The National Children's Study 2014: commentary on a recent National Research Council/Institute of Medicine Report.

The National Children’s Study 2014: Commentary on a Recent National Research Council/Institute of Medicine Report Marie C. McCormick, MD, ScD; Dean B. Baker, MD, MPH; Paul P. Biemer, PhD; Barbara Lepidus Carlson, MA; Ana V. Diez Roux, MD, MPH; Virginia M. Lesser, DrPH; Sara S. McLanahan, PhD; George R. Saade, MD; S. Lynne Stokes, PhD; Leonardo Trasande, MD, MPP; Greg J. Duncan, PhD From the Harvard School of Public Health, Boston, Mass (Dr McCormick); School of Medicine, University of California, Irvine, Calif (Dr Baker); RTI International, Research Triangle Park, NC (Dr Biemer); Mathematica Policy Inc, Boston, Mass (Ms Lepidus Carlson); Drexel University School of Public Health, Philadelphia, Pa (Dr Diez Roux); Oregon State University, Corvallis, Ore (Dr Lesser); Princeton University, Princeton, NJ (Dr McLanahan); University of Texas Medical Branch at Galveston, Galveston, Tex (Dr Saade); Southern Methodist University, Dallas, Tex (Dr Stokes); School of Medicine, New York University, New York, NY (Dr Trasande); and University of California, Irvine, Calif (Dr Duncan) Much of this commentary is drawn from NRC/IOM (2014). Conflict of Interest: The authors declare that they have no conflict of interest. Address correspondence to Marie C. McCormick, MD, ScD, Department of Social and Behavioral Sciences, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 (e-mail: mmccormi@hsph.harvard.edu). Received for publication August 22, 2014; accepted August 24, 2014. A CADEMIC P EDIATRICS 2014;14:545–546 T HE NATIONAL CHILDREN’S Study (NCS) was autho- NICHD specified that the panel’s review should cover such aspects of the Main Study design as the national prob- ability 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 prob- ability sample; the size of the supplemental convenience samples; optimal use of sibling births; use of health care providers to refer prospective participants; the proposed study visit schedule, with emphasis on more frequent data collection in pregnancy and early childhood; the proposed approach to assess health and developmental phenotypes; and the proposed approach to define and char- acterize health disparities. 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 antici- pated processes to design the Main Study. The panel re- viewed what the NCS program office provided by way of documentation and responses to several sets of written questions from the panel. The panel also listened to public comments during open meetings that included the NICHD staff. In addition, the panel engaged consultants to provide an expert cost analysis to support comparison of various design alternatives. rized by the Children’s Health Act of 2000 (Public Law 106-310) and is being implemented by a dedicated pro- gram office in the Eunice Kennedy Shriver National Insti- tute of Child Health and Human Development (NICHD). In the words of the program office, the NCS is planned to be a “longitudinal observational birth cohort study to eval- uate the effects of chronic and intermittent exposures on child health and human development in US children.” 1 The NCS would be the first US study to collect a broad range of environmental exposure measures for a national probability sample of about 100,000 children followed from birth or before birth to age 21. Detailed plans for the NCS were developed by 2007 and reviewed by an outside panel. 2 At that time, sample recruit- ment for the NCS Main Study was scheduled to begin in 2009 and to be completed within about 5 years. However, results from the initial 7 Vanguard Study (pilot) locations, which recruited sample cases in 2009–2010, indicated that the proposed household-based recruitment approach would be more costly and time-consuming than planned. In response, the program office conducted additional pilot tests in 2011–2013 to evaluate alternative recruitment methods. Based on these results, the study design was revised in early 2013, and a tentative 2015 start date was set for the Main Study. In March 2013, Congress requested a review of the revised study design by a panel of the National Research Council and Institute of Medicine. Congress stated the panel should “conduct a comprehensive review and issue a report regarding proposed methodologies for the NCS Main Study, including whether such methodologies are likely to produce scientifically sound results that are gener- alizable to the United States population and appropriate subpopulations.” 2 A CADEMIC P EDIATRICS Copyright a 2014 by Academic Pediatric Association O VERALL A SSESSMENT The National Research Council and Institute of Medi- cine released the panel’s report, The National Children’s Study 2014: An Assessment (NRC/IOM, 2014), on June 16, 2014. 3 The panel concluded that the National Chil- dren’s Study has the potential to add immeasurably to Volume 14, Number 6 November–December 2014