What Emergency Physicians Should Know About Informed Consent

Every patient with an intact mental capacity has the right to decide on treatment/procedures that he or she would like undergo. And as Emergency physicians, taking an "informed consent" is something that we do on everyday basis. This is another area where mishaps are likely in a chaotic ED. 

First take home point from this post would be to understand that "even if you perform a procedure that was necessary without any complications, you can still be held liable for not obtaining the consent." Therefore, it is vital to have a clear understanding about "informed consent" to avoid miscommunication and bad outcomes. 

So what does "informed consent" mean?
Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment (informed refusal). It originates from the legal and ethical right the patient has to direct what happens to their body and from the ethical duty of the physician to involve the patient in her health care. Informed consent may not be applicable only to procedures, but also to other significant management decisions.

Patient should get a clear understanding about the facts and the possible consequences before giving the consent. A good way to do that is, questioning yourself  "if you have disclosed the information clearly enough?" or ask yourself “Have I provided the patient with an understanding of what her or she would want to know?”

With an informed consent, we invite the patients to participate in the process of "shared decision making." Once again, stay away from medical jargon while explaining something to the patients. 

Elements of a full informed consent?

• Nature of the decision/procedure 
• Reasonable alternatives to the proposed intervention (regardless of there costs)
• The relevant risks, benefits, and uncertainties related to each alternative 
• Assessment of patient understanding 
• Acceptance of the intervention by the patient

Concept of Battery

Battery is legally defined as the intentional infliction of offensive or harmful bodily contact, regardless of whether the person was trying to harm or help. For instance, if a surgeon consented a patient for an operation on the right ear and while the patient was under anesthesia, he discovered the left ear was worse and operated on that ear with a poor outcome. The patient will get the damages not based on malpractice, but on lack of obtaining informed consent.

To prove lack of informed consent, patient must prove that:

• Physician failed to disclose adequate information regarding benefits and risks of proposed treatment, as well as alternative treatment options
• Patient need not prove negligence in the performance of the treatment; liability arises solely from inadequate disclosure (Physician is liable even if treatment was medically appropriate and performed skilfully right to damages arises from unauthorized contact)

What is informed refusal?

Informed refusal is when a patient refuses a recommended treatment/ procedure based upon his understanding of facts and implications of not following the treatment.

Waivers to informed consent:

• If the patient does not have decision-making capacity. Find the proxy, or surrogate decision-maker
• Implied consent in emergency
• When the patient has waived consent
• When a competent patient designates a trusted loved-one to make treatment decisions for him or her

For simple procedures like auscultation, drawing blood, physical examination etc. consent can be skipped (implied consent). We generally do not explain patients about risks, benefits and alternatives for auscultation!

How much information is enough?

There are three ways to look at it:

• Reasonable physician standard: What would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. This standard is generally considered inconsistent as the focus is on the physician rather than on what the patient needs to know. 
• Reasonable patient standard: What would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a typical patient would need to know in order to understand the decision at hand. 
• Subjective standard: What would this particular patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient.

As a physician, you must disclose all of the information that the patient needs to make a decision, but not so much that it frightens the patient from making a decision that would be of most benefit to him or her. This can sometimes be difficult and this is where you can employ some amount of discretion. I personally go with the "subjective standard" and individualise information as per the needs of each and every the patient. 

Consent Forms:
It is fine to have consent forms signed by the patients before the procedure/major treatment (tPA for stroke), making sure that they are aware of the process and understand it. In the ED, patients are distressed and sometimes they just want things to move quickly. This can be one reason for signing the consent form without going through it in detail. The way these forms are designed is scary. For a minute, if you read it through the patients eyes, it can give you goose bumps for sure. 

This is what a typical consent form says:

I confirm the following:

My physician has explained to me the nature, purpose, and possible consequences of the procedure(s) as well as the risks involved, and the possible complications and/ or alternative methods of treatment. I understand that the explanation I have received is not exhaustive because of unforeseen circumstances that may arise and I have been advised that a more detailed and complete explanation of the preceding matter will be given to me if I so desire. Upon reading the previous statement, I do not desire such further explanations. Furthermore, I acknowledge that I have received no guarantees or assurances as to the results that may be obtained from the performance of this operation or procedure.

When we purchase something (a mobile phone), we all enquire about the warranty/guarantee periods but when a patient submits their body to a physician to carry out a procedure/treatment for their own benefit, there are no assurances because every human body is unique and may respond differently to same treatment. 

These "consent forms" carry little value in the court of law. However they do acknowledge that a discussion took place between the physician and the patient but it is hard to find out what exact bits of the consent form were actually discussed.

  

Risk Management Strategies:

When obtaining an informed consent:

• Have a meaningful, unhurried conversation with patient. 
• Make the patient an active participant in the shared decision-making process.
• Provide supplementary information, such as brochures or videos.
• Disclose the most severe risks and the most common risks.
• Don't forget to mention about the alternatives.
• Obtain signed informed consent form.
• Avoid giving casual answers e.g This surgery is as risky as any other major surgery or I have done dozens of such surgeries. Be a little sensitive.
• Be professional.
• Avoid quoting exact numbers or percentages.
• Most important: Never ask a colleague or junior physician to obtain an informed consent on your behalf. This leads to confusion, chaos and miscommunication. Person doing the procedure (Yes, even the the senior physicians) must take the consent. It is important to make sure that the patient and family have the capacity, are clear on the facts and have their concerns addressed by an experienced physician before getting to YES,.

Informed consent requires disclosure, understanding, capacity and voluntariness. It is not just another signed document. Patients must have an intelligent understanding of their diagnosis, risks/benefits of proposed treatment and alternative options.

References:

1. Appelbaum PS. Assessment of patient’s competence to consent to treatment. New England Journal of Medicine. 2007; 357: 1834-1840. 
2. Moore, Gregory P., et al. "What Emergency Physicians Should Know About Informed Consent: Legal Scenarios, Cases, and Caveats." Academic Emergency Medicine 21.8 (2014): 922-927.