Consent and Information for Patients

Published on 27/02/2015 by admin

Filed under Anesthesiology

Last modified 22/04/2025

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Consent and Information for Patients

Competent adults have a fundamental right to give or withhold their consent to medical examination, investigation or treatment. Other than in specific or exceptional circumstances, anaesthetists must therefore at all times have been given the valid consent of their patients. Several important points must be borne in mind when considering consent. Is it given freely? Does the patient have the requisite information to make a decision? Do they have the capacity to make this decision?

TYPES OF CONSENT

In clinical anaesthetic practice, the vast majority of consent is implied consent. The person’s consent is inferred from his or her actions (or inactions). If an anaesthetist asks to check a patient’s pulse and he or she offers his/her wrist, then consent is implied. The same principle of implied consent applies to documenting the patient’s history in the medical notes, attaching monitoring, insertion of a venous cannula or positioning a patient for a local anaesthetic block. Conversely, refusal to participate in these acts would imply that the patient did not give his or her consent at that time.

Verbal consent may be simply an extension of implied consent. The anaesthetist may ask the patient if it is all right to insert a venous cannula and the patient says yes. At the other extreme, verbal consent may be a very thorough process in which the anaesthetist has explained specific risks and benefits of a proposed procedure in great detail and, following some deliberation, the patient agrees verbally.

Written consent involves the patient agreeing to the proposed procedure and confirming this in writing. This is most commonly facilitated by a pre-printed consent form for operative procedures, but there may be occasions on which the medical notes are used for this purpose. It is important to understand that the written form simply documents that the patient has given their consent. It does not necessarily provide any information about the quality of that consent. Written consent is no more ‘valid’ than verbal consent but the documentation may provide some evidence of the process in the event of problems.

At present, anaesthetists use a combination of all these types of consent in their daily practice: the patient implies consent to blood pressure monitoring by holding his or her arm in position; he or she may have agreed verbally to general anaesthesia and its attendant risks and benefits with the anaesthetist; he or she will almost certainly have signed a consent form for the proposed surgical procedure. Currently, the Association of Anaesthetists of Great Britain and Ireland (AAGBI) is of the view that a formal signed consent form is not necessary for anaesthesia and anaesthesia-related procedures, since it is the process of consent itself that is important, and a signed form does not increase the validity of the consent. However, it is recommended, particularly for procedures which are invasive or which carry significant risks, that both a patient’s agreement to the intervention and the discussions which led up to that agreement are documented. This can be done on a standard consent form, on the anaesthetic record or separately in the patient’s notes.

CONSENT AS AN ACTIVE PROCESS

Gaining consent should be considered a process, not an event. For most patients, the process starts long before they meet the anaesthetist when they are seen by their family doctor and then the surgeon. At each step in this process, they are being given information and consenting, however informally, to the next stage in the process. Healthcare professionals, family, friends and other sources will all be providing information which will help them to come to a decision. The anaesthetist adds to this process with information about planned anaesthetic techniques, risks and benefits. The final consent from the patient should reflect this whole process – and documentation should support this.

Voluntariness

A fundamental principle of valid consent is that it should be voluntary. Consent is always given or withheld by the patient. It is not something done to a patient. Anaesthetists, along with other healthcare professionals, should avoid references to ‘consenting the patient.’ The anaesthetist should take appropriate steps to satisfy him/herself that the patient is not being coerced by other people, however well meaning, or by the situation. In normal practice, this involves nothing more than straightforward discussion with the patient. Anaesthetists should be aware that the context of consent must be considered, not just whether there is undue pressure from family or friends. An elective patient who is in the anaesthetic room and given new, significant information about the anaesthetic technique may be viewed as being in a coercive context because it would be difficult to refuse the interventions offered.

The anaesthetist has a professional duty to offer his or her opinion about what he or she believes the best course of action might be, but this should not cross the line into coercion. Patients have the right to refuse offered treatments. However, this does not mean that anaesthetists have to provide a treatment which they feel is unsafe just because a patient requests it. In the unusual event that this problem arises, clear documentation and discussion with senior colleagues are vital.

Information

In broad terms, the anaesthetist should provide the individual patient with sufficient information to make a reasonable decision. The patient should have some understanding of what he or she is consenting to. The anaesthetist must consider the individual patient – as suggested by the AAGBI: ‘What would this patient regard as relevant when coming to a decision about which, if any, of the available options to accept?’. Conversely, information should not be withheld solely because the anaesthetist feels it may deter a patient from undergoing a particular intervention or therapy.

There is no statute which clearly defines what information should be given to patients about anaesthesia, and different countries’ legal systems have taken slightly divergent views. The AAGBI guidance is shown in Table 19.1. It must be emphasized that the anaesthetist should adapt this to the individual patient and surgery. For instance, visual loss after prone surgery is a rare but significant procedure-related complication which is relevant to specific patients.

TABLE 19.1

AAGBI Guidance on Information Which Should be Provided to Patients Relating to Anaesthesia

image Generally what may be expected as part of the proposed anaesthetic technique. For example, fasting, the administration and effects of premedication, transfer from the ward to the anaesthetic room, cannula insertion, noninvasive monitoring, induction of general and/or local anaesthesia, monitoring throughout surgery by the anaesthetist, transfer to a recovery area, and return to the ward. Intraoperative and postoperative analgesia, fluids and antiemetic therapy should also be described.

image Postoperative recovery in a critical care environment (and what this might entail), where appropriate.

image Alternative anaesthetic techniques, where appropriate.

image Commonly occurring, ‘expected’ side-effects, such as nausea and vomiting, numbness after local anaesthetic techniques, succinylcholine pains and post-dural puncture headache.

image Rare but serious complications such as awareness (with and without pain), nerve injury (for all forms of anaesthesia), disability (stroke, deafness and blindness) should be provided in written information, as should the very small risk of death.

image It is good practice to include an estimate of the incidence of the risk. Anaesthetists must be prepared to discuss these risks at the preoperative visit if the patient asks about them.

image Specific risks or complications that may be of increased significance to the patient, for example, the risk of vocal cord damage if the patient is a professional singer.

image The increased risk from anaesthesia and surgery in relation to the patient’s medical history, nature of the surgery and urgency of the procedure. If possible, an estimate of the additional risk should be provided.

image The risks and benefits of local and regional anaesthesia in comparison to other analgesic techniques.

image The risk of intra-operative pain, and the need to convert to general anaesthesia, should a proposed local or regional technique be inadequate or ineffective. The risks and benefits of adjunctive sedation or general anaesthesia should be discussed.

image The benefits and risks of associated procedures such as central venous catheterization, where appropriate.

image Techniques of a sensitive nature, such as the insertion of an analgesic suppository.

Patients may sometimes state that they do not wish to know anything at all. The anaesthetist has a responsibility to ensure that the patient has sufficient information to provide valid consent. When handled with sensitivity, it is usually possible to provide an appropriate degree of information without unnecessary distress.

Quantity

It is impossible to provide patients with complete information about every anaesthetic and to attempt to do so would be counterproductive. The anaesthetist is responsible for providing the patient with sufficient information – professional training and communication skills should allow the anaesthetist to provide adequate information in a form that the patient can understand without overburdening the patient.

Most studies have demonstrated that patients wish to know more than healthcare professionals think, although conversely, they are usually satisfied with the information they are given. Most patients would like to receive written information, but only a minority read it when it is given. In general, women wish to know more than men, and parents wish to know more on their children’s behalf than they might wish to know for themselves. Although clearly every patient is different, in general, anxious patients have the same desire for information as non-anxious patients.

Methods of Information Provision

There are numerous ways of conveying information to patients. Traditionally, the face-to-face preoperative consultation was the only method used by anaesthetists. This is clearly still very valuable, partly to help establish rapport between patient and anaesthetist, but also to allow the anaesthetist to discover any specific issues of concern to the patient. However, numerous studies have shown that understanding and information retention following simple verbal consultation are poor. As the AAGBI states:

Written information is a complement to the pre-operative consultation, not a replacement. It provides an opportunity to give more extensive information about the process of anaesthesia, and about benefit and risks, which the patient can read at leisure and discuss with friends, family and other healthcare professionals. Producing good written information is a time-consuming process which requires consultation with patients, colleagues and experts in clear writing. Ideally, such information should be supported by published evidence and updated regularly to ensure that new information is included. Individual clinicians are unlikely to have the time or skill-sets to achieve this to a high standard; nor are most anaesthetic departments. There are various sources of high quality information available from national bodies and commercial organizations which meet these requirements.

Multimedia/video information is an attractive alternative approach. As with written information, it is not a straightforward task to produce high quality information. The studies that have been published generally demonstrate that it aids understanding and information retention, at least in the short term. However, there are practical issues to be resolved, including how to make it available to all patients, and cost.

Whatever approach used, it is the anaesthetist’s final responsibility to ensure that the patient has had sufficient information to provide valid consent.

Communicating Risk

Humans are not very good at assessing risk. A variety of factors influence people’s acceptance and interpretation of risk. Self-inflicted risk is generally better accepted than externally imposed risk – as evidenced by smokers concerned about relatively small risks from anaesthesia. Immediate and high impact risks (e.g. hypoxic brain damage) are rated more strongly than short-term or distant risks even though they may be far less likely to occur. There is also a natural tendency to overestimate rare risks and underestimate common ones.

The context of risk is relevant. In general, when given identical data concerning themselves and other people, individuals tend to rate the risk of ‘bad things’ happening to other people as greater than the risk to themselves; the converse is true for ‘good things.’ Even if they understand the risks, people are subject to the myth of invulnerability – the risk is real, but applies only to other people.

Taking all the above into account, how should an anaesthetist give information about risks and benefits? It is important to remember that the information is for the benefit of the patient, not solely as a defence against possible legal action. However, there are legal consequences of failure to obtain consent or failure to provide sufficient information. If a Court finds that consent was invalid, there may be a finding that provision of treatment amounted to battery or assault. Alternatively, the patient may argue that, by refusing to undergo the procedure if appropriate warnings had been given, the complication would have been avoided. If this argument is successful, then the patient is entitled to compensation for the consequences of the injury, even if the injury occurred despite all reasonable care in undertaking the procedure.

Patients prefer to be given numerical estimates of risk; doctors prefer to provide less precise qualitative estimates. Given the current state of evidence, neither is more accurate. The risk to the individual patient is usually unknown with sufficient precision. There is reasonable evidence that patients (and doctors) do not have sufficient understanding of probabilities for these to be used alone. Verbal likelihood scales are therefore most commonly used. The problem lies in the interpretation by anaesthetist and patient of the scale. ‘Never’ and ‘always’ are straightforward, but ‘common’, ‘rare’ and ‘unusual’ are subjective terms. Even within anaesthesia information systems, these are used differently. Drug information uses the ‘Calman’ scale; the Royal College of Anaesthetists (RCOA) uses a different scale. In order to provide more personal context, the population scale is sometimes used, comparing the risk to the number of people on a street, village, town, etc. (Table 19.2).

The framing of risk changes perception of risk. A 90% success rate is better received than a 10% failure rate. Relative risks and benefits may have a greater influence on an individual than is necessarily warranted. The absolute risk of dying due to anaesthesia-related complications is very small, regardless of technique. However, the relative risk (e.g. regional versus general anaesthesia for Caesarean section) may be quite large.

Capacity

The vast majority of patients clearly have capacity to make their own decisions. However, there are a number of patients who may be unable to give valid consent, either temporarily or permanently. The largest group is children (see below). In adults, the Mental Capacity Act (2005) in the UK, and similar legislation in other countries, provides a legal framework for patients unable to provide their own consent.

1. Adult patients are assumed to have capacity unless it is established that they lack capacity. Capacity is the ability to (a) understand and remember the information and (b) use it to arrive at a decision.

2. Patients must be given a reasonable chance to demonstrate their capacity. A person’s lack of capacity cannot be assumed solely because they have taken drugs, alcohol or premedication, nor because they are making seemingly ‘wrong’ choices. In particular, the inability to communicate verbally does not imply a lack of capacity. Doctors (including anaesthetists) must make reasonable attempts to provide information for the patient so that they can decide on treatment options for themselves.

3. The treatment of adults without capacity must be in their best interests. This is a wider definition of best interests than solely medical best interests. Although generally more relevant to critical care than anaesthesia, the Act is clear that the treatment must be necessary, the least restrictive and in the patient’s wider best interests.

4. Patients may appoint proxy decision-makers with Lasting Power of Attorney (LPA). These individuals have the legal right to give or receive consent on behalf of a patient without capacity for carrying out or continuation of treatment. The exception is for life-sustaining treatment or treatment considered inappropriate by the doctor.

Advance directives have varying legal standing across the world. Within the UK, an advance directive is held to be legally valid if:

Advance directives should be honoured provided that the treating doctor believes the above conditions are met. Although most advance directives are written, oral directives are acceptable. Only decisions regarding refusal of life-sustaining treatment must be in writing; these should be witnessed and countersigned.

In emergency situations, doctors should not unreasonably delay treatment but should make reasonable efforts to ascertain whether a valid advance directive exists.

Consent in Special Circumstances

Children

Although legal definitions vary, consent, or refusal of consent, is usually given on behalf of the child by a parent. Up-to-date guidance should be referred to, because professional and legal frameworks change. In general, an adult with legal parental responsibility can give or refuse consent. Teachers may be acting in loco parentis, although in practice for truly emergency care, the provisions of the Mental Capacity Act apply. Older children who have capacity are able to consent for themselves, though under the age of 18 years, they may not legally be allowed to refuse consent.

Occasionally, anaesthetists become involved in complex issues around refusal of consent on religious grounds by parents on behalf of the child. This almost invariably should be discussed with experts such as hospital solicitors and medical defence societies.

When taking parental consent, the anaesthetist should be very clear about the limits of that consent, particularly if it is anticipated that the child may become distressed at induction of anaesthesia.

Pregnancy

The pregnant woman has exactly the same rights to give or withhold consent as any other person. She does not have to justify her decisions and the fetus has no legal rights until it is born. This raises two main issues for the anaesthetist.

The first is the provision of information for regional analgesia in the labour suite. A significant number of women are extremely anxious and in severe pain by the time that the anaesthetist is asked to insert an epidural catheter. They may therefore not wish to hear (and almost certainly will not retain) a long list of potential complications. However, the anaesthetist has a responsibility to provide at least a minimum amount of information about risks and benefits of the procedure. This must be documented at the time because there is good evidence that the mother’s recollection of the discussion may not be complete, even the next day.

The second is the refusal of regional anaesthesia for emergency Caesarean section. The anaesthetist may believe that general anaesthesia is the riskier option for the mother. However, due to the emergency nature of Caesarean section, the option of refusing to provide general anaesthesia may be the most risky for the fetus.

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