The National Children's Study 2014 An Assessment (2014) / Chapter Skim
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7 Summary, Conclusions, and Recommendations
7 Summary, Conclusions, and Recommendations
Pages 115-128
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From page 115... ...
We present them in the context of the overall conceptual framework proposed for the NCS: to serve as a "data platform," with a focus on child health and development and the study design principles that flow from that framework. In the first section below, we present that framework and our findings on how the current design of the NCS meets the principles of the framework.
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From page 116... ...
It then considered the proposed NCS design in light of the principles. • Principle: A scientific framework that encompasses current and antici pates future domains of high-priority scientific inquiry is needed to guide key study design elements, such as the target population, the sampling strategy, and the schedule and content of data collection.
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From page 117... ...
o Finding: The proposed supplemental samples of 10,000 do not add sufficient value to the study to warrant their inclusion, and they detract from the national probability sample's potential size and prenatal coverage. • Principle: Scientific quality is enhanced by using the most valid and standardized data collection measures and methods that are feasible while maintaining sufficient flexibility to assess emerging domains of scientific inquiry.
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From page 118... ...
• Principle: Transdisciplinary discovery and statistical sophistication are enhanced when all relevant scientific expertise is integrated into the project management structure. o Finding: The NCS design, as described, indicates a lack of suf ficient scientific expertise, which is a major weakness of the study.
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From page 119... ...
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. In making this recommendation, the panel also took into consideration the loss of the opportunity to recruit more prenatal cases if the preconception group is retained.
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From page 120... ...
CONCLUSION 3-2: Because of the lack of explicit hypotheses in the study design, it is not possible for the panel to judge whether the proposed sample size is justified on the basis of the study's objectives. A large appropriately stratified national probability sample in which children have an approximately equal chance of selection would be one that 1 As noted in Chapter 4, birth recruitment would be needed for the relatively small number of women who do not receive prenatal care or who receive prenatal care from a provider not on the provider list frame.
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From page 121... ...
With the proposed design, the secondary sampling stage would be prenatal care providers from the sampled hospitals, split into two strata: the prenatal stratum and the birth stratum. The ultimate sampling stage would be the sampling of pregnant women from selected providers or the sampling of women just after birth at selected hospitals.
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From page 122... ...
Any comparison needs to include a cost-effectiveness analysis of the options and an assessment of the ability to ensure coverage and to control for such characteristics as race and ethnicity, socioeconomic status, age, and marital status to ensure the sample will support evaluation of health disparities. Because a geographic-based first stage sample design has already been developed and would need only to be updated for population changes and because it appears feasible to sample prenatal care providers within geographic areas based on the Vanguard Study experience, the panel questions the decision to move to a hospital-based approach.
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From page 123... ...
CONTENT AND VISIT SCHEDULE The proposed approach to assess health and developmental phenotypes, the proposed study visit schedule, and the development of content for the NCS reflect a conceptualization of health and development that is a substantial advance from the one that was reviewed in the previous evaluation by the National Research Council and Institute of Medicine (2008)
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From page 124... ...
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. In addition to exemplar hypothesis, other aspects of the NCS content have not been sufficiently detailed to be used for design decisions.
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From page 125... ...
CONCLUSION 4-4: The panel agrees that more intensive data collection in the early years of the National Children's Study is important, but the panel did not receive sufficient scientific justification to assess the merits of the specific data collection schedule. RECOMMENDATION 4-3: The National Children's Study Main Study should collect data during the prenatal period at multiple times for as many of the study participants as the budget will allow.
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From page 126... ...
The NCS should obtain input from experts on health disparities in childhood as part of the documented process through which the measures for inclu sion are selected and the measures should be approved by the proposed oversight committee. A final data issue for any longitudinal study concerns the release of its data.
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From page 127... ...
In contrast with contacting and gaining the cooperation of respondents, modest changes in interview length contribute minimally to cost. CONCLUSION 5-3: For the same field costs and with the elimination of the 10,000 supplemental samples -- 5,000 nulliparous women and a 5,000 convenience sample -- the National Children's Study could afford to enroll a predominantly prenatal probability sample of 96,000 cases with no other changes to the proposed data collection protocol.
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From page 128... ...
Main Study requires a broader and deeper base of scientific expertise than currently exists in the NCS Program Office; an authoritative multidisciplinary oversight structure to ensure that the decisions of the Program Office are appropriately vetted in all relevant areas of expertise; and a provision for periodic comprehensive reviews of the study by an independent outside group. RECOMMENDATION 6-1: The National Institute of Child Health and Human Development (NICHD)
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