The Future of the National Children’s Study

Opinion VIEWPOINT Greg J. Duncan, PhD School of Education, University of California, Irvine. Marie C. McCormick, MD, ScD Department of Social and Behavioral Sciences, Harvard School of Public Health, Boston, Massachusetts. Constance F. Citro, PhD National Research Council, National Academy of Sciences, Washington, DC. Corresponding Author: Greg J. Duncan, PhD, School of Education, University of California, Irvine, 2001 Education, Irvine, CA 92697-5500 (gduncan@uci.edu). jamapediatrics.com The Future of the National Children’s Study On December 12, 2014, National Institutes of Health Director Francis Collins, MD, PhD, announced his inten- tion to discontinue the National Children’s Study (NCS), ending nearly 15 years of planning and pilot testing at a cost of $1.3 billion. As 3 of the authors and editors of the report by the National Research Council and Institute of Medicine The National Children’s Study 2014: An Assessment, 1 we welcome the opportunity to provide our perspectives on future directions for the study. The NCS was authorized by the Children’s Health Act of 2000 (Pub L No. 106-310) to accord priority to (1) gathering data from birth to adulthood to evaluate en- vironmental influences on diverse populations of chil- dren; (2) considering health disparities among chil- dren; and (3) incorporating behavioral, emotional, educational, and contextual consequences to enable complete assessment of the physical, chemical, biologi- cal, and psychosocial environmental influences on chil- dren’s well-being. The Program Office in the Eunice Kennedy Shriver National Institute of Child Health and Human Development designed the study as the first in the world to collect a broad range of environmental ex- posure measures for a national probability sample of about 100 000 children followed up from birth, or even before birth, to age 21 years. Our panel’s review of the study design concluded that the NCS had the potential to add substantially to sci- entific knowledge about the impact of environmental ex- posures, broadly defined, on children’s health and de- velopment in the United States. The panel supported almost all of the basic elements of the proposed design for the NCS Main Study, including the use of a national equal probability sample for a large cohort of births (the panel recommended that almost all of the sample be re- cruited prenatally), its concept of the study as a data col- lection platform with a focus on health and develop- ment guided by exemplar scientific hypotheses, its concentration of measurement on the prenatal and early childhood periods, and the collection and storage of bio- logical and environmental samples to permit subse- quent analysis of archived specimens. For many important issues regarding the NCS’s pro- posed design, the panel did not receive sufficiently de- tailed information from the Program Office to provide an informed assessment. Because of this lack of infor- mation and related reasons, the panel concluded that achieving a scientifically grounded and cost-effective de- sign and implementation would require expansion of the scientific expertise in the Program Office, establish- ment of an authoritative multidisciplinary oversight structure to review the Program Office’s decisions, and regular independent outside review. Collins’s December 12, 2014, statement about the NCS concluded that while research addressing the links between the environment and child health and devel- opment is important, the NCS is not feasible. He called for alternative designs to be initiated within the scien- tific community that would employ the use of the grow- ing number of clinical research networks. Neither Collins’s statement nor the report of the Working Group he commissioned explains why the basic NCS design is infeasible, which handicaps our efforts to point to prom- ising new directions. Our panel judged that the basic ele- ments of the data collection plan were indeed feasible and noted that most had been incorporated into suc- cessful national longitudinal birth cohort studies in other counties or proved their worth in the Vanguard testing sites. Although we judged that the study’s manage- ment structure and system of oversight needed to be re- formed, we also pointed to a number of successful man- agement models that could help to guide these efforts. Perhaps the key to the Working Group’s and Collins’s “infeasibility” judgment was the cost of the study de- sign. Our panel estimated that the data collection por- tion of study costs alone would range between $200 mil- lion and $300 million annually by the third year of data collection—amounts well above the past Congressional appropriations for the total costs of running the study. These high costs had little to do with the NCS Program Office’s decision to adopt probability methods for draw- ing the study’s sample, but instead were driven by the total sample size, the frequency of interviewing, and the need for periodic in-home visits to collect data on envi- ronmental exposures that could not be measured in blood or placentas. Any replacement collection of NCS-related studies—including those initiated in clini- cal research networks—involving similar total numbers of subjects and periodic in-home interviews would likely cost as much or more. As a final prefatory note, the importance of under- standing health disparities figured prominently in our pan- el’s deliberation. Ensuring adequate representation of our nation’s most disadvantaged children in studies such as the NCS is a formidable task. These children are unlikely to be well represented in studies that draw their samples from administrative records or patient pools. And the resi- dential mobility of disadvantaged children makes them exceedingly difficult to follow up in studies operating in limited geographic areas. These concerns contributed to our panel’s endorsement of a national scope and prob- ability sampling methods for the study. How best to address the priorities dictated by the Children’s Health Act of 2000 at considerably lower cost? Although it may be sensible to mount a number of valuable low-cost specialized studies, we see no substi- tute for a national study that follows up diverse groups of children through adolescence and engages in inten- sive assessments of a variety of environmental expo- sures through periodic home visits. And we reiterate the endorsements of our panel and the Working Group for (Reprinted) JAMA Pediatrics June 2015 Volume 169, Number 6 Copyright 2015 American Medical Association. All rights reserved. Downloaded From: http://archpedi.jamanetwork.com/ by a University of California - Irvine User on 06/28/2015