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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3612_Библиотеки_им_академика_М_И_Перельмана
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440
Key Questions in CONGENITAL CARDIAC SURGERY
Figure 2 continued. Standard consent form for investigation or
treatment in use in a tertiary centre. This form is used by clinicians when
patients are able and entitled to provide their own consent, for example,
adult congenital heart disease patients.
12 Informed consent in congenital cardiac surgery
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
441
Figure 3. Standard consent form for investigation or treatment in use in
a tertiary centre. This form is used by clinicians when patients are children
or a young person. The patient is still able to sign for his or her own
agreement, but the signature of a parent or legal guardian is required to
render the form legally valid. Continued overleaf.
442
Key Questions in CONGENITAL CARDIAC SURGERY
Figure 3 continued. Standard consent form for investigation or
treatment in use in a tertiary centre. This form is used by clinicians when
patients are children or a young person. The patient is still able to sign for
his or her own agreement, but the signature of a parent or legal guardian
is required to render the form legally valid. Continued overleaf.
12 Informed consent in congenital cardiac surgery
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
443
Figure 3 continued. Standard consent form for investigation or
treatment in use in a tertiary centre. This form is used by clinicians when
patients are children or a young person. The patient is still able to sign for
his or her own agreement, but the signature of a parent or legal guardian
is required to render the form legally valid.
444
Key Questions in CONGENITAL CARDIAC SURGERY
Figure 4. Form in use in a tertiary centre for consent in situations where
the patient is incapable to provide his or her consent due to severe
limitations (see point “B” on the form). Continued overleaf.
12 Informed consent in congenital cardiac surgery
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
445
Figure 4 continued. Form in use in a tertiary centre for consent in
situations where the patient is incapable to provide his or her consent
due to severe limitations (see point “B” on the form). Continued overleaf.
446
Key Questions in CONGENITAL CARDIAC SURGERY
Figure 4 continued. Form in use in a tertiary centre for consent in
situations where the patient is incapable to provide his or her consent
due to severe limitations (see point “B” on the form).
12 Informed consent in congenital cardiac surgery
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
20 To what extent is dialogue with the patient or parents
required?
When concerning the consent process, dialogue is mandatory. Both
•
courts and regulators consider open discussion between clinician
and patients to be of the greatest importance.
21 Is there an exception to the imperative for disclosure
prior to consent?
There is an exception to the imperative of disclosure, but it is highly
•
restrictive. The court in Montgomery acknowledged the rare situation
where the disclosure would be seriously detrimental to the patient’s
health. Plainly, this exception primarily refers to the health of a person
making a decision about their own treatment, so would be unlikely to
apply to a parent.
Nevertheless, it is foreseeable that adults suffering from congenital
•
cardiac disease might fall into the category where disclosure would
seriously harm their health. This ‘therapeutic exception’, however,
should be used only with great caution and would require a second
opinion, as a matter of urgency.
447
22 How do courts deal with patients’ claims that
insufficient information was disclosed to allow an
informed decision?
It is very unusual for cases where patients claim that they were not
•
provided with valid disclosure (and thus their consent was invalid) to
reach court. When this happens, however, English courts do not rely
on expert witnesses to set the standard for what the appropriate
disclosure should have been.
The trend is in contradistinction to the great majority of clinical
•
negligence cases, where a medical expert will be asked to set the
standard of care, against which the defendant doctor will be judged.
But it also gives an insight into the importance that the judiciary set
on disclosure for consent. Judges tend to put themselves in the
shoes of the ‘reasonable’ patient and enquire what such a person
would want to know, before giving consent in the particular set of
clinical circumstances.
448
Key Questions in CONGENITAL CARDIAC SURGERY
23 What should be the appropriate course of action if
doubts remain that a proposed elective operation is
appropriate?
Seeking consent from a person who is fully aware of the clinical risks
•
and benefits should concentrate the mind of both surgeon and
patient.
If the process has failed to dispel doubts in either mind that
•
intervention is the right thing to do, the procedure should be
abandoned, the situation should be reconsidered, and a different
course should be pursued.
At any stage, seeking a colleague’s opinion, promoting discussion at
•
multidisciplinary team (MDT) meetings and a pro-active stance
towards obtaining a formal second opinion are valid strategies to
reach a consensus and obtaining consent.
24 What is the role of multidisciplinary team deliberations
in congenital cardiac surgery?
In the NHS, there is no legal provision for shared responsibility. Each
•
patient is treated under the name of an identified consultant, who in
the first instance bears responsibility for the patient’s outcome.
Any conclusions reached and advice given following an MDT
•
discussion will have been based on individual contributions by the
specialists within the group. If the MDT conclusions or advice are
later challenged, a record of these contributions needs to be
available to assess whether the individual contributions were
reasonable.
It is foreseeable that an MDT might reach a majority conclusion that
•
a particular procedure or operation is in the best interests of the
patient but the consultant surgeon to whom the patient is now
referred to disagrees with this proposal. The surgeon should make
this known to the MDT, giving reasons. On no account should a
surgeon perform an operation which they believe to be counter to the
patient’s interests. When an agreement cannot be reached, it is
advisable to consider the opinion or intervention of a surgeon
colleague.
In any case, the disclosure of information prior to seeking consent is
•
the responsibility of the surgeon who is going to perform the
procedure. Whilst the sum of the information in relation to benefits,
risks and alternatives may reflect advice garnered at an MDT, the
‘consenting’ surgeon carries all the responsibility for the choices they
make when selecting what information to disclose.
12 Informed consent in congenital cardiac surgery
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
25 How should information be disclosed to a pregnant
mother?
Anything which is not proscribed by English law is lawful.
•
No laws prevent pregnant women from hang-gliding, bungee
•
jumping, taking drugs, smoking or driving in F1 racing cars, although
all of these activities may be highly prejudicial to the mother and her
baby. Equally, if a woman with congenital heart disease wishes to run
the risk that pregnancy might pose to her own health, she is entitled
to do so and a matter only for her to decide upon. In fact, this
decision falls outside the remit of consent for medical treatment,
since the conception is usually achieved without medical assistance.
It has to be very clear that the responsibility of carrying the risk to her
•
own health and that of the unborn child remains with the mother.
This is because until the baby is born and has a separate existence
•
from the mother, it has no legal personality and is considered a part
of the mother. Therefore, child protection laws do not apply to a
foetus. There are examples of women whose rights to refuse
caesarean section despite the certain consequent death of their baby
have been steadfastly upheld by English courts.
Reasonable steps, however, need to be taken to inform the putative
•
mother of the risks that she runs and if she requests information
relating to the risk she plans to run, the consulting doctor must
provide it.
With respect to the health of her putative foetus, if a prospective
•
mother with congenital heart disease seeks information regarding the
wisdom of becoming pregnant, any and all risks to the foetus that
derive either from her cardiac diagnosis (such as heritability) or her
cardiac health must be disclosed, insofar as that may have a bearing
on her ability to carry the baby to full term, or to adequately provide
circulation to the unborn child.
449
26 What is the role of a numeric threshold in choosing
what to disclose?
The assessment of whether a risk is ‘material’ cannot be reduced to
•
percentages. The significance of a given risk will reflect not only its
magnitude but also other factors. The nature of the risk, the effect
which its occurrence would have upon the life of the patient, the
importance to the patient of the benefits sought to be achieved by the
treatment, the alternative therapies available and the risks involved in
those alternatives, all play a part.
This assessment therefore depends on the facts of the case and
•
upon the characteristics of the patient. Basing a clinical decision
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