A legal ruling has highlighted the importance of ensuring patients are given sufficient information to make informed decisions about their treatment options.
A surgeon can no longer be deemed to be ‘the sole arbiter of determining what risks are material to the patient’, but are clinicians fully aware of the legal implications when obtaining consent?
Patients have a fundamental legal and ethical right to decide what happens to their bodies. It is therefore essential that patients have given valid consent for all treatments and investigations. The Royal College of Surgeons (RCS) has warned that NHS Trusts risk facing a dramatic increase in the number of litigation pay-outs made if they do not make changes to the processes they use to gain consent from patients before surgery. The warning comes after a landmark judgment given in a Supreme Court case in 2015, Montgomery vs Lanarkshire Health Board, clarified current understanding of patient consent.
The Royal College of Surgeons has published new guidance that aims to help clinicians understand the shift in the law and its implications, as well as give them the tools to assist in improving their practice.
According to the NHS Litigation Authority (NHSLA), which handles medical negligence claims on behalf of hospitals, NHS Trusts in England paid out more than £1.4 billion in claims during 2015/2016. The RCS is concerned that this bill could go up significantly if hospitals do not take the Montgomery ruling seriously.
Traditionally, clinical practice in the NHS has considered that it is up to doctors to decide what risks to communicate to patients. The court in the Montgomery case changed this and held that doctors must ensure patients are aware of any and all risks that an individual patient, not a doctor, might consider significant. In other words doctors can no longer be the sole arbiter of determining what risks are material to the patient.
For example, possible loss of sensation in the hand following bypass surgery may be a minor risk to one patient in comparison to the benefit of increased life expectancy, but a very important risk to another, and therefore material, depending on the patient’s lifestyle choices e.g. a pianist. Surgeons are now required to get to know their patient sufficiently to understand their patients’ views and values and support them in making decisions about their treatment.
Mr Leslie Hamilton, a Royal College of Surgeons Council Member, said: “The RCS is very concerned that doctors and hospitals haven’t fully appreciated how much the judgment given in 2015 changed our understanding of patient consent. The watershed judgment in the Montgomery case shifted the focus of consent towards the specific needs of the patient. Hospitals and medical staff are leaving themselves very vulnerable to expensive litigation and increased pay-outs by being slow to change the way the consent process happens.
“We cannot underestimate the psychological impact facing litigation can also have on doctors. It can do serious damage to their confidence in practice and their reputation. Doctors must protect themselves and their patients by ensuring the consent process is carried out properly.”
General Medical Council (GMC) guidance already states that doctors should not make assumptions about the information a patient might want or need. However, until the judgment in the Montgomery case, the perception within established clinical practice, as well as a large body of case law, followed a more paternalistic approach. This was reflected in the Bolam principle, which saw the judgement of medical experts as the main criterion for assessing reasonable care in negligence cases and for deciding what risks should be communicated to the patient for a chosen treatment.
The RCS is also concerned that many NHS Trusts are not allowing enough time for consent to be gained sufficiently during consultations. Mr Hamilton added: “The NHS is under huge pressure and seeing more patients than ever. It’s not hard to see how in many hospitals gaining a patient’s consent has become a paper tick-box exercise, hurriedly done in the minutes before a patient is wheeled into theatre for their procedure. Operating lists and consultation clinics are packed leaving little time for these important consent discussions.
“Patients must be given enough time to make an informed decision about their treatment and hospitals are going to have to give serious thought to how they plan in time for these discussions.”
Consent: Supported Decision-Making – A Guide to Good Practice explains the change in case law and the impact this has on gaining consent from patients. It offers a set of principles to help surgeons support patients to make decisions about their care and gives a step-by-step overview of how the consent process should happen.
The guidance states that consent to treatment must be confirmed in writing and must be given voluntarily by a person with the capacity to make the decision in question, based on appropriate information, which is understood. If any of these factors are missing, the patient is not considered to have given permission to proceed to treatment.
The RCS further advises that different options for treatment, including the option of no treatment, should be presented side by side and the benefits and material risks should be given objectively.
On the issue of assessing a person’s capacity to make a decision, the guidance refers to the Mental Capacity Act 2005, which sets out a two-stage test of capacity, consisting of the following questions:
Furthermore, surgeons should consider whether the patient is able to:
In addition, patients should be treated as ‘individuals’; surgeons must not assume that ‘a patient lacks capacity to make a decision solely because of their age, disability, appearance, behaviour, medical condition (including mental illness), their beliefs, their apparent inability to communicate, or the fact that they make a decision with which the surgeon disagrees. On occasions, patients with mental capacity may make decisions that may have negative implications for their health. Even in cases where patients choose to refuse treatment and this path is potentially dangerous or fatal, surgeons must respect the patient’s decision. (An example of this can be seen in the RCS guidance: Caring for Patients Who Refuse Blood – A Guide to Good Practice, RCS, 2016).
The guidance on consent includes patients in medical emergencies, such as those who are admitted to hospital unconscious. In such cases, it is inappropriate to delay treatment to try to facilitate the patient’s autonomous decisions. Healthcare staff should act in the patient’s best interests and attempt to communicate with them to keep them informed wherever possible.
The guidance emphasises that surgeons must ensure that the patient is provided with the information they need to make an informed decision about treatment and, to support discussion on issues of consent, it may be necessary to send information to the patient in advance. The RCS advises that surgeons should provide information about:
Surgeons should make patients aware of national guidelines on treatment choices, such as NICE (National Institute for Health and Care Excellence) and SIGN (Scottish Intercollegiate Guidelines Network) guidelines. If the recommended treatment is not in keeping with current guidelines, the surgeon must explain their reason for not following current standard guidelines.
When advising patients which treatment will be the most conducive to the good health of the patient, it is important that the advice given is impartial and factual. Surgeons must not allow their personal views and preferences to have an impact on the description or emphasis given for each of the options. However, if the patient then asks the surgeon for their view, it is reasonable to give an opinion as long as it does not push the patient into a decision that would not have been their choice.
The guidance concludes that the Montgomery case has changed the focus of the consent process from one in which the surgeon would explain the procedure to the patient and obtain their consent to proceed, to one in which the surgeon sets out the treatment options and allows the patient to decide. The RCS points out that this change requires the surgeon to take time to explore the patient’s values and wishes about their care and to have sufficient experience to fully understand the risks and benefits that are material to the patient. It follows therefore that the discussion about options lies with the surgeon responsible for the patient’s care or, if this is not practical, with an experienced member of the surgical team who has the time and skill to gain sufficient understanding of the patient’s views and wishes.
The RCS has produced a series of podcasts with a dramatised case study commentary by senior surgeons and a patient to support a cultural shift in the way doctors think about consent and how they apply it in practice. To download the guidance and view the podcasts, visit: https://www.rcseng.ac.uk/standardsand-research/standards-and-guidance/ good-practice-guides/consent/
To access the GMC’s guidance on consent and the law, a variety of learning materials, case studies, a mental capacity decision support tool, and other useful links, visit: http://www.gmc-uk.org/guidance/ 27164.asp
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