Informed consent in paramedic practice

Notes and terminology

The discussion that follows is concerned only with consent as it relates to a competent adult patient receiving treatment in England. Patients who lack capacity, are under 18 years of age, or unconscious, are special cases with regard to the granting of consent, and are not considered here.

While the majority of the literature on consent is couched in terms of doctors, it is well recognised that what applies to doctors applies equally to all other registered health professionals (Department of Health, 2009). In the following discussion therefore, the term ‘clinician’ will be employed to mean any registered health professional.

Introduction

The idea of consent is a relatively new one in healthcare. It has been argued that in the past consent was not sought because the patient/clinician relationship was built on trust in the clinician's beneficence and non-maleficence (Habiba, 2000). It has further been argued that the loss of this trust based relationship has been caused by a variety of factors including the increasingly complex healthcare system leading to a breakdown in the one to one relationship patients have with their doctors and also the increasing expectations of patients (Polani, 1983 cited in Habiba, 2000).

The ability of patients to make decisions about their care has been described as until recently lacking ‘a certain substance’ (Bowman et al, 2012). The attitude that ‘doctor knows best’ is regarded as paternalistic and does not fit with the modern healthcare system (Coulter, 1999). As the healthcare system has changed from a paternalistic attitude towards one where patients are encouraged to be active participants in decisions about their own care, the standards of what constitutes consent have also changed. Consent is much more than just the collection of a signature on a piece of paper (Dimond, 2005), and failures in gaining valid consent are now a frequent cause of lawsuits (Moore et al, 2014). The Department of Health of the United Kingdom (DH) has stated that there is a ‘general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation’ (DH, 2009). The practice of gaining consent has been described as one of the most important clinical skills (Bowman et al, 2012) and yet it is a skill in which many clinicians have not been adequately trained (Gaeta et al, 2007).

In the modern healthcare system, just getting the patient to ‘consent’ is not sufficient. What is sought instead is ‘informed consent’. Informed consent is a decision made by the patient about their own treatment which is based on an understanding of the nature of the treatment, the risks inherent in it, the potential consequences of those risks or the refusal of treatment, and also what alternative treatments there may be (Laurie et al, 2016). This is very different from the paternalistic model where the clinician makes the decision about what is to be done and tells the patient, who then gives their ‘consent’.

Gaining informed consent is not however, a straightforward process. Several questions immediately demand to be answered. How much information should be imparted in order to satisfy the requirement for consent to be ‘informed’? Should we measure how much information was imparted to the patient or rather how much the patient has actually understood? What if the patient does not want to receive all this information and would rather just trust the judgement of the clinician? And finally, we should ask just how well does modern paramedic practice comply with the legal requirements for consent to always be obtained in an informed manner? In order to answer the last of these questions we first need to understand the answers to the others.

The legal position

Legal actions relating to failures in the consenting process revolve around undisclosed risks (Laurie et al, 2016). The accusation is that of negligence, that the clinician was negligent in not informing the patient of a risk that subsequently transpired and as a result of which the patient suffered harm (Bowman et al, 2012). In order to prove negligence, the patient would normally have to show that had they been made aware of the risk they would not have consented to the procedure (Laurie et al, 2016).

There is a well-established standard in UK law called the Bolam Test. This states that the actions of a clinician should be judged by what is considered appropriate by a responsible body of his or her peers (Laurie et al, 2016). Determining negligence in this way is known as the professional standard (Sommerville, 2013) and up until a few decades ago had been the usual way of making such determinations (Bowman et al, 2012). By this standard it is up to the professional body to determine what constitutes negligence in terms of the amount of information that needs to be given for consent to be considered ‘informed’. However, this places a lot of power with the professional body, and was not unnoticed by the judiciary who felt that allowing professional experts to determine their own standards in this way undermined care (Bowman et al, 2012).

The concept of informed consent in UK law is not set in stone however, and has been continually re-examined since it first appeared in British case law in the 1980s (Gaeta et al, 2007, Laurie et al, 2016). Over the last few decades the emphasis has swung from the professional standard to what is known as the patient standard. This has been a gradual process played out through a number of significant court cases. The patient standard test attempts to establish negligence based not on what a group of professionals feel is appropriate but on what the patient feels is appropriate (Laurie et al, 2016). This is not something which is straightforward to determine though as no two patients are the same. Two ways have evolved to approach determining this standard, the objective patient standard and the subjective patient standard (Laurie et al, 2016).

The objective patient standard invokes the concept of a theoretical ‘reasonable patient’ and asks what that patient would deem to be adequate information (Laurie et al, 2016). There is a risk with this test that by not taking into consideration the individual circumstances of the patient in that particular case that it may be unfair to them (Laurie et al, 2016). For example there may be concerns that are of particular significance to them that would not necessarily be of significance to a more generalised ‘reasonable patient’.

This concern is addressed by the subjective patient standard which considers the individual patient in each case and asks what would have been appropriate information for them given their circumstances (Laurie et al, 2016). This standard is difficult for the clinician, especially in emergency situations where they may have little or no familiarity with their patient. There is also a danger that this standard may be abused by a patient who can claim with hindsight that had he been told about the potential for the harm that he did indeed suffer then he would not have consented in the first place even when in reality he almost certainly would have done so (Laurie et al, 2016).

The courts have recently moved towards a position that largely rejects the professional standard and instead combines the objective and subjective patient standards. The UKSC have recently clarified the requirements for informed consent in the case Montgomery v. Lanarkshire Health Board. In its ruling the UKSC stated that:

How much information?

The key question for a clinician when seeking informed consent then is ‘what information does this patient need in order for them to be able to give or withhold their consent in an informed manner?’ The ruling by the UKSC given above states that the answer to this question is ‘any material risks’ (Montgomery vs. Lanarkshire Health Board, 2015). But of course this begs the question, ‘what is a material risk?’ The technical answer to this further question is again found in the UKSC ruling which states that ‘the test of materiality is whether, 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 doctor is or should be reasonably aware that the particular patient would be likely to attach significant risk to it’ (Montgomery vs. Lanarkshire Health Board, 2015). However, this answer does not provide clinicians clear guidance as to what actually constitutes material risk, indeed this guidance has been described as ambiguous (Laurie et al, 2016).

In the same judgement, the UKSC ruled that the determination of materiality should not be reduced to percentages but should instead be judged on the characteristics of the individual patient and the context in which the procedure is undertaken (Montgomery vs. Lanarkshire Health Board, 2015). It has been remarked that this may lead to the disclosure of very low risk complications which then has the effect of increasing the likelihood of the patient refusing consent even when it would be in their best interests (Laurie et al, 2016). While percentages cannot be used as the sole determinant of whether to disclose a particular risk it is perhaps inevitable that they will have some bearing. In recent cases a risk of a serious complication, such as paralysis following spinal surgery, has been deemed necessary to disclose when it is as low as 1% but not as low as 0.1% (Laurie et al, 2016).

One aspect of these questions that has been settled with some certainty is that if a patient asks questions about a specific risk, this indicates that under the subjective patient standard that that particular patient deems that particular risk to be ‘material’ and so it should be discussed openly (Laurie et al, 2016). The UKSC ruling also cautions clinicians against bombarding patients with information which they cannot be reasonably expected to understand and makes clear that this would not fulfil the duty to inform thus establishing that the transfer of information is judged not by what was said but by what was heard. It is clear then that seeking informed consent should be a partnership between the patient and the clinician, a discussion rather than a lecture.

There is a concept in law that allows the clinician to actively withhold information about a complication where they feel that it is in the patient's best interests not to know about it. This is known as therapeutic privilege but it must be exercised with great caution by the clinician, and be used only for very specific reasons relating to the individual patient in question and must be fully justifiable if challenged (Moore et al, 2014). In the recent UKSC ruling therapeutic privilege was cautioned against, warning that information should not be withheld by clinicians in order to steer the patient towards the ‘correct’ decision (Montgomery vs. Lanarkshire Health Board, 2015). It has been argued that it is not sufficient justification when claiming therapeutic privilege to argue that the withheld information would upset the patient or cause them to refuse treatment (Sommerville, 2013).

What about the situation whereby a patient does not want to engage in the dialogue that is necessary to ensure informed consent? This type of ‘disengaged’ patient can be very problematic (Sommerville, 2013). The UKSC has ruled that ‘a person can of course decide that she does not wish to be informed of risks and a doctor is not obliged to discuss the risks inherent in treatment with a person who makes it clear that she would prefer not to discuss the matter’ (Montgomery vs. Lanarkshire Health Board, 2015), but other commentators have pointed out that in such circumstances it could be hard to argue that the requirements of informed consent have been met and that patients need to be aware of at least the core facts for their consent to be considered valid (Sommerville, 2013). One study found that in these situations clinicians would sometimes continue to provide the patient with information just to meet their legal requirement to do so (Wood et al, 2014) but Sommerville (2013) suggests the best course of action in these circumstances is advising such patients that this type of disengagement may affect what treatment options can be provided.

Application to the ambulance service

It is clear from the above discussions that informed consent is an open, two-way process between a clinician and a patient. How does this fit in with practice in a modern National Health Service (NHS) ambulance service and are there areas where we are failing to meet the legal standards?

Gaining and documenting informed consent

The first point to note here is that calling 999 does not in any way imply or constitute consent to treatment, or remove the need for the clinician to obtain consent (Griffith, 2009), nor does the fact that the situation being dealt with is an emergency (Brach, 2016). The giving of consent is a continuous process that can be withdrawn by the patient at any time and for any reason, good or bad (Dimond, 2005; Griffith, 2009). If they decline an intervention that the clinician feels would be beneficial to them then the clinician should discuss this and explain the reasons why it would be beneficial and the potential consequences of refusal, but should the refusal remain then the intervention cannot proceed. The clinician would be wise to document the discussions that had taken place (Sommerville, 2013) and should proceed with their clinical decision making, taking into account the absence of the information refused. Refusal of a part of the process does not imply a refusal of the whole and the patient should not be penalised for it, they must however be made aware of the implications and how it may adversely affect their outcome.

So, just how much information does the paramedic need to impart in order to meet the requirements for gaining informed consent? It is clear that there is no black and white answer to this question. The amount of information that needs to be given depends on the circumstances of each situation, and will vary depending on the severity of the presenting complaint, the information needs of the patient, and the severity and likelihood of any potential complications or side effects. It is incumbent on the paramedic to apply professional judgement to determine how much information this particular patient needs in order to be able to give their consent in an informed manner in these particular circumstances and this needs to be done to a high enough standard to be justifiable in a court of law.

The need to disclose a potential risk is determined by its possible severity, its likelihood, and the significance that this particular patient attaches to it. A relatively likely risk that also carries a high severity, for example, the risk of CVA secondary to thrombolytic treatment, would have to be disclosed in pretty much all circumstances and if not disclosed there would have to be an exceptionally good reason why. Bear in mind from the discussion above on therapeutic privilege that withholding information because the clinician fears it will cause the patient to refuse treatment is not considered to be acceptable practice. A risk that is very likely but not very serious should also be disclosed. This could be something as simple as explaining that inserting a cannula will cause some pain or that giving GTN may cause a headache.

Where a risk is both unlikely and not serious then an argument could be made for non-disclosure. For example, in the JRCALC, tinnitus is listed as a side effect of ibuprofen (Fisher et al, 2013). In reality this is a rare complication occurring in just 0.01–0.1% of cases (Cianfrone et al, 2011) and so following the guidance set out above from the UKSC non-disclosure would be seen as entirely appropriate unless the patient was to enquire specifically about it.

Finally, when a risk is potentially serious but very unlikely, the paramedic would need to decide whether in this particular instance the risk is material for this particular patient. For example giving morphine to patients for pain relief carries with it the risk of inducing respiratory depression although this risk is considered to be low at less than 0.5% (Dahan et al, 2010). This is potentially a very serious side effect and can even be fatal if it goes unrecognised but the risk itself varies from patient to patient depending on factors such as the patient's age, weight, previous exposure to opiates, and renal function. So in a 90-year-old with a fractured hip but a history of renal failure, the risk may be deemed more material than in a healthy 20-year-old rugby player with a dislocated shoulder.

How consent is documented on ambulance service paperwork varies between services but is often no more than either a tick-box on the patient report form along the lines of ‘Consent Given’ or asking the patient to sign a box under a statement such as ‘Consent Given to Assessment and Treatment’. From the discussions above it is clear that this ticking of a box or gaining of a signature do not, in themselves, satisfy the requirements of informed consent. In law, such practice is seen merely as proof that a discussion took place regarding the giving or withholding of consent, but does not evidence what was actually discussed (Moore et al, 2014). The mindset of seeing consent as ‘chasing down a signature’ should be avoided (Brach, 2016). Consider, for example, the legal implications of asking a patient to consent at the start of the assessment process to ‘assessment and treatment’. At this stage of the process it is not known what is wrong with the patient so it also cannot be known what treatment they might need. They are therefore being asked to consent to treatment before they even know what is wrong with them or what that treatment might be. This is clearly not informed consent.

Unnecessary treatment

What about the circumstance where a clinician undertakes a procedure on a patient which they have explained in regards to the nature of the procedure, what results it will yield, and what the risks and complications may be, but have neglected to mention that the procedure itself has no therapeutic benefit to the patient? The patient may consent to the procedure but is their consent ‘informed’?

Some routine examples of such a circumstance within UK ambulance practice would be the insertion of an intravenous (IV) cannula ‘just in case’ it may be needed later, or the recording of observations that are being done purely to satisfy a policy of the NHS Trust providing the care. For example, the author's Trust, the South Western Ambulance Service NHS Trust (SWAST), requires that any patient who is not conveyed to hospital receives at least two sets of observations. These must include pulse rate, respiratory rate, capillary refill, Glasgow Coma Score, blood pressure and temperature, and while blood sugar readings are not mandated, their recording is described as being ‘best practice’ (SWAST, 2014). In a patient where a particular observation clearly will have no bearing on the clinical situation, this requirement to record them regardless starts to look like defensive medicine. Defensive medicine is ‘any deviation from sound medical practice due to a perceived threat of liability through either assurance or avoidance behaviors’ (O'Leary et al, 2012). The behaviour being considered here looks like an ‘assurance behaviour’, an ‘assurance behaviour’ being defined as ‘providing additional services of minimal clinical value’ (O'Leary et al, 2012).

It is interesting to note that the UKSC themselves recognised the risk that consideration of informed consent could lead to the practice of defensive medicine (Montgomery v Lanarkshire Health Board, 2015), so does the patient give ‘informed’ consent by agreeing to allow the clinician to undertake the unnecessary observation? A clue to the answer to this question can be found on the other side of the world, in Australia.

The Australian legal system bears many resemblances to our own, and like other legal systems that were largely derived from the British system such as Canada and the USA precedents set in one can be seen to carry weight in the others, a system known as ‘persuasive precedent’ (Forrester and Griffiths, 2015). In a recent case from Australia, a dentist was sued for carrying out what were claimed unnecessary treatments on her patients (Stickley, 2015). There was no question that the treatments were being carried out in an unsafe manner or to an unsatisfactory standard, but they were simply not needed. The implication, and indeed the judgement, was that the dentist was carrying them out purely for financial gain. The court in this case ruled that if a procedure has been misrepresented as being of therapeutic benefit to the patient when the clinician knows it is not, and the patient is not made aware of this then there is no consent (Stickley, 2015). The question was raised in this case as to whether it is enough to show the lack of therapeutic purpose or whether there also has to be an element of fraud, the judge ruled that there did not need to be an element of fraud, such as financial gain, for the consent to be invalidated. It merely had to be determined that the treatment was unnecessary and offered no therapeutic benefit (Stickley, 2015).

This position is supported in the UK by the DH, which has stated that any misrepresentation as to the ‘nature and purpose’ of a proposed procedure will invalidate consent (DH, 2009). It is not clear however, if a similar case has been tried in the British courts. While the Australian ruling does not set a precedent in British law, it does hint at what the judgement in such a trial would likely be. It could certainly be argued that the judgement reached in Australia is in keeping with the spirit and tone of the UKSC's view of informed consent.

While recording a blood sugar reading on a patient when you know it is unnecessary, or inserting an IV cannula when you have no intention of using it is perhaps not as unethical as undertaking procedures purely for financial gain, the underlying principle is the same. If a procedure is misrepresented to the patient as being necessary, even if just by saying ‘I just need to do this test on you’, when the clinician knows it has no therapeutic benefit, then there can be no informed consent. If the clinician were to explain to the patient that they wanted to undertake the procedure purely because their policies say they have to, but that it has no bearing on their medical condition or treatment, and the patient were to then consent to it then this consent would presumably be regarded as being informed but otherwise it is not.

Conclusions

An understanding of the legal, ethical, and professional aspects of informed consent is essential for a clinician to function in a modern, non-paternalistic healthcare system. The legal definition of informed consent has changed greatly over the last four decades and the Supreme Court has recently settled on a definition that rejects the professional standard in favour of the patient standard.

Clinicians must understand the concept of informed consent not just to protect themselves from claims of negligence in their practice but more importantly to ensure that they are acting as advocates for their patients and empowering those in their care to be an active participant in the decision making process.

Within the ambulance service, clinicians should always ensure that they are obtaining informed consent from their patients even where policies and procedures do not specifically emphasise this. Clinicians should also avoid practising defensively and undertaking procedures for non-therapeutic reasons, as by doing so, they risk practising without informed consent and are thus exposed to potential claims of negligence.

Key Points