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The relation between cardiorespiratory fitness (CRF) and prostate cancer is not well established. The objective of this study was to determine whether CRF is associated with prostate cancer screening, incidence, or mortality.The Henry Ford Exercise Testing Project is a retrospective cohort study of men aged 40 to 70 years without cancer who underwent physician-referred exercise stress testing from 1995 to 2009. CRF was quantified in metabolic equivalents of task (METs) (6 [reference], 6-9, 10-11, and ≥12 METs), estimated from the peak workload achieved during a symptom-limited, maximal exercise stress test. Prostate-specific antigen (PSA) testing, incident prostate cancer, and all-cause mortality were analyzed with multivariable adjusted Poisson regression and Cox proportional hazard models.In total, 22,827 men were included, of whom 739 developed prostate cancer, with a median follow-up of 7.5 years. Men who had high fitness (≥12 METs) had an 28% higher risk of PSA screening (95% CI, 1.2-1.3) compared with those who had low fitness (6 METs. After adjusting for PSA screening, fitness was associated with higher prostate cancer incidence (men aged55 years, P = .02; men aged55 years, P ≤ .01), but not with advanced prostate cancer. Among the men who were diagnosed with prostate cancer, high fitness was associated with a 60% lower risk of all-cause mortality (95% CI, 0.2-0.9).Although men with high fitness are more likely to undergo PSA screening, this does not fully account for the increased incidence of prostate cancer seen among these individuals. However, men with high fitness have a lower risk of death after a prostate cancer diagnosis, suggesting that the cancers identified may be low-risk with little impact on long-term outcomes.

Introduction The DAPA-CKD trial assessed dapagliflozin in patients with chronic kidney disease (CKD) with or without type 2 diabetes (T2D). To aid interpretation of results, renal and cardiovascular outcomes plus healthcare resource utilization (HCRU) and costs were assessed in a real-world population similar to that of DAPA-CKD. Methods Henry Ford Health System (2006–2016) data were used to identify patients with CKD stages 2–4 [estimated glomerular filtration rate (eGFR) 25–75 ml/min/1.73 m2 at index and urine albumin-to-creatinine ratio (UACR) 0–5000 mg/g; n = 22,251]. Included patients had confirmatory eGFR ≥ 90 days post-index and no kidney transplant or progression to end-stage kidney disease during 12 months pre-index. The final population (n = 6557) was stratified by UACR (0–29, 30–199 and 200–5000 mg/g; the last comprising the DAPA-CKD-like cohort). Patients were followed for 5 years post-index. Results Adverse clinical outcomes incidence increased with UACR and was highest for the DAPA-CKD-like cohort (UACR 200–5000 mg/g) versus lower UACR categories (0–29 mg/g and 30–199 mg/g): renal composite outcome (progression to CKD stage 5, dialysis, transplant, ≥ 50% sustained eGFR decline): 26.0% versus 2.2% and 5.8%; heart failure (HF): 36.1% versus 13.9% and 24.6%; myocardial infarction: 11.3% versus 4.7% and 7.4%; stroke: 8.9% versus 4.0% and 5.7%; and mortality: 18.5% versus 6.0% and 11.7%, respectively. Within the DAPA-CKD-like cohort, patients with versus without T2D or HF had a higher frequency of adverse outcomes. The DAPA-CKD-like cohort also had significantly higher annualized per-patient healthcare costs ($39,222/year versus $19,547/year), hospital admission rate (0.55/year versus 0.20/year) and outpatient specialist visit rate (7.55/year versus 6.74/year) versus the lowest UACR category. Conclusion The significant adverse renal and cardiovascular outcomes observed, particularly in the DAPA-CKD-like cohort, represent a substantial burden resulting in increased mortality, HCRU and costs, demonstrating the need for additional treatment options. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-020-01609-2.

Background Influenza causes significant morbidity and mortality and stresses hospital resources during periods of increased circulation. We evaluated the effectiveness of the 2019–2020 influenza vaccine against influenza-associated hospitalization in the United States. Methods We included adults hospitalized with acute respiratory illness at 14 hospitals and tested for influenza viruses by reserve-transcription polymerase chain reaction. Vaccine effectiveness (VE) was estimated by comparing the odds of current-season influenza vaccination in test-positive influenza cases vs test-negative controls, adjusting for confounders. VE was stratified by age and major circulating influenza types along with A(H1N1)pdm09 genetic subgroups. Results A total of 3116 participants were included, including 18% (n = 553) influenza-positive cases. Median age was 63 years. Sixty-seven percent (n = 2079) received vaccination. Overall adjusted VE against influenza viruses was 41% (95% confidence interval [CI], 27%–52%). VE against A(H1N1)pdm09 viruses was 40% (95% CI, 24%–53%) and 33% against B viruses (95% CI, 0–56%). Of the 2 major A(H1N1)pdm09 subgroups (representing 90% of sequenced H1N1 viruses), VE against one group (5A + 187A,189E) was 59% (95% CI, 34%–75%) whereas no VE was observed against the other group (5A + 156K) (–1% [95% CI, –61% to 37%]). Conclusions In a primarily older population, influenza vaccination was associated with a 41% reduction in risk of hospitalized influenza illness.

We estimated vaccine effectiveness (VE) for prevention of influenza-associated hospitalizations among adults during the 2018–2019 influenza season. Adults admitted with acute respiratory illness to 14 hospitals of the US Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN) and testing positive for influenza were cases; patients testing negative were controls. VE was estimated using logistic regression and inverse probability of treatment weighting. We analyzed data from 2863 patients with a mean age of 63 years. Adjusted VE against influenza A(H1N1)pdm09–associated hospitalization was 51% (95% confidence interval [CI], 25%–68%). Adjusted VE against influenza A(H3N2) virus–associated hospitalization was −2% (95% CI, −65% to 37%) and differed significantly by age, with VE of −130% (95% CI, −374% to −27%) among adults 18 to ≤56 years of age. Although vaccination halved the risk of influenza A(H1N1)pdm09–associated hospitalizations, it conferred no protection against influenza A(H3N2)–associated hospitalizations. We observed negative VE for young and middle-aged adults but cannot exclude residual confounding as a potential explanation.

Objectives To evaluate the use of granulocyte colony-stimulating factor (G-CSF) prophylaxis in US patients with selected metastatic cancers and chemotherapy-induced febrile neutropenia (FN) incidence and associated outcomes among the subgroup who did not receive prophylaxis. Methods This retrospective cohort study was conducted at four US health systems and included adults with metastatic cancer (breast, colorectal, lung, non-Hodgkin lymphoma [NHL]) who received myelosuppressive chemotherapy (2009–2017). Patients were stratified by FN risk level based on risk factors and chemotherapy (low/unclassified risk, intermediate risk without any risk factors, intermediate risk with ≥ 1 risk factor [IR + 1], high risk [HR]). G-CSF use was evaluated among all patients stratified by FN risk, and FN/FN-related outcomes were evaluated among patients who did not receive first-cycle G-CSF prophylaxis. Results Among 1457 metastatic cancer patients, 20.5% and 28.1% were classified as HR and IR + 1, respectively. First-cycle G-CSF prophylaxis use was 48.5% among HR patients and 13.9% among IR + 1 patients. In the subgroup not receiving first-cycle G-CSF prophylaxis, FN incidence in cycle 1 was 7.8% for HR patients and 4.8% for IR + 1 patients; during the course, corresponding values were 16.9% and 15.9%. Most (> 90%) FN episodes required hospitalization, and mortality risk ranged from 7.1 to 26.9% across subgroups. Conclusion In this retrospective study, the majority of metastatic cancer chemotherapy patients for whom G-CSF prophylaxis is recommended did not receive it; FN incidence in this subgroup was notably high. Patients with elevated FN risk should be carefully identified and managed to ensure appropriate use of supportive care.

BACKGROUND Blood eosinophil counts correlate with exacerbations, but there is a lack of consensus on a clinically relevant definition of eosinophil count elevation. OBJECTIVE To analyze health care resource use among patients with elevated blood eosinophil counts defined at 150 cells/μL or greater and 300 cells/μL or greater. METHODS Data on patients who received a diagnosis of asthma between 2007 and 2016 were extracted from EMRClaims + database. Patients were defined as having elevated eosinophil counts if any test result during 3 months before follow-up found blood eosinophil count of 150 cells/μL or more or 300 cells/μL or more. Hospitalizations, emergency department visits, outpatient visits, and associated costs were compared. With logistic regression, likelihood of hospitalization was assessed in the presence of eosinophil elevation. RESULTS Among 3687 patients who met the study criteria, 1152 received a test within 3 months before the follow-up period, of whom 644 (56%) had elevated eosinophil counts of 150 cells/μL or greater and 322 (29%) had eosinophil counts of 300 cells/μL or greater. Overall, the mean (SD) number of hospitalizations for patients with elevated eosinophil counts vs the comparator was significantly greater (0.29 [0.92] vs 0.17 [0.57], P < .001 at ≥150 cells/μL and 0.30 [0.95] vs 0.18 [0.61] at ≥300 cells/μL, P = .001). The total mean cost was significantly greater for patients with elevated eosinophil counts (at ≥150 cells/μL: $10,262 vs $7149, P < .001 and at ≥300 cells/μL: $9966 vs $7468, P = .003). CONCLUSION Patients with asthma incurred greater health care resource use when their blood eosinophil counts were elevated at 150 cells/μL or greater and 300 cells/μL or greater as measured within 3 months of follow-up.

Background: A step-up approach (increasing inhaled corticosteroid [ICS] dose and/or add-on treatment) is recommended for asthma that is uncontrolled despite ICS plus long-acting beta-2‐agonist (LABA) combination treatment. Understanding the impact of different treatment options on health outcomes can help guide treatment decision-making. Objective: To compare the effectiveness of add-on tiotropium 1.25 µg (two puffs once daily) versus an increased ICS plus LABA dose in a real-world cohort of patients with asthma initiated on ICS plus LABA. Methods: De-identified data from patients ages ≥12 years and with asthma who were initiated on ICS plus LABA, and then had tiotropium added (Tio group; index date) or an ICS plus LABA dose increased (inc-ICS group; index date) were collected from two medical and pharmacy claims data bases (2014‐2018). To account for population/group differences, propensity score matching was performed. The primary end point was the exacerbation risk after the index date. Secondary end points included exacerbation rates 6 and 12 months postindex, health-care resource utilization, costs, and short-acting beta-2‐agonist (SABA) refills 12 months postindex. Results: Overall, 7857 patients (Tio group, 2619; inc-ICS group, 5238) were included. The exacerbation risk was 35% lower in the Tio group than in the inc-ICS group (hazard ratio 0.65 [95% confidence interval, 0.43‐0.99]; p = 0.044). Exacerbation rates in the Tio group also were significantly lower within 6 and 12 months postindex (64% and 73%, respectively). All-cause and asthma-related emergency department (ED) visits were 47% and 74% lower, respectively (p < 0.0001 for both), and all-cause and asthma-related hospitalizations were 48% (p < 0.01) and 76% (p < 0.001) lower, respectively, in the Tio group. Also, significantly fewer patients in the Tio group versus the inc-ICS group required SABA refills (56% versus 67%, p < 0.0001). Conclusion: Add-on tiotropium significantly decreased the risk and rate of exacerbations, decreased all-cause and asthma-related ED visits and hospitalizations, and reduced SABA refills compared with increasing the ICS plus LABA dose. The findings supported the use of add-on tiotropium for patients with uncontrolled asthma taking ICS plus LABA.

Background: Clinical practice guidelines recommend CSF prophylaxis for patients receiving chemotherapy regimens with a high risk of FN (>20%), and consideration of CSF prophylaxis for those receiving intermediate-risk regimens (10-20%) who have ≥1 risk factor for FN. The objective of this study was to estimate the use of CSF prophylaxis among patients with metastatic cancer, and the risk of FN among eligible patients not receiving it. Methods: This retrospective study was conducted at four US health systems—Geisinger Health System (PA), Henry Ford Health System (MI), Kaiser Permanente Northwest (OR, WA), and Reliant Medical Group (MA). Study population comprised patients who received chemotherapy for metastatic solid tumors (breast, colon/rectum, lung) or non-Hodgkin’s lymphoma (NHL) from 2009-2017. For each eligible patient, data on chemotherapy course, cycles, and regimens, as well as the use of supportive care (CSF, antimicrobials) and FN episodes during the course, were collected via a standardized case report form using electronic data warehouses, cancer registries, and medical charts. Analyses were non-comparative and descriptive only. Results: Study population totaled 1,457 patients (26% breast; 25% colon/rectum; 43% lung; 6% NHL). Nearly half of all patients received a chemotherapy regimen classified as either high-risk for FN (21%), or intermediate-risk for FN and had ≥1 FN risk factor (28%). Among patients receiving high-risk regimens, 51% did not receive primary prophylaxis with CSF (PP-CSF), and among those receiving an intermediate-risk regimen with ≥1 risk factor, 86% did not receive PP-CSF; among all remaining patients, 89% did not receive PP-CSF. Across these three subgroups of patients who did not receive PP-CSF (ie, high-risk regimen, intermediate-risk regimen with ≥1 risk factor, all others), FN risk during the course was 17%, 16%, and 14%, respectively. More than 90% of FN episodes required hospitalization, and FN-related mortality was 14%. Among metastatic breast cancer patients, 56% received a high-risk regimen (46%) or an intermediate-risk regimen and had ≥1 FN risk factor (10%); among this subset, 30% did not receive PP-CSF and their FN risk was 16%. Conclusions: In this real-world evaluation of patients with metastatic cancer of the breast or other sites receiving chemotherapy at four large US health systems, over two-thirds of patients who were candidates for PP-CSF (per clinical guidelines) did not receive it. Among the subset of candidates who did not receive PP-CSF, FN risk was high (16%) and associated consequences were severe. Careful consideration should be given to identifying metastatic patients at elevated risk of FN—based on their chemotherapy regimen and risk factors—to ensure appropriate use of supportive care. Table. FN risk factors and chemotherapy FN risk level among metastatic patientsBreast Cancer (N = 380)Colorectal Cancer (N = 360)Lung Cancer (N = 626)NHL (N = 91)All (N = 1,457)FN Risk FactorsAge ≥65y, %20.821.137.240.729.2Prior chemotherapy or radiation therapy, %39.234.248.445.142.3Prior neutropenia, %1.82.22.69.92.7Bone marrow involvement, %27.12.830.024.222.2Recent surgery, %40.042.216.914.329.0Liver dysfunction (bilirubin >2.0), %0.81.40.50.00.8Renal dysfunction (creatinine clearance Citation Format: Derek Weycker, Amanda Silvia, Ahuva Hanau, Lois Lamerato, Kathryn Richert-Boe, Manpreet Kaur, Neel Shah, Mark Hatfield, Gary H Lyman. Risk of chemotherapy-induced febrile neutropenia (FN) in patients with metastatic cancer of the breast or other sites not receiving colony-stimulating factor prophylaxis (CSF) in US clinical practice [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-08-24.

Evaluations of vaccine effectiveness (VE) are important to monitor as coronavirus disease 2019 (COVID-19) vaccines are introduced in the general population. Research staff enrolled symptomatic participants seeking outpatient medical care for COVID-19–like illness or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing from a multisite network. VE was evaluated using the test-negative design. Among 236 SARS-CoV-2 nucleic acid amplification test-positive and 576 test-negative participants aged ≥16 years, the VE of messenger RNA vaccines against COVID-19 was 91% (95% confidence interval, 83%–95%) for full vaccination and 75% (55%–87%) for partial vaccination. Vaccination was associated with prevention of most COVID-19 cases among people seeking outpatient medical care., With the test-negative design used to evaluate protection from messenger RNA vaccines, vaccine effectiveness against coronavirus disease 2019 among outpatients aged ≥16 years was 91% (95% confidence interval, 83%–95%) for full vaccination and 75% (55%–87%) for partial vaccination.

Evaluations of vaccine effectiveness (VE) are important to monitor as COVID-19 vaccines are introduced in the general population. Research staff enrolled symptomatic participants seeking outpatient medical care for COVID-19-like illness or SARS-CoV-2 testing from a multisite network. VE was evaluated using the test-negative design. Among 236 SARS-CoV-2 nucleic acid amplification test-positive and 576 test-negative participants aged ≥16 years, VE of mRNA vaccines against COVID-19 was 91% (95% CI: 83-95) for full vaccination and 75% (95% CI: 55-87) for partial vaccination. Vaccination was associated with prevention of most COVID-19 cases among people seeking outpatient medical care.

The test-negative design is validated in outpatient, but not inpatient, studies of influenza vaccine effectiveness. The prevalence of chronic pulmonary disease among inpatients can lead to nonrepresentative controls. Test-negative design estimates are biased if vaccine administration is associated with incidence of noninfluenza viruses. We evaluated whether control group selection and effects of vaccination on noninfluenza viruses biased vaccine effectiveness in our study. Subjects were enrolled at the University of Michigan and Henry Ford hospitals during the 2014–2015 and 2015–2016 influenza seasons. Patients presenting with acute respiratory infection were enrolled and tested for respiratory viruses. Vaccine effectiveness was estimated using 3 control groups: negative for influenza, positive for other respiratory virus, and pan-negative individuals; it was also estimated for other common respiratory viruses. In 2014–2015, vaccine effectiveness was 41.1% (95% CI: 1.7, 64.7) using influenza-negative controls, 24.5% (95% CI: −42.6, 60.1) using controls positive for other virus, and 45.8% (95% CI: 5.7, 68.9) using pan-negative controls. In 2015–2016, vaccine effectiveness was 68.7% (95% CI: 44.6, 82.5) using influenza-negative controls, 63.1% (95% CI: 25.0, 82.2) using controls positive for other virus, and 71.1% (95% CI: 46.2, 84.8) using pan-negative controls. Vaccination did not alter odds of other respiratory viruses. Results support use of the test-negative design among inpatients.

BackgroundDocumentation of influenza vaccination, including the specific product received, is critical to estimate annual vaccine effectiveness (VE).MethodsWe assessed performance of the Michigan Care Improvement Registry (MCIR) in defining influenza vaccination status relative to documentation by provider records or self-report among subjects enrolled in a study of influenza VE from 2011 through 2019.ResultsThe specificity and positive predictive value of MCIR were high; however, >10% of vaccinations were identified only by other sources each season. The proportion of records captured by MCIR increased from a low of 67% in 2013-2014 to a high of 89% in 2018-2019, largely driven by increased capture of vaccination among adults.ConclusionsState vaccine registries, such as MCIR, are important tools for documenting influenza vaccination, including the specific product received. However, incomplete capture suggests that documentation from other sources and self-report should be used in combination with registries to reduce misclassification.

Background and Aims Recent studies have shown an association between Sodium Glucose Co-Transporter 2 inhibitor (SGLT-2i) class of drugs and lower healthcare costs compared with other glucose lowering therapy, in type 2 diabetes (T2D) patients mainly as a result of reduced rates of cardiovascular and other T2D-associated outcomes. The DAPA-CKD Trial (A study to evaluate the effect of dapagliflozin on renal outcomes and CV mortality in patients with CKD) is the first SGLT-2i renal outcomes trial to test the efficacy and safety of an SGLT-2i, dapagliflozin, in patients with CKD with and without T2D. The objective of this study is to assess the healthcare resource utilization and cost in a “DAPA-CKD-like population” (eGFR 25-75ml/min/1.73m2 and UACR 200-5000mg/g) using a contemporary US healthcare system. Method Data from the Henry Ford Health System (HFHS) were used to identify persons with CKD stages 2 through 4 between 2006 and 2016 (based on eGFR labs) and patients were followed through 2018. Persons with no confirmatory eGFR > 90 days from index date, death within 30 days, history of renal transplant, and evidence of renal replacement therapy, or progression to CKD stage 5 during the baseline period (6 months pre or post index date) were excluded. Inpatient admissions, inpatient days, emergency department encounters, and ambulatory care encounters with primary care, specialty care and overall were assessed. Cumulative utilization was evaluated for all patients and evaluation based on the follow-up time. Patients were censored on date of death, last contact with the Health System or at December 31st, 2018. The utilization rates are the total observed utilization divided by follow-up time and reported as an annual rate. Billing records for all care with HFHS were used to estimate costs. Results 6,557 patients (mean age 62.9 years, 46.2% male) met the eligibility criteria and are included in the study cohort. The population was stratified by UACR (0- Conclusion This analysis of a contemporary US healthcare system demonstrated that there exists a high disease burden in the DAPA-CKD-like population as seen by the substantial increase in healthcare resource utilization and costs compared to other cohorts of patients with a lower UACR. These results highlight the need for innovative therapies to improve patient outcomes in this population.

Background and Aims The Sodium Glucose Co-Transporter 2 inhibitor (SGLT-2i) class of drugs have demonstrated significant cardiorenal benefits in patients with type 2 diabetes (T2D), including reducing the composite renal outcome of significant eGFR decline, End Stage Kidney Disease (ESKD) or renal death in patients with T2D and preserved renal function and also in patients with overt Diabetic Kidney Disease. In addition, SGLT-2i have proven to have beneficial effects on cardiovascular (CV) outcomes in patients with heart failure with reduced ejection fraction (HFrEF) independent of glycaemic status. The DAPA-CKD Trial (A study to evaluate the effect of dapagliflozin on renal outcomes and CV mortality in patients with CKD) is the first SGLT-2i renal outcome trial to test the efficacy and safety of an SGLT-2i, dapagliflozin, in patients with diagnosed CKD with and without T2D. In order to appropriately evaluate the future results and aid clinical interpretation of the DAPA-CKD trial, the present study assessed the renal and CV outcomes of a “DAPA-CKD-like population” (eGFR 25-75ml/min/1.73m2 and UACR 200-5000mg/g) in a contemporary US real healthcare system. Method Administrative data from the Henry Ford Health System was used to identify persons with CKD stages 2 through 4 between 2006 and 2016 based on eGFR lab reading (n=38,376). Exclusions included no confirmatory eGFR > 90 days from index date, death within 30 days, history of renal transplant, and evidence of renal replacement therapy, or progression to CKD stage 5 during the baseline period (6 months pre or post index date). Within that cohort, 17,742 had eGFR (25-75ml/min/1.73m2) and 9,177 had a UACR (0-5000 mg/g) within 12 months of index date. Additional exclusions included type 1 diabetes (n=2,546), lupus nephritis (n=1) and polycystic kidney disease (n=20). Patients were followed through December 31st, 2018. Results Of the 6,557 patients that met the eligibility criteria and were included in the study cohort, the mean age was 62.9 years and 46.2% were male. The population was stratified by UACR (0- Conclusion In a contemporary US healthcare system, there remains significant adverse renal, CV and mortality outcomes among patients fitting the DAPA-CKD study inclusion criteria. These results highlight the unmet need existing for additional therapies to delay disease progression and improve patient outcomes and survival in this population.

Background The 2017 American College of Cardiology and American Heart Association guideline defined hypertension as blood pressure (BP) ≥ 130/80 mmHg compared to the traditional definition of ≥140/90 mmHg. This change raised much controversy. We conducted this study to compare the impact of tight (TBPC) versus standard BP control (SBPC) on the incidence of myocardial infarction (MI) and stroke. Methods We retrospectively identified all hypertensive patients in an ambulatory setting based on the diagnostic code for 1 year at our institution who were classified by the range of BP across 3 years into 2 groups of TBPC ( Results Of 5640 study patients, the TBPC group showed significantly less incidence of stroke compared to the SBPC group (1.5% vs. 2.7%, P P = 0.476). Multivariate analysis showed that increased age independently increased the incidence of both MI (OR 1.518, 95% CI 1.038–2.219) and stroke (OR 1.876, 95% CI 1.474–2.387), and TBPC independently decreased the incidence of stroke (OR 0.583, 95% CI 0.374–0.910) but not of MI. Conclusions Our observational study suggests that TBPC may be beneficial in less stroke incidence compared to SBPC but it didn’t seem to affect the incidence of MI. Our study is limited by its retrospective design with potential confounders.

Normal ranges of serum alanine aminotransferase (ALT) may vary by race. However, results from research studies are contradictory, and many of these studies have included only small numbers of African Americans. We investigated ALT values in patients without evidence of liver disease to determine whether normal ranges differ across race groups. We also evaluated whether a race- and sex-dependent upper limit of normal (ULN) would improve the ability of ALT to predict liver disease compared to the sex-dependent ULN currently in use. We identified ICD9 codes for liver conditions and diabetes in medical records from a sample of 6719 patients. Analysis of variance (ANOVA) was used to assess differences in ALT log-transformed distributions by race. Logistic regression was used to evaluate whether the addition of race to the current sex-dependent ULN improves the ability of ALT to predict liver disease (assessed by area under the receiver operating characteristic curve (AUROC)). Among 1200 patients with BMI 18.5

Introduction: Two previous retrospective claims database analyses (Pocoski J, et al. Haemophilia. 2014;20(4):472-478 and Humphries TJ, et al. Am J Hematol. 2016;91(5):E298-299) reported increased prevalence and earlier onset of cardiovascular (CV) comorbidities in patients with vs without hemophilia A (HEM A). Because of many known limitations of claims databases, a comprehensive chart review at a large integrated delivery network was conducted to assess differential CV comorbidities. Aim: This study was designed to confirm the previous findings on CV risk factors and associated diseases in 2 large claims databases of male patients with HEM A in the United States. Methods: This was a retrospective chart review study conducted at the Henry Ford Health System in patients diagnosed with HEM A (n=74) and matched Control patients (3:1) without a diagnosis of HEM A (Control, n=222). Baseline demographics, bleeding events, treatment parameters, co-existing diseases, hemophilia-associated events, and the prevalence of 12 CV risk factors and associated diseases were compared between the HEM A and Control cohorts. P values generated from a chi-square test for categorical variables and a t test for continuous variables were reported. To address the small sample size, statistical differences between the cohorts were also assessed using absolute standardized difference (SDiff), where a value ≥0.10 was considered statistically meaningful. Results: The Control cohort was well matched to the HEM A group by age, race, healthcare payer, and study year. As expected, the prevalence of hepatitis B and C, hepatocellular carcinoma, and HIV/AIDS was much higher in the HEM A cohort. Gastrointestinal, intracranial, muscle, and joint bleeds occurred only in HEM A patients. Bleeds of various types were recorded in 35 HEM A patients vs 1 in the Control group. HEM A was severe in 52.7% of patients, moderate and mild in 10.8% each, and unknown in 25.7%. The prevalence of hypertension, diabetes, obesity, hyperlipidemia, coronary artery disease, heart failure, stroke, venous and arterial thrombosis, ventricular arrhythmias, atrial fibrillation, and chronic renal disease was numerically higher in the Control cohort, but differences were statistically significant (P≤0.05) for diabetes and hyperlipidemia only. Statistical significance using SDiff was not reached for venous and arterial thrombosis and atrial fibrillation. Conclusions:The results of this retrospective chart review did not confirm diffuse statistically significant differences in CV comorbidities and their earlier onset in HEM A vs Controls. Reasons for the lack of confirmation are not clear but may include differences in methodology and patient populations among the studies. The Control group in this current study may have a greater medical burden than in the published studies. Our current results suggest numerically higher comorbidities in Controls for most variables. The conclusions of this study are limited by the small sample size of the hemophilia cohort and a potential selection bias associated with identification of the Control cohort. Disclosures Pocoski: Bayer: Employment. Rule:Bayer: Employment. Ogbonnaya:Takeda: Research Funding. Lamerato:Amgen, Inc.: Research Funding. Lunacsek:Bayer: Research Funding. Humphries:Bayer: Employment.

Background The 2017 American College of Cardiology and American Heart Association guideline defined hypertension as blood pressure (BP) ≥ 130/80 mmHg compared to the traditional definition of ≥ 140/90 mmHg. This change raised much controversy. We conducted this study to evaluate incidences of myocardial infarction (MI) and stroke comparing tight (TBPC) and standard BP control (SBPC).Methods The data were collected and analyzed in 2018. We retrospectively identified hypertensive patients for 1 year at our institution who were classified by BP rate across 3 years into 2 groups of TBPC (< 130 mmHg) and SBPC (130-139 mmHg). We compared the incidence of new MI and stroke between the 2 groups across a 2-year follow-up. Multivariate analysis was done to identify independent risk factors.Results Of 5640 study patients, the TBPC group showed significantly less incidence of stroke compared to the SBPC group. No differences were found in MI incidence between the 2 groups. Multivariate analysis showed that increased age independently increased the incidence of both MI and stroke, and TBPC independently decreased the incidence of stroke but not of MI.Conclusions Our study showed that TBPC had a significant benefit in less stroke incidence compared to SBPC but did not affect the incidence of MI.

Our objective was to identify predictors of severe acute respiratory infection in hospitalised patients and understand the impact of vaccination and neuraminidase inhibitor administration on severe influenza. We analysed data from a study evaluating influenza vaccine effectiveness in two Michigan hospitals during the 2014–2015 and 2015–2016 influenza seasons. Adults admitted to the hospital with an acute respiratory infection were eligible. Through patient interview and medical record review, we evaluated potential risk factors for severe disease, defined as ICU admission, 30-day readmission, and hospital length of stay (LOS). Two hundred sixteen of 1119 participants had PCR-confirmed influenza. Frailty score, Charlson score and tertile of prior-year healthcare visits were associated with LOS. Charlson score >2 (OR 1.5 (1.0–2.3)) was associated with ICU admission. Highest tertile of prior-year visits (OR 0.3 (0.2–0.7)) was associated with decreased ICU admission. Increasing tertile of visits (OR 1.5 (1.2–1.8)) was associated with 30-day readmission. Frailty and prior-year healthcare visits were associated with 30-day readmission among influenza-positive participants. Neuraminidase inhibitors were associated with decreased LOS among vaccinated participants with influenza A (HR 1.6 (1.0–2.4)). Overall, frailty and lack of prior-year healthcare visits were predictors of disease severity. Neuraminidase inhibitors were associated with reduced severity among vaccine recipients.

Purpose: We examined the association between patient experience of care and utilization of hormone therapy (HT) in the treatment of non-metastatic hormone-receptor positive (HR+) breast cancer. Methods: Patients newly diagnosed with non-metastatic breast cancer were recruited from 2006 to 2010 for a longitudinal multisite cohort study in New York, NY, Detroit, MI, and Northern California. Of 1,145 patients surveyed, 797 had HR+ tumors eligible for HT and all necessary data. We assessed patient experience 4 to 8 weeks after recruitment using 6 subscales of the Interpersonal Processes of Care (IPC) survey: compassion, discrimination, and hurriedness in communication, as well as concern elicitation, result explanation, and patient-centered decision-making. Subscales ranged from 1 to 5 where higher values indicated better experiences. HT for 5 years is standard care for HR+ breast cancer so utilization was defined as time from diagnosis to HT initiation and time from HT initiation to early discontinuation before 5 years as calculated from follow-up survey responses. We evaluated the relationship between patient experience and utilization using Cox proportional hazard models, controlling for education, income, insurance, marital status, social support, site of care, age at diagnosis, stage, grade, tumor size, Charlson comorbidity index, and chemotherapy. Results: Median age at diagnosis was 59 years (interquartile range 51–66) with the majority diagnosed at clinical stage 1 (54%) and with low or moderate grade disease (78%). Less hurried communication was associated with increased probability of HT initiation (Hazards Ratio (HR) 1.15; 95% Confidence Interval (CI) 1.03, 1.30; p = 0.018). Conversely, more patient-centered decision-making was associated with increased probability of early discontinuation (HR 1.29; CI, 1.03, 1.63; p = 0.028). All other associations were null. Conclusion: While unhurried communication was associated with initiation of hormone therapy, patient-centered decision-making was associated with early discontinuation. Different aspects of patient experience may have vastly different relationships with patient utilization of health services. Actionable assessments of patient experience may require measurement along multiple dimensions.

Anti-cyclic citrullinated peptide (CCP) antibody positivity is an established diagnostic factor for severe disease activity and joint damage and a prognostic factor for aggressive disease in rheumatoid arthritis (RA).To compare RA-related treatment, healthcare utilization, and joint erosion between anti-CCP-positive and anti-CCP-negative RA patients.Newly-diagnosed RA patients were identified from the Henry Ford Health System database between January 1, 2009 and December 31, 2014; the date of the first RA diagnosis within the study period was the index date. Baseline anti-CCP test was used to categorize patients as anti-CCP-positive or anti-CCP-negative, and outcomes were evaluated in the 6 months post-index.There were 217 anti-CCP-positive and 191 anti-CCP-negative RA patients included in the study. A higher proportion of anti-CCP-positive patients were initiated on RA treatment than anti-CCP-negative patients (70.5% vs 23.0%; p .0001). More anti-CCP-positive patients received methotrexate (73.2% vs 56.8%; p = .0374), while more anti-CCP-negative patients received hydroxychloroquine (31.8% vs 13.1%; p = .0037) in first-line therapy. A higher proportion of anti-CCP-negative patients were tested for rheumatoid factor (RF) and erythrocyte sedimentation rate (ESR). Of those tested, there were more positive test results in the anti-CCP-positive cohort compared to the anti-CCP-negative cohort (RF: 84.4% vs 18.2%, p .0001; C-reactive protein [CRP]: 69.7% vs 48.3%, p = .0008; and ESR: 89.5% vs 53.9%, p .0001). Outpatient utilization predominated, with more anti-CCP-positive patients having any outpatient physician office visit (96.3% vs 77.5%, p .0001) and a higher mean number of visits (5.3 vs 2.5, p .0001) than anti-CCP-negative patients. Among anti-CCP-positive (n = 113) and anti-CCP-negative (n = 58) patients with imaging results, more anti-CCP-positive patients had joint erosion compared to anti-CCP-negative patients (18.6% vs 8.6%; p = .0858); however, statistical significance was not reached.RA patients with positive anti-CCP antibodies had higher degrees of inflammation and disease activity as indicated by laboratory results, which likely contributed to their higher rates of healthcare utilization, joint erosion, and proportions of RA treatment.

Purpose The purpose of this study was to estimate the risk and economic burden of peristomal skin complications (PSCs) in a large integrated healthcare system in the Midwestern United States. Design Retrospective cohort study. Subjects and setting The sample comprised 128 patients; 40% (n = 51) underwent colostomy, 50% (n = 64) underwent ileostomy, and 10% (n = 13) underwent urostomy. Their average age was 60.6 ± 15.6 years at the time of ostomy surgery. Methods Using administrative data, we retrospectively identified all patients who underwent colostomy, ileostomy, or urostomy between January 1, 2008, and November 30, 2012. Trained medical abstractors then reviewed the clinical records of these persons to identify those with evidence of PSC within 90 days of ostomy surgery. We then examined levels of healthcare utilization and costs over a 120-day period, beginning with date of surgery, for patients with and without PSC, respectively. Our analyses were principally descriptive in nature. Results The study cohort comprised 128 patients who underwent ostomy surgery (colostomy, n = 51 [40%]; ileostomy, n = 64 [50%]; urostomy, n = 13 [10%]). Approximately one-third (36.7%) had evidence of a PSC in the 90-day period following surgery (urinary diversion, 7.7%; colostomy, 35.3%; ileostomy, 43.8%). The average time from surgery to PSC was 23.7 ± 20.5 days (mean ± SD). Patients with PSC had index admissions that averaged 21.5 days versus 13.9 days for those without these complications. Corresponding rates of hospital readmission within the 120-day period following surgery were 47% versus 33%, respectively. Total healthcare costs over 120 days were almost $80,000 higher for patients with PSCs. Conclusions Approximately one-third of ostomy patients over a 5-year study period had evidence of PSCs within 90 days of surgery. Costs of care were substantially higher for patients with these complications.

African American (AA) women with breast cancer have persistently higher mortality compared to whites. We evaluated racial disparities in mortality among women with estrogen receptor (ER)/progesterone receptor (PR)-negative breast cancer. The study population included 542 women (45% AA) diagnosed with ER/PR-negative Stage I through III breast cancer treated at the Henry Ford Health System (HFHS) between 1996 and 2005. Linked datasets from HFHS, Metropolitan Detroit Cancer Surveillance System, and the U.S. Census Bureau were used to obtain demographic, socioeconomic, and clinical information. Economic deprivation was categorized using a previously validated deprivation index, which included 5 categories based on the quintile of census tract socioeconomic deprivation. Cox proportional hazards models were used to assess the relationship between race and mortality. AA women were more likely to have larger tumors, have higher Charlson Comorbidity Indices (CCI), and to reside in economically deprived areas. In an unadjusted analysis, AA women demonstrated a significantly higher risk of death compared to whites [hazard ratio (HR) 1.47, 95% confidence interval (CI) 1.09–2.00]. Following adjustment for clinical factors (age, stage, CCI) and treatment (radiation and chemotherapy), AA race continued to have a significant impact on mortality (HR 1.51, CI 1.10–2.08 and HR 1.63, CI 1.20–2.21). Only after adjusting for deprivation was race no longer significant (HR 1.26, CI 0.84–1.87). Social determinants of health play a large role in explaining racial disparities in breast cancer outcomes, especially among women with aggressive subtypes.

In the United States, influenza and pneumonia account significantly to emergency room use and hospitalization of adults >65 y. The Centers for Disease Control and Prevention recommends use of the annual influenza vaccine and 2 pneumococcal vaccines for older adults to decrease risks of morbidity and mortality. However, actual vaccine up-take is estimated at 61.3% for pneumococcal vaccines and 65% for influenza vaccine in the 2013–2014 season. Vaccine up-take is affected by multiple socio-cultural and economic factors including general healthcare access and utilization, social networks and norms, communication with health providers and health information sources, as well as perceptions related to vaccines and targeted diseases. In this study, 8 focus group discussions (total N = 48) were conducted with adults 65+ years living in urban and suburban communities in the Detroit Metropolitan Area. The research objective was to increase understanding of barriers and facilitators to vaccine up-take in this age cohort within the context of general healthcare availability and accessibility, social networks, information sources, and personal perceptions of diseases and vaccines. The data suggest the need to integrate broader health care service experiences, concepts of knowledge of one's own well-being and vulnerabilities, and self-advocacy as factors associated with older adults' vaccine-use decisions. These data also support recognition of multiple levels of vaccine acceptance which can be disease specific. Implications include potential for increasing vaccine up-take through general improvement in health care delivery and services, as well as specific vaccine-focused patient and provider education programs.

We sought to quantify socioeconomic disparities in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) at an urban, tertiary referral center. This retrospective case-control study identified 67 patients with severe AS (aortic valve [AV] area ≤1 cm2 or AV area index ≤0.60 cm2/m2 or AV velocity ≥40 mmHg) who underwent TAVR from November 5, 2013 to June 10, 2014. Study subjects were matched to controls with severe AS without TAVR in a 4:1 age-frequency match. Demographic data were collected using electronic medical records. Area-based median household income was obtained by geocoding patients’ addresses and linking with census data. Charlson comorbidity index for all subjects was calculated. Income disparity was significant in that with every $10,000 increase in income, the odds of receiving TAVR increased by 10% (p = 0.05). Non-blacks were significantly more likely to receive TAVR than blacks (odds ratio [OR] 2.812, confidence interval [CI] 1.007–7.853; p = 0.048). No differences in comorbidities were found between the two groups. Post hoc analysis to identify etiologies of the found disparities examined differences of AV area and AV area index, indication for two-dimensional echocardiography (echo), symptoms prior to echo, and action after echo within the control group. Black race significantly impacted the TAVR status despite the same AV area (OR 0.33, CI 0.09–0.97, p = 0.043). After echo, blacks were more likely to decline AVR, be lost to follow-up, and not be referred to cardiology (OR 4.41, CI 1.43–13.64; p = 0.010). Socioeconomic and racial disparities were associated with patients with severe AS receiving TAVR at a major referral center. This study emphasizes the importance of improving access to standard of care for these subgroups of cardiac patients.

Aims Constipation associated with opioid therapy for chronic pain may negatively impact colonoscopy success. This retrospective, observational study using administrative data and electronic medical records evaluated the impact of opioid use on colonoscopy outcomes. Methods and Results Procedural codes were used to identify patients who had a screening colonoscopy at two Henry Ford Health System centers (January 2015–December 2016). All patients had completed a standard uniform bowel preparation protocol. Medication orders and filled prescriptions were used to identify patients with a history of opioid use during the 28 days preprocedure (exposed) and a matched random sample of presumptive opioid nonusers (unexposed). Electronic medical records were reviewed for colonoscopy procedure data and outcomes. The exposed and unexposed groups included 964 and 1054 patients, respectively. Inadequate bowel preparation was significantly more common in the exposed versus unexposed group (18.5% vs 12.7%; P, Constipation associated with opioid therapy for chronic pain may negatively impact colonoscopy success. This retrospective, observational, cohort study using administrative data and electronic medical records showed that opioid exposure was associated with significant reductions in the quality of preprocedure bowel preparation and an increased risk of complications in patients undergoing colonoscopy.

Objectives: To investigate the relationship between maternal race/ethnicity, maternal age at delivery, and the risk of gestational diabetes mellitus (GDM).Research design: Patients of Henry Ford He...

BACKGROUND To the authors' knowledge, the relationship between cardiorespiratory fitness (CRF) and lung and colorectal cancer outcomes is not well established. METHODS A retrospective cohort study was performed of 49,143 consecutive patients who underwent clinician-referred exercise stress testing from 1991 through 2009. The patients ranged in age from 40 to 70 years, were without cancer, and were treated within the Henry Ford Health System in Detroit, Michigan. CRF, measured in metabolic equivalents of task (METs), was categorized as

The Health Care Systems Research Network (HCSRN; formerly HMO Research Network) held its annual conference in Atlanta, Georgia, in April 2016. A consortium of research organizations affiliated with 20 large health care delivery systems, the HCSRN met for the 22nd consecutive year to report on scientific achievements, develop and share skills and best practices, and promote new research collaborations. The 2016 conference, with a theme of “Advancing Population Health: New Models and the Role of Research,” was co-hosted on behalf of HCSRN by Marshfield Clinic Research Foundation and Henry Ford Health System’s Public Health Sciences Department. The 350 conference attendees included member investigators, research staff, federal funders, other research sponsors and a variety of existing and prospective collaborative partners. Key sessions reflecting the theme included plenary panels with a research focus on patient-centered care and population health management, a full-day symposium on precision oncology and a half-day patient-engaged research training workshop.

Background: It has been suggested that hyponatremia (HN) may be a negative prognostic factor in patients with cancer but little research has been conducted specifically in breast cancer (BC). We measured the incidence of hyponatremia (hypervolemic and euvolemic) after BC diagnosis and its prognostic importance for progression free (PFS) and overall survival (OS). Methods: This retrospective cohort analysis utilized data from the Henry Ford Health System electronic medical record, tumor registry, and administrative databases. Study data were collected electronically and via medical record abstraction. Adults diagnosed (2002-2010) with incident invasive BC were selected if they had a known disease stage at the time of tumor registration, were classified as an analytic case, had ≥ 1 administration of chemo/radiation therapy ≤ 6 months from diagnosis, met continuous enrollment thresholds, and did not experience hypovolemic HN post index. Only the first tumor registered from each patient was considered study-eligible. Hypervolemic or euvolemic HN incidence (serum sodium ≤ 135 mEq/L) was measured per 1000 person-years (PY) of observation and classified as mild (131–135 mEq/L), moderate (125–130 mEq/L) or severe ( Results: 527 patients were eligible (mean [SD] age 56.4±11.3 years, 61% Caucasian). Mean (SD) follow-up was 3.7±2.8 years. Eighty-five percent of patients had infiltrating ductal carcinoma; 72% and 65% had estrogen or progesterone sensitive tumor, respectively; 35% were HER2 positive; and 15% had triple negative disease. Eighty-two percent of patients had early stage (I, II) disease at time of diagnosis. HN episodes (n=377) occurred in 204 patients (39%) at a rate of 193 per 1000 PY (95% CI, 174–213.5), with 89% of the total episodes (337/377) classified as mild, 10% (36/377) as moderate, and 1% (4/377) as severe. Additionally, 7% of all BC patients (37/527) had at least one episode of moderate/severe HN. Median time to first HN episode was 174.5 days and the median HN episode duration was 24.0 days. Five year OS in patients developing HN was 92%, compared to 97% in patients who never developed HN. Hazard ratio (95% CI, p-value) for OS in the HN group was 4.4 (1.5-12.7; p=0.006) after controlling for age, diagnosis year, race, income, morphology, cancer stage, performance status, and hormone receptor status. Fifty patients had progressive disease during follow-up with a mean (SD) time to progression of 763.4 (758.1) days. Hazard ratio (95% CI, p-value) for PFS in the HN group was 1.4 (0.8-2.7; p=0.262) after controlling for age, race, income, morphology, cancer stage, performance status, and hormone receptor status. Conclusions: Incidence of hypervolemic or euvolemic HN is high (39%) after a BC diagnosis, and the occurrence is associated with significantly poorer OS. A significant impact on disease progression was not observed. Citation Format: Castillo JJ, Glezerman IG, Boklage SH, Lamerato LE, Chiodo JA, Tidwell BA, Schulman KL. Incidence and prognostic importance of hyponatremia in a cohort of patients with breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-08-49.

Detroit, Michigan, currently has the highest preterm birth (PTB) rate of large cities in the United States. Disproportionate exposure to ambient air pollutants, including particulate matter ≤2.5 μm (PM2.5), PM ≤ 10 μm (PM10), nitrogen dioxide (NO2) and benzene, toluene, ethylbenzene, and xylenes (BTEX) may contribute to PTB. Our objective was to examine the association of airshed pollutants with PTB in Detroit, MI. The Geospatial Determinants of Health Outcomes Consortium (GeoDHOC) study collected air pollution measurements at 68 sites in Detroit in September 2008 and June 2009. GeoDHOC data were coupled with 2008–2010 Michigan Air Sampling Network measurements in Detroit to develop monthly ambient air pollution estimates at a spatial density of 300 m2. Using delivery records from two urban hospitals, we established a retrospective birth cohort of births by Detroit women occurring from June 2008 to May 2010. Estimates of air pollutant exposure throughout pregnancy were assigned to maternal address at delivery. Our analytic sample size included 7961 births; 891 (11.2%) were PTB. After covariate adjustment, PM10 (P = 0.003) and BTEX (P

Background: Cardiorespiratory fitness (CRF) is associated with a reduction in both cancer- and cardiovascular-specific mortality. In men however, little is known about the impact of pre-diagnostic CRF on mortality after prostate cancer. We hypothesized that among men with prostate cancer, low levels of CRF, measured prior to diagnosis, are associated with a higher risk of all-cause mortality. Methods: From the Henry Ford FIT Project, a cohort of 37,730 men who underwent clinically-indicated exercise stress test from 1991 through 2009, we identified 1,440 men who developed prostate cancer after stress test. CRF was measured in peak metabolic equivalents of task (METs) and categorized as less than 6, 6 to 9, 10 to 11, and at least 12 (reference). Multivariable Cox proportional hazard models were developed to evaluate the association between CRF, measured prior to prostate cancer diagnosis, and all-cause mortality. Models were adjusted for age at prostate cancer diagnosis (baseline), race, BMI, current aspirin and statin use, smoking history, hypertension, diabetes, prior cardiovascular disease (myocardial infarction and heart failure), time from stress test to prostate cancer diagnosis, and cancer stage (local, regional, distant) at diagnosis. Results: Mean age at time of stress test was 61 +/- 9 yr (57% white, 39% black), with 7 (+/-4) yrs of follow up after prostate cancer diagnosis. 81% of men were diagnosed with localized prostate cancer; 15% with regional disease, and 2% with distant metastatic disease. Mean time from stress test to diagnosis was 6 +/- 5 yrs. Mean METs achieved was 9 (+/- 3). Patients with low fitness (METs less than 6) before diagnosis had 2.6 times the risk of all-cause mortality (95% CI 1.6-4.2) compared to those with high fitness (METS at least 12). Those with CRF of 6-9 METs had 1.9 times the risk (95% CI 1.2-3.0). The risk of mortality was not different between the two highest fitness groups (P= 0.71; P for trend across all fitness groups less than 0.01). Results were similar when stratified by race. Conclusion: Low CRF prior to the diagnosis of prostate cancer in men is associated with a higher risk of all-cause mortality. This study highlights the prognostic importance of fitness even before a cancer diagnosis. Citation Format: Cara Reiter-Brennan, Omar Dzaye, Mouaz H. Al-Mallah, Zeina Dardari, Clinton A. Brawner, Lois E. Lamerato, Steven J. Keteyian, Jonathan K. Ehrman, Kala Visvanathan, Michael J. Blaha, Catherine Handy Marshall. Cardiorespiratory fitness levels in men who develop prostate cancer and its association with all-cause mortality [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4348.

Background: High levels of cardiorespiratory fitness (CRF) have been associated with a decreased risk of many cancers, but the association with prostate cancer (PCa) is less clear. A possible explanation for the lack of consistency is that prostate specific antigen (PSA) screening and in turn prostate cancer detection is more frequent in men with higher fitness although the relationship between fitness and PSA screening is not established. Methods: The Henry Ford (HF) FIT Project is a retrospective cohort study of 69,894 consecutive patients who underwent physician-referred exercise stress testing from 1991 through 2009. Cancer diagnosis was identified through linkage to the HF tumor registry. We included men aged 40-70 yr who had CRF testing beginning in 1995 (when PSA screening became widespread), without prevalent cancer, followed at least 3 yrs and up to 10 years, who never develop prostate cancer (n=12,442). CRF was measured in metabolic equivalents of task (METs) and categorized as less than 6 (ref), 6-9, 10-11, and at least 12. PSA values were abstracted from the HF electronic medical record between 1995 and 2010. Individuals with at least 3 screening PSA tests were categorized as high screeners. Logistic regression was used to evaluate the relationship between CRF and high PSA screeners, adjusted for age at stress test and race. Results: Participants had a mean age of 54 ± 8 yrs (67% white; 25% black) and mean follow-up was 7±2 yrs. Compared to individuals with low fitness (less than 6 METs, reference), those with higher fitness (6-9, 10-11, at least 12 METs) had higher odds of being a high PSA screener (Table). When stratified by race, the OR for black patients were not statistically different than white patients (Table). Results were similar among those with comorbidities (myocardial infarction, heart failure, or diabetes) at baseline. Odds ratio of being a high screener (at least 3 PSA tests) in individuals followed 3-10 yearsMETs categoryAll (n=12,442Whites (n=8,356Blacks (n=3,049)Patients w/comorbidities (n=3,924)=122.4 (2.1-2.9)2.5(2.0-3.1)2.1(1.6-2.8)3.2(2.5-4.0) Conclusion: High CRF is associated with more frequent PSA screening. This points towards a healthy screening bias and should be accounted for in studies looking at fitness and incident prostate cancer. Citation Format: Cara Reiter-Brennan, Omar Dzaye, Mouaz H. Al-Mallah, Zeina Dardari, Clinton A. Brawner, Lois E. Lamerato, Steven J. Keteyian, Jonathan K. Ehrman, Kala Visvanathan, Michael J. Blaha, Catherine Handy Marshall. Cardiorespiratory fitness and PSA screening patterns in the Henry Ford FIT Project [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 5773.

7060 Background: The obesity paradox –i.e. inverse associations between body mass index (BMI) and mortality – has been reported in patients with cancer, heart failure, and diabetes. However, the influence of cardiorespiratory fitness (CRF) on this relationship is not well established. This study assesses the association of BMI and CRF with all-cause mortality among cancer patients. Methods: The Henry Ford (HF) FIT Project is a retrospective cohort study of 69,885 consecutive patients who underwent physician-referred exercise stress testing from 1991 through 2009. Cancer diagnosis was identified through linkage to the HF tumor registry. We included patients 40-70 years old, with BMI recorded, at time of exercise test, with a history of cancer > 6 months prior. BMI was categorized as normal (18.5-24.9kg/m2), overweight (25-29.9kg/m2), or obese ( > = 30kg/m2). All-cause mortality was obtained from the National Death Index. Because of a significant interaction between BMI and cancer type, patients with breast or prostate cancer were excluded. Multivariable adjusted Cox proportional hazard models were used to evaluate the association of CRF andBMI with all-cause mortality; adjusted for age at exercise test, sex, diabetes, smoking, cancer stage, and time from cancer diagnosis to exercise test. Results: Included were 676 patients with a mean age of 58 years (SD 7.5), 51% female, 70% White, 25% Black, with a median of 4.8 years from diagnosis to exercise test and median follow up time of 10.3 years. Among patients achieving < 10 METs, those who are overweight and obese had a lower risk of mortality HR 0.47 (95% CI 0.25,0.86) and HR 0.44 (95% CI 0.26, 0.74, respectively), compared to those with normal BMI. Among patients with METs > = 10, those who were overweight had the lowest risk of all-cause mortality (HR 0.23, 95% CI 0.09-0.62) compared to normal weight, while no statistically significant different risk of mortality was observed when comparing those who are obese to normal weight (HR 0.37, 95% CI 0.13-1.06). In an analysis combining BMI and fitness groups (four categories), those with BMI > = 25 and METs > = 10 had the lowest risk of all-cause mortality (Table). Conclusions: In non-breast/non-prostate cancer patients, increased BMI is associated with improved overall survival in those with METs < 10, while a U-shaped relationship between BMI and all-cause mortality exists among those with METs > = 10. [Table: see text]

BACKGROUND: Influenza vaccines are important for prevention of influenza-associated hospitalization. However, the effectiveness of influenza vaccines can vary by year and influenza type and subtype and mechanisms underlying this variation are incompletely understood. Assessments of serologic correlates of protection can support interpretation of influenza vaccine effectiveness in hospitalized populations. METHODS: We enrolled adults hospitalized for treatment of acute respiratory illnesses during the 2014–2015 and 2015–2016 influenza seasons whose symptoms began

Background Colorectal cancer (CRC) develops from colorectal adenomatous polyps. This study is to determine if diabetes mellitus (DM), its treatment, and hemoglobin A1c (HbA1c) level are associated with increased risk of colorectal adenomatous polyps. Methods This was a retrospective cohort study that included patients who had at least one colonoscopy and were continuously enrolled in a single managed care organization during a 10-year period (2002–2012). Of these patients (N = 11,933), 1800 were randomly selected for chart review to examine the details of colonoscopy and pathology findings and to confirm the diagnosis of DM. Multivariable logistic regression analyses were performed to assess the associations between DM, its treatment, HbA1c level and adenomatous polyps (our main outcome). Results Among the total of 11,933 patients with a mean (standard deviation) age of 56 (± 8.8) years, 2306 (19.3%) had DM and 75 (0.6%) had CRC. Among the 1800 under chart review, 445 (24.7%) had DM, 11 (0.6%) had CRC and 537 (29.8%) had adenomatous polyps. In bivariate analysis, patients with DM had 1.45 odds of developing adenomatous polyps compared to those without DM. This effect was attenuated (odds ratio = 1.25, 95% CI: 0.96–1.62, p = 0.09) after adjusting for confounders such as age, gender, race/ethnicity, and body mass index. There was no significant association between type or duration of DM treatment or HbA1c level and adenomatous polyps. Conclusions Our study confirmed the known increased risk of adenomatous polyps with advancing age, male gender, Hispanic race/ethnicity and higher body mass index. Although it suggested an association between DM and adenomatous polyps, a statistically significant association was not observed after controlling for other potential confounders. Further studies with a larger sample size are needed to further elucidate this relationship.

Understanding of acromegaly disease management is hampered in the U.S. by the lack of a national registry. We describe medical management in a population with confirmed acromegaly.Inpatient and outpatient electronic health records (EHRs) were used to create a database of de-identified patients assigned the Acromegaly and Gigantism International Classification of Diseases, 9Of 367 patients with validated acromegaly, available records showed that during the years studied, pituitary surgery was performed on 31%, 4% received radiosurgery, and 22% were prescribed a drug indicated for acromegaly. Insulin-like growth factor-1 (IGF-1) levels were measured in 62% of patients, 83% of whom had at least 1 normal value. Coded comorbidities reflect those reported previously in patients with acromegaly, with the exception of esophageal reflux in 20% of patient records. Fewer data regarding acromegaly-specific medications and testing were available for patients aged 65 and older.AcroMEDIC is a U.S. multisite retrospective study of acromegaly that captured medical management in the majority of patients included in the cohort. Chart review highlighted the importance of verification of coded diagnoses. Most of the acromegaly-related comorbidities identified here are known to increase with age and obesity. Patients ≥65 appeared to have less active management/monitoring of their disease. Medical attention should be directed to this population to address evolving needs over time.AcroMEDIC = Acromegaly Multisite Electronic Data Innovative Consortium; BMI = body mass index; CCI = Charlson Comorbidity Index; EHR = electronic health record; GH = growth hormone; GHRA = growth hormone receptor antagonist; ICD-9 = International Classification of Diseases, 9

It is imperative to measure the degree of contamination throughout the course of randomized controlled trials, as contamination, the receipt of the intervention arm regimen by control arm participants, can affect trial power. In the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, contamination was estimated through use of the self-administered Health Status Questionnaire (HSQ) annually to a randomly-selected subset of control arm participants. We examined agreement of self-report of chest x-ray on the HSQ with clinic records at one of the 10 PLCO screening centers (Henry Ford Health System, or HFHS). We focus on HFHS participants covered by the Health Alliance Plan (HAP), a managed health care insurance plan owned and operated by HFHS, because claims for care received both at HFHS and other facilities are available in HFHS databases for HAP enrollees. We examined agreement for the six years prior to HSQ completion, with HFHS clinic records considered to be the gold standard. For those who had complete HAP coverage during the six years, percent agreement was 0.69, sensitivity was 0.84, and positive predictive value was 0.76. Specificity and negative predicted value were low, however (0.28 and 0.38, respectively), and Cohen's kappa was 0.13. For groups with incomplete or no HAP coverage, and when timing of exam was considered, performance measures typically became lower, in some instances below 0.20. These data suggest that self-report of chest x-ray screening may not be accurate, although high prevalence of chest x-ray may make performance measures less interpretable.

The severity of liver disease in the hepatitis C virus (HCV)-infected population in the United States remains uncertain. We estimated the prevalence of cirrhosis in adults with chronic hepatitis C (CHC) using multiple parameters including liver biopsy, diagnosis/procedure codes, and a biomarker.Patients enrolled in the Chronic Hepatitis Cohort Study (CHeCS) who received health services during 2006-2010 were included. Cirrhosis was identified through liver biopsy reports, diagnosis/procedure codes for cirrhosis or hepatic decompensation, and Fibrosis-4 (FIB-4) scores ≥5.88. Demographic and clinical characteristics associated with cirrhosis were identified through multivariable logistic modeling.Among 9,783 patients, 2,788 (28.5%) were cirrhotic by at least one method. Biopsy identified cirrhosis in only 661 (7%) patients, whereas FIB-4 scores and diagnosis/procedure codes for cirrhosis and hepatic decompensation identified cirrhosis in 2,194 (22%), 557 (6%), and 482 (5%) patients, respectively. Among 661 patients with biopsy-confirmed cirrhosis, only 356 (54%) had an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for cirrhosis. Older age, male gender, Asian race, Hispanic ethnicity, genotype 3 infection, HIV coinfection, diabetes, history of antiviral therapy, and history of alcohol abuse were independently associated with higher odds of cirrhosis (all, P0.05). Conversely, private health insurance coverage, black race, and HCV genotype 2 were associated with lower odds of cirrhosis.A high proportion of patients with biopsy-confirmed cirrhosis are not assigned ICD-9 codes for cirrhosis. Consequently, ICD-9 codes may not be reliable as the sole indicator of the prevalence of cirrhosis in cohort studies. Use of additional parameters suggests a fourfold higher prevalence of cirrhosis than is revealed by biopsy alone. These findings suggest that cirrhosis in CHC patients may be significantly underdocumented and underdiagnosed.

BACKGROUND African American (AA) women are known to have poorer breast cancer survival than whites, and the differences may be related to underlying disparities in their clinical presentation or access to care. This study evaluated the relationship between demographic, treatment, and socioeconomic factors and breast cancer survival among women in southeast Michigan. METHODS The population included 2387 women (34% AA) with American Joint Committee on Cancer stage I to III breast cancer who were treated at the Henry Ford Health System (HFHS) from 1996 through 2005. Linked data sets from the HFHS, the Metropolitan Detroit Cancer Surveillance System, and the US Census Bureau were used to obtain demographic and clinical information. Comorbidities were classified with the modified Charlson comorbidity index (CCI). Economic deprivation was categorized with a census tract–based deprivation index (DI), which was stratified into 5 quintiles of increasing socioeconomic disadvantage. RESULTS Compared with whites, AA women were significantly more likely to have larger, hormone receptor–negative tumors and more comorbidities and to reside in an economically deprived area. In an unadjusted analysis, AAs had a significantly higher risk of death (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.16-1.59); however, after adjustments for clinical (age, stage, hormone receptor, and CCI) and societal factors (DI), the effect of race was not significant (HR, 1.13 [95% CI, 0.96–1.34] , and HR, 0.97 [0.80–1.19] respectively). CONCLUSIONS Racial differences in breast cancer survival can be explained by clinical and socioeconomic factors. Nonetheless, AA women with breast cancer remain disproportionately affected by unfavorable tumor characteristics and economic deprivation, which likely contribute to their increased overall mortality. Cancer 2015;121:3668–3675. © 2015 American Cancer Society.

BACKGROUND Adjuvant chemotherapy for early stage breast cancer decreases recurrence and increases survival. However, early discontinuation of chemotherapy occurs frequently and has a negative influence on patient outcomes. METHODS The Breast Cancer Quality of Care Study (BQUAL) is a prospective cohort study designed to investigate factors associated with early discontinuation of adjuvant chemotherapy among women diagnosed with non-metastatic breast cancer at three sites in the U.S between 2006 and 2010 (Columbia University Medical Center, Kaiser-Permanente of Northern California, Henry Ford Health System). Chemotherapy regimens were classified based on NCCN guidelines. Regimens were further categorized as standard and non-standard/experimental. Early discontinuation for standard treatments was defined as missing 20% of the recommended number of treatments for the prescribed regimen. We used multivariate analysis to examine the association between early discontinuation and sociodemographic factors, tumor characteristics, and baseline psychosocial factors. RESULTS Of 1157 women recruited, 478 patients initiated chemotherapy; 35 women received non-standard/experimental chemotherapy and an additional 17 did not complete all interviews and were excluded from the analysis. Of the remaining 426 patients, 59 (13.9%) did not complete the full course of prescribed chemotherapy. In multivariate analysis, compared to those who completed their full prescribed course of adjuvant chemotherapy, those who discontinued were more often >50 years of age (p=0.04). Early discontinuation of chemotherapy was less likely among Asian women (OR 0.12, 95% CI 0.01-0.96), those who held positive beliefs related to the efficacy of chemotherapy (OR 0.43, 95% CI 0.22-0.81), and those who were more optimistic (OR 0.93, 95% CI 0.86-0.99). Women prescribed chemotherapy regimens that had more cycles (>5 cycles) or contained paclitaxel/docetaxel were significantly more likely (OR 7.54, 95% CI 2.68-21.20 and OR 5.02, 95% CI 1.59-15.83, respectively) to discontinue chemotherapy treatment early than regimens with 6 or less cycles. CONCLUSIONS Women prescribed longer regimens were significantly more likely not to complete the full course. Positive beliefs about the efficacy of treatment were associated with continuation of treatment. Educational interventions focused on the importance of completing therapy may increase chemotherapy adherence. Citation Format: Alfred I Neugut, Grace C Hillyer, Lawrence W Kushi, Lois Lamerato, Jinjoo Shim, Dana H Bovberg, David Nathanson, Christine B Ambrisone, Jeanne S Mandelblatt, Carol Magai, Wei Yann Tsai, Judith S Jacobson, Dawn L Hershman. Early discontinuation of adjuvant chemotherapy in women with early stage breast cancer: The BQUAL study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-11-09.

During the 2013–2014 influenza season, we analyzed data from 6004 outpatients aged ≥6 months with acute respiratory illness (ARI). Among the 2786 ARI patients at higher risk for influenza complications, 835 (30%) presented to care ≤2 days from symptom onset; among those, 126 (15%) were prescribed an antiviral medication.