Consent revisited when the little things are the big things

Consent is a process and not a form. A glossy brochure just won’t cut it.

While the provision of relevant information is obvious to many, the importance of getting it right cannot be underestimated. Asking a patient to sign a consent form is important, but it’s only part of the consent process.

Among other things, the following information should always be clearly documented:

• the proposed treatment, aims and expected outcomes (including whether anaesthesia is required)
• details about the information provided to the patient
• all key points of the discussion – including questions raised by the patient, and your responses
• material risks (including specific risks) of any proposed procedure and potential complications discussed with the patient, if not otherwise recorded
• the risks and benefits of no treatment
• alternative options (including non-surgical options)
• the patient’s signature
• name and signature of the person who explained the consent process
• the date of consent
• any further resources provided to the patient.

Material risks specific to the patient are of the utmost importance, and these require a higher level of engagement and consideration. Generally, the more complex or risky the procedure, the more important it is for those details to be captured in the patient’s medical record.

Checklists have their place in practice, but they can be impersonal and robotic. If relied on too heavily, they can also shift attention away from discussing with the patient risks material to them based on their clinical history and presentation.

While all doctors will have their own nuanced approach, one approach can involve having the patient repeat back to you in their own words what they understand about the procedure and its risks. This will enable you to determine whether the patient understands the procedure, and has evaluated the risks sufficiently.

It should be remembered that consent obtained at one stage of your clinical management of a patient does not mean such consent is valid indefinitely. A change in patient circumstances will mean consent needs to be reobtained. This may occur when there is an improvement or deterioration in the patient’s condition, or new treatment options have been developed.

There can be multiple barriers to obtaining and documenting informed consent. A study from the UK1 compared the discussion of specific risks of surgery between two groups of patients: one in the trauma setting for distal radius fracture surgery, and the other in the elective setting for total knee arthroplasty.

It found specific risks of surgery were recorded more than 35 per cent less in the trauma setting. Significantly fewer risks were also recorded in that setting. It is a timely reminder that a shortage of time can lead to a rushed and sub-standard consent process.

Case study

Mr White is a right-hand dominant 25-year-old who worked FIFO as a driller’s offsider. He consulted a surgeon, Dr Jenkins, who obtained a history and clinical examination consistent with right-sided carpal tunnel syndrome.

Dr Jenkins advised that a trial of conservative treatment could be considered, including wrist splinting and steroid injection. He further indicated that surgery would be definitive management, where symptoms persisted or progressed, and may eventually be required regardless. Dr Jenkins handed Mr White a brochure on the procedure so he could “read up on it at home”.

Mr White informed Dr Jenkins that he wanted to proceed to surgery, because he was struggling to maintain his duties at work and couldn’t afford to take time off. Dr Jenkins said it was a simple procedure and he would be “as good as new”.

As Dr Jenkins had a surgical waitlist of six to eight weeks, Mr White agreed to trial conservative treatment in the meantime. Dr Jenkins said they could discuss the risks and benefits in more detail prior to surgery.

Two days following the consultation, Dr Jenkins’ assistant telephoned Mr White advising him that a surgical patient had cancelled at the last minute, and Dr Jenkins was happy to slot him in if he was keen to proceed with a carpal tunnel release. Keen to get back to full strength, Mr White agreed to be booked in for the following afternoon.

Dr Jenkins performed the procedure uneventfully, but Mr White still hadn’t recovered sufficient hand strength to return to full duties several months after the procedure. Mr White engaged lawyers who alleged their client had not been properly consented for surgery, and was not sufficiently warned about this risk of nerve damage with due regard given to his personal work circumstances.

In discussing obtaining the consent of the patient to this procedure, the [doctor said] he informed the patient that this was a new procedure and not well tested yet. He conceded that he had not written this down in the patient's consent form. The failure to record this in writing was said to be unsatisfactory. [at 22] – Dr Reid v Medical Council of NSW [2014] NSWCATOD 152

References

1. Bolam SM, Munro L, Wright M. Poor compliance documenting informed consent in trauma patients with distal radius fractures compared to elective total knee arthroplasty. ANZ J Surg 2022 Jul;92(7-8):1831-1838. doi: 10.1111/ans.17781. Epub 2022 May 19. PMID: 35588267; PMCID: PMC9543849.

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