Data Management in Multicountry Consortium Studies: The Enterics For Global Health (EFGH) Shigella Surveillance Study Example.

Background: Rigorous data management systems and planning are essential to successful research projects, especially for large, multicountry consortium studies involving partnerships across multiple institutions. Here we describe the development and implementation of data management systems and procedures for the Enterics For Global Health (EFGH) Shigella surveillance study-a 7-country diarrhea surveillance study that will conduct facility-based surveillance concurrent with population-based enumeration and a health care utilization survey to estimate the incidence of Shigella--associated diarrhea in children 6 to 35 months old. Methods: The goals of EFGH data management are to utilize the knowledge and experience of consortium members to collect high-quality data and ensure equity in access and decision-making. During the planning phase before study initiation, a working group of representatives from each EFGH country site, the coordination team, and other partners met regularly to develop the data management systems for the study. Results: This resulted in the Data Management Plan, which included selecting REDCap and SurveyCTO as the primary database systems. Consequently, we laid out procedures for data processing and storage, study monitoring and reporting, data quality control and assurance activities, and data access. The data management system and associated real-time visualizations allow for rapid data cleaning activities and progress monitoring and will enable quicker time to analysis. Conclusions: Experiences from this study will contribute toward enriching the sparse landscape of data management methods publications and serve as a case study for future studies seeking to collect and manage data consistently and rigorously while maintaining equitable access to and control of data.

Assessment of arsenic and polycyclic aromatic hydrocarbon (PAH) exposures on immune function among males in Bangladesh.

Arsenic and polycyclic aromatic hydrocarbons (PAH) are environmental pollutants to which people around the world are exposed through water, food and air. In mouse and in vitro studies of human cells, both of these chemicals have been shown to modulate the immune system. In some experimental studies, a synergistic disruption of immune function was observed by a combined exposure to arsenic and PAH. However, a joint effect of arsenic and PAH on immune function has not been studied in humans. We have conducted an epidemiological investigation to examine effects of chronic arsenic and PAH exposures on immune function. We assessed T-cell proliferation (TCP) and cytokine production of anti-CD3/anti-CD28 stimulated lymphocytes in human peripheral blood mononuclear cells (HPBMC) among 197 healthy men enrolled to the Health Effects of Arsenic Longitudinal (HEALS) cohort in Bangladesh. By design, approximately half were active smokers and the rest were never smokers. Our analyses demonstrated that IL-1b, IL-2, IL-4 and IL-6 were significantly stimulated as a function of urinary arsenic levels in models adjusted for age, body mass index (BMI), smoking status and PAH-DNA adducts. After correcting for false detection rate (FDR), only IL-1b remained statistically significant. We found a U-shaped dose response relationship between urinary arsenic and IL-1b. On the other hand, PAH-DNA adducts were associated with an inhibition of TCP and appeared as an inverted U-shape curve. Dose response curves were non-monotonic for PAH-DNA adduct exposures and suggested that cytokine secretion of IFNg, IL-1b, IL-2, IL-10 and IL17A followed a complex pattern. In the majority of donors, there was a trend towards a decrease in cytokine associated with PAH-DNA adducts. We did not observe any interaction between urinary arsenic and PAH-DNA adducts on immune parameters. Our results indicate that long-term exposures to arsenic and PAH have independent, non-monotonic associations with TCP and cytokine production.

The association between socioeconomic status and subclinical atherosclerosis in a rural Bangladesh population.

BACKGROUND: In Bangladesh, CVD accounts for the majority of non-communicable mortality. The purpose of this study was to determine the role of socioeconomic status (SES) on subclinical atherosclerosis measured as carotid intima-media thickness (IMT) in a rural Bangladesh population. METHODS: Carotid IMT was measured between 2010 and 2011 in 1022 participants (average age 46, 40% male) randomly selected from the Health Effects of Arsenic Longitudinal Study (HEALS), a population-based prospective cohort study based in rural Bangladesh. SES was measured as occupation type, land ownership, educational attainment, and television ownership. RESULTS: Half of the participants received formal education (53%) and under half owned land (48%) and a television (44%). Women were primarily homemakers (95%) and men worked as factory workers (24%), laborers (18%), or in business (55%). In univariate analysis, those owning greater than one acre of land (p=0.03), owning a television (p=0.02), or laborers and business owners compared to factory workers had higher levels of carotid IMT (p<0.01). In multivariate analysis after adjustment for confounders, only men employed in the business sector had elevated carotid IMT compared to factory workers. The association was strongest in older men (58.7µm, 95% CI 17.2-100.0, ≥50years old) compared to younger men (13.7µm, 95% CI -7.8-35.2, <50years old). CONCLUSION: Business sector employment was positively associated with subclinical atherosclerosis after adjustment for confounders. This finding is consistent with evidence from other developing nations suggesting that certain SES factors are independent predictors of CVD.