined for each cancer type by prescribing history. The primary exposure was the number of calendar years during 2013-2015 in which a physician received payments from the manufacturer of one of the studied drugs; the outcome was relative prescribing of that drug in 2015, compared with the other drugs for that cancer. We evaluated whether practice setting at a National Cancer Institute (NCI)-designated Comprehensive Cancer Center, receipt of payments for purposes other than education or research (compensation payments), maximum annual dollar value received, and institutional conflict-of-interest policies were associated with the strength of the payment-prescribing association. We used modified Poisson regression to control confounding by other physician characteristics.

Results: Physicians who received payments for a drug in all 3 years had increased prescribing of that drug (compared with 0 years), for renal cell (relative risk [RR] 1.81, 95% confidence interval [CI] 1.58-2.07), CML (RR 1.22, 95% CI 1.08-1.39), and lung (RR 1.69, 95% CI 1.58-1.82), but not prostate (RR 0.97, 95% CI 0.93-1.02). Physicians who received compensation payments or >$100 annually had increased prescribing compared with those who did not, but NCI setting and institutional conflict-of-interest policies were not consistently associated with the direction of prescribing change.

Conclusion: The association between industry payments and cancer drug prescribing was greatest among physicians who received payments consistently (within each calendar year). Receipt of payments for compensation purposes, such as for consulting or travel, and higher dollar value of payments were also associated with increased prescribing.

Implications For Practice: Financial payments from pharmaceutical companies are common among oncologists. It is known from prior work that oncologists tend to prescribe more of the drugs made by companies that have given them money. By combining records of industry gifts with prescribing records, this study identifies the consistency of payments over time, the dollar value of payments, and payments for compensation as factors that may strengthen the association between receiving payments and increased prescribing of that company's drug.
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http://dx.doi.org/10.1634/theoncologist.2018-0423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6516135PMC
May 2019

Quantifying downstream impact of inappropriate staging imaging in a cohort of veterans with low- and intermediate-risk incident prostate cancer.

Urol Oncol 2019 02 18;37(2):145-149. Epub 2018 Dec 18.

Department of Urology, New York University, NY; Department of Population Heath, New York University, NY; The Manhattan Veterans Affairs Medical Center, NY. Electronic address:

Introduction: According to current National Comprehensive Cancer Network guidelines, routine imagining for staging low-risk prostate cancer is not recommended. However, extensive overuse of guideline-discordant imaging continues to persist. Incidental findings are common on imaging and little is known about the optimal management. Rates of incidental findings vs. false positive diagnosis from inappropriate imaging are poorly understood and have yet to be quantified for low- and intermediate-risk prostate cancer patients.

Objective: To determine the frequency of positive radiologic findings in patients with low- and intermediate-risk prostate cancer during initial staging at VA New York Harbor Healthcare System.

Methods: We retrospectively reviewed all low- and intermediate-risk prostate cancer patients' medical records from the VA New York Harbor Healthcare System for diagnosis from 2005 to 2015. We reviewed each individual's prebiopsy prostate specific antigen (PSA), Gleason score, and clinical stage. We also determined if imaging obtained yielded a false positive, incidental finding, or if metastatic disease occurred within the 6 months following initial diagnosis.

Results: There were 414 men, who were classified as low- to intermediate-risk prostate cancer and underwent inappropriate staging imaging of 4,306 men diagnosed with prostate cancer. Of these 414 men, 178 (43%) had additional follow-up imaging for positive findings. We calculated an incidental finding rate of 10% and a false positive rate of 38% for patients. Five (1%) patients had metastatic disease.

Conclusion: Despite guideline recommendations, imaging overuse remains an issue for low-intermediate-risk prostate cancer patients. The false positive rate found in this analysis is alarmingly high at 38%. This use of scans is burdensome to the healthcare system and patient. This study highlights the frequency of inappropriate imaging and its negative consequences.
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http://dx.doi.org/10.1016/j.urolonc.2018.11.022DOI Listing
February 2019

More evidence on the limited impact of state oral oncology parity laws.

Cancer 2019 02 19;125(3):335-336. Epub 2018 Dec 19.

Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee.

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http://dx.doi.org/10.1002/cncr.31904DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6361375PMC
February 2019

Using Group-based Trajectory Models and Propensity Score Weighting to Detect Heterogeneous Treatment Effects: The Case Study of Generic Hormonal Therapy for Women With Breast Cancer.

Med Care 2019 01;57(1):85-93

Medical College of Wisconsin, Milwaukee, WI.

Background: We extend an interrupted time series study design to identify heterogenous treatment effects using group-based trajectory models (GBTMs) to identify groups before a new policy and then examine if the effects of the policy has consistent impacts across groups using propensity score weighting to balance individuals within trajectory groups who are and are not exposed to the policy change. We explore this by examining how adherence to endocrine therapy (ET) for women with breast cancer was impacted by reducing copayments for medications by the introduction of generic ETs among women who do not receive a subsidy (the "treatment" group) to those that do receive a subsidy and are not exposed to any changes in copayments (the "control" group).

Methods: We examined monthly adherence to ET using the proportion of days covered for women diagnosed with breast cancer between 2008 and 2009 using SEER-Medicare data. To account for baseline trends, we characterize adherence for 1 year before generic approval of ET using GBTMs, within each groups we generate inverse probability treatment weights of not receiving a subsidy. We compared adherence after generic entry within each GBTM using a modified Poisson model.

Results: GBTMs for adherence in the 1-year pregeneric identified 6 groups. When comparing patients who did and did not receive a subsidy we found no overall effect of generic introduction. However, 1 of the 6 identified adherence groups postgeneric adherence increased [the "consistently low" (risk ratio=1.91; 95% confidence interval=1.34-2.72)].

Conclusions: This study describes a new approach to identify heterogenous effects when using an interrupted time series research design.
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http://dx.doi.org/10.1097/MLR.0000000000001019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291347PMC
January 2019

Cost-effectiveness of Initiating an Insulin Pump in T1D Adults Using Continuous Glucose Monitoring Compared with Multiple Daily Insulin Injections: The DIAMOND Randomized Trial.

Med Decis Making 2018 11;38(8):942-953

Section of General Internal Medicine, University of Chicago, Chicago, IL (WW, MRS, AM, AGN, PZ, ESH).

Background: The economic impact of both continuous glucose monitoring (CGM) and insulin pumps (continuous subcutaneous insulin infusion [CSII]) in type 1 diabetes (T1D) have been evaluated separately. However, the cost-effectiveness of adding CSII to existing CGM users has not yet been assessed.

Objective: The aim of this study was to evaluate the societal cost-effectiveness of CSII versus continuing multiple daily injections (MDI) in adults with T1D already using CGM.

Methods: In the second phase of the DIAMOND trial, 75 adults using CGM were randomized to either CGM+CSII or CGM+MDI (control) and surveyed at baseline and 28 weeks. We performed within-trial and lifetime cost-effectiveness analyses (CEAs) and estimated lifetime costs and quality-adjusted life-years (QALYs) via a modified Sheffield T1D model.

Results: Within the trial, the CGM+CSII group had a significant reduction in quality of life from baseline (-0.02 ± 0.05 difference in difference [DiD]) compared with controls. Total per-person 28-week costs were $8,272 (CGM+CSII) versus $5,623 (CGM+MDI); the difference in costs was primarily attributable to pump use ($2,644). Pump users reduced insulin intake (-12.8 units DiD) but increased the use of daily number of test strips (+1.2 DiD). Pump users also increased time with glucose in range of 70 to 180 mg/dL but had a higher HbA1c (+0.13 DiD) and more nonsevere hypoglycemic events. In the lifetime CEA, CGM+CSII would increase total costs by $112,045 DiD, decrease QALYs by 0.71, and decrease life expectancy by 0.48 years.

Conclusions: Based on this single trial, initiating an insulin pump in adults with T1D already using CGM was associated with higher costs and reduced quality of life. Additional evidence regarding the clinical effects of adopting combinations of new technologies from trials and real-world populations is needed to confirm these findings.
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http://dx.doi.org/10.1177/0272989X18803109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6226055PMC
November 2018

Making Sure We Don't Forget the Basics When Using Machine Learning.

J Natl Cancer Inst 2019 Jun;111(6):529-530

Department of Medicine and Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI.

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http://dx.doi.org/10.1093/jnci/djy179DOI Listing
June 2019

Individualized Glycemic Control for U.S. Adults With Type 2 Diabetes: A Cost-Effectiveness Analysis.

Ann Intern Med 2018 02 12;168(3):170-178. Epub 2017 Dec 12.

University of Chicago, Chicago, Illinois (N.L., J.M.C., M.R.S., R.N.N., E.S.H.).

Background: Intensive glycemic control in type 2 diabetes (glycated hemoglobin [HbA1c] level <7%) is an established, cost-effective standard of care. However, guidelines recommend individualizing goals on the basis of age, comorbidity, diabetes duration, and complications.

Objective: To estimate the cost-effectiveness of individualized control versus uniform intensive control (HbA1c level <7%) for the U.S. population with type 2 diabetes.

Design: Patient-level Monte Carlo-based Markov model.

Data Sources: National Health and Nutrition Examination Survey 2011-2012.

Target Population: The approximately 17.3 million persons in the United States with diabetes diagnosed at age 30 years or older.

Time Horizon: Lifetime.

Perspective: Health care sector.

Intervention: Individualized versus uniform intensive glycemic control.

Outcome Measures: Average lifetime costs, life-years, and quality-adjusted life-years (QALYs).

Results Of Base-case Analysis: Individualized control saved $13 547 per patient compared with uniform intensive control ($105 307 vs. $118 854), primarily due to lower medication costs ($34 521 vs. $48 763). Individualized control decreased life expectancy (20.63 vs. 20.73 years) due to an increase in complications but produced more QALYs (16.68 vs. 16.58) due to fewer hypoglycemic events and fewer medications.

Results Of Sensitivity Analysis: Individualized control was cost-saving and generated more QALYs compared with uniform intensive control, except in analyses where the disutility associated with receiving diabetes medications was decreased by at least 60%.

Limitation: The model did not account for effects of early versus later intensive glycemic control.

Conclusion: Health policies and clinical programs that encourage an individualized approach to glycemic control for U.S. adults with type 2 diabetes reduce costs and increase quality of life compared with uniform intensive control. Additional research is needed to confirm the risks and benefits of this strategy.

Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.
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http://dx.doi.org/10.7326/M17-0537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989575PMC
February 2018

Out-of-Pocket and Health Care Spending Changes for Patients Using Orally Administered Anticancer Therapy After Adoption of State Parity Laws.

JAMA Oncol 2018 06 14;4(6):e173598. Epub 2018 Jun 14.

Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.

Importance: Oral anticancer medications are increasingly important but costly treatment options for patients with cancer. By early 2017, 43 states and Washington, DC, had passed laws to ensure patients with private insurance enrolled in fully insured health plans pay no more for anticancer medications administered by mouth than anticancer medications administered by infusion. Federal legislation regarding this issue is currently pending. Despite their rapid acceptance, the changes associated with state adoption of oral chemotherapy parity laws have not been described.

Objective: To estimate changes in oral anticancer medication use, out-of-pocket spending, and health plan spending associated with oral chemotherapy parity law adoption.

Design, Setting, And Participants: Analysis of administrative health plan claims data from 2008-2012 for 3 large nationwide insurers aggregated by the Health Care Cost Institute. Data analysis was first completed in 2015 and updated in 2017. The study population included 63 780 adults living in 1 of 16 states that passed parity laws during the study period and who received anticancer drug treatment for which orally administered treatment options were available. Study analysis used a difference-in-differences approach.

Exposures: Time period before and after adoption of state parity laws, controlling for whether the patient was enrolled in a plan subject to parity (fully insured) or not (self-funded, exempt via the Employee Retirement Income Security Act).

Main Outcomes And Measures: Oral anticancer medication use, out-of-pocket spending, and total health care spending.

Results: Of the 63 780 adults aged 18 through 64 years, 51.4% participated in fully insured plans and 48.6% in self-funded plans (57.2% were women; 76.8% were aged 45 to 64 years). The use of oral anticancer medication treatment as a proportion of all anticancer treatment increased from 18% to 22% (adjusted difference-in-differences risk ratio [aDDRR], 1.04; 95% CI, 0.96-1.13; P = .34) comparing months before vs after parity. In plans subject to parity laws, the proportion of prescription fills for orally administered therapy without copayment increased from 15.0% to 53.0%, more than double the increase (12.3%-18.0%) in plans not subject to parity (P < .001). The proportion of patients with out-of-pocket spending of more than $100 per month increased from 8.4% to 11.1% compared with a slight decline from 12.0% to 11.7% in plans not subject to parity (P = .004). In plans subject to parity laws, estimated monthly out-of-pocket spending decreased by $19.44 at the 25th percentile, by $32.13 at the 50th percentile, and by $10.83 at the 75th percentile but increased at the 90th ($37.19) and 95th ($143.25) percentiles after parity (all P < .001, controlling for changes in plans not subject to parity). Parity laws did not increase 6-month total spending for users of any anticancer therapy or for users of oral anticancer therapy alone.

Conclusions And Relevance: While oral chemotherapy parity laws modestly improved financial protection for many patients without increasing total health care spending, these laws alone may be insufficient to ensure that patients are protected from high out-of-pocket medication costs.
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http://dx.doi.org/10.1001/jamaoncol.2017.3598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6054307PMC
June 2018

Endocrine Therapy Initiation among Older Women with Ductal Carcinoma In Situ.

J Cancer Epidemiol 2017 13;2017:6091709. Epub 2017 Sep 13.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Although treatment of ductal carcinoma in situ (DCIS) is controversial, national guidelines recommend considering endocrine therapy for women with estrogen receptor- (ER-) positive DCIS or those undergoing breast conserving surgery (BCS) without radiation. We evaluated uptake and predictors of endocrine therapy use among older women with DCIS.

Methods: In the SEER-Medicare database, we identified women aged 65+ years diagnosed with DCIS during 2007-2011. We evaluated demographic, tumor, and treatment characteristics associated with endocrine therapy initiation.

Results: Among 2,945 women with DCIS, 41% initiated endocrine therapy (66% tamoxifen, 34% aromatase inhibitors). Initiation was more common among women with ER-positive than ER-negative DCIS (48% versus 16%; HR = 3.75, 95% CI: 2.91-4.83); 28% of women with unknown ER status initiated endocrine therapy. Initiation was less common after BCS alone compared to BCS with radiation (32% versus 50%; HR = 0.69, 95% CI: 0.59-0.80).

Conclusions: Less than half of older women with DCIS initiate endocrine therapy to prevent second breast cancers. Our findings suggest use was more common, but not exclusive, among women with ER-positive DCIS, but not among women who underwent BCS alone. Endocrine therapy should be targeted toward patients most likely to benefit from its use.
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http://dx.doi.org/10.1155/2017/6091709DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5615957PMC
September 2017

Reply to E. Ritchie et al.

J Clin Oncol 2017 05 13;35(15):1745-1746. Epub 2017 Feb 13.

Aaron N. Winn, University of North Carolina at Chapel Hill, Chapel Hill, NC; Nancy L. Keating, Harvard Medical School and Brigham and Women's Hospital, Boston, MA; and Stacie B. Dusetzina, University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center, and Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC.

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http://dx.doi.org/10.1200/JCO.2016.72.0037DOI Listing
May 2017

The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care.

Curr Diab Rep 2017 06;17(6):40

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Drive, McGravan-Greenberg Hall, CB #7411, Chapel Hill, NC, 27599-7411, USA.

Purpose Of Review: The Food and Drug Administration (FDA) is responsible for assuring the safety, effectiveness, and quality of medical devices in the USA. Extensive review times coupled with the demand for necessary treatments have prompted the policymakers to implement measures to speed medical devices to market.The purpose of this review is to summarize the evolution of the regulatory pathways through which medical devices utilized in diabetes care gain market access.

Recent Findings: Regulatory pathways, ranging from premarket notification to premarket approval, require distinct, yet necessary ("least burdensome") evidence demonstrating a device's safety and effectiveness. Collaboration between manufacturers, regulators, and patients has resulted in the development and approval of novel diabetes care devices, including the first hybrid closed-loop artificial pancreas. Policy provisions, ranging from the least burdensome approach to the "breakthrough device" expedited pathway, aim to balance innovation, access, and safety. Clinicians must be aware of the evolving regulatory landscape and play an active role in enhancing patient safety.
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http://dx.doi.org/10.1007/s11892-017-0871-6DOI Listing
June 2017

Assessing disruptions in adherence to antidepressant treatments after breast cancer diagnosis.

Pharmacoepidemiol Drug Saf 2017 Jun 19;26(6):676-684. Epub 2017 Mar 19.

Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Purpose: Long-term treatment with antidepressants can lessen the symptoms of depression, but health-related crises-such as a cancer diagnosis-may disrupt ongoing depression care. The study aims to estimate the effect of receiving a breast cancer diagnosis on antidepressant adherence among women with depression.

Methods: Using SEER-Medicare administrative claims, we identified women aged 65+ with newly diagnosed breast cancer between 2008 and 2011, who were diagnosed with depression and used antidepressants during the year before pre-diagnosis year. We compared antidepressant adherence among women with breast cancer to similar women without cancer using generalized estimation equations. Antidepressant adherence was estimated using the proportion of days covered 1 year before and after the index date.

Results: We included 1142 women with breast cancer and pre-existing depression and 1142 matched non-cancer patients with pre-existing depression. Mean antidepressant adherence was similar for both groups in the year before and after the index date (all around 0.71); adherence decreased by approximately 0.01 following breast cancer diagnosis in cancer group, with similar reductions among non-cancer group (p = 0.19). However, substantial proportion of patients had inadequate adherence to antidepressants in the post-diagnosis period, and almost 40% of patients in each group discontinued antidepressants over the study period.

Conclusions: Antidepressant adherence was not associated with receiving a breast cancer diagnosis beyond what would have been expected in a similar cohort of women without cancer; however, adherence was poor among both groups. Ensuring adequate ongoing depression care is important to improve cancer care and patient quality of life in the long term. Copyright © 2017 John Wiley & Sons, Ltd.
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http://dx.doi.org/10.1002/pds.4198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457339PMC
June 2017

Untangling the Black-White mortality gap in endometrial cancer: a cohort simulation.

Am J Obstet Gynecol 2017 03 26;216(3):324-325. Epub 2016 Dec 26.

Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Washington, Seattle, WA.

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http://dx.doi.org/10.1016/j.ajog.2016.12.023DOI Listing
March 2017