Transcript Too much information?

Too much information?
Pro-VIDE Law, 1/10/2015 @ Weightmans, Liverpool.
Participants
•
Mr. Charles Feeny, barrister;
•
Prof. Graeme Poston, Consultant Hepatobiliary
Surgeon; and
•
Prof. Gus Baker, professor of ClinicalNeuropsychology at the University of Liverpool.
The question in a nut shell…
Hippocratic Corpus
•
Physicians are advised to reveal nothing to the patient of
their present or future condition, ‘for many patients through
this cause have taken a turn for the worse’. Decorum XVI
of the Hippocratic Corpus.
Sidaway v Board of Governors of the
Bethel Royal Hospital [1985] AC 871
•
3 different approaches coming out of the case.
•
“If, therefore, the failure to warn a patient of the risks inherent in the operation which
is recommended does constitute a failure to respect the patient’s right to make his
own decision, I can see no reason in principle why, if the risk materialises and injury
or damage is caused, the law should not recognise and enforce a right in the
patient to compensation by way of damages.” Per Lord Scarman at page 884-885.
•
‘I am of opinion that the judge might in certain circumstances come to the
conclusion that disclosure of a particular risk was so obviously necessary to an
informed choice on the part of the patient that no reasonably prudent medical man
would fail to make it. The kind of case I have in mind would be an operation
involving a substantial risk of grave adverse consequences, as, for example, the
10% risk of a stroke from the operation… In such a case, in the absence of some
cogent clinical reason why the patient should not be informed, a doctor, recognising
and respecting his patient’s right of decision, could hardly fail to appreciate the
necessity for an appropriate warning.’ Per Lord Bridge at page 900.
Finally Lord Diplock…
“But when it comes to warning about
risks, the kind of training and
experience that a judge will have
undergone at the Bar makes it natural
for him to say (correctly) it is my right to
decide whether any particular thing is
done to my body, and I want to be fully
informed of any risks there may be
involved of which I am not already
aware from my general knowledge as a
highly educated man of experience, so
that I may form my own judgment as to
whether to refuse the advised
treatment or not.” Per Lord Diplock at
page 895
Chester v Afshar [2004] UKHL 41
•
The Claimant suffered from back pain. Three days after consultation with Mr Afshar
the Claimant was operated upon. It resulted in significant nerve damage and left her
partially paralysed.
•
There was a 1-2% risk associated with the surgery. The Claimant was not informed
of this risk and the trial judge accepted that the Claimant would not have had the
operation immediately but would have had it at a later date.
•
3:2 split in the House of Lords (Lords Bingham and Hoffman dissenting).
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“But if failure to warn and the occurrence of injury which should have been the
subject of the warning are, without more, enough to found a successful claim, the
claimant would presumably succeed even in a case like Smith v Barking, Havering
and Brentwood Health Authority [1994] 5 Med LR 285 , where it is found on the
balance of probabilities that the claimant would have consented to the operation
even if properly advised. That seems to me, with respect to those who hold
otherwise, to be a substantial and unjustified departure from sound and established
principle.” Per Lord Bingham at paragraph 9.
Montgomery v Lanarkshire Health Board
[2015] UKSC 11
•
The Claimant sought damages from the Health Board on behalf of
her son who suffered severe problems as a result of shoulder
dystocia.
•
The Claimant was of small stature and diabetic. The treating doctor
did not tell her that diabetic women had a 9–10% risk during a
vaginal delivery of shoulder dystocia as, in her view, the risk of a
grave problem resulting for the baby was very small and, if the
condition were mentioned, most women would ask for a caesarean
section, which was not in their interest.
‘An adult person of sound mind is entitled to decide which,
if any, of the available forms of treatment to undergo, and
her consent must be obtained before treatment interfering
with her bodily integrity is undertaken. The doctor is
therefore under a duty to take reasonable care to ensure
that the patient is aware of any material risks involved in
any recommended treatment, and of any reasonable
alternative or variant treatments. The test of materiality is
whether, in the circumstances of the particular case, a
reasonable person in the patient’s position would be likely
to attach significance to the risk, or the doctor is or should
reasonably be aware that the particular patient would be
likely to attach significance to it.’ Per Lords Kerr and Reid at
paragraph 87.
Implications
•
What are the implications
of Montgomery?
Informed consent:
where are we now?
Graeme Poston
Professor of Surgery
University of Liverpool
Consultant Surgeon
Aintree University Hospital, Liverpool
A long time ago….
• I qualified in 1979
• ‘Informed’ consent in 1979 was signing a
simple consent form stating the name of the
proposed procedure, signed by the
patient/guardian and countersigned by a
doctor
• This remained largely unchanged until
about 2000
In 2000
• The consent form changed
• In addition to stating the proposed procedure, it
now had to state:
- the intended benefit(s) of the procedure
- the well-recognised commonly occurring risks
and complications of the procedure
• The assumption was that all well-recognised
complications that occurred with a frequency of
>1% would be listed
In 2000
• The consent process changed
• Whereas previously consent could be obtained
by any doctor, regardless of grade and
specialty, it now had to be obtained by a doctor
of appropriate seniority and experience to
understand the procedure, its risks and
benefits (but not necessarily to be able to do it
unsupervised)
• Ideally consent should be obtained at some
time before the procedure, and certainly >24
hours beforehand
In 2000
• The consent process changed
• But did not take into account ‘material’ risk:
- Chester v Afshar
- Montgomery v Lanarkshire Health Board
• What then constitutes material risk in the light
of:
- Sidaway v Bethlam and the Maudsley?
- Bolam v Friern Barnet?
- Hunter v Hanley?
- Bolitho v City and Hackney?
Issues in Montgomery v
Lanarkshire
• Mrs Montgomery studied molecular biology at
Glasgow University and had a BSc
• She worked as a hospital sales representative for a
pharmaceutical company
• Both her mother and sister were medical
practitioners
• She was an insulin dependent diabetic of short
stature
• In 1999 she was expecting her first baby
• It is well-established that diabetic mothers tend to
have larger than average sized babies
Issues in Montgomery v
Lanarkshire
Issues in Montgomery v
Lanarkshire
• There was a misinterpretation of the antenatal
imaging, leading to an inappropriate
assumption that Mrs Montgomery’s baby was
not ‘large for dates’
• As such the risk of shoulder dystocia was
never discussed during the pregnancy
• A decision was made to offer Mrs Montgomery
an induced vaginal delivery in the 38th week of
her pregnancy
Issues in Montgomery v
Lanarkshire
• At 5.45 pm, during this attempted vaginal delivery
the baby became impacted in Mrs Montgomery’s
pelvis (bilateral shoulder dystocia)
• This was only realised when half of the baby’s head
had already delivered
• Dr McLellan had never dealt with this situation
before, and applied ‘significant traction’ to deliver the
head
• During this time the placenta detached from the
uterus so the baby was now being deprived of
oxygenated blood
Issues in Montgomery v
Lanarkshire
• No preparation had been made to convert from a
vaginal delivery to a Caesarian section delivery
• Eventually, “with just a huge adrenalin surge”, Dr
McLellan succeeded in pulling the baby free, and
delivery was achieved at 5.57 pm.
• The baby had been deprived of oxygen for ~10
minutes and suffered:
- cerebral palsy due to the oxygen deprivation
- bilateral Erb’s palsies, both arms paralysed due to
brachial plexi injuries because of the trauma of the
delivery
Issues in Montgomery v
Lanarkshire
• Antenatal care: It was contended that Mrs
Montgomery ought to have been given advice about
the risk of shoulder dystocia (the inability of the
baby’s shoulders to pass through the pelvis) which
would be involved in vaginal birth, and of the
alternative possibility of delivery by elective
caesarean section.
• The delivery: It was contended that Dr McLellan had
negligently failed to perform a caesarean section in
response to abnormalities indicated by
cardiotocograph (“CTG”) traces.
Issues in Montgomery v
Lanarkshire
• According to Dr McLellan’s evidence, in some cases
the mother may be entirely unaware that shoulder
dystocia has occurred.
• Dr McLellan gave evidence: “since I felt the risk of
her baby having a significant enough shoulder
dystocia to cause even a nerve palsy or severe
hypoxic damage to the baby was low I didn’t raise it
with her, and had I raised it with her then yes, she
would have no doubt requested a caesarean
section, as would any diabetic today.”
Judgement in Montgomery v
Lanarkshire
• Mrs Montgomery was told that she was having a larger
than usual baby.
• But she was not told about the risks of her experiencing
mechanical problems during labour. In particular she
was not told about the risk of shoulder dystocia.
• It is agreed that that risk was 9-10% in the case of
diabetic mothers. Unsurprisingly, Dr McLellan accepted
that this was a high risk.
• But, despite the risk, Dr McLellan said that her practice
was not to spend a lot of time, or indeed any time at all,
discussing potential risks of shoulder dystocia.
Judgement in Montgomery v
Lanarkshire
• Dr McLellan explained that this was because, in her
estimation, the risk of a grave problem for the baby
resulting from shoulder dystocia was very small.
• She considered, therefore, that if the condition was
mentioned, “most women will actually say, ‘I’d rather
have a caesarean section’”.
• She went on to say that “if you were to mention
shoulder dystocia to every [diabetic] patient, if you were
to mention to any mother who faces labour that there is
a very small risk of the baby dying in labour, then
everyone would ask for a caesarean section, and it’s
not in the maternal interests for women to have
caesarean sections”.
Judgement in Montgomery v
Lanarkshire
• Dr McLellan explained “since I felt the risk of
her baby having a significant enough shoulder
dystocia to cause even a nerve palsy or severe
hypoxic damage to the baby was low I didn’t
raise it with her, and had I raised it with her
then yes, she would have no doubt requested
a caesarean section, as would any diabetic
today.”
Issues in Montgomery v
Lanarkshire
Counsel for the Defender to Mr Stewart, one of the
Claimant’s Experts:
“And if Dr McLellan had said your baby appears to be on the
95th centile or whatever, so it’s borderline large, it's the top
end of the normal size, its largish … We know that you are
diabetic. We know you are whatever height you are, we've
estimated the size as best we can all the way through, there
are risks but I don't think the baby is so big that vaginal
delivery is beyond you and I think we should try for vaginal
delivery and if anything comes up we will go to caesarean
section. Now if that was the general tenor of the discussion,
could you criticise that? I know it's very vague and it's very
difficult because it's another hypothesis, Mr Stewart and I
appreciate that but yes I would ... are you able to answer
that question?”
Consent: the view of the GMC
• The doctor explains the options to the patient, setting out
the potential benefits, risks, burdens and side effects of
each option, including the option to have no treatment.
• The doctor may recommend a particular option which they
believe to be best for the patient, but they must not put
pressure on the patient to accept their advice.
• The patient weighs up the potential benefits, risks and
burdens of the various options as well as any non-clinical
issues that are relevant to them.
• The patient decides whether to accept any of the options
and, if so, which one.
Consent: patients and doctors making decisions together (2008)(para. 5)
But how does a patient view risk?
Especially material risk?
• If you were going on a picnic this afternoon and
the chance of rain was 10% you would probably
go?
• If you were flying to New York this afternoon and
the chance of the plane crashing was 10% you
probably wouldn’t board it?
• Clinical risk sits somewhere between these two
extremes and depends on:
- the significance of the benefit to be gained (e.g.
cured of cancer)
- the impact of the known complications, if they
were to happen
But how does a patient view risk?
Especially material risk?
• All surgery carries risk of complications
• For major operations this is ~40% for all risks
• Some are generic e.g.:
- wound infection
- bleeding
- DVT/PE
- complications relating to general anaesthesia
• Some are operation specific e.g.:
- bile duct injury during cholecystectomy
- chronic pain after groin hernia surgery
- 10% operative mortality for
cholangiocarcinoma surgery
But how does a patient view risk?
Especially material risk?
How does the patient balance risk vs benefit?
Risks:
Operative death
Heart attack
Stroke
Major incapacity
Benefits:
Cured of cancer
Relief from pain
Restoration of function
Ability to work
Future consent form?
• State the condition as well as the procedure?
• State the intended benefits?
• State the material risks as agreed between
clinician and patient? (but how assessed?)
• State the probability of the proposed treatment
being successful, especially in cancer surgery?
• State the alternative treatment strategies,
including doing nothing?
• State the risks and successes of the alternate
strategies, including doing nothing?
But does this go beyond just
informed consent?
• In 2005 the Parliamentary Health Select
Committee produced a report critical of the NHS
because 25,000 people were dying from
preventable and treatable veno-thrombotic
embolism (VTE) each year following admission to
English hospitals.
• The Committee instructed NICE to issue guidance
to attempt to reduce the incidence of this problem
• NICE issued guidance (CG46) in 2007 which
identified patients at high risk for VTE, how to
evaluate them, and how to offer VTE prophylaxis
But does this go beyond just
informed consent?
• However, nearly 25,000 people a year kept on dying
• NICE reconvened the Guideline Development
Group who published further guidance (CG92) in
January 2010
• This guidance was very similar to CG46 but with the
additional statement that patients not deemed to be
at high risk of VTE but were being admitted to a
hospital bed should be advised, ideally in leaflet
form, of the symptoms of VTE (swollen painful calf,
painfully coughing up blood) prior to discharge
• if so then seek prompt medical attention
But does this go beyond just
informed consent?
• Mr Spencer was a 49 year old senior manager with
no significant or relevant past medical history
• In January 2010 he presented to Hillingdon Hospital
with a symptomatic right inguinal (groin) hernia
• When examined he was found to have an
asymptomatic left inguinal hernia as well
• He was listed for laparoscopic repair of both hernias
under general anaesthetic
But does this go beyond just
informed consent?
• He was on the cusp of being at higher risk of a VTE
in a number of areas:
- BMI 29.7 (limit <30)
- abdominal procedure (laparoscopic v open
surgery)
- anaesthetic possibly >60 minutes
• However no VTE assessment was undertaken but
pneumatic boot were placed during surgery
• At surgery on 1st February 2010 the laparoscopic
procedure was abandoned due to bleeding, and the
symptomatic left side repaired using traditional open
surgery
But does this go beyond just
informed consent?
• He was discharged to home later that day with a
generic patient information form stating that if he
had concerns then contact either the day unit or the
hospital switchboard
• Mrs Spencer contacted the day unit on 2 occasions:
- 1st post-op day because of confusion
- 3rd day because of wound redness
• On the 5th day his left calf became swollen and
painful which he ascribed to stiffness from being
bed-bound, it appeared to resolve spontaneously
But does this go beyond just
informed consent?
• On 23rd April he suffered a massive near-fatal PE,
for which he was anticoagulated
• Two weeks later suffered further PEs and is now
anticoagulated for life
• Mr Spencer argued that regardless of how small the
risk of VTE, had he been told of the symptoms to
look out for, he would have proceeded with surgery,
but would have sought immediate medical help
when his calf became swollen
• He would have required anticoagulation, but on
balance, would have avoided the PEs, and
subsequent lifetime anticoagulation (and its
consequences)
But does this go beyond just
informed consent?
• It was not accepted by the Defendant in the course
of the trial that Mr Spencer suffered the symptoms
he described in his legs shortly after his discharge
home.
• His Honour Judge Collender QC observed:
‘Mr Spencer gave a reasonable explanation as to why
he did not make the association; he attributed the calf
symptoms simply to being laid up as a result of the
operation and not taking exercise. The fact that the
symptoms were remote from the operation site is of
significance’.
But does this go beyond just
informed consent?
• Professor Poston giving evidence on behalf of
the Claimant said:
“The Guidance is intended to encompass those
patients on the cusp of the very specific risk
factors for increased risk of DVT stated in both
guidelines, which in the Claimant’s case was at
attempted
laparoscopic
procedure,
an
anaesthetic time of just under 1 hour in a patient
whose BMI was just less than 30.”
But does this go beyond just
informed consent?
• Mr Thomas giving evidence on behalf of the
Defendant said:
“In my opinion the best advice is to say that if the
patient does have any further or future problems,
that they should contact the GP or A+E department.
It is impossible to either ask or give advice as to
every possible complication that can occur after
hernia operation or anaesthetic. The list would be
huge – furthermore the patient would not be able to
take such a list in. Therefore patients are only
warned or questioned over common complications
after such surgery.”
But does this go beyond just
informed consent?
HHJ Collender QC considered:
‘In the light of the Montgomery decision already
discussed above, I would express the test that I
should apply to be the Bolam test with the added
gloss that I should pay regard to what the ordinary
sensible patient would expect to have been told. Put
in the form of a question, the test I consider to be,
would the ordinary sensible patient be justifiably
aggrieved not to have been given the information at
the heart of this case when fully appraised of the
significance of it?’
But does this go beyond just
informed consent?
HHJ Collender QC considered:
‘I ask myself the question, would the ordinary
sensible patient expect to have been given the
information contended for; put another way I ask
myself, would such a patient feel justifiably
aggrieved not to have been given on discharge
the information contended if appraised of the
significance of such information. I consider that,
on the evidence before me, the answer to both
questions should be in the affirmative’.
But does this go beyond just
informed consent?
HHJ Collender QC consided:
‘I consider that modern, safe and responsible medical
practice should be to give such advice to patients
undergoing general anaesthetic’.
‘to inform such patients of the very particular signs
and symptoms of those conditions is a precaution that
can save lives and should be given’.
HHJ Collender QC ruled in favour of the Claimant
Consent: Psychological perspective
The process of making a decision
Professor Gus A Baker
Professor of Clinical Neuropsychology
Simple decision!
G&T
Vs
Wine
Complex decision
Australian Chardonnay
Pinot Noir
What decisions do clients have to make when
giving consent?
• Clinical Decisions relating to consent treatment
• Decisions in relation to instructing legal
representatives
• Decisions in respect of managing finances.
Decision Making
• How do people make decisions in relation to consent?
• How do they sift through the information without
drowning in a sea of alternatives?
• And what are the factors that lead them in a certain
direction?
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Capacity in a Clinical Setting
Neuropsychological factors
• Memory
• Attention/concentration
• Crystallised intelligence
• Dysexecutive
syndrome
• Case of Mr P
Personality Factors
•
•
•
•
•
Introvert versus Extrovert
Confident versus lack of confidence
Risk taker versus non risk taker
Optimist versus pessimist
Vulnerable or not
Emotional factors
•
Depression
•
Anxiety
•
Low self-esteem
•
Case of Mr S [no decision]
Authority figures
The individual
Partner
Judge
Headmaste
r
Barrister
Lawyer
Parent
Jacoby and Baker study
Importance of the decision
• Major medical procedure
• Large amounts of money
• Personal relationships
OUTCOMES
How can we help
• Improve understanding of risk by:
– Provide simple but appropriate explanation of the
decision to be made
– Discuss the risks of making or not making a decision
– Discuss the potential outcomes of the decision
• Ask the decision maker to feedback about their
understanding of the decision
• Allow time for further consideration and/or
discussion with others
Summary
• Determine the question that needs to be
addressed or the consent that has to be given
• Consider multiple information sources
• Consider the individual [intellect, personality
etc]
• Rehearse the decision stages
• Rely on your own judgment about whether the
person is capable of making a decision or giving
consent
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Decision making