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1 Introduction
Pages 11-26

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From page 11...
... . The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
From page 12...
... NOTE: Congress subsequently passed Public Law 110-154 in 2007 to rename the institute as the Eunice Kennedy Shriver National Institute of Child Health and Human Development. SOURCE: The full text of the law is available at http://www.gpo.gov/fdsys/pkg/PLAW 106publ310/html/PLAW-106publ310.htm [December 2013]
From page 13...
... The panel's review will cover such aspects of the Main Study design as the national probability sample's overall sample size and design; the use of hospitals and birthing centers as the primary sampling unit; relative size of the prenatal and birth strata in the probability sample; the size of the supplemental convenience sample; optimal use of sibling births; use of health care providers to refer prospective participants; proposed study visit schedule, with emphasis on more frequent data collection in pregnancy and early childhood; proposed approach to assess health and developmental phenotypes; and proposed approach to define and characterize health disparities. 2  The NCS Main Study is distinguished from the pilot "Vanguard Study," which is currently under way.
From page 14...
... 897) note, a number of recent national birth cohorts, including the Danish National Birth Cohort, the Norwegian Mother and Child Co hort, and the U.S.
From page 15...
... The decision that a nationally representative probability sample should be a core element of the study was reached in June 2004 by agreement of the NCS Program Office, the Advisory Committee, and an NCS Sampling Design Workshop Panel. Later that year the NCS, in collaboration with the National Center for Health Statistics, developed the NCS first-stage sample, comprising 110 and born in 2015.
From page 16...
... Beginning in 2005, the NCS Program Office awarded a number of contracts to design and implement the study. The initial NSC research plan was completed in June 2007, and the NICHD requested an external review of the plan, which is the subject of the National Research Council and Institute of Medicine (2008)
From page 17...
... NCS research plan completed 2008 National Research Council/Institute of Medicine review of NCS research plan published 2009 1. Field operations begun in 7 initial Vanguard locations 2.
From page 18...
... were defined as aggregations of contiguous census blocks that, when summed together within each primary sampling unit, would yield the desired target for the primary sampling unit. The secondary sampling only occurred in the primary sampling units that were designated to participate in one of the recruitment pilot (or Vanguard)
From page 19...
... The NCS Program Office awarded contracts in 2005 to academic programs in seven of the 110 sampled primary sampling units to pilot test the household recruitment and data collection protocols. The NCS uses the term "Vanguard Study" to refer to all pilot-testing activities used to plan the NCS Main Study.7 The seven units used for the initial pilot testing were called the initial Vanguard locations, and the academic programs that were contracted to implement the field work were called the initial Vanguard centers.
From page 20...
... This phase of pilot testing was called the alternative recruitment pilot of the Vanguard Study. To test recruitment strategies, the NCS Program Office developed three alternative recruitment strategies and implemented each of them in 10 of the primary sampling units that had been sampled for the Main Study.
From page 21...
... In this plan, hospitals identified as secondary sampling units would be selected from a geographically selected primary sampling unit. Prenatal care providers whose patients delivered at selected hospitals (or birthing centers)
From page 22...
... Prenatal providers whose patients deliver at the selected birthing hospitals and birthing centers would serve as secondary sampling units. The current proposal retains the 45-45-10 distribution of the sample among prenatal care providers, birthing hospitals, and the convenience sample, respectively.
From page 23...
... . Although the use of domains and primary observations, rather than predetermined disease categories, does not necessarily require a shift from the original disease-oriented outcomes of the NCS, the current proposed plan tends to deemphasize a focus on disease outcomes and gives greater emphasis to positive health and development domains.
From page 24...
... The panel members also reviewed publicly available documents on the NCS Website and searched the peer-review literature for publications related to the NCS and other large national birth cohort studies.14 The panel concluded that to meet its charge of evaluating the "scientific merit" of the Main Study, the NCS Program Office would need to provide specific documentation on the sampling design, the sample frame, the data collection protocols, and the study instruments, rather than just describe the conceptual framework, strategies, and anticipated processes to design the Main Study. For example, one key to assessing expected generalizability of results would be detailed information about the proposed sampling plan based on a list of hospitals: the completeness of the list, the number of primary sampling 14  The separate reference list for NICHD documents includes both those that are publicly available and those that were provided directly to the panel and are available in the Public Access File of the National Academy of Sciences.
From page 25...
... It also describes key issues that drive the sample design, including the utility of the proposed convenience samples. The chapter addresses the following key items the panel was asked to consider: the national probability sample's overall sample size and design; the relative size of the prenatal and birth strata in the probability sample; the 15  The NCS Program Office stated that they "anticipate that the Main Study will start a few months after the Institute of Medicine/National Research Council report is published." See http://www.nationalchildrensstudy.gov/newsandevents/announcements/Pages/ncsreceivesFY2013 appropriationapril2013.aspx [March 2014]
From page 26...
... It comments on statistical issues related to the survey design, as well as on the treatment of special populations. The chapter addresses the following key items the panel was asked to consider: the national probability sample's overall sample size and design; the use of hospitals and birthing centers as the primary sampling unit; the relative size of the prenatal and birth strata in the probability sample; the optimal use of sibling births; and the use of health care providers to refer prospective participants.


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