Consent in cardiac surgery A good practice guide to agreeing and recording consent
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Consent in cardiac surgery
A good practice guide
to agreeing and
recording consent
1
As Health Service Ombudsman I am committed to sharing
as widely as possible the learning from the complaints
I receive. The issue of consent and communication
of risk to patients is a key theme in a significant number
of complaints about the National Health Service that my
Office has investigated over a number of years. I therefore
welcomed the opportunity to work with the Society of
Cardiothoracic Surgeons, and others to develop good
practice guidance for the use of cardiac specialists
when dealing with this essential aspect of patient care
and choice.
Ann Abraham, Health Service Ombudsman for England
The increasing focus on patient centred healthcare
has led to greater interest in the issue of consent.
The growing complexity of modern intervention demands
even more clarity in the whole consent process.
The Society of Cardiothoracic Surgeons is committed
to improving patient care, and is therefore delighted
to have the opportunity of working alongside the
Ombudsman’s Office on this initiative.
Patrick Magee, President of the Society of Cardiothoracic
Surgeons of Great Britain and Ireland
2Contents
The aim of this guide is to Background 5
improve the quality of informed
Communication 5
consent in cardiac surgery.
The consent process 6
There will be times when the
outcome of surgery will not be The information 7
the desired one. This guide aims
to ensure that members of the Sharing information and
cardiac surgical team have taken discussing treatment options 8
appropriate steps to recognise Stages in the process 9
and discuss that possibility before-
hand with the patient – so that Relaying risk 10
unintended or unwanted conse- Risk chart 13
quences do not come as a surprise.
When things go wrong 16
This guide has been prepared by
the Health Service Ombudsman Keeping a record 17
and the Society of Cardiothoracic References 18
Surgeons (SCTS) with the support
of the General Medical Council Appendix
(GMC), the Healthcare Commission The development of
and the Department of Health consent procedures 19
(DoH) and with input from patients Risk ‘ready reckoner’ see insert
and patient representative bodies.
A full list of the organisations
which have contributed appears
on the back cover.
The guide concentrates on consent
for adult elective cardiac surgery
and does not address the areas
of capacity, paediatric practice,
advance refusals of treatment,
withdrawal of life-prolonging
treatment or research trials,
although we recognise that these
are important issues which may
be the subject of future work.
34
Background
The understanding of informed consent in UK surgical practice has shifted
over recent years from a doctor-centred to a patient-centred approach.
Previously the amount of information given to patients before surgery
was judged against the Bolam principle.
Since 1998 this principle has evolved: especially in the light of events at
the Bristol Royal Infirmary and developing case law. Current guidance on
consent from the GMC and the DoH sets out the concept of a reasonable
patient. Recent case law (Chester vs Asfar 2004) extends this further and
brings the UK much closer into line with the US and Australian ‘Prudent
Patient Test’. More detail of the context in which consent has developed
is set out on page 19.
This guide is informed by the report from the Bristol Royal Infirmary
enquiry – Learning from Bristol. It takes full account of, and stands
alongside, guidance produced by the DoH, and the GMC.
We aim to assist cardiac surgical teams in helping patients to make
well-informed decisions about their treatment. In the team approach
to care, patients may discuss consent with someone other than the
surgeon. Against this background, this guidance aims to help ensure
consistency in the way in which informed consent is achieved and in
the terminology and data used in the process.
Communication
Our advice assumes the patient has the capacity to consent. However,
cardiac teams need to recognise that patients vary: they include people
with learning difficulties and the highly educated, and discussions should
be tailored to meet the needs of each patient.
5The consent process
Obtaining consent should be an ongoing process
The patient’s journey through the consent process is
incremental. Patients need to be given time to consider,
understand and clarify the information provided and
to come back to ask questions. The methods chosen
to deliver the information, and the timescale needed,
will vary depending on the needs of the individual patient.
Cardiac surgical teams need to see consent as the
conclusion of a process of discussion and decision-
making rather than something that is done to a patient.
The GMC guidance booklet Seeking patient’s another. There should be a clear agreement
consent: the ethical considerations contains about whether the patient consents to all or
the following additional advice: only parts of the proposed plan of investigation
‘If you are the doctor providing treatment or treatment, and whether further consent will
or undertaking an investigation, you must give have to be sought at a later stage.
the patient a clear explanation of the scope ‘You should raise with patients the possibility
of consent being sought. This will apply of additional problems coming to light during
particularly where; a procedure when the patient is unconscious or
a. treatment will be provided in stages with otherwise unable to make a decision. You should
the possibility of later adjustments; seek consent to treat any problems which you
think may arise and ascertain whether there
b. different doctors (or other health care are any procedures to which the patient would
workers) provide particular elements object, or prefer to give further thought to
of an investigation or treatment before you proceed. You must abide by patients’
(for example anaesthesia in surgery); decisions on these issues. If in exceptional
c. a number of different investigations circumstances you decide, while the patient
or treatments are involved; is unconscious, to treat a condition which falls
d. Uncertainty about the diagnosis, or about outside the scope of the patient’s consent, your
the appropriate range of options for decision may be challenged in the courts, or be
treatment, may be resolved only in the light the subject of a complaint to your employing
of findings once investigation or treatment authority or the GMC. You should therefore seek
is underway, and when the patient may be the views of an experienced colleague, wherever
unable to participate in decision making. possible, before providing the treatment.
And you must be prepared to explain and
‘In such cases, you should explain how decisions justify your decision. You must tell the patient
would be made about whether or when to move what you have done and why, as soon as the
from one stage or one form of treatment to patient is sufficiently recovered to understand.’
6THE INFORMATION • Who will be doing the operation
and the surgeon’s experience
By the time they give consent,
with this procedure - patients
the patient, and (with his/her
often want to know if their
agreement) the patient’s carers,
surgeon is in training.
should have received a wide range
of information about: • The mechanisms by which the
unit’s and surgeon’s outcomes
• The nature of the illness.
are monitored by external
• The nature of proposed surgery. agencies, such as the SCTS,
the DoH and the Healthcare
• Any alternatives to surgical Commission.
treatment such as:
> medical intervention • Any new or unusual procedures
> medical drug therapy that have been proposed
> alternative surgical strategies (these must be discussed in
(e.g. on-pump vs. off-pump, detail with the professional
choice of conduits, valve who will perform the operation).
repair vs. replacement).
• The implications of no further
• The risks of surgery intervention.
(see pages 12-13).
7The consent process
(continued)
SHARING INFORMATION AND There is evidence that people
DISCUSSING TREATMENT OPTIONS who do not speak English as their
first language can achieve a far
The patient must have some face-
greater understanding of what
to-face contact with their surgeon
they are consenting to than
and the cardiac team – backed up
native speakers when a link
with other information sources in
worker is involved.
whatever media suits the patient’s
needs. Generally information In addition, units could consider
should be given in parallel with the use of regular open days to
the clinical assessment process. provide more in-depth information.
Information should be given by:
Surgical teams need to also
• Direct consultation with the recognise the possibility of
surgeon. ‘functional illiteracy’ in their
patients and consider the
• Providing generic information
use of specialists to aid the
available in printed form and/
consent process in such cases.
or other formats, such as
(‘Functional illiteracy’ describes
tapes, videos and web material
the condition when patients
(avoiding sending the patient on
appear able to make their way in
unstructured Internet searches).
life, yet are actually so deficient
• Providing informal contact in reading and writing that they
with the multidisciplinary team are essentially illiterate.)
/ enablers to allow the patient
to ask further questions,
The ‘enabler’ may be a nurse,
a patient care advisor or
members of the rehabilitation
team (‘prehab’).
8CARDIAC TEAM PATIENT
Patient notified Patient reads
of surgery general
information
Initial Discussion of risks
consultation and operative
mortality – do not
STAGES IN THE PROCESS overload patient.
Suggest further
A generic booklet/written reading material
information should be supplied
before the patient’s initial direct
consultation with their surgeon Patient allowed
to provide a framework for time to reflect
discussion. Some units send on information
this routinely with the booking
confirmation for the outpatient
Follow up with Discussion
appointment. support staff of suggested
During the initial consultation treatments
the surgeon should specifically
discuss the most frequent and At the return visit the patient
high impact risks to the patient should see support staff such
including the risk of operative as nurses, care advisors and
mortality. In giving information rehabilitation team workers who
surgeons should aim to be can check their understanding
consistent and clear whilst and get more information in
not overloading the patient. an informal and possibly less
The aim is not to protect the threatening environment.
surgeon but to inform the patient,
Patients undergoing repeat
avoiding defensive medicine.
procedures need to have
Following this initial consultation information repeated. As the
the patient needs to be given risks of repeating a procedure
access to further information are generally higher than the
in a format that they can take first intervention, it is important
home. The patient can then to take care in the consent
consider this in detail (as part process: it should not be assumed
of their responsibility) and come that the patient ‘already knows
back after time for reflection. all about it’.
9The consent process
(continued)
Where an anaesthetist is involved RELAYING RISK
in a patient’s care, that person has
Remember, it is the patient who
the responsibility (not the surgeon)
is being asked to take the risk
to seek consent for anaesthesia,
having discussed the benefits and Very few of us understand the
risks. In elective treatment it concept of risk. To help patients
is not acceptable for the patient make decisions based on
to receive no information about risk clinicians need to tailor
anaesthesia until their immediate explanations to each individual
pre-operative visit from the whilst allowing them to apply
anaesthetist: at such a late their own value judgments.
stage the patient will not be
in a position to make a decision When relaying degrees of risk
about whether or not to undergo members of the cardiac team
anaesthesia. Patients should will need to find out what ‘high’,
therefore either receive a ‘medium’ and ‘low’ mean to the
general leaflet about anaesthesia patient by describing these
in outpatients, or have the in easily understandable terms.
opportunity to discuss anaesthesia When determining how to
in the pre-assessment clinic. inform the patient the expected
The anaesthetist should ensure frequency of any adverse outcome
that the discussion with the and its potential impact on the
patient and their consent is patient’s lifestyle needs to be
recorded in the anaesthetic considered.
record, in the patient’s notes
or on the consent form. The impact of an adverse outcome
will vary between patients.
For example, disfigurement
may be more serious for a young
person than for an elderly one,
a speedy return to fitness may
be significant for a worker and
less so for someone who is retired.
But only the individual can make
those judgments, cardiac team
members cannot know and should
not make assumptions.
10Care needs to be taken when • The outcomes for high volume
presenting statistics (they are operations, e.g. how many
essential but must be supplied people have had complications
in a relevant context for the in the unit during the year.
patient), and when using (This needs to be made available
metaphors. All statistical on an institutional basis and
information should be validated where appropriate on a surgeon
although a combination of specific basis. In high risk cases
statistics and stories can be patients need to be made aware
used if necessary. When quoting that comparison to national
percentages – pictorial examples and local results may be
(e.g. 1 in 100 dots on a page) inappropriate.)
can be useful.
• Chances of success i.e. will
Patients have told us that they the operation deliver what
feel metaphors are dangerous it is designed to achieve.
and are not a good way of
• Unit infection rates.
explaining risk as they may not
apply in context. Metaphors are To help communicate risk we
subjective and culturally specific have included (as an insert to
and generally should not be used. this leaflet) a simple ready
reckoner guide for use in
When describing best and worst-
discussions with patients.
case scenarios actual stories and
cases can be useful for some
patients.
In any discussion of risk patients
should be told about:
• Potential benefits.
• Potential side effects.
• Potential complications
(differentiating between side
effects and complications).
11Risk chart
The chart overleaf is a standard The Frequency of an event can be
risk assessment tool (we think described as:
it reasonable to use statistical
• Improbable – unlikely to
risk models to arrive at objective
happen, exceptional
estimates of patient-specific
circumstances only.
operative mortality).
• Highly unlikely –
The chart is a useful aid in
occurs annually in UK.
discussing risk with patients.
The accompanying leaflet for • Unlikely – has occurred in last
patients includes blank charts 3-5 years in this unit / surgeon’s
to be filled in for the patient – practice.
providing a record of the
discussion about risk for the • Potential – occurs annually in
patient to take away and consider. this unit or in this surgeon’s
practice.
Patients need to be informed
that the impact of a particular • Possible – occurs weekly /
adverse event will vary according monthly in this unit or in this
to the individual. The predicted surgeon’s practice.
frequency of an event will vary
according to unit, surgeon and
patient-specific factors and
individual surgeons should know
their own rates of mortality and
morbidity and when they vary
from national or international
data.
12The Impact on lifestyle can be Risks should be shown as
divided into: generalised areas on the chart
rather than as discrete points
• Catastrophic – permanent
as their frequency and impact
disability or death.
will fall within a range.
• Severe – marked reduction
Patients need to decide on their
in quality of life which is
own interpretation of the impact
permanent or which has a
of a particular outcome but,
recovery period of more than
having discussed this, relative
12 months, and / or more than
risks can then be demonstrated
10 days extra hospital stay.
by the surgeon using the chart.
• Moderate – temporary pain,
Examples of how this chart could
disability and / or reduction
be used are given overleaf.
in quality of life with recovery
within 1 – 12 months and / or
up to 10 days extra hospital
stay, extra operative
intervention required.
• Slight – temporary discomfort
or loss of function, less than
3 days extra hospital stay,
recovery within 1 month.
• Low – transient discomfort,
no extra hospital stay.
13Risk chart
(continued)
Example 1, using the chart to explain risk to a patient visually,
comparing the mortality risk of not proceeding with an operation
to that of proceeding.
No
Catastrophic Operation operation
Severe
READY RECKONER
Moderate
SURGICAL
Slight
IMPACT
Low
FREQUENCY
Improbable Highly Unlikely Potential Possible
unlikely
14Example 2, using the chart to explain various risks to a patient, showing
the relative risk of various complications after a proposed procedure.
Red risks should be explained in the direct consultation between the
surgeon and the patient, amber risks should be covered in the patient
information at subsequent appointments with members of the cardiac
team, as described above on pages 8-9. Green risks need only be
discussed if the patient specifically asks.
Catastrophic Death
Deep
Severe infection
READY RECKONER
Stroke
Moderate
SURGICAL
Slight
IMPACT
Bleeding AF
Low
FREQUENCY
Improbable Highly Unlikely Potential Possible
unlikely
15When things go wrong
As this guidance acknowledges, It is especially important that,
there will be times when the wherever possible, the surgeon
outcome of surgery will not be who carried out the procedure
the desired one. Following should be directly involved.
the advice in this guide should It is not acceptable to send
help ensure that unintended or a junior doctor to take on this
unwanted consequences of surgery role. The surgeon will need to
do not come as a surprise to the demonstrate appropriate sympathy
patient or their family. and, where appropriate, give an
apology. It is important that the
Following surgery which has
approach of the doctor concerned
not been successful the surgeon
is honest and open and that a full
should talk to patients and/or
explanation of events is given.
their families as soon as possible
after the event. However, enough Discussions will need to take
time needs to be allowed for place in private and in a location
thorough discussion and, if that allows issues to be discussed
necessary, patients and/or in detail, with dignity.
relatives should be given a
further opportunity to talk
again at a later stage: perhaps,
then, to members of the wider
cardiac team.
16Keeping a record
The process is more important Record what additional information
than a signature on a form but sources were given and highlight
it must be recorded. where specific mention has been
made to certain topics within
Currently the language of consent
them. Show the patient any
can be a negative and defensive
written record of consent in the
element in the relationship
notes and where possible obtain
between the surgeon and the
their signature in the case file.
patient. There is a need to move
instead to centre on the patient’s An effective method of
choice about their treatment documenting the consultation
(including ‘doing nothing’). is to dictate clinic letters
describing the consultation
A key issue is how to document
in the presence of the patient
consent in a way that provides
and then send a copy to the
an evidence trail for everyone
patient.
involved in the different stages
of the process. A standardised
form is a way of doing this but
a written record in the notes
is more patient-centred.
Record who was present during
each consultation, what was
discussed, the patient’s responses
and your perception of their
understanding of the information
given. Record whether the patient
wanted any carers present.
17References
General Medical Council. Nottingham City Hospital Trust.
Seeking patients’ consent: Policy Ref C0.0903 Issue 7. Policy
the ethical considerations. for consent to treatment, 2004.
GMC, London, November 1998
Popp RL and Smith JR.,
Department of Health. ‘ACCF/AHA consensus conference
Reference guide to consent report on professionalism and
for examination or treatment. ethics’ Journal of the American
Department of Health, London, College of Cardiology. 2004;
April 2001 44: pp1718-21
Department of Health. ACC/AHA 2004 guideline update
12 key points on consent: the law for coronary artery bypass graft
in England. Department of Health, surgery. Circulation. 2004: 110:
London 2001 pp1168-1176
Learning from Bristol:
the report of the public inquiry
into children’s heart surgery
at the Bristol Royal Infirmary
1984 –1995 Command Paper:
CM 5207, London TSO
Society of Cardiothoracic Surgeons
of Great Britain and Ireland.
Fifth National Adult Cardiac
Surgical Database Report 2003.
Dendrite Clinical Systems,
Henley-on-Thames, 2004
18Appendix: The development of consent procedures
The GMC’s guidance Seeking to a course of treatment,
patients’ consent: the ethical should be regarded as a
considerations (1998) is based process and not a one-off
on the following principles: event consisting of obtaining
a patient’s signature on a form.’
• Patients have a right to choose
what treatment if any to accept, • ‘As part of the process of
based on their own assessment obtaining consent, except
of the likely benefits and when they have indicated
burdens to themselves. otherwise, patients should
be given sufficient information
• Doctors have a duty to offer
about what is to take place,
patients the treatments which
the risks, uncertainties, and
are appropriate in meeting their
possible negative consequences
clinical and non clinical needs.
of the proposed treatment,
The Department of Health has about any alternatives and
also issued a number of guidance about the likely outcome,
documents on consent including; to enable them to make a
12 key points on consent: the law choice about how to proceed.’
in England a one-page document
In November 2004 the Lords
which summarises those aspects
of Appeal passed judgment
of the law on consent which arise
on the case of Chester vs Asfar.
on a daily basis and in 2001;
The ‘headline’ point in this case
Reference guide to consent
is the way the ‘causation’ test
for examination or treatment
was interpreted, allowing the
a comprehensive summary
Claimant to recover damages
of the current law on consent.
for a complication that the
These documents introduced the surgeon should have - but didn’t -
concept of the reasonable patient warn the patient about, even
in order to determine how much though she would probably have
information should be supplied. had the operation had she been
so warned.
The 2001 Learning from Bristol
report advanced this concept The important issue raised by
further with the following: this judgment is the emphasis
it places on the need to ensure
• ‘Achieving patient partnership a patient’s autonomy in decision-
will require that patients are making, bringing the UK much
given the information that they closer into line with the US and
want about themselves and their Australian ‘prudent patient’ test.
care and ensuring they are This lays a considerably greater
treated with respect as partners burden on clinicians to explain
in their care.’ risks prior to treatment.
• ‘The process of informing the
patient, and obtaining consent
19To provide feedback on this guide contact:
The Health Service Ombudsman
Millbank Tower
Millbank
London SW1P 4QP
Tel: 0845 015 4033
Email: phso.enquiries@ombudsman.org.uk
www.ombudsman.org.uk
Please note
CONTRIBUTORS TO THIS GUIDE The telephone numbers of the
Parliamentary and Health Service
Academy of Medical Royal Colleges Ombudsman changed on 15 March 2009.
Action against Medical Accidents
The new contact details are:
Association of Litigation Helpline: 0345 015 4033
and Risk Managers Fax: 0300 061 4000
Association of Personal
Injuries Lawyers
Clinical Disputes ADR Group
Commission for Patient and
Public Involvement in Health
Consumers Association
Department of Health
Heart Team
Expert Witness Institute
General Medical Council
Grown Up Congenital Heart
Patients Association
Healthcare Commission
Edited and compiled May 2005
Independent Complaints
Advocacy Service
National Clinical Assessment
Service
Nursing and Midwifery Council
St Bartholomew’s Patient Advice
and Liaison Service
South Manchester Patient
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