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 National Children's Study Sampling Design Workshop (June 2004)

Sources Sought for Procurements

The Web addresses that follow connect to the FedBizOpps Web site, which has the following federal business opportunities available:

National Children's Study Initial Sites/Vanguard Centers Sources Sought

National Children's Study Coordinating Center Sources Sought

Upcoming Events

Racial/Ethnic Disparities and Racism from a Developmental Perspective Workshop

Date tentative: June 21–22, 2004. Location tentative: Rockville, MD.

NCSAC Meeting

Date: June 28–29, 2004. Location: Holiday Inn Select, Old Town, Alexandria, VA.

Assessing Dietary Intakes and Patterns in Women and Young Children: Methodological Issues with Implications for the Design of the National Children's Study Workshop

Date tentative: July 2004. Location: TBD.

Body Composition Measurement for the National Children's Study Workshop

Date tentative: October 7–8, 2004. Location tentative: Washington, DC.

Identification of Measures for Health Care Processes and Outcomes in the National Children's Study Workshop

Date and Location: TBD.

Measures of Neurodevelopment and Environmental Exposures Workshop

Date and Location: TBD.

Information on these events will be posted on the National Children's Study Web site as it becomes available.

Since the February 2004 E-Update was published, the following workshops were held:

Addressing Rural Children in the National Children's Study Workshop

Date: March 2, 2004. Location: Holiday Inn Select, Bethesda, MD.

Sampling Design Workshop

Date: March 21–22, 2004. Location: Sheraton Crystal City, Arlington, VA.

Expanding Methodologies for Capturing Day-Specific Probabilities of Conception Workshop

Date: May 17–18, 2004. Location: Doubletree Hotel Rockville, Rockville, MD.

Cancer in the National Children's Study: Opportunities and Challenges Workshop

Date: May 20, 2004. Location: Holiday Inn Select, Bethesda, MD.

Measurement of Maternal and Fetal Infection and Inflammation Workshop

Date: May 20–21, 2004. Location: Embassy Suites Hotel Baltimore at BWI, Linthicum, MD.

Methods for the Assessment of Asthma-Related Health Outcomes Workshop

Date: May 27–28, 2004. Location: Rosen Centre Hotel, Orlando, FL.

Gene Environment Interaction and the Regulation of Behavior Workshop

Date: June 2–3, 2004. Location: Holiday Inn Select, Bethesda, MD.

Good To Know

Lead: Prenatal Exposure Linked to Increased Incidence of Schizophrenia

Schizophrenia is a chronic, disabling mental disorder of unknown origins characterized by distorted perceptions of reality, hallucinations, illusions, delusions, and disordered thinking. Although the prevalence rate of the disorder is 1.1 percent of the population, the direct cost of treating individuals with schizophrenia has been reported to total $19 billion. There is no known single cause of schizophrenia, however, a growing body of evidence suggests that toxins or infections may affect certain events during prenatal development and may therefore play a role in the development of the disease.

To test these claims, a team of scientists measured lead in the blood samples of women in Alameda County, California. According to an April 2004 article published in Environmental Health Perspectives Online, researchers discovered that the blood samples with high lead levels were more than twice as likely to be from mothers of children who became schizophrenic. However, based on limitations such as sample size and confounding variables, further research is needed to confirm the exact relationship between prenatal lead exposure and schizophrenia.

The National Children's Study provides the size, scope, and longitudinal design needed to enable researchers to further evaluate the relationship found between prenatal exposures such as lead and outcomes like schizophrenia. A central goal of the Study is to provide information that may establish causal associations between a variety of environmental exposures and outcomes. The National Children's Study aspires to examine all aspects of children's health and development to gather a more complete picture of the development of health and disease across the lifespan.


National Children's Study Sampling Design Workshop

The Sampling Design Workshop was held on March 21–22 with the goal of furthering the process of identifying a promising and efficient sampling design for the National Children's Study. To this end, an expert panel of nine distinguished researchers, with disciplines covering a broad range of scientific areas of importance in the Study, was asked to deliberate on issues and trade-offs involved in selecting the sampling design.

The charge set out for this panel was fourfold. They were asked to:

  • Identify an approach to making decisions about the design given the competing priorities, needs, and limitations (including feasibility and cost) for the Study;
  • Assess the background white papers prepared to inform the workshop panel of possible design options and key issues and tradeoffs related to the sampling design;
  • Identify strengths and weaknesses of selected design options in relation to National Children's Study requirements; and
  • Identify up to two sampling designs or features of these designs that require pilot testing for their feasibility, costs, or other facts prior to making final decisions on the Study sampling design.

The workshop began with presentations from selected individuals involved in the planning of the National Children's Study, and with a variety of viewpoints on the needs of the Study. The second day of the workshop consisted primarily of discussion by the expert panel and touched on a variety of topics such as: the merits and feasibility of a nationally representative probability-based sampling scheme versus other sampling designs, centralization of key study activities, the need for engaging the broader research community, the need for engaging communities, the benefits and difficulties associated with preconception recruitment, the relative merits of different design approaches, and issues that require pilot testing.

At the conclusion of the workshop, the panel summarized their deliberations to the National Children's Study Interagency Coordinating Committee and Duane Alexander, M.D., director, National Institute of Child Health and Human Development. A final report with recommendations from the panel will be published on the Study Web site. The findings of the workshop will be presented and discussed at the Advisory Committee meeting June 28–29.

NCSAC Meeting Update

The National Children's Study Advisory Committee (NCSAC) met on March 4–5 to discuss current activities and new goals as the Study shifts from planning into the implementation phase. After hearing an overview of the Study timeline and activities from Program Office Director Peter Scheidt, M.D., M.P.H., NCSAC members reviewed the status of Working Group products, including proposed hypotheses and completed or upcoming workshops.

NCSAC members discussed how best to respond to the request by the President's Council on Bioethics to include the study of assisted reproductive technology in the National Children's Study. Other meeting activities included updates on protocol development and a discussion of defining positive health as a specific outcome to be addressed.

Funding Update
Fiscal year 2005 is a key year for the National Children's Study. Implementation activities are the central focus and will require $27 million. During 2005, a range of interim goals point the Study toward beginning enrollment in fiscal year 2006. These include:

  • Selecting and setting up a handful of local National Children's Study sites across the U.S. More sites will be selected in 2006;
  • Intensive work with local community leaders to engage potential participating families;
  • Trying out the Study protocols in a "mini-National Children's Study" pilot test;
  • Focusing scientific pilot and methods development studies on key issues such as evaluating the best ways to measure aspects of neurodevelopment, trying out technologies like handheld computers for participants to record data themselves, and how to easily measure certain environmental exposures in the home;
  • Selecting a system of biological and physical sample repositories to store the millions of samples for the Study;
  • Setting up a coordinating center to help the many Study sites work in parallel and produce high-quality data;
  • Planning for a system of laboratories to analyze biological and physical samples to help assess exposure to environmental influences or presence of disease in the participants; and
  • Developing and testing the nationwide information management system to facilitate and enhance participation in the Study and collect, manage, and store the data.

Terry Cox and Terry Dwyer Join the National Children's Study Program Office

Terry A. Cox, M.D., Ph.D., of the Division of Epidemiology and Clinical Research at the National Eye Institute, will now spend a portion of his time working in the National Children's Study Program Office. He is involved in protocol development, with a special emphasis on visual and other neurosensory systems. Trained as an ophthalmologist with a subspecialty in neuro-ophthalmology, Dr. Cox also has a Ph.D. in biostatistics. Much of his career has focused on clinical trials and epidemiological studies, as well as educating clinicians in the principles of clinical research. He is primarily interested in study design and data analysis and will serve as a statistical consultant for the Study.

Dr. Cox will be developing standards for visual assessment; a primary focus will be standard eye exams that will be given to all National Children's Study participants. These tests will look for milestones in neurological development, especially concerning vision and visual processing. In addition, Dr. Cox will investigate other sensory data and neurological behavior, since visual disorders are often a starting point for neurological disorders. Visual system development and maturation tests may be utilized for understanding conditions such as dyslexia and attention deficit disorder.

Terry Dwyer, M.D., M.P.H. is consulting in the National Children's Study Program Office working principally on protocol development. Dr. Dwyer is an accomplished epidemiologist who specializes in researching preventable causes of disease related to environmental, lifestyle, and genetic factors. At the Menzies Centre for Population Health Research in Tasmania, Australia, Dr. Dwyer has directed an ongoing longitudinal cohort study of 10,000 children for the past 16 years to observe a variety of health outcomes; these include SIDS, asthma, bone density, and diabetes. Dr. Dwyer and his team provided important prospective evidence that prone sleeping position is a primary cause for SIDS. His findings influenced the development of the Back to Sleep campaign in the United States. Dr. Dwyer is currently researching the role of genes and the environment in diseases such as skin cancer and multiple sclerosis. Dr. Dwyer has been appointed Director of the Murdoch Children's Research Institute in Melbourne, Australia and upon returning from sabbatical, will begin his work there in December 2004.

Dr. Dwyer is applying his operational experience in running a large cohort study to the National Children's Study protocol development. He is providing input in hypothesis-testing and optimizing the Study implementation to best utilize time and resources. Dr. Dwyer is eager to participate in the planning of a study of such size and involving such a range of detailed measurements. While at the NICHD, he hopes to build international networks with other scientists in the study of children's health.

National Children's Study in the News

The National Children's Study continues to gain media attention. The following includes some recent news coverage:

Associated Press — April 5, 2004
"How Does Environment Affect Kids? U.S. Plans Major Study"
(This story was picked up by 25 newspapers with a combined circulation of over four million, as well as 84 television stations, two radio stations, and 91 Web sites)

Washington Post — April 27, 2004
"Following Children to Identify Health Risk, Study Will Examine Genes, Environment"
(This story was picked up by seven newspapers and four Web sites with an estimated audience of over 1.8 million)

CNN Headline News — April 7, 2004
Philip Landrigan, M.D., Mt. Sinai School of Medicine, was interviewed on CNN Headline News about the National Children's Study

St. Paul Pioneer Press — April 25, 2004
"In Children's Interest"

American Medical News — May 3, 2004
"Ambitious Study Focuses on Children's Health, Illness"

The Environmental Forum — May 2004
"Watch Children's Study Grow Up"

Chemical Policy Alert — April 6, 2004
"Patient Groups To Urge Federal Research On Widely Used Chemicals"

E/The Environmental Magazine — April 9, 2004
"U.S. Plans Study on Environment and Kids"

Chemical and Engineering News — April 26, 2004
"Long-range Study is Nearly Ready, But Funds Aren't Available For Implementation"

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The National Children's Study is led by a
consortium of federal agency partners:

National Institutes of Health
Centers for Disease Control and Prevention