- Patients need to consent to all the risks, all the benefits and all the various options that are relevant to their case and circumstances. You need to ask yourself:
1. Have you stated all the risks, benefits and options?
2. Are you completely satisfied that your patient understands all the pros and cons involved?
3. Does the patient understand what the treatment can and cannot deliver, in terms of benefits and improvement of symptoms?
- Provided you can answer ‘Yes’ to each of those questions, then this is likely to result in providing informed consent.
Informed consent in elective surgery
Where does the clinician stand in a post-Montgomery landscape of consent, where patients are akin to consumers? And how can you ensure your approach to consent, especially in elective surgery is up-to-date, patient-focussed and likely to withstand the scrutiny of a clinical negligence lawyer?
Informed consent in elective surgery, allows time to obtain consent and to fully advise your patient. It also gives your patient time to consider all their options. It is the ideal clinical situation, but as such, there is no room for error. To ensure you are obtaining consent and to remove the risk that it is anything but informed, you need to be considering the what, when, who, why and how.
In Montgomery v Lanarkshire Health Board , Mrs. Montgomery claimed she should have been warned of the 9-10% risk of shoulder dystocia in her pregnancy. The Health Board defended the claim on the basis that not advising Mrs. Montgomery of the risk was in accordance with responsible practice. The Supreme Court however, favoured a patient-centred legal test, specifically providing:
…a duty to take reasonable care to ensure … the patient is aware of any material risks involved in any recommended treatment, and of any responsible alternative or variant treatments….
Rather than being a matter for clinical judgment to be assessed by professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told. Since the decision in Montgomery, cases have repeatedly followed this ‘materiality rule’.
What, when, who, why and how you should consent
What do you need consent for?
When do you need consent?
- In elective surgery, consenting should be thought of as a process, not a single event. The clinical records, your letters to the patient’s GP and the consent form should demonstrate that your approach throughout the clinical history was patient-centred.
- It is crucial that your patient should have sufficient time between providing consent and undergoing treatment. This allows your patient to reflect upon their decision and ensures that they truly are making an informed decision about their options.
Who is providing the consent and who is the consent for?
- You are gaining consent from this patient. Therefore, you must be very clear in understanding what your patient wants from the treatment and that you know what risks are going to be important to this individual. Do not assume all patients have the same needs and concerns.
- Equally important is whether your patient knows, or thinks they know, who is performing the surgery. In Jones v Royal Devon & Exeter NHSFT , the claimant recovered damages for complications, which arose when Mr B performed surgery instead of Mr A, his more experienced colleague. The claimant persuaded the court that she went ahead with the surgery specifically on the understanding that Mr A would operate. Mr B was not found to have been negligent, but the claimant had not consented for him performing surgery.
Why do we need informed consent?
- Following a detailed consent process, helps to remind you to pause and reflect on the treatment rationale. It also allows the patient to ask questions and to reflect on the advice given.
How should you obtain the informed consent?
- There are various ways to obtain informed consent. A pre-printed or handwritten form, a pro-forma sticker and an extra signature box for the day of the surgery to ensure the patient has not changed their mind. All can be good options and, practicalities dependant, can all be done for a belt and braces approach.
- In many ways, the format of the consent is less important than the meaning of the form as a culmination of advice, discussion, options, time to reflect and a decision made. These important aspects of informed consent should be evident in all your dealings with the patient.
You need to ensure you have a clearly defined approach to consent. Decide on one that works for your clinical practice, whether the work you tend to do is routine, emergency, elective, or complex. Then ensure you and your colleagues adhere to it as closely and consistently as possible. You should make explicit reference to consent in your records, letters and conversations. Record consent whenever it is discussed. Finally, do not assume anything about your patient, their priorities, understanding or expectations.
Consent law is now clearer than ever before and aligns itself to current General Medical Council guidance.