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Women of reproductive age (WRA) are at increased risk for anemia and iron deficiency. However, there is limited population-level data in India, which could help inform evidence-based recommendations and policy.To conduct a population-based biomarker survey of anemia, iron deficiency, and inflammation in WRA in Southern India.Participants were WRA (15-40 y) who were not pregnant or lactating. Blood samples (n = 979) were collected and analyzed for hemoglobin (Hb), serum ferritin (SF), soluble transferrin receptor (sTfR), C-reactive protein (CRP), and alpha-1 acid glycoprotein (AGP). Anemia and severe anemia were defined as Hb 12.0 and 8.0 g/dL. Serum ferritin was adjusted for inflammation using BRINDA methods. Iron deficiency was defined as SF 15.0 μg/L, iron insufficiency was defined as SF 20.0 and 25.0 μg/L, and iron deficiency anemia was defined as Hb 12.0 g/dL and SF 15.0 μg/L. Inflammation was defined as CRP5.0 mg/L or AGP1.0 g/L. Restricted cubic spline regression models were also used to determine if alternative SF thresholds should be used t to classify iron deficiency.A total of 41.5% of WRA had anemia, and 3.0% had severe anemia. Findings from spline analyses suggested a SF cut-off of15.0 μg/L, consistent with conventional cut-offs for iron deficiency. 46.3% of WRA had SF 15.0 μg/L (BRINDA-adjusted: 61.5%), 55.0% had SF 20.0 μg/L (72.7%), 61.8% had SF 25.0 μg/L (81.0%), and 30.0% had IDA (34.5%). 17.3% of WRA had CRP5.0 mg/L and 22.2% had AGP1.0 g/L. The prevalence of ID (rural vs. urban: 49.1% vs. 34.9%; p = 0.0004), iron insufficiency (57.8% vs. 43.8%; p = 0.0005), and IDA (31.8% vs. 22.4%; p = 0.01) were significantly higher in rural areas, although CRP levels were lower and there were no differences in elevated CRP or AGP.The burden of anemia and iron deficiency in this population was substantial, and increased after adjusting for inflammation, suggesting potential to benefit from screening and interventions.NCT04048330.

As of November 14, 2022, monkeypox (mpox) cases had been reported from more than 110 countries, including 29,133 cases in the United States.* Among U.S. cases to date, 95% have occurred among males (1). After the first confirmed U.S. mpox case on May 17, 2022, limited supplies of JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) were made available to jurisdictions for persons exposed to mpox. JYNNEOS vaccine was approved by the Food and Drug Administration (FDA) in 2019 as a 2-dose series (0.5 mL per dose, administered subcutaneously) to prevent smallpox and mpox disease.

As of October 28, 2022, a total of 28,244* monkeypox (mpox) cases have been reported in the United States during an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), administered subcutaneously as a 2-dose (0.5 mL per dose) series (with doses administered 4 weeks apart), was approved by the Food and Drug Administration (FDA) in 2019 to prevent smallpox and mpox disease (2); an FDA Emergency Use Authorization issued on August 9, 2022, authorized intradermal administration of 0.1 mL per dose, increasing the number of persons who could be vaccinated with the available vaccine supply

Human monkeypox is caused by Monkeypox virus (MPXV), an Orthopoxvirus, previously rare in the United States (1). The first U.S. case of monkeypox during the current outbreak was identified on May 17, 2022 (2). As of September 28, 2022, a total of 25,341 monkeypox cases have been reported in the United States.* The outbreak has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) (3). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), administered subcutaneously as a 2-dose (0.5 mL per dose) series with doses administered 4 weeks apart, was approved by the Food and Drug Administration (FDA) in 2019 to prevent smallpox and monkeypox infection (4). U.S. distribution of JYNNEOS vaccine as postexposure prophylaxis (PEP) for persons with known exposures to MPXV began in May 2022. A U.S. national vaccination strategy

Anemia is an important public health problem, and accurate estimates may inform policy and programs. Although hemoglobin assessment of venous blood via automated hematology analyzers (AHA) is recommended, most population-based surveys are based on analysis of capillary blood via portable hemoglobinometers to estimate anemia prevalence.To evaluate screening methods for hemoglobin and anemia assessment using paired venous samples.Participants were women of reproductive age (15-40y) who were not pregnant or lactating. Paired venous whole blood samples (n = 896) were analyzed for hemoglobin (Hb) via portable hemoglobinometer (HemoCue 301) and Coulter Counter AHA. Anemia and severe anemia were defined as Hb12.0 and8.0 g/dL, respectively. Bland-Altman methods were used to assess level of agreement for Hb results (mean difference, standard deviation of differences, limits of agreement). Diagnostic accuracy parameters (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) were calculated to evaluate HemoCue performance compared to the AHA reference, overall and by sociodemographic, nutritional, and metabolic characteristics.The estimated anemia prevalence was significantly lower via HemoCue vs. AHA (36.3% vs. 41.6%; p-value0.0001). The HemoCue had 84.4% accuracy for anemia screening and 98.8% for severe anemia, compared to the AHA reference. The HemoCue had 74.8% sensitivity and 91.2% specificity, compared to AHA. HemoCue sensitivity was higher in WRA with iron deficiency (SF15.0 μg/L 81.6% vs. SF ≥15.0 μg/L: 41.3%), and lower in WRA with metabolic risk factors, including overweight (BMI≥25.0 kg/m2; 63.9% vs. 78.8%), or elevated CRP (CRP1.0 mg/L: 67.2% vs. ≤1.0 mg/L: 82.9%), trunk fat (TF35%: 62.7% vs. ≤35%: 80.1), or whole-body fat (WBF35%: 63.9% vs. ≤35%: 80.3%).Findings suggest that women with anemia may be incorrectly identified as not anemic via portable hemoglobinometer, and the anemia prevalence may be underestimated at the population level. Registration number: NCT04048330.

BACKGROUND: Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects (NTDs) and other pregnancy complications. Vitamin B(12) deficiency is a risk factor for NTDs and may modify folate biomarkers that predict NTD risk at the population level. There is an interest in mandatory fortification with vitamin B(12) and folic acid for anemia and birth defect prevention. However, there are limited population-representative data needed to inform policy and guidelines. OBJECTIVES: This randomized trial will be conducted to evaluate the efficacy of quadruple-fortified salt (QFS; iron, iodine, folic acid, vitamin B(12)) in 1,000 households in Southern India. METHODS: Women 18 to 49 y who are not pregnant or lactating and reside within the catchment area of our community-based research site in Southern India will be screened and invited to participate in the trial. After informed consent, women and their households will be randomized to receive one of the following 4 interventions: 1) double-fortified salt (DFS; iron, iodine), 2) DFS + folic acid (iron, iodine, folic acid), 3) DFS + vitamin B(12) (iron, iodine, vitamin B(12)), or 4) DFS + folic acid and vitamin B(12) (QFS; iron, iodine, folic acid, vitamin B(12)) for 12 mo. Structured interviews will be conducted by trained nurse enumerators to collect sociodemographic, anthropometric, dietary, health, and reproductive history data. Biological samples will be collected at baseline, midpoint, and endpoint. Whole blood will be analyzed for hemoglobin using Coulter Counter. Total vitamin B(12) will be measured by chemiluminescence; red blood cell folate and serum folate will be evaluated using the World Health Organization-recommended microbiologic assay. CONCLUSIONS: The results of this randomized trial will help to evaluate the efficacy of QFS to prevent anemia and micronutrient deficiencies. Clinical trial registration numbers: NCT03853304 and Clinical Trial Registry of India REF/2019/03/024479. REGISTRATION NUMBER: NCT03853304 and REF/2019/03/024479.

This analysis was conducted to evaluate the evidence of the efficacy of iron biofortification interventions on iron status and functional outcomes. Iron deficiency is a major public health problem worldwide, with a disproportionate impact on women and young children, particularly those living in resource-limited settings. Biofortification, or the enhancing of micronutrient content in staple crops, is a promising and sustainable agriculture-based approach to improve nutritional status. Previous randomised efficacy trials and meta-analyses have demonstrated that iron-biofortification interventions improved iron biomarkers; however, no systematic reviews to date have examined the efficacy of biofortification interventions on health outcomes. We conducted a systematic review of the efficacy of iron-biofortified staple crops on iron status and functional outcomes: cognitive function (e.g. attention, memory) and physical performance. Five studies from three randomised efficacy trials (i.e. rice, pearl millet, beans) conducted in the Philippines, India and Rwanda were identified for inclusion in this review. Iron status (Hb, serum ferritin, soluble transferrin receptor, total body iron, α-1-acid glycoprotein) was measured at baseline and endline in each trial; two studies reported cognitive outcomes, and no studies reported other functional outcomes. Meta-analyses were conducted using DerSimonian and Laird random-effects methods. Iron-biofortified crop interventions significantly improved cognitive performance in attention and memory domains, compared with conventional crops. There were no significant effects on categorical outcomes such as iron deficiency or anaemia. Further studies are needed to determine the efficacy of iron-biofortified staple crops on human health, including additional functional outcomes and other high-risk populations.

OBJECTIVES: To estimate the serum folate insufficiency threshold (sf-IT) corresponding to the red blood cell (RBC) folate insufficiency threshold for optimal neural tube defect (NTD) prevention. METHODS: Participants were 977 women of reproductive age (WRA; 15–40y; not pregnant or lactating) from a population-based biomarker survey in Southern India. Venous blood samples were collected at enrollment. Plasma, serum, and red blood cells were centrifuged, processed, and stored < -80°C until batch analysis. Total vitamin B12 concentrations were measured via chemiluminescence; RBC and serum folate concentrations were measured using the World Health Organization-recommended microbiological assay. Vitamin B12 deficiency was defined as total vitamin B12

Background Women of reproductive age (WRA) are a high-risk population for anemia and micronutrient deficiencies. However, there are few representative population-level data from India, which could help inform evidence-based recommendations and policy. Objective To conduct a population-based biomarker survey of anemia and vitamin B-12 and folate status in WRA as part of a periconceptional surveillance program in southern India. Methods Participants were WRA (15–40 y) who were not pregnant or lactating. Whole blood (n = 979) was analyzed for hemoglobin via a Coulter counter (Coulter HMX). Plasma, serum, and RBCs were processed and stored at −80°C or less until batch analysis. Vitamin B-12 concentrations were measured via chemiluminescence; RBC and serum folate concentrations were evaluated via microbiological assay. Anemia and severe anemia were defined as hemoglobin

BackgroundVitamin B12deficiency during pregnancy has been associated with adverse maternal and infant health outcomes. Few prospective studies have investigated vitamin B12status early in pregnancy, and its links to infant vitamin B12status, particularly in India where the burden of vitamin B12deficiency is estimated to be the highest globally. The objective of this study was to examine the associations of maternal vitamin B12biomarkers with neonatal vitamin B12status.MethodsPregnant women (~12 weeks’ gestation) were enrolled in a perinatal cohort study in Bangalore, India. Total vitamin B12, methylmalonic acid (MMA), and homocysteine concentrations were evaluated in maternal samples at enrollment and in neonates at birth using cord blood. Linear and binomial regression models were used to evaluate the associations of maternal vitamin B12biomarkers with neonatal vitamin B12status and perinatal outcomes.ResultsA total of 63.2% of women had vitamin B12deficiency (12insufficiency (12status (vitamin B120.26μmol/L) at enrollment; 40.8% of neonates had vitamin B12deficiency, 65.6% were insufficiency, and 38.1% had impaired vitamin B12status at birth. Higher maternal vitamin B12concentrations at enrollment were associated with increased neonatal vitamin B12concentrations (β(SE): 0.40 (0.05); p12deficiency (Risk Ratio [RR]: 0.53; 95% CI: [0.43, 0.65]; p12deficiency (RR: 1.97 [1.43, 2.71]; p12status (RR: 1.49 [1.13, 1.97]; p = 0.005) predicted a two-fold increase in the risk of neonatal vitamin B12deficiency at birth.ConclusionsThe prevalence of vitamin B12deficiency was high early in pregnancy and predicted neonatal vitamin B12status. Future research is needed to determine the role of vitamin B12in the development of pregnancy and infant outcomes, and to inform screening and interventions to improve maternal and child health.

OBJECTIVES: To examine the burden of anemia and micronutrient deficiencies among young children living in urban slums of Mumbai, India. METHODS: Participants were children 10–18 months of age (n = 278) residing in urban slums in Mumbai who were screened as part of a randomized feeding trial of biofortified pearl millet. Venous blood was collected by a pediatric phlebotomist and hemoglobin (Hb) concentrations were assessed via Coulter counter. Samples were processed and stored 5.0 mg/L. Iron deficiency anemia was defined as Hb 5.0 mg/L. The prevalence of vitamin B(12) deficiency was 17.0%, 41.8% of children had vitamin B(12) insufficiency, and 19.9% had folate deficiency. Among anemic children, 84.5% had ≥1 micronutrient deficiency and 22.7% had ≥ 2 micronutrient deficiencies. Iron deficiency (RR: 2.15; 95% CI: 1.55, 2.99; P

BACKGROUND When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador. OBJECTIVE This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. METHODS We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. RESULTS ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection). CONCLUSIONS ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

It is unclear whether cancer and its treatments increase the risk of adverse pregnancy outcomes. Our aim was to examine whether cancer survivors have higher risks of poor outcomes in pregnancies conceived after diagnosis than women without cancer, and whether these risks differ by cancer type and race. Diagnoses from cancer registries were linked to pregnancy outcomes from birth certificates in three U.S. states. Analyses were limited to the first, live singleton birth conceived after diagnosis. Births to women without a previous cancer diagnosis in the registry were matched to cancer survivors on age at delivery, parity, race/ethnicity and education. Log-binomial regression was used to estimate risk ratios. Cervical cancer survivors had higher risks of preterm birth (Risk ratio = 2.8, 95% Confidence interval: 2.1, 3.7), as did survivors of invasive breast cancer (RR = 1.3, 95% CI: 1.1, 1.7) and leukemia (RR = 2.1, 95% CI: 1.3, 3.5). We observed a higher risk of small for gestational age (SGA) infants (

OBJECTIVES: To conduct a biomarker survey to examine the anemia burden and vitamin B(12) and folate status in women of reproductive age as part of an ongoing periconceptional surveillance program in Southern India. METHODS: Participants were women of reproductive age (15–40 y) who were not pregnant or lactating and resided in households within the 50 km(2) catchment area of our community-based research site in Southern India. Venous blood samples were collected at enrollment (n = 813), and whole blood samples were analyzed for hemoglobin using an automated Coulter counter. Plasma, serum, and red blood cells (RBC) were separated by centrifugation, processed, and stored

OBJECTIVES: To examine biomarkers of heavy metal exposure in women of reproductive age as part of an ongoing periconceptional surveillance program in Southern India. METHODS: Participants were women of reproductive age (15–40 y) who were not pregnant or lactating and resided in households within the 50 km(2) catchment area of our community-based research site. Venous blood samples were collected in metal-free blue top K2EDTA vacutainers, and urine samples were collected in acid-washed containers. Plasma and red blood cells were separated by centrifugation, processed, and stored 5.8 µg/L. A total of 31.1% of participants had detectable chromium plasma concentrations (median (IQR): 2.5 (1.0, 15.0) µg/L), with 15.7% of samples >2.1 µg/L. Concentrations of two or more heavy metals detected in plasma were found in 41.4% of participants: 7.1% lead and mercury, 18.6% lead and chromium, 10.0% mercury and chromium, and 5.7% with all three detected in plasma. No participants in this pilot sub-sample had plasma concentrations of arsenic or cadmium above the detection limit for this method (≥1.0 µg/L). CONCLUSIONS: Findings from this pilot study provide preliminary evidence of heavy metal exposure – including lead, mercury, and chromium – in women of reproductive age in this setting. Because of potential interactions between exposure to heavy metals and folate status that may impact the risk of birth defects, biomarker surveillance of heavy metals remains a critical component of this program. FUNDING SOURCES: Centers for Disease Control and Prevention. AF was supported by the National Institutes of Health #5 T32 HD087137

OBJECTIVES: To examine the burden of metabolic outcomes and associations of vitamin B(12) status with metabolic health in women of reproductive age (WRA), as part of a population-based biomarker survey in Chittoor, India. METHODS: Participants (980 WRA; 15–40y nonpregnant or lactating) were assessed for glycated hemoglobin (HbA1c; nephelometry) and serum vitamin B(12) concentrations (chemiluminescence). Anthropometric measurements and systolic (SBP) and diastolic (DBP) blood pressures were collected in triplicate. Bioelectrical impedance analysis was used to evaluate whole body (WF%) and trunk (TF%) fat among women ≤ 18y. We defined elevated HbA1c as ≤ 6.5% and ≤ 5.7-< 6.5%, and hypertension as stage 1 (SBP 130–139 or DBP 80–89 mmHg) and stage 2 (SBP ≤ 140 or DBP ≤ 90 mmHg). Vitamin B(12) was natural logarithmically transformed prior to analyses; vitamin B(12) deficiency was defined as

IntroductionWomen of reproductive age (WRA) are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in WRA as part of a periconceptional surveillance programme in Southern India.MethodsWRA (15–40 years) who are not pregnant or lactating and reside within 50 km2 of our community research site in Southern India will be screened and invited to participate in the biomarker survey at our research facility at Arogyavaram Medical Centre. After informed consent/assent, structured interviews will be conducted by trained nurse enumerators to collect sociodemographic, dietary, anthropometry, health and reproductive history data. Venous blood samples will be collected at enrolment; whole blood will be analysed for haemoglobin. Plasma, serum and red blood cells (RBCs) will be processed and stored 12 concentrations will be measured via chemiluminescence, and RBC and serum folate concentrations will be evaluated using the World Health Organisation (WHO)-recommended microbiological assay at our laboratory in Bangalore. A WHO surveillance system will also be established to determine the baseline prevalence of birth defects in this setting.Ethics and disseminationThis study has obtained clearance from the Health Ministry Screening Committee of the Indian Council of Medical Research. The study protocol was reviewed and approved by the Institutional Review Board at Cornell University and the Institutional Ethics Committees at Arogyavaram Medical Centre and St. John’s Research Institute. Findings from this biomarker survey will establish the burden of anaemia and micronutrient deficiencies in WRA and directly inform a randomised trial for anaemia and birth defects prevention in Southern India. The results of this study will be disseminated at international research conferences and as published articles in peer-reviewed journals.Trial registration numbersClinical trials registration number NCT04048330, NCT03853304 and Clinical Trials Registry of India (CTRI) registration number REF/2019/03/024479.

Background When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador. Objective This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs. Methods We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage. Results ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection). Conclusions ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.

OBJECTIVES: To conduct a biomarker survey to examine the burden of anemia, iron deficiency, and inflammation in women of reproductive age in Southern India. METHODS: Participants were women of reproductive age (15–40 y; n = 980) who were not pregnant or lactating and resided in households within the 50 km,(2) catchment area of our periconceptional surveillance program in Southern India. Venous blood samples were collected at enrollment by a trained laboratory technician at our research facility. Whole blood samples were analyzed for hemoglobin (Hb) using an automated Coulter counter. Plasma, serum, and red blood cells were separated by centrifugation, processed, and stored 5.0 mg/L, AGP > 1.0 g/L). RESULTS: A total of 41.1% of women were anemic and 2.9% had severe anemia. In the biomarker analyses, 53.8% of women were iron deficient (67.2% after BRINDA adjustment) and 29.1% had iron deficiency anemia (31.2% after BRINDA adjustment). A total of 14.7% of women had elevated CRP levels (>5.0 mg/L) and 24.4% had elevated AGP (>1.0 g/L) concentrations. CONCLUSIONS: The substantial burden of anemia and iron deficiency in this study population suggest an opportunity for prevention of anemia and micronutrient deficiencies. Findings from this biomarker survey will inform the development of a randomized efficacy trial for the prevention of anemia and birth defects in Southern India. FUNDING SOURCES: This study was supported by the Centers for Disease Control and Prevention (CDC), and the University of South Carolina's Disability Research and Dissemination Center through its cooperative agreement with the Centers for Disease Control and Prevention. AF was supported by the National Institutes of Health.

Objective To compare markers of fertility and ovarian reserve between cancer survivors and cancer-free women with and without polycystic ovary syndrome (PCOS). Design Furthering Understanding of Cancer, Health, and Survivorship in Adult (FUCHSIA) Women's Study—a population-based cohort study. Setting Not applicable. Patient(s) Female cancer survivors (n = 1,090) aged 22–45 years, diagnosed between ages 20 and 35 years, and at least 2 years after diagnosis; 369 participated in a clinic visit. Three hundred seventy-four reproductive-aged women without cancer also completed a clinic visit. Intervention(s) None. Main Outcome Measure(s) Infertility, time to first pregnancy after cancer diagnosis, and measures of ovarian reserve (antimullerian hormone [AMH] and antral follicle count [AFC]). Results Seventy-eight cancer survivors (7.2%) reported a PCOS diagnosis, with 41 receiving gonadotoxic treatment. Survivors with PCOS exposed to gonadotoxic treatment (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.2–4.5) and unexposed (OR 3.4, 95% CI 1.7–6.9) were more likely to report infertility than unexposed survivors without PCOS and were more likely to have fewer children than desired (exposed: OR 2.1, 95% CI 1.0–4.2; unexposed: OR 3.0, 95% CI 1.4–6.8). After adjusting for age, comparison women with PCOS had the highest markers of ovarian reserve (AMH: 2.43 ng/mL, 95% CI 1.22–4.82 ng/mL; AFC: 20.7, 95% CI 15.3–27.8), and cancer survivors without PCOS treated with gonadotoxic agents had the lowest levels (AMH: 0.19 ng/mL, 95% CI 0.14–0.26 ng/mL; AFC: 7.4, 95% CI 6.4–8.5). Conclusion(s) Despite having higher AMH and AFC on average after cancer treatment, cancer survivors with PCOS were less likely to meet their reproductive goals compared with survivors without PCOS.

In a 1989 paper, Marchbanks et al. (Am J Epidemiol. 1989;130(2):259-267) noted inconsistent definitions of infertility across research and clinical practice and examined differences in prevalence estimates across definitions. Since their study, there have been substantial changes in society, technology, and clinical practice related to female reproductive health. In response, we revisited the original paper using data from a recent study among reproductive-aged women. Internal comparisons across various definitions of infertility were made by assessing how many and which women were classified as infertile, their age at infertility, and the probability of spontaneous pregnancy after infertility. Results were also compared with Marchbanks et al. Black women were more likely to be classified as infertile than white women based on the definition "12 months of unprotected intercourse" (40.1% vs. 33.7%) but less likely by "12 months of attempting pregnancy" (14.3% vs. 21.8%) and "visiting a doctor for help getting pregnant" (8.4% vs. 19.7%). After unprotected intercourse for 12 months, 36.1% of women who were attempting pregnancy spontaneously conceived by 6 months compared with 13.5% of women who were not attempting pregnancy. While our results for most infertility definitions were similar to those of Marchbanks et al., prevalence estimates continued to differ across demographic groups by definition.

OBJECTIVES: To characterize the reproductive history and pregnancy outcomes in women of reproductive age as part of an ongoing periconceptional surveillance program in Southern India. METHODS: Participants were women of reproductive age (15-40 y) who were not pregnant or lactating and resided in households within the 50 km(2) catchment area of our community-based research site in Southern India (n = 813). After obtaining informed consent/assent, reproductive and obstetric histories were captured by a trained OB/GYN nurse via an electronic interviewer-administered questionnaire with the study participants. RESULTS: In this population, most participants reported being married (76.1%) and having some formal education (83.7%), with a median age of 30 (interquartile range [IQR] 24, 36) years. The average age of menarche reported was 13.0 (IQR 12.0, 14.0) years, and the median age at first pregnancy was 19.0 (IQR 17.0, 21.0) years. A total of 76.6% of women reported at least one previous pregnancy; 7.9% were primiparous and 65.7% were multiparous, with a median of 2.0 (IQR 2.0, 2.0) children currently living per woman. Approximately 80% of women reported taking any iron (80.4%) or folic acid (77.9%) supplements at any point during pregnancy. To date, women reported a total of 1,614 previous pregnancies with 1,318 live births (n = 1,308 singleton live births, n = 5 sets of twins), 169 spontaneous abortions, 94 induced abortions, and 42 stillbirths. Fifteen pregnancies were reported to have been affected by birth defects (n = 1 cleft lip, n = 2 cleft palate with cleft lip, n = 2 talipes equinovarus/clubfoot, n = 3 spina bifida, n = 3 encephalocele, n = 1 anencephaly, and n = 3 other birth defects). A total of 48 women reported a biological relative with a birth defect diagnosed at birth. CONCLUSIONS: A substantial burden of birth defects was reported in this population (7 neural tube defects in 1,614 pregnancies). Findings from this survey will inform the establishment of an ongoing birth defects surveillance system and a randomized efficacy trial for prevention of anemia and birth defects in Southern India. FUNDING SOURCES: Centers for Disease Control and Prevention. AF was supported by the National Institutes of Health #5 T32 HD087137

Vitamin B12 deficiency has been associated with increased risk of adverse pregnancy outcomes. Few prospective studies have investigated the burden or determinants of vitamin B12 deficiency early in life, particularly among pregnant adolescents and their children. The objectives of this study were to determine the prevalence of vitamin B12 deficiency and to examine associations between maternal and neonatal vitamin B12 status in a cohort study of healthy pregnant adolescents. Serum vitamin B12 and folate concentrations were measured in adolescents at mid-gestation (n = 124, 26.4 &plusmn, 3.5 weeks) and delivery (n = 131, 40.0 &plusmn, 1.3 weeks), and in neonates at birth using cord blood. Linear regression was used to examine associations between maternal and neonatal vitamin B12 status. Although the prevalence of vitamin B12 deficiency (&lt, 148.0 pmol/L, 1.6%) in adolescents was low during pregnancy, 22.6% of adolescents were vitamin B12 insufficient (&lt, 221.0 pmol/L, 22.6%) at mid-gestation. Maternal vitamin B12 concentrations significantly decreased from mid-gestation to delivery (p &lt, 0.0001), and 53.4% had insufficient vitamin B12 status at delivery. Maternal vitamin B12 concentrations (p &lt, 0.001) and vitamin B12 deficiency (p = 0.002) at delivery were significantly associated with infant vitamin B12 concentrations in multivariate analyses, adjusting for gestational age, maternal age, parity, smoking status, relationship status, prenatal supplement use, pre-pregnancy body mass index, race, and intake of vitamin B12 and folate. Maternal vitamin B12 concentrations significantly decreased during pregnancy and predicted neonatal vitamin B12 status in a cohort of healthy pregnant adolescents.

Background and Purpose— Transient ischemic attacks are a frequent diagnosis in the emergency department setting, yet expert opinion as to the proper follow-up and need for hospitalization differs widely. Recently, an effort has been made to risk-stratify patients presenting with transient ischemic attacks through scoring systems such as the ABCD and ABCD2 scales. The aim of our study was to independently validate these scores using a population-based cohort. Methods— Using the data from the Rochester Stroke and Transient Ischemic Attack Registry and resources of the Rochester Epidemiology Project, medical records of all residents of Rochester, Minn, with a diagnosis of incident transient ischemic attack from 1985 through 1994 were examined (N=284). Patients were scored on the ABCD and ABCD2 scales and new scores were created by adding hyperglycemia and a history of hypertension. The end points of stroke and death were collected previously and were verified through the Rochester Epidemiology Project data. Results— Although our study did find that scores >4 had a statistically significant predictive value for future stroke, a substantial proportion of strokes within 7 days (9 of 36 cases [25%]) occurred in patients with low or intermediate risk scores (≤4) on the ABCD2 scale. Including history of hypertension and hyperglycemia on presentation increased the sensitivity of the score to identify patients who had a stroke within 7 days. Conclusions— Reliance on the ABCD and ABCD2 scores misses some patients who will have a stroke within 7 days of a transient ischemic attack. Adding hyperglycemia and a history of hypertension to the predictive model could be useful, but the value of these additions need to be evaluated further.

248 Background: Some cancer treatments can cause sub-fertility in female cancer survivors, which has led to recommendations that all reproductive-aged cancer patients receive fertility counseling at the time of cancer diagnosis. However, little is known about how reproductive-aged cancer survivors feel about their quality of life with respect to their ability to have children. Methods: The FUCHSIA Women’s Study recruited reproductive-aged (22-45 years) female cancer survivors diagnosed with cancer between the ages of 20-35 years, who were at least 2 years post-diagnosis (median 7). All reportable malignant cancers and in situ breast cancer diagnosed from 1990 to 2009 in Georgia were eligible. Participants (n = 1,282) completed a detailed interview about their reproductive history including questions about their feelings about their ability to get pregnant and to have more children as well as their comfort with assisted reproductive technology (ART). Women were classified as premenopausal or menopausal, which included surgical and non-surgical menopause. Results: At the time of the interview, 31% of the study participants did not have a child. Overall, childless women were less likely to feel that having a biologic child was important (46%) than women who had a child (89%). However, 61% of childless, premenopausal women wanted to have a biologic child in the future, and 89% of menopausal women without children reported that they would have liked to have a child if they could. Menopausal women without children were more likely to report being comfortable with the idea of using ART to become pregnant (67% vs. 38% of menopausal women with children). A quarter of premenopausal women without children indicated that they would be dissatisfied with life if they were unable to have a child, and 10% of menopausal women without children indicated they were dissatisfied with life because they could not have children. Conclusions: In general, women without children were more likely to report a poorer quality of life with respect to their reproductive potential. However, our results suggest there is a complex relation between women’s reproductive desires and their feelings about their actual situation.

Rapid identification of microorganisms causing bloodstream infections directly from a positive blood culture would decrease the time to directed antimicrobial therapy and greatly improve patient care. Matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) mass spectrometry (MS) is a fast and reliable method for identifying microorganisms from positive culture. This study evaluates the performance of a novel filtration-based method for processing positive-blood-culture broth for immediate identification of microorganisms by MALDI-TOF with a Vitek MS research-use-only system (VMS). BacT/Alert non-charcoal-based blood culture bottles that were flagged positive by the BacT/Alert 3D system were included. An aliquot of positive-blood-culture broth was incubated with lysis buffer for 2 to 4 min at room temperature, the resulting lysate was filtered through a membrane, and harvested microorganisms were identified by VMS. Of the 259 bottles included in the study, VMS identified the organisms in 189 (73%) cultures to the species level and 51 (19.7%) gave no identification (ID), while 6 (2.3%) gave identifications that were considered incorrect. Among 131 monomicrobic isolates from positive-blood-culture bottles with one spot having a score of 99.9%, the IDs for 131 (100%) were correct to the species level. In 202 bottles where VMS was able to generate an ID, the IDs for 189 (93.6%) were correct to the species level, whereas the IDs provided for 7 isolates (3.5%) were incorrect. In conclusion, this method does not require centrifugation and produces a clean spectrum for VMS analysis in less than 15 min. This study demonstrates the effectiveness of the new lysis-filtration method for identifying microorganisms directly from positive-blood-culture bottles in a clinical setting.

Introduction: Breast cancer remains the most common cancer in women. Although treatment advances have improved the prognosis for many women, many existing therapies have significant associated toxicities. A major goal of current research is to develop targeted therapies based on characteristics of each individual's cancer. Polyploidy can provide a potential difference between cancer and normal cells that can be harnessed to selectively destroy cancer cells. We hypothesize that polyploidy is common in aggressive triple negative breast cancer. If this is the case, polyploidy could provide a target for therapy in triple negative cancers. Methods:We conducted a retrospective review of data collected by the University of Wisconsin Tumor Registry and HER2 testing by the state lab of hygiene between 2003 and 2011. Patients from the two data sets were matched by name and/or medical record number. Tumors were considered polyploid if ≥3 CEP17 signals were detected. Chi square testing and student T-tests were used to identify statistical correlations. Results: A total of 1211 were identified meeting eligibility criteria and 170 women had polyploid tumors. Of these, 72 had unknown or equivocal results for ER/PR or HER2 and were excluded from analyses. Polyploid tumors correlated with TNBC (p=0.028) and hormone receptor negative cancer (p=0.02). Subgroup analysis showed a positive correlation between HER2 positive tumors and polyploid tumors (p=0.0005). Polyploidy tumors were more likely to be either stage I or stage IV (p=0.0019). Vital status at last contact and age at diagnosis were not significantly different between the two groups (p=0.2875 and 0.7826, respectively). Discussion:We conclude that polyploid tumors cross all known subtypes of breast cancer, but are enriched among triple negative cancers. This may represent a viable group of cancers that can be targeted with specialized therapy. Table 1 Polyploid Euploid P HER2- 122 857 0.0005 Hormone- 38 164 0.02 Triple negative cancers 29 121 0.028 Stage I 80 612 0.002 Stage II 54 275 Stage III 29 99 Stage IV 4 49 Unknown stage 3 6 Mortality 33 168 0.29 Mean Age 59 58 0.78 Citation Format: Amy Fothergill, Mark Burkard. Polyploidy across breast cancer subtypes. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 1927. doi:10.1158/1538-7445.AM2013-1927