The National Children's Study 2014 An Assessment (2014) / Chapter Skim
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4 Study Content
4 Study Content
Pages 71-98
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From page 71... ...
The panel did not receive specific study protocols, information on specific data collection methods, or study instruments. Consequently, this review cannot address the scientific merit or quality of these aspects of the NCS data collection.
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From page 72... ...
Some, like the Norwegian Mother and Child Cohort Study, appear to use the "platform" approach of the NCS or follow specific precedents, such as the Millennium Cohort Study and earlier British birth cohort studies. However, more commonly, studies are organized around key questions or assessments of specific exposures and provide details on specific subquestions and how they inform the data collection.
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From page 73... ...
Other than mentioning that hypotheses were used as a general guide to estimating sample size, the NCS documents did not clarify how the exemplar hypotheses informed key decisions regarding the study design. The sample size discussed in the document focused only on main effects, although effect modification or interactions is an important justification for a sample size in the range proposed for the NCS.
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From page 74... ...
Even if multiple study planning tools will be used, the NCS plan still must delineate specific scientifically robust exemplar hypotheses that can be used by the NCS and the scientific community to formally evaluate sample size and design issues, as well as the NCS proposals for the nature and timing of data collection. CONCLUSION 4-1: A strategy of using a few exemplar hypotheses rather than stating a large list of hypotheses requires that the planners of the National Children's Study ensure that the exemplar hypotheses are important and scientifically robust to guide the study design and data collection.
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From page 75... ...
A profile includes observable char acteristics about the participant plus information about the environment such as air particle measures, noise level, family structure and dynamics, access to health care, etc. Thus, at each study visit a participant will be assessed using a health phenotype framework and will be the subject of collection of environmental data and biospecimens.
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From page 76... ...
The NCS documents mention the need to identify priorities for data collection, but the discussion does not adequately address how the NCS will overcome what is likely to be a major impediment in operationalizing the health phenotype concept, since respondent burden and limitations in collecting biological and environmental specimens will be critical considerations in designing the study content. CONCLUSION 4-2: While using a dynamic health phenotype concept to plan the content of the National Children's Study appears to be a promis ing strategy, the panel lacked sufficient information to judge whether the implementation of such an approach would be feasible given constraints imposed by respondent burden and overall study costs.
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From page 77... ...
CONCLUSION 4-3: Many of the principles and concepts guiding devel opment of the study design and the concept of having processes for devel oping future hypotheses and study content are consistent with the study platform framework for the National Children's Study. However, it is not clear whether and how those principles and concepts can be effectively used to design the study content.
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From page 78... ...
Table 4-2 shows the study visit schedule and collection mode planned for ages 3.5 through 21. The concentration of data collection in the early years is apparent in both the 2008 and 2013 schedules, with the current schedule including two prenatal interviews (rather than three as in the previous plan)
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From page 79... ...
, hair [M] Environmental: indoor air, house dust Questionnaire/diary: demographics, household composition, medication use, health behaviors, housing characteristics, chemical exposures, product use, occupational exposures, diet Examinations: anthropometrics [M]
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From page 80... ...
Questionnaire/diary: psychosocial occupational and on demographics, household composition, hobby exposures, health behaviors, medications, medication use, health behaviors, housing treatments and medical events, consumer product characteristics, chemical exposures, product use, dietary assessment 80 use, occupational exposures, diet, medical
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From page 81... ...
, plans for product use, treatments and medical events, pain infant feeding, sleeping, etc. or other complications, recent medical social and environmental history, planned health behaviors, medical record review including abstration for hearing screen and neonatal exam Examinations: anthropometrics [C]
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From page 82... ...
, breast milk and oral swab [C] Environmental: indoor air, house dust, Environmental: air, dust, water, visual assessment of drinking water, soil, visual assessment of house and neighborhood house and neighborhood Questionnaire/diary: stress and social Questionnaire/diary: [M]
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From page 83... ...
, breast milk and oral swab [C] Environmental: indoor air, house dust, Environmental: air, dust, water, visual assessment of drinking water, soil, visual assessment, noise house and neighborhood survey Questionnaire/diary: household composition Questionnaire/diary: core questionnaire, age update, family process and parenting specific and other modules, dietary assessment, practices [M, P]
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From page 84... ...
, housing update, specific and other modules, dietary assessment, chemical and occupational exposures [M, C] neurodevelopmental 2 Years Telephone Environmental: indoor air and house dust self-collected and mailed in Questionnaire/diary: child care, medical update [C]
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From page 85... ...
Questionnaire/diary: core questionnaire, noise exposures, risk and safety behaviors, social activities, physical activity, sun exposure, toilet training, occupational/ hobby exposures, reported height and weight, Ages and Stages, SWAN, NIH Toolbox Early Childhood Cognition Battery, Neuro-Psycholosocial Direct Observation Data Collector Instrument, WAST, Major Life Events, alcohol tobacco and substance use. Examinations: height or length, weight, circumferences, upper arm length, blood pressure, physical activity (subsample)
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From page 86... ...
. These statements provide a rationale for having a frequent visit schedule based on operational considerations; however, they do not describe the scientific basis for choosing the precise study visits schedule and content.
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From page 87... ...
Nevertheless, it is not clear whether or how the planned data collection would be modified during the postnatal period for enrolled families to be able to address scientific hypotheses related to the preconception environment of the not-yet-born subsequent sibling. In addition, the current proposed data collection schedule for families when the target child is between 1 and 5 years of age, when the vast majority of subsequent siblings would be conceived, includes only one in-person and one remote data collection event per year.
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From page 88... ...
Although the prenatal period data collection protocol for the Main Study has not been finalized, the NCS documents list the most important domains and subdomains the NCS will try to measure. The importance of collecting prenatal data derives in part from the fact that many factors to be measured, such as diet or medication use, may not be reliably recalled in postnatal questionnaires.
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From page 89... ...
The apparent lack of a draft final protocol and limited descriptions of possible data collection elements raises questions about the status of the NCS protocol. After several years of Vanguard Study pilot testing and based on the description of an elaborate process to develop study content, the panel expects that the NCS should be able to provide well-justified, near-final data collection protocols and study instruments, at least for the initial periods of the Main Study through the children's first year.
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From page 90... ...
Due to the lack of detailed information on how the NCS would implement the strategy of a core plus modules and the actual measures to be used, the panel cannot assess whether the proposed strategy would be able to contain respondent burden while collecting the data needed to characterize outcomes, identify key issues for health disparities, and operationalize the health phenotype concept. Environmental Assessments As noted in Chapter 1, the Children's Health Act of 2000 mandated that the NCS should be 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
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From page 91... ...
As previously mentioned, although the congressional mandate for this panel's study called for "a comprehensive review and issue a report regarding proposed methodologies for the NCS Main Study," the NICHD did not ask the panel to review the environmental assessments, and the panel did not receive sufficient information to evaluate the scientific merit of the draft environmental assessment protocols. When discussing the environmental assessment, the NCS documents (e.g., NICHD, 2013b, p.
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From page 92... ...
The panel also judges that the proposed methods to assess environmental exposures by relying on maternal collection of in-home environmental samples have not been adequately pilot tested. CONCLUSION 4-6: Exposure assessment, including collection of bio logical and environmental specimens during multiple study visits begin ning during the prenatal period, is a critical component of the National Children's Study in addressing the mandate of the Children's Health Act of 2000 and fulfilling the study's goal to serve as a platform for future scientific inquiry.
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From page 93... ...
RECOMMENDATION 4-6: The National Children's Study Program Office should finalize the study visit data collection protocols that it intends to use for the Main Study (including questionnaires and other measurements) , at least through age 1, and then pilot test the protocols before implementing the Main Study.
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From page 94... ...
Although the domains identified by the NCS documents are standard and reasonable, there was no indication that the NCS has developed or adopted a conceptual framework for health disparities (e.g., similar to the framework the NCS has developed to guide assessment of child development) or a strategy to identify additional domains and measures relevant to health disparities, such as psychosocial factors or features of social or physical environments that may be of special relevance to understanding health disparities.
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From page 95... ...
Additional details about the NCS study data release policies were provided in documents made available to the panel (NICHD, 2013a, 2013d) and are based on review of the data release policies of a number of federal government and university-based surveys.
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From page 96... ...
and through the Census Bureau's national network of Remote Data Centers.10 Given the similarities between NHANES and the National Children's Study, the panel views the general structure of the NHANES's data release policy and performance of NHANES as a model for the NCS. Confidentiality concerns arising from the longitudinal nature of the NCS may affect somewhat the balance of data released publicly and confidentially, but the panel would expect these kinds of changes to be relatively minor.
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From page 97... ...
Beyond a rapid end-of-wave data release, the 7-year data cycle argues for consideration of an "early release" data policy 2 or 3 years into the cycle to encourage data quality exploration. Given the complications of the sampling design, these preliminary data could not be used to generate national or local estimates.
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