Design Development Projects for the National Childrens Study NCS

1
Design Development Projects for the National
Childrens Study (NCS) Sherry G. Selevan,1 Carole
A. Kimmel,1 Pauline Mendola,2 James
Quackenboss,3 Nigel Fields,4 Rebecca Brown,1
Peter Scheidt5 1 ORD/NCEA, 2 ORD/NHEERL, 3
ORD/NERL, 4 ORD/NCER, 5 NCS Director, NICHD/NIH
Technology
Results/Conclusions
Lessons Learned . . .
Science Questions

• Background
• ORD has organized several efforts to identify
  technologies to increase efficiency and accuracy
  of the data while reducing respondent burden.
• Use new and emerging technologies to encourage
  long-term participation and enhance data quality
  for biologic and environmental monitoring, and
  collection of questionnaire data.
• Examples of technologies that could be used or
  adapted in the NCS
• Biologic measures
• bioelectrical impedance scales
• automatic blood pressure cuffs
• Medical data
• digital medical record systems
• computer/video distance examinations or
  interviews
• Key pad devices hooked up to phone lines to
  transmit data
• Environmental data
• GPS
• Sensors, pumps, passive monitors in the home
• Completed activities
• White Paper, ERG Identification of Emerging and
  Innovative Technologies for Use in The National
  Childrens Study. Evaluation of the state of the
  science. 2002
• Workshop Innovative Technologies for Remote
  Collection of Data. 2003
• White Paper, RTI Use of Sensors and RFID for the
  NCS. 2004

• . . . from the NIEHS/EPA Childrens Environmental
  Health Centers
• Goals
• To develop a series of manuscripts to provide the
  collective lessons learned from the NIEHS/EPA
  Centers for Childrens Environmental Health and
  Disease Prevention Research for the National
  Childrens Study.
• To develop such papers on 6 topic areas study
  design, exposure assessment for pesticides and
  air pollution, neurobehavioral development,
  asthma, and community-based participatory
  research.
• To publish the papers as a mini-monograph in
  Environmental Health Perspectives.
• To integrate the information as appropriate to
  the study plan and protocol for the National
  Childrens Study.
• Papers, all submitted to Environmental Health
  Perspectives
• Kimmel CA, et al. Lessons Learned from the
  NIEHS/EPA Centers for Childrens Environmental
  Health and Disease Prevention Research for the
  National Childrens Study.
• Eskenazi B, et al. Methodological issues in
  conducting longitudinal birth cohort studies
  Lessons learned from the Centers for Childrens
  Environmental Health and Disease Prevention
  Research.
• Israel BA, et al. Community-based participatory
  research Lessons learned from the Centers for
  Childrens Environmental Health and Disease
  Prevention Research.
• Dietrich KN, et al. Principles and practices of
  neurodevelopmental assessment in children
  Lessons learned from the Centers for Childrens
  Environmental Health and Disease Prevention
  Research.
• Eggleston PA, et al. Lessons learned for the
  study of childhood asthma from the Centers for
  Childrens Environmental Health and
  Disease Prevention Research.
  
• Fenske RA, et al. Lessons learned for the
  assessment of childrens pesticide
  exposure critical
  sampling and analytical issues for
  future studies.
• Gilliland F, et al. Air pollution exposure
  assessment for epidemiologic studies of
  pregnant women and children
  lessons learned from the
  Centers for Childrens
  
  Environmental Health and Disease Pre-
  vention Research.

• ORDs efforts are critical to the design and
  implementation of the NCS, and the ability of
  this study to identify childrens environmental
  risk factors for disease. This is being achieved
  through
• Drawing from previous work for use in the NCS,
  and other studies of childrens environmental
  health
• Using information from a North Carolina cohort to
  inform the design and execution of the national
  study
• Identifying technologies to reduce the burden and
  decrease costs for large cohort studies and
• Influencing sampling design decisions for the NCS
  (a nationally representative probability sample)

• What lessons can we learn from other projects to
  assist in planning and executing the NCS?
• How can the sample best be selected to answer the
  diversity of questions in the NCS?
• How can innovations in technology be used to
  reduce respondent burden and increase data
  quality?

Research Goals
Impact and Outcomes
ORD scientists have led several projects that
impact the design of the NCS. These
include The examination of the experience of
others in the field for example, the NIEHS/EPA
Childrens Environmental Health Centers have much
experience in conducting long-term birth and
school-age cohort studies. ORD scientists have
worked with Center scientists to develop
publications highlighting lessons learned with
regard to study design, community-based
participatory research, pesticide and air
pollution exposure assessment, asthma, and
neurobehavioral development (LESSONS LEARNED . .
. Panel 1). Given the depth and length of data
collection in the NCS, planners are concerned
about the study being overly burdensome to the
participants. ORD scientists, along with those
from the other lead agencies, have been exploring
alternative ways to collect data from respondents
that are less burdensome, allow collection of
information between clinical visits, increase
data accuracy, and allow analysis in a more
timely fashion. This has included the
development of an annotated bibliography of
available technologies, a workshop on innovative
technologies for remote collection of data
(questionnaire, health and exposure data), and
white papers (TECHNOLOGY Panel 2). ORD is
leading an interagency effort to initiate an
early cohort in North Carolina that will have
sufficient power to answer some research
questions of interest to the NCS. Just as
importantly, this initial project will allow
implementation of the methods and approaches
identified for the larger study to assess their
suitability for field use (NC COHORT Panel 3).
Finally, one critical question is the sample
design for selection of study areas and
participants. Different questions within the NCS
have different design requirements to obtain
valid results. ORD scientists played major
roles, along with scientists at the other lead
agencies and the NCS Advisory Committee, in
exploring the strengths and limitations of design
options through white papers, an expert workshop,
and other discussions. ORD scientists are
currently working with the National Center for
Health Statistics to implement the sampling
strategy (SAMPLE DESIGN WORKSHOP Panel 4).
The National Childrens Study will greatly
contribute to understanding the role environment
plays in healthy growth and development. The
longitudinal study design and large number of
families followed will allow examination of a
range of exposures not possible in smaller
studies. These data will contribute to risk
assessments, by providing quantitative exposure
measures at different points in development, and
directly linking them to health outcomes of
importance.
Sample Design Workshop
North Carolina Cohort

• Background
• ORD scientists participated in (and chaired) a
  subcommittee to gather information needed to make
  the decision about the sample design of the
  study.
• Membership of the subcommittee also included
  members from other federal partners, the NCS
  Advisory Committee and its working groups.
• This process was initiated due to the recognition
  of a spectrum of opinions of the appropriate
  design of the study, given the variety of issues
  addressed.
• Implementation
• Identification of the Study Design
• The subcommittee identified topics for background
  papers, including
• Comparison of sampling approaches Effects
  on recruitment and retention
• Power for the priority areas Costs of
  different approaches
• The subcommittee identified a multidisciplinary
  panel to recommend approaches
• After advise from the panel, the Advisory
  Committee and the Interagency Coordinating
  Committee, the Director, NICHD selected the
  sample design.
• Development of the Study Design
• A federal subcommittee was formed, including ORD
  scientists from the prior subcommittee, with the
  addition of other federal members, including a
  sampling statistician from NCHS.
• The workshop identified the following key items
  used in the development of the design
• A national probability sample is preferred to
  other sampling approaches
• Centralization of key activities is needed to
  maintain standard methods and quality control,
  and for follow up of children over the extended
  study period
• include siblings to allow for special studies of
  genetic and gene-environment effects
• include some proportion of women who would be
  enrolled and monitored prior to conception
• need for geographic clustering in the sampling
  strategy. (The final number of 101 PSUs is
  lower than suggested based on cost and logistical
  considerations)

• Study Concepts
• Support the implementation of the full NCS -
  testing methods, protocols and policies
• High quality longitudinal study of children,
  their families and their environment in NC
• Provide a platform for federal scientists to
  participate
• Not an EPA study, but a joint effort across the
  lead agencies
• Implementation
• Builds on the NCS Study Plan
• Supports full implementation by field testing
• Sampling strategies Community engagement
• Recruitment and retention Data collection
  strategies
• Logistics
• Key differences from the NCS National Probability
  Sample and Vanguard sites
• Earlier timeframe (FY 06) No teen mothers
• Earlier results (1-2 years ahead)
  Focused study
• Conduct more validation substudies
• Exposure measures Incentives
• Recruitment strategies Alternative measures

Future Directions
ORD will continue these activities, as listed in
the next steps. In addition to those projects
listed here, discussions of potential ORD/EPAs
activities are currently underway for

• providing scientific expertise and technical
  support (including development and evaluation of
  the Study IT system)
• a proposed Study Scientific Applications Center
  (including environmental-related analyses and
  modeling)
• potential science portal and grid applications
• scoping requirements for providing back-up
  capability for the Study Coordination Center.

References
For additional information, visit
www.nationalchildrensstudy.gov.