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The National Children's Study Research Plan: A Review (2008)
Committee on National Statistics (CNSTAT)
 Board on Children, Youth and Families (BOCYF)
 Board on Population Health and Public Health Practice (BPH)

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The National Children’s Study Research Plan: A Review

The National Children’s Study Research Plan

A REVIEW

Panel to Review the National Children’s Study Research Plan

Committee on National Statistics

Division of Behavioral and Social Sciences and Education

NATIONAL RESEARCH COUNCIL

Board on Children, Youth, and Families

Division of Behavioral and Social Sciences and Education

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE

and

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

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I

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The National Children’s Study Research Plan: A Review The National Children’s Study Research Plan A REVIEW Panel to Review the National Children’s Study Research Plan Committee on National Statistics Division of Behavioral and Social Sciences and Education NATIONAL RESEARCH COUNCIL Board on Children, Youth, and Families Division of Behavioral and Social Sciences and Education NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE and Board on Population Health and Public Health Practice INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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The National Children’s Study Research Plan: A Review NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. NO1-OD-4-2139 between the National Academy of Sciences and the National Institute of Child Health and Human Development. Support of the work of the Committee on National Statistics is provided by a consortium of federal agencies through a grant from the National Science Foundation (Number SBR-0453930). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-12056-2 International Standard Book Number-10: 0-309-12056-X Additional copies of this report are available from National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Research Council and Institute of Medicine. (2008). The National Children’s Study Research Plan: A Review. Panel to Review the National Children’s Study Research Plan. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Board on Children, Youth, and Families and Board on Population Health and Public Health Practice, Institute of Medicine. Washington, DC: The National Academies Press.

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The National Children’s Study Research Plan: A Review THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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The National Children’s Study Research Plan: A Review This page intentionally left blank.

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The National Children’s Study Research Plan: A Review PANEL TO REVIEW THE NATIONAL CHILDREN’S STUDY RESEARCH PLAN SAMUEL H. PRESTON (Chair), Department of Sociology, University of Pennsylvania ELLEN WRIGHT CLAYTON, Center for Biomedical Ethics and Society and School of Law, Vanderbilt University GREG DUNCAN, School of Education and Social Policy and Institute for Policy Research, Northwestern University DAVID HARRINGTON, Department of Biostatistics, Harvard School of Public Health, and Department of Biostatistics and Computational Biology, Dana Farber Cancer Institute RUSS HAUSER, Departments of Environmental Health and Epidemiology, Harvard School of Public Health WILLIAM KALSBEEK, Department of Biostatistics, University of North Carolina SHARON LEE REILLY KARDIA, Public Health Genetic Program, School of Public Health, University of Michigan DANIEL KASPRZYK, Mathematica Policy Research, Inc., Washington, DC MILTON KOTELCHUCK, Maternal and Child Health Department, School of Public Health, and Medical School, Boston University MARIE McCORMICK, Department of Society, Human Development, and Health, Harvard School of Public Health NORA S. NEWCOMBE, Department of Psychology, Temple University PATRICIA O’CAMPO, Centre for Research on Inner City Health, St. Michael’s Hospital, University of Toronto GOOLOO S. WUNDERLICH, Study Director BRIDGET EDMONDS, Administrative Assistant

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The National Children’s Study Research Plan: A Review COMMITTEE ON NATIONAL STATISTICS WILLIAM F. EDDY (Chair), Department of Statistics, Carnegie Mellon University KATHARINE ABRAHAM, Department of Economics, University of Maryland, and Joint Program in Survey Methodology WILLIAM DuMOUCHEL, Lincoln Technologies, Inc., Waltham, Massachusetts JOHN HALTIWANGER, Department of Economics, University of Maryland V. JOSEPH HOTZ, Department of Economics, Duke University KAREN KAFADAR, Department of Statistics, Indiana University DOUGLAS MASSEY, Department of Sociology, Princeton University SALLY C. MORTON, Statistics and Epidemiology, Research Triangle Institute, North Carolina VIJAYAN NAIR, Department of Statistics and Department of Industrial and Operations Engineering, University of Michigan JOSEPH NEWHOUSE, Division of Health Policy Research and Education, Harvard University SAMUEL H. PRESTON, Department of Sociology, University of Pennsylvania KENNETH PREWITT, School of International and Public Affairs, Columbia University LOUISE RYAN, Department of Biostatistics, Harvard University ROGER TOURANGEAU, Joint Program in Survey Methodology, University of Maryland ALAN ZASLAVSKY, Department of Health Care Policy, Harvard Medical School CONSTANCE F. CITRO, Director

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The National Children’s Study Research Plan: A Review BOARD ON CHILDREN, YOUTH, AND FAMILIES BERNARD GUYER (Chair), Bloomberg School of Public Health, Johns Hopkins University BARBARA L. WOLFE (Vice Chair), Department of Economics and Population Health Sciences, University of Wisconsin WILLIAM R. BEARDSLEE, Department of Psychiatry, Children’s Hospital, Boston JANE D. BROWN, School of Journalism and Mass Communication, University of North Carolina, Chapel Hill LINDA MARIE BURTON, Sociology Department, Duke University P. LINDSAY CHASE-LANSDALE, Institute for Policy Research, Northwestern University CHRISTINE C. FERGUSON, School of Public Health and Health Services, George Washington University WILLIAM T. GREENOUGH, Department of Psychology, University of Illinois RUBY HEARN, Robert Wood Johnson Foundation (emeritus), Princeton, New Jersey MICHELE D. KIPKE, Saban Research Institute, Childrens Hospital, University of Southern California BETSY LOZOFF, Center for Human Growth and Development, University of Michigan SUSAN G. MILLSTEIN, Division of Adolescent Medicine, University of California, San Francisco CHARLES A. NELSON, Laboratory of Cognitive Neuroscience, Children’s Hospital, Boston PATRICIA O’CAMPO, Centre for Research on Inner City Health, St. Michael’s Hospital, Toronto FREDERICK P. RIVARA, Schools of Medicine and Public Health, University of Washington, and Children’s Hospital and Regional Medical Center, Seattle LAURENCE D. STEINBERG, Department of Psychology, Temple University JOHN R. WEISZ, Judge Baker Children’s Center and Harvard Medical School MICHAEL ZUBKOFF, Development of Community and Family Medicine, Dartmouth Medical School ROSEMARY CHALK, Director

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The National Children’s Study Research Plan: A Review BOARD ON POPULATION HEALTH AND PUBLIC HEALTH PRACTICE JAMES W. CURRAN (Chair), Rollins School of Public Health, Emory University SUSAN M. ALLAN, Oregon Department of Human Services, Portland GEORGES C. BENJAMIN, American Public Health Association, Washington, DC BOBBIE A. BERKOWITZ, Department of Psychosocial and Community Health, School of Nursing, University of Washington DAN G. BLAZER, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center R. ALTA CHARO, School of Law, University of Wisconsin-Madison JOSE JULIO ESCARCE, David Geffen School of Medicine, University of California, Los Angeles STEPHEN B. FAWCETT, Department of Applied Behavioral Science, University of Kansas HOWARD HU, Environmental Health Sciences, Schools of Public Health and Medicine, University of Michigan MATTHEW W. KREUTER, Division of Behavioral Science and Health Education, School of Public Health, St. Louis University MARTIN JOSE SEPULVEDA, Global Well-being Services and Health Benefits, International Business Machines Corporation, Somers, New York JOSHUA M. SHARFSTEIN, Department of Health, City of Baltimore SAMUEL SO, School of Medicine, Stanford University DAVID J. TOLLERUD, Institute of Public Health Research and Department of Environmental and Occupational Health Sciences, School of Public Health, University of Louisville WILLIAM VEGA, University Behavioral Health Care, Robert Wood Johnson Medical School PATRICIA WAHL, School of Public Health and Community Medicine, University of Washington PAUL J. WALLACE, Health and Productivity Management Programs, Kaiser Permanente, Oakland, California GINA M. WINGOOD, Department of Behavioral Science and Health, Rollins School of Public Health, Emory University ELENA O. NIGHTINGALE, Scholar in Residence, Institute of Medicine, National Academies ROSE MARIE MARTINEZ, Director

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The National Children’s Study Research Plan: A Review Acknowledgments The Panel to Review the National Children’s Study (NCS) Research Plan acknowledges with appreciation the contributions of the many individuals who gave generously of their time and knowledge to this report. Support for the review was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). We particularly wish to thank Peter Scheidt, director of NCS, NICHD, who served as project officer for the review. He was very helpful in providing information and in responding to many questions from the panel and staff. We are grateful to Carla Maffeo, Westat, project officer for the NCS Coordinating Center, for speaking to the panel and providing relevant documents. Members of the panel gave very generously of their time and expert knowledge in the deliberations that produced this report. Their timely and thoughtful work in drafting written reviews of the National Children’s Study is gratefully acknowledged. Staff members of the Committee on National Statistics (CNSTAT) and the Division of Behavioral and Social Sciences and Education (DBASSE) provided important support and assistance to the panel. We acknowledge with gratitude their contributions. Gooloo S. Wunderlich, study director, was responsible for organizing the meetings of the panel, preparing drafts of large portions of the report based on the reviews prepared by panel members, and responding to the many comments from the reviewers on behalf of the panel. Bridget Edmonds provided administrative support. We gratefully acknowledge the important role of Constance F. Citro, director

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The National Children’s Study Research Plan: A Review of CNSTAT, in the preparation of this report. Christine McShane, senior editor of the DBASSE reports office, provided professional editing advice, and Kirsten Sampson Snyder efficiently shepherded the report through the report review process. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the Report Review Committee of the National Research Council. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: Lia C. H. Fernald, School of Public Health, University of California, Berkeley; Elizabeth T. Gershoff, School of Social Work, University of Michigan; Howard Hu, Department of Environmental Health Sciences, University of Michigan Schools of Public Health and Medicine; Aletha C. Huston, Human Development and Family Sciences, University of Texas at Austin; Lorraine V. Klerman, Institute for Child, Youth, and Family Policy, The Heller School for Social Policy and Management, Brandeis University; Roderick J. A. Little, Department of Biostatistics, University of Michigan; Jenae M. Neiderhiser, Human Development and Family Studies, The Pennsylvania State University; Thomas Smith, National Opinion Research Center, The University of Chicago; Deborah Klein Walker, Principal Associate, Abt Associates Inc., Cambridge, MA; Lawrence Wissow, Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health; and Robert Wright, Division of Emergency Medicine, Children’s Hospital Boston. Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the report nor did they see the final draft of the report before its release. The review of this report was overseen by Nancy Adler, Center for Health and Community, University of California, San Francisco. Appointed by the National Research Council, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring panel and the institution. Samuel H. Preston, Chair Panel to Review the National Children’s Study Research Plan

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The National Children’s Study Research Plan: A Review Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   15      Background,   15      The Panel’s Review,   18      Organization of This Report,   21 2   NCS GOALS, CONCEPTUAL FRAMEWORK, AND CORE HYPOTHESES   23      Design in Brief,   24      Study Goals,   33      Conceptual Framework,   42      Core Hypotheses,   47      Using the Vanguard Centers as Pilots,   51 3   PRIORITY OUTCOME AND EXPOSURE MEASURES   53      Priority Outcomes,   54      Exposure Measures,   78 4   STUDY DESIGN, DATA COLLECTION, AND ANALYSIS   101      Design Summary,   101      Sampling Design,   103      Data Collection,   110      Data Analysis and Dissemination,   117

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The National Children’s Study Research Plan: A Review 5   ETHICAL PROCEDURES AND COMMUNITY ENGAGEMENT   121      Approach to Review,   121      Criteria for Giving Information to Participants,   122      Protection and Release of Information,   124      IRB Review Authority,   126      Informed Consent,   127      Community Engagement,   127      Conclusion,   129 6   CONCLUSIONS AND RECOMMENDATIONS   131      Chapter 2:  NCS Goals, Conceptual Framework, and Core Hypotheses,   131      Chapter 3:  Priority Outcome and Exposure Measures,   133      Chapter 4:  Study Design, Data Collection, and Analysis,   137      Chapter 5:  Ethical Procedures and Community Engagement,   138     REFERENCES   141     BIOGRAPHICAL SKETCHES OF PANEL MEMBERS   147