Medical Record Abstraction Research Articles

Relationship Between Dietary Magnesium Intake and Incident Heart Failure Among Older Women: The WHI.

BackgroundWomen represent a large proportion of the growing heart failure (HF) epidemic, yet data are lacking regarding optimal dietary and lifestyle prevention strategies for them. Specifically, the association between magnesium intake and HF in a multiracial cohort of women is uncertain.Methods and ResultsWe included 97 725 postmenopausal women from the WHI (Women's Health Initiative) observational studies and placebo arms of the hormone trial. Magnesium intake was measured at baseline by a 122‐item validated food‐frequency questionnaire and stratified into quartiles based on diet only, total intake (diet with supplements), and residual intake (calibration by total energy). Incident hospitalized HF (2153 events, median follow‐up 8.1 years) was adjudicated by medical record abstraction. In Cox proportional hazards models, we evaluated the association between magnesium intake and HF adjusting for potential confounders. Analyses were repeated on a subcohort (n=18 745; median‐follow‐up, 13.2 years) for whom HF cases were subclassified into preserved ejection fraction (526 events), reduced ejection fraction (291 events) or unknown (168 events). Most women were white (85%) with a mean age of 63. Compared with the highest quartile of magnesium intake, women in the lowest quartile had an increased risk of incident HF, with adjusted hazard ratios of 1.32 (95% CI, 1.02–1.71) for diet only (P trend=0.03), 1.26 (95% CI, 1.03–1.56) for total intake, and 1.31 (95% CI, 1.02–1.67) for residual intake. Results did not significantly vary by race. Subcohort analyses showed low residual magnesium intake was associated with HF with reduced ejection fraction (hazard ratio, 1.81, lowest versus highest quartile; 95% CI, 1.08–3.05) but not HF with preserved ejection fraction.ConclusionsLow magnesium intake in a multiracial cohort of postmenopausal women was associated with a higher risk of incident HF, especially HF with reduced ejection fraction.

Medical record abstraction in a hospital with paper-based records: experience of early career psychiatrists in northern Borneo.

We used medical record abstraction to conduct research in a psychiatric hospital with paper-based medical records. The challenges we encountered included: the difficulty in retrieving files; the extensive effort and time needed to extract clinical information; the lack of a standardised documentation system of medical records; and the need for advanced computer literacy. To promote future research using electronic medical records, potential solutions include creating a registry of all patients receiving treatment, as well as equipping busy clinicians with computer skills.

The association between depression and type of treatments received for chronic low back pain.

Depression is associated with receipt of opioids in non-cancer pain. To determine whether the receipt of opioid therapy modifies the relationship of depression and use of multiple non-opioid pain treatments. Patients (n = 320) with chronic low back pain (CLBP) were recruited from family medicine clinics and completed questionnaires that measured use of home remedies, physical treatments requiring a provider and non-opioid medication treatments. A binary variable defined use (yes/no) of all three non-opioid treatment categories. Depression (yes/no) was measured with the PHQ-2. The use of opioids (yes/no) was determined by medical record abstraction. Unadjusted and adjusted logistic regression models, stratified on opioid use, estimated the association between depression and use of all three non-opioid treatments. Participants were mostly female (71.3%), non-white (57.5%) and 69.4% were aged 18 to 59 years. In adjusted analyses stratified by opioid use, depression was not significantly associated with using three non-opioid treatments (OR = 2.20; 95% CI = 0.80-6.07) among non-opioid users; but among opioid users, depression was significantly associated with using three non-opioid treatments (OR = 3.21; 95% CI: 1.14-8.99). These odds ratios were not significantly different between opioid users and non-users (P = 0.609). There is modest evidence to conclude that patients with CLBP and comorbid depression, compared with those without depression, were more likely to try both opioid and non-opioid pain treatments. Non-response to other pain treatments may partly explain why depression is associated with greater prescription opioid use.

A National Behavioral and Clinical Surveillance System of Adults With Diagnosed HIV (The Medical Monitoring Project): Protocol for an Annual Cross-Sectional Interview and Medical Record Abstraction Survey.

BackgroundThe Medical Monitoring Project (MMP) is a national population-based behavioral and clinical surveillance system of adults with diagnosed HIV in the United States, and it is sponsored by the Centers for Disease Control and Prevention (CDC). Its purpose is to provide locally and nationally representative estimates of factors affecting HIV transmission risk and clinical outcomes.ObjectiveThis study aimed to describe the rationale for and methodology of the MMP, in addition to its contribution to evaluating and monitoring HIV prevention, care, and treatment efforts in the United States.MethodsMMP employs a stratified 2-stage sample design to select annual samples of persons living with diagnosed HIV from the National HIV Surveillance System and conducts interviews and medical record abstractions with participating persons.ResultsMMP data are published routinely via annual reports, conference presentations, and scientific publications. Data may be accessed upon request from the CDC, contingent on the guidelines established for the security and confidentiality of HIV surveillance data.ConclusionsMMP is the only source of annual population-based data on the behaviors and clinical care of persons with diagnosed HIV in the United States. It provides essential information for monitoring progress toward national treatment and prevention goals and guiding efforts to improve the health of persons with diagnosed HIV and prevent HIV transmission.International Registered Report Identifier (IRRID)RR1-10.2196/15453

Stroke Risk in Blood or Marrow Transplant (BMT) Survivors - a Report from the BMT Survivor Study (BMTSS)

BACKGROUND: BMT recipients are vulnerable to accelerated atherosclerosis due to prior exposure to radiation with or without chemotherapy, and consequent long-term cardiovascular morbidity, such as stroke. A comprehensive evaluation of the risk of late-occurring stroke in adult BMT survivors and the associated risk factors has not been performed. We addressed this gap using the resources offered by the BMTSS. METHODS: BMTSS includes patients transplanted between 1974 and 2014 at 3 US sites who survived ≥2y after BMT, were alive and ≥18y at BMTSS survey completion. The survey asked participants to report if a healthcare provider had diagnosed specific chronic health conditions (including stroke), or relapse of primary cancer or development of new cancer, along with age at diagnosis. The participants provided information on sociodemographics, health behaviors and medication use. Medical record abstraction was used for information regarding primary cancer diagnosis, therapeutic exposures (pre-BMT chemotherapy/radiation, transplant preparative regimens), stem cell source (autologous, allogeneic), graft type (bone marrow, cord blood or peripheral blood stem cells), and history of chronic graft vs. host disease (GvHD). A cohort of 908 siblings also completed the BMTSS survey and served as a comparison group. Informed consent was obtained from all participants. RESULTS: The study included 3,479 BMT survivors; 50.3% had received an allogeneic BMT, 54.8% were males; 71.4% were non-Hispanic whites. Median age at study participation was 59y (range: 18-89y) for BMT survivors and 57y (range: 18-90y) for siblings. Patient characteristics are shown in Table 1. BMT survivors were followed for a median of 9y (range: 2-41 y) from BMT. Stroke was reported by 136 BMT survivors (67 allogeneic, 69 autologous); of these, 75 (55%) patients developed stroke ≥2y after BMT. Conditional on surviving ≥2y after BMT, the 10y cumulative incidence of stroke was 3.8% (Fig 1), and was comparable for allogeneic (3.4±0.5%) and autologous (4.2±0.6%) BMT recipients, p=0.3. Stroke in BMT recipients compared with siblings: Using logistic regression, and after adjusting for sociodemographics, physical activity and relevant comorbidities, we found that allogeneic BMT survivors were at a 2.1-fold higher odds of reporting stroke as compared to siblings (95%CI: 1.2-3.7, p=0.01), and autologous BMT recipients were at a 1.7-fold higher odds of reporting stroke compared to siblings (95%CI: 0.9-3.0, p=0.09). Stroke after Allogeneic BMT: History of hypertension (HR=2.2, 95%CI: 1.2-3.9, p=0.007), venous thromboembolism (HR=3.4, 95%CI: 1.6-7.1, p=0.002), diagnosis of acute lymphoblastic leukemia (HR=4.9, 95%CI: 1.6-15.0, p=0.006), acute myeloid leukemia/ myelodysplastic syndrome (HR=5.2, 95%CI: 1.4-19.0, p=0.013) (ref: non Hodgkin lymphoma), pre-BMT exposure to alkylating agents (HR=3.3, 95%CI: 1.3-8.5, p=0.01) and pre-BMT neck radiation (HR=5.4, 95%CI: 1.2-23.8, p=0.03) were associated with increased stroke risk. Exercise was associated with lower stroke risk (HR: 0.5, 95%CI: 0.3-0.9, p=0.01). Stroke after Autologous BMT: The risk factors for stroke in autologous BMT survivors included: increasing age at BMT (HR=1.02/y, 95%CI: 1.0-1.1, p=0.05), history of hypertension (HR=1.8, 95%CI: 1.1-3.2, p=0.03), coronary heart disease (HR=2.8, 95%CI: 1.3-6.4, p=0.01) and venous thromboembolism (HR=2.3, 95%CI: 1.1-4.7, p=0.02). Relapse of primary disease or development of new cancer were not associated with increased stroke risk in either autologous or allogeneic BMT recipients. CONCLUSION: In this large study, we found that the incidence of stroke was 4% among BMT survivors, and that they are at an increased risk of developing stroke when compared to an unaffected comparison group. The study also identified subgroups among BMT survivors at increased risk of stroke such as those who received neck radiation and those with cardiovascular comorbidity. These findings suggest a need for increased awareness of stroke as a late complication of BMT, such that aggressive management of cardiovascular risk factors can be instituted among those at highest risk. Disclosures Weisdorf: Incyte: Research Funding; Fate Therapeutics: Consultancy; Pharmacyclics: Consultancy.

Abstract P103: Atherosclerotic Cardiovascular Disease Risk Reduction in High Risk Populations: A Resident Driven Quality Improvement Initiative

Background: Current guidelines recommend statins for patients with clinical ASCVD and more specifically, to target LDL-C levels <70mg/dL. However, recent studies suggest that overall statin usage in ASCVD patients is suboptimal (58%), with less than one-third of these individuals on a high-intensity dose. Our goal was to assess LDL-C levels amongst patients with known ASCVD within a large safety-net academic medical center, while identifying factors leading to suboptimal cholesterol control, to determine potential targeted interventions to improve patient outcomes and guideline compliance. Methods: We obtained data from the medical record data warehouse of a primary care outpatient medicine clinic that is predominantly staffed by internal medicine residents with attending physician guidance. Patients with a diagnosis of ASCVD who were evaluated from Jan-Dec 2016 were reviewed. Medical record abstraction was performed and bivariate analyses were conducted to identify potential factors affecting high-intensity statin prescriptions rates and resultant LDL-C levels. Results: Our patient population was predominantly African American (93%; 1015/1091). Statins were prescribed for 82% of these patients (897/1091), of which, only 69% (615/897) were on a high-intensity statin. However, LDL-C levels <70 mg/dL were seen in only 41% and 34% of patients on a high-intensity vs non-high-intensity statin respectively. Younger age, female sex, lack of insurance, PHQ scores >4 (indicative of mild depression or greater), and the presence of ≥4 comorbidities were all associated with a lower likelihood of being prescribed a high-intensity statin and/or having controlled LDL-C levels (p<0.05 for all variables). Conclusion: LDL-C control appears suboptimal among ASCVD patients within our safety-net patient population. This may reflect the inherent complexity of our patient population, which is predominantly low income, uninsured, and African American. Our future goals are to develop resident driven interventions to properly monitor LDL-C levels, escalate guideline based therapies, and manage comorbid conditions such as depression, hypertension, and diabetes, to decrease ASCVD risk and improve guideline compliance.

How to do (or not to do) … using the standardized patient method to measure clinical quality of care in LMIC health facilities.

Standardized patients (SPs), i.e. mystery shoppers for healthcare providers, are increasingly used as a tool to measure quality of clinical care, particularly in low- and middle-income countries where medical record abstraction is unlikely to be feasible. The SP method allows care to be observed without the provider's knowledge, removing concerns about the Hawthorne effect, and means that providers can be directly compared against each other. However, their undercover nature means that there are methodological and ethical challenges beyond those found in normal fieldwork. We draw on a systematic review and our own experience of implementing such studies to discuss six key steps in designing and executing SP studies in healthcare facilities, which are more complex than those in retail settings. Researchers must carefully choose the symptoms or conditions the SPs will present in order to minimize potential harm to fieldworkers, reduce the risk of detection and ensure that there is a meaningful measure of clinical care. They must carefully define the types of outcomes to be documented, develop the study scripts and questionnaires, and adopt an appropriate sampling strategy. Particular attention is required to ethical considerations and to assessing detection by providers. Such studies require thorough planning, piloting and training, and a dedicated and engaged field team. With sufficient effort, SP studies can provide uniquely rich data, giving insights into how care is provided which is of great value to both researchers and policymakers.

Differences by Sex in Cardiovascular Comorbid Conditions Among Older Adults (Aged 50-64 or ≥65 Years) Receiving Care for Human Immunodeficiency Virus.

Differences by sex in cardiovascular comorbid conditions among human immunodeficiency virus (HIV)-infected persons aged 50-64 years have been understudied; even fewer data are available for persons aged ≥65 years. We used matched interview and medical record abstraction data from the 2009-2012 data cycles of the Medical Monitoring Project, a nationally representative sample of HIV-infected adults in care. We included men and women aged 50-64 and ≥65 years at time of interview. We calculated weighted prevalence estimates and used logistic regression to compute adjusted prevalence differences and 95% confidence intervals (CIs) assessing sex differences in various characteristics and cardiovascular comorbid conditions. Comorbid conditions included overweight/obesity (body mass index ≥25), abnormal total cholesterol level (defined as ≥200 mg/dL), diagnosed diabetes mellitus, or diagnosed hypertension. Of 7436 participants, 89.5% were aged 50-64 years and 10.4% aged ≥65 years, 75.1% were men, 40.4% (95% CI, 33.5%-47.2%) were non-Hispanic black, 72.0% (70.4%-73.6%) had HIV infection diagnosed ≥10 years earlier. After adjustment for sociodemographic and behavioral factors, women aged 50-64 years were more likely than men to be obese (adjusted prevalence difference, 8.4; 95% CI, 4.4-12.3), have hypertension (3.9; .1-7.6), or have high total cholesterol levels (9.9; 6.2-13.6). Women aged ≥65 years had higher prevalences of diabetes mellitus and high total cholesterol levels than men. Cardiovascular comorbid conditions were prevalent among older HIV-infected persons in care; disparities existed by sex. Closer monitoring and risk-reduction strategies for cardiovascular comorbid conditions are warranted for older HIV-infected persons, especially older women.

Health Care Resource Utilization and Exacerbation Rates in Patients with COPD Stratified by Disease Severity in a Commercially Insured Population.

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and is associated with substantial economic burden. There is a lack of data regarding COPD outcomes and costs in a real-world setting, particularly by Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity. To (a) characterize a commercially insured U.S. population with COPD and (b) assess prevalence of exacerbations, health care resource utilization (HCRU), costs, and treatment patterns in a cohort of patients with confirmed COPD, overall and stratified by GOLD stage. This retrospective observational cohort study used administrative claims data from the HealthCore Integrated Research Database to identify patients with ≥ 1 inpatient, emergency room (ER), or office visit claim for COPD between January 1, 2012, and November 30, 2013, and continuous enrollment for 1 year before and 2 years after the first COPD diagnosis date. Patients with a spirometry claim within 12 months were eligible for medical record abstraction to confirm COPD diagnosis (forced expiratory volume in 1 second [FEV1]/forced vital capacity ratio < 0.7) and GOLD 1-4 classification (based on postbronchodilator FEV1 percent predicted). HCRU, costs, treatment patterns, and rate of moderate/severe exacerbation were identified from diagnosis up to 24 months. Outcomes were analyzed by univariate analysis stratified by GOLD classification. Multivariable analysis was conducted to assess associations between GOLD classification and outcomes of interest. 53,484 patients newly diagnosed with COPD were identified who met initial inclusion criteria: 14,293 (27%) had a qualifying spirometry claim, and 1,505 had confirmed COPD (GOLD 1, 333 [22%]; GOLD 2, 823 [55%]; GOLD 3, 317 [21%]; GOLD 4, 32 [2%]). Patients with greater disease severity had higher rates of moderate/severe COPD exacerbations (GOLD 1 and 2, 40.4 and 48.9 per 100 person-years, respectively; GOLD 3 and 4, 83.6 and 89.1 per 100 person-years, respectively). All-cause and COPD-related inpatient admissions, COPD-related office visits, and COPD-related ER visits were more prevalent with more severe GOLD classification. Mean annual COPD-related medical costs increased with GOLD classification ($5,945 for GOLD 1 patients, $18,070 for GOLD 4). COPD maintenance medication was filled by 42%, 56%, 73%, and 75% of patients in GOLD 1-4 (57% overall), respectively; combination corticosteroid/long-acting beta2-agonist inhalers were the most commonly used medication, regardless of GOLD classification. Patients with more severe disease had greater adherence (range 44%-68% of days covered for GOLD 1-4) and persistence (range 107-209 days for GOLD 1-4). Trends toward increases in exacerbations, HCRU, and costs were observed as airflow limitation worsened. Adherence and persistence with COPD maintenance therapy was suboptimal even with severe disease. This study was supported by Boehringer Ingelheim Pharmaceuticals (Ridgefield, CT), which was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Willey and Singer are employees of HealthCore (parent company Anthem), which received funding from Boehringer Ingelheim to complete this study. Wallace and Shinde were employed by HealthCore at the time of this study. Wallace and Singer report stock ownership in Anthem. Napier is an employee of Anthem. Kaila, Bayer, and Shaikh are employees of Boehringer Ingelheim Pharmaceuticsls. Portions of this research were presented at the following conferences: (a) A. Wallace, S. Kaila, V. Zubek, A. Shaikh, M. Shinde, V. Willey, M. Napier, and J. Singer, Healthcare resource utilization, costs, and exacerbation rates in patients with COPD stratified by GOLD airflow limitation classification in a US commercially insured population, presented at AMCP Nexus 2017; October 16-19, 2017; Dallas, TX; and (b) A.E. Wallace, V. Zubek, S. Kaila, A. Shaikh, M. Shinde, V. Willey, M.B. Napier, and J.R. Singer, Real-world treatment patterns among newly diagnosed COPD patients according to GOLD airflow limitation severity classification in a U.S. commercially insured/Medicare Advantage population, presented at CHEST 2017 Annual Meeting; October 28-November 1, 2017; Toronto, Ontario, Canada.

Training as an Intervention to Decrease Medical Record Abstraction Errors Multicenter Studies.

Studies often rely on medical record abstraction as a major source of data. However, data quality from medical record abstraction has long been questioned. Electronic Health Records (EHRs) potentially add variability to the abstraction process due to the complexity of navigating and locating study data within these systems. We report training for and initial quality assessment of medical record abstraction for a clinical study conducted by the IDeA States Pediatric Clinical Trials Network (ISPCTN) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) using medical record abstraction as the primary data source. As part of overall quality assurance, study-specific training for medical record abstractors was developed and deployed during study start-up. The training consisted of a didactic session with an example case abstraction and an independent abstraction of two standardized cases. Sixty-nine site abstractors from thirty sites were trained. The training was designed to achieve an error rate for each abstractor of no greater than 4.93% with a mean of 2.53%, at study initiation. Twenty-three percent of the trainees exceeded the acceptance limit on one or both of the training test cases, supporting the need for such training. We describe lessons learned in the design and operationalization of the study-specific, medical record abstraction training program.

Effect of Prenatal Smoke Exposure on Birth Weight: The Moderating Role of Maternal Depressive Symptoms.

Both prenatal smoke exposure and depression have been linked to lower birth weight, a risk factor for morbidity and mortality. Few studies have looked at the interaction between these risk factors and none have used a biomarker to objectively measure prenatal smoke exposure. The current study sought to examine independent and interactive effects of cotinine and depression on birth weight. The effect of race was also explored. Data were drawn from a prospective study of pregnant women (N = 568) in the southeastern United States. Maternal demographic, health information, depressive symptoms, and birth data were collected via self-report and medical record abstraction. Prenatal blood samples were assayed for cotinine. Controlling for covariates, multiple regression analyses indicated that both cotinine and depressive symptoms independently predicted lower birth weight and a significant interaction was also observed. Upon probing the interaction, a negative association between cotinine levels and birth weight was found in the context of higher depression but not lower depression scores. Similarly, logistic regression analyses revealed a significant interaction between cotinine and depression, such that cotinine predicted having a baby less than 2500 g among women who fell above the indicated cutoff score. African American women had the highest levels of cotinine and lowest weight babies; however, race was not a significant moderator. Results suggest prenatal smoke exposure has a greater negative effect on birth weight for women endorsing co-occurring depressive symptoms. Findings can inform targeted interventions and assist medical providers with identifying women at increased risk for poor perinatal outcomes. Despite the common occurrence of smoking during pregnancy and prenatal depression, the interaction between these risk factors on birth weight has rarely been examined. Further, the extant results have been mixed, likely due in part to difficulties in measurement. The current study was the first to use prenatal cotinine to assess bias-free, continuous levels of prenatal smoke exposure. Results indicate that prenatal cotinine was a significant predictor of birth weight only in the context of maternal depressive symptoms. These findings have important implications for mitigating negative perinatal outcomes for pregnant women and their children.

Clinical Features, Severity, and Incidence of RSV Illness During 12 Consecutive Seasons in a Community Cohort of Adults ≥60 Years Old.

BackgroundThe epidemiology and burden of respiratory syncytial virus (RSV) illness are not well defined in older adults.MethodsAdults ≥60 years old seeking outpatient care for acute respiratory illness were recruited from 2004–2005 through 2015–2016 during the winter seasons. RSV was identified from respiratory swabs by multiplex polymerase chain reaction. Clinical characteristics and outcomes were ascertained by interview and medical record abstraction. The incidence of medically attended RSV was estimated for each seasonal cohort.ResultsRSV was identified in 243 (11%) of 2257 enrollments (241 of 1832 individuals), including 121 RSV type A and 122 RSV type B. The RSV clinical outcome was serious in 47 (19%), moderate in 155 (64%), and mild in 41 (17%). Serious outcomes included hospital admission (n = 29), emergency department visit (n = 13), and pneumonia (n = 23) and were associated with lower respiratory tract symptoms during the enrollment visit. Moderate outcomes included receipt of a new antibiotic prescription (n = 144; 59%), bronchodilator/nebulizer (n = 45; 19%), or systemic corticosteroids (n = 28; 12%). The relative risk of a serious outcome was significantly increased in persons aged ≥75 years (vs 60–64 years) and in those with chronic obstructive pulmonary disease or congestive heart failure. The average seasonal incidence was 139 cases/10 000, and it was significantly higher in persons with cardiopulmonary disease compared with others (rate ratio, 1.89; 95% confidence interval, 1.44–2.48).ConclusionsRSV causes substantial outpatient illness with lower respiratory tract involvement. Serious outcomes are common in older patients and those with cardiopulmonary disease.

Symptoms of Depression and Preterm Birth Among Black Women.

To investigate the relationship between depressive symptoms and preterm birth (PTB) while adjusting for social support, both general and from the father of the baby. Retrospective study design. Participants of the Life-course Influences of Fetal Environments (LIFE) study were recruited from a suburban hospital in Metropolitan Detroit, Michigan. The LIFE data consisted of 1,410 self-identified Black women age 18 to 45 years; 1,207 women were included in this analysis. Women were interviewed using a structured questionnaire administered 24 to 48 hours after birth during their postpartum hospitalization. Data on the newborns and their mothers' health were collected through medical record abstraction. The Center for Epidemiologic Studies Depression Scale (CES-D) was used to measure symptoms of depression. The CES-D scores ≥23 were considered severe symptoms of depression. Modified Poisson regression models were built using a stepwise approach to assess association between symptoms of depression and PTB. Approximately, 17% of women had a PTB and 20% of women in the sample had a CES-D scores ≥23. Women who had CES-D score ≥23 were about 70% more likely to have a PTB compared with women with CES-D scores <23 (PR = 1.68, 95% CI: 1.24-2.16) after adjustment for both general social support and father of the baby support. Women with CES-D scores ≥23 were almost twice more likely to have PTB compared with women with CES-D scores <23. Referrals for mental healthcare providers might benefit women with symptoms of depression and improve birth outcomes. Nurses should encourage women to seek support beyond the father of the baby.

Abstract B01: Immune cell infiltrates differ by obesity in tumor and adjacent normal breast tissue in African American women with triple-negative breast cancer

Abstract Introduction: Obesity is a risk factor for breast cancer, including the more aggressive triple-negative (TN) subtype, but the relevance of obesity to prognosis remains unclear. Unlike other subtypes, triple-negative breast cancer (TNBC) is not hormonally responsive and is characterized by a lack of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor-2 expression. Thus, obesity-related development of TN tumors is unlikely to rely on the peripheral aromatization of androgens to estrogens in fat. Chronic, low-grade inflammation elicited by obesity could increase risk of TNBC. Here we sought to assess which mechanisms mediate obesity’s effect on normal tissue and TN tumors using a gene expression approach. Because African American women are more likely to be obese and twice as likely to develop TNBC compared to white women, understanding the mechanisms of obesity-related risk of TNBC is critical for this high-risk group. Methods: We performed whole-genome expression profiling on formalin-fixed, paraffin-embedded samples from 104 African American women with TNBC (59 tumor, 45 adjacent normal). Body mass index was obtained by medical record abstraction, and women with BMI at least 30 kg/m2 were classified as obese. Gene Ontology (GO) was used to identify biologic processes enriched in differentially expressed genes by obesity status in tumors and adjacent normal tissue (p-value&amp;lt;0.05). CIBERSORT was used to estimate proportions of 22 immune cell subtypes using expression profiles, and differences in median immune cell proportions by obesity status were evaluated. Results: 28 (47%) TNBC tumor and 29 (64%) adjacent normal samples were from obese women. Among genes more highly expressed in tumors from obese compared to nonobese women, GO analysis revealed enrichment for proinflammatory processes involving regulation of immune system, activation of immune responses, leukocyte activation, and neutrophil activation (FDR-corrected p-value &amp;lt;0.05). In contrast, GO analysis showed that genes in pathways related to B and T cell activation, cytokine production, regulation of immune system, and immune response (all FDR-corrected p &amp;lt;0.05) were downregulated in adjacent normal tissue from obese compared to nonobese women. Tumors from obese women exhibited a proinflammatory environment with increased levels of CD4 T memory resting cells, resting mast cells, and neutrophils, and reduced levels of regulatory T cells, resting dendritic cells, and activated mast cells (p &amp;lt; 0.1). We also found reduced proportions of naïve B cells, CD4 T memory resting cells, and M1 macrophages but an increased proportion of resting mast cells in the adjacent normal tissue of obese women compared to nonobese women (p&amp;lt; 0.1). Conclusions: Obesity modifies the immune cell environment present not only in TN tumors but also in the surrounding normal tissue. Obesity promotes a more proinflammatory setting within TN tumors, and in contrast, an anti-inflammatory setting in normal tissue adjacent. These findings may have important implications for understanding how obesity influences TNBC risk and prognosis, particularly among African American women who are at high risk for both. Citation Format: Asra N. Shaik, Julie L. Boerner, Michele L. Cote, Gregory Dyson, Rouba Ali-Fehmi, Sudeshna Bandyopadhyay, Kristen S. Purrington. Immune cell infiltrates differ by obesity in tumor and adjacent normal breast tissue in African American women with triple-negative breast cancer [abstract]. In: Proceedings of the AACR Special Conference: Advances in Breast Cancer Research; 2017 Oct 7-10; Hollywood, CA. Philadelphia (PA): AACR; Mol Cancer Res 2018;16(8_Suppl):Abstract nr B01.

Abstract 5371: The Metastatic Breast Cancer Project: Partnering with patients to accelerate progress in cancer research

Abstract The Metastatic Breast Cancer Project (MBCproject) is a research study that directly engages patients (pts) through social media and advocacy groups, and empowers them to share samples, clinical data, and experiences. The goal is to create a publicly available database of genomic, molecular, clinical, and patient-reported data to enable research. Working with pts and advocates, a website (MBCproject.org) was developed that allows pts with metastatic breast cancer (MBC) to register. Registered pts are sent an online consent form that asks for permission to obtain and analyze their medical records and samples. Once enrolled, pts are sent a saliva kit and asked to mail back a saliva sample, which is used to extract germline DNA. We contact participants' medical providers and obtain medical records and a portion of their stored tumor biopsies. Pts may be asked to mail in a blood sample, which is used to extract cell free DNA (cfDNA). Whole-exome sequencing (WES) is performed on tumor DNA, germline DNA, and cfNDA; transcriptome sequencing is performed on tumor RNA. Clinically annotated genomic data are used to study specific pt cohorts (including outliers) and to identify mechanisms of response and resistance to therapies. All de-identified data are shared via public databases. Study updates are shared with participants regularly. From 10/2015-11/2017, 4237 MBC pts registered, representing over 1,000 institutions. 95% answered the 16-question survey about their cancer, treatments, and demographic information. 2471 (58%) completed the consent form. 2,136 saliva kits were mailed to pts and 1,523 saliva samples were sent in (71%). 408 blood kits were mailed to pts and 175 blood samples have been received for cfDNA analysis. To date, we have obtained medical records from 311 pts and 190 tumors from 127 pts. In 10/2017, all data generated so far were publicly released on cbioportal.org, including WES for 103 tumors from 78 pts linked to clinical data including pathology (22 elements), medical record abstraction including all treatments and timelines/durations (67 elements), and patient-reported data (11 elements). 81% of biopsies included in this release were from the breast and 19% from metastatic sites. 75% were obtained prior to any therapy, 24% following therapy. New data will be released 4/2018 and every six months thereafter, as they are generated. Additional patient-reported data, including treatments, side effects, quality of life, family history, pregnancies, and sites of metastasis, will also be collected and shared. In summary, a patient-driven approach enabled rapid identification of thousands of MBC pts willing to share samples and clinical data. Remote acquisition of medical records, saliva, blood, and tumor tissue for pts across the U.S. is feasible. This shared clinico-genomic database should enable research in MBC and may serve as a model for patient-driven research in other cancers. Citation Format: Nikhil Wagle, Corrie Painter, Elana Anastasio, Michael Dunphy, Mary McGillicuddy, Rachel Stoddard, Esha Jain, Dewey Kim, Simona Di Lascio, Brett N. Tompson, Sara Balch, Beena Thomas, Priti Kumari, Shawn Johnson, Jamie Holloway, Ofir Cohen, Erik H. Knelson, Katie Larkin, Sam Pollock, Alicia Wong, Samira Bahl, Simone Maiwald, Andrew Zimmer, Esme O. Baker, Jen Hendry Lapan, Scott Sutherland, Scott Sassone, Viktor Adalsteinsson, Eric S. Lander, Todd R. Golub. The Metastatic Breast Cancer Project: Partnering with patients to accelerate progress in cancer research [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 5371.

A Multisite Intervention for Pediatric Community-acquired Pneumonia in Community Settings.

The majority of children with community-acquired pneumonia (CAP) are primarily evaluated in community hospital emergency departments (EDs); however, studies on the management of pediatric CAP have largely targeted care provided in freestanding children's hospital EDs or inpatient settings. The objectives of this study were to examine whether implementation of a CAP pathway within three community hospital EDs and inpatient units improved process measures related to appropriate laboratory testing and antibiotic prescribing and to compare performance on these measures between the community hospitals and a freestanding children's hospital. Through a multidisciplinary approach (including general emergency medicine [EM] providers, pediatric fellowship-trained EM providers, and pediatric hospitalists), a CAP pathway was designed and implemented at three community hospitals in January and February 2016. Diagnostic and therapeutic process measures were collected using administrative data and medical record abstraction 1 year pre- and postintervention. Chi-square statistics and statistical process control P-charts were used to examine adherence to these process measures. Across the community hospitals, 544 patients preintervention and 321 patients postintervention met inclusion criteria, with 290 children's hospital patients meeting criteria in the postintervention period. Adherence to process measures increased postintervention for appropriate laboratory testing, narrow-spectrum antibiotic stewardship and macrolide stewardship by 10.8% (95% confidence interval [CI]= 4.7% to 16.9%), 8.3% (95% CI= 21.5% to 15.2%), and 3.1% (95% CI= -4.3% to 10.4%), respectively. Statistical process control P-charts demonstrated special cause variation immediately after implementation of the intervention in regards to appropriate laboratory testing. Implementation of a CAP pathway through a multisite community hospital intervention improved adherence to evidence-based recommendations for laboratory testing and antibiotic stewardship. Similar interventions may improve the quality of care for children with CAP on a population level, as community hospitals are where these patients are seen most frequently.

Five successful pregnancies with antenatal anakinra exposure.

Our aim is to add to the limited existing prospective data on IL-1 inhibitor use in pregnancy. Data were obtained from the Organization of Teratology Information Specialists Autoimmune Disease in Pregnancy Project, a prospective cohort study of pregnancy outcomes in the USA and Canada. Eligible women were enrolled prior to 19 weeks' gestation between 2004 and 2017. Outcomes were obtained by maternal interview and medical record abstraction. Five pregnancies with anakinra exposure were identified, all resulting in full-term singleton live births with no major or long-term complications. Three maternal subjects used anakinra for adult-onset Still's disease and two for systemic JIA. For all individuals who discontinued anakinra, some amount of steroid medication was necessary for treatment of disease flare. Two maternal subjects developed oligohydramnios, one also with pregnancy-induced hypertension. Two women had Caesarian sections, one medically indicated and one scheduled. One infant had low birth weight, but follow-up records indicated normal adjusted weight at 1 year. Three women successfully breastfed their infants, at least two of whom continued anakinra while breastfeeding. Anakinra was used successfully in five full-term pregnancies; however, two subjects developed oligohydramnios, a process that can be linked to fetal renal anomalies. Given previously reported cases of congenital renal anomalies associated with both antenatal anakinra use and maternal hyperthermia, the relationship between maternal IL-1 inhibitor use, uncontrolled maternal febrile disease and fetal outcomes should be further explored.

Abstract WP162: Outcomes and Long-Term Mortality After Ischemic Stroke in the Young: A Preliminary Analysis From the Greater Cincinnati/Northern Kentucky Stroke Study

Introduction: There is a trend towards ischemic stroke (IS) occurring at younger ages. We sought to better characterize outcomes and mortality over 3 years by age at time of stroke within a large, biracial population. Methods: Incident IS were ascertained during the 2005 and 2010 study periods of our population based epidemiology study via ICD-9 codes 430-436. Research nurse coordinators performed medical record abstraction on all potential events, which were then adjudicated by study physicians as case/not a case. Abstractions included discharge or 30-day outcomes (if available) as measured by modified Rankin scale (mRS). Mortality for IS events out to 3 years was determined via all available information including the Social Security Death Index. We compared the outcomes and post-stroke mortality by 20-55 (young stroke) versus &gt;55 years, and by decade. Descriptive statistics are reported as n (%), and mean (SD) or median (25 th and 75 th %ile) as appropriate. The primary analysis examined the effect of age, race and sex using regression, life table and proportional hazards models. Results: Results are shown in the table. IS in the young occurred more frequently among black cases. The median rNIHSS was 3 although the NIHSS distribution trended towards more severe IS in the older age group. Young strokes had lower baseline and 30-day mRS. The mortality rate was greater in the older ages, at each time point and overall. After adjusting for race, sex and stroke severity the hazard ratio for lower survival in the strokes &gt;55 years old was 4.03 (95% CI 3.15, 5.17). Conclusion: IS patients &lt; 55 years old are less likely to die after stroke. Young stroke occurs in demographically different populations than older strokes and this group would benefit from further study.

Patterns of Care at the End of Life for Children and Young Adults with Life-Threatening Complex Chronic Conditions

To characterize patterns of care at the end of life for children and young adults with life-threatening complex chronic conditions (LT-CCCs) and to compare them by LT-CCC type. Cross-sectional survey of bereaved parents (n = 114; response rate of 54%) of children with noncancer, noncardiac LT-CCCs who received care at a quaternary care children's hospital and medical record abstraction. The majority of children with LT-CCCs died in the hospital (62.7%) with more than one-half (53.3%) dying in the intensive care unit. Those with static encephalopathy (AOR, 0.19; 95% CI, 0.04-0.98), congenital and chromosomal disorders (AOR, 0.28; 95% CI, 0.09-0.91), and pulmonary disorders (AOR, 0.08; 95% CI, 0.01-0.77) were significantly less likely to die at home compared with those with progressive central nervous system (CNS) disorders. Almost 50% of patients died after withdrawal or withholding of life-sustaining therapies, 17.5% died during active resuscitation, and 36% died while receiving comfort care only. The mode of death varied widely across LT-CCCs, with no patients with pulmonary disorders dying receiving comfort care only compared with 66.7% of those with CNS progressive disorders. A majority of patients had palliative care involvement (79.3%); however, in multivariable analyses, there was distinct variation in receipt of palliative care across LT-CCCs, with patients having CNS static encephalopathy (AOR, 0.07; 95% CI, 0.01-0.68) and pulmonary disorders (AOR, 0.07; 95% CI, 0.01-.09) significantly less likely to have palliative care involvement than those with CNS progressive disorders. Significant differences in patterns of care at the end of life exist depending on LT-CCC type. Attention to these patterns is important to ensure equal access to palliative care and targeted improvements in end-of-life care for these populations.

Prehospital Delay in Older Adults with Acute Myocardial Infarction: The ComprehenSIVe Evaluation of Risk Factors in Older Patients with Acute Myocardial Infarction Study.

Timely administration of antiischemic therapies improves outcomes in individuals with acute myocardial infarction (AMI). Prior literature on delays in AMI care has largely focused on in-hospital delay ("door to balloon" time). Our objective was to identify factors associated with prehospital delay in a contemporary national cohort of older adults with AMI. Cross-sectional analysis of data from the ComprehenSIVe Evaluation of Risk Factors in Older Patients with Acute Myocardial Infarction (SILVER-AMI) study, an observational study of older adults hospitalized for AMI. U.S. academic and community hospitals (N = 94). Individuals aged 75 and older hospitalized for AMI (N = 2,500). Prehospital delay was defined as symptom duration of 6 hours or longer before hospital presentation and was obtained according to participant or caregiver report during AMI hospitalization. Potential predictors of delay from demographic, clinical presentation, comorbid conditions, function, and social support domains were obtained through in-person assessment during the index hospitalization and medical record abstraction. Nonwhite race (adjusted odds ratio (aOR) = 1.54, P = .002), atypical symptoms (aOR = 1.41, P = .001), and heart failure (HF) (aOR = 1.35, P = .006 for HF) were significantly associated with delay. In contrast with younger AMI populations, female sex and diabetes mellitus were not associated with delay in this older cohort, but factors from other domains (nonwhite race, atypical symptoms, and HF) were significantly associated with delay. These results can be used to customize future public health efforts to encourage early presentation for older adults with AMI.