Consent and information for patients

Capacity

A patient must have the capacity to consent to medical intervention. In what is often referred to as the ‘four-step assessment of capacity’, capable patients can understand , in broad terms, the nature of the proposed intervention; retain this information for long enough to weigh it in the balance; and use it to make a decision. Finally, they can communicate their decision.

In the UK, all patients older than age 16, including those with mental illness, are assumed to have capacity to consent to their treatment unless serious doubt exists to the contrary. Capacity is not an all-or-nothing state, and so a patient's ability to make a choice may depend on how complex the factors involved in that decision are. Capacity may also fluctuate, and where possible, doctors should defer making treatment decisions if they anticipate the return of the patient's ability to decide.

Voluntariness

Consent should be given voluntarily – that is, without coercion. The anaesthetist should take appropriate steps to satisfy himself or herself that, however well meaning, the patient is not being coerced by other people or by the situation. In normal practice this involves nothing more than straightforward discussion with the patient.

In our increasingly multicultural society, it is not uncommon to find that language barriers prevent us from communicating easily with our patients. The Association of Anaesthetists advises that, in these situations, we should not rely on the patient's family members or friends to translate as we cannot be certain of the quality or accuracy of information relayed. Instead we should use independent professional translators provided by the hospital or translation telephone services.

The law does permit doctors to offer their advice as to the best course of action, but they must not pressure the patient to accept their advice.

Types of consent

For most patients the consent process begins when they first present to their primary care provider. At every subsequent interventional step, they give consent, however informally, before proceeding. A patient with capacity has the absolute right to accept or refuse medical intervention and so, if the patient refuses, we may not proceed. This remains the case even if we believe that the treatment is in their best interests and their refusal is irrational and may result in dire consequences, including death. Disagreeing with one's doctors is not diagnostic of a lack of capacity. Although patients have the right to refuse treatment, they cannot insist on receiving treatment which the medical team does not consider to be in their best interests.

Written consent is not a legal requirement for all medical interventions; much of what we do in our clinical practice is permitted with the patient's implied or verbal consent. For example, if a doctor asks to check the patient's pulse and the patient holds out a wrist, or asks to insert a cannula and the patient says yes, then the doctor may reasonably continue.

The Association of Anaesthetists is of the view that a signed consent form is not necessary for anaesthetic procedures performed to facilitate another treatment because a signed form ‘does nothing to validate or invalidate the consent. The anaesthetic can be considered a component of another treatment or part of a larger and interrelated process (e.g. epidural pain relief for childbirth), rather than a treatment in itself’. The Association of Anaesthetists advises, however, that, ‘whether consent is verbal or written, [we] should document the patient's agreement to the proposed intervention and the discussion that lead to that agreement, including the patient's questions and the responses given’. Discussions can be recorded on the anaesthetic chart, a preprinted consent form or in the patient's medical notes. When the anaesthetic intervention is the primary procedure, for example, therapeutic injections for chronic pain, hospitals may insist on formal, written consent, and anaesthetists should follow the guidelines of the institution in which they work.

The General Medical Council (GMC) advises that written consent should be sought if:

• 1.

  the investigation or treatment is complex or involves significant risks;

• 2.

  there may be significant consequences for the patient's employment or social or personal life;

• 3.

  providing clinical care is not the primary purpose of the investigation or treatment; or

• 4.

  the treatment is part of a research programme or is an innovative treatment designed specifically for their benefit.

Although written consent is usually facilitated by preprinted consent forms for operative procedures, it is important to appreciate that these forms do not make the consent any more ‘valid’. Written consent provides a useful record of the process but does not, in itself, add to the quality of that consent. It is the two-way sharing of information that renders consent valid, not simply a signed piece of paper.

Information

We must give patients sufficient information to ensure that their consent is ‘informed’ or ‘valid’ ( Table 21.1 ). If patients can demonstrate that their decision to proceed would have been altered by different information, then they may successfully sue in negligence.

The ruling of the Supreme Court in the case of clarified the legal standard we must reach when disclosing information to ensure that our patients are able to give valid consent. The Court ruled that patients must be warned of ‘all material risks’ inherent in the proposed treatment or procedure. To allow them genuine choice, they must also be counselled about alternative treatments, including the option for no treatment at. The Court defined a risk as ‘material’ if ‘a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor should reasonably be aware that the particular patient would be likely to attach significance to it’.

This means that consent must be tailored to the individual, and each patient must be warned of all risks he or she might find significant, no matter how unlikely they are to materialise. This demands that we know our patients well enough to understand what each might find uniquely significant. In the same ruling the Court goes on to caution against bombarding patients with information and technical details for fear of omitting material risks, because this may promote confusion rather than autonomy.

These standards might seem incredibly stringent, but in fact this Supreme Court ruling has done nothing more than bring the law into line with the long-standing guidance on consent issued by the and . We may feel it is impossible to counsel the patient adequately within the time constraints of the system; however, the Court says that lack of time will provide no defence for inadequate provision of information. If doctors are not allowed sufficient time for these essential discussions, then they must raise this issue with their employing Trust.

There are only three situations where it is acceptable, in law, not to provide patients with information about diagnosis or risks of treatment:

• 1.

  When the patient has expressed a repeated wish not to be told about his or her treatment. In this situation the doctor should explore and revisit this request in a sensitive manner before acquiescing.

• 2.

  Where disclosure of information will cause harm to the patient; this must be harm beyond merely causing distress, such as exacerbating the risk of suicide.

• 3.

  In cases of necessity where a patient needs lifesaving treatment and cannot give consent because of temporary incapacity, such as after a head injury.

The judges in the Montgomery ruling warned that these exceptions must not be abused.

Methods and timing of information provision

Patients not only need to be given information but also need time to reflect before coming to a decision. We should not be presenting patients with new information immediately before surgery as they will not have sufficient time for assimilation or reflection; one could argue that these circumstances are coercive and will invalidate the consent. In its guidance the Association of Anaesthetists stipulates categorically that taking consent ‘immediately before the induction of anaesthesia, for example in the anaesthetic room, is not acceptable…other than in exceptional circumstances’.

Information about anaesthesia should be provided in advance of the day of surgery, and there are numerous ways of conveying that information to the patients aside from the traditional face-to-face consultation. Written information, which can be sent to the patient ahead of time, provides an opportunity to give more extensive information; the patient can read and discuss this at their leisure. Shared decision-making aids are also becoming more prevalent across all specialties. These tools help patients to weigh the pros and cons of proposed treatment and usefully quantify risk.

Producing good quality, user-friendly information, regardless of the medium, is a time-consuming and skilled process that requires consultation with patients, colleagues and experts. There is plenty of high-quality information available from national bodies such as the Royal College of Anaesthetists, Obstetric Anaesthetists’ Association, Royal College of Surgeons’ Patient Liaison Group and other surgical specialty associations. Patients can be directed to these and other trusted websites, and information leaflets can be downloaded to save individual departments both time and expense.

The Mental Capacity Act and incapacity

The vast majority of patients will have capacity to make their own decisions. However, a number of patients may be unable to give valid consent, either temporarily or permanently. In England and Wales, the Mental Capacity Act 2005 provides a legal framework governing the treatment of patients who lack capacity to consent to their care. Similar legislation exists in other countries.

Doctors must do everything practicable to maximise the capacity of their patients. People's lack of capacity cannot be assumed solely because they have taken drugs, alcohol or premedication, nor because they have learning difficulties or mental illness or they seem to be making ‘the wrong’ choices. In particular, the inability to communicate verbally does not imply a lack of capacity.