# Presentation: 511476

## Design Development Projects for the National Children’s Study (NCS)

**Design Development Projects for the National Children’s 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

- 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**

**Results/Conclusions**

**Future Directions**

**Science Questions**

- 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 Children’s 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]).

- ORD’s efforts are critical to the design and implementation of the NCS, and the ability of this study to identify children’s environmental risk factors for disease.  This is being achieved through:
- Drawing from previous work for use in the NCS, and other studies of children’s 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)

- The National Children’s 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.

- ORD will continue these activities, as listed in the next steps.  In addition to those projects listed here, discussions of potential ORD/EPA’s activities are currently underway for:

**References**

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

***Lessons Learned . . .***

- . . . from the NIEHS/EPA Children’s Environmental Health Centers
- Goals:
- To develop a series of manuscripts to provide the collective lessons learned from the NIEHS/EPA Centers for Children’s Environmental Health and Disease Prevention Research for the National Children’s 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 Children’s Study.
- Papers, all submitted to Environmental Health Perspectives:
- Kimmel CA, et al. Lessons Learned from the NIEHS/EPA Centers for Children’s Environmental Health and Disease Prevention Research for the National Children’s Study.
- Eskenazi B, et al. Methodological issues in conducting longitudinal birth cohort studies: Lessons learned from the Centers for Children’s Environmental Health and Disease Prevention Research.
- Israel BA, et al. Community-based participatory research: Lessons learned from the Centers for Children’s Environmental Health and Disease Prevention Research.
- Dietrich KN, et al. Principles and practices of neurodevelopmental assessment in children: Lessons learned from the Centers for Children’s Environmental Health and Disease Prevention Research.
- Eggleston PA, et al. Lessons learned for  the study of childhood asthma from the Centers for Children’s Environmental Health and 					                 Disease Prevention Research.
- Fenske RA, et al. Lessons learned for the 				           assessment of children’s 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 Children’s                                                                           Environmental Health and Disease Pre-					                 vention Research.

**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
**Next Steps**
- Protocol development
- How can we best support the full NCS?
- Breadth and depth issues
- Identifying study communities
- Preparing for the human studies research review process

***North Carolina Cohort***

***Sample Design Workshop***

**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)
- Use a mixed approach to second stage sampling, with some centers (or some portion of each center) devoted to recruitment and retention of a volunteer or quota sample.
**Next Steps**
- Pilot the approach to assure its feasibility in terms of recruitment/retention, collection of needed biologic and environmental samples, costs, etc.

***Technology***

**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 Children’s 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
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**	****	****	****	****	****	****	****        ****Next Steps**
- Using the study plan, work with other groups (e.g. Exposure Committee, ICCPO) to develop technology plans for implementation.

- 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.