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.

Age and Sex Normalization of Intestinal Permeability Measures for the Improved Assessment of Enteropathy in Infancy and Early Childhood: Results From the MAL-ED Study.

OBJECTIVES: The aim of the study was to describe changes in intestinal permeability in early childhood in diverse epidemiologic settings. METHODS: In a birth cohort study, the lactulose:mannitol (L:M) test was administered to 1980 children at 4 time points in the first 24 months of life in 8 countries. Data from the Brazil site with an incidence of diarrhea similar to that seen in the United States and no growth faltering was used as an internal study reference to derive age- and sex-specific z scores for mannitol and lactulose recoveries and the L:M ratio. RESULTS: A total of 6602 tests demonstrated mannitol recovery, lactulose recovery, and the L:M ratio were associated with country, sex, and age. There was heterogeneity in the recovery of both probes between sites with mean mannitol recovery ranging for 1.34% to 5.88%, lactulose recovery of 0.19% to 0.58%, and L:M ratios 0.10 to 0.17 in boys of 3 months of age across different sites. We observed strong sex-specific differences in both mannitol and lactulose recovery, with boys having higher recovery of both probes. Alterations in intestinal barrier function increased in most sites from 3 to 9 months of age and plateaued or diminished from 9 to 15 months of age. CONCLUSIONS: Alterations in recovery of the probes differ markedly in different epidemiologic contexts in children living in the developing world. The rate of change in the L:M-z ratio was most rapid and consistently disparate from the reference standard in the period between 6 and 9 months of age, suggesting that this is a critical period of physiologic impact of enteropathy in these populations.

Infant feeding practices in the Peruvian Amazon: implications for programs to improve feeding.

OBJECTIVE: To characterize feeding practices in a community in the Peruvian Amazon and to consider how this information could be used to strengthen programs and policies designed to improve nutrition and reduce child malnutrition in vulnerable communities. METHODS: Data from three structured questionnaires were combined to produce a comprehensive depiction of feeding in a sample of 246 infants from birth through 8 months of life in the community of Santa Clara de Nanay near Iquitos, Peru. Breastfeeding initiation practices, exclusive breastfeeding in the first 180 days of life, the introduction of solids, and complementary feeding practices from 6-8 months, were described and related to maternal, infant, and household characteristics, including food insecurity. RESULTS: The median duration of exclusive breastfeeding was 19 days. However, over the first 180 days of life, children were exclusively breastfed on 46.1% of days. Overall, 68.3% of infants received some semi-solid or solid food between 0-6 months and all had received semi-solids by the end of 8 months of age. The proportion of infants consuming a minimally acceptable (frequent and diverse) complementary diet was 2.9%, 7.9%, and 16.1% at 6, 7, and 8 months respectively. CONCLUSIONS: Although breastfeeding is nearly universal, promotion programs are needed in Santa Clara to 1) delay the introduction of plain water, other non-breast milk liquids, and semi-solid foods; 2) extend the period of exclusive breastfeeding; and 3) increase food diversity and the frequency of feeding during the period of complementary feeding. These results can be used to guide programs and policies to improve nutrition and reduce child malnutrition.

An instrument for the assessment of diarrhoeal severity based on a longitudinal community-based study.

OBJECTIVE: Diarrhoea is a significant contributer to morbidity and is among the leading causes of death of children living in poverty. As such, the incidence, duration and severity of diarrhoeal episodes in the household are often key variables of interest in a variety of community-based studies. However, there currently exists no means of defining diarrhoeal severity that are (A) specifically designed and adapted for community-based studies, (B) associated with poorer child outcomes and (C) agreed on by the majority of researchers. Clinical severity scores do exist and are used in healthcare settings, but these tend to focus on relatively moderate-to-severe dehydrating and dysenteric disease, require trained observation of the child and, given the variability of access and utilisation of healthcare, fail to sufficiently describe the spectrum of disease in the community setting. DESIGN: Longitudinal cohort study. SETTING: Santa Clara de Nanay, a rural community in the Northern Peruvian Amazon. PARTICIPANTS: 442 infants and children 0-72 months of age. MAIN OUTCOME MEASURES: Change in weight over 1-month intervals and change in length/height over 9-month intervals. RESULTS: Diarrhoeal episodes with symptoms of fever, anorexia, vomiting, greater number of liquid stools per day and greater number of total stools per day were associated with poorer weight gain compared with episodes without these symptoms. An instrument to measure the severity was constructed based on the duration of these symptoms over the course of a diarrhoeal episode. CONCLUSIONS: In order to address limitations of existing diarrhoeal severity scores in the context of community-based studies, we propose an instrument comprised of diarrhoea-associated symptoms easily measured by community health workers and based on the association of these symptoms with poorer child growth. This instrument can be used to test the impact of interventions on the burden of diarrhoeal disease.