It depends. The term Informed Consent means that you have been told of the reason for a procedure, the alternatives to the procedure, the risks and benefits, and the likelihood that the procedure will be helpful. The term applies not only to medical care that you need but also to clinical trials in which you are participating.
Informed Consent is key to patient autonomy and empowerment involving a two-way process of physician input and the patient’s understanding of what she has been told. Integral to the process is giving time for the patient to consider her options, formulate questions, and ask for additional information. The idea behind Informed Consent is that one has the right to know what is being done to his body, and the right to refuse treatment if he chooses. Informed Consent signifies that the patient is sharing in the decisions being made for his treatment.
The term is a bit of a misnomer, for a patent can decline to give consent to the physician’s treatment plan. A better term would be “informed decision-making.”
Most people do not ask enough questions about their procedure.
Key to the patient’s comprehension of her options is knowing the questions to ask when presented with the physician’s proposal. If asked by the patient to do so, healthcare advocates often intervene to assure that their client does indeed fully understand the information given.
Components of Informed Consent include one’s diagnosis and prognosis, alternative treatment plans, and the advantages and disadvantages of all options. If health literacy is an issue, and it often is, information is required to be communicated at the patient’s level of understanding, avoiding medical-eze and legal-eze.
Your doctor must explain why he believes the procedure needs to be done.
The steps of the procedure must be described.
The risks of the treatment must be explained, including any health care quality issues that exist.
Your doctor must tell you what to expect while you recover from the operation.
You must be told about alternative treatments.
You must be told what might happen if you refuse the treatment.
Your doctor must explain why the procedure will benefit you, and what the likelihood is that the operation will be successful.
You must be told the cost range of the procedure, and given a breakdown if you ask for it.
You must be told what will be involved in your care after the procedure, and shown how to perform any tasks needing to be done after you are home. If home health care assistance will be needed, a case manager, if asked, will inform you of how it can be obtained and paid for.
Your doctor must explain any residual effects from the operation.
You must be told when you can expect to resume normal activities.
You may have as many conversations as you need with any member of your medical team until you are comfortable with your knowledge and ability to make an informed decision that is right for you.
You may alter the Informed Consent document to more precisely reflect what you know.
All of the above must be given to you in writing before you sign anything.
So how can the components of Informed Consent not be met?
First, realize that due to time constraints and a physician’s “need to know” orientation, you typically are given generalized information that is often a template extended to all patients with your disease. Additional information is often not volunteered. You may be encouraged to ask questions, but most healthcare consumers do not have the extreme medical sophistication needed to know what questions to ask. This is where your patient advocate can be extremely helpful.
Sometimes the language may mislead you. Watch out for phrases that are vague or overly generalized. The information you are given may be sugar-coated. For instance, when a doctor or nurse uses the word “discomfort,” what they mean is PAIN. If you are told that success is “likely,” ask for specific percentages. “Likely” often is code for a 50/50 chance. You might want better odds than that. Ask what the historical success of the operation has been in the past, and when there have been complications, a description of the most frequent types.
Ask how many times the physician has performed the procedure. You want someone who frequently performs the operation proposed to be done to you.
Is there any reason you should not have the procedure? There almost always is, but is there a slight risk, or a “significant” risk? “Significant” in medical-eze means “almost certain to happen.”
Ask to see how the procedure is described to your insurance company. You hope to see the same explanation to your insurer that you are given (although you may have to have the language translated out of medical-eze or legal-eze so that it is understandable). Talk it over with your hospital case manager, if relevant, and/or your insurance company’s case manager.
Get everything in writing. Scrutinize it, and ask a trusted friend, family member, or your advocate to also read it for any ambiguity. If you don’t like something on the document you have been asked to sign, feel free to mark it so that it reflects your preference, and ask the physician to initial it.
Finally, repeat back what you understand you have been told and ask your doctor to confirm or amplify your knowledge.
Further reading: The American Medical Association discusses this standard in depth.