The National Children’s Study, the largest and longest-running study of children’s total health, kicks off next year, with Tulane University School of Public Health researchers and partners providing both essential early data and a role in recruitment and data management for the next 25 to 30 years.
Nationally, the goal is to recruit and follow 100,000 children from pre-birth through adulthood. Along the way, researchers will gather a broad spectrum of information related to their health, ranging from their mother’s health during pregnancy to environmental exposures in the home and community. Blood and urine samples will be included in the data collection, creating a massive database of information intended to shed some light on the complexity of children’s health.
This study builds upon the knowledge gained from smaller studies that have examined facets of children’s health, such as lead exposure or early heart disease risk factors.
“While there is a lot that we know from smaller, issue-specific studies, there is just a lot we don’t know,” says Associate Dean for Academic Affairs LuAnn White, professor of global environmental health sciences. White directs the Tulane Center for Applied Environmental Public Health and is principle investigator for the Tulane children’s study site. “This is a comprehensive study that follows the health of children from pre-birth and it will be a monumental amount of data that will be coordinated in many ways, environmental, behavioral, and sociological.”
White compares the study to the Nurses Health Study, which looked at the health of adult women over a long period of time. The National Children’s Study is a study without a hypothesis, she stresses. Instead, it is simply observational, seeking to gather as many datapoints as possible for analysis. For example, within a few years of the start of the study, researchers hope to have a rich source of data that can answer questions about health factors during pregnancy, birth outcomes, and early development.
“While we tend to study diseases and illnesses, very seldom do we look at health and what makes us healthy,” continues White, explaining “most of our normal values for clinical parameters of health for children were set back in the 50s on very few people. This study should help develop a gold standard for what is to be expected of healthy children in terms of those clinical values.”
As ambitious as the study is, researchers know that its success hinges on the participation of over 100,000 families in communities around the country. The first challenges for study sites – challenges that the Tulane team has embraced – seemed at first to be simple: recruit participants and protect the confidentiality of their data.
Challenges of Recruitment
Imagine a researcher coming to your door, asking about your pregnancy or plans for pregnancy, to recruit you or your wife and your unborn child for a 25-year-long study of children’s health, starting with a three-hour interview. Invasive and costly, this recruitment method (used by the first seven study centers in the NCS) raised red flags early in the study’s planning process. As a result, the first part of the study – the phase that is in process now – seeks to test a variety of recruitment methods.
In 2008, Tulane received a contract for $14.9 million to assist with the NCS. Tulane is one of 30 study sites nationwide. In 2011 the team, based in the school’s Center for Applied Environmental Health Sciences, began implementing several recruitment strategies developed between 2008 and 2010. Tulane is one of 10 study centers testing a recruitment strategy that relies on mass advertising (billboards, radio, and direct mail) and on community outreach through partners and community events such as health fairs and the weekly Freret Street Market. Twenty additional study centers are testing provider-based and door-to-door recruitment approaches.
“The buzzwords they’ve been using lately are acceptability, feasibility, and cost,” says program manager Elizabeth Langlois, MPH. Between 2008 and 2010 Langlois and Tulane researchers assisted in developing the initial study to find recruitment methods that were acceptable to the participants, feasible for all involved, and cost-effective. The communities identified using a national sampling approach vary around the country in terms of population density, ethnic makeup, and factors such as rural or urban development. But, for most, says Langlois, finding willing pregnant women is “like finding a needle in a haystack.”
Families who agree to participate at this stage will be in either a high or low level of data collection. The high level is a little more intense, explains Langlois, as women will be agreeing to the collection of biological (blood and urine) and environmental samples (such as soil and dust).
Response from the community has been wary but increasingly warm to the idea, says Langlois, who adds that the Tulane study site already includes some babies born after recruitment began in March 2011. Participants do receive a small amount of compensation for their time and their contribution of information to the study. During pregnancy and the first years of a child’s life, participants may be interviewed approximately every three months.
“We’ve had a pretty good representation of people calling into our study line,” says Langlois. “I think generally most people seem on board that this is a great idea and is something this city needs to have because we have such problems with our children.”
However, she notes, people in New Orleans also feel somewhat fatigued by the seemingly endless studies that have been done in Orleans Parish, especially since Hurricane Katrina. As a result, she says, the question of how to retain participants for the full course of the study and how to build a sense of community support for them stays at the forefront.
These issues will be addressed as the national study participants develop the final protocol, which will roll out in 2012. Those women who have enrolled already will continue to participate in the larger study.
But exactly who is participating remains a secret that Tulane researchers keep in a virtual – and literal — vault.
Floor Plans, Ceilings, and Data Management
Langlois and White both state – often – that this study has more levels of confidentiality than any other study they have worked on.
“Part of it is because of the sensitivity of pregnant women and children and it’s a national study,” says Langlois. “We’ve been building our own information management system which means we are dealing with lots of security standards defined by the federal information management security act, which governs how you keep data safe.”
The data collected at individual sites also has to be compatible with data collected elsewhere around the country, while still protecting individual health information.
“The idea is to make it a restricted public data set. People can apply to it and use the data for a variety of research projects,” explains Langlois. But since the data collection could include genetic information, some participants are concerned about how their samples will be labeled and used.
“These are not screening samples,” she emphasizes. “They are research samples and any individual’s name will be struck off it and it will go into a large database with everyone else who is in the study.”
In order to gain approval for the team’s data storage plan, Langlois and others had to provide floor plans and building details like wiring to demonstrate that not only was the virtual database secure, but its physical location was, too. A high-quality data management program has allowed Tulane to build a clinical training and research center specifically for the study, with an investment in equipment and materials that supports the level of confidentiality required by the study.
Ultimately, these early investments in identifying the most appropriate recruitment strategies and carefully planning a data management system will yield a solid foundation for the largest study of children’s health in US history.
“There’s nothing like this in the U.S.,” says Langlois. “Really the idea is just to look at what is making children healthy and for those who aren’t healthy, what could explain their poor health.”
Tulane is joined in this study, which was mandated at the congressional level with the Children’s Health Act of 2000, by several partners: Battelle Center for Public Health Research and Evaluation, Louisiana State University Health Sciences Center’s Department of Obstetrics/Gynecology, the Louisiana Public Health Institute, Women with a Vision, and the Louisiana Office of Public Health.