Consent 17
4 Consent
Michael R. E. Dean
M. R. E. Dean, FRCR, FFRRCSI
Consultant Radiologist, Imaging Directorate, Royal Shrews- bury Hospital NHS Trust, Mytton Oak Road, Shrewsbury, SY3 8XQ, UK
4.1
Introduction
The last 20 years have seen a considerable increase in the number of patients who resort to legal action when their medical or surgical treatment fails to live up to their often overoptimistic expectations. Over the same period of time there has been a marked increase in the amount of damages awarded to the patient when the court finds that the doctor or hospi- tal has been negligent. It is therefore of great impor- tance that, when consent is obtained, the patient is given a realistic description of the intended treat- ment or operation and this must include details of its limitations and possible complications. Giving an overoptimistic description of the likely efficacy of the proposed treatment will lead to disillusionment and a consequent mistrust of both the treatment and of the doctor delivering it. It is essential therefore that the vascular radiologist is confident that the chosen procedure is preferable to the alternatives, be it sur- gery or conservative management. One must not be influenced by a desire to try out a new procedure or a new endovascular device unless it is in the patient’s best interest. Equally one must not be influenced by pressure from clinicians who do not necessarily appreciate the limitations of procedures.
Interventional radiological vascular procedures are quite correctly referred to as minimally invasive.
This term may lead the patient to believe that they can be performed without risk, whereas in reality the complications of some procedures can result in serious morbidity or even death. For this reason the possible complications must be carefully outlined when obtaining the consent of the patient before the procedure. The process of obtaining consent, how- ever, should not be regarded as a means of defence against possible litigation but as an essential part of the whole clinical process. The discussions involved in obtaining consent are an important part of estab- lishing effective communication and trust between the doctor and the patient.
4.2
Consent for Routine Procedures
Every patient who attends the radiology department for routine angiography or for simple or complex endovascular procedures must have given proper consent. For consent to be valid it must have been obtained voluntarily and without undue pressure from any source, and the patients must fully under- stand the procedure and its implications. Consent for routine procedures should be obtained before the patient’s admission to hospital if at all pos- sible. It is not acceptable to obtain consent outside the radiology suite on the day of the procedure as this would be seen as putting undue pressure on the patient to accept the proposed treatment, and even obtaining consent after admission to hospital may be regarded as coercive. There has been some reluctance from radiologists to devote proper time to discussion with the patient. Radiologists his- torically have not been involved with the delivery of treatment but with investigation and diagno- sis. The development of interventional techniques has altered this situation over the last 20 years and radiologists must take their clinical responsibili-
CONTENTS
4.1 Introduction 17
4.2 Consent for Routine Procedures 17 4.3 Who Should Obtain Consent? 18 4.4 Consent for Emergency Procedures 19 4.5 Consent for the Use of New Medical Devices
and New Procedures 19 4.6 After the Procedure 19 4.7 Conclusion 20
18 M. R. E. Dean
ties seriously. The ideal time to obtain consent from the patient is in an outpatient clinic a few days before the procedure since this allows the patient time for thought and time to discuss the informa- tion with relatives or friends if they so wish. It is well known that a patient’s recall of informa- tion provided at the time of obtaining consent is at best patchy and may be very poor. The provision of information sheets which describe the procedure, its limitations and its possible complications can overcome some of these problems of recall. To be effective, however, the information sheets must be very clearly and simply written so that they can be easily understood by a lay person. When the patient is admitted to hospital the radiologist who is to perform the procedure should be available to answer any further questions which may have arisen after time for thought or discussions with friends or relatives.
When obtaining consent the radiologist should explain to the patient in simple terms why the intended procedure is considered to be in their best interest and why the alternatives, such as surgery or conservative management have been rejected.
It goes without saying that the patient still has the right to reject the advice and to opt for alternative therapies. In such circumstances it is quite accept- able to outline the possible risks of not accepting the proffered advice but it is not acceptable to pressure the patient to agree to the proposed procedure.
The radiologist should then describe the proce- dure in plain and simple terms. Drawings or other visual material can be invaluable in helping the patient to understand the details. The likely success rates of the procedure and the possibility of recur- rence should then be discussed. The success rates should be, as far as possible, based on the doctors own experience and not on figures quoted in the radiological literature which are often optimistic.
Finally the patient should be informed of the pos- sible complications. There is still some discussion as to which complications should be mentioned.
Clearly common complications must be mentioned, and as a rule complications which occur in 1% or more of procedures would be regarded as in this cat- egory. In England it is likely that a court would rule that serious or significant complications, however rare, should be mentioned if they might affect a rea- sonable patient’s judgement as to their acceptance of the procedure. There is a very delicate balance to be struck between providing the patient with full information and deterring them from accepting a procedure which is clearly in their best interests. At
the end of the process of consent it is usual for the patients to sign a form to indicate their agreement to the procedure. The signature alone is not proof of proper consent if the procedure and its compli- cations have not been fully described. In England the standard consent form asks the doctor obtain- ing consent to outline the reasons for the procedure and to list the possible complications that were described to the patient. Where such a form is not used the outline of the discussion with the patient should be recorded in the patient’s notes and in par- ticular the possible complications which were men- tioned should be listed.
Should the patient decline to accept the intended course of treatment their decision, however illogi- cal or perverse it may seem, must be accepted unless there is reason to believe that the patient lacks the capacity to make a reasonable decision. In this situ- ation the doctor should discuss the proposed treat- ment with the patient’s relatives or with other mem- bers of the health care team, but no relative or any other person may give consent on the behalf of the patient. If the procedure is considered to be in the patient’s best interests and if they lack the capacity to consent then it is possible to continue but the rea- sons for doing this must be clearly recorded in the patient’s notes. Where there is doubt or opposing views then it will be necessary to obtain legal advice and in some cases it will be necessary to obtain a ruling from the court.
There will be a small number of patients who refuse to be given full information about the pro- cedure and its possible complications preferring instead to trust in the doctor’s judgement that this is the correct course of action. In these circumstances this refusal should be recorded in the patient’s notes together with the reasons why the treatment is con- sidered appropriate.
4.3
Who Should Obtain Consent?
Ideally the doctor who is going to perform or super- vise the intended procedure should personally be responsible for obtaining the consent of the patient.
When this is not possible the task can be delegated
to a junior doctor or, in certain circumstances, to a
nurse, if the doctor in charge of the patient is sat-
isfied that the person obtaining consent has been
properly trained to fully understand the procedure,
its indications, its limitations and its possible com-
Consent 19
plications. The person obtaining consent must be able to answer any question about the procedure that the patient wishes to ask; if they are unable to do this fully then the task has been improperly delegated. The doctor in charge of the patient ulti- mately is responsible for ensuring proper delegation and ultimately is responsible for ensuring that valid consent has been obtained.
4.4
Consent for Emergency Procedures
In an emergency consent clearly cannot be obtained in the same manner as for a routine procedure as time is at a premium. Where possible the patient should be given a brief account of the need for the procedure and its possible complications. If the patient is unconscious, heavily sedated or otherwise unable to give consent then such treatment as is nec- essary to preserve life or to deal with the immediate emergency should be given. Any further procedures required that are not immediately necessary should be postponed until they can be properly discussed with the patient.
4.5
Consent for the Use of New Medical Devices and New Procedures
Since 1998 the regulations for the use of new medical devices have been standardised across the Member States of the European Community under the Euro- pean Medical Devices Directive. This allows free movement of medical devices across the Commu- nity and under the directive all new devices must have obtained a CE mark before they can be sold.
This CE mark indicates that the device satisfies the stated essential requirements intended to ensure the following:
1. A device does not compromise the clinical condi- tion of the patient, the users, or, if applicable, any third party.
2. A device achieves its intended purpose as desig- nated by the manufacturer.
3. Any risks associated with the device are judged by informed clinical opinion to be acceptable when they are weighed against the benefi ts to the patient and when they are compatible with a high level of protection of health and safety.
Member States of the European Community each have a competent authority which is responsible for ensuring that the Directive is properly implemented.
A CE mark can only be obtained when the manu- facturer has proven to the competent authority that the device satisfies the essential requirements for safety and performance. This proof may be based on extracts from the existing scientific literature or it may be based on the outcome of a specifically designed trial which has been previously approved by the competent authority. A manufacturer wish- ing to carry out a trial of a new device must give written notice of this to the competent authority.
This must be accompanied by a full description of the investigation and a letter indicating the approval of the research ethical committee of each hospital which is to participate in the trial. Devices without a CE mark may thus only be used as part of a specific trial which has received the approval of the compe- tent authority and the local research ethical com- mittee. When obtaining consent prior to use of the device the patient must be given a careful explana- tion of the possible advantages of the new device and that there is little information as to the short term or long term outcomes. They must be given the right to decline the use of the device if they so wish, and be reassured that the best alternative form of treatment will still be available.
When a truly innovative form of new procedure is to be tried then there must be prior approval for the procedure from the local research ethical com- mittee. In the United Kingdom, in addition, the National Institute for Clinical Excellence (NICE) has a New Procedures Committee which is respon- sible for the evaluation of new procedures and any new procedure should be registered with NICE. The local research ethical committee will require a stan- dardised consent form to be used to ensure that the patient is fully aware of the experimental nature of the new procedure but the doctor obtaining consent must be sure that the patient fully understands the implications spelt out in the consent form.
4.6
After the Procedure
After the procedure the radiologist should always
write a detailed account of the whole procedure in
the patient’s notes. This should start with the name
of the procedure performed, the name of the opera-
tor and the names of any staff that have assisted.
20 M. R. E. Dean
