The National Children's Study 2014 An Assessment (2014) / Chapter Skim
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. In the words of the Program Office, the NCS is planned to be a "longitudinal observational birth cohort study to evaluate the effects of chronic and intermittent exposures on child health and human development in U.S.
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OVERALL ASSESSMENT The National Children's Study has the potential to add immeasurably to scientific knowledge about the impact of environmental exposures, broadly defined, on children's health and development in the United States. The panel supports a number of elements of the proposed design for the NCS Main Study, including; • the use of a national equal probability sample for a large cohort of births, • the concept of the study as a data collection platform with a focus on health and development guided by exemplar scientific hypotheses, • the inclusion of siblings born within the 4-year recruitment window, and • the collection and storage of biological and environmental samples to permit subsequent analysis.
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, the panel concludes that achieving a scientifically grounded and cost-effective design and implementation for the Main Study will require expansion of the scientific expertise in the Program Office, establishment of an authoritative multidisciplinary oversight structure to review the Program Office's decisions, and regular independent outside review. STUDY DESIGN The panel evaluated whether the current NCS plan embraces a scientific approach that identifies current and anticipated future subject domains and measures that are of high priority for understanding children's health and development.
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As part of its evaluation, the panel commissioned a cost analysis to enable it to identify alternative sample designs that could achieve nearly 100 percent prenatal recruitment and be largely cost neutral with the design as currently proposed. SAMPLE DESIGN The current NCS design calls for a national, equal probability of selection sample of 90,000 births using a stratified list sample design: hospitals are the primary sampling units, and prenatal care providers whose patients deliver at the selected hospitals are the secondary sampling units.
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The panel endorses this change, as siblings provide many analytic advantages, most prominently collection of preconception exposure information for second and higher-parity births. Overall, however, the documents that NCS made available to the panel did not provide sufficient details for an evaluation of whether the proposed sample would meet the minimal standards of a scientifically based sample design required for large national data collections.
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Cost-effective and scientifically grounded operation of the NCS Main Study requires a broader and deeper base of scientific expertise for the Program Office; an authoritative multidisciplinary oversight structure to ensure that the decisions of the Program Office are appropriately vetted by all relevant experts; and provision for periodic comprehensive reviews of the study by an independent outside group. The panel's recommendations to address these shortcomings are below.
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RECOMMENDATION 2-5: While the panel appreciates the possible scientific value of gathering preconception exposure information on 5,000 first-birth children as part of the National Children's Study Main Study, this supplemental sample should be dropped because of high costs, the lack of any evidence of the value of such a sample, the lack of detailed plans for both selection and analysis, and potential limitations in the pro posed data collection schedule. RECOMMENDATION 2-6: The other supplemental convenience sam ples proposed for the National Children's Study Main Study should be dropped from the design, including samples of children exposed to natural disasters or geographically defined environmental exposures, samples of additional members of disadvantaged groups, and samples of siblings born outside the 4-year birth window.
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should develop scientifically well grounded exemplar hypotheses that should be used to guide and evaluate decisions regarding the NCS design and data collection schedule and domains. RECOMMENDATION 4-2: Because hypotheses will change over time, the National Children's Study should implement a strong and public pro cess to revise and develop new exemplar hypotheses to guide future study implementation, engaging with the extramural and intramural research communities.
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The protocols and findings of the pilot tests should be peer reviewed and approved by the proposed inde pendent oversight committee prior to initiating the Main Study. RECOMMENDATION 4-7: The relevance to health disparities should be an explicit criterion for selecting the constructs that will be assessed as part of the National Children's Study (NCS)
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Pro gram Office should establish a mechanism, such as a study section like those in the National Institutes of Health, or use a qualified independent organization to conduct periodic comprehensive outside scientific reviews of the design and operations of the NCS Main Study. To facilitate the work of such a committee and transparency for the study more generally, the NCS Program Office should promptly post on its website all scientific studies conducted for the NCS.
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