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 December 2003 NCSAC Meeting Summary: Injury

Appendix III: National Children’s Study Advisory Committee 8th Meeting

Thematic Group Breakout Meeting Summary: Injury

December 15, 2003
Sheraton Atlanta Hotel
Atlanta, GA

Chair: Alan R. Fleischman, M.D., NCSAC Member, New York Academy of Medicine


Dr. Fleischman convened the group, and participants introduced themselves. Dr. Fleischman noted that no members of the Injury Working Group were in attendance, and he gave a brief synopsis of work accomplished to date by that group:

  • The Injury Working Group initially developed seven hypotheses. The Working Group received feedback for the Interagency Coordinating Committee (ICC) and the National Children’s Study Advisory Committee (NCSAC). As a result of this feedback, the Working Group developed three broader hypotheses.
  • The Working Group then asked for examples of approved hypotheses, and the ICC sent them three well-developed hypotheses.
  • Despite reminders, the Injury Working Group has done no further work.
  • Barry Zuckerman, M.D., Boston University School of Medicine, is the NCSAC liaison to the Injury Working Group. Peter Scheidt, M.D., M.P.H., NICHD, NIH, DHHS, is the ICC liaison to the Working Group.

Working Hypotheses

Members of the group discussed the status of the working hypotheses of the Injury Working Group. The suggested hypotheses from the September 2003 meeting concerned:

  • Physical environment and injury risk
  • Cumulative effects of repeated mild traumatic brain injury
  • Predictors of child maltreatment.

Dr. Scheidt said that the physical environment hypothesis was not written in a way that it could be proven or disproven. He asked how to determine actual incidence and develop reporting mechanisms. Another issue that needs clarification is the definition of the environment of the child (home, community, school). How would the Study track multiple environments? Specific risk factors for injury in the home were presence of smoke detector, full flights of stairs, and carpet or hardwood floors.

Warren Galke, Ph.D., NICHD, NIH, DHHS, mentioned that there were no validated instruments for assessing the house of a child, although there is one validated for seniors. Robert Bradley, Ph.D., Center for Applied Studies in Education, University of Arkansas, added that the home environment stretches as the child gets older and that home and play areas are different in inner city, suburban, or rural environments. Different ethnic groups may have multiple home settings (for example, Native Americans). Other settings in which children are injured include:

  • Daycare (home and institutional)
  • Schools (elementary, middle, high school, and college)
  • Neighborhood land recreational areas (playgrounds)
  • Neighborhood water recreational areas (pools, lakes)
  • Places of employment (teens and young adults).

Dr. Fleischman mentioned that instruments would need to be developed for each setting. Dr. Scheidt said that a large sample size is necessary to validate rare but devastating injuries such as burns or drowning.

To study the cumulative effects of repeated mild traumatic brain injury, researchers need to define the injuries that qualify and determine ways to identify them. Questions posed during the discussion were:

  • Should only injuries that require medical care be evaluated?
  • How will researchers obtain consent?
  • Should linkage to Child Protective Services data sets be used?
  • Will information be collected from interviews or observations?

Attendees commented that there is overlap between repeated traumatic brain injury and child maltreatment.

Dr. Galke mentioned the potential for neurotoxic chemicals to affect behaviors that might predispose children to injury. Dr. Scheidt responded that the ICC proposed a specific hypothesis on that topic and asked the Injury Working Group for a response. Dr. Bradley said that neurotoxic exposures in utero could affect injuries in adolescents. Therefore, it is necessary to test exposures to toxic substances and measure cognitive function years later, including measures of regulatory systems (for example, impulsivity). Damage to the ability to plan, organize, process information, and control behavior can result in increased risk of injury, poor school performance, limited ability to comply with medical treatment, and other comorbidities. Participants said that some neurotoxicants that might affect risk of later injury are:

  • Environmental tobacco smoke
  • Pesticides
  • Carbon monoxide
  • Over-the-counter and prescribed medications
  • Herbal products or folk remedies
  • Nutritional supplements
  • Alcohol
  • Illicit drug use
  • Chemical exposures from home-based businesses
  • Infectious agents
  • Intrauterine nutrition
  • Physical environment (for example, living on a farm or next to a factory).

Dr. Fleischman said that measures of neurotoxin exposure, later brain function, and later injuries are necessary to identify interrelationships.

Ethical Considerations

A lengthy discussion began on ethical issues related to child maltreatment. At what point, beyond legal requirements, should the researchers intervene if they found something that predisposes a child to injury? There was general agreement that the Study cannot fix public health problems, but that specific situations required intervention to fulfill basic ethical responsibilities and to avoid possible adverse publicity that could damage the Study. Some suggestions were:

  • Develop a comprehensive policy for Study researchers about situations that require intervention, and what form it should take (for example, reporting concerns to health care providers who would then determine whether reporting to authorities is warranted).
  • Consider providing general safety information to all participants and referrals to community resources for specific help.
  • Educate and prepare Study public relations specialists and lawyers on intervention requirements.
  • Include reporting requirements in Study consent.
  • Develop a process for intervention if the participant has no health care provider.
  • Devise a method for dealing with Study participants after intervention has occurred.

Participants agreed that it was important to:

  • Measure injuries (including child maltreatment)
  • Sustain participation
  • Protect confidentiality
  • Protect the children.

Dr. Scheidt said that previous studies showed that it was possible to explain limits of confidentiality to families during the consent process without impacting enrollment.


Participants then discussed genetic polymorphisms that may increase susceptibility to injury or affect the outcome of injury. Examples discussed were:

  • Inflammatory mediators
  • Neural mediators
  • Apo-E
  • Genes that activate or inactivate mechanisms of neurofunction
  • Genes that determine ability to detoxify specific substances
  • Genes linked with particular disorders associated with injuries (for example, attention deficit hyperactivity disorder).
  • Dr. Fleischman asked if there was a way to evaluate family propensity to take risks. Dr. Bradley remarked that the Social Environment Working Group was dealing with that topic. He added that family conflict and neglect increased risk for injuries in childhood and adolescence. Family disruption from substance abuse or serious mental health problems increases the chance of family conflict or neglect of children. Dr. Bradley suggested that the study should evaluate who cares for participating children: parents, neighbors, older siblings, or the children themselves (latch-key kids).

Healthy Development

The Study can assess antecedents that correlate with injuries and also identify factors that maximize function after injury, allowing identification of ways to prevent injuries. Correlation of antecedents with children who were not injured can help identify factors that enhance resilience. Participants suggested that the hypotheses could evaluate the importance of risk taking, exploration, and adventurousness for healthy development. Outcomes can be stated in explicitly positive terms (for example, disability-free days up to
age X). Identification of factors that limit injuries and maximize function should be explored. These factors can then be evaluated with longer term outcomes such as job and school performance.

Participants then discussed hypothesis endpoints. Dr. Bradley stressed that an injury should not be the endpoint of the Study hypotheses. He said that the response to injury, future function, response to rehabilitation, and extent of recovery are more appropriate endpoints. Response to injury includes comorbidities such as decreased school performance and depression. The Study affords a unique opportunity to study both antecedents to injury and injury resolutions. This will allow researchers to identify what enhances and what inhibits rehabilitation after injury.

Injury Measurements

Participants discussed ways to define injury and determine who would tell Study researchers about injuries and their severity. Dr. Scheidt said that two ways to define injuries for the Study are:

  • Injuries that require medical attention
  • Injuries that interfere with normal daily activities.

He added that 28 percent of all children in the United States go to the doctor for injuries in each calendar year. He suggested exploring innovative, more automated reporting for information on injuries such as developing a Study-specific medical record or a smart card. Some of the suggestions for learning about injuries and their severity were:

  • Self-reports
  • Parent reports
  • Visits to doctors
  • Visits to emergency rooms
  • Hospitalizations
  • Mortality.

William Lawrence, M.D., M.S., Agency for Healthcare Research and Quality, DHHS, said that consents were needed from parents, children, health care providers, and treating institutions. This poses an administrative challenge for learning about injuries. In addition, many injuries result from abuse, and family members would not readily report these to researchers. Dr. Scheidt said that one of the posters discussed a feasibility study at a health maintenance organization comparing parental reports to medical records. Doing this on a large scale for the Study would be extremely expensive.

Satisfaction with Thematic Areas

The last topic discussed during this session was the level of satisfaction with the six thematic areas. Participants stated that they felt generally satisfied with the outcome domains, but they were less comfortable with the set of hypotheses that represent those domains. They felt that the current set of hypotheses did not represent the richness of what could be learned from children in the Study. Some worry was expressed that the protocol would be developed strictly from the hypotheses, and this would limit possible findings. Others expressed concern that the hypotheses did not reflect the true scope of the Study. Dr. Fleischman asked how the hypotheses could be enhanced to reflect the richness, breadth, and depth of the study.

Dr. Scheidt explained that 70 hypotheses were sent to the ICC. Most of these were sent back to the Working Groups for more work. Hypotheses needed to have public health importance, require a study of this size, and include questions that were answerable by a study of this size. He also stated that many compelling exposure and outcome measures would be obtained, whether or not they were specified in a hypothesis.


  • The Social Environment and the Development and Behavior Working Groups should work with the Injury Working Group on exposures and outcomes. The liaisons from the NCSAC and ICC should participate in this process to ensure that it occurs.
  • The NCSAC and ICC should try to reignite the Injury Working Group’s interest in finalizing the hypotheses because this thematic area is of critical importance.
  • The ICC should clearly communicate what it needs from the Working Group because some confusion exists on the process.
  • The Program Office needs to explore ways to appoint a nonacademic person who is administratively responsible for communication among liaisons and Working Groups to decrease confusion and increase communication.

In Attendance

Thematic Group Members

Christine A. Bachrach, Ph.D., NICHD, NIH, DHHS
Robert H. Bradley, Ph.D., Center for Applied Studies in Education, University of Arkansas
Alan R. Fleischman, M.D., New York Academy of Medicine
Warren Galke, Ph.D., NICHD, NIH, DHHS
Roderick Joseph A. Little, Ph.D., Department of Biostatistics, University of Michigan
William F. Lawrence, M.D., M.S., Agency for Healthcare Research and Quality, DHHS
Peter C. Scheidt, M.D., M.P.H., NICHD, NIH, DHHS
Marshalyn Yeargin-Allsopp, M.D., CDC, DHHS

Observers and Other Participants

Marion J. Balsam, M.D., NICHD, NIH, DHHS
Kathy Schneider, Iowa Foundation for Medical Care