Moral Distress and Misguided Paternalism

Keith J BarringtonCHU Sainte Justine

Montréal

• I have no conflicts of Interest to disclose

Moral Distress

• It is not rare in the NICU to feel ethically conflicted

• Dealing with high risk patients who need intensive care support ‘naturally’ leads to situations where opinions differ

• Differing opinions lead to conflict about treatment options

Moral Distress in the NICU

• Janvier A, Nadeau S, Deschenes M, Couture E, Barrington KJ: Moral distress in the neonatal intensive care unit: caregiver's experience. J Perinatol 2007, 27(4):203-208.

• Questioned nurses and pediatric residents

Results• 279 questionnaires• Nurses in MUHC: Children's Hospital NICU,

obstetrics and NICU at Royal Victoria Hospital:– 78-90% participation full time nurses: total

= 115 nurses• Residents in pediatrics and obstetrics at all

Quebec Universities: McGill (Montreal), Montréal, Laval (Québec), Sherbrooke – 90-100% participation: 164 residents

Ethical confrontation vs estimations of outcome of infants born at 25 weeks GA and willingness to

intervene>often

Nurses Outborn 56Nurses Inborn 24Nurses OB 22Ped A 28Ped B 22Ped C 0Ped D 36Obs A 6Obs B 6Obs C 0Obs D 25

>25% CP CP 40% alw brad 2569 39 1837 8 7054 6 6548 4 3653 22 5669 38 2341 12 7150 6 2861 28 2864 7 2931 0 69

Why do caregivers experience moral distress in the NICU?

• Our data showed that many residents and nurses frequently (19% and 35%) experienced ethical confrontation

• Strong association between overestimate of disability among former extremely preterm infants and moral distress.

• Nurses who experienced a lot of moral distress were more likely to overestimate the proportion of extremely preterm babies who were ‘handicapped’

Caregivers and moral distress

• We also showed big differences in the frequency of moral distress between residents working in different universities

• Also between nurses working in a children’s hospital NICU and those working in a maternity hospital NICU

• Residents who worked in a center where 23 week babies were never resuscitated thought that a very high proportion of them would develop CP.

• They were rarely morally distressed, they thought that what they were doing was just fine.

• Nurses working in a children’s hospital NICU thought that most very premature babies were impaired. They were frequently morally distressed.– The extremely preterm babies that they see do

indeed have more CP• Nurses in the maternity hospital NICU also over-

estimated the prevalence of CP, but much less, and they were much less frequently distressed.

Misapprehension

• Many respondents had very erroneous estimates of impairment among very preterm babies

• If they then had to take care of them anyway, they were distressed.

• Those with the most erroneous estimates of impairment were much less likely to want to resuscitate a very preterm baby.

What kinds of Conflicts do we Encounter?

• Most ethical conflicts in the NICU (in several different countries) occur over end of life care.

• Usually; parents desire is to continue active care and the care team, or some members of it, think that comfort care would be more appropriate (80% of EoL conflicts)– Some activists seem to think it is the converse, that we

are commonly coercing parents into NICU care• Many of these differences of opinion turn around

neurological prognosis

Neurologic Prognosis in the NICU

Neonatologists love numbers

23 weeks

Comfort care:Baby dies

intervention, 25% survival

BUT, she might still dieIn the NICU (75% do)

IF she survives

1 in 2 areOK

1 / 4 have major disability

-CP (8-10%)-deafness (3%)-blindness (2%)-developmental delay- Bla bla bla

40% have a minor disability:-Hyperactivity-Dyslexia-Behavior- Learning difficulty

Trying to Predict Handicap

• 'An impairment is any loss or abnormality of psychological, physiological or anatomical structure or function;

• a disability is any restriction or lack (resulting from an impairment) of ability to perform an activity in the manner or within the range considered normal for a human being;

• a handicap is a disadvantage for a given individual, resulting from an impairment or a disability, that prevents the fulfilment of a role that is considered normal (depending on age, sex and social and cultural factors) for that individual'.– WHO 1976

Predicting Disability

• Which disabilities do you want to talk about?• A low Bayley score is not a disability!• A low Bayley score is an indication of delayed

development, • Many infants with low Bayley scores will not

have ‘Cognitive Impairment’• Very few infants with low Bayley scores will be

so badly impaired that there is substantial effect on their QoL

Does a low Bayley MDI mean that an infant has cognitive impairment? Hack et al

Neurosensory Status at 20 Months

Total Population (n = 200):

8-Year MPC Normal (n = 154): 8-Year MPC

Abnormal (n = 46): 8-Year MP

20-month MDI

<70 70–84 85 Total <70 70–84 85 Total <70 70–84 85 Total

<70 29 21 28 78 (39%)

9 16 20 45 (29%)

20 5 8 33 (72%)

70–84

2 15 39 56 (28%)

1 12 36 49 (32%)

1 3 3 7 (15%)

85 1 6 59 66 (33%)

0 5 55 60 (39%)

1 1 4 6 (13%)

Total 32 42 126 10 33 111 22 9 15

(16%) (21%) (63%) (7%) (21%) (72%) (48%) (20%) (32%)

Colombo and CarlsonPediatrics: June 2012

• The BSID is a global test designed to identify developmental delay. Its role and place within the field of developmental science is relatively well established. The BSID is, to be charitable, only modestly related to school-age cognitive development (ie, the outcome that is most meaningful to investigators in this field). The BSID is a global measure of developmental status in infancy that assesses and aggregates the timely attainment of relatively crude milestones in infancy and early childhood.

• Simply, the BSID is not an adequate indicant of specific cognitive skills that may be differentially affected by interventions or exposures, nutritional or otherwise, and so its use to evaluate the construct of infant cognition is seriously deficient in the context of recent advances in developmental science.

Reasons for trying to predict disability

• To focus follow up programs• To initiate targeted early intervention• To prepare parents for their future• To understand the causes of disability• To perform research to reduce disability, or the

impacts of disability

• To redirect intensive care to comfort care, and eliminate disabled children

Head Ultrasounds

• What is their sensitivity and specificity for predicting outcomes?

• Systematic Review of findings on ultrasound and long term

• Outcomes of babies with normal ultrasounds

What about the 3 day ultrasound?

• If we focus specifically on the ultrasound done at 72 hours…

• What is the PPV of ANYTHING that you can see on the ultrasound at 72 hours.

Kuban et al ELGAN study 2007

Table 2 The percentage of all scans read by pairs of readers that were read concordantly (positive/positive, negative/negative) and discordantly (positive/negative, negative/positive)

Second reader

First reader

Intraventricular hemorrhage

Ventriculomegaly (moderate/severe)

Hyperechoic lesion

Hypoechoic lesion

Positive Negative Positive Negative Positive Negative Positive Negative

Positive 19 6 9 5 11 11 5 3

Negative 6 69 4 83 13 65 3 89

Agreement (%)

76 92 69 94 46 86 63 97

Kappa 0.68 0.63 0.32 0.62

N=1450

Results of review

Authors year Outcome Age Ultrasound Grade PPV n with this lesion

Whitaker 1996 IQ < -2SD 6y Parenchymal Lesion or VE 42% 46Pinto-Martin 1995 Disabling CP 2y Parenchymal Lesion or VE 52% 63Aziz 1995 CP and/or DQ<-2SD1y IVH + IPE + VE 79% 14EpiPage 2006 Disabling CP 2y Parenchymal Lesion 65% 85Vollmer 2005 Disabling CP 8y Parenchymal lesion on L 16% 17

Parecnhymal lesion on R 8% 16Bilateral parenchymal 31% 106

Ment 1999 IQ < -2SD 4.5y Ventriculomegaly Mod/severe 56% 11Broitman 2007 DQ < -2SD 18-22mo "Grade 4" 52% 145

Disabling CP 18-22mo "Grade 4" 42% 145DQ < -2SD 18-22mo Cystic PVL 60% 50Disabling CP 18-22mo Cystic PVL 50% 50

de Vries 2004 CP 2y Cystic PVL 50% 49Mirmiran 2004 CP 31mo Parenchymal abN or VE 33% 14Pierrat 2001 CP 36mo Extensive cystic PVL 96% 28

Localized cystic PVL 74% 38McMenamin 1984 CP and/or DQ<-2SD2y Large IPE 75% 8

Small IPE 30% 22

ELGAN study

• Infants less than 28 weeks gestation (n= 1450)• Followed to 2 years• Of those with Normal Head ultrasound scans:• Bayley 2 MDI 23% <70• Bayley 2 PDI 26% <70

O’Shea TM et al, Pediatrics 2008

Ultrasound Lesion, Bayley

Scale < 70

Ventriculomegaly Echolucent Lesion

MDI PDI MDI PDIPredictive value positive

45 55 45 61

Predictive value negative

76 72 75 71

Sensitivity 17 17 12 14

Specificity 93 94 95 96

TABLE 7Measures of the Ability of Head Ultrasound Abnormalities Evident Before Discharge From the NICU to Predict an MDI or PDI >2 SDs Below the Expected Mean at 24 Months’ Corrected Age

Grade and laterality of intraventricular haemorrhage to predict 18–22 month neurodevelopmental outcomes in extremely low birthweight infants

Acta PaediatricaVolume 101, Issue 4, pages 414-418, 16 JAN 2012 DOI: 10.1111/j.1651-2227.2011.02584.xhttp://onlinelibrary.wiley.com/doi/10.1111/j.1651-2227.2011.02584.x/full#f3

Grade and laterality of intraventricular haemorrhage to predict 18–22 month neurodevelopmental outcomes in extremely low birthweight infants

Acta PaediatricaVolume 101, Issue 4, pages 414-418, 16 JAN 2012 DOI: 10.1111/j.1651-2227.2011.02584.xhttp://onlinelibrary.wiley.com/doi/10.1111/j.1651-2227.2011.02584.x/full#f2

Is the MRI better?

• MRI at discharge

MRIWoodward et al, NEJM 2006167 infants <30 wk, MRI at term and 2 yr exam.

Woodward et al

• What really matters to a parent: with this finding on MRI what is the likelihood that my baby will be severely impaired?– I.E. what is the PPV

• Now that the MRI is normal what is likelihood that my baby will be “normal”? – What is the NPV

• PPV from Woodward et al of Moderate to Severe AbN on MRI for severe impairment (incl. MDI or PDI < 70) 30%

• NPV 95%

Miller et al

• Moderate or severe White matter injury on preterm MRI– PPV = 29% for a DQ <70 or disabling CP at 2 y

• Moderate or severe White matter injury on MRI at term– PPV = 42% for a DQ <70 or disabling CP at 2 y

• In other words when we see moderate or severe WMI on an MRI most of the babies will have a good outcome!

Other MRI prediction studies

• Shah DK 2006, – PPV 50%, NPV 97%

• Mirmiran M 2004 – PPV for CP 50%

• Valkamaran AM 2000 – PPV of parenchymal lesions for CP, 58%

• Arzoumanian 2003– PPV 10%

• Leijser LM 2008– PPV 43% for severe abN outcome

MRI near term for predicting outcome

• An important research tool, which might help us to understand the long term difficulties of preterm infants

• This is not the same as saying that everyone should have one!

• It has become a default in many NICUs• The medical community has decided that this is

now standard of care

Neonatalresearch.org

• The outcome articles are often trying to predict?

• 18 to 24 month Bayley MDI less than 70.

• We have often counselled parents for withdrawal of life sustaining interventions because of an increased risk of that outcome

• Is this misguided paternalism?

Clinical Course

• Clinical Features are more predictive of long term outcome than any finding on head ultrasound or MRI– NEC, Postnatal Dexamethasone, Sepsis, poor

nutrition, surgery (any)

– Surgical NEC and sepsis increases CP prevalence by more than 4 fold

Socio-economic status of parents

• The most important factor predicting long term outcomes

Criteria for a Screening Test• Highly Sensitive• Very Specific• Identify treatable conditions• http://www.screening.nhs.uk/criteria

– 6. The distribution of test values in the target population should be known and a suitable cut-off level defined and agreed.

– 8. There should be an agreed policy on the further diagnostic investigation of individuals with a positive test result and on the choices available to those individuals

– 10. There should be an effective treatment or intervention for patients identified through early detection, with evidence of early treatment leading to better outcomes than late treatment

– 13. There should be evidence from high quality Randomised Controlled Trials that the screening programme is effective in reducing mortality or morbidity. Where screening is aimed solely at providing information to allow the person being screened to make an “informed choice” (eg. Down’s syndrome, cystic fibrosis carrier screening), there must be evidence from high quality trials that the test accurately measures risk. The information that is provided about the test and its outcome must be of value and readily understood by the individual being screened.

Do ultrasounds/MRI qualify?

• None of the ‘screening tests’ adequately discriminate between babies with impairment and without

• None of them qualify as routine screening tests according to published criteria

Valid reasons for trying to predict disability in order to limit therapy

• Handicap that is so profound that an individual could be considered ‘better off dead’ is a valid reason for trying to predict long term outcomes.

• Very difficult to predict this in the preterm.• Easier for asphyxia

Valid reasons for performing screening ultrasounds

• To detect treatable lesions– Posthemorrhagic ventricular dilatation

• To detect reliably predictive lesions– Devastating bilateral periventricular hemorrhagic

infarction?– Extensive bilateral cystic PVL

• Good for detection of disabling CP, not for cognition

A thought experiment

• Twin babies are born at 32 weeks gestation requiring initial resuscitation

• One baby has no known antenatal problems• The other has an antenatally diagnosed

condition which gives a 100% chance of intellectual impairment, mean IQ of 50.

• Is it ethically acceptable to resuscitate #1 and not #2?

• Baby 2 has Down’s syndrome

• Is it still acceptable to not resuscitate?

Experiment #2

• Twin babies are born at 32 weeks gestation requiring initial resuscitation

• One baby has no known antenatal problems• The other has an antenatally diagnosed

condition which gives a 50% chance of intellectual impairment

• Is it ethically acceptable to resuscitate #1 and not #2?

Experiment #3

• Twin babies are born at 23 weeks gestation requiring initial resuscitation

• One baby has a normal head ultrasound• The other has a unilateral grade 4 hemorrhage, a

condition which gives a 10% chance of cerebral palsy and a 50% chance of delay in development, and is associated with, (on average in a large group), an IQ score 15 points lower at 8 years

• Is it ethically acceptable to continue actively treating #1 and not #2?

Reliably predicting Outcomes

• If we want to predict Quality of Life:• According to published data among preterm

infants• We can predict acceptable to excellent quality of

life at discharge with one test….

Is the baby alive?If yes 98% PPVIf no 100% NPV

Implications

• Does this mean we never talk to parents about the long term?

• We never consider limiting therapy?

• We should reconsider why we do our prognostic testing, and what impairments we want to predict.

Implications

• Our over reliance on brain imaging introduces inappropriate worries and fears

• Increases moral distress• Has been another example of medical

paternalism: who asked the parents?• Guidelines for routine preterm ultrasound

imaging– no parents involved in setting the guidelines

Date of download: 3/21/2013Copyright © 2012 American Medical Association.

All rights reserved.

From: The Shared Decision-Making Continuum

JAMA. 2010;304(8):903-904. doi:10.1001/jama.2010.1208

Pearce R, Baardsnes J: Term MRI for small preterm babies: do parents really want to know and why has

nobody asked them? Acta Paediatrica 2012.

• Parents of Lily and Maren• The NICU experience is like living through a

nightmare that you just cannot wake up from

• The NICU is full of numbers: As and Bs, grams per day, ounces of milk, q3 hours, % of oxygen, level of sodium,etc.

• We constantly read research papers and abstracts, trying to digest the information. Our lives revolved around the numbers, percentages and statistics regarding cognitive impairment, behaviour abnormalities and motor disabilities

• the outcomes for 25-week preemies with severe BPD were not particularly great. But percentages are statistics.

• We did not have a hundred babies. We had two but 50% had died.

• One was left. What did that mean for Maren?

Pearce R, Baardsnes J: Term MRI for small preterm babies: do parents really want to know and why has

nobody asked them? Acta Paediatrica 2012.

• (The term MRI)…had identified moderate cerebellar damage

• Our daughter had brain damage. Two of the most horrific words a parent can ever hear.

• The doctor was compassionate but vague about the possible motor, cognitive and behavioural problems that Maren could face. He also said that it was hard to predict outcomes from MRIs, and it was not certain at all Maren would be disabled. In fact, many children with abnormal MRIs are not disabled.

• When he left, I thought ‘okay, maybe this isn’t so bad after all’. …

• I looked on PubMed for abstracts about cerebellar damage in preterm infants. One of the few articles that I found (Limperopoulos et al. 2007) was totally devastating… babies with cerebellar damage had a much greater chance of expressive and receptive language delays, severe motor disabilities, cognitive disabilities and autism symptoms.

• This could be our child. We thought that we finally saw the light at the end of the tunnel, and then, we were handed this earth-shattering, crushing information.

• For the first year, we were petrified and hypervigilant,• the MRI always in our minds. Was she making eye contact?

Reaching for things? Showing any signs of ataxia? Babbling appropriately? Drooling too much? Acting ‘strange’?

• She was our first child, so we did not really know what ‘strange’ was, but were watching for it! I would imagine Maren in a wheelchair or with leg braces, in a group home or with severe autism.

• I started seeing a psychologist on a regular basis.• In our case, Maren’s MRI gave us no information about

what she is like today, it served only to completely terrify us.

• Slowly, as she started meeting her milestones, our utter panic settled into something less acute.

25 weeks, twin, early onset septic shock, fungal sepsis, prolonged HFOV and inhaled NO for marginal saturations, PDA ligation and postop hemodynamic compromise, severe BPD receiving steroids… Cerebellar hemorrhage found on discharge MRI

Our commentary

• Janvier A, Barrington K: Trying to predict the future of ex-preterm infants: who benefits from a brain MRI at term? Acta Paediatr 2012, 101(10):1016-1017.

• We do many things to try to predict outcomes in the NICU• We rarely investigate how this affects parents• A lot of the long term outcomes of preterm infants

depend on what happens after the NICU, at home, with parents

• We are actually increasing moral distress, among parents and caregivers

• ‘MRI preterm brain’ on PubMed = 642 articles, a considerable amount of research is being performed and enormous research funds have been expended.

• No studies demonstrate MRIs at term helps families

• No study investigating their effect on families• No study even raises the possibility that MRI

results may in fact harm to some families

Concerns

• Paucity of studies actively investigating how to improve – as opposed to describe – the long-term outcomes of preterm infants or their parents coping abilities.

• Every year, more investigations are presented that generally describe how abnormal, abnormally wired, and not exactly perfect ex-preterms are.

• Rarely do the studies describe what ex-preterms can in fact do and how we can help them and their parents.

Reducing Moral Distress

• Education of everyone involved in the NICU on the outcomes, and the good quality of life of former NICU patients

• Involving parents in decisions, not just individual medical decisions, but on setting policies, designing research, interpreting what is significant

Cerebral Protection

• Only postnatal agent proven to reduce IVH is prophylactic indomethacin (antenatal steroids are also effective).

• Severe IVH and total IVH are both reduced: Severe IVH RR 0.66 (95% CI 0.53-0.82).

• But long term outcomes are not significantly affected

Cerebral Protection

• The largest trial (TIPP, n=1200) showed a reduction in Severe IVH from 13% to 9% among infants 1000 g birth weight.

• If indomethacin has no other effects on the CNS, then a 4% reduction in severe IVH would be expected to lead to about a 2% decrease in the number of impaired children.

• Sample size required to show such a benefit = 9493 per group

Prophylactic Indomethacin and severe IVH

Research Priorities

• Ask parents if they think that a significant reduction in severe cerebral hemorrhage is a benefit that interests them, (also reduces the number of PDA ligations, and severe pulmonary hemorrhages, without proven adverse effects).

• Parents should be involved in setting research priorities, designing studies, choosing outcomes, interpreting results, and deciding clinical applications

• An end to academic paternalism

Moral Distress and Futility

• I have been concentrating on the preterm, because I like numbers too!

• Most of the data is from studies of the preterm

• Much of the moral distress has to do with patients who have prolonged NICU care and little chance of survival, either babies who started out as premies, or those with other problems

Predicting death

• We are lousy at predicting who will die… in general

• Sometimes it may be clearer

Case

• Antenatal diagnosis of prune belly syndrome, with oligohydramnios, delivery at 32 weeks

• Postnatal diagnosis megacystis megaureter microcolon syndrome.– Pulmonary hypoplasia, dependent on HFO with NO– Poor renal function, slowly increasing creatinine– Cannot tolerate feeds– Parents do not want to withdraw life sustaining

interventions

• Child lived for several weeks• Parents asked for a nephrology consult• Eventually we came to the agreement that we

would not offer renal replacement therapy, as the pulmonary situation continued to deteriorate we were eventually able to allow a peaceful end in the mothers arms.

Moral Distress?

• In this case yes, but we were able to minimize it• Constant discussions with all the involved

disciplines,– ‘we can’t just say to the parents ‘’I don’t care what

you think, I know better than you’’ they love their baby, they are struggling as well’

• A group of nurses who appreciated the love of the parents for their baby

• Active pain control

Date of download: 3/21/2013Copyright © 2012 American Medical Association.

All rights reserved.

From: The Shared Decision-Making Continuum

JAMA. 2010;304(8):903-904. doi:10.1001/jama.2010.1208

neonatalresearch.org

• This presentation will soon be available on my blog, with a blog post and as a downloadable pptx file, with all the references.