The Impact of Obtaining Documented Informed Consent on MS/MS Screening L.A. Faulkner 1, L.B....
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Transcript of The Impact of Obtaining Documented Informed Consent on MS/MS Screening L.A. Faulkner 1, L.B....
![Page 1: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/1.jpg)
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
![Page 2: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/2.jpg)
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)
![Page 3: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/3.jpg)
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
![Page 4: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/4.jpg)
Informed Consent Process
Hospital staff use yes or no stickers
Women choose or decline MS/MS screening
Women get 2nd booklet at hospital
Patients ask questions of providers or 1-800 #
Prenatal care providers educate patients
State educates prenatal care providers
State IRB review
![Page 5: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/5.jpg)
Consent Form
![Page 6: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/6.jpg)
![Page 7: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/7.jpg)
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
![Page 8: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/8.jpg)
Summary of MS/MS Screening
Total NBS Specimens 756,000 Unknown MS/MS
360,000 (48%)
No MS/MS 42,000 (6%)
Yes MS/MS 354,000 (47%)
No MS/MS Screening 402,000 (53%)
MS/MS Screening 354,000 (47%)
Detected Cases* 52
Missed Cases* 3
Reported Cases* 12
IEM Registry* 67
*Excludes PKU
![Page 9: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/9.jpg)
Hospital MS/MS Participation
68
56
92
63
20
0
10
20
30
40
50
60
70
80
90
100
0%Participation
1-24%Participation
25-49%Participation
50-74%Participation
75+%Participation
Num
ber o
f Hos
pita
ls
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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
13%
10%
56%
13%
8%
NP/PAMidwifeOB/PerinatologistFamily PracticeOther
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How Providers Learned GDB Offered MS/MS Screening
26%
26%
34%
12%3%
Just found out from this surveyNBS NewsLetter from GDB
Colleague/TrainingOther
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How Providers Handed Out Educational Materials to Patients
29%
9%
44%
17%
To no patients
To patients who ask/other
In packet
Hand out & answer questions
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Focus Group Questions• 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?
• 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?
![Page 14: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/14.jpg)
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
![Page 15: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/15.jpg)
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
![Page 16: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/16.jpg)
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)
![Page 17: 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.](https://reader036.fdocuments.in/reader036/viewer/2022062523/5a4d1ad37f8b9ab0599722fc/html5/thumbnails/17.jpg)
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.