An ambitious new government study to follow the health of 100,000 U.S. children from before birth to age 21 is launching in January, and information technology for data collection and analysis is playing a central role.
The National Institutes of Health National Children's Study, which was authorized by Congress in the Children's Health Act of 2000, will examine the effects of genes and environmental factors on the health of American children based on volunteer participants in 105 locations, representing a composite of the U.S. population.
The study involves collecting genetic, biological, and environmental samples from children from across all racial groups, income and educational levels, and geographies, including rural, suburban, and urban areas. The goal of the project is to improve the health and well being of American children.
The study kicks off in January with a pilot project enrolling 1,250 infants from Queens, N.Y., and Duplin County, N.C. Then, during the next five years, approximately 1,000 babies from 105 locations in the United States will be enrolled in the study, including the recruitment of pregnant and not-yet-pregnant women. The study will investigate factors influencing the development of a range of conditions, such as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma, cancer, violent behavior, and obesity.
Central to the study is the collection of data about the patients, including information prior to conception, from the deliveries of the babies, and all the way up to young adulthood, said Sarah Keim, deputy director for operations and logistics for the National Children's Study in an interview with InformationWeek. Findings of the study will be released for publication in medical and clinical journals along the way, said Keim.
"We know that not all [children] will stick with the study, so we're recruiting more women than initially needed. The goal is to follow these children up to age 21," she said.
While the study received $110.9 million in federal funding in fiscal 2008, and $69 million in fiscal 2007, it's still uncertain how much funding the project will get next year, Keim said. Approximately 10% to 11% of the study's fiscal 2008 budget was allocated toward developing an information management system for the project, "which includes a combination of commercial off-the-shelf, government off-the-shelf, and custom code for best-of-breed solutions," said Keim.
"A major challenge is to provide an IT architecture that supports 105 study locations with additional field sites at each location that is FISMA-compliant and still reasonable easy to use," she said. FISMA, or the Federal Information Security Management Act, is federal security methodologies and guidelines, and is part of the E-Government Act of 2002.
"We use a .Net and a VPN communication with defense in depth to meet FISMA," she added. "The applications use best-of-breed modules from Westat, our coordinating center, and commercial off the shelf from a variety of vendors that are integrated by Booz Allen Hamilton, our IMS integrator," Keim said.
An inventory management system based on commercial off-the-shelf software from eCity will be used to track supplies and equipment used in the study, she said.