The importance of carrying out a detailed and robust consenting process before performing any aesthetic procedure cannot be overstated. A well-structured and documented consultation is crucial for patient safety and protecting yourself from potential legal repercussions.
Here, we'll explore some of the key considerations for obtaining informed consent and provide practical tips to enhance your consultation process, incorporating insights from our Head of Marketing, Owen Woods and Senior Client Services Technician, Emma Bracchi.
You can also watch our video, which is packed with even more helpful tips from Hamilton Fraser experts.
Principles of consent
Patients have the right to give or withhold consent for any procedure or treatment. Performing a procedure without proper consent can be considered assault and may result in serious legal consequences. However, obtaining consent alone is not sufficient. It's essential to make sure that the patient is fully informed about the risks and benefits of the procedure before they agree to it. Failure to do so can be perceived as negligence, increasing the risk of litigation.
Medical practitioners must, therefore, make sure that they obtain ‘informed consent’ from their patients. While you may not want to ‘frighten a patient off’ by drawing their attention to the potential risks of going ahead with a procedure, the impact on your practice of being successfully sued is likely to be more detrimental in the long run than losing a patient in this way.
As claims specialist Emma Bracchi emphasises, "The consultation is the most important part of the treatment. You need to make sure that everything is consented to and that the patient is aware of all the risks before they can make an informed decision whether to proceed with the treatment."
Head of Marketing Owen Woods adds, “We all know that litigation in both the NHS and private practice continues to increase. If you don't obtain consent, how can you provide evidence that you've actually discussed the risks of the treatment with the patient?”
Best practices for gaining informed consent
The process of obtaining informed consent is based firstly on the assumption that the patient has the capacity to provide consent. Next, it requires the aesthetic practitioner to discuss with the patient the purpose, risks, and benefits of the proposed treatment and communicate and document this process in detail. The practitioner doesn’t have to approve of the patient’s choice – a patient is free to make an ill-advised choice – although the practitioner may decide it is safer to say ‘no’ if they feel the patient is not suited to the treatment and you can read more about patient selection in our separate guide.
The critical factor when it comes to consenting is that the patient’s consent must be informed by having all the risks and benefits of their chosen option explained clearly to them. This raises the crucial question – what risks should you warn a patient of?
To make sure that the consenting process is thorough and legally sound, consider the following best practices:
Face-to-face consultations: While initial consultations should be conducted in person, follow-up discussions can occur remotely, provided they are well-documented. Owen comments, “A patient should always have a consultation face-to-face and that consultation should be with the person actually performing that treatment.”
Consent separately for each procedure: In cases where there are a number of risks to the patient, consider breaking the aesthetic consultation consent form into clearly headed sections with a signature box after each section. This helps to draw the patient’s attention to each specific risk. While a more detailed form will take additional time to complete, it could save time and help safeguard your reputation in the future. Emma says, "We recommend separate consent forms, all signed and dated by the patient. The consent form details each type of treatment. It lists the risks and different aftercare for different kinds of treatments.”
Ongoing consent: Consent should be obtained each time a patient returns for treatment, regardless of previous procedures. Owen emphasises, “The consultation isn’t a one-off. Every time you see that patient, you should go through the exact same process. Even if it's a patient that we've known for five years and they've continuously come back to you for different treatments, you should always seek consent.”
Principles guiding communication of risk
The courts do not specify a minimum level of risk that must be communicated, but several guiding principles have emerged from legal precedents:
A patient should be advised of any material risk inherent in the treatment proposed – a risk is ‘material’ if it is likely that a patient would ‘attach significance to it’
The more serious the possible risk, the more likely it is that you should warn a patient about it
If there is a one to two per cent risk of a significant adverse event then the patient should be made aware of that risk, even if they have not asked about it
If the patient specifically asks about the risks associated with a procedure or treatment, you should warn them about all potential complications and risks, however rare they may be
If alternative (lower risk) treatments exist to achieve a particular result, you should discuss them with the patient
Owen points out that "it's essential to explain the risks and make sure patients fully understand them. For instance, even if the chance of bruising from an injectable treatment is minimal, the patient should be informed, especially if they have a significant event coming up soon."
This highlights the importance of understanding each patient's individual circumstances and motivations.
The guidance on communicating risk to patients is vague, but if you don't follow the correct procedure for obtaining informed consent from a patient and the treatment is unsuccessful (even if it is not your fault), you could be sued.
It's also important to note that consent may be effectively withdrawn during the course of a procedure. For example, if a patient asks you to stop during a procedure due to pain or discomfort, continuing would then constitute assault or negligence. To reduce the risk of a claim being made against you resulting from a treatment you have carried out, there are two key principles that you must follow:
1) Make sure that you always take informed consent 2) Make sure that you can always produce evidence that it has been taken
Tips for taking consent
Here are a few other tips to help you when taking consent:
Consider using a two-stage consenting process. This is particularly beneficial if the procedure is likely to result in a significant change in the patient’s appearance. When you see the patient twice, you can provide them with details of the risks and benefits at the first appointment and confirm evidence of consent at the second appointment. If you adopt a two-stage process, make sure that the patient has enough ‘cool off’ time between appointments to have considered their options carefully. “The most important thing is giving the patient enough time to think that the treatment is right for them”, says Emma.
Use clear language, as your patient is unlikely to be familiar with medical terminology. This helps to manage your patient’s expectations as well as reduce the likelihood of any misunderstanding. Emma comments, “You need to make sure that they are fully aware of the issues and the risks...they need to be aware of everything that you said, and you need to make sure that they have understood it."
Use diagrams to explain risks and benefits. Visual aids can significantly enhance a patient’s understanding of complex medical information.
Ask the patient about specific concerns. Make sure that the patient’s specific concerns are addressed in your discussions with them, and ask if there are any questions they would like to discuss.
Make sure the patient understands the treatment’s realistic outcomes. Clarify whether further treatment may be needed to achieve the desired outcome.
Avoid consent directed to a particular choice. Courts generally do not favour this approach.
Bear in mind that risk is relative from one person to the next. A risk that is insignificant to one person may matter greatly to another. For example, minimal risk of impaired vision following treatment may be far more important to a fighter pilot than an office worker; remember, you consent to the patient in front of you, not the general population.
Document the patient’s expectations and motivations. If you cannot achieve the patient’s desired outcome, discuss what is possible and document everything. Owen notes, "Managing the patient's expectations should also be included in the documentation. It is about having that dialogue with the patient. What is the reason they are having this treatment now?” Emma adds, "Everything you discuss should be in the patient file ... If it's not written down, it never happened."
Check that a patient can comply with any necessary aftercare. For example, if they must stay out of the sun for two weeks after the treatment, check that they don’t have a beach holiday booked for the following week. Emma states, “If they are booked in for a laser treatment, but you know they are doing a six-week tour of Australia where there is a lot of sunshine, then we wouldn't recommend that you go ahead with the treatment at that time because following laser you are not supposed to be exposed to sunlight.”
Always ask about a patient’s psychiatric as well as physical medical history. Assess very carefully whether you know enough about their psychiatric history before agreeing to treat them. If you sense that there are gaps, consider asking their GP for more information. Beware of the patient who minimises a psychiatric history.
At the conclusion of the consenting process, ask yourself whether you are satisfied that the patient has listened to and understood the information you have provided. If necessary, confirm they have taken it all in by asking them what they understand the risks to be. This allows you the opportunity to go through any information they have missed.
Tips for documenting the consenting process
If a complaint or formal claim is made against you, the aesthetic consent form along with any other paperwork and digital records that you complete with your patient during the consenting process will be used as evidence in your defence. This documentation should therefore be as thorough as possible and you need to be able to locate it easily, if required.
A patient has three years and four months to make a formal claim against you. This can be in the form of a solicitor’s letter or direct request for compensation. If you have only seen the patient once and don’t receive notification of a claim until three years later, then you will need to rely on your documentation to remind yourself of the patient and their treatment journey.
There is no single ‘best way’ of documenting the consenting process, but the more comprehensive your records, the better position you will be in to defend a claim against you. Becoming a ‘paperless practitioner’ can help you not only be more organised, but compliant too.
Provide the patient with written information to take away with them. It is a well-known fact that patients don’t retain all the information they’re given verbally, so provide your patient with the relevant documentation to take away with them if you’ve had a face-to-face consultation or follow-up electronically. In addition, you should record the fact that you have provided this information and discuss the risks and benefits with them in person or via a virtual consultation. At the treatment stage, ask and record whether or not they have any questions about the information you provided. Emma comments, “What we would say is, once you've gone through all the consultation and the risks, the best thing to do is actually give them leaflets with the information in them so not only have they heard it from you, they've also got something in writing. The best way of documenting that you have actually done that is to send them by email, so you've actually got proof that you have sent it to them. This can be a great defence if a claim is brought against you, as you can demonstrate that the patient was provided with all the necessary information."
Carry out a two-stage consent process. As discussed above, a two-stage consent process is where you provide your patient with documentation at the first appointment so that they can review it and ask questions about it at the second appointment before giving consent on the aesthetic consent form.
Provide aftercare documentation. It's also a good idea to provide documentation to the patient explicitly explaining any aftercare needed and the risks of noncompliance or contra-indicated medication. Always make sure that you record that this information has been provided and get your patient to initial the consent form or tick a box to acknowledge receipt.
Keep detailed notes. Keep detailed notes and follow up on any phone conversations in writing. If you have used diagrams or drawings to illustrate a treatment or procedure, keep them with the notes. Emma says, “If you have any discussions over the phone or over the internet, it is always best practice to follow up with an e-mail, referring to the conversation again, so that there is written proof that these aspects have been discussed.”
Take ‘before’ and ‘after’ photographs of the patient. In surgery cases, these photographs can include the patient in a ‘marked up’ state, evidencing the patient’s compliance in identifying where the surgery will take place. Patients can easily provide their own photographs in the event of a claim, and having your originals will be evidence if that a patient were to alter their own photographs, which is easily done with digital technology.
Make sure any specific or unusual issues raised by your patient are documented, together with the advice given.
Don’t assume that a patient having a ‘repeat’ treatment does not need to be consented again. Much will depend on the gap between treatments – for example there is a world of difference between a patient undergoing a course of treatments each week over five weeks and a patient re-attending for a second single treatment after a gap of six months.
Make sure that the aesthetic consent form is signed (this could be electronically) and dated. If you have follow-up appointments, make sure that any documentation or consent forms are also signed and dated each time you see the patient, whether virtually or face-to-face.
As the practitioner, it is your responsibility to seek informed consent before carrying out a procedure on a patient. This not only protects the patient but also safeguards your practice from potential legal claims. Following these best practices, including thorough documentation and patient education, will help you build a robust consenting process that minimises risk and enhances patient trust.
Remember, as Emma succinctly puts it, "Note everything."