An Electronic Data Capture Framework (ConnEDCt) for Global and Public Health Research: Design and Implementation.

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.

Investigation of Childhood Lead Poisoning from Parental Take-Home Exposure from an Electronic Scrap Recycling Facility ­ Ohio, 2012.

Lead affects the developing nervous system of children, and no safe blood lead level (BLL) in children has been identified. Elevated BLLs in childhood are associated with hyperactivity, attention problems, conduct problems, and impairment in cognition. Young children are at higher risk for environmental lead exposure from putting their hands or contaminated objects in their mouth. Although deteriorating lead paint in pre-1979 housing is the most common source of lead exposure in children, data indicate that ≥30% of children with elevated BLLs were exposed through a source other than paint. Take-home contamination occurs when lead dust is transferred from the workplace on employees' skin, clothing, shoes, and other personal items to their car and home. Recycling of used electronics (e-scrap) is a relatively recent source of exposure to developmental neurotoxicants, including lead. In 2010, the Cincinnati Health Department and Cincinnati Children's Hospital Pediatric Environmental Health Specialty Unit (PEHSU) investigated two cases of childhood lead poisoning in a single family. In 2012, CDC's National Institute for Occupational Safety and Health (NIOSH) learned about the lead poisonings during an evaluation of the e-scrap recycling facility where the father of the two children with lead poisoning worked. This report summarizes the case investigation. Pediatricians should ask about parents' occupations and hobbies that might involve lead when evaluating elevated BLLs in children, in routine lead screening questionnaires, and in evaluating children with signs or symptoms of lead exposure.

A community-based participatory research partnership to reduce vehicle idling near public schools.

The authors implemented and assessed the effectiveness of a public health initiative aimed at reducing traffic-related air pollution exposure of the school community at four Cincinnati public schools. A partnership was fostered with academic environmental health researchers and community members. Anti-idling campaign materials were developed and education and training were provided to school bus drivers, students, parents, and school staff. Pledge drives and pre- and posteducation assessments were documented to measure the effectiveness of the program. After completing the educational component of the public health initiative, bus drivers (n = 397), community members (n = 53), and staff (n = 214) demonstrated significantly increased knowledge about the health effects of idling (p < .05). More than 30% of parents signed the pledge to reduce idling after the public health intervention. A community-driven public health initiative can be effective in both 1) enhancing community awareness about the benefits of reducing idling vehicles and 2) increasing active participation in idling reduction. The partnership initially developed has continued to develop toward a sustainable and growing process.

Conducting a statewide health examination survey: the Arkansas Cardiovascular Health Examination Survey (ARCHES).

INTRODUCTION: The Arkansas Cardiovascular Health Examination Survey is a health and nutrition examination survey designed to serve as a demonstration project for collection of data on the prevalence of chronic diseases and their risk factors at the state level. The survey was conducted from mid-2006 through early 2008. METHODS: We chose a cross-sectional representative sample of adult residents in Arkansas by using a 3-stage, cluster sample design. Trained interviewers conducted interviews and examinations in respondents' homes, collecting data on risk factors and diseases, blood pressure and anthropometric measurements, and blood and urine samples for analysis and storage. Food frequency questionnaires provided dietary and nutrient intake data. We accomplished the project using a collaborative model among several programs and partners within the state. RESULTS: A total of 4,894 eligible households were contacted by telephone. Of these, refusals accounted for 2,748, and 2,146 gave initial consent to participate, for an initial response rate of 44%. The final number of completed household visits was 1,385, resulting in a final response rate of 28.3%. CONCLUSION: The Arkansas Cardiovascular Health Examination Survey is among the first state-level health and nutrition examination surveys to be conducted in the United States. By using a collaborative model and leveraging federal funds, we engaged several partners who provided additional resources to complete the project. The survey provides the state with valuable state-level data and information for program design and delivery.

Outcomes of screening mammography performed prior to fertility treatment in women ages 40-49.

OBJECTIVE: There are currently various conflicting recommendations for breast cancer screening with mammography in women between ages 40-49. There are no specific guidelines for breast cancer screening in women of this age group prior to assisted reproductive technology (ART) for the treatment of infertility. The purpose of our study was to evaluate outcomes of screening mammography, specifically ordered for the purpose of pre-fertility treatment clearance in women aged 40-49 years old. MATERIALS AND METHODS: This was an IRB approved retrospective study of women aged 40-49 presenting for screening mammography prior to ART between January 2010 and October 2018. Clinical history, imaging, and pathology results were gathered from the electronic medical record. Descriptive statistics were performed. RESULTS: Our study cohort consisted of 118 women with a mean age of 42 years (range 40-49). Sixteen of 118 (14%) women were recalled from screening for additional diagnostic work-up. Five of the 16 (31%) were recommended for biopsy (BI-RADS 4 or 5). One of 5 biopsies yielded a malignant result (PPV 20%). Overall cancer detection rate was 0.85% or 8.5 women per 1000 women screened. The single cancer in this cohort was an ER+ PR+ HER2- invasive ductal carcinoma. CONCLUSION: Screening mammography in women 40-49 performed prior to initiation of ART may identify asymptomatic breast malignancy. In accordance with ACR and SBI guidelines to screen women of this age group, women of this age group should undergo screening mammography prior to ART.

The impact of prenatal WIC participation on infant mortality and racial disparities.

OBJECTIVES: We assessed the value of Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) services as a public health intervention seeking to improve birth outcomes and reduce racial disparities. METHODS: We compared the infant mortality rate (IMR) per 1000 live births and percentage of preterm births overall and by race for prenatal WIC versus non-WIC participants in Hamilton County, Ohio, from 2005 to 2008. RESULTS: The IMR was lower for WIC participants than for non-WIC participants (8.0 vs 10.6; P = .04). For African Americans, the IMR of WIC participants was much lower than that of non-WIC participants (9.6 vs 21.0; P < .001). For Whites, IMR and preterm birth rates were not improved by WIC participation; however, there was a higher rate of maternal smoking among Whites. The racial disparity in IMR was dramatically reduced in WIC participants (9.6 for African Americans vs 6.7 for Whites; P = .14) as compared with non-WIC participants (21.0 for African Americans vs 7.8 for Whites; P < .001). CONCLUSIONS: Prenatal WIC participation is associated with significant improvements in African American IMR. WIC participation reduces racial disparities in IMR between African Americans and Whites.

Vitamin A Requirements in Pregnancy and Lactation.

Pregnancy and lactation are critical life stages with unique nutritional requirements, including for vitamin A (VA). Current DRIs for VA were published in 2001. The objective of this review was to identify and categorize evidence related to VA requirements in pregnancy and lactation since these DRIs were formulated. We searched MEDLINE and included articles according to an analytic framework of maternal VA exposure on status and health outcomes in the mother-child dyad. Intermediate and indirect evidence supports that maternal VA intakes can impact the mother's VA status, breastmilk, and health outcomes, as well as the child's VA status and select health outcomes. Food-based approaches can lead to more sustained, sufficient VA status in mothers and children. Research needs include further study linking maternal VA intakes on maternal and child VA status, and further associations with outcomes to determine intake requirements to optimize health.

Cystatin C and creatinine in an HIV cohort: the nutrition for healthy living study.

BACKGROUND: Human immunodeficiency virus (HIV)-infected persons have an increased risk of chronic kidney disease (CKD). Serum creatinine level may underestimate the prevalence of CKD in subjects with decreased lean body mass or liver disease. Level of serum cystatin C, an alternative kidney function marker, is independent of lean body mass. STUDY DESIGN: Cross-sectional. SETTING & PARTICIPANTS: 250 HIV-infected subjects on highly active antiretroviral therapy in the Nutrition for Healthy Living (NFHL) cohort; 2,628 National Health and Nutrition Examination Survey (NHANES) 2001-2002 subjects. PREDICTORS & OUTCOMES: Comparison of serum creatinine levels in NFHL to those in NHANES subjects; comparison of CKD in NFHL subjects ascertained using serum creatinine versus cystatin C levels. MEASUREMENTS: Standardized serum creatinine, serum cystatin C, glomerular filtration rate (GFR) estimated from serum creatinine and cystatin C levels. RESULTS: Creatinine levels were lower in NFHL than NHANES subjects despite greater rates of hepatitis, diabetes, and drug use (mean difference, -0.18 mg/dL; P < 0.001 adjusted for age, sex, and race). Of NFHL subjects, only 2.4% had a creatinine-based estimated GFR less than 60 mL/min/1.73 m(2), but 15.2% had a cystatin-based estimated GFR less than 60 mL/min/1.73 m(2). LIMITATIONS: GFR was estimated rather than measured. Other factors in addition to GFR may affect creatinine and cystatin C levels. Measurements of proteinuria were not available. CONCLUSIONS: Serum creatinine levels may overestimate GFRs in HIV-infected subjects. Kidney disease prevalence may be greater than previously appreciated.

Using "socially assigned race" to probe white advantages in health status.

OBJECTIVES: We explore the relationships between socially assigned race ("How do other people usually classify you in this country?"), self-identified race/ethnicity, and excellent or very good general health status. We then take advantage of subgroups which are discordant on self-identified race/ethnicity and socially assigned race to examine whether being classified by others as White conveys an advantage in health status, even for those who do not self-identify as White. METHODS: Analyses were conducted using pooled data from the eight states that used the Reactions to Race module of the 2004 Behavioral Risk Factor Surveillance System. RESULTS: The agreement of socially assigned race with self-identified race/ethnicity varied across the racial/ethnic groups currently defined by the United States government. Included among those usually classified by others as White were 26.8% of those who self-identified as Hispanic, 47.6% of those who self-identified as American Indian, and 59.5% of those who self-identified with More than one race. Among those who self-identified as Hispanic, the age-, education-, and language-adjusted proportion reporting excellent or very good health was 8.7 percentage points higher for those socially assigned as White than for those socially assigned as Hispanic (P=.04); among those who self-identified as American Indian, that proportion was 15.4 percentage points higher for those socially assigned as White than for those socially assigned as American Indian (P=.05); and among those who self-identified with More than one race, that proportion was 23.6 percentage points higher for those socially assigned as White than for those socially assigned as Black (P<.01). On the other hand, no significant differences were found between those socially assigned as White who self-identified as White and those socially assigned as White who self-identified as Hispanic, as American Indian, or with More than one race. CONCLUSIONS: Being classified by others as White is associated with large and statistically significant advantages in health status, no matter how one self-identifies.

A Community-Academic Partnership to Reduce Lead Exposure From an Elevated Roadway Demolition, Cincinnati, Ohio, 2012.

Disseminating public health recommendations to community members is an important step in protecting the public's health. We describe a community-academic partnership comprising health-based organizations, community groups, academia, and government organizations. This partnership undertook an iterative process to develop an outreach plan, educational materials, and activities to bring lead-poisoning prevention recommendations from a health impact assessment of a roadway demolition/construction project to the residents of an affected neighborhood in Cincinnati, Ohio, in 2012. Community partners played a key role in developing outreach and prevention activities. As a result of this project, activities among members of the partnership continue.

Microalbuminuria in the US population: third National Health and Nutrition Examination Survey.

Microalbuminuria (MA) is associated with adverse health outcomes in diabetic and hypertensive adults. The prevalence and clinical significance of MA in nondiabetic populations is less clear. The purpose of this study was to generate national estimates of the prevalence of MA in the US population. Untimed urinary albumin concentrations (UACs) and creatinine concentrations were evaluated in a nationally representative sample of 22,244 participants aged 6 years and older. Persons with hematuria and menstruating or pregnant women were excluded from analysis. The percent prevalence of clinical proteinuria (UAC > or = 300 mg/L) was similar for males and females. However, the prevalence of MA (urinary albumin-creatinine ratio [ACR], 30 to 299 mg/g) was significantly lower in males (6.1%) compared with females (9.7%). MA prevalence was greater in children than young adults and increased continuously starting at 40 years of age. MA prevalence was greater in non-Hispanic blacks and Mexican Americans aged 40 to 79 years compared with similar-aged non-Hispanic whites. MA prevalence was 28.8% in persons with previously diagnosed diabetes, 16.0% in those with hypertension, and 5.1% in those without diabetes, hypertension, cardiovascular disease, or elevated serum creatinine levels. In adults aged 40+ years, after excluding persons with clinical proteinuria, albuminuria (defined as ACR > or = 30 mg/g) was independently associated with older age, non-Hispanic black and Mexican American ethnicity, diabetes, hypertension, and elevated serum creatinine concentration. MA is common, even among persons without diabetes or hypertension. Age, sex, race/ethnicity, and concomitant disease contribute to the variability of MA prevalence estimates.

Connecting at-risk inpatient asthmatics to a community-based program to reduce home environmental risks: care system redesign using quality improvement methods.

INTRODUCTION: Connecting patients admitted with asthma to community-based services could improve care and more efficiently allocate resources. We sought to develop and evaluate an intervention to mitigate in-home environmental hazards (eg, pests, mold) for such children. METHODS: This was a controlled, quality improvement study on the inpatient units of an urban, academic children's hospital. Clinicians and public health officials co-developed processes to identify children with in-home risks and refer them for assessment and remediation. Processes assessed were the rate at which those identified as eligible were offered referrals, those referred received inspections, and primary care physicians (PCPs) were notified of risks and referrals. Consecutively occurring and seasonally matched intervention (n = 30) and historical control (n = 38) subcohorts were compared with respect to postdischarge mitigating actions (eg, discussions with landlords, PCPs), remaining risks, and morbidity (symptom-free days in previous 2 weeks and Child Asthma Control Test scores). RESULTS: In the first year, the percentage of eligible children offered referrals increased to a sustained rate of ∼90%; ∼65% of referrals led to in-home inspections (n = 50); and hazards were abated in 30 homes. PCP notification increased from 50% to ∼80%. After discharge, referred parents were more likely to discuss concerns with landlords, the health department, attorneys, and PCPs than patients admitted preimplementation (all P < .05). Referred households were more likely to report reduced presence of ≥2 exposures (P < .05). No differences in asthma morbidity were observed. CONCLUSIONS: We integrated environmental hazard mitigation into inpatient care. Community-engaged care delivery that reduces risks for poor asthma outcomes can be initiated within the hospital.

Addressing the social determinants of children's health: a cliff analogy.

This paper presents a "Cliff Analogy" illustrating three dimensions of health intervention to help people who are falling off of the cliff of good health: providing health services, addressing the social determinants of health, and addressing the social determinants of equity. In the terms of the analogy, health services include an ambulance at the bottom of the cliff, a net or trampoline halfway down, and a fence at the top of the cliff. Addressing the social determinants of health involves the deliberate movement of the population away from the edge of the cliff. Addressing the social determinants of equity acknowledges that the cliff is three-dimensional and involves interventions on the structures, policies, practices, norms, and values that differentially distribute resources and risks along the cliff face. The authors affirm that we need to address both the social determinants of health, including poverty, and the social determinants of equity, including racism, if we are to improve health outcomes and eliminate health disparities.

Epidemic of end-stage renal disease in people with diabetes in the United States population: do we know the cause?

BACKGROUND: The number of individuals initiating renal replacement therapy in the United States population grew exponentially over the past two decades. Cases of end-stage renal diseae (ESRD) attributed to diabetes accounted for most of this increase. In this report we examined factors that may account for the increase to determine whether it truly represents an epidemic of ESRD due to diabetes. METHODS: We reviewed time trends in data of the United States Renal Data system, the Diabetes Surveillance Program of the Centers for Disease Control and Prevention, and diabetes literature. RESULTS: Recent growth of the number of individuals with diabetes accounted for less than 10% of the increase in the number of diabetes-related ESRD. Instead, most of it was due to a threefold increase in risk of ESRD in people with diabetes and, therefore, qualifies as an epidemic. Curiously, this epidemic occurred despite widening implementation of effective renoprotective therapies. Individuals with type 2 diabetes, regardless of gender, age, or race, experienced the greatest increase in risk. There is no evidence that diabetic patients have been surviving longer, so the increased risk was not attributable to the high risk associated with long duration diabetes. CONCLUSION: We hypothesize that an epidemic of ESRD has occurred in people with diabetes in the United States population over the last two decades. The nature of the factor responsible for the epidemic and the reasons it affects patients with type 2 diabetes particularly are unknown. Research efforts to identify the putative factor deserve high priority, as does a commitment of resources to provide care for the burgeoning number of patients with ESRD and type 2 diabetes.

Hypertension and renal dysfunction: NHANES III.

The incidence rate of end-stage renal disease has increased in many countries in the past 20 yr, including the United States and Singapore. The increase in ESRD incidence in the United States is primarily attributable to diabetes and to hypertension. In Singapore the major cause of ESRD is diabetes, however the prevalence of hypertension in the Singapore population is rising rapidly, and renal complications of hypertension may become more common in the future. Information on the association of hypertension with renal dysfunction and ESRD in the United States may be useful in predicting future trends in the incidence of ESRD due to hypertension in Singapore. This paper describes published and unpublished data presented at a conference to assist in developing plans for a comprehensive renal disease prevention program in Singapore. It compares recent data on the reported prevalence of hypertension in the United States and Singapore; and presents information on the association of hypertension with serum creatinine, urinary albumin excretion, and ESRD in the United States.

Time trends in reported prevalence of kidney stones in the United States: 1976-1994.

BACKGROUND: A body of evidence establishes that the occurrence of kidney stone disease has increased in some communities of industrialized countries. Information on recent temporal trends in the United States is lacking and population-based data on epidemiologic patterns are limited. Study objective was to determine whether kidney stone disease prevalence increased in the United States over a 20-year period and the influence of region, race/ethnicity, and gender on stone disease risk. METHODS: We measured the prevalence of kidney stone disease history from the United States National Health and Nutrition Examination Survey (II and III), population-based, cross-sectional studies, involving 15,364 adult United States residents in 1976 to 1980 and 16,115 adult United States residents in 1988 to 1994. RESULTS: Disease prevalence among 20- to 74-year-old United States residents was greater in 1988 to 1994 than in 1976 to 1980 (5.2% vs. 3.8%, P < 0.05), greater in males than females, and increased with age in each time period. Among 1988 to 1994 adults, non-Hispanic African Americans had reduced risk of disease compared to non-Hispanic Caucasians (1.7% vs. 5.9%, P < 0.05), and Mexican Americans (1.7% vs. 2.6%, P < 0.05). Also, age-adjusted prevalence was highest in the South (6.6%) and lowest in the West (3.3%). Findings were consistent across gender and multivariate adjusted odds ratios for stone disease history, including all demographic variables, as well as diuretic use, tea or coffee consumption, and dietary intake of calcium, protein, and fat did not materially change the results. CONCLUSION: Prevalence of kidney stone disease history in the United States population increased between 1980 and 1994. A history of stone disease was strongly associated with race/ethnicity and region of residence.

Predictors of loss of residual renal function among new dialysis patients.

Residual renal function (RRF) in end-stage renal disease is clinically important as it contributes to adequacy of dialysis, quality of life, and mortality. This study was conducted to determine the predictors of RRF loss in a national random sample of patients initiating hemodialysis and peritoneal dialysis. The study controlled for baseline variables and included major predictors. The end point was loss of RRF, defined as a urine volume <200 ml/24 h at approximately 1 yr of follow-up. The adjusted odds ratios (AOR) and P values associated with each of the demographic, clinical, laboratory, and treatment parameters were estimated using an "adjusted" univariate analysis. Significant variables (P < 0.05) were included in a multivariate logistic regression model. Predictors of RRF loss were female gender (AOR = 1.45; P < 0.001), non-white race (AOR = 1.57; P = <0.001), prior history of diabetes (AOR = 1.82; P = 0.006), prior history of congestive heart failure (AOR = 1.32; P = 0.03), and time to follow-up (AOR = 1.06 per month; P = 0.03). Patients treated with peritoneal dialysis had a 65% lower risk of RRF loss than those on hemodialysis (AOR = 0.35; P < 0.001). Higher serum calcium (AOR = 0.81 per mg/dl; P = 0.05), use of an angiotensin-converting enzyme inhibitor (AOR = 0.68; P < 0.001). and use of a calcium channel blocker (AOR = 0.77; P = 0.01) were independently associated with decreased risk of RRF loss. The observations of demographic groups at risk and potentially modifiable factors and therapies have generated testable hypotheses regarding therapies that may preserve RRF among end-stage renal disease patients.