Transcript 2-LANTOS REV - Seattle Children's

John D. Lantos M.D.
Children’s Mercy Bioethics Center
Children’s Mercy Hospital, KCMO
What Makes the Gray Zone Gray?
Conventional wisdom
• Three ethical/medical “zones”
– Non-viable: <22 (or 23) weeks
– The “gray zone”: 22-26 weeks
– High survival: >26 weeks
• Doctors determine gray zone boundaries
• In gray zone, parents may choose.
Three sources of grayness
• Poor chance for survival (futility)
• Sequelae among survivors (quality of life)
• Too expensive (cost-effectiveness)
Poor survival rates
• Outcomes vary from center to center.
• At 22 wks and 400g, survival is possible.
• Below 22wks and 400g, very unlikely
Peripartum outcome of inborn infants who were born
at 401- 500g in Vermont-Oxford Network, 1996-2000
Lucey, J. F. et al. Pediatrics 2004;113:1559-1566
Copyright ©2004 American Academy of Pediatrics
Among 400-500g infants
• 16% survive until discharge
• 35% of those admitted to the NICU survive to
discharge
• Survival more likely after antenatal steroids
and c-sections.
Survival by gestational age, all Canadian NICUs
Data from 1996
Survival by GA between 1986 and 2000,
University of Minnesota
Hoekstra, R. E. et al. Pediatrics 2004;113:e1-e6
Copyright ©2004 American Academy of Pediatrics
GA-specific neonatal mortality and
mortality before discharge
42 centers in Japan, 2003
Kusuda, S. et al. Pediatrics 2006;118:e1130-e1138
Copyright ©2006 American Academy of Pediatrics
Algorithms improve accuracy
• Tyson et al – NICHD
• Bader et al – Israeli Neonatal Network
Add risk factors
• A simple Web-based tool allows clinicians to
estimate the likelihood that intensive care will
benefit individual infants.
• www.nichd.nih.gov/neonatalestimates
Tyson, et al, NEJM, 2008
Five factors
1. Gestational Age
2. Birth Weight
3. Sex
4. Singleton Birth
5. Antenatal Corticosteroids (<7 Days Before Delivery)
Gestational Age:23 weeks
Birth Weight:450 grams
Sex:Female
Singleton Birth:Yes
Antenatal Corticosteroids:Yes
Outcomes
Survival
All infants
22%
Infants given MV
32%
Survival Without
Profound Impairment
14%
21%
Survival Without Moderate
to Severe Impairment
8%
12%
http://www.nichd.nih.gov/about/org/cdbpm/pp/prog_epbo/
Gestational Age:25 weeks
Birth Weight:575 grams
Sex:Male
Singleton Birth:No
Antenatal Corticosteroids:Yes
Survival
All infants
53%
Infants given MV
54%
Survival Without
Profound Impairment
34%
35%
Survival Without Moderate
to Severe Impairment
17%
18%
Birthweight percentiles
Bader et al Peds 2010
Mortality rates by GA and birthweight percentile
Bader et al Peds 2010
Physical and cognitive impairments
• Quality of life is complicated
– Probability of a bad outcome,
– Judgment about how bad.
• Probabilities are fraught with uncertainty
• Judgments are fraught with subjectivity
Key question
How bad does life have to be before it
is thought to be worse than death?
Misunderstanding or value clash?
• 587 subjects, 4/05-7/07, Hong Kong.
– 135 health care workers,
– 155 mothers of term infants,
– 288 parents of preterm infants.
• Ranked five health states and death
Lam et al, Pediatrics, June, 2009
Worst health states
1. Death.
2. Severe global impairment – wheelchair,
intelligence of 1y.o., unable to speak, read or
write, incontinent, no independent ADLs.
5. Moderate global impairment – crutches, attends
special school, cannot read or write, unable to live
independently, continent.
Bars represent 3 different groups of respondents.
Blue stripe: proportion who thought that death was worst outcome,
severe delay next, and moderate delay best.
Red stripe: those who thought severe delay was worst outcome,
followed by death and then moderate delay.
Lam, H. S. et al. Pediatrics 2009;123:1501-1508
Copyright ©2009 American Academy of Pediatrics
What percentage think that severe disability is
worse than death?
• Doctors and nurses
• Mothers of term babies
• Parents of preemies
55%
40%
25%
Parents and professionals ratings of quality of life
• Interviews with:
– 100 neonatologists
– 103 neonatal nurses from 3 NICUs
– 264 adolescents, including
• 140 who were ELBW infants and
• 124 sociodemographically matched term controls
– 275 parents of the recruited adolescents.
• Main Outcome Measure Preferences (utilities) for 4 to 5
hypothetical health states of children.
Saigal et al JAMA 1999
“Best” and “Worst” children
• Jamie – can see, hear, talk, walk, bend, lift,
jump, and run normally, does schoolwork
more slowly than classmates.
• Pat – blind, deaf, unable to talk, needs
equipment to walk, learns schoolwork very
slowly and needs special help, needs help
from another person to eat, bathe, dress or
use the toilet.
Comparison of Preferences of Health Care
Professionals and Parents for 4 Hypothetical Health States
Saigal, S. et al. JAMA 1999;281:1991-1997.
Summary of empirical studies
• Parents more tolerant of disabilities than doctors or
nurses
• They rate quality of life higher
• More likely to opt for treatment even if survival is
likely to be with neurocognitive problems.
• Parents who have had a preemie are more likely to
favor treatment.
Overall Disability at 30 Months for 314 Children
Born at 22 through 25 Weeks of Gestation
Wood, et al, NEJM, August 2000
Med 2000;343:378-384
Disability rates among survivors, by
gestational age
•
•
•
•
22 weeks - 1/2 (50%)
23 weeks - 14/26 (54%)
24 weeks - 52/100 (52%)
25 weeks - 84/186 (45%)
• In each group, half of disability was “severe.”
Cognitive Scores for 241
Extremely Preterm Children
and 160 Age-Matched
Classmates Who Were Full
Term at Birth, According to
Sex and Completed Weeks
of Gestation.
Kaufman Assessment
Battery for Children scores
for the Mental Processing
Composite or developmental
scores according to the
Griffiths Scales of Mental
Development and NEPSY
(possible range, 39 -150)
Marlow et al. NEJM, 2005: 352 (1): 9
Disability and cost-effectiveness
• Studies of the burden of disability also incorporate
cost-effectiveness analyses.
• Outcomes reported as
– $$/QALY (quality-adjusted life-year) or
– $$/DALY (disability-adjusted life-year)
Cost-effectiveness
• What is the cost of saving a life?
• What is the long term cost of health needs and
educational needs?
• How do the costs of saving a premature baby
compare to other medical costs?
Cost-effectiveness and cost-utility ratios
(1997 Australian dollars)
Doyle, L. W. et al. Pediatrics 2004;113:510-514
Copyright ©2004 American Academy of Pediatrics
Cost-benefit analysis, premature babies,
1960 and 1990
Cuttler and Meara
Summary
• To define the gray zone, need to consider survival,
impairment, and cost.
• Only survival differs significantly by gestational age or
BW/GA – cost and QOL do not.
• How likely does survival need to be in order to deem
treatment obligatory?
Ethics and knowledge
• Precise, individualized predictions of survival could
eliminate the gray zone:
– Treat babies who will survive
– Do not treat babies who will die
• Precise, individualized predictions of impairment will
not….
– Trisomy 13 and 18
Starting and stopping
• Many ethical frameworks focus on the decision about
starting treatment
• Preferable to focus on decisions about when to stop.
• Parental demands for futile treatment far more
common than parental refusals of beneficial treatment.
Key question
Can we tolerate moral diversity?