What is informed consent
Introduction
Informed consent is the process of providing information to the patient, so that the patient is able to, based on this information, make a decision about their healthcare. Doctors have a legal and ethical responsibility to provide adequate and high quality information to the patient.
Capacity
For the informed consent process to be valid, the patient MUST have capacity. This means that the patient has the ability to understand, retain and analyse the information presented to them.
Just because you do not agree with the decision that the patient is making, does not mean that the patient does not have capacity!
Generally, capacity is not formally assessed and the decision is made clinically during the interaction with the patient, meaning that the patient is already ‘assumed’ to have capacity. If there are concerns in regards with capacity, further testing with cognitive screening assessment tools such as Mini-Mental State Exam, can be used. However, an important caveat to this, is that cognitive screening assessment tools by itself cannot decide if a patient has capacity or not. It is still a clinical decision!
Tip#1 If during the clinical interaction, you feel that something is not right or perhaps the family member present has complained of memory concerns, escalate this to your Senior.
Voluntary
The patient must also be able to make their decision voluntarily. This means that pressure is not applied to ‘force’ a patient into making a particular decision. This also means that just because a patient has provided consent, they are also able to withdraw their consent at any point in time. Therefore, you can now see that consent is a fluid process.
What do I need to discuss during informed consent?
When providing education, the material facts that needs to be discussed are:
Procedure (Describe the procedure. Is it under General Anesthesia? How big is the cut? How long will it take? How many days in hospital approximately? What does the procedure entail?)
Alternative treatment options (is surgery really the best option? Can medications be used? Radiotherapy?)
Risk and benefits of the procedure (What are the general risks? Are there any risks that are specific to my current situation?)
What happens if the procedure does not go ahead
Tips for a successful informed consent process
The informed consent process is a communication exercise. The more you do it, the better you will get!
General tips are:
Have a private room and space when discussing
Avoid medical jargon. Use simple language. How might you explain this to your friend?
Allow time for patients to ask question
Educational materials Pamphlets and information booklets are a great way to reinforce information given
Good documentation It is good clinical practice to document what was discussed, what questions were asked by the patient, who was present in the discussion, what pamphlets were given etc
Who should do the informed consent process?
Good question! Ideally, it should be the person performing the procedure, who should provide information and discuss this with the patient.
For example, the Orthopaedic Consultant should provide informed consent to Patient A about Hip replacement.
However, this is not always possible. If you feel that you have adequate knowledge (for example you have seen the procedure a few times, and have assisted etc) then you should go ahead and do it. May be do a mock practice with a Senior Doctor first!
HOWEVER, if you feel that you don’t have adequate knowledge about the particular procedure and have been asked to obtain consent from a patient;
PLEASE say NO.
It is not good clinical practice, and if anything goes wrong, you might be held medicolegally liable.
Shared Decision Making Model
Shared decision making is a key part in Perioperative Medicine, especially during the informed consent process. Shared decision making means that in making any healthcare related decisions, the patient also has an important say. Patients are actively encouraged to participate in the decision making process.
Thus, decisions are made not just by the healthcare team (as was the case many years ago when it was a ‘Doctor knows best approach’). The patient's values, goals and preferences are taken into account when making medical decisions. Advantages of this approach is better doctor and patient relationship, reducing the potential for misinformed patient expectations, and reducing the number of inappropriate tests and treatment.
ResoucesAppelbaum PS. Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med 2007; 357:1834.D'Souza RS, Johnson RL, Bettini L, et al. Room for Improvement: A Systematic Review and Meta-analysis on the Informed Consent Process for Emergency Surgery. Mayo Clin Proc 2019; 94:1786.Elwyn G, Frosch D, Thomson R, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361-1367. doi:10.1007/s11606-012-2077-6Sokol D, Dattani R. How should surgeons obtain consent during the covid-19 pandemic? BMJ 2020; 369:m2539.Shared Decision making. Australian Commission on Safety and Quality in Healthcare. 2019 https://www.safetyandquality.gov.au/our-work/partnering-consumers/shared-decision-makingPicone D. Shared decision making: what do clinicians need to know and why should they bother? Med J Aust. 2014 Nov 3;201(9):513. doi: 10.5694/mja14.01022. PMID: 25358568.