Recent media reports about device failures1 and the discovery, sometimes years afterwards, of adverse outcomes raise the issue of what information a surgeon should give to their patients when using new and innovative procedures or techniques.
Being an early adopter of a new procedure can be exciting, but also challenging. A new procedure or device can offer benefits over more traditional approaches, but there may be many unknowns. If the new procedure is the subject of a clinical trial, there are clear processes that need to be followed particularly regarding consent, and this is a key part of the ethics approval required. However, many innovations fall short of requiring a clinical trial.
How do you manage the consent discussion with a patient in these circumstances?
There are a few things that you should do before using a new approach, procedure or device:
- Study the theory behind the new approach.
- Consider the evidence base – is there enough evidence of benefit, or should the new approach be the subject of a clinical trial?
- Use devices that are approved by the Therapeutic Goods Administration, however it is advisable to do some wider research about clinical efficacy before making the decision to use a new device.
- Make sure you are adequately trained – observe some cases before undertaking your first case and engage with an experienced mentor or supervisor to assist with case selection and ensure they are present for the initial procedure. The extent of supervision/mentorship will depend on the degree of novelty and complexity of the treatment.
- Work within your approved scope of practice.
- Ensure that your institution or facility’s resources are appropriate and that the institution is aware that you are using a new approach.
- You may need to notify Avant before you start using a new approach.
Patient selection is important and if you are unsure about using a new approach with a particular patient, it may be worthwhile suggesting a second opinion, and/or discussing your proposed approach with colleagues.
Patients can often think new is better, but sometimes this can cloud their judgement and lead them to overestimate the benefits. Critically question whether new is better. If you do not think a new procedure or device is better for the patient, explain this to the patient. You are certainly under no obligation to provide a particular treatment to a patient if you do not think it is clinically appropriate, even if the patient requests it. It is reasonable and appropriate to talk a patient out of surgery if you do not recommend it.
Bear in mind that auditing your outcomes is an important aspect of using a new approach. Advise patients that they may require long-term follow up or be subject to a review, revision or recall if problems arise in the future.
You will need to maintain records of your patients’ contact details to facilitate any follow up.
The consent discussion
Obtaining patient consent to use a new or innovative approach or device can be a challenge. The main challenge arises because the approach is new, so clinical experience is limited, and many risks and complications may be unknown and unknowable.
Nevertheless the legal principles are the same for new procedures or devices as for more traditional approaches. Your obligation is to take reasonable steps to provide information to your patient that is material to them in their particular circumstances and allows them to make an informed decision about their treatment. This includes informing the patient that you are using a new or innovative approach.
- Discuss with the patient the place of the new approach among the options available, including the evidence supporting the new approach, and the clinical experience in using the new approach.
- Explain your rationale for recommending the new approach for this patient, compared with other options.
- Outline your experience and training using the new approach and whether you will be supervised or assisted.
- Take care to cover potential risks and complications as well as potential benefits.
- Explore with the patient what is important for them in terms of outcomes – what would they be prepared to live with?
- Make it clear that long term outcomes and expectations may be unknown.
- Discuss any cost difference to the patient.
Using models, diagrams and information sheets can be helpful aids to your discussion with the patient.
It is important to test the patient’s understanding of what you have told them. Ensure that they understand that the approach is new, and give them the opportunity to ask questions. It can be useful to have more than one consultation with the patient, to allow them time to digest the information you have provided.
Finally, comprehensively document the discussion you have with the patient in their records. In a time of stress, patients often do not remember what you told them. Consider sending a copy of your letter back to the referring doctor to the patient as well.
For more information view: Avant’s webinar Brave New World New Technologies and Techniques.
This article was originally published in the AOA Bulletin Volume 40 No. 1 Summer 2019.
1The Implant Files: Deadly Devices and Revealed: faulty medical implants harm patients around the world