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Leukemia and lymphoma are cancers affecting children, adolescents, and young adults and may affect reproductive outcomes and maternal metabolism. We evaluated for metabolic changes in newborns of mothers with a history of these cancers.A cross-sectional study was conducted on California births from 2007 to 2011 with linked maternal hospital discharge records, birth certificate, and newborn screening metabolites. History of leukemia or lymphoma was determined using ICD-9-CM codes from hospital discharge data and newborn metabolite data from the newborn screening program.A total of 2,068,038 women without cancer history and 906 with history of leukemia or lymphoma were included. After adjusting for differences in maternal age, infant sex, age at metabolite collection, gestational age, and birthweight, among newborns born to women with history of leukemia/lymphoma, several acylcarnitines were significantly (The varied metabolite levels suggest history of leukemia or lymphoma has metabolic impact on newborn offspring, which may have implications for future metabolic consequences such as necrotizing enterocolitis and urea cycle enzyme disorders in children born to mothers with a history of leukemia or lymphoma.

We investigated whether patients receiving surgical treatment for metastatic disease of bone (MDB) at hospitals with higher volume, medical school affiliation, or Commission on Cancer accreditation have superior outcomes.Using the Surveillance, Epidemiology, and End Results-Medicare database, we identified 9413 patients surgically treated for extremity MDB between 1992 and 2014 at the age of 66 years or older. Cox proportional hazards models were used to calculate the hazards ratios (HR) for 90-day and 1-year mortality and 30-day readmission according to the characteristics of the hospital where bone surgery was performed.We observed no notable differences in 90-day mortality, 1-year mortality, or 30-day readmission associated with hospital volume. Major medical school affiliation was associated with lower 90-day (HR: 0.88, 95% confidence interval [CI]: 0.80-0.96) and 1-year (HR: 0.92, 95% CI: 0.87-0.99) mortality after adjustments for demographic and tumor characteristics. Surgical treatment at Commission on Cancer accredited hospitals was associated with significantly higher risk of death at 90 days and 1 year after the surgery. This effect appeared to be driven by lung cancer patients (1-year HR: 1.17, 95% CI: 1.07-1.27).Our findings suggest surgical management of MDB at lower-volume hospitals does not compromise survival or readmissions. There may be benefit to referral or consultation with an academic medical center in some tumor types or clinical scenarios.

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.

Hypertension during pregnancy can adversely affect maternal and fetal health. This study assessed whether diagnosis of leukemia or lymphoma prior to pregnancy is associated with hypertensive disorders of pregnancy including gestational hypertension, preeclampsia and eclampsia.A cross-sectional study used two statewide population-based datasets that linked birth certificates with sources of maternal medical history: hospital discharges in California and Surveillance, Epidemiology, and End Results (SEER) cancer registry data in Iowa. Birth years included 2007-2012 in California and 1989-2018 in Iowa.Primary outcome measure was hypertension in pregnancy measured from combined birth certificate and hospital diagnoses in California (for gestational hypertension, preeclampsia, or eclampsia) and birth certificate information (gestational hypertension or eclampsia) in Iowa.After adjusting for maternal age, race, education, smoking, and plurality, those with a history of leukemia/lymphoma were at increased risk of hypertensive disorders of pregnancy in Iowa (odds ratio (OR) = 1.86; 95% CI 1.07-3.23), but not in California (OR = 1.12; 95% CI 0.87-1.43). In sensitivity analysis restricting to more severe forms of hypertension in pregnancy (preeclampsia and eclampsia) in the California cohort, the effect estimate increased (OR = 1.29; 95% CI 0.96-1.74).In a population-based linked cancer registry-birth certificate study, an increased risk of hypertensive disorders of pregnancy was observed among leukemia or lymphoma survivors. Findings were consistent but non-significant in a second, more ethnically diverse study population with less precise cancer history data. Improved monitoring and surveillance may be warranted for leukemia or lymphoma survivors throughout their pregnancies.

ObjectiveTo explore trends in blood pressure (BP) control before and during the COVID-19 pandemic.Patients and methodsHealth systems participating in the National Patient-Centered Clinical Research Network (PCORnet) Blood Pressure Control Laboratory Surveillance System responded to data queries, producing 9 BP control metrics. Averages of the BP control metrics (weighted by numbers of observations in each health system) were calculated and compared between two 1-year measurement periods (January 1, 2019, through December 31, 2019, and January 1, 2020, through December 31, 2020).ResultsAmong 1,770,547 hypertensive persons in 2019, BP control to

The objective of this study was to assess perceptions, health behaviors, and disruptions related to the COVID-19 pandemic in a largely rural, Midwestern state, and to examine differences between rural and urban respondents.A questionnaire was mailed August 2020 to a sample of 10,009 registered voters in Iowa ages 18-100 years, with oversampling from 6 select rural counties. Previously validated and tested items assessed COVID-19 precautions, health care disruptions, emotional reactions, health behavior changes, telehealth and experiences with the internet, and demographic characteristics.There were 4,048 respondents (40% response rate); 65% were rural and 35% were urban residents. The average age of respondents was 58.3 years and 45% of respondents identified as female. Rural respondents reported less concern about COVID-19 in their community (29% vs 40%, P.001) and lower perceived importance of social distancing (51% vs 64%, P.001). Urban respondents more often reported experiencing disruption to daily living, stronger negative emotional reactions, and displayed more pronounced behavior change compared to their rural counterparts. For example, urban respondents reported more pandemic-related job losses (6% vs 4%, P = .05), disruptions to daily activities (48% vs 35%, P.001), and use of telehealth services during the pandemic (24% vs 16%, P.001).The majority of respondents reported disruptions to normal activities, medical appointment cancellations, and emotional distress during the first 6 months of the pandemic. The impact of the pandemic on urban residents appeared to be greater than for rural respondents. Timing of pandemic spread and varying beliefs are potential explanations.

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 (POC) 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

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.

Sepsis is a life-threatening infection that affects over 1.7 million Americans annually. Low-volume rural hospitals have worse sepsis outcomes, and emergency department (ED)-based telemedicine (tele-ED) has been one promising strategy for improving rural sepsis care. The objective of this study is to evaluate the impact of tele-ED consultation on sepsis care and outcomes in rural ED patients. The TELEvISED study is a multicenter (n = 25) retrospective propensity-matched comparative effectiveness study of tele-ED care for rural sepsis patients in a mature tele-ED network. Telemedicine-exposed patients will be matched with non telemedicine patients using a propensity score to predict tele-ED use. The primary outcome is 28-day hospital free days, and secondary outcomes include adherence with guidelines, mortality and organ failure. ClinicalTrials.gov: NCT04441944 .

PURPOSE Examine the ability of PCORnet data resources to investigate molecular-guided cancer treatment. PATIENTS AND METHODS Patients (N = 86,154) had single primary solid tumors (diagnosed 2013-2017) from hospital oncology registries linked to the PCORnet Common Data Model (CDM) at 11 medical institutions. Molecular and anatomic test procedures and oral and infused therapies were identified with Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, RxNorm Concept Unique Identifier, and National Drug Codes from CDM tables. Chart review (2 institutions, n = 213) for advanced colorectal cancer and Medicare claims linkages (7 institutions, n = 1,731) for breast cancer explored options for increasing electronic data capture. RESULTS Molecular testing prevalence detected via analyte-specific molecular CPT/HCPCS codes was 5.5% (n = 4,784); for the nonspecific anatomic pathology codes, for which only some testing is performed to guide therapy selection, it was an additional 44.8% (n = 38,610). Molecular-guided therapy prevalence was 5% (n = 4,289). Testing and treatment were most common with stage IV disease and varied across cancer types and study institutions (testing, 0%-10.4%; treatment, 0.8%-8.4%). Therapy-concordant test results were found in charts for all 36 treated patients with colorectal cancer at the 2 institutions, 3 (8.3%) of whom received treatment outside the institution. Breast cancer Medicare claims linkage increased rates of identified testing from 62.7%-98.9% and treatment from 3.9%-8.2%. CONCLUSION Although a minority of patients received molecular-guided therapies, the majority had testing that could guide cancer treatment. Claims data extended electronic data capture for therapies and test orders but often was uninformative for types of test ordered. Test results continue to require text data curation from narrative pathology reports.

Despite evidence of superior outcomes for rectal cancer at high-volume, multidisciplinary cancer centers, many patients undergo surgery in low-volume hospitals.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.In this retrospective cohort study, patients were surveyed about what they considered when selecting a cancer surgeon.Study data were obtained via survey and the statewide Iowa Cancer Registry.All eligible individuals diagnosed with invasive stages II/III rectal cancer from 2013 to 2017 identified through the registry were invited to participate.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).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.This study took place in a Midwestern state with a predominantly white population, which limited our ability to evaluate racial/ethnic associations.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).

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.

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.

Currently there is little evidence to guide the treatment of depression in Huntington's disease (HD). The primary objective was to determine the effectiveness of antidepressant medications on lowering depressive symptom scores in patients with manifest HD. The secondary objective was to determine the effect of antidepressant use on measures of disease progression.After retrospectively identifying motor-manifest HD participants with at least borderline depressive symptoms from the Enroll-HD database, 86 new users of antidepressant medication were exact matched with non-users on depression score, and matched on propensity scores developed using age, sex, CAG repeat length, anxiety scores, and disease progression measures. Linear mixed effect models were used to assess the change in depression scores, anxiety scores, and disease progression measures based on antidepressant use between two visits approximately one-year apart.There was no significant difference in the change in depression score between antidepressant users and non-users (p = 0.46). There were also no significant differences in the change in total motor score (p = 0.88), total functional capacity score (p = 0.16), number correct on the symbol digit modality test (p = 0.49), or anxiety score (p = 0.68).Initiation of antidepressant medication was not associated with a greater reduction in depressive symptoms or changes in other symptoms when compared to non-use. The findings of this study support further research on the effectiveness of antidepressants in Huntington's disease patients. Clinical trials or studies with a larger sample of new antidepressant users should be used to assess the causal effects of antidepressant medications on depressive symptoms.

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, post-treatment worry about both ipsilateral and contralateral recurrence was higher in the BCS group than the CPM group (both p

BACKGROUND: We developed a remote cardiovascular risk service (CVRS) managed by clinical pharmacists to support primary care teams. The purpose of this study was to examine whether the CVRS could improve guideline adherence in primary care clinics with diverse geographic and patient characteristics. METHODS: This study was a cluster-randomized trial initiated in 20 primary care clinics across the US. Clinics were stratified as high or low minority and then randomized to receive the intervention or maintain usual care for 12 months. The primary outcome was adherence to relevant The Guideline Advantage (TGA) criteria met. TGA is a compilation of criteria from practice guidelines intended to improve the quality of primary care. Post-hoc outcomes included changes in individual TGA measures. RESULTS: A total of 401 study subjects were included in the analysis. Mean TGA scores remained the same in the intervention group (n=193, 0.72) and slightly decreased in the usual care group (n=208, 0.67 to 0.66) over the 12-month study period. There was no significant difference between the mean TGA scores in intervention and usual care groups for the overall population at 12 months (0.72 versus 0.66 respectively, p=0.10). For under-represented minority subjects, there was no significant difference between TGA scores at 12 months (n=186; 0.70 versus 0.67, respectively, p=0.50). In a post-hoc analysis of subjects uncontrolled at baseline, there was a significant improvement in systolic BP at 12 months in the intervention group versus usual care (model-based difference of −8.03mmHg, p=0.03). CONCLUSIONS: Improvements in individual TGA measures were limited, in part, due to higher than expected baseline TGA scores. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02215408; https://clinicaltrials.gov/ct2/show/NCT02215408?id=NCT02215408

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. 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. 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

The US Food and Drug Administration’s Sentinel System was established to monitor safety of regulated medical products. Sentinel investigators identified known associations between drugs and adverse events to test reusable analytic tools developed for Sentinel. This test case used a comparator with a different indication. We tested the ability of Sentinel’s reusable analytic tools to identify the known association between warfarin and gastrointestinal bleeding (GIB). Statins, expected to have no effect on GIB, were the comparator. We further explored the impact of analytic features, including matching ratio and stratifying Cox regression analyses, on matched pairs. This evaluation included data from 14 Sentinel Data Partners. New users of warfarin and statins, aged 18 years and older, who had not received other anticoagulants or had recent GIB were matched on propensity score using 1:1 and 1:n variable ratio matching, matching statin users with warfarin users to estimate the average treatment effect in warfarin-treated patients. We compared the risk of GIB using Cox proportional hazards regression, following patients for the duration of their observed continuous treatment or until a GIB. For the 1:1 matched cohort, we conducted analyses with and without stratification on matched pair. The variable ratio matched cohort analysis was stratified on the matched set. We identified 141,398 new users of warfarin and 2,275,694 new users of statins. In analyses stratified on matched pair/set, the hazard ratios (HR) for GIB in warfarin users compared with statin users were 2.78 (95% confidence interval [CI] 2.36–3.28) in the 1:1 matched cohort and 3.10 (95% CI 2.76–3.49) in the variable ratio matched cohort. The HR was lower in the analysis of the 1:1 matched cohort not stratified by matched pair (2.22, 95% CI 1.97–2.49), and highest early in treatment. Follow-up for warfarin users tended to be shorter than for statin users. This study identified the expected GIB risk with warfarin compared with statins using an analytic tool developed for Sentinel. Our findings suggest that comparators with different indications may be useful in surveillance in select circumstances. Finally, in the presence of differential censoring, stratification by matched pair may reduce the potential for bias in Cox regression analyses.

PURPOSE: Care coordination is a strategy to reduce healthcare navigation challenges for cancer patients. The objectives of this study were to assess the association between having a cancer care coordinator (CCC) and long-term health-related quality of life (HRQoL), and to evaluate whether this association differed by level of health literacy. METHODS: A population-based sample of survivors diagnosed with breast, prostate, or colorectal cancer in 2015 from the Iowa Cancer Registry participated in an online survey conducted in 2017–2018 (N=368). Chi-squared tests and logistic regression were used to model the association between patient characteristics and having a cancer care coordinator. Linear regression was used to model the association between patient perception of having a cancer care coordinator and post-treatment physical or mental HRQoL by differing levels of health literacy while controlling for sociodemographic and clinical factors. RESULTS: Most survivors (81%) reported having one healthcare professional who coordinated their cancer care. Overall, patient perception of having a coordinator was not significantly associated with physical HRQoL (p=0.118). However, participants with low health literacy (21%) who had a coordinator had significantly higher physical HRQoL scores compared to those who did not (adjusted mean difference 5.2, p=0.010), while not so for medium (29%) or high (51%) health literacy (p=0.227, and p=0.850, respectively; test for interaction p=0.001). Mental HRQoL was not associated with having a coordinator in our analyses. CONCLUSION: Findings suggest that care coordinators improved post-treatment physical HRQoL, particularly for participants with low health literacy. Care coordinators may be beneficial to the most vulnerable patients struggling to navigate the complex healthcare system during cancer treatment. Future research should focus on the mechanisms by which care coordination may affect post-treatment HRQoL.

Hand hygiene compliance decreased significantly when opportunities exceeded 30 per hour. At higher workloads, the number of healthcare worker types involved and the proportion of hand hygiene opportunities for which physicians and other healthcare workers were responsible increased. Thus, care complexity and risk to patients may both increase with workload.

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.

Objective:To determine whether the order in which healthcare workers perform patient care tasks affects hand hygiene compliance.Design:For this retrospective analysis of data collected during the Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) study, we linked consecutive tasks healthcare workers performed into care sequences and identified task transitions: 2 consecutive task sequences and the intervening hand hygiene opportunity. We compared hand hygiene compliance rates and used multiple logistic regression to determine the adjusted odds for healthcare workers (HCWs) transitioning in a direction that increased or decreased the risk to patients if healthcare workers did not perform hand hygiene before the task and for HCWs contaminating their hands.Setting:The study was conducted in 17 adult surgical, medical, and medical-surgical intensive care units.Participants:HCWs in the STAR*ICU study units.Results:HCWs moved from cleaner to dirtier tasks during 5,303 transitions (34.7%) and from dirtier to cleaner tasks during 10,000 transitions (65.4%). Physicians (odds ratio [OR]: 1.50; P < .0001) and other HCWs (OR, 2.15; P < .0001) were more likely than nurses to move from dirtier to cleaner tasks. Glove use was associated with moving from dirtier to cleaner tasks (OR, 1.22; P < .0001). Hand hygiene compliance was lower when HCWs transitioned from dirtier to cleaner tasks than when they transitioned in the opposite direction (adjusted OR, 0.93; P < .0001).Conclusions:HCWs did not organize patient care tasks in a manner that decreased risk to patients, and they were less likely to perform hand hygiene when transitioning from dirtier to cleaner tasks than the reverse. These practices could increase the risk of transmission or infection.

OBJECTIVE: Leukemia and lymphoma are top cancers affecting children, adolescents and young adults with high five-year survival rates. Late-effects of these cancers are a concern in reproductive-age patients, including pregnancy outcomes such as preterm birth. Our study aimed to evaluate whether diagnosis of leukemia or lymphoma prior to pregnancy was associated with preterm birth (

Objective Despite evidence of volume-outcome relationships for cancer surgery, treatment at low-volume hospitals remains common. Our objective was to evaluate whether individuals actively involved in selecting their cancer surgeon were more likely to go to hospitals recognized for quality cancer care. Methods Individuals diagnosed with breast, prostate and colorectal cancer in 2015 completed online surveys in 2017–2018. Participants were categorized as “directed” to a surgeon (relied on referral) or “active” (sought additional information), and hospitals were categorized by NCI-designation, CoC accreditation, and academic affiliation. Results Of 299 participants, 42% were active. Individuals with breast cancer were more active (aOR = 2.46,95%CI:1.32–4.59). Active participants had nonsignificantly higher odds of surgery at NCI-designated facilities (aOR = 2.04,95%CI:0.95–4.38), or academic centers (aOR = 1.51,95%CI:0.86–2.64). Conclusions While most participants were directed to their cancer surgeon, active participants tended to select NCI-designated/academic hospitals. Although centralization of cancer care would require altering referral patterns, decision-support resources may help patients make informed choices.

Objective Evaluate whether breast cancer endocrine therapy adherence is affected by access to primary and mental health care, particularly among at-risk patients with mental illness. Methods The study included 21,892 SEER-Medicare women aged 68 or older with stage I-IV ER+ breast cancer, 2007 to 2013. Patient home counties during breast cancer diagnosis, if evaluated for HPSA care shortage status, were categorized as least, moderate, or highest shortage; unevaluated counties (no known shortage) were a fourth category. Endocrine therapy initiation and discontinuation were analyzed with Cox regression, and daily adherence with longitudinal linear regression. Results After multivariate adjustment, patients in high primary care shortage counties were less likely to initiate endocrine therapy, reference least shortage [HR 0.92 (95% CI 0.86–0.97)]. Unevaluated counties had more oncologists per capita, fewer residents below the federal poverty level, and higher incomes. Mental health shortages were not associated with outcomes, however subgroups living in unevaluated counties were less likely to discontinue: patients with bipolar and psychotic disorders [discontinuation HR 0.35 (95% CI 0.17–0.73)], substance use [HR 0.48 (95% CI 0.24–0.95)], anxiety disorders [HR 0.56 (95% CI 0.35–0.90)]. Conclusions Poor primary care access was associated with a lower likelihood of initiating endocrine therapy but living in counties without established mental health shortages may reduce the harmful association between mental illness and incomplete treatment receipt. Patients with mental illness may be more equipped to complete cancer treatment if given better mental health care access, suggesting a need for care coordination between primary and mental health care.

Introduction Few studies have addressed how to select a study sample when using electronic health record (EHR) data. Objective To examine how changing criterion for number of visits in EHR data required for inclusion in a study sample would impact one basic epidemiologic measure: estimates of disease period prevalence. Methods Year 2016 EHR data from three Midwestern health systems (Northwestern Medicine in Illinois, University of Iowa Health Care, and Froedtert & the Medical College of Wisconsin, all regional tertiary health care systems including hospitals and clinics) was used to examine how alternate definitions of the study sample, based on number of healthcare visits in one year, affected measures of disease period prevalence. In 2016, each of these health systems saw between 160,000 and 420,000 unique patients. Curated collections of ICD-9, ICD-10, and SNOMED codes (from CMS-approved electronic clinical quality measures) were used to define three diseases: acute myocardial infarction, asthma, and diabetic nephropathy). Results Across all health systems, increasing the minimum required number of visits to be included in the study sample monotonically increased crude period prevalence estimates. The rate at which prevalence estimates increased with number of visits varied across sites and across diseases. Conclusion In addition to providing thorough descriptions of case definitions, when using EHR data authors must carefully describe how a study sample is identified and report data for a range of sample definitions, including minimum number of visits, so that others can assess the sensitivity of reported results to sample definition in EHR data. Key words Electronic Health Records, Sampling Studies, Prevalence, Methods

Background We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk. Methods We used data for a retrospective cohort from a large U.S. health plan for Medicare beneficiaries age > =65 years with AF who initiated dabigatran or rivaroxaban during 2010–2016. Stroke and major bleeding were quantified in patients who were eligible for low dose but received standard dose, and in patients who were eligible for standard dose but received low dose. Results We identified 8035 and 19,712 patients who initiated dabigatran or rivaroxaban, respectively. Overall, 1401 (17.4%) and 7820 (39.7%) patients who received dabigatran and rivaroxaban met criteria for low dose, respectively. Of those, 959 (68.5%) and 3904 (49.9%) received standard dose. In contrast, 1013 (15.3%) and 2551 (21.5%) of patients eligible for standard dose dabigatran and rivaroxaban received low dose. Mean follow-up for patients eligible for low and standard dose dabigatran and rivaroxaban were 13.9, 15.1, 10.1, and 12.3 months, respectively. In unadjusted analyses, patients eligible for low or standard dose dabigatran and rivaroxaban but receiving off-label dose, had no differences in the rates of ischemic stroke. Among patients who met criteria for standard dose direct oral anticoagulants (DOAC), use of low dose was associated with significantly higher risk of any major bleeding (Dabigatran: HR = 1.44; 95% CI 1.14–1.8, P = 0.002, Rivaroxaban HR 1.34, 95% CI 1.11–1.6, P = 0.002) and gastrointestinal bleeding (Dabigatran: HR = 1.48; 95% CI 1.08–2, P = 0.016). In patients who met criteria for low dose DOACs, there was lower risk of major bleeding (Dabigatran: HR = 0.59; 95% CI 0.43–0.8, P P = 0.03) and intracranial bleeding (Dabigatran: HR = 0.33; 95% CI 0.12–0.9, P = 0.001) with standard dosing. After propensity matching, use of off-label doses was not associated with stroke, major, gastrointestinal or intracranial bleeding for either dabigatran or rivaroxaban. Conclusions While a significant number of patients receive higher or lower dose of dabigatran and rivaroxaban than recommended, we found no evidence of significant impact on thromboembolic or hemorrhagic outcomes.

BACKGROUND: Health literacy is the ability to perform basic reading and numerical tasks to function in the health care 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 PCORI-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=1,221). Multivariable analysis of variance was used to characterize the association between presence of a single health care 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

Purpose The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. Methods In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. Results Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age

Background Novel targeted therapies offer excellent short-term outcomes in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL). However, there is disagreement over how widely these therapies should be used in place of standard chemo-immunotherapy (CIT). We investigated whether stratification on the length of the interval between first-line (T1) and second-line (T2) treatments could identify a subgroup of older patients with relapsed CLL/SLL with an expectation of normal overall survival, and for whom CIT could be an acceptable treatment choice. Patients and Methods Patients with relapsed CLL/SLL who received T2 were identified from the SEER-Medicare Linked Database. Five-year relative survival (RS5; ie, the ratio of observed survival to expected survival based on population life tables) was assessed after stratifying patients on the interval between T1 and T2. We then validated our findings in the Mayo Clinic CLL Database. Results Among 1974 SEER-Medicare patients (median age = 77 years) who received T2 for relapsed CLL/SLL, longer time-to-retreatment was associated with a modestly improved prognosis ( P = .01). However, even among those retreated ≥ 3 years after T1, survival was poor compared with the general population (RS5 = 0.50 or lower in SEER-Medicare). Similar patterns were observed in the younger Mayo validation cohort, although prognosis was better overall among the Mayo patients, and patients with favorable fluorescence in situ hybridization retreated ≥ 3 years after T1 had close to normal expected survival (RS5 = 0.87). Conclusion Further research is needed to quantify the degree to which targeted therapies provide meaningful improvements over CIT in long-term outcomes for older patients with relapsed CLL/SLL.

Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs. glipizide) and serious hypoglycemia. Thirteen data partners who contribute to the Sentinel Distributed Database participated in this analysis. A pretested and customizable analytic program was run at each individual site. De-identified summary results from each data partner were returned and aggregated at the Sentinel Operations Center. We identified a total of 198,550 and 379,507 new users of glyburide and glipizide, respectively. The incidence of emergency department visits and hospital admissions for serious hypoglycemia was 19 per 1000 person-years (95% confidence interval = 17.9, 19.7) for glyburide users and 22 (21.6, 22.7) for glipizide users. In cohorts matched by propensity score based on predefined variables, the hazard ratio (HR) for glyburide was 1.36 (1.24, 1.49) versus glipizide. In cohorts matched on a high-dimensional propensity score based on empirically selected variables, for which the program ran to completion in five data partners, the HR was 1.49 (1.31, 1.70). In cohorts matched on propensity scores based on both predefined and empirically selected variables via the high-dimensional propensity score algorithm (the same five data partners), the HR was 1.51 (1.32, 1.71). These findings are consistent with the literature, and demonstrate the ability of the Sentinel Propensity Score Matching Tool to reproduce this known association in an expedited fashion.See video abstract at, http://links.lww.com/EDE/B275.

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.Data from the 2005-2007 Medicaid Analytic eXtract files were used. Frequent fills of short-acting betaOf 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.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.

We hypothesized that the length of treatment-free survival following (a) initial diagnosis and (b) first-line treatment would be associated with improved subsequent five-year relative survival (RS5) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). 19,879 patients incident CLL/SLL cases (median age = 76 years) were identified from SEER-Medicare. RS5 improved from 0.73 (95% CI: 0.72, 0.74) at diagnosis to 0.81 (95% CI: 0.80, 0.82) at year 1 and 0.89 (95% CI: 0.83, 0.96) at year 10 among those who had not received treatment. In our analysis of survival patterns following first-line treatment, RS5 improved from 0.55 (95% CI: 0.53, 0.57) at initiation of first-line treatment to 0.84 (95% CI: 0.75, 0.92) among patients who had not been retreated at year 5 following first-line therapy. Longer periods of treatment-free survival following initial diagnosis and first-line treatment were both predictive of meaningfully improved prognosis in CLL/SLL patients.

Objective: To estimate long-term costs and outcomes attributable to a physician-pharmacist collaborative intervention compared with physician management alone for treating essential hypertension. Methods: A Markov model cohort simulation with a 6-month cycle length to predict acute coronary syndrome, stroke, and heart failure throughout lifetime was performed. A cohort of 399 patients was obtained from two prospective, cluster randomized controlled clinical trials implementing physician-pharmacist collaborative interventions in community-based medical offices in the Midwest, USA. Framingham risk equations and other algorithms were used to predict the vascular diseases. SBP reduction due to the interventions deteriorated until 5 years. Direct medical costs using a payer perspective were adjusted to 2015 dollar value, and the main outcome was quality-adjusted life years (QALYs); both were discounted at 3%. The intervention costs were estimated from the trials, whereas the remaining parameters were from published studies. A series of sensitivity analyses including changing patient risks of vascular diseases, probabilistic sensitivity analysis, and a cost-effectiveness acceptability curve were performed. Results: The lifetime incremental costs were $26 807.83 per QALY (QALYs gained = 0.14). The intervention provided the greatest benefit for the high-risk patients, moderate benefit for the trial patients, and the lowest benefit for the low-risk patients. If a payer is willing to pay $50 000 per QALY gained, in 48.6% of the time the intervention would be cost-effective. Conclusion: Team-based care such as a physician-pharmacist collaboration appears to be a cost-effective strategy for treating hypertension. The intervention is most cost-effective for high-risk patients.

Background Most articles on hand hygiene report either overall compliance or compliance with specific hand hygiene moments. These moments vary in the level of risk to patients if healthcare workers (HCWs) are noncompliant. We assessed how task type affected HCWs’ hand hygiene compliance. Methods We linked consecutive tasks individual HCWs performed during the Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) study into care sequences and identified task pairs—2 consecutive tasks and the intervening hand hygiene opportunity. We defined tasks as critical and/or contaminating. We determined the odds of critical and contaminating tasks occurring, and the odds of hand hygiene compliance using logistic regression for transition with a random effect adjusting for isolation precautions, glove use, HCW type, and compliance at prior opportunities. Results Healthcare workers were less likely to do hand hygiene before critical tasks than before other tasks (adjusted odds ratio [aOR], 0.97 [95% confidence interval {CI}, .95–.98]) and more likely to do hand hygiene after contaminating tasks than after other tasks (aOR, 1.12 [95% CI, 1.10–1.13]). Nurses were more likely to perform both critical and contaminating tasks, but nurses’ hand hygiene compliance was better than physicians’ (aOR, 0.94 [95% CI, .91–.97]) and other HCWs’ compliance (aOR, 0.87 [95% CI, .87–.94]). Conclusions Healthcare workers were more likely to do hand hygiene after contaminating tasks than before critical tasks, suggesting that habits and a feeling of disgust may influence hand hygiene compliance. This information could be incorporated into interventions to improve hand hygiene practices, particularly before critical tasks and after contaminating tasks.

PURPOSE This pilot study examined the ability to operationalize the collection of real-world data to explore the potential use of real-world end points extracted from data from diverse health care data organizations and to assess how these relate to similar end points in clinical trials for immunotherapy-treated advanced non–small-cell lung cancer. PATIENTS AND METHODS Researchers from six organizations followed a common protocol using data from administrative claims and electronic health records to assess real-world end points, including overall survival (rwOS), time to next treatment, time to treatment discontinuation (rwTTD), time to progression, and progression-free survival, among patients with advanced non–small-cell lung cancer treated with programmed death 1/programmed death-ligand 1 inhibitors in real-world settings. Data sets included from 269 to 6,924 patients who were treated between January 2011 and October 2017. Results from contributors were anonymized. RESULTS Correlations between real-world intermediate end points (rwTTD and time to next treatment) and rwOS were moderate to high (range, 0.6 to 0.9). rwTTD was the most consistent end points as treatment detail was available in all data sets. rwOS at 1 year post–programmed death-ligand 1 initiation ranged from 40% to 57%. In addition, rwOS as assessed via electronic health records and claims data fell within the range of median OS values observed in relevant clinical trials. Data sources had been used extensively for research with ongoing data curation to assure accuracy and practical completeness before the initiation of this research. CONCLUSION These findings demonstrate that real-world end points are generally consistent with each other and with outcomes observed in randomized clinical trials, which substantiates the potential validity of real-world data to support regulatory and payer decision making. Differences observed likely reflect true differences between real-world and protocol-driven practices.

IntroductionFew studies have addressed how to select a study sample when using electronic health record (EHR) data.MethodsYear 2016 EHR data from three health systems was used to examine how alternate definitions of the study sample, based on number of healthcare visits in one year, affected measures of disease period prevalence. Curated collections of ICD-9, ICD-10, and SNOMED codes were used to define three diseases.ResultsAcross all health systems, increasing the minimum required number of visits to be included in the study sample monotonically increased crude period prevalence estimates. The rate at which prevalence estimates increased with number of visits varied across sites and across diseases.ConclusionsWhen using EHR data authors must carefully describe how a study sample is identified and report outcomes for a range of sample definitions, so that others can assess the sensitivity of reported results to sample definition in EHR data.