The National Children’s Study (the NCS or the Study) is a Congressionally mandated portfolio of activities that includes a longitudinal birth cohort study intended to examine the effects of environmental exposures on the growth, development, and well-being of children. The Study underwent several changes in the past few years evolving from an activity driven by consensus of expert opinion into a series of integrated activities that are driven by data, evidence based, and participant and community informed. The initial Study plan was reviewed by the Institute of Medicine and adjusted on the basis of reported strengths and weaknesses. Data collection began in January 2009 in a pilot phase, and by July 2009, the observed data differed from the expected data to such a degree that the pilot Study design and implementation were changed.
The initial plan for a sequential series of activation of about 100 locations across the United States into a single study became a separate pilot (or “Vanguard Study”) to study logistics and operations and a “Main Study” to examine exposure-outcome relationships. The initial recruitment approach was not resource effective with regard to time or cost, necessitating the development and testing of additional recruitment strategies. Three alternative recruitment strategies were field tested based on initial point of contact with potential participants-Direct Outreach, Household based through an NCS contractor, and Provider based through a licensed health care practitioner. The recruitment approach, using health care providers as the point of entry, was the most resource effective. Currently, the Study is testing a further refinement of the provider-based recruitment strategy using hospitals and birthing centers in addition to clinics and offices, in a sample frame adjusted from the initial sampling frame. The NCS plans to utilize data from the ongoing provider-based sample recruitment substudy as a bridging study to the proposed Main Study design.
Other changes to the Study include:
•The implementation of a collaborative improvement process for quality control, consistency, and to stimulate innovation;
•Establishment of a network to develop and validate objective, quantitative, inexpensive and rapid assessments of health across the human developmental spectrum;
•Expansion of a formative research program to address components of the Congressional mandate that cannot be adequately addressed in a longitudinal birth cohort study;
•Development, testing and implementation of modern informatics platforms that are open architecture, conform to international data standards, modular and interoperable;
•Establishment of federal security standards compliant data transmission and archive process;
•Implementation of a cooperative federated model for Institutional Review Board clearance and review;
•Development of operational toolkits to engage underrepresented populations; establishment of a national board of community advisors;
•Development of new tools to customize the sharing of information with participants;
•Development of innovative data based hybrid model for the sampling frame for the Main Study.
The Vanguard Study is also implementing a new generation of informatics platforms, continuing the consolidation of data collection activities into regional operations centers, integrating the systematic development of health measurements into the regional operations centers, and embarking on a new generation of Study visits using a core questionnaire with supplemental modules triggered by events and exposures.
The proposed Main Study design, developed through a data driven, evidence based, and participant and community informed process, systematically addresses the major comments from the 2008 Institute of Medicine review of the NCS Scientific Plan.
Please see attached PDF for more information: ncs-white-paper-october-2012