Establishment of the MAL-ED Birth Cohort Study Site in Vellore, Southern India

SUPPLEMENT ARTICLE Establishment of the MAL-ED Birth Cohort Study Site in Vellore, Southern India Sushil M. John,1 Rahul J. Thomas,2 Shiny Kaki,2 Srujan L. Sharma,2 Karthikeyan Ramanujam,2 Mohan V. Raghava,3 Beena Koshy,4 Anuradha Bose,3 Anuradha Rose,3 Winsley Rose,5 Anup Ramachandran,2 A. J. Joseph,2 Sudhir Babji,2 and Gagandeep Kang2 1 Low Cost Effective Care Unit, 2Department of Gastrointestinal Sciences, 3Department of Community Health, 4Department of Developmental Pediatrics, and 5Department of Child Health, Christian Medical College, Vellore, India Keywords. birth cohort; India; malnutrition; MAL-ED. The Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED) Network is conducting a multicountry, longitudinal prospective cohort study on the etiology, risk factors, and interactions of enteric infections and malnutrition and the effects of these factors on child growth, cognitive development, and vaccine response. The 8 MAL-ED cohort sites are epidemiologically and geographically diverse and comprise low-income populations; they are located in Bangladesh, Brazil, India, Nepal, Pakistan, Peru, South Africa, and Tanzania. Correspondence: Gagandeep Kang, MD, PhD, Department of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu 632004, India (gkang@ cmcvellore.ac.in). Clinical Infectious Diseases® 2014;59(S4):S295–9 © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: . DOI: 10.1093/cid/ciu390 The strengths of longitudinal studies lie in their ability to document the natural history of outcomes over time and to elucidate temporal and possibly causal relationships among variables. Although expensive, long, and difficult, cohort studies largely overcome the problems of recall and can be used to investigate multiple exposures and determinants with a low possibility of selection bias, recall bias, and confounding [1, 2]. MATERIALS AND METHODS The 2005–2006 Indian National Family Health Survey 3 (NFHS 3), a nationally representative survey, showed that 48% of Indian children <5 years old were stunted, 43% underweight, and 20% wasted [3]. It was estimated that in India about 54% of deaths in children <5 years old were related to malnutrition, and approximately 70% of children aged 6–59 months have some level of anemia [3]. Given these alarming statistics and a large population that contributes to nearly one-fourth of all MAL-ED India Site Description • CID 2014:59 (Suppl 4) • S295 The Indian Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED) site is in Vellore, Tamil Nadu, in south India and is coordinated by the Christian Medical College, Vellore, which has many years of experience in establishing and following cohorts. India is a diverse country, and no single area can be representative with regard to many health and socioeconomic indicators. The site in Vellore is an urban semiorganized settlement or slum. In the study site, the average family size is 5.7, adults who are gainfully employed are mostly unskilled laborers, and 51% of the population uses the field as their toilet facility. Previous studies from Vellore slums have reported stunting in well over a third of children, comparable to national estimates. The infant mortality rate is 38 per 1000 live births, with deaths due mainly to perinatal and infectious causes. Rigorous staff training, monitoring, supervision and refinement of tools have been essential to maintaining the quality of the significantly large quantity of data collected. Establishing a field clinic within the site has minimized inconvenience to participants and researchers and enabled better rapport with the community and better follow-up. These factors contribute to the wealth of information that will be generated from the MAL-ED multisite cohort, which will improve our understanding of enteric infections and its interactions with malnutrition and development of young children. deaths and malnutrition in children <5 years old worldwide, the Indian cohort represents an important part of the MAL-ED study. The Christian Medical College, Vellore (CMC), is located in the southern Indian state of Tamil Nadu and has many years of experience and expertise in setting up and following cohorts for various studies, in particular the documentation of infections and morbidity and growth [4–6]. However, CMC has not participated in a multisite cohort study with standardized methods. In this article, we describe the establishment of the MAL-ED study site and its relationship to the surrounding community and discuss the need for specific approaches. MAL-ED India Cohort Study Site The MAL-ED study site is located in Vellore, a city with a population of approximately 500 000 inhabitants about 130 km from Chennai, the capital of the southern state of Tamil Nadu and the nearest large city. The climate of Tamil Nadu ranges from dry subhumid to semiarid. The state has 3 distinct seasons: advancing monsoon with the southwest monsoon from S296 • CID 2014:59 (Suppl 4) • John et al June to September; the northeast monsoon period from October to December; and the dry season from January to May. The language predominantly spoken is Tamil, and the main religion is Hinduism (89%); Muslims and Christians comprise 11% of the state’s population. The CMC is a private, not-for-profit medical school and 2600-bed referral hospital. It has 1.6 million outpatient visits and 120 000 inpatient admissions annually and also provides primary and secondary care to local residents and approximately 250 000 residents of periurban and rural service areas through a range of outreach facilities. Old Town, Salavanpet, and neighboring areas in central Vellore have an approximate population of 13 000. The CMC Low Cost Effective Care Unit provides healthcare to the 13 000 residents of this low-income urban population through field visits, clinic, and outpatient and inpatient services at a small base hospital. Because CMC personnel were aware of the basic population demographics and anticipated an appropriate recruitment and retention rate for the MAL-ED study, Old Town, Salavanpet, and neighboring areas in central Vellore were selected as the cohort sites. Figure 1. Location of the Vellore MAL-ED study site in the geographic context of Southern India. Shading represents the study areas, with the main streets indicated by black lines. Data Sources MAL-ED India Study Recruitment For study recruitment, a team of field workers identified pregnant women and new births in the area [8]. The size of the study catchment area was chosen based on the expected recruitment of approximately 10 children per month over a period of 2 years, such that every child born within the study area had the oppo (...truncated)