Sunday, December 21, 2008

Mayo Clinic Skipped Written Informed Consent - Bravo!

A headline caught my eye this morning - "Mayo Skipped Written Consent."

Before I say more I have to acknowledge a conflict of interest. I admire the Mayo Clinic. I've never been there, but I respect the thoughtfulness of the medical program as reflected in documented outcomes and publications, and the values Mayo has been known for.

Here's the story. George R. Studnicka, a federal prisoner, developed lymphatic cancer. He was referred to the Mayo Clinic for treatment. Mr. Studnicka subsequently claimed that Dr. Daniel Pinheiro operated on him without consent and Dr. Yolanda Garces performed radiation therapy on him, also without consent. (See here for the US District Court Appeal opinion.) Mr. Studnicka's lawyer found no signed informed consent form in the record and complained to the state. An on-site inspection of 12 records showed that none contained signed consent forms.

Mayo wasn't defensive. An administrator told the inspectors "There is no written surgical consent...We don't use them here." The state inspectors reported that Mayo officials told them they "didn't agree with the federal definition of written consent."


The March 2008 issue of the "Proceedings of the Mayo Clinic" had an article on "Medical Informed Consent:General Considerations for Physicians." I don't know whether the timing of the article was coincidental or whether it was meant to present Mayo's philosophy of informed consent. Here's the key summary table from the article:
TABLE 2. Prudent Behaviors of Physicians Engaged in the Process of Medical Informed Consent
* The physician directly involved in the proposed treatment should conduct the informed consent discussion. The discussion should include the treatment, the risks and benefits of treatment, and alternative therapies with associated risks and benefits
* The physician directly involved in the proposed treatment should discuss the most likely outcome with no treatment, on the basis of the best available medical or surgical evidence
* The physician directly involved in the proposed treatment should always discuss the severe risks, such as death, paralysis, loss of cognition, or loss of a limb, even if the probability of occurrences is negligible
* The physician involved in the proposed treatment should always disclose less severe risks that occur frequently. Courts do not place emphasis solely on consequences; they recognize frequency as an important component of risk
* The physician directly involved in the proposed treatment should discuss informed consent in language the patient can understand, and treatment should not proceed until the physician believes the patient understands the risks and benefits and has made a rational decision
* The physician directly involved in the proposed treatment must understand that the medical consent form is not medical consent; it represents evidence that the consent process occurred. The dialogue between the patient and physician is the essence of the consent process (emphasis added)
* The physician directly involved in the proposed treatment should document all patient-imposed restrictions in the medical record and the discussion with the patient about how the restrictions limit the physician’s ability to provide standard medical care...
* When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a partnership, with shared authority, decision making, and responsibility for outcomes The physician directly involved in the proposed treatment can enhance the informed consent process through appropriate use of additional learning materials, such as pamphlets and video, and through involvement of support staff, such as physician assistants, in providing information that can be discussed by the responsible physician
In my view this represents an exemplary approach to informed consent. The recurrent reference to "the physician directly involved..." and the concluding bullet correctly portray informed consent as a crucial clinical process between clinician and patient, not as a bureaucratic event between pen and paper. Sadly, medical students I've taught have described being sent onto the hospital ward to "consent the patient" - i.e., get the patient to sign a document, which demeans informed consent and invites the student to become cynical.

Apparently, and not surprisingly, the level of documentation in Mayo charts was variable. That's not acceptable. And apparently federal regulations require signed forms in certain circumstances. Mayo agreed to implement a written consent form. I hope the Clinic does this in the clinically sensitive spirit embodied in the passage I quoted.


bakquak said...

There is no question that the information Mayo's policy required them to include in the chart about consent is an important part of the informed consent process. But requiring a signed consent form in the chart before surgery is also crucial, both because the United States and Minnesota legislatures require it and because without it the only proof the patient consented comes from the doctor.

Having a signed informed consent form in the chart before surgery is, in logical terms, necessary but not sufficient for an appropriate informed consent. Alone, it isn't enough to show the patient was sufficiently informed. Without it, there is no proof the patient consented to anything.

Let's not confuse the fact that Mayo does many things well with the fact that they must also comply with the law.

Knowingly violating a law written to protect patients from unwanted medical care can never justify a "bravo", even if other components of the care are exemplary.

I am Mr. Studnicka's lawyer, as well as a Neurologist for the last 27 years.

Jim Sabin said...

Dear Bakquak -

I APOLOGIZE for only now coming upon your comment. When you posted it I was on my way to India for a month, and I somehow missed it until now. I am VERY appreciative for a comment from Mr. Studnicka's lawyer and for your thoughtful analysis of the situation.

My reason for applauding Mayo's overall approach is that the signed consent form so often replaces a true process of informed consent. I would be surprised if a jury did not see a well documented note describing a well conducted informed consent process as adequate "proof" that the patient had been informed and had consented to the intervention(s). That's the approach I always followed in my practice. I agree that there needs to be good documentation, but I preferred doing that myself rather than asking my patient to sign on the dotted line. The signing felt like self-protection, not patient care, and I felt that I could protect myself in my own clinical note.

That said, not following legal requirements is a serious step for a healthcare facility or individual physician and should only be done for well thought out, serious reasons.

While I never liked the ritualistic signing process, I'm completely in favor of providing patients with written information, website links, videotapes/CDs, and any and all materials that can help them deepen their understanding of their situations and choices.

Again, thank you!



Anonymous said...

Mr Studnicka is my mother's husband. She never divorced/remarried and has been waiting for his release for many years. Is it possible that a signed written consent was disregarded because he is a federal prisoner?

Jim Sabin said...

Dear Anonymous -

First, I want to send best wishes to your mother, who is waiting for her husband's release.

It is possible that signed informed consent was ignored because Mr. Studnicka is a federal prisonor, for two reasons I doubt that that is what happened. First, as I indicated in my post with quotes from a Mayo Clinic article, Mayo focuses on informed consent as a transactional process between physician dna patient, not as an event, such as signing a document.

Second, from my own experience, when the legal system is involved, as it is when one is treating a prisoner, physicians tend to be more careful about bureaucratic requirements, rather than less so.

But, sadly, prisoners are often treated disrespectfully, so your speculation about the informed consent process could be correct.