Consent after Montgomery: What next for healthcare professionals?

Introduction

Throughout the twentieth century the importance of the patient being involved in their own care was recognised. Patients are, after all, sentient human beings, capable of making decisions about what is done to them. The principle of personal freedom in healthcare was defined in Re T. ¹ ‘Every adult has the right to decide whether or not he will accept medical treatment, even if a refusal may risk permanent injury to his health or even lead to premature death’.

The purpose of sharing information with a patient, and recognising their right to make their own decisions, is to allow the patient to demonstrate that they consent to the treatment proposed. Providing, and proving consent to treatment provides the practitioner with both a defence to any claim of a trespass to the person and also to any claim in the civil tort of negligence, within the scope of that consent.

Modern healthcare practice places the patient at the heart of all care decisions. The landmark case of Montgomery ² in 2015 has fundamentally altered the balance of power between health professional and patient in the UK. It has finally brought the legal doctrine of ‘informed consent’ into English legal meaning and accepted the patient as an equal participant in their healthcare treatment experience.

A duty to take care

The existence of a healthcare professional’s duty to take care towards his patient is enshrined in law ³ and assumed to exist; it does not have to be established. The duty to ‘take care’ cannot be absolved under any circumstances. But what is the nature of that duty? Put simply, a health professional must provide a reasonable standard of care. This has long been established by the Bolam Standard ⁴ which is ‘a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular act’.

This means that the standard of care for all treatment, which also includes the information and advice patients ought to receive is based only on what the practitioner considers appropriate to disclose. This is referred to as the ‘prudent practitioner’ standard.

Informed consent – What’s in a phrase?

The ‘prudent practitioner’ standard was first challenged in Canterbury v Spence ⁵ in which it was ruled

The question whether, and to what extent, a patient should be warned before he gives his consent to treatment is to be answered not by reference to medical practice, but by accepting the patient has a right to be informed of the risks inherent in the treatment. The Courts should not allow medical opinion as to what is best for the patient override the patient’s right to decide for himself whether he will submit to the treatment offered to him.

Information transfer

Receiving information is a fundamental aspect of how a patient decides whether to agree to a proposed treatment or not. The boundaries on the extent of how much information the prudent practitioner is required to provide has been tested at various times in the UK during the 1980s, ⁷ 1990s ⁸ and 2000s. ⁹

Whilst these cases have given some degree of clarity around the nature and extent of the risks that must be explained to a patient, none has fundamentally shifted the focus of information provision away from the ‘prudent practitioner’, and all have asserted that the Bolam Standard for information disclosure remains the acid test.

In particular, Sidaway ⁷ ruled that a ‘prudent patient’ approach was impractical in English law as it was not sensitive to the realities of the doctor–patient relationship. However, the minority dissenting view held that the test of a reasonable standard of care in information giving ‘… was whether in the particular circumstances, the risk was such that this particular patient would think it significant, if he were told it existed’. Chester ⁸ took another step towards the ‘prudent patient’ standard by recognising that a failure to provide a reasonable standard of advice could be considered separately to any claim with regard to the reasonable standard of treatment.

The Department of Health first issued guidance to clinicians on consent to treatment in 2001. ¹⁰ The guidance acknowledged that information provision was central to the consent process. Patients could ask for differing levels of information provision, ranging from being informed of everything, to allowing the practitioner to make the decisions for them. Such policy statements were taken by health professionals to represent the benchmark of good clinical practice and were soon followed by guidance on consent issued by many healthcare organisations.^11–13 ‘Informed consent’ entered the health professionals’ lexicon and despite, or perhaps because of, the international differences in the interpretation and legal meaning of the phrase everyone started talking about ‘informed consent’ – what is it and how do we know when we’ve got it? ¹⁴

Montgomery: Dawn of a new legal era

Montgomery was an obstetric case where it was held that a patient was entitled to receive any information she wanted on any matter relevant to her decision making to undergo any particular course of treatment. Understanding the ramifications of Montgomery is vital for all health professionals to ensure that they act reasonably to avoid any claim of negligence by failing to provide relevant information prior to treatment. Consent may now more easily be brought into a clinical negligence claim as a separate issue alongside any claim for treatment negligence even if the patient experiences no physical harm as a result of not being properly informed. Harm is ordinarily a fundamental step in establishing clinical negligence but not so now for information giving, following Montgomery.

Changing information provision – What’s new?

Montgomery fundamentally shifts the balance of power with regard to information giving and consent. Patients are now entitled to receive any information they ask for in order to make their own decisions, regardless of whether the health professional would usually explain the nature of the information to the patient. Save for limited circumstances, this is also regardless of any professional judgement as to whether the information is relevant. The default position is now that information to be shared is ‘what the patient wants to know’ not ‘what the health professional wants to tell’. The ‘prudent patient’ has arrived.

In echoes of Sidaway, Montgomery for the first time defines both informed consent and the ‘prudent patient’ in UK legal terms as meaning providing information about risks which

… in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the [health professional] is, or should reasonably be, aware that the particular patient would be likely to attach significance to it.

Montgomery and patient safety

In absolute terms, a health professional simply has to provide a reasonable standard of care; care that is safe and effective. But was does ‘safe’ mean? It now includes ensuring that you have provided your patient with all the information you can provide about the treatment, and answered all the patient’s questions, in order that you are satisfied that the patient has given informed consent. Existing guidance from professional bodies and regulators already robustly advises practitioners what good practice requires.^15–17 Montgomery acknowledges that the law is now clarifying what many practitioners have been doing for some time. But it is also clear how clinicians must change how they provide information to patients:

The health professional’s duty is not fulfilled by bombarding the patient with technical information which she cannot be reasonably expected to grasp, let alone by demanding a signature on a consent form. It is necessary to impose legal obligations so that even those health professionals who have less skill or inclination for communication, or are more hurried, are obliged to pause and engage in the discussion which the law requires.

Too much information?

Changing the process of information discussion with patients may require some wholesale review of the systems and processes within which healthcare professionals work. Sometimes the consent process is delegated to a person who does not actually carry out the procedure. Practitioners must now ensure that when they cannot answer a patient’s question themselves, they allow the patient to discuss their questions with a professional who is in a position to answer the question. To fail to do so may be subsequently challenged as negligent.

If there is doubt as to whether informed consent has been given, patients must be allowed a cooling off period to consider their decisions, save of course, for clear life-threatening immediate emergencies. For most surgical techniques, patients already usually discuss their procedure some time before the operation date. But elsewhere, invasive treatments such as therapeutic injection therapy are delivered within the same appointment that the patient first attends for their condition. Some patients later allege in litigation that they were given no option other than to proceed there and then despite not having their questions fully answered or adequate time to think about it. Such an allegation may now, if proven, lead to a finding that the practitioner was negligent.

Context and circumstances are key and a thorough assessment is imperative to help understand how the patient perceives their condition. Clinicians might argue that discussing the rare risks of catastrophic vertebral artery damage that may be caused from upper cervical spine manipulation serves only to scare patients and disrupt the natural flow of a patient–therapist interaction. Montgomery means it is no longer for the clinician to decide if a question, or risk, is relevant. Whilst the rare risks may never materialise in the lifetime of the clinician, they must be raised. Clinicians must adapt how they discuss rare risks with patients, perhaps by giving some meaningful comparator to help the patient. For example, if a risk has a 1:90,000 chance of occurring it could be expressed as ‘If Wembley Stadium was full, this event would happen to one person in the crowd’. It may be a case of needing to spend some time googling the capacity of your local venues to help with the contextualisation of risk for your interventions.

Getting the point across

Montgomery requires that clinicians translate their professional knowledge into something meaningful for the average patient. Patient information leaflets (PILs) are a legal requirement for supplying medicines to patients, so why aren’t they more innovatively used as part of the informed consent process? They should not just be for interventions. Many patients do not understand beforehand, for example, the extent to which they may be asked to undress as part of a physiotherapy assessment, or how much they will be handled by their therapist.

If your PILs are not correct, you may still be liable for the information in them even if you are not the primary author. ¹⁸ Montgomery provides further imperative for the review of PILs. More use should be made of existing credible sources of patient information for both the average patient and professional, e.g. patient.co.uk, in developing localised documents. A clear improvement would be to ensure that locally produced PILs have space left within them to add points and questions raised by the patient as well as further information that the clinician has provided as a result of their professional judgement. Copies must be retained in the patient record – it is no help at a later stage in litigation when a subsequent generic version of the PIL is provided as being evidence of what a patient was told.

Patients must be given the information directly as it relates to them. In many cases, services describe in great detail what will happen at an appointment or during a procedure, within a webpage. Despite the widespread accessibility of technology, many patients do not, for whatever reason, look at web links provided, and after Montgomery simply relying on having information buried on a website is unlikely to be sufficient evidence of sharing information directly with a patient.

Tick boxes and disclaimers

Despite guidance that has been around for decades, it is surprising how often tick boxes are still relied on to prove consent. Whilst a tick box may give some evidence that a health professional has, at least fleetingly, turned their attention to the fact they must consider patient consent, it does no more than that. Tick boxes for consent do not help the expert witness understand the nature or quality of any consent conversation that may have been held, the patient’s decisions or provide any proof that consent was properly given. Whilst tick boxes may have a useful purpose in prompting busy health professionals to remember all the things they need to consider, they certainly do not have any place in the consent process and must be avoided.

Consent conversations may be difficult, particularly when a patient may choose a course of action which the health professional would not recommend. However, practitioners may not under any circumstances, in the UK, use any form of disclaimer to absolve their professional obligation to exercise a reasonable standard of care in advising and treating patients. Asking a patient to sign that ‘treatment is at your own risk’ is inappropriate. Even if you do decide to use one, they are meaningless as the patient has an absolute established right to expect you to take care when treating them.

Consent forms

Written consent forms are not required for all treatments provided, but when used, they must now record all the risks of a procedure, including rare risks and any specific risk the patient asks about. The only forms that can be used are Department of Health forms. Post Montgomery the focus will be on how comprehensively completed the forms are. Consent forms are no proof that consent has been given, they merely serve to provide evidence that it has been considered. It is surprising how often incomplete forms, with just an interventional procedure and a signature are disclosed in litigation. If a consent form makes reference to a PIL being provided or discussed, then the PIL must be attached to provide the detail of what was discussed.

Record keeping – Less is more

‘Thankfully we have some records’ is a fading phrase used by the lawyers, now replaced by ‘thankfully we have a good set of records’. It is worth saying again – the clinical record is the essential document in clinical negligence litigation. It is for the claimant to prove their case and the clinical records are the often the only robust means by which a clinician can address any claims made. Consent is a process and, post Montgomery, the outcome of an equal discussion. Consent is documented not by ticking a box or writing ‘consent obtained’, but by evidencing an entire consultation that records the assessment made, the diagnosis provided and the discussions that took place around the proposed interventions, and of course what treatment was provided.

Pages of narrative records may record ‘what’ happened, yet they provide no insight into ‘why’ decisions were made. An expert witness will need to establish that the clinician turned their mind to the relevant factors and exercised professional judgement. Pre-printed standard assessment forms are invaluable, not only in saving writing time, but also in providing prompts in key assessment areas. Don’t be tempted to leave areas blank – always write ‘n/a’ and why, to show that you haven’t ignored or forgotten something.

Conclusion

Consent as a fundamental principle of healthcare is well established. The nature and extent of that consent has been evolving in healthcare for some time to move patients towards equity with their practitioners. Montgomery marks a new dawn. Patients now have their right to be fully informed and equal partners in their healthcare decisions properly recognised. The law has finally caught up with modern healthcare practise and not a moment too soon. A good clinical record showing discussion and professional judgment remains the best evidence of informed consent. Practitioners must ensure they focus on the ‘whys’ of treatment choices, and beware the pitfalls of sticking to the ‘whats’.