An Introduction to Advocacy Issues
Agenda
 The Nuts and Bolts of Screening, Dr. Paul Matherne
 Overview of Benefits and Potential Obstacles, Dr. John
Hokansen
 Update a Federal Landscape, Annamarie Saarinen
 Grassroots Advocacy, Saiza Elayda
 Questions
The Nuts and Bolts of Screening
G. Paul Matherne MD, MBA
Professor of Pediatrics
Division Head Pediatric Cardiology
University of Virginia Health System
United States
4,000,000
Births Per Year
40,000 Births
All Congenital
Heart Disease
U
10,000 Births
Severe Congenital
Heart Disease
The Nightmare
 Some children with critical congenital heart disease
will have no symptoms and have an entirely normal
physical examination at the time they are sent home
from the hospital after birth.
 These children may become critically ill or die in the
next few days if their congenital heart disease is not
recognized.
 It has been estimated, conservatively, that 100-200
babies each year may die from unrecognized critical
congenital heart disease in the United States.
Pulse Oximetry Screening Is:
 An assessment of oxygen level to check for
cyanosis in newborns before they leave
the hospital.
 Low blood oxygen levels may indicate the
presence of congenital heart defects or
other serious health conditions.
Pulse Oximetry Screening Is:
 Painless. It requires the application of a probe to the
hand and foot. The probe does not puncture the skin.
 Quick. A measurement can be read in 30 to 60
seconds.
 Simple. It is easy for all healthcare personnel to
perform.
 Low Cost Supplies. Disposable or reusable probes are
inexpensive.
Pulse Oximetry Screening Is:
 Life-saving. Early detection can save
lives.
 Disability-reducing. Early intervention
can prevent or reduce disability.
 The right thing to do.
Overview of Benefits and Potential Obstacles
John S. Hokanson, MD
Pediatric Cardiologist, Faculty
University of Wisconsin School of Medicine and Public Health
What will screening involve?
 Minimal inconvenience for most patients
 Moderate inconvenience for occasional patients
 Significant inconvenience for a few patients
 Life saving for a handful of babies
What happens if a baby
fails the screening process?
 The next logical step is to perform an echocardiogram
before sending the baby home.
 When same-day neonatal echocardiography is not
available, a decision to extend the hospitalization or to
transfer the baby to a center where an echocardiogram
can be performed must be made.
 The availability of neonatal echocardiography is
critical to the planning for any large scale pulse
oximetry screening project.
Other Issues
 The best data comes from European studies, but there
aren’t any large US studies.
 A large US study is unlikely in the foreseeable future.
 No studies have been done in very small nurseries,
much less in home delivery or birthing center settings.
 Any screening program has costs and risks.
 Unfortunately, we don’t know as much about how
screening would work as we would like.
Pulse Oximetry
 Strengths
 Weaknesses
 Adds one last safety net
 Will not detect all forms
for a couple hundred
babies a year in the US.
 Oximetry devices are
cheap, non-invasive and
ubiquitous in hospitals.
 Even the two-site
protocols are fairly
straight forward.
of congenital heart
disease.
 False positives and
negatives will occur.
 The main costs are
incurred by the followup testing to the
oximetry screening.
Strengths of Pulse Oximetry
 The costs of the oximeter and the nursing time
required are low.
 The screening is non-invasive (harmless).
 Pulse oximetry screening can detect babies with
critical congenital heart disease that will otherwise be
missed AND who will suffer harm due to the missed
diagnosis.
 The defects detected by oximetry are those most likely
to lead to death and disability if unrecognized.
Weakness of Pulse Oximetry
 Any screening costs money.
 Pulse oximetry will not detect many serious, although
not immediately life threatening heart defects.
 A great deal of cost and anxiety are incurred every time
a child fails the screening. All will be forgiven if the a
catastrophe is prevented, but there may be backlash if
the baby is normal after all.
 This screening is difficult to complete in settings
where echocardiography is not immediately available.
Mandated Screening
 May increase rate of screening and the uniformity of
screening
 May meet resistance from hospital groups
 May be difficult for Midwives or others doing home
deliveries
 May allow for tracking and quality assurance in a way
that is probably not possible for screening which is
recommended but not required
Follow the Money
 Pulse Oximeter <$1,000 per device
 Nursing Time to perform screening
 Echocardiography >$1,000 per study
$
$
$$$
Follow the Money
 Pulse Oximeter <$1,000 per device
 Nursing Time to perform screening
 Echocardiography >$1,000 per study
 Transport
 50 miles by ambulance >$5,000
 50 miles by helicopter >$10,000
 Cardiology clinic visit >$250
 Evaluation in ER >$500
 One night in hospital >$1,500
 Telephone call to pediatric cardiology
$
$
$$$
$$$$
$$$$$
$$
$$$
$$$
Free
Dan Beissel MD
John S. Hokanson MD
University of Wisconsin
Pediatric Cardiology
Practices
Wisconsin as an example of how
pulse oximetry screening might
work in the real world
 Wisconsin is a rural state with many small nurseries.
 Some of these nurseries are more than 100 miles from
the nearest level II NICU.
 Some of these nurseries are 200 miles from the nearest
pediatric cardiac surgery center.
 Wisconsin 2002-2006
 Babies discharged as normal newborns who were
hospitalized or died due to unrecognized critical
congenital heart disease in the first two weeks after birth
 Death or Hospitalization
 1 in 24,684 births
3 per year in WI
 Death
 1 in 38,397 births
2 per year in WI
2009 Wisconsin Birth Statistics
 60,421 Hospital Births in survey hospitals
 99 Hospitals did deliveries, 88 responded
 25 Hospitals had 250 to 500 deliveries
 35 Hospitals had less than 250 deliveries
 Typically there are 1,000 birthing center and home
births per year in Wisconsin.
2011 February-March Survey
 At present 1/3 of the babies born in Wisconsin
undergo pulse oximetry screening for congenital heart
disease.
 At present 2/3 of the babies born in Wisconsin are
born in a setting where same-day neonatal
echocardiography is available.
 The average distance required to transport a baby to a
facility with echocardiography was just over 50 miles
when same day echocardiography was not available.
A year in America’s Dairyland when
all babies are screen with oximetry
 65,000+ babies pass the screening with minimal
inconvenience
 10-100 babies fail the screening test?
 5 or so have unrecognized severe CHD
 All the rest turn out to be normal, but 1/3 of these will
have to leave the place where they were born to get an
echocardiogram.
Going Forward
 Pulse oximetry does provide a valuable last safety net
for a small group of babies.
 An effective strategy will be one which can practically
be performed in all settings in which babies are born.
 Screening is currently underway as a huge
uncontrolled experiment and tracking of the results is
a vital piece of the equation.
Newborn Screening for Critical Congenial Heart
Defects Using Pulse Oximetry
Annamarie Saarinen
Federal Landscape
 Unprecedented support
 Public Health Need
 Patient Access to Specialty Care
Federal Recommendation Hurdles: Public Health
As a point of care evaluation – this screening is only the
second of its kind, and the first to detect a birth defect.
Hurdles to state by state adoption include:
Infrastructure needs
Uniform screening technologies and protocols
Diagnostic follow up
Health information exchange
Reporting and surveillance
Standards and education
Federal Recommendation Hurdles: Access
Newborns and infants represent the largest patient transfer
population in health care.
Less than 3% of the nation’s hospitals have onsite pediatric
specialty services.
Babies are born at community hospitals representing the
remaining 97%.
Only 150 facilities can address cardiac conditions in infants.
Transport and referral guidelines are essential: majority of US
hospitals do not have on-site pediatric echo capability, would
need to transfer.
More about the SACHDNC:
http://www.hrsa.gov/heritabledisorderscommittee/
More about the SACHDNC: Workgroup on Screening for
Critical Congenital Cyanotic Heart Disease
http://altarum.cvent.com/events/ccchd-meeting/custom-22f8929dc795694e7aa6c588c263e31554.aspx
SACHDNC letter to Secretary Sebelius Recommending Newborn
Screening for CCHD
http://www.hrsa.gov/heritabledisorderscommittee/correspondenc
e/October15th2010letter.htm
Statement from AAP New Jersey on Pulse Oximetry screening:
http://pulseoxadvocacy.com/wp-content/uploads/2011/07/BillA3744-1.pdf
Saiza Elayda
American College of Cardiology
seylada@acc.org
Grassroots Advocacy – What is it?
 To effect change
 Citizen-driven movement
 Bottom-up approach
Grassroots Advocacy – Why is it
important?
 No participation = no right to blame
 Necessary for change to occur
 Responsibility to participate
State vs. Federal Grassroots
 Different session lengths
 Different timeline for bill
introduction
 More accessible
 Focused more on local issues
How do you start?
Define your objective
New local initiative?
Introduce legislation?
Initiate regional program?
Know the Opposition
 Identify opponents and their
motivation
 Be prepared to respond
 Is there common ground?
Build Grassroots Support
 Recruitment forums
 Explain the issue and position
 Articulate why the issue is important to you and
to them
 Get commitments for support
 Discuss strategy and resources
 Mobilize at critical moments
 Provide support and appreciation
Research
 Determine your audience
 Understand where your audience stands
 Prior actions
 Know the issues and facts
 Understand possible impacts
 Look at results from other communities
Messaging
Develop and deliver a central
message
Make the issue personal
Message Mode
How will the message be sent?
Email?
Letter?
Phone call?
Personal visit?
Scheduling a Meeting
 Call the appropriate office in advance
 Realize that the average meeting will
last between 5 to 15 minutes
Leave Behind
Prepare materials to leave behind
Sharp, punchy bullets
Include contact information
Close the Deal
 At the end of your meeting, be direct.
Can we count on you for your
support?
Follow-Up
 Send a “Thank You” note
 Offer additional information/resources
 Maintain communication
 Keep your legislator apprised of events that your
organization is having in his/her district.
 Attend town halls and other local events

Make yourself known
Resources
 1in100.org
 pulseoxadvocacy.org
 advocacy@mendedlittlehearts.org
Questions
Thank You
Join us for the next in our Series:
Pulse Oximetry Advocacy–
An In-Depth Look at the Issues
Tuesday, August 23
8pm EDT, 7pm CST
Important Screening Terms
 False Positive: Failed Test but Normal Heart
 False Negative: Passed Test but Abnormal Heart
 Negative Predictive Value: The chance the baby has a
normal heart if they pass the test.
 Positive Predictive Value: The chance there is a critical
heart defect if the baby fails the test.
False Positive
(Failed Screening/Normal Heart)
 Rates of False positive range from
 1:300 (Tennessee: Walsh) to
 1:10:000 (Wisconsin: Boelke) to
 1:15,000 (Texas: Sendelbach)
 Factors
 Definition of normal (lung disease, sepsis,…), what if
you find something other that heart disease?
 Was the screening done too early?
 Was the result confirmed?
 Was it a one site or two site protocol?
False Negative
(Passed Screening/Abnormal Heart)
 Rate is more difficult to determine as the study must
extend after the baby goes home.
 German data suggests a false negative rate of less than
1:10,000
 What heart defects are you screening for?
 If you include all defects, FN goes up
 If you only look at critical defects, FN goes down
 The same issues apply to negative predictive value
Positive Predictive Value
 If a baby fails the pulse oximetry screening, what is the
chance that they really have life-threatening
congenital heart disease? Do you only care about heart
defects?
 The two large European studies with screening done
after 24 hours suggest that if a baby fails their pulse
oximetry testing, there is somewhere between 21% and
26% chance they have critical congenital heart disease.