BACKGROUND:Treatment of gestational diabetes improves maternal and infant health, although diagnostic criteria remain unclear. METHODS:We randomly assigned women at 24 to 32 weeks' gestation in a 1:1 ratio to be evaluated for gestational diabetes with the use of lower or higher glycemic criteria for diagnosis. The lower glycemic criterion was a fasting plasma glucose level of at least 92 mg per deciliter (≥5.1 mmol per liter), a 1-hour level of at least 180 mg per deciliter (≥10.0 mmol per liter), or a 2-hour level of at least 153 mg per deciliter (≥8.5 mmol per liter). The higher glycemic criterion was a fasting plasma glucose level of at least 99 mg per deciliter (≥5.5 mmol per liter) or a 2-hour level of at least 162 mg per deciliter (≥9.0 mmol per liter). The primary outcome was the birth of an infant who was large for gestational age (defined as a birth weight above the 90th percentile according to Fenton-World Health Organization standards). Secondary outcomes were maternal and infant health. RESULTS:A total of 4061 women underwent randomization. Gestational diabetes was diagnosed in 310 of 2022 women (15.3%) in the lower-glycemic-criteria group and in 124 of 2039 women (6.1%) in the higher-glycemic-criteria group. Among 2019 infants born to women in the lower-glycemic-criteria group, 178 (8.8%) were large for gestational age, and among 2031 infants born to women in the higher-glycemic-criteria group, 181 (8.9%) were large for gestational age (adjusted relative risk, 0.98; 95% confidence interval, 0.80 to 1.19; P = 0.82). Induction of labor, use of health services, use of pharmacologic agents, and neonatal hypoglycemia were more common in the lower-glycemic-criteria group than in the higher-glycemic-criteria group. The results for the other secondary outcomes were similar in the two trial groups, and there were no substantial between-group differences in adverse events. Among the women in both groups who had glucose test results that fell between the lower and higher glycemic criteria, those who were treated for gestational diabetes (195 women), as compared with those who were not (178 women), had maternal and infant health benefits, including fewer large-for-gestational-age infants. CONCLUSIONS:The use of lower glycemic criteria for the diagnosis of gestational diabetes did not result in a lower risk of a large-for-gestational-age infant than the use of higher glycemic criteria. (Funded by the Health Research Council of New Zealand and others; GEMS Australian New Zealand Clinical Trials Registry number, ACTRN12615000290594.).

BACKGROUND:Maternal education has been shown repeatedly to be inversely associated with preterm birth. Both preterm birth and educational level of families are correlated across generations, but it is not clear if educational level of grandparents affects the risk of preterm delivery of their grandchildren, and, if so, if the association with grandmother's education is independent of mother's education. METHODS:We used New Jersey birth certificates to create a transgenerational dataset to examine the effect of grandmother's education on risk of PTB in White, Black and Hispanic grandchildren. We matched birth certificates of girls born in 1979-1983 to mothers listed on NJ birth certificates for the years 1999-2011. Thus, grandmothers were the women delivering in 1979-1983, and mothers were those born to the grandmothers who in turn delivered grandchildren in 1999-2011. We performed descriptive tabulations and multivariate logistic regression to develop risk estimates. RESULTS:Overall, maternal education was associated inversely with PTB in each of the demographic groups. There was a substantial inter-generational increase in education between grandmothers and mothers in each group, which was most striking in Hispanics After adjusting for maternal age and education, grandmother's education continued to be associated with preterm birth of her grandchildren. CONCLUSIONS:Grandmother's education was an additional, independent predictor of PTB in her grandchildren. This result supports the idea that mother's childhood and preconception socioeconomic environment, including the educational level of her childhood household affect her reproductive health.

This study aimed to compare diagnosis and treatment delays in elderly breast cancer patients with and without pre-existing mental illness.

In an effort to explain racial disparities in breast cancer survival, this study aimed to investigate how comorbidity affects breast cancer-specific mortality by race.

Background: The incidence of myocardial infarction (MI) has been decreasing for several decades. However, scant data are available on whether this decline has been magnified, diminished, or remained stable over the recent 15 year period. Methods: Using the Myocardial Infarction Data Acquisition

Purpose Limited data are available on the survival of patients with breast cancer with preexisting mental illness, and elderly women are of special interest because they experience the highest incidence of breast cancer. Therefore, we compared all-cause and breast cancer-specific mortality for elderly patients with breast cancer with and without mental illness. Methods A retrospective cohort study was conducted by using SEER-Medicare data, including 19,028 women ≥ 68 years of age who were diagnosed with stage I to IIIa breast cancer in the United States from 2005 to 2007. Patients were classified as having severe mental illness if an International Classification of Diseases, Ninth Edition, Clinical Modification code for bipolar disorder, schizophrenia, or other psychotic disorder was recorded on at least one inpatient or two outpatient claims during the 3 years before breast cancer diagnosis. Patients were followed for up to 5 years after breast cancer diagnosis to assess survival outcomes, which were then compared with those of patients without mental illness. Results Nearly 3% of patients had preexisting severe mental illness. We observed a two-fold increase in the all-cause mortality hazard between patients with severe mental illness compared with those without mental illness after adjusting for age, income, race, ethnicity, geographic location, and marital status (adjusted hazard ratio, 2.19; 95% CI, 1.84 to 2.60). A 20% increase in breast cancer-specific mortality hazard was observed, but the association was not significant (adjusted hazard ratio, 1.20; 95% CI, 0.82 to 1.74). Patients with severe mental illness were more likely to be diagnosed with advanced breast cancer and aggressive tumor characteristics. They also had increased tobacco use and more comorbidities. Conclusion Patients with severe mental illness may need assistance with coordinating medical services.

BackgroundThe incidence rates of ischemic stroke and ST‐segment elevation myocardial infarction (STEMI) have decreased significantly in the United States since 1950. However, there is evidence of flattening of this trend or increasing rates for stroke in patients younger than 50 years. The objective of this study was to examine the changes in incidence rates of stroke and STEMI using an age‐period‐cohort model with statewide data from New Jersey. Methods and ResultsWe obtained stroke and STEMI data for the years 1995–2014 from the Myocardial Infarction Data Acquisition System, a database of hospital discharges in New Jersey. Rates by age for the time periods 1994–1999, 2000–2004, 2005–2009, and 2010–2014 were obtained using census estimates as denominators for each age group and period. The rate of stroke more than doubled in patients aged 35 to 39 years from 1995–1999 to 2010–2014 (rate ratio [RR], 2.47; 95% CI, 2.07–2.96 [P<0.0001]). We also found increased rates of stroke in those aged 40 to 44, 45 to 49, and 50 to 54 years. Strokes rates in those older than 55 years decreased during these time periods. Those born from 1945–1954 had lower age‐adjusted rates of stroke than those born both in the prior 20 years and in the following 20 years. STEMI rates, in contrast, decreased in all age groups and in each successive birth cohort. ConclusionsThere appears to be a significant birth cohort effect in the risk of stroke, where patients born from 1945–1954 have lower age‐adjusted rates of stroke compared with those born in earlier and later years.

PURPOSE:The purpose of this study was to evaluate associations between hormonal therapy for breast cancer and subsequent diabetes incidence. METHODS:The Surveillance, Epidemiology and End Results-Medicare linked data were used. Stage I-III breast cancer patients 65 years or older who filled at least two prescriptions for an aromatase inhibitor (AI) or tamoxifen by the end of 2008, and within 12 months of breast cancer diagnosis, were selected. Women without cancer from a 5% random sample of Medicare beneficiaries were frequency matched to patients by age group, and new onset diabetes was monitored for 24 months postbaseline in both groups of women. RESULTS:Cox-proportional hazards analysis failed to show an association between AI use and subsequent diabetes onset after adjusting for age, race, and comorbidity (hazard ratio: 0.99; 95% confidence interval: 0.84-1.18). This study also failed to show an association between tamoxifen use and diabetes onset (hazard ratio: 0.79; 95% confidence interval: 0.54-1.17). CONCLUSIONS:Study findings provide evidence that postmenopausal AI and tamoxifen users do not experience an increased risk of diabetes in the 2 years after treatment initiation. Whether these findings will hold with longer duration follow-up deserves a closer look.

To evaluate the effect of skin self-examination (SSE) on melanoma mortality, we estimated the survival for individuals performing SSE compared with those who did not. Participants were from a previously carried out case–control study, who were newly diagnosed melanoma cases in 1987–1989. A 20-year survival analysis was carried out using death (event) and other causes of death (competing). Cumulative incidence functions were evaluated using Gray’s test and proportional subdistribution hazards regression models were fitted to study the effect of SSE and other covariates on melanoma survival. Forty-five percent of patients died, with 48.4% melanoma deaths. Individuals who did not perform SSE experienced a continuous increase in the risk of melanoma death trending toward significance for nearly 20 years after diagnosis, whereas melanoma deaths in skin self-examiners plateaued before 10 years after diagnosis (P=0.32). Univariate analyses suggested a 25% lower risk of melanoma death for those who performed SSE [hazard ratio (HR)=0.75, 95% confidence interval (CI)=0.43–1.32, P=0.32]. After adjusting for competing risks, the multivariate risk estimate was above one (HR=1.12, 95% CI=0.61–2.06, P=0.71). Skin awareness (HR=0.46, 95% CI=0.28–0.75, P≤0.01) was associated independently with a decreased risk of melanoma death. Although we did not find a significant association between melanoma mortality and SSE when adjusting for competing mortality and other covariates, we extended previous findings that increased skin awareness and tumor thickness are strongly inversely related to survival. Research is needed to continue developing best practices for melanoma screening and to further explore the components of SSE and long-term melanoma survival.

BACKGROUNDDelays in diagnosis and treatment for breast cancer may contribute to excess deaths among African Americans. We examined racial differences in delays in diagnosis and surgical treatment for early-stage breast cancer and evaluated race-specific predictors associated with delay.METHODSA retrospective cohort study was conducted among 634 African American and white women diagnosed with invasive breast cancer between 2005 and 2010 in New Jersey. Detailed medical-chart abstraction and patient interviews were undertaken. Time intervals were calculated from symptom recognition to diagnosis (diagnosis delay) and from diagnosis to first operation (surgical delay). Binomial regression models were used to examine racial differences in delay and factors associated with ≥2 months delay in the overall population and stratified by race. Reasons responsible for diagnosis delay were also examined by race.RESULTSCompared to white women, African American women experienced significantly higher risk of ≥2 months delay in diagnosis and surgical treatment (adjusted relative risks=1.44 (1.12-1.86) and 3.08 (1.88-5.04), respectively). For the African Americans, predictors of diagnosis delay included mode of detection, insurance, and tumor size; for whites, mode of detection and tumor grade. Surgical delay was associated with operation type and education among African Americans but with operation type and tumor size for whites. Patient-related factors were commonly noted as reasons for diagnosis delay.CONCLUSIONSThese findings emphasize the need to raise further awareness, especially among African American patients and their providers, of the importance of prompt evaluation and treatment of breast abnormalities. Research on effective ways to accomplish this is needed.

Abstract Objective Hurricane Sandy, one of the most destructive natural disasters in New Jersey history, made landfall on October 29, 2012. Prolonged loss of electrical power and extensive infrastructure damage restricted access for many to food and water. We examined the rate of dehydration in New Jersey residents after Hurricane Sandy. Methods We obtained data from 2008 to 2012 from the Myocardial Infarction Data Acquisition System (MIDAS), a repository of in-patient records from nonfederal New Jersey hospitals (N=517,355). Patients with dehydration had ICD-9-CM discharge diagnosis codes for dehydration, volume depletion, and/or hypovolemia. We used log-linear modeling to estimate the change in in-patient hospitalizations for dehydration comparing 2 weeks after Sandy with the same period in the previous 4 years (2008–2011). Results In-patient hospitalizations for dehydration were 66% higher after Sandy than in 2008–2011 (rate ratio [RR]: 1.66; 95% confidence interval [CI]: 1.50, 1.84). Hospitalizations for dehydration in patients over 65 years of age increased by nearly 80% after Sandy compared with 2008–2011 (RR: 1.79; 95% CI: 1.58, 2.02). Conclusion Sandy was associated with a marked increase in hospitalizations for dehydration. Reducing the rate of dehydration following extreme weather events is an important public health concern that needs to be addressed, especially in those over 65 years of age. (Disaster Med Public Health Preparedness. 2016;10:188–192)

Introduction: African American (AA) women are less likely to receive recommended standard treatment or discontinue treatment early for their breast cancer in comparison to white women. Dose reductions and delays during breast cancer chemotherapy can negatively affect survival. The purpose of this study was to examine racial differences in chemotherapy dose modifications among early stage breast cancer patients. We also explored the role of neutropenia in explaining these differences. Methods: Patients were selected from the Breast Cancer Treatment Disparity Study that is composed of AA and white women from New Jersey who were diagnosed with stage I, II, and T3N1M0 breast cancer between 2005-2010, with no prior history of cancer, and age ≤ 85 years. Patients who received chemotherapy as part of their breast cancer treatment were included. Detailed data on chemotherapy administration was abstracted from patient medical records. Chemotherapy dose delivered was measured using relative dose intensity (RDI), defined as the amount of drug delivered per unit time expressed as a fraction of expected dose intensity of a standard regimen. The National Cancer Comprehensive Network Guidelines were used for reference (expected) values of chemotherapy dose and schedule. RDI captures modifications resulting from both delays in administration or reduction in dose and it was computed for the entire course of therapy as well as for each cycle delivered. Racial differences in the mean RDI delivered (per subject and per cycle) and risk of >15% reduction in RDI (per subject) were examined using repeated measures linear and binomial regression models, respectively. The models were adjusted for white blood cell (WBC) level during chemotherapy. Results: The study included 143 AA and 145 white patients (with a total of 2063 chemotherapy cycles). The majority of patients received adjuvant chemotherapy (white= 93.1%, AA= 91.6%) and the remaining received neoadjuvant chemotherapy (white= 6.9%, AA= 8.4%) with no differences by race. Commonly administered regimens were dose-dense doxorubicin/cyclophosphamide followed by paclitaxel every two weeks (AA= 25.2%, white= 32.4%), docetaxel/cyclophosphamide every three weeks (AA= 23.1%, white= 17.2%), doxorubicin/cyclophosphamide every three weeks (AA= 11.9%, white= 12.4%), and doxorubicin/cyclophosphamide followed by weekly paclitaxel (AA= 9.8%, white= 13.1%). Receipt of anthracycline-based regimen was similar between AAs and whites (67.1% and 69.7%, respectively), as was addition of taxanes to anthracycline-based regimen (AA= 82.3%, white= 80.2%). A higher proportion of AA patients (10.5%) did not complete the recommended number of cycles in comparison to whites (5.5%), though the difference was not statistically significant (p= 0.120). Mean RDI per subject was 94.4% for AAs and 100.0% for whites (difference= −5.62%, p= 0.005). After adjusting for WBC level during chemotherapy, the mean RDI difference was −5.29% (p= 0.009). When RDI per cycle was examined, the mean unadjusted and adjusted RDI difference between AAs and whites were −8.27% (p 15% reduction in RDI was more than twice among AAs than whites (21.7% versus 8.3%, p=0.001). The unadjusted risk of >15% reduction in RDI was 2.62 (95% CI: 1.40, 4.89) in AA women as compared to white women; and was 2.50 (95% CI: 1.33, 4.70) after adjusting for WBC level. Conclusions: We found that AA breast cancer patients were significantly more likely to receive a reduced dose of chemotherapy as compared to white patients. WBC levels during the course of chemotherapy did not explain the racial disparity in chemotherapy dose reduction. The reasons for dose reduction in AA breast cancer patients merit investigation. This abstract was also presented as Poster A91. Citation Format: Sheenu A. Chandwani, Kim M. Hirshfield, Adana A. Llanos, Elisa V. Bandera, Yong Lin, George G. Rhoads, Kitaw Demissie. Chemotherapy modification by race in early breast cancer treatment. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr PR08.

BACKGROUND:Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. METHODS:In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. FINDINGS:Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4-4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95-1·25]; p=0·21). INTERPRETATION:Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25% or cause of death. FUNDING:National Heart, Lung, and Blood Institute.

To examine the role of preoperative magnetic resonance imaging (pMRI) on time to surgery and rates of reoperation and contralateral prophylactic mastectomy (CPM) using a population-based study of New Jersey breast cancer patients.

Abstract Introduction There are a large number of randomized clinical trials comparing short-term mortality between liberal and restrictive transfusion strategies. However, transfusion is thought to have long-term consequences related to alteration of immune function. These effects have been hypothesized to increase the risk of subsequent infections and recurrence of cancer. Thus, it is possible that transfusion will increase the risk of long-term mortality by increasing the deaths due to infections and recurrent cancer. Alternatively, more liberal transfusion might reduce cardiac complications by increasing oxygen to vulnerable myocardium and reduce deaths from cardiovascular disease. We hypothesized that liberal transfusion would affect cause specific mortality and might affect all-cause mortality, depending on the predominant impact of transfusion. Methods We performed a secondary analysis of the FOCUS trial that randomly allocated patients undergoing hip fracture repair with postoperative hemoglobin concentrations below 10 g/dL within 3 days of surgery. Patients were eligible for the trial if they had underlying cardiovascular disease (coronary artery disease, congestive heart failure, stroke, peripheral vascular disease) or cardiovascular risk factors (diabetes mellitus, hypertension, hyperlipidemia, tobacco use, or renal insufficiency). We randomly allocated patients to liberal transfusion where patients received blood transfusion to maintain hemoglobin 10 g/dL or greater, or restrictive transfusion where patients received blood transfusion when hemoglobin level was less than 8 g/dL or for symptoms. Long-term mortality was determined by linking the study subjects to national death registries in US and Canada. We compared survival time between the two transfusion treatment strategies using the unadjusted log-rank test and Cox proportional hazard models. The underlying cause of death was identified by the national death registries and grouped into seven categories: cardiovascular disease, cancer, infection, stroke, dementia, pulmonary, and other. Results There were 1007 subjects randomly allocated to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The baseline clinical status was similar between the two groups; mean age of the study population was 81.6 years (range, 51 to 103). The liberal transfusion group were transfused a total of 1866 units and restrictive transfusion group 652 units. We established long-term survival for 2002 (99.3%) of the study population. The median follow-up was 3.1 years (interquartile range, 2.4 to 4.1 years) and there were 841 (42.0%) deaths. There was no difference in the long-term mortality between the liberal transfusion strategy (N=432 deaths) and restrictive transfusion strategy (N= 409 deaths); hazard ratio =1.09; 95% confidence interval 0.95 to 1.25 (Figure). The results were consistent across all subgroups including demographics and multiple co-morbidities. There was also no difference in the underlying cause of death between the transfusion strategies (p=0.99) (Table); Cardiovascular disease (liberal-32.6%, restrictive-33.5%), Cancer (liberal-12.5%, restrictive-12.0%), Infection (liberal-9.5%, restrictive 9.0%). Conclusions Liberal transfusion of 10 g/dL did not reduce or increase long-term mortality compared to restrictive transfusion strategy using an 8 g/dL threshold or symptoms in a high risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death were similar in both arms of the trial and liberal transfusion did not appear to increase risk of death from infection or cancer or reduce the risk of death from cardiovascular disease. These results do not support the hypotheses that transfusion leads to long-term immunosuppression that is severe enough to influence mortality or cause of death. Our findings suggest that clinicians should primarily consider short-term effects of transfusion when deciding whom to transfuse. Table Total N (%) LiberalN (%) Restrictive N (%) Cardiovascular Disease 278 (33.1) 141 (32.6) 137 (33.5) Cancer 103 (12.2) 54 (12.5) 49 (12.0) Infection 78 (9.3) 41 (9.5) 37 (9.0) Stroke 57 (6.8) 27 (6.3) 30 (7.3) Dementia 108 (12.8) 56 (13.0) 52 (12.7) Pulmonary 58 (6.9) 29 (6.7) 29 (7.1) Other 147 (17.5) 79 (18.3) 68 (16.6) Unknown 12 (1.4) 5 (1.2) 7 (1.7) Totals 841 432 409 Figure 1 Figure 1. Disclosures Magaziner: Ammonett : Consultancy; Sanofi: Consultancy; Regeneron: Consultancy; Novartis: Consultancy; Eli Lilly: Consultancy; American Orthopedic Association: Consultancy.

Background: To determine the extent to which the accuracy of reporting maternal and fetal clinical diagnoses and procedural coding varies between clinical utilization and perinatal services records.Methods: Information on perinatal outcomes was extracted from Kaiser Permanente Southern California (KPSC) health plan perinatal service system (PSS) and clinical utilization records.A random sample of 400 charts was selected from eligible medical records.Clinical codes were abstracted for two time periods: 1/1/2003 through 12/31/2004 (paper medical records) and 1/1/2008 through 12/31/2008 (electronic medical records [EMRs]).Abstracted clinical codes were compared with corresponding diagnosis and procedural records, both maternal and fetal.Differences in coding accuracy between time periods were assessed through comparisons of sensitivity, specificity, positive and negative predictive value.Results: The accuracy of clinical diagnoses and procedural coding varies considerably by outcome.Sensitivities were generally higher with clinical utilization than PSS records for placental abruption (97%), placenta previa (100%), preeclampsia (94%), gestational anemia (91%), PROM (83%), chorioamnionitis (97%), intrauterine growth restriction (80%), fetal distress (91%), malpresentation of the fetus (92%), incompetent cervix (73%), vaginal birth after cesarean delivery (75%), chronic hypertension (98%), and respiratory conditions (51%).Specificities and predictive values were acceptable for the majority of conditions.Conclusion: Our findings suggest that many perinatal outcomes are not reliably coded in the PSS records.Accuracy of perinatal outcome identification can be improved by supplementing PSS records with electronic diagnosis and procedural codes from clinical utilization.Completeness of collected medical and obstetrical outcomes improved slightly after implementation of the EMR system at KPSC.