The National Children's Study Research Plan A Review (2008) / Chapter Skim
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6 Conclusions and Recommendations
6 Conclusions and Recommendations
Pages 131-140
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From page 131... ...
The panel believes that this landmark study offers an unparalleled opportunity to examine the effects of environmental influences on child health and development, as well as to explore the complex interactions between genes and environments. The database derived from the study will be valuable for investigating the hypotheses described in the research plan as well as additional hypotheses that will evolve.
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From page 132... ...
These areas are: • insufficient attention to understanding disparities in child health and development among population groups of children defined by race, ethnicity, language, socioeconomic status, and geo graphic area, which the act explicitly mandates; • inadequate conceptualization of important constructs, including health and development, and an overemphasis on disease and impairment relative to health and functionality and on risk fac tors relative to protective health-promoting factors; • impaired data collection schedules and types of measures to sup port evaluation of some of the effects of chronic and intermittent exposures on child health and development; and • underappreciation of the challenges to obtaining the highest possible quality of data from an observational design, which include the decentralized data collection structure of the study and limitations on the frequency of home and clinic visits and on the collection of medical and other administrative records for study participants. Recommendation 2-1: The NCS should give priority attention to seeking ways to bolster the ability of the study to contribute to un derstanding of health disparities among children in different racial, ethnic, and other population groups, including the reestablishment of a working group to oversee this area and the encouragement of appropriate adjunct studies.
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From page 133... ...
CHAPTER 3: PRIORITY OUTCOME AND EXPOSURE MEASURES Pregnancy Outcomes Recommendation 3-1: The NCS should consider replacing research on subclinical maternal hypothyroidism as a factor in adverse preg nancy outcomes with research on the effects of a broader set of maternal physical and mental health conditions, such as maternal depression, maternal perceived stress, and maternal periodontal disease. Recommendation 3-2: The NCS should develop refined, detailed protocols for investigating all pregnancy outcomes, specifically a detailed protocol for obtaining information on various types of pregnancy loss, before beginning data collection at the Vanguard Centers, given that pregnancy outcomes are among the first out comes to be examined; many outcomes lack clarity in measure ment; and there are important questions regarding the adequacy of statistical power and the planned data collection (for example, the need for prepregnancy measurements of some exposures)
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From page 134... ...
. Hormonally Active Agents and Reproductive Development Recommendation 3-7: The NCS should develop refined and de tailed protocols for studying reproductive development outcomes, which, as presented in the research plan, often lack clarity in
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From page 135... ...
Physical Exposure Measures Recommendation 3-11: The NCS should provide a clearer ra tionale for some of the housing and neighborhood conditions it proposes to measure and revisit its data collection plans to ensure that needed measures are obtained at developmental stages when children may be more vulnerable to risk factors. The goal should be a set of measures and data collection plans that are optimal with regard to analytic utility and response burden.
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From page 136... ...
Recommendation 3-13: The NCS should dedicate a portion of funds to support research and development of reliable and valid instruments of key psychosocial measures that are practical and economical to administer. Biological Exposure Measures Recommendation 3-14: The NCS should review some of the pro posed measures of biological exposures, such as maternal glucose metabolism and child cortisol levels, to ensure that the proposed times for data collection are appropriate for capturing the underly ing exposure.
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From page 137... ...
Such arrangements must safeguard the confidentiality of NCS respondents. CHAPTER 4: STUDY DESIGN, DATA COLLECTION, AND ANALYSIS Sampling Design Conclusion 4-1: We strongly endorse the use of probability sampling to select the NCS national sample of births.
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From page 138... ...
Conclusion 4-7: The NCS research plan provides little information concerning best methods for sample recruitment to achieve initial and follow-up target response rates, sample maintenance and sample re tention procedures for implementation at the study sites, community involvement plans consistent with the uniform implementation of data collection procedures, or contingency plans to support study sites that do not achieve target response rates.
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From page 139... ...
Recommendation 4-5: Because of the complexity of the proposed organizational model for data collection and the difficulty of main taining the quality and uniformity of data collection procedures across a large number of study sites, the NCS program office should establish and monitor strict standards for enrollment, reten tion, and data collection at each of the study sites and be prepared to take immediate corrective action if sites do not meet high-quality standards in data collection. Recommendation 4-6: The NCS should prepare a plan for moni toring progress of the study in reaching its sample size goals.
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From page 140... ...
Dissemination includes not only the publication of findings through reports and scientific papers and the production of documented data files for researchers, but also active support in the use of NCS data by the broadest possible range of qualified investigators. CHAPTER 5: ETHICAL PROCEDURES AND COMMUNITY ENGAGEMENT Criteria for Giving Information to Participants Recommendation 5-1: The NCS should define the criteria and the process for deciding what individual clinical and research informa tion, such as environmental assessments, test results, and survey scales, will be given to children and their families.
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