The Power of Stories over Statistics: Illustrations from Neonatal Jaundice

and Infant Airplane Safety

Thomas B. Newman MD, MPHProfessor of Epidemiology and Biostatistics and Pediatrics, University of California, San

Francisco

\sabbatical\stories&StatsForExeter.ppt

Overview

Introduction Jaundice in newborns and kernicterus Infant safety seats on airplanes Stories vs Statistics; Politics and Risk

research Possible approaches and

recommendations Questions and discussion

Idealized public health decision making Recognize resources are limited Estimate the number of people who would

benefit, and how much, from various courses of action

Select course of action with highest expected benefit

Alternative basis for decisions: stories

Jaundice --Background 1

Bilirubin: Yellow breakdown product of heme (from red blood cells)

Jaundice: Yellow color of whites of eyes and skin due to high bilirubin. Usually indicates liver or blood disease, but generally normal in newborns

Hemolysis: Destruction of red blood cells Kernicterus: Rare, severe, permanent brain

damage from very high bilirubin levels

Jaundice --Background 2

Phototherapy: Shining light on the babies skin -- helps lower bilirubin levels

Exchange transfusion: replace baby’s blood with donor blood

Jaundice – Background 3 Exchange transfusion for Rh disease 1950s

much less kernicterus Phototherapy 1970s TN a resident in pediatrics 1980-83

– Phototherapy for Total Serum Bilirubin (TSB) > 14-15 mg/dl (240 uMol/L)

– Exchange transfusion for TSB > 20 mg/dl (340 uMol/L)

– Beginning of AIDS epidemic Watchko and Oski’s “Vigintiphobia” article

(1983)*

*Watchko JF, Oski FA. Pediatrics 1983;71:660-63

Jaundice--Current issues We know jaundice used to be over-treated “Kinder, gentler” approach (1992) and AAP

jaundice guideline (1994) -- far less treatment– Phototherapy for TSB >= 20 mg/dL– Exchange for TSB > 25-30 mg/dL

Concern about the return of kernicterus; evidence is poor

New diagnostic technologies Formation of PICK, a parents group; push for

universal bilirubin screening

Phototherapy (PT) and Exchange Transfusion (ET) in 2 Hospitals in Israel Pre- and Post AAP guideline*

N PT % PT ET % ET1992-3 6499 514 7.9% 15 0.23%1995-6 8650 251 2.9% 3 0.03%

*Seidman DS et al. Acta Paediatr 2001;90:292-5

• 63% reduction in phototherapy

• 85% reduction in exchange transfusions

Year of Birth< 1984 84-86 87-89 90-92 93-95 96-98 99-02N

umbe

r of

Ker

nict

erus

Cas

es

0

5

10

15

20

25

30

BIND CENTER - Pennsylvania Hospital

PILOT KERNICTERUS REGISTRYConfirmed Cases of Acute Kernictrerus (Voluntary Reporting)

“Healthy” Term and Near Term Infants Born in 34 States

http://www.pickonline.org/presentation.ppt, accessed 7/10/03

Concern about Return of Kernicterus Brown and Johnson registry: 90 cases

in 15 years in the US Northern California Kaiser Permanente

– No cases in 111,000 births, 1995-8– No cases found in 1991-4 (N~119,000)– BUT: Evidence of increase in babies with

very high bilirubin levels 1999-2003.

Deaths from Kernicterus (773.4, 774.7), < 1 year-olds, USA*

YearDeath Count Population

Crude Death Rate/ 100K

1979 2 3,494,398 0.1 (UNRELIABLE)1980 2 3,612,258 0.1 (UNRELIABLE)1981 1 3,629,238 0 (UNRELIABLE)1982 2 3,680,537 0.1 (UNRELIABLE)1983 1 3,638,933 0 (UNRELIABLE)1984 1 3,669,141 0 (UNRELIABLE)1985 1 3,760,561 0 (UNRELIABLE)

*CDC Wonder, Accessed 7/10/03

Deaths from Kernicterus (773.4, 774.7), < 1 year-olds, USA*

*CDC Wonder, Accessed 7/10/03, 9/4/05

Deaths Population Rate /100 K1979-88 10 36,960,517 0.03 1989-02 9 51,966,560 0.02

New Diagnostic Technologies

Cost: $4000 + $7/use

Cost: $19,000 + $15 per use

New Diagnostic Technologies -2

Stories: Cal Sheridan

36-37 wk 2900 g boy b.t.a. 35 y.o. G1 O+ Mom

Nursing Notes, Age 17 hours

No bilirubin level sent.

Clinic Visit, 4.5 days

(-9%)

Return visit and outcome Next day, bilirubin 34.6 mg/dl Outcome:

Kernicterus (?) Verdict for defense in malpractice suit,

settled on appeal Same day: father diagnosed with spine

tumor, misdiagnosed as benign

Parents of Infants and Children with Kernicterus (PICK)

www.kernicterus.org

“Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it's the only thing that ever has.”

Margaret Mead (1901 - 1978) US anthropologist

JCAHO Sentinel Alert

NEWS RELEASEJOINT COMMISSION ON ACCREDITATION OF HEALTHCARE

ORGANIZATIONS

JOINT COMMISSION ISSUES ALERT: TREATABLE BLOOD DISORDER

PUTS BABIES AT RISK FOR BRAIN DAMAGE, DEATH

JCAHO Sentinel Alert -2Sentinel Event Alert • Issue 18 - April 2001

Kernicterus threatens healthy newbornsKernicterus is a condition of newborns that leads to severely disabling brain damage or death. It results from hyperbilirubinemia that can be caused by a number of factors. Kernicterus is preventable with techniques currently available.

"This is probably happening more than clinicians know about. With these recent cases, risk assessments were

inadequate and unreliable, and bilirubin levels were not measured--or measured in time."

- Sue Sheridan

1 /Kernicterus in Full-Term Infants --- United States, 1994--1998

“In early 2001, a national support group for parents of children with kernicterus conducted a survey on kernicterus. A convenience sample of 15 families was identified by word-of-mouth or through the Internet... Among the sample families, seven did not complete the questionnaire, four had children who did not meet the case definition, and the remaining four had children who did meet the case definition..”

Neonatal jaundice/kernicterus summary No dispute about former over-treatment or

current treatment thresholds No good data on current incidence of

kernicterus, but it is rare Definition of the problem and proposed

solution strongly influenced by 1 story (assisted by industry funding)

Weak data, powerful stories Universal bilirubin screening is coming

Press Release

AAP CALLS FOR AN END TO LAP TRAVEL FOR CHILDREN

ON PLANES

AMERICAN ACADEMY OF PEDIATRICS

Committee on Injury and Poison Prevention

Pediatrics 2001;108:1218-1221

Ending lap travel: Background

Children under 2 can ride on parent’s lap with no ticket

July 19, 1989: UAL #232 crash at Sioux City, Iowa. Unrestrained infant dies.

1990: US NTSB recommends universal restraint

July 12, 1994: Another “lap child” dies in crash, NTSB urges FAA to require infant restraint

FAA Study, report to Congress, 1995 Methods

– Detailed analyses of survivability of previous crashes

– Models of price-sensitivity of travel decisions Results:

– Infant restraint would prevent maximum of 5 infant deaths over 10 years

– Net increase of 82 deaths over 10 years due to diversion to less safe modes of travel

Rejected as “flawed” by NTSB and Congress

Effects and Costs of Requiring Child Restraint Systems for Infants Traveling on Commercial

Airplanes*

Benefits: similar to FAA (6 deaths in 10 years) Risks: less than FAA when likely

characteristics of drivers and driving considered (Net increase in deaths over 10 years 0-30 vs 82 )

Costs: still high

*Newman TB, Johnston B, Grossman D. Arch Pediatr Adol Med 2003;157:969-74

Deaths caused or prevented

Relative Risk of Auto Death for Families

Prop

ortio

n C

hoos

ing

to D

rive

0.20 0.36 0.52 0.68 0.84 1.00

0.20

0.18

0.16

0.14

0.12

0.10

0.08

0.06

0.04

0.02

0.00

Increased deaths

Decreased deaths

-0.250.00

0.250.50

1.00

2.00

3.00

4.00

5.00

Estimated Costs

Assume no diversion to less safe modes of travel

*Assumes 3% discounting

Cost per round trip

Cost per life saved

Cost per life-year saved*

$200.00 $1,283,594,063 $42,786,469 $10.00 $64,179,703 $2,139,323

$1.00 $6,417,970 $213,932 $0.25 $1,604,493 $53,483

Congressional Testimony: Cost effectiveness

Congressman Geren: “... five million enplanements. Say it only costs $20. That's $100 million...If we gave you $100 million and you were entrusted with saving lives, where would you apply it, top priority?”

Barry Sweedler, Director, Office of Safety Recommendations, NTSB: “There is a long list of safety issues that need addressing, and I think it's probably best for us to try to lay out what the issues are and try not to prioritize which safety issue is more important than other safety issues...this seems to be one of those areas where it just seems to make common sense to go ahead and take that extra step.”

Congressional Testimony: Evidence

Coming into Washington we ran into some turbulence around some thunderstorms and there were some other lap children that the mothers were having trouble restraining. Many of them were crying and screaming. The little kid in the safety seat slept through the whole thing.

So I think there is more than enough evidence that substantiates what we're trying to do.

The question, I think, Mr. Chairman, comes down to how many more children must die, how many more have to be hurt before we reach the threshold of FAA's ghoulish cost/benefit ratio?

--Congressman Jim Lightfoot, Iowa

“Real” vs “Theoretical” Children “The argument in support of the FAA’s

resistance to the NTSB...is unreasonable on its face and ridiculous in its justification. It protects theoretical children driving in cars at the expense of real flesh-and blood infants whose safety is unquestionably compromised when flown as a lap-baby”

Nader R, Smith WJ. Collision course: the truth about airline safety. Blue Ridge Summit, PA: TAB Books, 1994. Cited by Beshai D. Arch Ped Adol med 2003;157:953-4

Stories: UAL Flight 232: Jan Brown-Lohr

Child Restraint on Airplanes: Summary Good data

– Very little benefit– Very high cost per benefit– May cause net harm

Notice of Proposed Rule-making issued by FAA in 2001

Decision NOT to change rule 8/25/05 Victory for data?

AP Story: NTSB on FAA Ruling

"During takeoff, landing and turbulence, adults are required to be buckled up, baggage and coffee pots are stowed, computers are turned off and put away, yet infants and toddlers need not be restrained," [NTSB Acting Chair] Rosenker said in a statement.

Miller, L: Plane safety seat ruling unchanged for children http://www.buffalonews.com/editorial/20050827/1073311.asp, accessed 9/4/05

AP Story –FAA Response

FAA spokesman Greg Martin said requiring the seats would harm more children than it would protect. "A lap child held firmly by a parent doesn't result in second- or third-degree burns like an unsecured pot of coffee," Martin said.

Three children who sat in their parents' laps were among the 309 who survived the fiery crash of an Air France Airbus A340 after it overshot the Toronto runway, Martin noted.

Miller, L: Plane safety seat ruling unchanged for children http://www.buffalonews.com/editorial/20050827/1073311.asp, accessed 9/4/05

Babies caught up in 'no-fly' confusion WASHINGTON --Infants have been stopped

from boarding planes at airports throughout the U.S. because their names are the same as or similar to those of possible terrorists on the government's "no-fly list."

It sounds like a joke, but it's not funny to parents who miss flights while scrambling to have babies' passports and other documents faxed...

Miller, L. http://homelandsecurity.osu.edu/focusareas/transportation.html accessed 9/4/05

What makes stories powerful?

More interesting than numbers More understandable than numbers Emotional connection to story teller (a

real person,” not scientific or political establishment)

Passion, sustained commitment of story teller

Stories

““Humans are primates who tell stories.”Stephen Jay Gould, PhD

“Humans are primates whose cognitive capacity shuts down in the absence of a story.”

Robyn M. Dawes, PhDCognitive psychologistAuthor: “Everyday

Irrationality”

Stories and Politics “Rather than understanding policy-makers as

problem-solvers who apply objective, scientific, and value-free methods to cure society’s ills...think of policy-makers as performers who seek to persuade an audience...

A policy argument, in consequence, tells a story: it provides a setting, points to the heroes and villains, follows a plot, suggests a solution, and, most importantly, is guided by a moral.*

*John Adams and Michael Thompson. Taking account of societal concerns about risk: Framing the problem. A report for the Health and Safety Executive.

Risk perceptions and preferences Involuntary risks perceived as worse than

voluntary risks Identifiable victims/lives saved valued much

more than statistical lives saved– Cure valued more than prevention– Preventing rare disease valued more than

decreasing common disease even if fewer lives saved

Equity is valued

Jaundice Story

Heroic PICK mothers fighting ignorance and managed care efforts to save money

Solution: Universal bilirubin screening Moral: need to protect the vulnerable Risk involuntary: PICK moms not warned

that jaundice can cause brain damage. Identifiable victims: KI considered separately

from Cerebral Palsy

Safety Seat Story Story -- heroic, dedicated flight attendants,

congressmen against unfeeling bureaucrats Solution: Require universal child restraint Risk is both involuntary (to infant and other

passengers) and voluntary (parents decide) Plane crash victims are identifiable; car crash

victims an anonymous “drop in the bucket” Equity: Infants deserve same level of

protection

Possible approaches/ Recommendations -1 Divide and conquer Recognize and publicize the problem Get stories (and story tellers) that

support best public health choices– Harder to get stories that support NOT

doing something that is only too expensive Avoid polarization -- meet with the

opposition.

Possible approaches/ Recommendations -2

Focus on deliberative bodies and opinion leaders

Try to discuss how decisions should be made separately from the specifics of a particular decision

Get passionate about good decision making

Year-over-year Changes in Passenger Enplanements and Passenger Car and Light Truck Miles Traveled, 1981-2002

-8%

-6%

-4%

-2%

0%

2%

4%

6%

8%

10%

12%19

81

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

% Change in Passenger Enplanements

% Change in Passenger Car and Light Truck Miles Traveled

Air Traffic Controller Strike Gulf War

Sept. 11, 2001

Passenger Car and Light Truck Fatalities and Aircraft Passenger Enplanements, 1980-2002

250,000,000

350,000,000

450,000,000

550,000,000

650,000,000

750,000,000

19

80

19

81

19

82

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00

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20

02

En

pla

nem

ents

20,000

25,000

30,000

35,000

40,000

45,000

Fat

alit

ies

Domestic Passenger Enplanements

Passenger Car and Light Truck Occupant Fatalities

Motor Vehicle Occupants Under 5 Years of Age Killed in Crashes, 2000-2002

539513

472

350317

291

179 180 168

0

100

200

300

400

500

600

2000 2001 2002

Total All Types Passenger Cars Light Trucks· Totals include crashes involving passenger cars, light trucks, large trucks, motorcycles, buses, and other/unknow n vehicle types.· Data available from the National Highw ay Traff ic Safety Administration at

http://w w w -nrd.nhtsa.dot.gov/pdf/nrd-30/NCSA/TSFAnn/TSF2002Final.pdf

Children Under 5 Years Old

Road fatalities to all vehicle occupants under 5 years old decreased 12.4% between 2000 and 2002.

Injuries decreased 11.9% between 2000 and 2002.

Estimated resident population of children under 5 years old increased 1.9% between 2000 and 2002.

Summary Even in extreme cases, the historic

relationship between diversion from air travel and increased risk of fatality or injury in highway accidents is not clearly apparent.

Accident risk is not evenly distributed among all drivers, vehicle types, and trip conditions.

No evidence was found to suggest an increased risk for children under 5 years old.

Additional Application: Pseudodisease Pseudodisease: disease that looks just

like real disease pathologically but would cause no problems

Identified with screening tests, causing net harm

Can’t tell from disease in an individual patient

Hard for people to grasp because there are no stories

Alternative story line Villains -- emotional, irrational,

nonscientific people and for-profit corporations

Heroes -- rational, scientific, impartial researchers who do not accept industry money

Moral: follow the money, keep the broadest possible perspective!

www.kernicterus.org

Information for Parents: The Jaundiced Baby

Jaundice in Newborns and its Treatment

About 60% of newborn infants in the United States are jaundiced, that is they look yellow. Excessive jaundice in newborn infants may cause brain damage.

The Nuclear Non Proliferation Treaty, Article VI

“Each of the Parties to the Treaty undertakes to pursue negotiations in good faith on effective measures relating to cessation of the nuclear arms race at an early date and to nuclear disarmament, and on a treaty on general and complete disarmament under strict and effective international control.”

Signed by the U.S. 1968, ratified 1969

http://disarmament.un.org:8080/TreatyStatus.nsf

What does if mean if a treaty is ratified?

Article VI, U.S. Constitution:– “This Constitution... and all treaties made, or

which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby...

– “The Senators and Representatives...and the members of the several state legislatures, and all executive and judicial officers, both of the United States and of the several states, shall be bound by oath or affirmation, to support this Constitution...”

AAP Guidelines (1994)

Total Serum Bilirubin, mg/dL

Age(hrs)

ConsiderPhoto-therapy

Photo-therapy

ExchangeTransfusionif Intensive

PhototherapyFails

ExchangeTransfusion

and IntensivePhototherapy

24 hrs --- --- --- ---

25-48 hrs 12 15 20 2549-72 hrs 15 18 25 30>72 hrs 17 20 25 30

Reemergence of Kernicterus In Babies Discharged As Healthy In 1990s:

Review of 5 Decades of Reports in the Literature. Vinod K.

Bhutani and Lois H. Johnson

0

2

4

6

8

10

12

53-62 83-72 73-82 83-85 86-88 89-91 92-94 95-97 98-01

Calender Years

Case

Rep

orts

per

Eac

h Ye

ar

Plus new

Cases

PAS Meeting 2003: Abstract

N=154

http://www.pickonline.org/presentation.ppt, accessed 7/10/03

66

Kernicterus Registry: Definition and Eligibility*

Acute phase kernicterus– Irritability and hypertonia with early retrocolis and

opisthotonus and drowsiness, poor feeding, high-pitched cry, alternating tone or failed ABR

Chronic kernicteric sequelae: Abnormality in at least 2 of the following, at least one severe:– Extrapyramidal movement disorder– Gaze abnormalities– Auditory disturbances– Intellectual deficits– Enamel dysplasia of deciduous teeth

Johnson LH, Bhutani VK, Brown AK. J Pediatr 2002; 140: 396-403

How common is kernicterus? Pilot kernicterus registry: 90 cases in 15

years in the US Northern California Kaiser Permanente

– No cases in 111,000 births, 1995-8. (11 had TSB > 30 mg/dl1 )

– No cases found yet in 119,000 births, 1991-4– ? 2 potential cases 2003?

California Cerebral Palsy Project2 – 1 case in 155,636. – (Total of 192 cases of CP in that study.)

Denmark, 1994-8 ~1/65,0003

1 Newman TB et al. Pediatrics 2003;111:1303-11

2 Cummins SC. Personal communication. 3Ebbesen F Acta Paediatr 2000;89:1-5

How Common Is Kernicterus? Problems:

– No uniform surveillance– Trade-off between sensitivity and specificity in

case definition – no standard– Diagnosis of kernicterus often delayed, uncertain

and contentious Probably between 1/100,000 and 1/250,000 =

16-40 cases per year in the US MUCH more common in some other

countries, especially in Africa– Southern Nigeria: 9/20 infants readmitted with

TSB > 15 mg/dl (45%)1

1 Slusher TM et al. Pediatr Res 2003 Abst #2865

CO

Pathophysiology

MMWR Case Reports: missing information #2 (Cal Sheridan) The follow-up visit

when OM diagnosed #3 The child has congenital nephrotic

syndrome -- a low albumin probably contributed to risk

#4 At 4 days Mother declined a home health visit and reported that jaundice appeared to be fading