Effective Consent Practice following Montgomery v Lanarkshire Health Board
News and updates from today's conference focusing on effective consent practice following the Supreme Court judgement in March 2015 in the case of Montgomery v Lanarkshire Health Board.
Understanding decision making within the consent process: how can we ensure patients truly understand the risk v benefit of a treatment
Professor Felicity Astin Professor of Nursing and Applied Health Research University of Huddersfield
Obtaining valid consent for any invasive treatment is a legal and ethical principle that reflects the right of patients to determine what happens to their own bodies and is a central tenet of best practice. Research evidence suggests that the informed process is seen as an event rather than a process. In this presentation informed consent will be considered within the context of decision making and potential barriers and enablers to best practice outlined. Percutaneous Coronary Intervention (PCI), a common treatment given to people to relieve narrowing or blockages in blood vessels that supply heart muscle, will be used as an example from which we can better understand the informed consent process from the perspectives of patients and cardiologists. This is important as evidence tells us that the amount and quality of the information provided to patients as part of the PCI consent process is variable. Often patients tend to overestimate the benefits of PCI, forget the risks and are not always made aware of alternative treatments. Observations from this applied health research are likely to be of value in considering the informed consent process across all invasive medical treatments provided for patients across multiple NHS settings. A brief summary of interventions known to improve the informed consent process will conclude the presentation.
Individualising Consent: Consent and communication of risk
Mr Samer Nashef Consultant Cardiac Surgeon Papworth Hospital
Clinicians have a duty to ensure that consent to procedures is truly informed. A patient cannot give truly informed consent without a reasonable understanding of the risks and benefits of having a procedure and the risks and benefits of not having it, so that these can be properly compared and a decision reached. That argument is all the more powerful when one of the risks is death.
Heart operations and other interventions are carried out for one or both of two possible indications. The symptomatic indication is when an intervention is embarked upon to improve symptoms or quality of life. The prognostic indication is when the intervention is carried out to improve prognosis or quantity of life. In the symptomatic indication the benefit (symptom relief) is compared to the risk of the procedure, and the patient decided if that benefit justifies the risk. The size of the risk can be quite accurately assessed using a risk model, such as EuroSCORE II, but should be adjusted to reflect the institution’s (and perhaps even the surgeon’s) own performance by the risk-adjusted mortality ratio (RAMR).
For interventions carried out on prognostic grounds alone, the process is, on the face of it, easier as it simply involves a comparison between two risks: that of intervention versus that of non-intervention. However, the situation is more complex than that, as the risk of intervention is upfront and immediate, whereas that of non-intervention is spread over time. Time until treatment equipoise (TUTE) is a method which allows the comparison between a risk that instantaneous and one that is spread over time in a way that is easily grasped by patients. This allows patients to make an informed choice, and should be used when operations are done on prognostic grounds.
TUTE, risk modelling and RAMR calculations, are tools which allow for individualised patient information, truly informed patient decision-making, and may also help doctors make better decisions.
LEGAL UPDATE SESSION: Capacity and Consent
Leslie Hamilton Consultant Cardiac Surgeon, Assistant Coroner Member Council Royal College of Surgeons
For a patient to give their consent to a procedure they have to have capacity, be acting voluntarily and must have been given the appropriate information (explored by the Conference in the light of Montgomery). This presentation looks at Capacity.
The Mental Capacity Act 2005 (MCA) puts the patient at the centre of decision making. It consolidated previous case law and is based on two fundamental concepts: the lack of capacity and “best interests”. The MCA describes how to assess capacity and sets out a framework for working out the patient’s “best interests”. The Act is accompanied by a Code of Practice and all healthcare staff have a duty to be familiar with it and have regard to it.
The most important concept is that everyone is assumed to have capacity until it is established otherwise. Capacity to make a decision is both time and decision specific. The second is that, if they lack capacity, all decisions must be taken in the patient’s “best interests”. “Best interests” are wider than medical questions and encompass social and psychological issues: a holistic view.
All adults with capacity have the absolute right to consent (or refuse) medical treatment. This includes the right to make a decision which appears unwise or irrational to others, even if it leads to their death. What matters is the ability to make the decision, not the outcome.
Consent and Refusal of treatment
Dr Raj Mohindra Consultant Cardiologist, Member of Newcastle Clinical Ethics Committee and Member of the Board of Trustees of UKCEN
There has been an ongoing battle in relation to the extent of disclosure of risk to patients. The range of options were doctor determined (Bolam), patient determined (the pure subjective test) or some hybrid in between. The rise of patient autonomy is based on the idea that the goal of the relationship between doctor and patient is to promote the welfare of the patient. Coupling this with the idea that social pluralism is now deeply embedded in society the Court has moved from the original Bolam yardstick to a mixed objective/subjective test but looked at from the perspective of the patient rather than the doctor.
Note that I submit that there are in fact 2 things going on here. It is the shift of viewpoint from:
(1) the doctor viewpoint orientated; towards
(2) patient viewpoint orientated;
rather than any shift of the standard along the scale from:
(1) doctor determined (Bolam); towards
(2) a standard determined by reference, in part, to the reasonable patient;
that makes the transition disorientating.
The shift in the law is difficult because it is not trivial. The damages in Montgomery were about £5.25m. In my view, although couched in terms of duties arising within the doctor-patient relationship, the real issue is organisational.
How should the process of consent be changed in light of Montgomery? The answer must be specific to the particular practitioner and particular organisation. However, the core objectives would seem to be to:
(1) secure a process that delivers the correct quantity and form of information such that a reasonable patient in the particular situation and with the particular characteristics of P can make the real choice in the context of their care planning; and
(2) find a way to evidence that this has been successfully done.
Future Events of Interest:
In-depth legal masterclass: Informed Consent After Lanarkshire
Deprivation of Liberty Safeguards: Ensuring Compliance & Moving towards a new system of 'Protective Care'
Caldicott Guardians: National Annual Conference
9 February 2016