What is Informed Consent (and Why is it Important to Understand for My Spine)?
Before you undergo a procedure on your spine, your doctor will give you information to help you decide whether or not you wish to have a particular treatment or test done. This includes explaining the risks, benefits and other details of the procedure. This process is known as informed consent.
What is informed consent?
Informed consent is the process by which physicians help patients make informed, voluntary decisions about their care. This includes educating them about the risks and benefits of a procedure, as well as alternative treatments.
Informed consent is more than just patients reading and signing a form. It also involves them actively participating with physicians in deciding what care is best for them. This is known as shared decision making. This collaborative approach between physician and patient allows the patient the right to ask questions and express concerns ahead of treatment. Patients able to understand their treatment options and make choices based on the information given are then able to receive treatment once they consent.
What are the components of informed consent?
Informed consent should include the following components:
- An explanation of the medical condition that requires a treatment, procedure or test
- An explanation of the purpose, benefits and risks of the proposed treatment, procedure or test
- An explanation of alternative treatments, procedures or tests, along with their benefits and risks
- A discussion of the consequences of not undergoing the treatment, procedure or test
Informed consent also involves letting patients know that they have a right to say no to any treatment.
As part of the informed consent process, the physician will assess whether the patient understands the information provided. The patient then signs a document, either paper or electronic, to show that they have understood the information and give consent.
Which procedures related to my back require informed consent?
Procedures requiring informed consent include:
- Spine surgeries such as fusion, artificial disc replacement, discectomy and more.
- All surgery requiring general or spinal anesthesia
- Procedures requiring local anesthesia
- Procedures using contrast media (e.g. lumbar spine CT scans)
Routine medical procedures and tests may not require written informed consent because consent is implied. For example, taking a patient’s blood pressure is commonly done during a patient evaluation, but health providers do not usually need to talk to patients about the risks and benefits of using a blood pressure device.
Is informed consent required by law?
In the United States and many other countries, informed consent is required by law for medical procedures. This stems from a patient’s right to choose which procedures they undergo.
Informed consent is also an ethical obligation for physicians and other health providers. Many medical professional organizations offer guidance to physicians on the best ways to carry out informed consent.
Are there ethical and legal concerns to consider?
Exceptions to informed consent. There are situations in which informed consent is not needed before a medical procedure. This includes when a patient is unconscious and requires treatment, or during life-threatening emergencies when there is isn’t enough time to obtain consent.
Inability to provide consent. Patients who cannot make decisions on their own are not able to give informed consent. For example, people with an intellectual or mental health disability, or a person who is severely drunk may need someone else to decide for them. In these cases, a family member or court-appointed guardian may act as a surrogate decision-maker.
Children and consent. Children cannot give informed consent. This usually means those under 17 years old. In this case, the parents or legal guardian need to give “informed permission.” A minor who is legally emancipated — such as teens who are married or financially independent — can give informed consent for themselves.
Language barriers. Informed consent documents are sometimes written at too high a reading level for some patients to understand. This makes it even more important for physicians to communicate in ways that work for patients.
What is the physician’s responsibility to the patient?
The physician has to provide the patient with enough information to make an informed decision. This information should be thorough and unbiased.
Physicians should also include patients in the decision-making process and avoid trying to force a patient into undergoing a certain procedure. The physician should make a recommendation and provide their reasons, but leave the final decision up to the patient. Examples of this as it relates to spine care include the need for spine surgeons to provide patients with all of their potential courses of care that are both non-surgical and surgical. Additionally, if there are various approaches to the spine or fusion versus motion preserving options surgeons must also discuss this with their patients.
|Real Patient Insights|
Jay Resio, BackerNation's Founder and CEO shares a personal story related to this topic.
"After my third herniation, I went to see an orthopedic surgeon to assess my situation. He told me that his recommendation was a fusion and that within 2 months, I would be all fixed up and doing whatever I want again.
Two problems with this. One, that he was setting some very unrealistic expectations for recovery from a spinal fusion. And two, related to informed consent, he didn't discuss any other options. Had I agreed and had the fusion surgery. Would this have been a violation of informed consent. I believe so.
I did ask him about disc replacement and his only response to me was... "You are more than welcome to get a second opinion."
At the end of the day, he was only suggesting a solution he knew how to perform even if it wasn't the best solution. Had I not been an informed patient, I would have been led down a path that was not in my best interest. What would have happened if the fusion was a failure? Could I have sued for malpractice? I believe so.
I did not get the fusion. I eventually had a discectomy because research data was somewhat favorable in regards to the reherniation rate. However, my disc was total junk and really just needed out of my body. I reherniated a month after the surgery and then fast-tracked moving forward with a lumbar disc replacement.
My advice to you. Always ask questions. Dive deep. Lay out all the potential options. Get "opinions" from 3 different sources and see what makes the most sense for your situation. The best surgeons will suggest the best option for you even if they can't perform it. I have experienced them personally and have heard many stories from others as well."
What if the surgeon knowingly doesn’t provide all available options?
Physicians who don’t provide patients with a reasonable amount of information during the informed consent process may be subject to a medical malpractice suit, lose their hospital privileges, or be removed from preferred-provider lists. This includes not telling patients about approved alternatives.
For example, if a patient is told that they need lumbar fusion surgery, the physician should also inform them of alternative treatments such as lumbar artificial disc replacement. If the physician doesn't offer an alternative treatment, patients should seek out a second opinion from another surgeon before deciding which procedure to undergo.
What are the spine patient’s rights and why is it important to understand them?
U.S. states have laws that protect the rights of patients. Health care facilities and medical professional associations also often have patient bills of rights.
When patients fully understand their rights, they are better able to take charge of their own health care. This allows them to work with their doctor to make decisions.
One important patient right is informed consent. This process ensures that patients have enough information to make informed, voluntary decisions about their care.
Patients also have the right to:
- Respect, dignity and courtesy during interactions with health care providers
- Ask questions about their health status or the recommended treatment
- Have their privacy and confidentiality respected by health care providers and staff
- Obtain copies of their medical records
- Refuse to undergo a treatment, test or procedure
- Obtain additional medical opinions
- Be told about any conflicts of interest their physician may have that could affect their care
How long is informed consent valid?
There is no set number of days or hours that it is valid. Generally, informed consent for a procedure expires after a patient is discharged from a hospital. Health care facilities may set their own rules for when informed consent expires. This is often included on the informed consent document.
What questions should I ask during informed consent?
The informed consent process is all about making sure you understand the benefits and risks of the procedure that your physician is recommending, as well as your other treatment options.
Before you sign the informed consent form, you should ask any questions you might have. It’s a good idea to write down your questions before your appointment and bring them with you. Here are a few basic ones to keep in mind:
- Why do I need this procedure?
- What are the benefits and risks of the procedure?
- What are the risks of not having the procedure?
- Are there alternative treatments for my condition? What are the benefits and risks of these alternatives? Do you offer those?
- How many times have you performed the procedure?
- Where will the procedure be done?
- What will my recovery be like? How long will it be before I can go back to my normal activities?
- Does my insurance cover this procedure? How much will I have to pay?
The informed consent process is one of the most important rights that patients have in regard to their health care. It is particularly important when it comes to spine care because there are so many different approaches and philosophies to treating back and neck pain. An increasingly common practice of spine surgeons who perform artificial disc replacement surgery is the use of psychological evaluations to ensure a patient’s complete understanding of how the procedure will affect them. It is the patient’s right to be informed and the physician’s duty to help. Their signature on the consent document, though, is only one small part of this process. At its heart, informed consent is about physicians communicating with patients and helping them make decisions about their care.