Effective Consent Practice: Implementing the new duty to explain risks to patients
Chaired by Sharon Burton Head of Standards and Ethics Section at General Medical Council, today's conference opens with an extended session delivered by Mark Barnett Partner at Browne Jacobson LLP who will discuss Consent: The new Duty to explain risks to patients - The implications of the Supreme Court Judgement in the case of Montgomery v Lanarkshire Health Board. Mark will discuss:
- what does the Supreme Court Judgement mean for consent?
- what is material risk?
- taking into account the individual characteristics of the patient
- how can organisations support individuals to improve consent practice?
- ensuring choices are explained and consent is robust even when the choice is no treatment or non surgical treatment
- best practice including the use of protocols and written evidence
- the impact for professionals and organisations
- Legal update: Capacity and Consent
In his presentation Mark dicussed:
The Bolam Test established that if a doctor acts in accordance with a responsible body of medical opinion, he or she will not be negligent, this care test was amended – the Bolitho amendment – to include the requirement that the doctor should also have behaved in a way that ‘withstands logical analysis’ regardless of the body of medical opinion.
“In sideway the majority view - the issue whether non-disclosure should be condemned as a breach of the doctor’s duty of care is an issue to be decided primarily on the basis of medical evidence, applying the Bolam test. What a patient should be told is a medical issue, not a legal one”
“Sidaway – Lord Scarman minority view - I think that English Law must recognise a duty of the doctor to warn his patient of risk inherent in the treatment he is proposing…The duty is confined to material risk…The test of materiality is whether… a reasonable person in the patient’s position would be likely to attach significance to the risk”
Pearce v United Bristol Healthcare NHST (1999) Doctor advised a mother to delay childbirth, but the child was then stillborn. She complained that he should have advised her of the risk of the baby being stillborn. Judge stated “If there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that risk, if the information is needed so that the patient can determine…what course to adopt”
Montgomery v Lanarkshire Health Board (2015) - This case basically banished the bolam test.
Montgomery – the facts
- C gave birth to her son 1 October 1999
- C had diabetes. D accepted that women with diabetes have large babies and there was a 9-10% risk of shoulder dystocia in the case of a diabetic mother
- The risk of a serious problem for the baby from shoulder dystocia was small (brachial plexus injury 0.2%; hypoxia 0.1%)
- As a result of complications of shoulder dystocia he had serious disabilities
Montgomery – the issues - The doctor stated:
- “if you were to mention shoulder dystocia to every [diabetic] patient … then every one would ask for caesarean section and it is not in the maternal interests for women to have caesarean sections”
- “if you do that you would be sectioning virtually all diabetics”
- The doctor did not give the information about a c section as an option to the patient.
Montgmery – the end of Bolam for consent - Expressly approved Lord Scarman in Sidaway, and the decision in Pearce “whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question of which responsible professional opinion will have an influential…role to play; whether the patient has been given all the relevant information to choose between undergoing and not undergoing treatment is a question of a different order. Generally speaking, it is not a question the answer to which depends upon medical standards or practices”
Montgomery – Test (para 67)
The Doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.
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 a significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it
Risk cannot be reduced to percentages – materiality is fact and case sensitive.
There is therapeutic exception - Doctor is entitled to withhold information if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health. It does have to be detrimental to physical and mental health. But should not be abused (court stated): “It is not intended to subvert [the general principle] by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers contrary to her best interests”
Montgomery in practice
- Reiterates that risk and consent cannot be reduced to percentages – patient information leaflets, don’t leave out low risk information
- Consent is about the individual patient as well as the reasonable patient – do think about the individual person and not generally what would a patient want to be warned of
- Re-think written information to ensure it reflects the new law – make sure you document the consent process in black and white, clearly
- Think about what will be the best way to approach consent discussions
“The principles set out by the 2008 Consent: Patients & Doctor making decisions together states working with patients, discussing conditions and treatments with patients, involving the patient”
“No decisions about, without me is backed up by the Mental Capcity Act 2005 (fundamentally about autonomy), Gillick competency, European Convention Human Rights Article 8 – the right to respect for private and family life (Duty to involve the patient in decisions relating to her treatment – Glass v UK),
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine – Article 5.”
The Mental Capacity Act 2005 is principally about autonomy
- Presumption of capacity
- A person should not be treated as unable to make a decision because he makes an unwise decision
- A person is not to be treated as unable to make a decision unless all practicable steps to help in do so have been taken without success – may information simpler to understand and ensure they have all the information to make a decision.
- Take the least restrictive option
- And otherwise safeguarding:
- An act done or decision made on behalf of a person who lacks capacity must be done in his best interests
12 Fundamental Standards (minimum standards) where introducted by the health and social care act 2008 (regulated activities) regulations 2014. All providers are expected to comply with at all times:
- No. 3 - Care and treatment must only be provided with consent - Maximum fine of £50,000.
- No. 9 - Systems and processes must be established to ensure compliance with the fundamental standards
There is a requirement to provide the CQC with written report on compliance within 28 days – maximum fine of £2,500
What does this mean in practice?
- Working in partnership with the patient
- Doctor’s advisory role involves dialogue
- Patient must be aware of material risks, reasonable alternative or variant treatments
- Make a judgment as to how best to explain the risks to this patient
- Assessment of whether a risk is material is not about percentages
- The significance of any risk will reflect a variety of factors:
- Nature of the risk
- The effect its occurrence would have on the patient
- The importance to the patient of the benefits sought
- The alternatives available
- The risks involved in those alternatives
- Not obliged to discuss risks with a patient who makes it clear that she would prefer not to discuss – but record clearly
- What are the individual characteristics of this patient?
- Does the patient understand the seriousness of her condition?
- Does the patient understand the anticipated benefits and risks of the proposed treatment?
- And of any reasonable alternatives?
- Including the option not to treat?
- Can the information you are providing be understood by the patient?
- Lots of technical information is unlikely to help…
- And will not discharge the duty
- If not, how can you help them understand?
- If you know, or ought to know that the patient considers a risk significant – you must advise of it (this is an accept of the law that we see quite often)
- Can be withheld under the therapeutic exception - but that does not include withholding because you think the patient will refuse
- It is the patient’s choice as to what, if any, of the available options for treatment to undergo
- Clinician's advisory role involves dialogue – “pause and engage”
- Consider patient’s capacity and any aspect of their presentation which might limit their understanding – apply MCA 2005 as required
- The consent form is evidence of consent, not the consenting process itself (make sure the process is carefully recorded also)
- The “therapeutic exception” is not the basis for the general rule
- If it applies – record carefully
- Governance - are there robust consenting processes and pathways in place?
- Are policies, consent forms and training up to date?
- Patient information leaflets
- Are they up to date?
- Are they easy to understand?
- Do you have them in different languages and formats?
- Do clinicians have proper training and support in ensuring the consent process is robust?
Mark Barnett is a Partner in Browne Jacobson’s Health Advisory Litigation Team. He is an experienced litigator with a background in defending clinical negligence claims on behalf of the NHSLA, including successfully defending numerous claims to trial. Mark deals with high value and complex cases and has particular expertise in dealing with claims against mental health providers.
Mark has also developed expertise in advising health and social care providers and commissioners on the Mental Capacity Act and the Deprivation of Liberty Safeguards, including taking cases before the Court of Protection. Mark also advises and presents on a wide range of health law topics, including consent, confidentiality, duty of candour and Inquests and has appeared before numerous coroners.
Following Mark is Professor Felicity Astin Professor of Nursing and Applied Health Research at the University of Huddersfield who will present a session on Understanding decision making within the consent process: How can we ensure patients truly understand the risk v benefit of a treatment. The session will look at:
- Patients’ perspectives about their health, interventions and consent
- Identifying obstacles and enablers to best practice informed consent
- Learning from a mixed methods study to optimise informed consent for angioplasty
- How to optimise informed consent
In her presentation Professor Felicity Astin discussed:
“For consent to be valid it must be Voluntary, informed and there must be capacity”
Shared decision making – process in which patients are encouraged to participate in selecting appropriate treatment or management options
The barriers and facilitators to shared decision making include:
- Time constraints
- Lack of applicability due to patients characteristics
- Lack of applicability due to clinical situation –(if they are coming in for an emergency service)
- Provider motivation
- Positive impact on care
- Positive impact on patient outcomes
Mixed Methods Study – optimising Informed Consent is 4 phase
- Systematic review
- Qualitative Study
- Survey Study
- Knowledge Transfer
The informed consent process - There are 2 ways of seeing this from a patients view
Consent as an event
- Not improving clients comprehension
- Creating a more bureaucratic and less humane interaction
- Client sensing participation in process not desired
Consent as a process
- Promotes ongoing communication regarding expectations
- Ensures client able to integrate their information into a well organised understanding
- Shift from passive to active participation
Our interview finding for the consent process found some people said ‘I’m a firm believer in if the medical profession give me a decent reason then I’m quite happy to go along with it. I’ll do a bit of research but I’m prepared to be guided by what Dr’s say’, ‘The surgeon came and gave me booklets…I said ‘Look do you know what you are doing? If you do just get on with it!’ and some people just say I don’t want to know anything about risks.
Approaches to Optimising Consent
- Patient Education/ Communications
- Use ‘Teach-back’ technique – giving the patient in advanced and then asking them if there is anything they would like to know. We provided patients with a DVD 3/4 weeks before with all the information. Really good for optimising the understanding
- Consider setting & timings
- Value the process
- Health professional education
- Information resources/Aids
- Written information
- Decision making aids
- Tailored consent forms?
- Shorten & simplify
- Require documentation of comprehension
- Model training programme
- Survey national practice
Professor Felicity Astin's biography:
Felicity is a Registered Nurse who is currently employed in a joint clinical academic position at Huddersfield University and Calderdale and Huddersfield NHS Trust. She is Principal Investigator on a National Institute Health Research grant about optimising informed consent for people undergoing coronary angioplasty.
Also of interest:
In-depth legal masterclass: Informed Consent After Lanarkshire
Wednesday 12 October 2016
Hallam Conference Centre, London
5 July 2016