Appendix E
National Children’s Study Assembly Meeting
Breakout Session Summary: Priority Outcomes in Your Community (Birth Outcomes, Asthma, Developmental Problems, Obesity, Injury)
December 17, 2003
Sheraton Atlanta Hotel
Atlanta, GA
Facilitator:
Pauline Mendola, Ph.D., National Health and Environmental Effects Research Laboratory, EPA
The breakout session was well attended with approximately 32 participants. There was a general consensus that the priority outcomes of the Working Groups (pregnancy outcomes, neurobehavioral development, asthma, injury, and obesity) are good choices for the Study.
Participants were concerned about behavioral disorders and wanted to ensure that a broad spectrum of behavioral outcomes would be studied. One participant asked about including childhood cancer as a priority outcome. Given that that the number of expected cases was too low to support a Study hypothesis, the group discussed ways that the Study’s data could be informative to ongoing pediatric cancer case-control studies. The group recommended providing population control data and/or detailed longitudinal exposure information to cancer studies in which Study children participate.
Most of the discussion focused on measurements and design features that attendees felt were important for the Study to consider, including potential confounding factors, social context variables that might be effect modifiers, and factors that would enhance measurement validity. Suggestions and questions included:
- Evaluate the potential effects of chronic sleep problems, such as obstructive apnea, on developmental or cognitive outcomes.
- Conduct economic modeling of the health cost and consequences of not doing the Study--a business case that could be helpful for advocacy groups.
- Ensure that there is a high-quality early neurological assessment of the newborns. If the Study has good inter-rater reliability, it can capture outcomes for the entire cohort (for example, the hospital stay as a unique opportunity).
- Recommend inclusion of homebirths (generally attended by midwives) as the "no intervention" group. This group can serve as a control group for the impact of medical treatment on normal birth. (Don’t forget these infants for the newborn assessments. This will require extra cooperation of these mothers and caregivers, but if they are motivated, they will come through.)
- Include a preconception cohort to study the effects of assisted reproductive technologies.
- Look at interim outcomes so there are early results from the Study. This will help to maintain momentum among participants as well as funding sources.
- Will there be an intervention component to the Study? The group noted that there would be naturally occurring interventions just as a result of participation. A suggestion was made to consider a control group for the cohort (a secondary cohort/population-based data). If there is a drift towards a healthier community due to interventions received as part of the Study, how will the Study control for that effect?
- Be sure to recruit the uninsured.
- Use health information as an incentive, for example, a hearing assessment. Give parents access to testing that they might not otherwise have and refer if a problem is detected.
- Recognize the importance of measuring infectious agents as confounders, for example, otitis media altering hearing outcomes.
- How will the study design address the issue of multiple comparisons? This is particularly a concern for data analyses that do not address an a priori hypothesis.
- Be sure to include other exposures, such as sleep environment, community factors (for example, presence of parks, grocery stores), physical environment, and occupational exposures.
- Include "women at risk of pregnancy."
- Make certain there is input from professional organizations such as the American Dental Association and the American Academy of Pediatrics.
In Attendance:
Marilee C. Allen, M.D., Johns Hopkins University Medical Institutions
Linda Clark Amankwaa, Ph.D., R.N., Albany State University
Anastasia Antoniadis, M.A., M.P.H., Pennsylvania Training and Technical Assistance Network
Robert Beckerman, M.D., Tulane University Medical Center
Luenda E. Charles, Ph.D., M.P.H., National Institute for Occupational Safety and Health, CDC, DHHS
Edward B. Clark, M.D., University of Utah Health Sciences Center
Doris B. Haire, American Foundation for Maternal and Child Health
Daniel E. Hale, M.D., University of Texas-San Antonio Health Science Center
Ellen C. Hale, R.N., B.S., Emory University
Susan Hodges, Citizens for Midwifery
Carol A. Johnson, M.P.H., National Center for Environmental Health, CDC, DHHS
Carol Jones, M.A., Psychotherapist
Susan S. LaFountaine, P.T., M.P.H., Kapiolani Medical Center for Women and Children
Lorie A. Martel, R.N., State of North Dakota Department of Health
Toyojiro Matsuishi, Kurume University School of Medicine, Japan
Lucas M. Neas, Sc.D., Office of Research and Development, EPA
Rebecca Prevots, Ph.D., M.P.H., National Institute of Allergy and Infectious Diseases, NIH, DHHS
Matthew Reese, Ph.D., University of Kansas Medical Center
Jerry D. Rench, Ph.D., Epidemiology and Medical Studies Program, RTI International
Richard R. Ricketts, M.D., American Pediatric Surgical Association
Perri Ruckart, M.P.H., National Center for Environmental Health, CDC, DHHS
Wesley Rutland-Brown, M.P.H., National Center for Injury Prevention, CDC, DHHS
Yoichi Sakakihara, University of Tokyo, Japan Csaba Siffel, National Center on Birth Defects
and Developmental Disabilities, CDC, DHHS
Darcy L. Strouse, Ph.D., Aspen Systems Corporation
Jeffrey H. Sullivan, M.D., M.H.S, University of Washington
Erik Svendsen, Ph.D., M.S., Office of Research and Development, EPA
Meow-Keong Thong, National Center on Birth Defects and Developmental Disabilities, CDC, DHHS
Jean Wactawaski-Wende, Ph.D., State University of New York, Buffalo
Emmanuel B. Walter, Jr., M.D, M.P.H., Duke University
Tara S. Wass, Ph.D., University of Tennessee, Knoxville
Barbara Weissman, M.D., Emory University