Achievement of LDL-C <55 mg/dL among US Adults : Findings from the cvMOBIUS2 Registry.

BACKGROUND: Reflecting clinical trial data showing improved outcomes with lower LDL-C levels, guidelines across the globe are increasingly recommending a goal of LDL-C <55 mg/dL in persons with atherosclerotic cardiovascular disease (ASCVD). What proportion of patients with ASCVD are already meeting those goals in the US remains understudied. METHODS: Using electronic health record data from 8 large US health systems, we evaluated lipid-lowering therapy (LLT), LDL-C levels, and factors associated with an LDL-C <55 mg/dL in persons with ASCVD treated between 1/1/2021-12/31/2021. Multivariable modeling was used to evaluate factors associated with achievement of an LDL-C <55 mg/dL. RESULTS: Among 167,899 eligible patients, 22.6% (38,016) had an LDL-C <55 mg/dL. While 76.1% of individuals overall were on a statin, only 38.2% were on a high-intensity statin,;5.9% were on ezetimibe, and 1.7% were on a PCSK9i monoclonal antibody (mAb). Factors associated with lower likelihood of achieving an LDL-C <55 mg/dL included: younger age (odds ratio [OR] 0.91 per 10y), female sex (OR 0.69), Black race (OR 0.76), and non-coronary artery disease forms of ASCVD including peripheral artery disease (OR 0.72) and cerebrovascular disease (OR 0.85), while high-intensity statin use was associated with increased odds of LDL-C <55 mg/dL (OR 1.55). Combination therapy (statin+ezetimibe or statin+PCSK9i mAb) was rare (4.4% and 0.5%, respectively) and was associated with higher odds of an LDL-C <55 mg/dL (OR 1.39 and 3.13, respectively). CONCLUSION: Less than a quarter of US patients with ASCVD in community practice are already achieving an LDL-C <55 mg/dL. Marked increases in utilization of both high intensity statins and combination therapy with non-statin therapy will be needed to achieve LDL-C levels <55 mg/dL at the population level in secondary prevention.

Preventive Service Usage and New Chronic Disease Diagnoses: Using PCORnet Data to Identify Emerging Trends, United States, 2018-2022.

Background: Data modernization efforts to strengthen surveillance capacity could help assess trends in use of preventive services and diagnoses of new chronic disease during the COVID-19 pandemic, which broadly disrupted health care access. Methods: This cross-sectional study examined electronic health record data from US adults aged 21 to 79 years in a large national research network (PCORnet), to describe use of 8 preventive health services (N = 30,783,825 patients) and new diagnoses of 9 chronic diseases (N = 31,588,222 patients) during 2018 through 2022. Joinpoint regression assessed significant trends, and health debt was calculated comparing 2020 through 2022 volume to prepandemic (2018 and 2019) levels. Results: From 2018 to 2022, use of some preventive services increased (hemoglobin A1c and lung computed tomography, both P < .05), others remained consistent (lipid testing, wellness visits, mammograms, Papanicolaou tests or human papillomavirus tests, stool-based screening), and colonoscopies or sigmoidoscopies declined (P < .01). Annual new chronic disease diagnoses were mostly stable (6% hypertension; 4% to 5% cholesterol; 4% diabetes; 1% colonic adenoma; 0.1% colorectal cancer; among women, 0.5% breast cancer), although some declined (lung cancer, cervical intraepithelial neoplasia or carcinoma in situ, cervical cancer, all P < .05). The pandemic resulted in health debt, because use of most preventive services and new diagnoses of chronic disease were less than expected during 2020; these partially rebounded in subsequent years. Colorectal screening and colonic adenoma detection by age group aligned with screening recommendation age changes during this period. Conclusion: Among over 30 million patients receiving care during 2018 through 2022, use of preventive services and new diagnoses of chronic disease declined in 2020 and then rebounded, with some remaining health debt. These data highlight opportunities to augment traditional surveillance with EHR-based data.

Comparing COVID-19 Response Behaviors between a Cancer Patient Sample and a Population-Based Cancer-Free Sample in a Rural Midwestern State.

INTRODUCTION: The COVID-19 pandemic caused an increase in fear, anxiety, and depressive symptoms globally. For populations at increased risk for adverse outcomes due to illness, such as cancer patients, these worries may have been exacerbated. Understanding how the pandemic impacted cancer patients will inform better preparation for future events that cause disturbances to cancer care delivery. METHODS: This study analyzed data from two surveys to determine whether cancer patients' responses differed from a cancer-free population-based sample in terms of concerns, preventive behaviors, and thoughts on their healthcare provider's communication regarding COVID-19 in a US Midwestern state. In August 2020, a survey was sent to 10,009 Iowans aged 18 and older, randomly selected from the 2018 Iowa voter registration file. In September 2020, a survey was emailed to 2,954 cancer patients aged 18 and older who opted into the University of Iowa Holden Comprehensive Cancer Center's Patients Enhancing Research Collaborations at Holden program. Previously validated and pretested Likert-type and multiple-choice items assessed concern regarding COVID-19, social distancing perception and behaviors, and demographic characteristics of respondents. We used χ2 tests and logistic regression to examine differences between the cancer patient and general population survey responses. RESULTS: We included 3,622 responses from the general population survey and 780 responses from the cancer patient survey in this analysis. Cancer patient survey respondents were more frequently older, lived in urban areas, had Medicare insurance coverage, had a college degree or higher, and were married. Cancer patients were more likely to report engaging in social distancing behaviors and greater concern regarding the pandemic. CONCLUSION: This study suggests differences in the impact of the COVID-19 pandemic on cancer patients compared to cancer-free members of the general population. These results indicate the need for consideration of cancer patients' physical and mental health during large-scale disruptions to cancer care.

Influence of rurality on lymph node assessment among women diagnosed with ductal carcinoma in situ and treated with mastectomy, SEER 2000-2015.

PURPOSE: Despite recommendations from national organizations supporting the use of lymph node assessment (LNA) among patients with ductal carcinoma in situ (DCIS) at time of mastectomy, variation in practice patterns across the United States has been observed. However, few studies have evaluated LNA differences and rurality. METHODS: Data from the SEER Patterns of Care studies were used to identify women who underwent mastectomy for newly diagnosed DCIS during 2000, 2005, 2010, and 2015. Weighted multivariate logistic regression was used to evaluate the association between rural-urban residence and the use of LNA. A subgroup analysis was performed comparing the use of axillary lymph node dissection (ALND) versus sentinel lymph node biopsy (SLNB). RESULTS: Of the 504 patients included in the analysis, approximately 81% underwent LNA at time of mastectomy with lower rates of use observed among rural patients (66%) versus urban patients (82%). In multivariate analysis, LNA increased over time (p < 0.0001), and rural patients were less likely to receive LNA compared to urban patients [adjusted odds ratio (aOR) = 0.19; 95% confidence interval (CI) 0.06-0.66]. However, the likelihood of undergoing ALND relative to SLNB was lower among rural compared to urban patients (aOR = 0.16; 95% CI 0.03-0.73). CONCLUSIONS: Over time, the use of LNA with mastectomy has increased among DCIS patients. However, significant rural-urban differences in the use and type of LNA persist. The findings of this study highlight the importance of continued research aimed at examining the impact of rurality on the receipt of high-quality cancer care.

Referrals and Decision-Making Considerations Involved in Selecting a Surgeon for Rectal Cancer Treatment in the Midwestern United States.

BACKGROUND: Despite evidence of superior outcomes for rectal cancer at high-volume, multidisciplinary cancer centers, many patients undergo surgery in low-volume hospitals. OBJECTIVE: This study aimed to examine considerations of former patients with rectal cancer when selecting their surgeon and to evaluate which considerations were associated with surgery at high-volume hospitals. DESIGN: In this retrospective cohort study, patients were surveyed about what they considered when selecting a cancer surgeon. SETTINGS: Study data were obtained via survey and the statewide Iowa Cancer Registry. PATIENTS: All eligible individuals diagnosed with invasive stages II/III rectal cancer from 2013 to 2017 identified through the registry were invited to participate. MAIN OUTCOME MEASURES: The primary outcomes were the characteristics of the hospital where they received surgery (ie, National Cancer Institute designation, Commission on Cancer accreditation, and rectal cancer surgery volume). RESULTS: Among respondents, 318 of 417 (76%) completed surveys. Sixty-nine percent of patients selected their surgeon based on their physician's referral/recommendation, 20% based on surgeon/hospital reputation, and 11% based on personal connections to the surgeon. Participants who chose their surgeon based on reputation had significantly higher odds of surgery at National Cancer Institute-designated (OR 7.5; 95% CI, 3.8-15.0) or high-volume (OR 2.6; 95% CI, 1.2-5.7) hospitals than those who relied on referral. LIMITATIONS: This study took place in a Midwestern state with a predominantly white population, which limited our ability to evaluate racial/ethnic associations. CONCLUSION: Most patients with rectal cancer relied on referrals in selecting their surgeon, and those who did were less likely to receive surgery at a National Cancer Institute-designated or high-volume hospitals compared to those who considered reputation. Future research is needed to determine the impact of these decision factors on clinical outcomes, patient satisfaction, and quality of life. In addition, patients should be aware that relying on physician referral may not result in treatment from the most experienced or comprehensive care setting in their area. See Video Abstract at http://links.lww.com/DCR/B897.REMISIONES Y CONSIDERACIONES PARA LA TOMA DE DECISIONES RELACIONADAS CON LA SELECCIÓN DE UN CIRUJANO PARA EL TRATAMIENTO DEL CÁNCER DE RECTO EN EL MEDIO OESTE DE LOS ESTADOS UNIDOSANTECEDENTES:A pesar de la evidencia de resultados superiores para el tratamiento del cáncer de recto en centros oncológicos de gran volumen y multidisciplinarios, muchos pacientes se someten a cirugía en hospitales de bajo volumen.OBJETIVOS:Examinar las consideraciones de los antiguos pacientes con cáncer de recto al momento de seleccionar a su cirujano y evaluar qué consideraciones se asociaron con la cirugía en hospitales de gran volumen.DISEÑO:Encuestamos a los pacientes sobre qué aspectos consideraron al elegir un cirujano oncológico para completar este estudio de cohorte retrospectivo.AJUSTE:Los datos del estudio se obtuvieron mediante una encuesta y el Registro de Cáncer del estado de Iowa.PACIENTES:Se invitó a participar a todas las personas elegibles diagnosticadas con cáncer de recto invasivo en estadios II/III entre 2013 y 2017 identificadas a través del registro.PRINCIPALES MEDIDAS DE RESULTADO:Los resultados principales fueron las características del hospital donde fue realizada la cirugía (es decir, designación del Instituto Nacional del Cáncer, acreditación de la Comisión de Cáncer y volumen de cirugía del cáncer de recto).RESULTADOS:Hubo 318 de 417 (76%) encuestas completadas. El sesenta y nueve por ciento seleccionó a su cirujano en función de la referencia / recomendación de su médico, el 20% por la reputación del cirujano/hospital, y el 11% por sus conexiones personales con el cirujano. Los participantes que eligieron a su cirujano en función a la reputación tuvieron probabilidades significativamente más altas de cirugía en el Instituto Nacional del Cáncer designado (OR = 7,5, IC del 95%: 3,8-15,0) o en hospitales de alto volumen (OR = 2,6, IC del 95%: 1,2-5,7) que aquellos que dependían de la derivación.LIMITACIONES:Este estudio se llevó a cabo en un estado del medio oeste con una población predominantemente blanca, lo que limitó nuestra capacidad para evaluar las asociaciones raciales/étnicas.CONCLUSIONES:La mayoría de los pacientes con cáncer de recto dependían de las derivaciones para seleccionar a su cirujano, y los que lo hacían tenían menos probabilidades de recibir cirugía en un hospital designado por el Instituto Nacional del Cáncer o en hospitales de gran volumen en comparación con los que consideraban la reputación. Se necesitan investigaciones a futuro para determinar el impacto de estos factores de decisión en los resultados clínicos, la satisfacción del paciente y la calidad de vida. Además, los pacientes deben ser conscientes de que depender de la remisión de un médico puede no resultar en el tratamiento más experimentado o integral en su área. Consulte Video Resumen en http://links.lww.com/DCR/B897. (Traducción-Dr Osvaldo Gauto).

Self-controlled assessment of thromboembolic event (TEE) risk following intravenous immune globulin (IGIV) in the U.S. (2006-2012).

Since 2013, the U.S. Food and Drug administration (FDA) has required that intravenous immune globulin (IGIV) products carry a boxed warning concerning the risk of thromboembolic events (TEEs). This study assessed the incidence of TEEs attributable to IGIV in a large population-based cohort. A self-controlled risk interval design was used to quantify the transient increase in TEE risk during the risk interval (days 0-2 and 0-13 following IGIV for arterial and venous TEEs, respectively) relative to a later control interval (days 14-27 following IGIV). Potential IGIV-exposed TEE cases from 2006 to 2012 were identified from the FDA-sponsored Sentinel Distributed Database and confirmed through medical record review. Inpatient IGIV exposures were not included in the venous TEE analysis due to concerns about time-varying confounding. 19,069 new users of IGIV who received 93,555 treatment episodes were included. Charts were retrieved for 62% and 70% of potential venous and arterial cases, respectively. There was a transient increase in the risk of arterial TEEs during days 0-2 following IGIV treatment (RR = 4.69; 95% CI 1.87, 11.90; absolute increase in risk = 8.86 events per 10,000 patients, 95% CI 3.25, 14.6), but no significant increase in venous TEE risk during days 0-13 following outpatient IGIV treatments (RR = 1.07, 95% CI 0.34, 3.48). Our results suggest there is a small increase in the absolute risk of arterial TEEs following IGIV. However, lower-than-expected chart retrieval rates and the possibility of time-varying confounding mean that our results should be interpreted cautiously. Continued pharmacovigilance efforts are warranted.

Hospital Rurality and Gene Expression Profiling for Early-Stage Breast Cancer among Iowa Residents (2010-2018).

Objective: Given the challenges rural cancer patients face in accessing cancer care as well as the slower diffusion and adoption of new medical technologies among rural providers, the aim of our study was to examine trends in gene expression profiling (GEP) testing and evaluate the association between hospital rurality and receipt of GEP testing. Methods: Data from the Iowa Cancer Registry (ICR) were used to identify women with newly diagnosed, histologically confirmed breast cancer from 2010 through 2018 who met eligibility criteria for GEP testing. Patients were allocated to the hospitals where their most definitive surgical treatment was received, and Rural-Urban Commuting Area codes were used to categorize hospitals into urban (N = 43), large rural (N = 16), and small rural (N = 48). Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were estimated using multivariable logistic regression to evaluate the association between hospital rurality and GEP test use, adjusting for demographic and clinical characteristics. The association between test result and treatment received was assessed among patients who received Oncotype DX (ODX) testing. Results: Of 6,726 patients eligible for GEP test use, 46% (N = 3,069) underwent testing with 95% receiving ODX. While overall GEP testing rates increased over time from 42% between 2010 and 2012 to 51% between 2016 and 2018 (P trend < 0.0001), use continued to be the lowest among patients treated at hospitals in small rural areas. The odds of GEP testing remained significantly lower among patients treated at hospitals located in small rural areas (aOR 0.55; 95% CI 0.43-0.71), after adjusting for demographic and clinical characteristics. ODX recurrence scores were highly correlated with chemotherapy use across all strata of hospital rurality. Conclusions: GEP testing continues to be underutilized, especially among those treated at small rural hospitals. Targeted interventions aimed at increasing rates of GEP testing to ensure the appropriate use of adjuvant chemotherapy may improve health outcomes and lower treatment-related costs.

Hospital and Surgeon Selection for Medicare Beneficiaries With Stage II/III Rectal Cancer: The Role of Rurality, Distance to Care, and Colonoscopy Provider.

OBJECTIVE: To determine factors associated with rectal cancer surgery performed at high-volume hospitals (HVHs) and by high-volume surgeons (HVSs), including the roles of rurality and diagnostic colonoscopy provider characteristics. SUMMARY OF BACKGROUND DATA: Although higher-volume hospitals/surgeons often achieve superior surgical outcomes, many rectal cancer resections are performed by lower-volume hospitals/surgeons, especially among rural populations. METHODS: Patients age 66+ diagnosed from 2007 to 2011 with stage II/III primary rectal adenocarcinoma were selected from surveillance, epidemiology, and end results-medicare data. Patient ZIP codes were used to classify rural status. Hierarchical logistic regression was used to determine factors associated with surgery by HVH and HVS. RESULTS: Of 1601 patients, 22% were rural and 78% were urban. Fewer rural patients received surgery at a HVH compared to urban patients (44% vs 65%; P < 0.0001). Compared to urban patients, rural patients more often had colonoscopies performed by general surgeons (and less often from gastroenterologists or colorectal surgeons), and lived substantially further from HVHs; these factors were both associated with lower odds of surgery at a HVH or by a HVS. In addition, whereas over half of both rural and urban patients received their colonoscopy and surgery at the same hospital, rural patients who stayed at the same hospital were significantly less likely to receive surgery at a HVH or by a HVS compared to urban patients. CONCLUSIONS: Rural rectal cancer patients are less likely to receive surgery from a HVH/HVS. The role of the colonoscopy provider has important implications for referral patterns and initiatives seeking to increase centralization.

Surgical Decision-Making Surrounding Contralateral Prophylactic Mastectomy: Comparison of Treatment Goals, Preferences, and Psychosocial Outcomes from a Multicenter Survey of Breast Cancer Patients.

BACKGROUND: Differences in patient characteristics and decision-making preferences have been described between those who elect breast-conserving surgery (BCS), unilateral mastectomy (UM), or contralateral prophylactic mastectomy (CPM) for breast cancer. However, it is not known whether preferred and actual decision-making roles differ across these surgery types, or whether surgery choice reflects a woman's goals or achieves desired outcomes. METHODS: Women diagnosed with stage 0-III unilateral breast cancer across eight large medical centers responded to a mailed questionnaire regarding treatment decision-making goals, roles, and outcomes. These data were linked to electronic medical records. Differences were assessed using descriptive analyses and logistic regression. RESULTS: There were 750 study participants: 60.1% BCS, 17.9% UM, and 22.0% CPM. On multivariate analysis, reducing worry about recurrence was a more important goal for surgery in the CPM group than the others. Although women's preferred role in the treatment decision did not differ by surgery, the CPM group was more likely to report taking a more-active-than-preferred role than the BCS group. On multivariate analysis that included receipt of additional surgery, posttreatment worry about both ipsilateral and contralateral recurrence was higher in the BCS group than the CPM group (both p < 0.001). The UM group was more worried than the CPM group about contralateral recurrence only (p < 0.001). CONCLUSIONS: Women with CPM were more likely to report being able to reduce worry about recurrence as a very important goal for surgery. They were also the least worried about ipsilateral breast recurrence and contralateral breast cancer almost two years postdiagnosis.

Measuring Multimorbidity: Selecting the Right Instrument for the Purpose and the Data Source.

BACKGROUND: Adults have a higher prevalence of multimorbidity-or having multiple chronic health conditions-than having a single condition in isolation. Researchers, health care providers, and health policymakers find it challenging to decide upon the most appropriate assessment tool from the many available multimorbidity measures. OBJECTIVE: The objective of this study was to describe a broad range of instruments and data sources available to assess multimorbidity and offer guidance about selecting appropriate measures. DESIGN: Instruments were reviewed and guidance developed during a special expert workshop sponsored by the National Institutes of Health on September 25-26, 2018. RESULTS: Workshop participants identified 4 common purposes for multimorbidity measurement as well as the advantages and disadvantages of 5 major data sources: medical records/clinical assessments, administrative claims, public health surveys, patient reports, and electronic health records. Participants surveyed 15 instruments and 2 public health data systems and described characteristics of the measures, validity, and other features that inform tool selection. Guidance on instrument selection includes recommendations to match the purpose of multimorbidity measurement to the measurement approach and instrument, review available data sources, and consider contextual and other related constructs to enhance the overall measurement of multimorbidity. CONCLUSIONS: The accuracy of multimorbidity measurement can be enhanced with appropriate measurement selection, combining data sources and special considerations for fully capturing multimorbidity burden in underrepresented racial/ethnic populations, children, individuals with multiple Adverse Childhood Events and older adults experiencing functional limitations, and other geriatric syndromes. The increased availability of comprehensive electronic health record systems offers new opportunities not available through other data sources.

The association between cancer care coordination and quality of life is stronger for breast cancer patients with lower health literacy: A Greater Plains Collaborative study.

PURPOSE: Health literacy (HL) and cancer care coordination (CCC) were examined for their relationship to quality of life (QOL) among breast cancer survivors. CCC was hypothesized to have a stronger relationship to QOL for women with lower HL. METHODS: Women (N = 1138) who had completed treatment for Stage 0-III, ductal carcinoma breast cancer between January 2013 and May 2014 at one of eight large medical centers responded to a mailed questionnaire. Responses to questions about survivorship care planning and presence of professional care coordinator were combined to form an index of CCC. An index of HL was also derived. QOL was measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) scales. RESULTS: 74.3% (N = 845) of patients reported having a health professional coordinate their care during treatment and 78.8% (N = 897) reported receiving survivorship care planning. CCC was classified as none, partial, or high for 7.1%, 32.7%, and 60.2% of the patients, respectively. Except for emotional well-being, the interaction between HL and CCC was significant for all QOL domains (p < .05); the effect of CCC on FACT-B scores was largest for people with lower HL. For the 39.8% of patients with less than high CCC, 111 (27.3%) had a level of HL associated with clinically meaningful lower QOL. CONCLUSIONS: The association between CCC and later QOL is strongest for people who have lower HL. Prioritizing care coordination for patients with lower health literacy may be an effective strategy in a setting of limited resources.

Household endotoxin reduction in the Louisa Environmental Intervention Project for rural childhood asthma.

Endotoxin exacerbates asthma. We designed the Louisa Environmental Intervention Project (LEIP) and assessed its effectiveness in reducing household endotoxin and improving asthma symptoms in rural Iowa children. Asthmatic school children (N = 104 from 89 homes) of Louisa and Keokuk counties in Iowa (aged 5-14 years) were recruited and block-randomized to receive extensive (education + professional cleaning) or educational interventions. Environmental sampling collection and respiratory survey administration were done at baseline and during three follow-up visits. Mixed-model analyses were used to assess the effect of the intervention on endotoxin levels and asthma symptoms in the main analysis and of endotoxin reduction on asthma symptoms in exploratory analysis. In the extensive intervention group, dust endotoxin load was significantly reduced in post-intervention visits. The extensive compared with the educational intervention was associated with significantly decreased dust endotoxin load in farm homes and less frequent nighttime asthma symptoms. In exploratory analysis, dust endotoxin load reduction from baseline was associated with lower total asthma symptoms score (Odds ratio: 0.52, 95% confidence interval: 0.29-0.92). In conclusion, the LEIP intervention reduced household dust endotoxin and improved asthma symptoms. However, endotoxin reductions were not sustained post-intervention by residents.

Impact of preexisting mental illness on breast cancer endocrine therapy adherence.

PURPOSE: Patients with estrogen receptor positive (ER+) breast cancer are often non-adherent to endocrine therapies, despite clear survival benefits. We utilized a nationally representative cancer cohort to examine the role of specific mental illnesses on endocrine therapy adherence. METHODS: Using the SEER-Medicare database, we included 21,894 women aged 68+ at their first surgically treated stage I-IV ER+ breast cancer during 2007-2013. All had continuous fee-for-service Medicare Parts A and B for 36+ months before, 18+ months after diagnosis, and continuous Part D for 4+ months before, 18+ after diagnosis. Mental illness was defined as occurring in the 36 months prior to cancer onset. We analyzed endocrine therapy adherence, initiation, and discontinuation using longitudinal linear and Cox regression models. RESULTS: Unipolar depression (11.0%), anxiety (9.5%), non-schizophrenia psychosis (4.6%), and dementias (4.6%) were the most prevalent diagnoses. Endocrine therapies were initiated by 80.0% of women. Among those with at least one year of use, 28.0% were non-adherent (< 0.80 adherence, mean = 0.84) and 25.7% discontinued. Patients with dementia or bipolar depression/psychotic/schizophrenia disorders had lower adjusted initiation probabilities by year one of follow-up, versus those without these diagnoses [0.74 95% CI (0.73-0.74) and 0.73 (0.72-0.73), respectively, reference 0.76 (0.76-0.77)]. Patients with substance use or anxiety disorders less frequently continued endocrine therapy for at least one year, after adjustment, [0.85 95% CI (0.85-0.86) and 0.88 (0.87-0.88), respectively, reference 0.90 (0.89-0.90)]. Patients with substance use disorders had 2.3% lower adherence rates (p < 0.001). CONCLUSIONS: Nearly one-quarter of female Medicare beneficiaries have diagnosed mental illness preceding invasive breast cancer. Those with certain mental illnesses have modestly reduced rates of initiation, adherence, and discontinuation and this may help define patients at higher risk of treatment abandonment. Overall, endocrine therapy adherence remains suboptimal, unnecessarily worsening recurrence and mortality risk.

Upper extremity disability and quality of life after breast cancer treatment in the Greater Plains Collaborative clinical research network.

PURPOSE: Chronic upper extremity disability (UED) is common after breast cancer treatment but under-identified and under-treated. Although UED has been linked to quality of life (QoL), the role of UED as mediator between contemporary treatment practices and QoL has not been quantified. This investigation describes UED in a contemporary sample of breast cancer patients and examines its relationship with personal and treatment factors and QoL. METHODS: Eight hundred and thirty-three women diagnosed at eight medical institutions during 2013-2014 with microscopically confirmed ductal carcinoma in situ or invasive stage I-III breast cancer were surveyed an average of 22 months after diagnosis. UED was measured with a modified QuickDASH and QoL with the FACT-B. The questionnaire also collected treatments, sociodemographic information, comorbidity, body mass index, and a 3-item health literacy screener. RESULTS: Women who received post-mastectomy radiation and chemotherapy experienced significantly worse UED and QoL. Women who had lower income, lower health literacy and prior diabetes, arthritis or shoulder diagnoses had worse UED. Patients with worse UED reported significantly worse QoL. Income and health literacy were independently associated with QoL after adjustment for UED but treatment and prior conditions were not, indicating mediation by UED. UED mediated 52-79% of the effect of mastectomy-based treatments on QoL as compared with unilateral mastectomy without radiation. UED and QoL did not differ by type of axillary surgery or post-mastectomy reconstruction. CONCLUSIONS: A large portion of treatment effect on QoL is mediated by UED. Rehabilitation practices that prevent and alleviate UED are likely to improve QoL for breast cancer survivors.

Smoking Status and Survival Among a National Cohort of Lung and Colorectal Cancer Patients.

INTRODUCTION: The purpose of this study was to explore the association of smoking status and clinically relevant duration of smoking cessation with long-term survival after lung cancer (LC) or colorectal cancer (CRC) diagnosis. We compared survival of patients with LC and CRC who were never-smokers, long-term, medium-term, and short-term quitters, and current smokers around diagnosis. METHODS: We studied 5575 patients in Cancer Care Outcomes Research and Surveillance (CanCORS), a national, prospective observational cohort study, who provided smoking status information approximately 5 months after LC or CRC diagnosis. Smoking status was categorized as: never-smoker, quit >5 years prior to diagnosis, quit between 1-5 years prior to diagnosis, quit less than 1 year before diagnosis, and current smoker. We examined the relationship between smoking status around diagnosis with mortality using Cox regression models. RESULTS: Among participants with LC, never-smokers had lower mortality risk compared with current smokers (HR 0.71, 95% CI 0.57 to 0.89). Among participants with CRC, never-smokers had a lower mortality risk as compared to current smokers (HR 0.79, 95% CI 0.64 to 0.99). CONCLUSIONS: Among both LC and CRC patients, current smokers at diagnosis have higher mortality than never-smokers. This effect should be further studied in the context of tumor biology. However, smoking cessation around the time of diagnosis did not affect survival in this sample. IMPLICATIONS: The results from our analysis of patients in the CanCORS consortium, a large, geographically diverse cohort, show that both LC and CRC patients who were actively smoking at diagnosis have worse survival as compared to never-smokers. While current smoking is detrimental to survival, cessation upon diagnosis may not mitigate this risk.

Variation in coordination of care reported by breast cancer patients according to health literacy.

BACKGROUND: Health literacy is the ability to perform basic reading and numerical tasks to function in the healthcare environment. The purpose of this study is to describe how health literacy is related to perceived coordination of care reported by breast cancer patients. METHODS: Data were retrieved from the Patient-Centered Outcomes Research Institute-sponsored "Share Thoughts on Breast Cancer" Study including demographic factors, perceived care coordination and responsiveness of care, and self-reported health literacy obtained from a mailed survey completed by 62% of eligible breast cancer survivors (N = 1221). Multivariable analysis of variance was used to characterize the association between presence of a single healthcare professional that coordinated care ("care coordinator") and perceived care coordination, stratified by health literacy level. RESULTS: Health literacy was classified as low in 24% of patients, medium in 34%, and high in 42%. Women with high health literacy scores were more likely to report non-Hispanic white race/ethnicity, private insurance, higher education and income, and fewer comorbidities (all p < 0.001). The presence of a care coordinator was associated with 17.1% higher perceived care coordination scores among women with low health literacy when compared to those without a care coordinator, whereas a coordinator modestly improved perceived care coordination among breast cancer survivors with medium (6.9%) and high (6.2%) health literacy. CONCLUSION: The use of a single designated care coordinator may have a strong influence on care coordination in patients with lower levels of health literacy.

Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy.

In patients with hypogammaglobulinemia secondary to chronic lymphocytic leukemia (CLL) or multiple myeloma (MM), intravenous immune globulin (IVIg) may be administered to reduce the risk of infection. Since 2013, IVIg products have carried a boxed safety warning about the risk of thromboembolic events (TEEs), with TEEs reported in 0.5% to 15% of patients treated with IVIg. In this retrospective cohort study of older patients with CLL or MM identified from the Surveillance, Epidemiology, and End Results-Medicare Linked Database, we assessed rates of clinically serious TEEs in 2724 new users of IVIg and a propensity-matched comparison group of 8035 nonusers. For the primary end point, arterial TEE, we observed a transient increased risk of TEE during the day of an IVIg infusion and the day afterward (hazard ration = 3.40; 95% confidence interval [CI]: 1.25, 9.25); this risk declined over the remainder of the 30-day treatment cycle. When considered in terms of absolute risk averaged over a 1-year treatment period, the increase in risk attributable to IVIg was estimated to be 0.7% (95% CI: -0.2%, 2.0%) compared with a baseline risk of 1.8% for the arterial TEE end point. A statistically nonsignificant risk increase of 0.3% (95% CI: -0.4%, 1.5%) compared with a baseline risk of 1.1% was observed for the venous TEE end point. Further research is needed to establish the generalizability of these results to patients receiving higher doses of IVIg for other indications.

Geographic variation in inhaled corticosteroid use for children with persistent asthma in Medicaid.

OBJECTIVE: Geographic variation in the rates of inhaled corticosteroid (ICS) use for children with persistent asthma in Medicaid has been reported, but the source of this variation is unknown. The objective of this study was to quantify the geographic variation in ICS use for children with persistent asthma in Medicaid that remains after adjusting for the characteristics of children in an area. METHODS: Data from the 2005-2007 Medicaid Analytic eXtract files were used. Frequent fills of short-acting beta2-agonist (SABA) were used to identify children 5-18 years of age with persistent asthma across the United States. A child was considered to have used an ICS if the child initially filled an ICS following frequent SABA use. Areas were determined using published methods, and the unadjusted ICS rate and the area treatment ratio for ICS, which adjusted for demographic and clinical characteristics, were calculated for each area. RESULTS: Of 15,917 children, 13% used an ICS. The median unadjusted ICS rate for all areas was 10% but ranged from 0% to 64%. ICS use was less than expected for more than half of the areas based on the characteristics of the children in the area, but use was nearly five times what was expected in some areas. Areas with higher than expected ICS use were found contiguous to areas with lower than expected use. CONCLUSIONS: Geographic variation in ICS not attributable to the demographic and clinical characteristics of the children in an area exists and could prove useful in the struggle to reduce asthma exacerbation rates.

Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug-outcome associations: The case of clindamycin and Clostridium difficile infection.

PURPOSE: The Food and Drug Administration's Sentinel System developed parameterized, reusable analytic programs for evaluation of medical product safety. Research on outpatient antibiotic exposures, and Clostridium difficile infection (CDI) with non-user reference groups led us to expect a higher rate of CDI among outpatient clindamycin users vs penicillin users. We evaluated the ability of the Cohort Identification and Descriptive Analysis and Propensity Score Matching tools to identify a higher rate of CDI among clindamycin users. METHODS: We matched new users of outpatient dispensings of oral clindamycin or penicillin from 13 Data Partners 1:1 on propensity score and followed them for up to 60 days for development of CDI. We used Cox proportional hazards regression stratified by Data Partner and matched pair to compare CDI incidence. RESULTS: Propensity score models at 3 Data Partners had convergence warnings and a limited range of predicted values. We excluded these Data Partners despite adequate covariate balance after matching. From the 10 Data Partners where these models converged without warnings, we identified 807 919 new clindamycin users and 8 815 441 new penicillin users eligible for the analysis. The stratified analysis of 807 769 matched pairs included 840 events among clindamycin users and 290 among penicillin users (hazard ratio 2.90, 95% confidence interval 2.53, 3.31). CONCLUSIONS: This evaluation produced an expected result and identified several potential enhancements to the Propensity Score Matching tool. This study has important limitations. CDI risk may have been related to factors other than the inherent properties of the drugs, such as duration of use or subsequent exposures.

Chart validation of inpatient ICD-9-CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database.

BACKGROUND: The Sentinel Distributed Database (SDD) is a large database of patient-level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases. PURPOSE: In this chart validation study, we report on the positive predictive value (PPV) of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification AMI administrative diagnosis codes (410.x1 and 410.x0) in the SDD. METHODS: As part of an assessment of thromboembolic adverse event risk following treatment with intravenous immune globulin, charts were obtained for 103 potential post-intravenous immune globulin AMI cases. Charts were abstracted by trained nurses and physician-adjudicated based on prespecified diagnostic criteria. RESULTS: Acute myocardial infarction status could be determined for 89 potential cases. The PPVs for the inpatient AMI diagnoses recorded in the SDD were 75% overall (95% CI, 65-84%), 93% (95% CI, 78-99%) for principal-position diagnoses, 88% (95% CI, 72-97%) for secondary diagnoses, and 38% (95% CI, 20-59%) for position-unspecified diagnoses (eg, diagnoses originating from separate physician claims associated with an inpatient stay). Of the confirmed AMI cases, demand ischemia was the suspected etiology more often for those coded in secondary or unspecified positions (72% and 40%, respectively) than for principal-position AMI diagnoses (21%). CONCLUSIONS: The PPVs for principal and secondary AMI diagnoses were high and similar to estimates from prior chart validation studies. Position-unspecified diagnosis codes were less likely to represent true AMI cases.