In the US, we have never had so many college graduates. Presumably, they can read. And I get that consent forms used by physicians and hospitals need to be readable for all patients. So, a recent study grabbed my attention.
The key finding:
In this nationwide survey study and readability analysis, only 9 (8%) of 113 cancer radiotherapy clinical consent forms met the most permissive national recommendation (eighth grade level) for patient materials. Moreover, consent forms contained an average of 7.2 common difficult words.
This study included 89 academic radiation oncology departments.
Readability levels were measured by 7 validated readability indices, including the Ford, Caylor, Sticht (FORCAST) index for nonnarrative texts. Difficult words were identified using The Living Word Vocabulary, which describes the readability grade levels of 40,000 common words.
There are a number of online tools (free) that provide similar from-the hip analyses.
Best practices describe readability at the 8th grade level. With that standard, most academic radiation oncology centers are falling short.
I would argue that medical literacy is not one size fits all. Some highly educated people prefer to receive a message commensurate with their ability to comprehend complexity. They don’t want language that is dumbed down. They may even be able to handle medical jargon once defined. Often, these people have done their homework and know the material well.
On the other end of the spectrum are those without much formal education. They likely require language which allows for solid comprehension.
These two cohorts want a different message. One size does not fit all.
In the radiation oncology consent study, even though only 8% of the forms read at an eighth-grade level, many patients were able to understand the precise message conveyed. I’m always leery of conforming to the lowest common denominator – assisting the few at the expense of the many. Wouldn’t two messages work better?
How would you know which patient to give which message? Yes, it might be difficult to separate the two groups.
I think most of the time, you’d just know.
That said, it is critical a patient comprehends the risks of a procedure. Otherwise, his ability to “consent” is suspect – and will certainly become suspect in the event of a bad outcome. And don’t be surprised – a patient who enters a treatment plan with an incomplete understanding of the procedure, recovery process, and finances may be more likely to experience a bad outcome. Make sure your consent forms are bullet-proof and digestible.
If this a challenge for your practice, become a member of Medical Justice. In addition to protecting doctors from a bevy of medicolegal threats, we also assist our members in the production of materials that are critical to the practice of good medicine. Consent forms represent one of many examples.
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What do you think? Let us know in the comments below.
Jeffrey Segal, MD, JD, FACS
Chief Executive Officer and Founder
Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.
Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.
Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With decades of combined experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.
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There is a big difference between a signed consent form and obtaining informed consent. Signing the form theoretically attests to the (hopefully a) fact that a patient has given an informed consent. The obtaining of the consent itself is the job of the physician. It is ~not~ the job of a physician delegate, such as a PA, nurse or nurse practitioner. It is definitely not the job of a medical student.
Informed consents for, say, a procedure/operation contain a minimum of 4 elements: 1) technique, 2) indications, 3) alternatives, and 4) risks. To say that these are never on a consent form, let alone in a readable format would be high British in its understatement. Doesn’t happen. Ever. Further, some patients–roughly 5% in my experience–want to ask questions after I give them the big 4 (above). The remaining 95% aren’t very curious. Every one of the 5% get as detailed answers as they want.
I stress specific one specific point in the consent: namely that there are real risks. And the way I say it is a formula I came up with something north of 40 years ago. I say, “Now, Mr/Ms [fill in the blank], in order for you to give informed consent, you have to be informed and understand that, although it is highly unlikely, it always possible for complications, including stroke, paralysis, blindness, even death to result from what we are planning to do.” The large blank spaces are intentional pauses. “But as I said, these are quite rare. Do you have any questions?”
And this is where the 95/5 % come in: only 5% want to know more. But somewhere between 99.8% and 100% understood what I said: I watch their faces very carefully.
Readability of consent forms is arguably important; obtaining genuine “consent” is not arguable. Other than in an emergency, if you don’t obtain it and you do an operation, by definition you’re being unethical, and possibly committing a crime.
If a form is readable by everyone and even moderately comprehensive, then it may have to be so long that most people won’t actually read it. If it’s terse and technical, most people won’t understand it even if they do try to read it. Whichever way you go, a plaintiff’s lawyer will try to get a jury to agree that you did it wrong: too simple means undetailed–or failed to list the possibility that you could lose a finer when having an ingrown toenail removed–or so complex that it’s undecipherable.
But the whole concept of “informed consent” itself is fatally flawed. To me, consent implies agreeing with something someone else has come up with. When I was doing neurointerventions, I never left it at that. After laying out and dealing with the “questions” option, I asked, “Would you like us to proceed?”
In other words, I wanted an ~informed request,~ not a consent (which means permission) to allow me to do something. And that conversation happens at the level of the patient: I’m not there to recite a litany of things and pretend to be concerned; I’m there to lay things out–especially the options– and make sure the patient understands. If I sense they don’t, I try another way. And another. And yet another. I can recall maybe two patients in my entire practice who didn’t understand what I was explaining. There are people with IQs , 75. Not many, but they do exist.
Years ago we had a Health Quiz device designed to quiz patients and act as an aid to anesthesiologists regarding what lab tests to order. The patients we tested it on, answered unsure to almost all questions, when asked, do you have heart problems. It was normed on an 8th grade reading level. In our area of the country it would have to be normed on 5th grade reading level.
The other side of this coin is that many physicians when treating other physicians give the VIP informed consent…. “aw you know this already”. The treated physician stays mute. But in actuality most physicians in other specialties do not know what another specialist does, or how they do it, nor do they understand the risks. It is not appropriate for any physician to treat another physician differently than any other patient when it comes to informed consent.
As for the paperwork aspects of this problem, most patients sign voluminous consent forms when they enter the hospital. These forms are as bad as the 6 page 8 point font type that is on the sales forms from car dealerships. Lawyers put them there for other lawyers. Most people never ever bother to read them. They should not have to. They either have a trustworthy dealer or they do not. But why did lawyers think that it was going to prevent lawsuits to have 6 pages of tiny type legalese for lay purchasers to read? It won’t. People will sue for any and everything, because a lawyer will take the case.
Only in the United States of America.
Consent forms should really be geared toward 5th grade. Highly intelligent people often don’t want to think if they really don’t need to, especially with regards to a field they know nothing about. And those less than highly intelligent will be more able to understand. And if a person has done their homework, a very simple informed consent will confirm and reinforce what they learned.