An Introduction to Advocacy Issues

AgendaThe Nuts and Bolts of Screening, Dr. Paul

MatherneOverview of Benefits and Potential Obstacles,

Dr. John HokansenUpdate a Federal Landscape, Annamarie

SaarinenGrassroots Advocacy, Saiza ElaydaQuestions

The Nuts and Bolts of Screening

G. Paul Matherne MD, MBAProfessor of Pediatrics

Division Head Pediatric CardiologyUniversity of Virginia Health System

U

United States4,000,000

Births Per Year

40,000 Births40,000 BirthsAll Congenital All Congenital Heart DiseaseHeart Disease

10,000 Births10,000 BirthsSevere CongenitalSevere CongenitalHeart DiseaseHeart Disease

The NightmareSome 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, MDPediatric Cardiologist, Faculty

University of Wisconsin School of Medicine and Public Health

What will screening involve?

Minimal inconvenience for most patientsModerate inconvenience for occasional

patientsSignificant inconvenience for a few patientsLife 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 IssuesThe 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 OximetryStrengthsAdds one last safety

net 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.

WeaknessesWill not detect all

forms of congenital heart disease.

False positives and negatives will occur.

The main costs are incurred by the follow-up testing to the oximetry screening.

Strengths of Pulse OximetryThe 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 OximetryAny 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 ScreeningMay increase rate of screening and the

uniformity of screeningMay meet resistance from hospital groupsMay be difficult for Midwives or others doing

home deliveriesMay allow for tracking and quality assurance

in a way that is probably not possible for screening which is recommended but not required

Follow the MoneyPulse Oximeter <$1,000 per device $

Nursing Time to perform screening $Echocardiography >$1,000 per study $$

$

Follow the MoneyPulse 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 MDJohn S. Hokanson MD

University of Wisconsin

Pediatric CardiologyPractices

Wisconsin as an example of how pulse oximetry screening might work in the real worldWisconsin 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 2002-2006Babies 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 Hospitalization1 in 24,684 births 3 per year in WI

Death1 in 38,397 births 2 per year in WI

2009 Wisconsin Birth Statistics60,421 Hospital Births in survey hospitals

99 Hospitals did deliveries, 88 responded 25 Hospitals had 250 to 500 deliveries35 Hospitals had less than 250 deliveries

Typically there are 1,000 birthing center and home births per year in Wisconsin.

2011 February-March SurveyAt 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 oximetry65,000+ babies pass the screening with

minimal inconvenience10-100 babies fail the screening test?

5 or so have unrecognized severe CHDAll 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 ForwardPulse 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 LandscapeUnprecedented 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 needsUniform screening technologies and protocolsDiagnostic follow up Health information exchangeReporting and surveillanceStandards 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 Diseasehttp://altarum.cvent.com/events/ccchd-meeting/custom-22-f8929dc795694e7aa6c588c263e31554.aspx

SACHDNC letter to Secretary Sebelius Recommending Newborn Screening for CCHDhttp://www.hrsa.gov/heritabledisorderscommittee/correspondence/October15th2010letter.htm

Statement from AAP New Jersey on Pulse Oximetry screening: http://pulseoxadvocacy.com/wp-content/uploads/2011/07/Bill-A3744-1.pdf

Saiza ElaydaAmerican College of Cardiology

seylada@acc.org

Grassroots Advocacy – What is it?

To effect changeCitizen-driven movementBottom-up approach

Grassroots Advocacy – Why is it important?

No participation = no right to blame

Necessary for change to occurResponsibility to participate

State vs. Federal GrassrootsDifferent session lengths

Different timeline for bill

introduction

More accessible

Focused more on local issues

Define your objectiveNew local initiative?

Introduce legislation?

Initiate regional program?

Know the OppositionIdentify opponents and their

motivation

Be prepared to respond

Is there common ground?

Build Grassroots SupportRecruitment forums Explain the issue and positionArticulate why the issue is important to

you and to themGet commitments for support Discuss strategy and resourcesMobilize at critical momentsProvide support and appreciation

ResearchDetermine your audienceUnderstand where your audience

standsPrior actions

Know the issues and factsUnderstand possible impactsLook at results from other

communities

MessagingDevelop and deliver a

central message

Make the issue personal

Message ModeHow will the message be sent?Email?Letter?Phone call?Personal visit?

Scheduling a MeetingCall the appropriate office in

advance

Realize that the average

meeting will last between 5 to

15 minutes

Leave BehindPrepare materials to leave

behind

Sharp, punchy bullets

Include contact information

Close the DealAt the end of your meeting, be direct.

Can we count on you for your support?

Follow-UpSend a “Thank You” noteOffer additional

information/resourcesMaintain communication

Keep your legislator apprised of events that your organization is having in his/her district.

Attend town halls and other local eventsMake yourself known

Resources1in100.orgpulseoxadvocacy.orgadvocacy@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 238pm EDT, 7pm CST

Important Screening TermsFalse Positive: Failed Test but Normal HeartFalse 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) to1:15,000 (Texas: Sendelbach)

FactorsDefinition 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 1:10,000What heart defects are you screening for?

If you include all defects, FN goes upIf you only look at critical defects, FN goes down

The same issues apply to negative predictive value

Positive Predictive ValueIf 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.