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 September 2003 NCSAC Meeting Recommendations Summary

September 14–16, 2003
Holiday Inn Select
Bethesda, MD

Recommendations Summary

Committee Discussion

  • The National Children’s Study should try to engage representatives from various communities at the Study Assembly.
  • In the case of dispersed communities, a series of focus groups might yield insights that could enhance the Study design.
  • The NCSAC should request an update from the Community Outreach and Communications Working Group.

Update by Program Office: Study Timelines and Protocol Development

  • Dr. LeMasters asked about the timeline for protocol development. Dr. Scheidt replied that the timeline calls for a preliminary first draft of the protocol by December, with a final protocol by summer 2004. Difficulties and delays in recruiting and hiring full-time staff might cause some slippage of that timeline. However, the hope is to be able to share with the NCSAC and others a preliminary outline or draft of a protocol as close as possible to the December timeline. Because of the necessity for openness, the draft will probably be made available on the Web page as well, for access by the interested scientific community can see what is evolving.
  • The Study should solicit advice from federal QA experts with regard to timing.

Update of "Sampling" Strategies

  • The result of the workshop would be a recommendation to the Study planners (ICC, Study Program Office, and NCSAC) for the sampling designs and/or the features of designs that should be pilot tested.
  • Background papers might be completed in November.
  • Dr. Scheidt responded to the above comments by saying that from his perspective as a member of the committee, that the most important aspects of this process are open and balanced deliberation and bringing as much fact as possible to the deliberation. The committee views the consensus-type conference as a means to that deliberation and has specified open-mindedness as a criterion for membership in the workshop panel. However, while the panel will make a recommendation based on a fair and balanced processing of as much information as possible, the final decision about the sampling design will be based on input from the NCSAC to the ICC and to the Institute Director.

Update by Injury Working Group

  • The Study should be sure to assess the impact of violence in the home.

American Psychological Association

  • Dr. Michael commented that he would like to know from the APA how much data capture, in terms of duration and frequency, would be required to get a sound indicator of healthy development of the child over time.
  • Dr. LeMasters asked about the precursors to resiliency and the method to measure them. Dr. Bullock replied that resiliency is a relatively new concept and that there are experts in that area who would be able to respond to these questions.
  • The Study should look at childhood mental disorders, such as autism, as well as positive mental health, such as resilience.
  • The APA recommends oversampling in minority groups from low- and high-socioeconomic backgrounds to gather critical information to address health disparities.
  • Consider seeking APA advice about measuring the impact of a potential major traumatic event in the United States or elsewhere that would likely affect the mental and emotional health of children.
  • Develop a mechanism for obtaining assistance from behavioral experts.

Update by Exposure to Chemical Agents Working Group

  • The pilot study report will be available in about one month.
  • Dr. Mattison responded that the coordination of timelines would be a task for the Executive Committee.
  • There is a need for some sort of "exposure assessment for the complete idiot" to be developed that would outline what kinds of things can be done for what kinds of costs and show the tradeoffs between the high cost and invasive measures versus less invasive measures. He also stressed the need for coordination among the Working Groups regarding the tools for exposure assessment.
  • Exposure to Chemical Agents Working Group members could assist in getting more specificity on the chemicals, drugs, or other exposures involved as the Study hypotheses are finalized and then communicate with other Working Groups.
  • There is a need for coordination among the Working Groups regarding the tools for exposure assessment.

Asthma Thematic Sub-Group

  • In the course of making asthma measurements, data on normal lung development could also be obtained.

Injury Thematic Sub-Group

  • Dr. Zuckerman stated that the results of the discussion would go back to the Working Group, which will revise the hypotheses to make them more specific. Also, there might be another iteration before the revised hypotheses would be seen by the NCSAC.

Altered Neurobehavioral Development, Developmental Disabilities, and Psychiatric Outcomes Thematic Sub-Group

  • Dr. Foorman reported on the discussion concerning the hypotheses from the Development and Behavior Working Group. The Working Group has not made much progress: the existing hypotheses are diffuse, and the Working Group has not really addressed developmental and behavioral outcomes in its hypotheses. Dr. Foorman’s group suggested that the Working Group be reconstituted; that the new members react to Battelle’s forthcoming white paper on outcome measures; and that this new group should interact with other Working Groups, such as the Social Environment Working Group, the Gene-Environment Interactions Working Group, and the Exposure to Chemical Agents Working Group.
  • Dr. Mattison suggested that he, Dr. Foorman, and Deborah A. Phillips, Ph.D., Georgetown University (and others as appropriate) could discuss making changes to the membership of the Working Group and how to deal with inviting new members. He added that he would appreciate nominations from others as well for new members for the Working Group.
  • Dr. Scheidt replied that a full-time behavioral scientist is being added to the staff and will be involved in moving the process along.
  • Dr. Michael recommended that the Health Services Working Group also be involved in this process because of its relevant orientation and mindset. Dr. Mattison agreed.
  • The Development and Behavior Working Group should be reconstituted. Drs. Mattison, Foorman, and Phillips will work on this issue. NCSAC members should provide Dr. Mattison with nominations for new members for the Working Group. The reconstituted Working Group should react to Battelle’s forthcoming white paper on outcome measures and interact with other Working Groups (such as the Social Environment, the Gene-Environment Interactions, and the Exposure to Chemical Agents Working Groups).
  • All Working Groups should be asked whether collecting data on siblings would benefit or detract from studying their hypotheses, with the goal of getting back some input for the Study Design Working Group as early as possible.
  • A workshop should be conducted to address the biology of race, the definition of race, and the handling of race within this Study, in order to sample in a way that makes sense and to have data that will be useful in relation to the U.S. population.
  • The Health Services Working Group should also be involved in this process because of its relevant orientation and mindset.
  • The Social Environment Working Group should provide input across the board.

Obesity and Altered Physical Development Thematic Sub-Group

  • Regarding the health services hypotheses, Dr. Doswell said that although the group’s definitions of health were good, there needed to be a streamlining of the many hypotheses that the group had under different subcategories.
  • There were no hypotheses in the community outreach area
  • Mr. Swartz reported that the Nutrition, Growth, and Pubertal Development Working Group had concluded that that their hypotheses do not need 100,000 people, so the group is not submitting any core hypotheses because the questions can be answered elsewhere.
  • Dr. Mattison asked whether the Nutrition, Growth, and Pubertal Development Working Group should be reconstituted. There was some additional NCSAC discussion about this Working Group.
  • Dr. LeMasters asked whether it was time to consider consolidating the Working Groups and whether it was the role of the NCSAC to address this issue. Dr. Mattison indicated that the answer to both questions was "yes." Dr. Suarez suggested discussing this matter the following day, and Dr. Mattison agreed.
  • The Early Origins of Adult Health Working Group should coordinate with other groups about genomic issues.
  • The NCSAC should consider consolidating the Working Groups.

Undesirable Outcomes of Pregnancy: Birth Defects and Preterm Birth Thematic Sub-Group

  • With regard to the Fertility and Early Pregnancy Working Group’s hypotheses, Dr. Daston said the group would be asked to identify the key exposures that need to be evaluated and encouraged to make their proposals uniform. One of the Working Group’s proposals, related to assisted reproductive technologies, would best be done elsewhere.
  • Regarding the Medicine and Pharmaceuticals Working Group, Dr. Daston said that group would be charged with developing a tiered approach, including a questionnaire that would be applied uniformly across the Study to assess exposures to prescription and over-the-counter medications, as well as herbal, botanical, and other agents. This should also consider exposures in extraordinary circumstances, such as when a parent, a pregnant woman, or a child is treated aggressively in a hospital setting for a disease or condition.
  • A core list of potential etiological agents or contributors to good or bad outcomes should be compiled and evaluated uniformly throughout the Study.
  • Other Working Groups, such as Fertility and Early Pregnancy, Exposure to Chemical Agents, and Medicine and Pharmaceuticals, should identify those agents or factors and outcomes that need to be included in the Study as a whole.

Report from Joint ICC/NCSAC Executive Committee

  • The NCSAC should notify the Executive Committee if there are additional activities that it should be undertaking or if there are problems with processes that should be addressed.

General Discussion and Comments, End of Day 1

  • Dr. Scheidt commented that he was puzzled about the lack of hypotheses from the Nutrition, Growth, and Pubertal Development Working Group. He suggested that the NCSAC might want to further discuss this issue further.
  • Mr. Swartz remarked that the Working Group’s belief was that nutritional factors should be integrated into other hypotheses with the Working Group’s advice. He added that the NCSAC needed to determine whether or not the other sets of hypotheses asked the appropriate nutritional questions.
  • Dr. Graham agreed with Mr. Swartz and said that the thematic sub-group had created a "no-brainer" list of measures that included things such as folate. She added that all the nutritional elements needed to be measured and that other Working Groups, such as the Medicine and Pharmaceuticals and the Exposure to Chemical Agents Working Groups, would need to address these measures. Dr. Spence agreed and mentioned a folate hypothesis from the Gene-Environment Interactions Working Group. Dr. Zuckerman suggested that a nutritionist be included in the other related Working Groups.

Hypotheses Submitted by the American Foundation for Maternal and Child Health (AFMCH)

  • Documenting children’s intrapartum exposure to drugs and procedures administered to the mother during labor and birth is essential to any meaningful environmental study of human development.

Discussion of Agenda

  • Include ICC liaisons when NCSAC members conduct conference calls with Working Group chairs.
  • Circulate thematic sub-group meeting notes to the sub-group members first.
  • Schedule conference calls among the liaisons before speaking with the Working Groups.
  • Ms. Leahey will confer with the NIH attorneys to obtain information regarding Working Group members possibly being precluded from being considered as Study centers.
  • Ms. Leahey will circulate thematic sub-group meeting notes to the sub-group members first.

Summaries by Thematic Sub-Group Liaisons

  • Dr. Michael said that he disagreed with the concept that one can separate the hypothesis from the instrumentation. Dr. Mattison agreed and said that was why the Working Groups should recommend specific instruments and methods
  • Development and Behavior Working Group: the main issues are reconstituting the Working Group and how the new group will interface with the Battelle white paper on measures.
  • Dr. Graham suggested when the Development and Behavior Working Group is reconstituted, it should include a neurotoxicologist. She suggested seeking the advice of Dr. Kevin Crofton in the neurotoxicology division of EPA’s National Health and Environmental Effects Research Laboratory. Dr. Graham drew a distinction between the person who is a coauthor of the latest review article on neurotoxicology and the exposure group person who is capable of making the needed measurement.
  • The Working Groups should review each hypothesis, look at potential collaboration with other Working Groups, and think about which Working Group is most appropriate to address each hypothesis.
  • In refining a hypothesis, each group should refer to the original checklist that was prepared by the Study Design Working Group and approved by the NCSAC.
  • The lack of specificity (for example, whether the hypothesis requires a study of this size and complexity or details about methods and measures), needs to be addressed at the December meeting.
  • There should be a hypothesis on classes of chemicals.
  • The Asthma Working Group needs to communicate with the Community Outreach and Communications Working Group and that the biological and the social sciences should be linked together.
  • The Health Services Working Group and the thematic sub-group interacting with this Working Group should develop a module on expenditures on behalf of the whole Study, as well as a module designed for those children with special needs, because these expenditures are atypical.
  • The Fertility and Early Pregnancy Working Group should rework three hypotheses into a combined, more comprehensive hypothesis that specifies exposure agents and outcomes over the life course. This Working Group should interact with the Birth Defects Working Group and the Medicine and Pharmaceuticals Working Group.
  • The Gene-Environment Working Group should develop questions related to siblings; these questions should be disseminated to all Working Groups.
  • NCSAC should move ahead on scheduling and conducting a workshop on race. While the Gene-Environment Working Group may take the lead, this matter will be brought to all the Working Groups for comment.
  • The Nutrition, Growth, and Pubertal Development Working Group should review all references to obesity within the Study. This Working Group should collaborate with the new Physical Environment Working Group to ensure that the obesity hypotheses are adequate.
  • The cultural aspects of diet and nutrition needed to be considered in the hypotheses.

Timeline for Advisory Committee

  • The Executive Committee should continue to work on coordinating timelines.
  • The Executive Committee should consider a schedule with hypotheses due in December, reviewed in January by the Study Design Working Group, revisions made in February, and reviewed by the NCSAC at the end of March.
  • Dr. Graham, Chair of the Executive Committee, will report at the December meeting on finalizing a timeline and what it means with respect to the Working Groups and to Study implementation.
  • The process of moving hypotheses will be from each Working Group to the Study Design Working Group to the NCSAC by the end of January. However, the Study Design Working Group will be consulted as to the feasibility of this schedule.

Planning for December Meeting

  • Ms. Leahey will provide NCSAC members with rosters of all current Working Group members and the co-chairs.
  • Ms. Leahey will schedule conference calls with Working Group co-chairs and their NCSAC and ICC liaisons to discuss plans for the December meeting and determine whether additional Working Group members should be invited to the meeting.
  • Ms. Leahey will provide the committee with the cross-Working Group notes from the December 2002 meeting for reference.
  • Before the conference call, committee members should review a proposed letter to Working Group members calling for the revised hypotheses. Committee members also should review the letter that the NCSAC had previously issued to the Working Groups.

Breakout: Asthma

Asthma Incidence/Prevalence

  • Hypotheses should reflect a merging of biomedical and social science, as well as incorporate poverty.
  • Behavioral factors should be included.

Specificity of Asthma Study Questions

For clearer definitions

  • How is asthma defined?
  • At what age or developmental point is wheezing predictive?
  • What elements in the future are predicted by a wheezy child?
  • How do should asthma be defined at different ages?

More information

  • Reactions to cold air
  • The age at which respiratory outcomes distinguish children at great risk.
  • What are asthma phenotypes and how are they measured at different ages?
  • How do you measure airway obstruction in the first 2 years of life?
  • Should the hypotheses include measuring:
    -indoor exposure to environmental agents such as bioaerosol agents
    -environment of tobacco smokers
    -exposure to nitrogen dioxide for a specific period
  • Should the Study focus on identifying baselines on background levels of agents?
  • How do the hypotheses measure the relations between independent and dependent variables?

All four subtypes in the first hypothesis should receive equal weight.

A study of this magnitude is necessary to consider interactions.

Asthma in Urban Populations

  • City populations had a remarkable increase in the incidence of asthma as a result of pollutants
  • Test drug and exposure measures
  • Exposures of concern would be measured.


  • Whereas the overall hypotheses are well written, the Working Group should now address more specificity (for example, exposure measures and the effects of asthma on parent and child).
  • Conduct a workshop on the diagnosis of asthma.
  • Select specific population groups to identify and over sample for risk exposures (for example, bronchial challenge could be limited to those with symptoms).
  • Consider having the Working Groups do nested studies and case control studies.

Next Steps

Participants agreed that the hypotheses are solid. Participants urged the Working Group to move on to delineating specifics and priorities:

  • What species do we need to measure?
  • Within what timeframes?
  • At what sensitivity (quantitative assessment)?
  • What are expected outcomes?
  • What is asthma?
  • At what age will incidence/prevalence of asthma be first measured?
  • What is the measure?
  • How do we test pulmonary function in young children—for example, squeeze test?

Giving Back to the Community

Benefit of giving something from the Study to the community


  • There should be consideration of what the Study could give back to the community, for example:
    • Community-based resources concerning asthma
    • Short-term deliverables
    • A built-in protocol so that the community is always getting something back
    • An educational component
    • Information on exposures during pregnancy and food allergies; including early pregnancy exposure to pesticides.
  • Feedback to the community should occur annually or every 6 months.
  • Educational intervention and assessment need to be linked.
  • Consider the possibility of cross-pollination among:
    • Community
    • Exposure
    • Gene environment
    • Immunology
    • Pregnancy
    • Adolescence

Structure of Future Meetings

  • Working Groups should propose what they need to move to the next step (for example, a literature review).
  • Working Groups should make proposals about what they want done before proceeding.
  • Working Groups should notify the NCSAC when they need to access the expertise of a member from another Working Group.
  • Refrain from arbitrarily assigning individuals to various groups (as was the case for the Baltimore meeting).
  • Make better use of outside experts where underused.


  • The Study should included personal details, such as an indoor/outdoor measures, community experience, and questionnaires; critical agents such as diesel versus indoor cooking sources; and culprit pollutions’ links with asthma.
  • Hypotheses need to be very specific about what is to measured, and allow enough time to collect these measurements. For example, should indoor dust sampling occur once a year or should it be seasonal?
  • There should be a definitive and cost-effective plan supporting how asthma would be measured.
  • Working Groups need biomarkers for early assessment of asthma outcomes. These can be extended to embrace one other component (for example, a community/social piece or another component).

Breakout: Injury


  • Injury Working Group initially developed seven hypotheses
  • As a result of this feedback, the Working Group developed three broader, overarching hypotheses.
  • Working Group would like some clear direction from the NCSAC on what modifications are required in its hypotheses.

Review of Meeting Purpose

Lack of feedback to members of the Working Groups is a weakness in the process.

Physical Environment and Injury Risk

  • How will land use be defined, and who will be asked about it?
  • How will traffic be defined and who will be asked about it?
  • Where will presence of crossing guards be measured—on the child’s way to school or within a certain distance from the home?
  • How will fire department response time be obtained?
  • Where will the volume and speed of motor vehicle traffic be measured—on the child’s block?
  • Do standard instruments exist?
  • Have these kinds of measurements been done previously?
  • How will the data ultimately be coded and analyzed?

Recommendations for the Physical Environment and Injury Risk Hypothesis

  • The hypothesis must be able to be proven or disproved.
  • The hypothesis needs to make clear what is to be tested so that power calculations and other design issues can be addressed. For example, it should specify the variables involved, including environmental factors, family factors, and type of injury.
  • Collecting epidemiological evidence about the incidence of unintentional injuries could be a goal of the Study.
  • Ascertainment beyond the data collected through self-reports should also be addressed.
  • The Ethics Working Group consider the need to collect clinical data (such as visits to the emergency room or doctor’s office).
  • The Working Group should select and prioritize a subset of the variables listed to examine.
  • The Injury Working Group should ask the Social Environment Working Group about what kinds of community measures that Working Group is considering.

Cumulative Effects of Repeated Mild Traumatic Brain Injury (TBI)

  • TBI hypothesis addresses issues that are significant to public health and human development and are appropriate to a large prospective study
  • A method of ascertainment must be identified

Recommendations for the Hypothesis on Cumulative Effects of Repeated Mild Traumatic Brain Injury (TBI)

  • The hypothesis should be expanded to address both mild and severe TBI, and both repeat and single incidents of TBI.
  • Rather than basing measurements on the intervals selected for the Study by the NCSAC, the Working Group should inform the NCSAC of the optimal measurement intervals based on the literature.
  • Members of the Injury Working Group are more familiar with the injury literature than the Development and Behavior Working Group. Therefore, the Injury Working Group should provide guidance to the Development and Behavior Working Group.
  • Add a fourth focus on parenting function. For example, a sub-hypothesis could stipulate that outcomes from TBI are worse among children whose families fit a particular profile.

Predictors of Child Maltreatment

Functional outcomes are also relevant to head and other kinds of injury. Dr. Zuckerman suggested that these outcomes "represent trajectories in any part of childhood gone awry."`

Recommendations for the Predictors of Child Maltreatment

  • The Working Group should justify explicitly the need for CPS data.
  • Outcomes must be specified for each hypothesis.
  • The Working Group should address the pros and cons of retrospective reporting versus a surveillance approach to help those designing the Study.

Physical Aggression

  • How will aggression be defined and operationalized for younger children and adolescents?
  • How will children with childhood aggression be identified?
  • Are standardized measures available?
  • Will these questions be asked of everyone?

Recommendations for the Physical Aggression Hypothesis

  • Assessments should be conducted once in early childhood, once in latency, and once in early adolescence.
  • Because it is unclear which instrument will be most sensitive to later aggression, the hypothesis should include several instruments.
  • The Study will need to obtain academic records.

Functional Outcome of Injury: Influence of Antecedent Factors

Recommendation for the Hypothesis on Functional Outcome of Injury: Influence of Antecedent Factors: The Working Group should specify the kind of functional outcome and the kind of injury being studied. The same approach should be used for TBI.

Psychosocial Environment and Injury Risk

  • What parts of the psychosocial environment are being referenced?
  • What factors increase risk?

Recommendations for the Psychosocial Environment and Injury Risk Hypothesis

  • The hypothesis should address controlling for protective factors while examining risk factors.
  • The hypothesis should specify direction of the independent predictor in the regression model.
  • This hypothesis should be coordinated with the Development and Behavior Working Group, which has several hypotheses about parental actions and practices.
  • The hypothesis should clearly delineate how to measure parental and caregiver supervision.

Outcomes of Child Maltreatment

  • Does "multiple" refer to two or more, three or more, or something else?
  • How is "severity" defined?
  • How is "maltreatment" defined?
  • How are "moderate," "episodic," and "chronic" defined?
  • How are "emotional/psychological," "cognitive," and "physical" defined?
  • How and when will this be measured?

Recommendations for the Outcomes of Child Maltreatment Sub-Hypotheses

  • The Working Group should clarify whether outcomes a–d in sub-hypothesis A are likely to be the same. If not, the Working Group should specify the order of these four groups.
  • Resilience should be incorporated into the hypothesis.
  • The Study should control for maternal depression or violence in the home, which might have an impact.
  • The Working Group should consider deleting sub-hypothesis A.
  • The Working Group should utilize current literature to inform the direction of the hypothesis.
  • The Study should ask parents about their physical and nonphysical disciplinary strategies.
  • The Injury Working Group should solicit input from the Development and Behavior Working Group because that Working Group is focusing on some of these same characteristics of families.

Next Steps

  • The Working Group needs to further delineate hypotheses with definitions and measurements.
  • The Working Group should retain all of its current hypotheses, prioritizing hypotheses in each category but not across categories.
  • The Working Group should do some power calculations to determine, based on the frequency of some of these events, what size odds ratios could be detected. Hypotheses could then be sorted by feasibility.
  • All of the hypotheses should address measurements, timing, and definitions.

Breakout: Obesity and Altered Physical Development

Outcome Measures

  • Quality health care services connect to mediate the genetic and environmental influences on health: safe, effective, patient- and family-centered, timely, efficient, equitable, and coordinated with public health.
  • Theme of good health should be included in the overall discussion.

Redundant/Overlapping Hypotheses

Quality health services could reduce disparities in health and developmental outcomes. However, this is a very broad hypothesis.


  • Measurable variables should be defined, as should terms such as "other disasters."
  • The Study should be specific about parental attitudes versus abilities.
  • This Working Group should cooperate with the Development and Behavior Working Group to specifically identify mental health areas to be included (for example, ADHD, depression, and schizophrenia).
  • Develop a set of questions on expenditures (including insurance coverage) that would take less than 10 minutes to answer.
  • The new approach to MH4 obviates MH5.
  • Delete MC1. (This hypothesis has already been answered).
  • Delete the item in the PS section on behavioral and developmental testing. (This is already well established.)
  • Delete the entire PS section. (This material is covered by DHHS guidelines.)
  • Refer the issue of EMR to the Immunity, Infections, Vaccines Working Group, with the caveat that the nearly universal reliance on EMR will make the hypothesis difficult to test).
  • Refer MC3 to the Gene-Environment Interactions Working Group.
  • Delete MC4.
  • Delete MC5, concerning surgical outcomes for children cared for in children’s hospitals.
  • Delete MC6—children with special health care needs.
  • Delete MC7.
  • Refer MC8 to the Nutrition, Growth, and Pubertal Development Working Group, with the guideline to ensure that data on dental care and dental health disparities are captured. Also MC8 should be tied to health disparities.

Community Health Services

  • Refer CH2 A, B, and C to the Gene-Environment Interactions Working Group.
  • Refer CH2B and CH3 to the Development and Behavioral Working Group.
  • Refer CH4A and B to the Nutrition, Growth, and Pubertal Development Working Group.
  • Consider including normal pediatric care.

Community Outreach and Communications Working Group

  • Share some of the hypotheses with the focus groups, and perhaps even provide some feedback to the participants.
  • Even with monetary reimbursement for focus group participation, there should be a rewards formula for extra effort, since no effort would produce a certain minimum participation anyway.
  • The Working Group should begin to develop a list of incentives and recruitment strategies for the community (that is, worship centers, government, schools, businesses, and residents).
  • Ensure inclusion of Native Americans in the Study.
  • Develop a plan for disseminating Study results.

Early Origins of Adult Health Working Group (Tab F)

  • Delete the life course hypothesis in its present form (see page 15).
  • The Working Group should address item 6 (see page 15) in terms of methodology.
  • Delete the hypotheses under items 7 and 8. These data already are collected in routine care.

Breakout: Undesirable Outcomes of Pregnancy: Birth Defects and Pre-Term Birth

Measures Clarification

importance of increasing the specificities of Study measures

Data Collection

questionnaire was frequently cited as a way to obtain information

Other methods for obtaining information were discussed. These included reviews of medical records, access to pharmaceutical databases, readings of physiological indices, and procurement of biological samples.

Measurement Versus Hypotheses

A recurring issue emerged concerning whether the Working Groups had confused measures with hypotheses

focus on a basic set of measurements

value of storing biological samples

Overlap/Duplication of Hypotheses

  • Several hypotheses should be combined into one large broad hypothesis, or the Working Group should select one of several hypotheses, with the recognition that they cannot measure everyone and everything.
  • In some instances, Working Groups should be instructed to work together, or they should seek out individuals from other Working Groups with particular expertise relevant to their proposals.

Operational Definitions

Appropriate operational definitions


  • Studies relating to the developmental stage of puberty should be reassigned to the Obesity and Physical Development thematic area.
  • Create a new thematic area, called Reproductive Development (including puberty); or, broaden the Birth Defects and Pre-Term Birth thematic area.

Ethical/Legal Implications

ethical considerations and legal obligations of the researchers when they encountered subjects in the Study who engaged in illegal activities

Recommendation: The Ethics Working Group should be changed to a standing committee to address overall legal and ethical issues.

Breakout: Altered Neurobehavioral Development, Developmental Disabilities, and Psychiatric Outcomes

Data Collection

that key hypotheses may not be initially identifiable, but capturing data on exposures and outcomes early is important.

Merely obtaining DNA samples on a large population will not be useful without developing a focused study plan.

Gene-Environment Interactions Working Group

Gene-Environment Interactions Working Group to develop a framework for a hypothesis or developmental outcome


  • Consider conducting a workshop to lay the foundation for developing a hypothesis.
  • Consider identifying an outside expert to assist or participate in the Working Group.

Study Questions

  • What are the Sub-Group concerns about what the Gene-Environment Interactions Working Group should address?
  • Could the other Working Groups agree on what studies can be practically and reasonably designed?
  • How important a role should genetics play in the Study (which is not inherently a genetics study)?
  • Should the genetics segment extend to siblings? This would significantly increase the value of the Study, but might dilute the target population for the main part of the Study.
  • Should every Working Group consider including siblings and/or multiple births?

Clarifying/Refining Hypotheses

need to clarify hypotheses 19 through 21, and especially hypotheses


  • Direct specific questions to the Gene-Environment Interactions Working Group.
  • Clarify hypotheses 19–21, especially hypotheses 20.
  • The hypothesis concerning stress and asthma may be too narrow; the candidate genes should be expanded.
  • The Nutrition, Growth, and Pubertal Development Working Group should reconsider the study on genetic determinants of obesity and the effect of environmental factors and return the study to the Gene-Environment Interactions Working Group for review. The two Working Groups should consider the study together. [Did they mean hypothesis rather than study?]
  • Conduct a conference call to resolve issues that cross across the purviews of two or more Working Groups.
  • Convene a general meeting to identify issues that require cooperative effort, and then make whatever arrangements are appropriate to work on those issues.
  • The NCSAC should identify cross-cutting issues and direct that one or more Working Groups address these issues.
  • There should be a mechanism to provide access to expert consultants.

Social Environment (Tab N)

Whether race outcomes will be part of the Study. If so, how will these outcomes be defined? Participants agreed that this is an important issue because race is a concept that will probably change significantly over the course of the Study.


  • Conduct a workshop on the aspects of race that might impact the Study.
  • Consider assigning the issue of race to the Gene-Environment Interaction Working Group.

Cross-Cutting Issues


  • Solicit input from the various Working Groups on Study outcomes, and prepare a list of key developmental/behavioral outcomes (including well-child and more serious impairments and conditions).
  • Convene a meeting to identify issues most appropriate to the Study. Include a neurologist to discuss serious developmental conditions (such as epilepsy, mental retardation, and autism).

Developmental Measures


  • The Working Group should work with the NCSAC and Battelle as the report is prepared.
  • Interim reports from Battelle should be distributed to all Working Groups.
  • Consider restructuring the Development and Behavior Working Group to ensure appropriate attention to behavioral as well as developmental issues.
  • Request further clarification from the Development and Behavior Working Group on the major hypothesis (positive environment), which would be well-informed by making the hypothesis more specific. However, if the Working Group were reconstructed, it would probably be best to wait for the Battelle report.


Specificity, the broad range of data routinely collected using standard instruments (for example, IQ tests), and the need to identify neurodevelopmental conditions for the Study.


  • Consider identifying other relevant behaviors (such as parental behaviors) that may create an environment of child endangerment).
  • Target select sub-groups from the entire sample to look at specific behaviors and/or conditions that would be relatively rare among the overall Study population.

Spanish-Language Study Component

The importance of having a Spanish language component