Parental Education and Choice about Newborn Screening and Bloodspot Retention
NIH R01 HG006266-01 (Botkin, PI) 7/2011–6/2016 R01
It is widely recognized that new parents receive insufficient information about newborn screening (NBS) and little or no information regarding the retention of residual newborn screening samples. Our current research (R01 HD058854) clearly demonstrates that parents are supportive of NBS and the research use of residual specimens, but they want information before the child is born and want an informed choice regarding the retention and use of residual samples. Previous research has outlined the basic elements of what parents want to know about NBS generally. However, given that many states are adopting an “opt-out” approach for residual samples, it is unclear what basic information parents want to know to enable an informed choice about this practice. While it is recognized that retention and use of residual NBS samples is a valuable research resource, there are prevalent concerns in the NBS community that discussion of this will lead some parents to decline NBS altogether. Some authorities have suggested that discussions of NBS and residual sample retention be conducted separately to reduce the risk that parents will confuse the issues and decline NBS altogether. To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically, this project has the following specific aims:
Specific Aim 1) To determine what pregnant women, young mothers, and their partners want to know regarding the retention and use of residual bloodspot samples
- Methods include 15 focus groups comprised of a diverse set of participants conducted in five states (NY, CA, UT, MN, WA) to ascertain their information needs to make an informed choice about residual sample retention and use.
Specific Aim 2) To create multimedia educational tools to be used in the prenatal care environment that will provide basic information about NBS and the core information determined through Specific Aim 1 about residual sample retention and use.
- Methods include the development of state-of-the-art movie, printed and web-based materials
Specific Aim 3) To determine the impact of the prenatal education intervention on parental knowledge, attitudes, and decisions regarding NBS services and the retention and use of residual samples in diverse populations of English and Spanish speaking pregnant women.
3a. To determine the impact on knowledge and attitudes about NBS and the retention of residual samples
- Women at 30 – 36 weeks gestation will be provided the educational interventions in the prenatal environment including the movie-based and written materials.
- Intervention Group A will have education provided on the two topics (NBS education only and NBS education plus education on sample retention and use) at separate prenatal visits while Group B will receive this education at a single visit.
- A control group will receive standard information that is provided to new parents in the OB and/or newborn nursery environments
- Participants will be surveyed at 3 – 6 weeks post delivery about their knowledge and attitudes about NBS and sample retention and use.
- A random subset of partners (N=150) will be surveyed at 3 – 6 weeks post delivery regarding their knowledge and attitudes
3b. To determine the impact on parents’ decisions regarding NBS services and the permission for retention and use of residual samples
- Intervention versus control groups will be compared with respect to decisions to opt-out of the retention and use of NBS residual samples and refusals of NBS altogether.
Specific Aim 4) To examine the normative/ethical implications of the results of SA3 for the conduct of state NBS programs. Recommendations on the content and timing of parental NBS education will be developed.
Jeffrey R. Botkin, M.D., M.P.H. (PD/PI)
Rebecca A. Anderson, R.N., Ph.D., B.S. (Other Professional, Project Manager)
Erin Rothwell, Ph.D. (Co-Investigator, Qualitative)
Louisa A. Stark, Ph.D. (Co-Investigator, Multi-media Education)
Bob Wong Ph.D. (Co-Investigator, Statistician)
Aaron Goldenberg, Ph.D., M.P.H. (Co-investigator)
Miriam Kuppermann, Ph.D., M.P.H., (Co-Investigator, Site PI)
Siobhan M. Dolan, M.D., M.P.H. (Co-Investigator, Site PI)
Nancy Rose, M.D. (Co-Investigator, Site PI)