Friday, August 08, 2014

That's "informed" consent

My friend and colleague, Doug Hanto (a world class transplant surgeon) reports on Facebook about the birth of his grandson at St. Vincent Carmel Hospital in Indiana:

Interesting. Lindsay is about to have a C-section this morning, and we will welcome John Douglas into the world. The nurse handed Lindsay informed consent for C-section, anesthesia, blood transfusion, circumcision, and HBV vaccine with no explanation. Like signing the agreement you have to sign when updating your OSX or windows software. They all say "Your physician has explained ..." No one has explained anything. Trust is alive and well in the real world. This is "informed consent?" Hmmmmm!

Gee, I thought the purpose of informed consent was to be informed.  I also thought it was illegal for nurses to administer them, or, if not illegal, certainly inappropriate. 

Indiana hospital licensure rules say:

Sec. 13.4. "Informed consent" means a patient's authorization or agreement to undergo surgery or other invasive procedure that is based upon communication between a patient and his or her physician regarding the surgery or other invasive procedure. (Indiana State Department of Health)


Anonymous said...

Unfortunately informed consent and shared decision making is not being done correctly through out the country
Hence everyone needs to watch the Michael Skolnik Story
Especially consumers so you can stop the line. We have much work to do! Go to you tube Transparent Health and watcjh.

nonlocal MD said...

Informed consent has been blown off at least since I was a medical student 39 years ago when I, as well as the nurses, was tasked with obtaining them. Sadly, it just means there haven't been enough lawsuits on it yet. But that may change as patients become more aware.

David said...

You are absolutely correct in your understanding of informed consent. I have reviewed innumerable patient records for negligence, quality of care issues etc. Frequently, the anesthesia consent is performed by a nurse who is not trained in anesthesiolgy, and consent is obtained days before the actual procedure. The anesthesiologist who sees the patient on the day of surgery and will be conducting the anesthetic is therefore not involved in obtaining a signed informed consent because it is already on the chart. However, it is not an INFORMED consent, but a boilerplate, perfunctory, generic consent in which the patient acknowledges being told about some generic complications like aspiration, nerve damage, risk of death etc.

Since the nurse cannot know the anesthetic plan, the specific risks of the anesthetic approach, use of specific drugs, or special concerns to the patient given their individual health issues, by definition, such a consent cannot be informed. Let me give you an excellent example:

Suppose a patient with carotid artery stenosis is going to have routine shoulder surgery. The orthopedic surgeon plans to do it in the beach chair (upright) position which places the head about 10-12 inches above the heart. In this position, because of the gravitational effects of the head being above the heart (unlike the supine position), blood pressure perfusing the brain will be 20-25mmhg lower than measured in the arm because of the height difference between the brain and the heart.(1)(2). Furthermore, in the sitting position under general anesthesia, blood pressure itself usually decreases because of venous pooling, and vasodilation from the anesthetic. If little or nothing is done to raise blood pressure using fluids or vasopressors, blood pressure in the brain will often be 40mmHg or more below baseline blood pressures when the patient was awake, and often below the threshold for cerebral vascular autoregulation. Obviously the risk of inadequate cerebral blood flow during the procedure is even higher in the patient with carotid artery stenosis. Yet, I have never reviewed a case where either the surgeon or anesthesia provider explained the risk of a stroke to the patient and suggested or insisted upon a different position for the surgery.The obvious solution to this problem is to maintain the blood pressure at baseline (awake) levels using low dose vasopressors, or not do the case in the beach chair position.

Some surgeons even insist on deliberately lowering blood pressure further to minimize blood loss and improve visualization, without appreciating the increased risk of a stroke caused by deliberate hypotension in the sitting position. In all the cases I’ve reviewed when deliberate hypotension was used, the patient was never informed of the increased risk of stroke by the surgeon or anesthesiologist. Clearly, a pre-operative evaluation by a nurse done well before the actual operation takes place will not include a discussion of this risk because the nurse will not know which position the surgeon is going to use, or if there is a demand for deliberate hypotension.

This is just one of many examples supporting your concern about the need to tighten up the informed consent process.


(1)Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: A case series. J. Clin Anesth.. 2005;17: 483

(2) Kirby RR, Cullen DJ Complications of the beach chair position. In: Lobato EB, Gravenstein N, Kirby RR.Complications in Anesthesiology, 3rd ed. Philadelphia: Lippincott, Williams and Wilkins 2007. 844-853.

Tim said...

The problem described at St. V’s in Indy [an excellent hospital , by the way] is all too common even within health systems where the leadership is committed to patient safety and candor. I think the Michael Skolnik film captures the essence of the current problem, especially in the scene where we describe how these documents have become like lease agreements.

A couple of years ago,we were doing a gap analysis hospital where we meet with all of the various stakeholder groups, including individual groups of front line nurses, physicians, administrators, risk managers, and leadership. During these meetings we have conversations with these groups about their perceptions of the current status of Informed Consent, Event Reporting, Disclosure and Care for the Caregiver at their hospitals. At this one hospital, when we asked the frontline nurses about their perceptions of Informed Consent many started to openly cry once we encouraged them to “open up.” They described the many instances when “special” physicians bullied them into obtaining consent which included having the conversation and obtaining the proper signatures from patients or family members. These same nurses told us that the one thing our team could do to change the culture completely in that hospital would be to fix the Informed Consent process.

When we presented our gap analysis report to the CEO of that hospital, he appeared “shocked” and claimed we must have “gotten this all wrong” until several folks from his own hospital who were there for our presentation backed up our findings.

As I move on in this work, I realize that the problems described in your post are the norm instead of the exception at many many hospitals.

Anonymous said...

The nurse is just dropping off paperwork that says, "Has your doctor explained this to you?"

If the answer is no, don't sign. It'll jog his memory.

Anonymous said...

In November 2012, I had a cerebral hemorrhage and was sent to a hospital in Portland, Oregon for repair. I was never told of any other illnesses, including arrhythmia, lung collapse, anemia, metabolic acidosis, and other problems I had. They released me from the hospital to go back to work with a residual aneurysm, which they failed to tell me about. What is scary is the fact they failed to tell me about future upright procedures which could give me a stroke. They signed me up for genetic testing while I was on pain medication for the brain aneurysm and failed to read the entire document to me. I was not in my right frame of mind to sign any legal document, let alone to know what rights I gave up. They later released my private information, i.e., social security numbers of myself and my husband, and other private letters I wrote about my health to the Oregon Department of Justice. I felt so violated and still do. They are so incompetent to train people. I had bruises up and down both arms, they took blood from veins in my feet. What a horrible experience!