I'd like to welcome you to the first National Children's Study (NCS) e-update. Because many of you are involved with the planning process for this large-scale effort, the study organizers felt that messages like these would help keep you informed of progress throughout the study's development. We encourage you to voice recommendations, ideas, and strategies for the NCS-a work-in-progress that will evolve with your input.
President Bush signed the federal appropriations bill for fiscal year 2003 on February 20, 2003, which allotted approximately $10 million to the NCS. This amount will help move the study another step closer to implementation.
Study organizers are currently working to update the NCS timeline to reflect the fiscal year 2003 federal budget. We hope to share the updated timeline with you in June. Meanwhile, we appreciate your feedback on topics related to the NCS, or on this e-update. You can use the link below to contact the study.
Thank you for your important participation in this landmark study.
Duane Alexander, M.D.
Director, National Institute of Child Health
and Human Development (NICHD)
National Institutes of Health
U.S. Department of Health and Human Services
NCS Plenary Session on Study Hypotheses, December 17, 2002
At December's Study Assembly Plenary Session, attendees learned about the progress of structuring the hypotheses that will be examined by the NCS.
The purpose of establishing core hypotheses is to build a framework for the study design to create the study protocol. The protocol will determine the sampling strategies, the frequency of follow-up activities, and the collection of data. The study framework will also help to prioritize recommended pilot studies and to provide a public identity for the study, which will be important for helping NCS funders understand what the study is trying to accomplish.
Based on the recommendations of the NCS Advisory Committee (NCSAC), the Interagency Coordinating Committee (ICC) reviewed the more than 50 hypotheses proposed by the Working Groups and others and grouped them into a condensed list of five broad areas or themes.
- Pregnancy outcomes
- Altered neurobehavioral development, developmental disabilities, and psychiatric outcomes
- Injury outcomes
- Asthma outcomes
- Obesity and altered physical development outcomes
Dr. Robert Michael, a member of the NCSAC, noted that even a very large study couldn't address every issue worthy of investigation; he added that there was a limit to the amount of questioning and examining with which participants could be expected to cooperate. He explained that priorities would have to be set, and that the hypotheses were critical to guiding the content of the study.
The refinement of the hypotheses will be driven by feedback from the Working Groups, the NCSAC, and the rest of the Study Assembly. Evaluation guidelines for hypotheses had been developed by the Study Design Working Group and were adopted by the NCSAC.
Presenters at the Session emphasized the importance of receiving feedback on the more than 50 proposed hypotheses in a timely manner.
"The NCS is a large, complex, and challenging effort," said Dr. Peter Scheidt, director of the NCS program office. "The planning process involves many individuals. Interaction among them is critical to the success of the NCS."
Dr. Duane Alexander, director of the NICHD, noted the hard work and input from the hundreds of members of the Working Groups and the NCSAC. "I am very pleased with the progress of the NCS," he said. He also emphasized the need to move ahead with refining and defining the core hypotheses.
It was also noted that, although the NCS received federal funding to support planning for fiscal year 2003, the lead agencies hope for augmented funding for fiscal year 2004, to complete pilot work and to move forward with NCS activities.
Mark Your Calendars for the Next NCSAC Meeting
Dates and Times
Thursday, March 6, 2003, 8:00 a.m. to 5:00 p.m.
Friday, March 7, 2003, 8:00 a.m. to 3:00 p.m.
6100 Executive Boulevard
5th Floor Conference Room
Rockville, MD 20892
R.S.V.P. to (Space is Limited)
Primary objectives for this meeting are to discuss: the ICC primary outcome and core hypotheses; recruitment prior to conception; life-course timeline and study architecture; thematic areas for study focus; and prioritization of pilot studies. Ethical and community outreach issues will also be reviewed.
Comments or Questions?
Visit our Web site at http://nationalchildrensstudy.gov