1 / 17

The Impact of Obtaining Documented Informed Consent on MS/MS Screening

The Impact of Obtaining Documented Informed Consent on MS/MS Screening. L.A. Faulkner 1 , L.B. Feuchtbaum 2 , M. Hanlon 1 , F.W. Lorey 2 , K. Velazquez 2 , and G.C. Cunningham 2. Funded by Health Resources and Services Administration grant #5 H46 MC00199-03.

alban
Télécharger la présentation

The Impact of Obtaining Documented Informed Consent on MS/MS Screening

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Impact of Obtaining Documented Informed Consent on MS/MS Screening L.A. Faulkner1, L.B. Feuchtbaum2, M. Hanlon1, F.W. Lorey2, K. Velazquez2, and G.C. Cunningham2 Funded by Health Resources and Services Administration grant #5 H46 MC00199-03 1 Public Health Institute, 2 Genetic Disease Branch (GDB), California Department of Health Services

  2. Purpose of Research To assess the impact of obtaining documented informed consent on participation & informed decision-making during population-based newborn screening for inborn errors of metabolism (IEM) using tandem mass spectrometry (MS/MS)

  3. Introduction to Newborn Screening in California • Mandatory newborn screening (NBS) program allows refusal for religious reasons only • 18 month supplemental screening research project required written informed consent to ensure voluntary MS/MS screening

  4. Informed Consent Process

  5. Consent Form

  6. Overview of Methods • Tracked uptake of MS/MS screening in prospective cohort by hospital • Surveyed prenatal care providers by mail • Conducted 5 focus groups with 31 pregnant women

  7. Summary of MS/MS Screening *Excludes PKU

  8. Hospital MS/MS Participation

  9. Prenatal Care Provider Survey • Mailed 12 question survey to 6200 providers • Questions asked about knowledge & experience • 700 surveys returned for 11% response rate as shown

  10. How Providers Learned GDB Offered MS/MS Screening

  11. How Providers Handed Out Educational Materials to Patients

  12. Focus Group Questions • What information is most important? • What would influence you to not have test? • How else would you like to receive this info? • Importance of choosing to participate? • What should the State address before making it mandatory? • Introductions? • How many received IIP booklet? • What do you think of it? • Advantages/Concerns? • Feelings about making the decision? • What information do you think should be in the IIP booklet?

  13. What Participants Told Us • Benefits and risks not understood • Importance of testing not conveyed • Purpose of research not obvious • Didn’t hear from prenatal provider but want to • Choice is important, but not to all • Don’t overwhelm with dense or confusing text • Provide more information in their words

  14. Burdens of Informed Consent • Increased time and effort for Genetic Disease Branch, State IRB, and hospitals • Reduced population screened • 354,000 for MS/MS vs. 756,000 mandatory NBS • <1% refusal in mandatory NBS vs. 10 – 50% non-acceptance in MS/MS • 52 diagnosed disorders in screened population vs. 12 (59 expected) in non-screened population • Didn’t meet parents’ needs

  15. Recommendations for Population-based Research • Obtain waiver of informed consent, if possible, by demonstrating: • Minimal risk to participants • Participant rights not adversely affected • Informed consent is impractical • Educational materials still provided • Improve educational materials, especially by using parents’ words • Reduce barriers for prenatal care providers (e.g. combine prenatal and newborn screening materials)

  16. More Details About Evaluation Study Available Visit our web-site www.CaliforniaMsMs.org Special thanks to all staff at the Genetic Disease Branch, California providers, patients and contract staff.

More Related