To the Study Assembly,
As the National Children's Study passes the halfway mark in its five-year planning phase, I would like to highlight a few accomplishments from the last two years.
With advice and support from the federally chartered National Children's Study Advisory Committee (NCSAC) and the 20 Working Groups of scientific experts, we have produced more than 50 candidate hypotheses, pilot studies, and a corresponding number of proposed measures. From these products, the Interagency Coordinating Committee (ICC) has proposed an initial set of core hypotheses. The ICC and NCSAC continue to review additional and modified hypotheses working along the timeline to be on track to begin the Study.
Recruiting scientific staff for the Program Office has been challenging, but we are close to bringing in two staff scientists and a behavioral or social scientist. We anticipate that the current available positions will be filled this summer, with additional staff positions to follow.
To keep the Study on track, the ICC pitched in and started work on the protocol at a retreat in May. Using a tracking database structure built specifically for the Study by the Information Resource Management Branch at the National Institute of Child Health and Human Development (NICHD), the ICC began framing the protocol by applying the proposed core hypotheses discussed at the Study Assembly meeting in December 2002. The content was based on many of the proposed measures from the Working Groups. As we refine the system over the next year, we will plan reviews and consultations with the NCSAC and Working Groups to review draft schedules of measures and provide expert input.
Finally, there is the ever-present question, "What about funding?" In spite of September 11th, a major economic downturn, and a war in the Middle East, optimism about funding remains strong. Broad support and enthusiasm for National Children's Study steadily increases as the process for future federal funding approaches, and we are reminded to continue planning Study details, pushing to keep to our timeline for first enrollment, and working toward necessary funding for the Study.
We have come a long way in a very short time. The timeline is on track, and we are optimistic that we can begin to recruit participants in 2005.
Peter C. Scheidt, MD, MPH
National Children's Study Pilot Studies Will Help Shape Best Practices
The National Children's Study currently has several pilot studies underway. The aim of these studies is to help investigators refine the overall study design and protocols, and to ensure that they identify best methods and practices for meeting the Study's complex scientific goals. The National Children's Study is conducting three different types of pilot studies to fulfill these objectives:
Workshops: Workshops provide opportunities to bring together experts from different fields to discuss issues of importance related to the Study. A recent workshop in May 2003 examined new technological approaches for measurement.
Review/White Papers: These projects review the available data relevant to issues pertaining to the National Children's Study and provide a useful tool for measuring the growth and development of the Study. A recent white paper analyzed several potential participant sampling strategies.
Research Pilots: These studies examine important study design components, including exposure monitoring strategies, community involvement, subject recruitment, and retention issues.
Pilot Study Process
The NCSAC has developed a process for receiving and reviewing pilot study proposals. Currently, Working Groups and others can submit a pilot study proposal to the National Children's Study Program Office for review. If recommended, the proposal is then sent to the NCSAC for further review.
Studies approved by the NCSAC will receive funding from the National Children's Study Program Office, which will develop a statement of work to complete the pilot study. Once fully funded and approved, the Study can proceed and results will be reported to all interested parties.
Several pilot studies currently under review intend to study a variety of issues, including:
- Examining different strategies for obtaining lead samples
- Identifying the use of primary care sites as a valid source of contact and data collection
- Criteria for defining injuries throughout the Study
According to Carole Kimmel, PhD, of the Environmental Protection Agency and NICHD, "Not only will the pilot studies help to frame the National Children's Study design, but they will also help us to address potential issues as they arise."
Recap of the NCSAC Meeting
At this month's NCSAC meeting, members reviewed issues surrounding possible sampling strategies, received an update on the status of pilot and methods development studies, and conducted their second review of hypotheses submitted by the Working Groups.
Duane Alexander, MD, NICHD director, reported on support for the National Children's Study among scientists, policymakers, and advocacy organizations.
Support for the National Children's Study
According to Dr. Alexander, there have been three briefings on the development of the National Children's Study with Elias Zerhouni, MD, Director of the National Institutes of Health (NIH), who has offered strong support for the Study. In addition, several other NIH Institutes have stressed the need for the National Children's Study and offered their support of the Study to Dr. Zerhouni.
Last month, Study staff also met with Richard Carmona, MD, MPH, U.S. Surgeon General, to present the Study goals. Dr. Carmona was strongly supportive of the National Children's Study and offered his assistance in implementing the Study.
National Children's Study staff members recently met with Congressman Patrick Kennedy, a member of the House Appropriations Committee, and staffers from Senator Hillary Clinton's office. At another recent meeting, they also briefed more than 90 congressional staff members from 30 members' offices and several advocacy groups. Friends of the NICHD, a coalition of organizations that advocate for increased funding for NICHD, has also addressed staff during recent visits to congressional offices in support of the Study.
Although planning money will be sustained, continued support for the National Children's Study is particularly important. Dr. Alexander urged NCSAC members to get the word out to scientific and advocacy communities to garner support for the National Children's Study.
"The goals of the National Children's Study can only be realized through efforts by the federal government," said Dr. Alexander. "This is the right time ? like never before ? to take advantage of the science and technology available today to study environmental effects on children. We are finally able to collect and measure the largest data ever possible. It is an opportunity to finally understand influences on children's health that are still unknown in communities, in homes, and in schools. The answers will give us the means to prevent disease and to help our children live longer and healthier lives."
New Database Provides Online Tracking of Hypotheses
NCSAC members learned that the ICC is developing an online database to guide protocol and hypothesis development. Currently, the database contains more than 2,000 entries of possible exposure and outcome measures. The database will allow searches across hypotheses by any level of measure, including timing, instrument, and technique. For example, a user could eventually search for "school readiness" or "language" to access protocols that contain these components. As new hypotheses are added, the database will facilitate the development of data collection schedules and help to merge them into a single Study protocol.
Individual committee members also reviewed more than 50 hypotheses submitted by Working Groups and outside organizations. After review by the NCSAC as a whole, several of the hypotheses were sent to the ICC for further consideration.
After lengthy discussion and consideration of its benefits and challenges, the NCSAC passed a motion to recommend a probability-based sampling approach for the Study that would allow for broad-based representation of the current population of the country's children. It was generally felt that, if feasible, for a study of this size a probability-based sampling method would come closest to realizing the National Children's Study goal of creating a life-course study to show the cumulative effects of a broad array of environmental exposures on children over time.
According to Dr. Scheidt, Program Office director, "The discussion of sampling strategies for the National Children's Study has been one of the most intensive preoccupying issues for the Study thus far."
The NCSAC will send its recommendation for a probability-based sampling strategy to the ICC for review.
Comments or Questions?
Visit our Web site at http://nationalchildrensstudy.gov
The National Children's Study is led by a
consortium of federal agency partners:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY