How Informed Is Your Consent Process?

My first day as an interventional cardiology fellow was supposed to start with an ostial left main lesion, and I was tasked to obtain consent from that patient. Having completed and observed what I thought were enough consents, I didn’t think this was going to be such a big deal. Still, to obtain consent in the best way possible, I decided to read the published literature on this process and soon realized that in a rush to get a "Yes" from the patient, we could easily skip some important steps. All of us have ethical and legal obligations to understand the medical informed consent process and not blaze through it. Here are the eight key components of informed consent for interventional cardiology fellows:

1. Obtain More Than a Signature

Obtaining a patient’s consent is not the same as having a patient sign a consent form. While a written, countersigned document provides important evidence if consent is disputed in court, in order for consent to be valid, it must be given voluntarily by an appropriately informed person who has mental capacity to exercise informed choice. This means that your conversation with the patient matters and you must be confident in your ability to explain what the patient is consenting to before he or she signs any document.

2. Be Reasonable

The level of disclosure needed per the courts is termed "prudent person." This means that physicians must disclose what a reasonable person in the patient’s position would want to know to make an intelligent decision with respect to choices of treatment and diagnosis. This may sound subjective, but it is different from the “professional-person” standard that means that all possible adverse event risks need to be disclosed, which could be cumbersome and confusing to lot of patients.

3. Think About Risk Level

Your duty to disclose treatment risks increases alongside the magnitude of risk. Usually, an adverse event thought of as “significant risk” is one which occurs at a prevalence in excess of 1%, and the best way to communicate risk is in hard numbers such as events per 100 patients treated. However, serious risks such as death, stroke, MI, and loss of limb should always be disclosed, even if probability of occurrence is negligible. Also, risks that might have particular relevance to a patient—such as risk of ending up on dialysis in a chronic kidney disease patient—need to be discussed.

4. Explore Alternatives

In the event there are alternative treatment options, the patient needs to be informed about each of these and their risks as well as benefits. In the same vein, you should also discuss the potential consequences of no treatment with each patient.

5. Give Them an Out

Something that is fairly obvious but can often be forgotten is that the patient is ultimately in control of his or her medical decision making and always has a right to withdraw consent. While this is a pathway most physicians would prefer not to take preprocedure, you need to explain to patients the proper way for them to do so if desired.

6. Don’t Disclose Experience Level, Unless Asked

As a fellow, do you need to disclose your training status voluntarily to patients while obtaining preprocedural consent? Unless specifically asked by the patient, no. You will always be supervised by attending physicians in a GME-accredited program, which are designed to ensure that experience and level of training are immaterial to outcomes. To the anxious patients, introducing yourself as a member of the physician team helping the attending in the cath lab to obtain best outcomes may allay concerns.

7. Keep it Simple

As physicians, we can get wrapped up in our world of complex concepts and jargon, but when communicating with patients, especially when obtaining consent, we need to keep our communication as simple and clear as possible. The consent process should be conducted in the patient’s primary language and all concepts should be explained in basic terminology. As such, the consent form should also be in the patient’s primary language and at no higher than a sixth-grade reading level.

8. Have a Plan B

The consent process does not always go according to plan. Patients are not always in a state to provide informed consent, and family members are not always reachable when their opinions are needed. In an emergent situation when both the patient and family are unable to provide consent in time for a procedure, two attending physicians can and will need to certify the urgent intervention to proceed. This is not an ideal situation, but know that it is a possibility.

To summarize, although we always expect to hear "Yes" from our patients, we do need to be certain that we have empowered them to ask questions and even say “No” during the informed consent process. Ultimately, this will foster better communication between you and your patients, protect you and your institution from lawsuits, and overall improve your patient care.