Issues around consent are a dominant allegation in a substantial proportion of medicolegal claims handled by Medical Protection in Hong Kong in 2022. This article provides practical tips on informed consent and highlights case studies of complaints and claims handled by Medical Protection to facilitate learning.
Throughout undergraduate and postgraduate medical education, the main focus of learning is technical skills and knowledge. While this is understandable, clinical care is built upon a foundation of the relationship between the clinician and the patient. Whether it is just a single consult in an emergency department or decades of caring for a family, decisions are made and implemented based on conversations. From a doctor’s perspective, these conversations can involve explanations about conditions, management options and risks. Meanwhile, from the patients’ perspective, it involves communicating their experience, understanding, priorities and wishes. From these conversations flow decisions. It is for this reason that informed consent for decisions is crucial for keeping patient autonomy at the heart of clinical care.
At Medical Protection, we assist with a range of medicolegal cases where there has been a complaint or an adverse outcome. It is not unusual for us to see issues around consent forming part of a wider picture of dissatisfaction. In fact, consent was the dominant allegation in almost a third (32 percent) of the highest value claims in which we supported Hong Kong members in 2022. Of course, claims are not the only possible consequence for inadequate consent. It can also lead to complaints to the Medical Council of Hong Kong (MCHK) and even criminal investigations.
As outlined in the MCHK’s Code of Professional Conduct, a patient’s consent is only valid if it is given freely, the patient is competent, understands the nature and implications of the proposed treatment, and the decision is informed – meaning the patient has received a proper explanation of the nature, effects, and risks of the proposed treatment, as well as alternative options, including the option of no treatment.
How much information?
The requirement of providing a proper explanation of the proposed treatment and risks is outlined in the MCHK Code of Professional Conduct. The language for these explanations should be clear, and the subject matter should be communicated in a way and in terms that the patient can understand. Sufficient information should be provided so that the patient’s decision can be truly informed, and this is matter of judgement based on the patient and complexity of the situation. An explanation of treatment options, risks and benefits, including significant risk as well as risks that have a low probability of occurring but carry serious consequences, should also be discussed, as is the option of no treatment/ intervention.
The concept of individuality and materiality also applies – what may be significant for the patient sitting in front of you, given their circumstances, wishes and lifestyle.
How much time? How often?
The MCHK guidelines also emphasize the matter of time. It recommends allowing the patient ‘reasonable’ time to make the decision ‘properly’ after the explanation is given, taking into consideration the complexity, significance and urgency.
Some queries received by Medical Protection come from doctors asking whether consent needs to be revisited, for example, just before a procedure if consent has already been given. Of course, consent is not just a singular conversation or agreement; it is a process and it is dynamic. Patient may later have concerns that they did not have before, their circumstances may have changed, they may have further questions to ask, or perhaps they may benefit from further counselling about a medication, and of course they are entitled to withdraw their consent once given. Consent is not just a singular issue that can be revisited, but the shared understanding and agreement that underlies the care a clinician is providing.
What to write?
Good contemporaneous record keeping is essential to effective continuity of care. Writing in the records is evidencing what happened during clinical interactions as well as the decision-making process.
Future clinicians seeing the patient, whether that is you or someone else, should be able to review the notes and understand what happened and why. It is not unusual for patients to request a copy of their medical records so they may understand what happened and why, and of course they may seek this when looking to pursue a claim or complaint. Having a clear contemporaneous record of consent discussions is crucial to defending such a claim or complaint.
Even if the consent discussion was sufficient and thorough, if it is not documented, the case would be very difficult to defend. Signed standardized consent forms are not sufficient as they are evidence that the form was signed, but not evidence that a discussion took place, for example, with options and risks explained, questions answered, and understanding checked.
