Adult Patient Consent and Information (Royal College of Radiologists)

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http://www.rcr.ac.uk/index.asp?PageID=149&PublicationID=131
N.B> - (Dated 1995)

Foreword

There is an increasing demand for patients with cancer to receive better
information about their disease and its treatment. This report contains
guidance on the information to be given to patients prior to treatment,
with particular emphasis on the possible late side-effects of therapy. The
use of a written consent form is recommended and guidance offered on the
design of such a form if this procedure is adopted by a department.

The Board of the Faculty of Clinical Oncology hopes that the advice will
be helpful to members and Fellows in the desire to improve patients'
understanding about their treatment. The Board also hopes that the
guidance will prove of value to all who purchase or provide services in
departments of clinical oncology.

The advice contained in this report has also been endorsed by the Joint
Council for Clinical Oncology of the Royal College of Physicians and the
Royal College of Radiologists.

Dr Margaret F Spittle
Vice-President
Dean, Faculty of Clinical Oncology
Chairman, Joint Council for Clinical Oncology

1 Introduction

There is an increasing demand for patients with cancer to receive better
information about their disease and its treatment than has been customary
in the past, and this is coupled with the issue of consent for treatment.
Clinical oncologists are well aware of the wish for more information and
have responded sympathetically to this need. Whilst the desire to give
every possible support to patients is the principal motivation for better
communication there are also medico-legal aspects to be considered,
particularly with respect to consent. The Board of Faculty of Clinical
Oncology has recently issued a report on Risk Management in Clinical
Oncology 1 in which it was emphasised that the risk of litigation from a
failure to explain procedures and their possible consequences should be
minimised. This document seeks to give guidance on how both the interests
of the patient and the position of the oncologist may be protected in this
complex situation.

2 Background

2.1 The Declaration of Rights of People with Cancer, produced by
CancerLink 2, states that cancer patients should have the right 'to know I
have cancer, to be told in a sensitive manner, and to share in all
decision-making about my treatment in honest and informative discussions
with relevant specialists and other health professionals', and in the
subsequent paragraph 'to be informed fully about treatment options and
have explained to me the benefits, side-effects and risks of any
treatment'. A report by the Audit Commission, published in 19933,
addresses the issue of breast cancer and again supports the view that
improvements in both the quantity of information given and its quality are
required.

2.2 From a strictly medico-legal aspect, claims against clinical
oncologists are relatively unusual. In 1989 the Medical Defence Union
(MDU) settled four claims in radiotherapy and two in oncology, compared
with 219 in obstetrics and gynaecology and 107 in accident and emergency.
The MDU note, however, that the total number of claims received is now
doubling every two years. Claims involving issues of consent, as opposed
to negligence, are, however, relatively unusual at present.

2.3 Consent for treatment can no longer be assumed or implied by patients
presenting themselves for treatment, and many departments now formally
record completion of the process of obtaining consent by the use of a
written consent form which is signed by the patient prior to treatment.
Increasingly, however, patients claim that despite having given 'consent'
to treatment, they were not told of significant side-effects which might
occur, even if only rarely, and maintain that had this been done their
decision might have been different. This could form the basis of future
medico-legal claims and is a further reason for this review of the process
of patient information and consent in cancer patients.

2.4 The basis of much advice on this subject is the judgement from the
House of Lords in the Sidaway case which required disclosure of
'particular risks obviously necessary to an informed choice that no
reasonably prudent medical man would fail to make it' and that a doctor
needs 'to draw the attention of a patient to a danger which may be special
in kind or magnitude, or special to the patient'4. Current guidelines from
the Department of Health given in A Guide to Consent for Examination or
Treatment, published in 19905, state that 'patients are entitled to
receive sufficient information in a way that they can understand about the
proposed treatment, the possible alternatives and any substantial risks so
that they can make a balanced judgement'. It later states that 'a doctor
will have to exercise his or her professional skill and judgement in
deciding what risks the patient should be warned of and the terms in which
the warning should be given'. However, a doctor has a duty to warn
patients of substantial or unusual risk inherent in any proposed
treatment.

2.5 In March 1991 the Royal College of Radiologists sent a letter 6, the
text of which had been agreed with the Department of Health, to all
Fellows and Members. This sought to clarify the Department's circular with
respect to radiotherapy and chemotherapy. Three of the key questions
addressed in that letter were: 2.5.1 What is a substantial risk of
treatment hazard and can it be defined?
2.5.2 Does all radiotherapy and chemotherapy automatically require written
consent?
2.5.3 Should the College provide a model consent form?
2.6 The answer to the first question was that ultimately this was a matter
of clinical judgement, but the recommendation was made that 'it will
usually be best to discuss possible serious side-effects of radiotherapy
or cytotoxic chemotherapy if they are likely to occur in more than a very
few percent of patients treated. Evidence should then be obtained on the
signed consent form that this discussion has taken place.' However, in
response to the second question, it was stated that 'if there is a
relatively low risk of side-effects of a serious kind, written consent
need not be obtained for radiotherapy or chemotherapy'. On the subject of
a College consent form it was recognised that the decision on implementing
the Department of Health's model form, or an alternative, rested with the
NHS management at a local level and could not be dictated by the College.

3 The current situation

3.1 There can be no doubt that expectations regarding consent are changing
and that in the light of this the legal position on consent is likely to
reflect an increasing onus upon doctors to ensure that patients receive
full information regarding treatment and its side-effects before giving
informed consent. It may well become the responsibility of the doctor to
prove that sufficient information has been given rather than for the onus
to be on the patient to request that information7,8 .

3.2 Most, but not all, departments of clinical oncology now obtain written
consent for radiotherapy and in many cases for chemotherapy also. Patient
information booklets and leaflets are in general use. More formal back-up
and the use of audio tapes or videos are increasing but are still unusual.
A proportion of departments provide access to further counselling.

3.3 The delivery of information to patients covers four main areas:

3.3.1 The diagnosis.
3.3.2 Management recommendations including proposed treatment, alternative

treatments and realistic expectations from treatment.
3.3.3 The treatment process.
3.3.4 Treatment toxicity.
3.4 It is not possible at present to evaluate how much information is
given about these four areas. Most information booklets which have been
reviewed from individual centres take up the situation from the time of
acceptance of the decision to give radiotherapy or chemotherapy. As a
rule, the process of treatment is well-described in these booklets and
acute reactions during radiotherapy or chemotherapy are generally listed,
together with appropriate advice on management. Site specific information
booklets from agencies such as BACUP or CancerLink provide more
information with respect to individual conditions. However, very little,
if any, of this written information available to patients gives any
details regarding the key area of late morbidity of treatment.

4 Proposals for future practice

The Faculty of Clinical Oncology recommends that when departments are
developing quality assurance standards the following points be considered:

4.1 Initial consultation

4.1.1 The consultation should take place in privacy and comfort.
Precautions should be taken to prevent interruptions and telephone calls.
Patients should be fully dressed and a friend or relative should be
allowed to accompany them if it is their wish. This should be indicated in
the appointment letter. 4.1.2 Information regarding treatment decisions
should be given by a specialist in clinical oncology accompanied by,
wherever possible, a nurse specialist or other health professional. 4.1.3
Ideally the consultation should be distant from the arrangements for
treatment so that the patient feels a true choice is being offered rather
than a fait accompli. 4.1.4 The initial consultation must be backed up
with appropriate supporting written information which should cover not
only the process of treatment but also alternative treatments, realistic
expectations from treatment and details of both acute and late toxicities.
Written information should be available in a language which the patient
can understand. In some centres this may be augmented by tape recordings
or video recordings. Patients should also be made aware of relevant local
support groups and agencies such as CancerLink and BACUP. 4.1.5 All
patients should be given the opportunity to ask for information beyond
that which is volunteered by the clinician. This should include access to
clarification and further information following the initial discussion.
The latter need not be with a member of the medical team and may be more
appropriately delivered by a clinical nurse specialist or trained
counsellor based in either the department or a recognised cancer support
agency. 4.1.6 It is important that there is full documentation of all
advice, and of any written information or other back-up material given to
the patient. It is recommended that this process includes completion of a
signed written consent form (vide infra).

4.2 Extent of information

The extent of information to be given to the patient remains an extremely
difficult area in which to draw firm guidelines. Undoubtedly individual
patients will desire different levels of information and each patient
should be encouraged to define their own needs during the consultation
with the oncologist. There should be a minimum level of information
offered to all patients, as follows:

4.2.1 Diagnosis: all patients should expect to be offered a comprehensible
explanation of the precise nature of their illness and its severity as
defined by the natural history of the tumour, its stage and grade. 4.2.2
Management recommendations: the options for treatment should be outlined
to the patient, including the roles of surgery, radiotherapy and
chemotherapy, and the consequences of failure to treat or of deferring
treatment. A recommendation or choice should then be offered to the
patient with the reasons for doing so, but alternative options should also
be discussed, for example the case for and against radical surgery or
radical radiotherapy in a locally advanced tumour such as T3 carcinoma of
the larynx or bladder. All patients should be offered a realistic
expectation of the outcome of treatment in terms of tumour control and
survival. It should be made clear to patients whether treatment is aimed
at controlling symptoms, preventing problems in the future (such as
avoiding local recurrence) or extending life. An estimate of the
likelihood of success should be given in terms which the patient can
readily understand, rather than in purely mathematical terms. 4.2.3 The
treatment process: patients should be made aware of where they are to
receive treatment, the staff they are likely to meet and the part these
staff will play in their management. The steps involved in preparing for
treatment (for example head shell preparation, simulation, the use of skin
tattoos or the need for intravenous cannulation) should be explained in
full together with the actual treatment events. Some estimate of the time
these may take is important, together with a mention of logistical
arrangements such as transport and car parking. 4.2.4 Side-effects of
treatment: radiotherapy patients should be made aware of both acute and
late toxicities. As is generally the current practice, acute toxicities
should be described in full, together with their likely incidence,
duration and appropriate management. It is the question of late toxicities
which presents the greater problem but which is of paramount importance in
delivering information to the patient. It is therefore recommended that
all patients should be made aware of late side-effects for which there is
a recognised body of published evidence defining the likely incidence.
This does not, however, include all rare events, which are more likely to
be found in anecdotal case reports rather than published series, and which
do not allow the probable frequency of the problem to be estimated.
Ultimately the decision on what potential toxicities are considered is a
matter of clinical judgement and experience but the College guidance in
19916 indicated 'it will usually be best to discuss the possible serious
side-effects of radiotherapy or chemotherapy if they are likely to occur
in more than a very few percent of patients treated'. Thus patients
receiving radiotherapy to the axilla should expect to know about the risk
of lymphoedema and brachial plexus neuropathy but not necessarily the
remote risk of radiation-induced lymphangio-sarcoma (However, where a rare
toxicity may have particular relevance for an individual patient, for
example laryngeal necrosis in a professional reliant on the voice, then
there is a clear duty to give information on this.) It is also important
when giving a realistic view of the likelihood of side-effects, and their
incidence and impact on the patient's life-style, to interpret these
potential hazards and their possible severity in the light of the natural
history and prognosis of the condition to be treated.

5 Consent forms

5.1 Patient consent for all radiotherapy and chemotherapy should result
from the exchange of information between the oncologist and the patient.
The use of signed consent forms in this process is felt by some to be
intrusive. Certainly the practice of obtaining signed consent should not
detract from the fundamental principle of establishing a relationship of
mutual trust and respect between the doctor and the patient, within which
the patient should expect to be given an honest and factual account of
their condition and its treatment.

5.2 Recommendations from the Department of Health do, however, support the
use of a written informed consent form for procedures such as radiotherapy
and chemotherapy. Furthermore, in the event of subsequent litigation, a
consent form signed by the patient, acknowledging the receipt of specific
information, may be of value if this were to be denied. It is therefore
recommended that written informed consent, including details of the
information given and understood by the patient, is obtained for all
treatments where there is perceived to be a risk of side-effects which may
influence the lifestyle of the patient either at the time of treatment or
at a later date.

5.3 The decision on whether to implement this recommendation is the
responsibility of local NHS management, advised by individual oncology
departments and their oncologists. If a department does adopt signed
consent forms the specific design of these documents is, once again, a
matter of local decision, but it is recommended that the following points
should be included:

5.3.1 The name and address of the patient. 5.3.2 The name of the doctor
obtaining consent. 5.3.3 Details of proposed treatment for which consent
has been obtained. 5.3.4 Details of information given to the patient as
defined either by a written list on the consent form or by identifying the
type of pre-prepared information given (for example, relevant patient
information booklets) or both. 5.3.5 An acknowledgement by the patient of
the receipt of this information. 5.3.6 A signature representing consent to
treatment defined on the basis of the information received. 5.3.7 The date
of obtaining consent.

6 Summary and conclusions

6.1 There is an increasing demand for patients with cancer to receive
better information about their disease and its treatment than has been
customary in the past.

6.2 Guidance is offered on delivery of information covering the four main
areas of giving the diagnosis, explaining the natural history and
management of the condition, discussing the treatment process, and
detailing the possible side-effects of therapy.

6.3 It is recommended that these discussions be confirmed by the
completion of a written consent form signed by the patient.

6.4 Guidance is offered on the content of such a form.

Board of the Faculty of Clinical Oncology
Council of the Royal College of Radiologists
September 1995
BFCO (95)3

7 References

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