"Informed consent": another example of how those slimy lawyers will screw you over

[MacGyver]

Common practice in the hospital is for a doc to spend a few minutes talking to the patient about the possible alternatives, benefits, and risks to a procedure/medication. Usually for serious interventions, such as surgery, a lengthy consent form is signed that fills in all the particulars.

However, thru strident efforts of idiot judges and trial lawyers, these forms have now been rendered useless.

Case example:

The Hawaii Supreme Court, deciding the case of Kemoaka vs Zakaib, there was a surgeon who was sued for failing to provide informed consent. There was a signed consent form, which had listed the exact possible complications that the plaintiff complained about later. The patient signed the form.

The original trial resulted in a defendant verdict, however on appeal the HSC reversed, stating

a physician's affirmative duty is not fulfilled by merely having a patinet sign a printed informed consent document because a signed consent form is not a substitute for the required disclosure by the physician

IN other words, the Hawaii Supreme Court has mandated that the surgeon must sit down and describe VERBALLY, every single possible outcome of the surgery, every single possible alternative, and every single possible benefit.

This isnt just in Hawaii either. Many courts have thrown out legit consent forms

Absolutely outrageous.

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[docB]

That is outrageous. I imagine that the outcome will be that the ubiquitous consent forms will have some lawyeresque word changes so that istead of saying "possible complications are:" they will read "I acknowledge having been told by the doctor that the possible complications are:" And won't that make healthcare better?

 

[kate_g]

I think that a lot of these kind of consent forms (EULA for software, for example, or "if I die I won't sue you" forms for risky recreational activities) fall to legal challenge on the "nobody actually reads those things, you can't really hold them to it" argument... and I'm not sure I think that's outrageous. Sure, the doc talks to you for a few minutes, then hands you a lengthy form that explains the details. And then a nurse glares at you and taps her foot impatiently until you just give up reading and sign the damn thing. And if you simply don' t have the English language skills to comprehend the explanations? I'm not suggesting any particular solution here, but it seems to me that having some better assurance that the patient actually did take in the information about risks and side effects and whatnot could be a good thing. Feeling pressured into signing a form you didn't read really can't qualify as "informed consent."

 

[MissMuffet]

I think that a lot of these kind of consent forms (EULA for software, for example, or "if I die I won't sue you" forms for risky recreational activities) fall to legal challenge on the "nobody actually reads those things, you can't really hold them to it" argument... and I'm not sure I think that's outrageous. Sure, the doc talks to you for a few minutes, then hands you a lengthy form that explains the details. And then a nurse glares at you and taps her foot impatiently until you just give up reading and sign the damn thing. And if you simply don' t have the English language skills to comprehend the explanations? I'm not suggesting any particular solution here, but it seems to me that having some better assurance that the patient actually did take in the information about risks and side effects and whatnot could be a good thing. Feeling pressured into signing a form you didn't read really can't qualify as "informed consent."

I hate malpractice-suit happy lawyers as much as anyone, but what you say is too true.

Unfortunately, I don't have a great solution, either. Maybe the safest thing is for a nurse to go through it with the pt, and record the session.

 

[fab4fan]

I hate malpractice-suit happy lawyers as much as anyone, but what you say is too true.

Unfortunately, I don't have a great solution, either. Maybe the safest thing is for a nurse to go through it with the pt, and record the session.

Not.

It's a nurse's responsibility to make sure that the doc went over the consent with the pt and obtained the pt. signature. Legally, nurses are not allowed to go over complications, expected outcomes, etc. That's the responsibility of the doc.

If a pt. starts asking a lot of questions after he's already signed the consent, I tell the doc he/she needs to go back and talk to the pt. again because the pt. has numerous questions and does not appear to understand the consent.

 

[southerndoc]

What annoys me is when a surgical intern consents a patient for surgery. I do not think this should be allowed. An intern doesn't have the necessary experience to properly consent a patient and discuss possible complications of the surgery. This is even worse when it's an off-service rotator consenting the patient (family practice, emergency medicine, etc.).

I think it is the responsibility of the attending surgeon to consent his or her patients.

 

[fab4fan]

What annoys me is when a surgical intern consents a patient for surgery. I do not think this should be allowed. An intern doesn't have the necessary experience to properly consent a patient and discuss possible complications of the surgery. This is even worse when it's an off-service rotator consenting the patient (family practice, emergency medicine, etc.).

I think it is the responsibility of the attending surgeon to consent his or her patients.

Bingo!

I've had attendings hand me blank consents and ask me to get the signature; uh, no thank you! Sheesh!

 

[MissMuffet]

Thanks, fab4. Good to know.

 

[docB]

I think that a lot of these kind of consent forms (EULA for software, for example, or "if I die I won't sue you" forms for risky recreational activities) fall to legal challenge on the "nobody actually reads those things, you can't really hold them to it" argument... and I'm not sure I think that's outrageous. Sure, the doc talks to you for a few minutes, then hands you a lengthy form that explains the details. And then a nurse glares at you and taps her foot impatiently until you just give up reading and sign the damn thing. And if you simply don' t have the English language skills to comprehend the explanations? I'm not suggesting any particular solution here, but it seems to me that having some better assurance that the patient actually did take in the information about risks and side effects and whatnot could be a good thing. Feeling pressured into signing a form you didn't read really can't qualify as "informed consent."

And that's just the problem. Too many people feel that it would be nice if things were better without an idea of how to get there. It would be great if a doc could sit down with every patient and spend an unlimited amount of time consenting them, teaching them English and whatever else. That's not practical. You reach a point when you just have to say that these are the facts and the patient can take it or leave it.

As for the idea that you should be able to sue based on the fact that you didn't read the warning documents, that's just crazy. That's basically saying that someone tried to warn you but you refused to listen but now you want to sue anyway. And as for the people who sue for getting hurt doing dangerous recreational activities how stupid does someone have to be to not know that skydiving is dangerous? You'd basically have to argue that you are mentally handicapped. Well so and so has an IQ of 60 so they couldn't appreciate that bungee jumping isn't as safe as reading a book. I guess in the country where the courts have found that the average adult can not be assumed to have the mental competence to deal with a cup of hot coffee none of this should be surprising.

 

[8744]

My favorite kind of informed consent is that which we obtain from illegal aliens, say only a month or two removed from some jungle village in the Yucatan, who stare blankly as the Spanish translator jabbers away describing the purpose of the Multiple Marker Screen, how it stratified their risk of major fetal chromosomal fetal defects and how the positive results coorelates with a one in 270 chance of having an aneuploidy which is the risk of the aminocentesis to the fetus should they decide to undergo this procedure.

"Comprende?"

Blank look.

"Uh, Okay Senora Ramirez De Jesus. Just sign here..thanks...preguentes?...No?...great...thanks."

And you get that look that says in their village, the Heffe just does what he wants and doesn't ask permission.

Then the translator confides that she could barely understand their Spanish, neither of the husband nor the wife can read or write, and she's not sure she knew what I was talking about let alone whether the patient did.

 

[8744]

What annoys me is when a surgical intern consents a patient for surgery. I do not think this should be allowed. An intern doesn't have the necessary experience to properly consent a patient and discuss possible complications of the surgery. This is even worse when it's an off-service rotator consenting the patient (family practice, emergency medicine, etc.).

I think it is the responsibility of the attending surgeon to consent his or her patients.

Oh, I agree. I despise doing consents. I have never had somebody refuse the offered procedure even after I explain the blood-curdling risks of hernia repair.

One day I'm going to say that risk of a procedure is an 85 percent chance of their penis shriveling to a blackened stump and then falling off and see if they still sign the consent.

 

[MacGyver]

I think that a lot of these kind of consent forms (EULA for software, for example, or "if I die I won't sue you" forms for risky recreational activities) fall to legal challenge on the "nobody actually reads those things, you can't really hold them to it" argument... and I'm not sure I think that's outrageous. Sure, the doc talks to you for a few minutes, then hands you a lengthy form that explains the details. And then a nurse glares at you and taps her foot impatiently until you just give up reading and sign the damn thing. And if you simply don' t have the English language skills to comprehend the explanations? I'm not suggesting any particular solution here, but it seems to me that having some better assurance that the patient actually did take in the information about risks and side effects and whatnot could be a good thing. Feeling pressured into signing a form you didn't read really can't qualify as "informed consent."

The problem with your logic (and the courts logic) is that it imposes an impossibly high burden on the doctor.

NOt only do you have to present the data on risks, benefits, but the patient has to FULLY COMPREHEND IT.

Basically the burden of proof is on the doctor to PROVE that hte patient FULLY COMPREHENDED the consent.

Do you have any idea how ridiculously hard of a burden that is to meet? Its virtually impossible to PROVE that somebody comprehended everything on the consent form.

Now you tell me how you are going to PROVE that the patient comprehended everything. Apparently a signed form isnt good enough. ARe you going to videotape every consent session? That wont cut it, that doesnt prove comprehension.

 

[anystream]

Basically the burden of proof is on the doctor to PROVE that hte patient FULLY COMPREHENDED the consent.

Do you have any idea how ridiculously hard of a burden that is to meet? Its virtually impossible to PROVE that somebody comprehended everything on the consent form.
.

just a thought, but could one test the patient (give them a short quiz to fill out) to test their understanding of the procedure and risks involved? I agree that the idea of a surgeon sitting through lengthy consent sessions just isn't practical.

 

[southerndoc]

I've had attendings hand me blank consents and ask me to get the signature; uh, no thank you! Sheesh!

When I was an off-service rotator on surgery, I had one chief resident get pissed because I didn't consent the patient. He didn't seem to care that I was not a surgeon.

 

[logos]

just a thought, but could one test the patient (give them a short quiz to fill out) to test their understanding of the procedure and risks involved? I agree that the idea of a surgeon sitting through lengthy consent sessions just isn't practical.

I thought I about that a little. It seems to me that this not only would take up a bunch of time and energy, but would also present major problems when the patient couldnt pass the test. "Sorry...cant do your surgery until you can pass this test...try it again..."

 

[MacGyver]

I thought I about that a little. It seems to me that this not only would take up a bunch of time and energy, but would also present major problems when the patient couldnt pass the test. "Sorry...cant do your surgery until you can pass this test...try it again..."

There are other problems as well....

The bottom line is that if a lawyer can throw out a consent form, it will be even EASIER for them to throw out a testing form like the one under consideration.

 

[southerndoc]

The bottom line is that if a lawyer can throw out a consent form, it will be even EASIER for them to throw out a testing form like the one under consideration.

Maybe we should fight fire with fire and encourage more MD's and DO's to become JD's as well.

 

[kate_g]

The problem with your logic (and the courts logic) is that it imposes an impossibly high burden on the doctor.

NOt only do you have to present the data on risks, benefits, but the patient has to FULLY COMPREHEND IT.

Basically the burden of proof is on the doctor to PROVE that hte patient FULLY COMPREHENDED the consent.

Do you have any idea how ridiculously hard of a burden that is to meet? Its virtually impossible to PROVE that somebody comprehended everything on the consent form.

Now you tell me how you are going to PROVE that the patient comprehended everything. Apparently a signed form isnt good enough. ARe you going to videotape every consent session? That wont cut it, that doesnt prove comprehension.

Whoo boy... Hold on with all those capital letters, friend. I wasn't saying consent forms should always fail legal challenge. If I read the form, had an opportunity to ask questions, and signed it, then it should stand. And I side with DocB and hope there are plenty of cases where a judge says "Son, you'd have to have an IQ of 60 to not realize that bungee jumping is dangerous." I just disagree with the original two posts' apparent view that any legal challenge to a medical consent form is "outrageous."

My point is very simple. The law requires informed consent. It is common practice to be asked to sign a form with information beyond what was verbally related by the doctor. If I'm pressured into signing that form without reading it, I have not given informed consent.

So it's too much to ask that a hospital be able to provide a translator for every Mayan dialect. But it's definitely not too much to ask to leave me in peace with my form for 15 minutes instead of having some nurse or administrator wait around hating me for backing up their already over-scheduled day by actually reading the information. And it's also not too much to ask to see the doctor again if I have questions about something on the form that was not covered in our original conversation.

What I *do* think is a shame is that the control of medicine by for-profit companies means that the hospital is forced to view my 15 minutes reading the form as time in which they can't treat another paying customer.

 

[caroladybelle]

When I was an off-service rotator on surgery, I had one chief resident get pissed because I didn't consent the patient. He didn't seem to care that I was not a surgeon.

Heck, I've known several GI MDs that will give verbal orders to consent endo patients, when they have not physically seen or examined the patient, much less told them that would be having a procedure.

Not to mention, orthos that go in, say that they will fix the leg by putting a pin in, walk out and then tell me to consent the patient.

There are some great and good MDs that truly attempt to get an "informed" consent. Then there are some that dump it on the nursing staff or others, that ruin things for the vast amount of their fellow MDs.

 

[anystream]

There are other problems as well....

The bottom line is that if a lawyer can throw out a consent form, it will be even EASIER for them to throw out a testing form like the one under consideration.

why would it be easier for them to throw out a test form? i don't understand how the law works in that regard. i guess it would just be a relatively simple way to check if they had been through the material and understood it. you could give them a packet with all the information regarding the procedure that they could reference while they filled the questions out.

 

[caroladybelle]

just a thought, but could one test the patient (give them a short quiz to fill out) to test their understanding of the procedure and risks involved? I agree that the idea of a surgeon sitting through lengthy consent sessions just isn't practical.

And who will administer the test? Who will grade it? How long is it before the ACLU/JCAHO/etal reviews it and says that it is racially/politically/sexually/religiously/language biased against some obscure minority group?

Or that it is cultural insensitive?

 

[docB]

scantron? i don't know. i guess it would have to be in several languages. if doctors are getting slapped with lawsuits right and left, wouldn't it be best to bolster their case with more paperwork? i feel like it could also be a good patient education tool.

You guys have to remember that this issue is not really about informed consent at all. It's about lawyers wanting to get their cut of the biggest award possible. The only time this ever becomes an issue is when there's a bad outcome and the lawyer is trying to work backwards to increase the liability. So in reality there is the issue of how do we make sure patients know what's going on which as admirable but the medicolegal issue is how do we effectively prove in the documentation that a patient was told the relevent info. Then we're into the point that MacGyver made (and it's an excellent point) that it's a hugely difficult proposition to prove that a patient understood what was going on.

 

[caroladybelle]

scantron? i don't know. i guess it would have to be in several languages. if doctors are getting slapped with lawsuits right and left, wouldn't it be best to bolster their case with more paperwork? i feel like it could also be a good patient education tool.

And how long have you worked in healthcare.

JCAHO, etc. are determined to make virtually everything in hospital virtually foolproof, bureacratically over the top, and requiring way too much work to be useful.

For example, a hemoccult card used to take a nurse minutes to perform and result, saving a great deal of time an expense. Now, d/t the genuises at JCAHO, decided that a nurse might be colorblind and might be too embarassed to admit. So either the MD does the hemoccult (which most won't), or it gets sent to the lab. If it doesn't get lost or misplaced, you may get the result, oh in a day or two, at substantially higher cost.

Same with urine pHs and simple urine analysis.

There will be no simple test for competency, love. Some paperpusher will have to do a multiphasic study, randomize the results, create a new hospital department, book of policy and procedure at the cost of several million bucks to do anything. And then pass it through a committee, that will vote it down several times, because they do not like the language.

And 90% of the patients will just answer "Yes" to everything because they really just want to be fixed.

 

[MacGyver]

My point is very simple. The law requires informed consent. It is common practice to be asked to sign a form with information beyond what was verbally related by the doctor. If I'm pressured into signing that form without reading it, I have not given informed consent.

Thats NOT what we are talking about.

The hawaii case I brought up had nothing to do with these issues. The plaintiff never claimed that he was "pressured" into it, or didnt have enough time to consider it properly.

The problem with the court system in general is that the courts are extremely aggressive in stating what is "wrong" with a consent process, but they NEVER lay out a model for what is acceptable.

This issue wouldnt bother me so much if the Supreme Court or somebody came along and said "if your consent form meets requirements a, b, c, d then its acceptable" and then docs could avoid these needless lawsuits. But the courts REFUSE to do this. It gives lawyers UNLIMITED WIGGLE ROOM to file suit after suit, and nothing ever gets resolved.

There should be a standard for consent forms that will preclude lawsuits. If lawyers were really interested in patient's best interests, they would agree to work with doctors to come up with some kind of standard to be used, that would preclude any lawsuits. But lawyers arent interested in that, they are interested in playing "gotcha" semantics games in court and taking a nice fat legal fee in the process.

 

[anystream]

Thats NOT what we are talking about.

The hawaii case I brought up had nothing to do with these issues. The plaintiff never claimed that he was "pressured" into it, or didnt have enough time to consider it properly.

The problem with the court system in general is that the courts are extremely aggressive in stating what is "wrong" with a consent process, but they NEVER lay out a model for what is acceptable.

This issue wouldnt bother me so much if the Supreme Court or somebody came along and said "if your consent form meets requirements a, b, c, d then its acceptable" and then docs could avoid these needless lawsuits. But the courts REFUSE to do this. It gives lawyers UNLIMITED WIGGLE ROOM to file suit after suit, and nothing ever gets resolved.

There should be a standard for consent forms that will preclude lawsuits. If lawyers were really interested in patient's best interests, they would agree to work with doctors to come up with some kind of standard to be used, that would preclude any lawsuits. But lawyers arent interested in that, they are interested in playing "gotcha" semantics games in court and taking a nice fat legal fee in the process.

those are really good points. aren't there any groups out there that stand up for doctors?

 

[docB]

those are really good points. aren't there any groups out there that stand up for doctors?

Yes but they are relatively impotent compared to the groups that stand up for the lawyers.

 

[Squad51]

You guys have to remember that this issue is not really about informed consent at all. It's about lawyers wanting to get their cut of the biggest award possible. The only time this ever becomes an issue is when there's a bad outcome and the lawyer is trying to work backwards to increase the liability. So in reality there is the issue of how do we make sure patients know what's going on which as admirable but the medicolegal issue is how do we effectively prove in the documentation that a patient was told the relevent info. Then we're into the point that MacGyver made (and it's an excellent point) that it's a hugely difficult proposition to prove that a patient understood what was going on.

Actually, it is impossible (for a patient understood what was going on). Look, after four years of medical school, 5 years of surgical training, and x years in practice, a surgeon can still only guess at the outcome. And the patient can not fully appriciate the risks versus the benefits unless they, themselves, have undergone both. Let's look at diabetic gangrene requiring a BKA. Does the patient really understand what life without a limb will mean? - NO. Can they honestly appriciate the risk their condition places them in? - NO; but an experienced physician does. And that is a cut and dry case, now look at the risk versus benefit of PCTA after thrombolytics for persistent pain post STEMI. You have to be a biostats expert to interpret the studies. Guess wrong (or just have a bad outcome) and there is no way to prove that the patient really understood the risks. He11, I'm going into my fourth year of medical school and I don't fully comprehend the issue, how is the truck driver with a high school education supposed to?

There are two big problems, the first is that without a full medical education and experience in the specialty of concern, you can not be fully informed. Obviously the line has to be drawn short of that, but where you draw the line (in the amount of information given to a patient) will now be a matter for the courts to second guess. And, as usual, the wallet of the physician is exposed in the process.

The second issue is with midlevels and nurses (or even worse non-medical "care providers") interjecting. The problem is that full knowledge of risk and benefit does take four years of schooling and several years of residency to obtain. A couple of years (and relatively few patients) doesn't qualify you. Yes, experience plays a role, but how many RNs get feedback on every patient they see in the manner that a resident or fellow does? I recently was present at the mother of all consent meetings. A 80 year old woman set to undergo stenting following an STEMI. The woman's children were a chiropractor and a nurse. Both constantly interjected their erroneous opinions into the conversation to the point that the patient had no idea what to think. The chiro was trying to convince her that she wouldn't require all of the post MI drugs (once released to the OP setting) because he could control her BP with adjustments. She (and her daughter, the nurse) were questioning why beta-blockers would be needed at all as she "never had hypertension before". I was almost laughing out loud as the nurse (who worked in peds) was arguing that we should "just wait to see if hypertension develops" while the chiro is nearly screaming that it "doesn't matter if it does develop" because he can "control it for her". Now, in this setting, is it possible the woman understands the role of pharmacology for secondary and tertiary prevention of an MI? I am not trying to slam nurses (or chiropractors for that matter). But I am pointing out that we, as physicians, are being asked to fully communicate some very complex issues to our patients. The full understanding of these issues (including how much information to share), requires the time and depth of training that only a physician acquires in today's healthcare settings.

 

[kate_g]

Thats NOT what we are talking about.

More capital letters... Look, I was just making a general comment about the process not being foolproof, and it was like post #3 in the thread so we were hardly talking about anything at all by that point. Really, no offense meant.

There should be a standard for consent forms that will preclude lawsuits.

Heh... Speaking of idealism and unlikely resolutions...

So this Hawaii case was a criminal charge against the doctor? Because even if you got a consent process that was foolproof from a legal standpoint, you can still bring a civil (e.g. "pain and suffering") suit against anyone, for anything. That's one of those treasured American rights. You can walk into civil court and say "I was consented exactly according to legal specifications and the doctor did no wrong - but I'm unsatisfied with the outcome and I think he should pay me a million dollars." Ideally that kind of case would be pretty instantly thrown out - and I'm sure a lot of them are. But there are many persistent (greedy) lawyers in the world and I'm guessing some would still manage to win judgements against your lawsuit-precluding consent form on no legal grounds whatsoever. Certainly they would still try, anyway.

 

[MissMuffet]

This is all I could find on it:

RICHARD KEOMAKA, Plaintiff-Appellant, v. GEORGE ZAKAIB, M.D., Defendant-Appellee.

APPEAL FROM THE SECOND CIRCUIT COURT
MAY 14, 1991
http://www.hsba.org/htdocs/hsba/Legal_Research/Hawaii/members/ica/14174.HTM

The whole thing is over my head, but as far as I can tell, this is the most relevant part of the case:

(Dr. Zakaib argued that Keomaka's failure to read the consent form before signing it constituted contributory negligence.)

CONTRIBUTORY NEGLIGENCE In Instructions 39-42, the trial court instructed the jury on contributory negligence. Keomaka contends that the evidence adduced at trial did not support the giving of any instruction on contributory negligence. We agree.

The printed consent form signed by Keomaka on July 31, 1984, merely stated in "ordinary or lay language" that (1) Keomaka's condition was a "numb (L) long finger" and (2) the planned procedure of treatment was "repair (L) long finger nerve with possible graft from ankle." Defendant's Exhibit B. The form contained twelve itemized printed paragraphs and, just above Keomaka's signature, included the following printed words: I AGREE THAT MY PHYSICIAN HAS INFORMED ME OF THE:

a) DIAGNOSIS OR PROBABLE DIAGNOSIS.

b) NATURE OF THE TREATMENT OR PROCEDURES RECOMMENDED.

c) RISKS OR COMPLICATIONS INVOLVED IN SUCH TREATMENT OR PROCEDURES.

d) ALTERNATIVE FORMS OF TREATMENT, INCLUDING NON-TREATMENT, AVAILABLE.

e) ANTICIPATED RESULTS OF THE TREATMENT.

Dr. Zakaib argues that Keomaka's failure to read the consent form before signing it constituted contributory negligence. He therefore states that the giving of the jury instructions relating to contributory negligence was proper. This argument is without merit. Contributory negligence is the plaintiff's conduct that contributes as "a legal cause to the harm he has suffered, which falls below the standard to which he is required to conform for his own protection." Prosser and Keeton  65, at 451.

Under the defense of contributory negligence, although the defendant would be liable for his negligence, "the plaintiff is denied recovery because his own conduct disentitles him to maintain the action."7/ Id. at 451-52. Under the doctrine of informed consent, a physician has a duty to timely and adequately inform the patient. This "is an affirmative duty requiring an affirmative act." Cunningham v. Parikh, 472 So. 2d 746, 748 (Fla. App. 1985), rev'd on other grounds, 493 So. 2d 999 (Fla. 1986). On the other hand, because of "the superior knowledge of the doctor with his expertise in medical matters and the generally limited ability of the patient to ascertain the existence of certain risks and dangers that inhere in certain medical treatments," Morrison v. MacNamara, 407 A.2d 555, 567 (D.C. 1979), it would be unfair and illogical to impose on the patient the duty of inquiry or other affirmative

____________________

7/ Because the doctrine of contributory negligence unfairly bars any recovery by the injured plaintiff even if his degree of negligence was less than that of the defendant, many jurisdictions have adopted some form of comparative negligence. Hawaii has enacted a modified comparative negligence statute. HRS  663-31 (1985). duty with respect to informed consent. Thus, where a patient has no duty in the informed consent context, we cannot see how the patient can be contributorily negligent. We agree with Professor Capron that contributory negligence "has no place in an action for failure to obtain informed consent." Capron, Informed Consent in Catastrophic Disease Research and Treatment, 123 U. Pa. L. Rev. 340, 410 (1974).

Moreover, a physician may not fulfill his affirmative duty of timely and adequate disclosure by merely having the patient sign a printed informed consent form. A signed consent form is not a substitute for the required disclosure by a physician.

The problem regarding consent forms is expressed as follows: There is a growing reason for concern that consent forms are becoming substitutes for, rather than documentary evidence of, an ongoing process of disclosure, discussion, and decisionmaking between physician and patient. If physicians come to believe (often incorrectly) that their obligation to obtain the patient's informed consent can be satisfied by securing a signature--even that of a drowsy, drugged, or confused patient on an abstruse, jargon-ridden, and largely unintelligible preprinted consent form--the law's reliance on written documentation may come to pervert its central purpose in requiring informed consent.
Weisbard, Informed Consent: The Law's Uneasy Compromise With Ethical Theory, 65 Neb. L. Rev. 749, 756-57 (1986) (footnote omitted).

In our view, Keomaka's failure to read the consent form before signing it clearly did not constitute contributory negligence. Assuming a patient has a duty to read, the form itself did not disclose anything other than that a repair would be done on Keomaka's left long finger's nerve with a possible graft from his ankle.

There was nothing on the form concerning the possible effects or risks of the August 1, 1984 surgery or alternative forms of treatment, assuming such were available. As a lay person, Keomaka had neither the knowledge nor the duty to ask specific questions to obtain from Dr. Zakaib the information the doctor was required to disclose. Accordingly, the trial court reversibly erred in giving the jury instructions on contributory negligence.

 

[f_w]

'Informed consent is a process, not a form'.

This was a point hammered home by the risk management folks at the place I did my fellowship at. They had actual case law showing that if you properly documented a verbal discussion with the patient in a pre-surgical clinic visit, you can win a 'consent challenge' even in the absence of a signed consent form. On the other side of the issue are plenty of cases where the signed form just gets tossed out based on a variety of grounds noted earlier in this thread. That place was also quite strict in that only a provider credentialed to perform the procedure was allowed to obtain consent (e.g. a 2nd year surg resident can consent for a central line but not for a complex reconstructive plastics procedure).

'Consents' obtained on the day of a procedure with a patient in a gown are pretty much useles and routinely fail when challenged. Except of course in cases of emergent procedures, the consent conversation should be on a day separate from the actual procedure. In our lazyness and the interest of 'keeping things moving', we often consent patients right before a procedure, every time I do that I wonder whether this will come back to bite me one day.

If you really want to see a perversion of the concept of 'informed consent', you have to work at a VA hospital. In their quest to regulate the amount of toilet paper you are allowed to use, they have moved the consent on a computer interface. The patient is expected to read the consent on a little cart mounted PC and then to sign on one of these little credit card processing pads (I refused to use that thing and kept using the 'downtime' paper form + documentation in the pre-procedure note format. in their slowness VA administration never got around to penalize me for this insubordination).

 

[SanDiegoSOD]

those are really good points. aren't there any groups out there that stand up for doctors?

There are many groups that do this. When I worked for Congress this year, one of my jobs was to keep many of these medical lobbyists off my boss' back - that was a lot of fun As I did this, I learned how truly fragmented the medical lobby is. Turf wars within the medical field are just as strong as wars between medicine and other professions. Sometimes its physicians fighting against each other to keep their larger share of the pie as medicare/medicaid reimbursement declines - go look at the history of the development of the RBRVS... that was an ugly set of battles Other times, its home-health care groups fighting hospitals fighting physicians to maintain payments and avoid additional oversight. So when all is said and done, precious little lobbying is done for the advancement of the medical field in general, and the bit that is done for doctors is not very effective (ask a professional staffer in congress what they think of the AMA - they'll either laugh, scoff, or both).

Combine all that junk I just mentioned with the reality of lobbying for healthcare - the fact that everyone needs healthcare, feels entitled to healthcare, but is insulated from the costs and doesnt feel they should have to pay for it - and you've got an extremely difficult sector to lobby for to begin with. If I can promise you one thing, one clairvoyant look into the future of the US healthcare system, it's that reimbursement for physicians will continue to decline, as they have for the past two decades. Future physicians here (and current physicians ) need to understand this. The golden days of medicine are over, and one has to be a bit crafty if they want to enjoy a lucrative career in medicine.

Oh yeah, I know that what I'm talking about here isn't directly related to the purpose of this thread, I'm just bored and rambling. Carry on

 

[RuralMedicine]

And how long have you worked in healthcare.

JCAHO, etc. are determined to make virtually everything in hospital virtually foolproof, bureacratically over the top, and requiring way too much work to be useful.

For example, a hemoccult card used to take a nurse minutes to perform and result, saving a great deal of time an expense. Now, d/t the genuises at JCAHO, decided that a nurse might be colorblind and might be too embarassed to admit. So either the MD does the hemoccult (which most won't), or it gets sent to the lab. If it doesn't get lost or misplaced, you may get the result, oh in a day or two, at substantially higher cost.

Same with urine pHs and simple urine analysis.

Not in any way disputing that JCAHO has not improved health care, but at our institution we actually got smart and started testing our physicians and nurses for colorblindness. If you pass you can do hemoccults, UAs etc. Admittedly our floor nurses frequently forget that they are now allowed to do them so some still end up going to the lab. Still at least we have developer and cards on the floor so doing them with a rectal exam is no problem (and my standard practice) it's the patients who refuse a rectal or in the case where you want to test all stools we still run into problems.

 

[docB]

Not in any way disputing that JCAHO has not improved health care, but at our institution we actually got smart and started testing our physicians and nurses for colorblindness. If you pass you can do hemoccults, UAs etc. Admittedly our floor nurses frequently forget that they are now allowed to do them so some still end up going to the lab. Still at least we have developer and cards on the floor so doing them with a rectal exam is no problem (and my standard practice) it's the patients who refuse a rectal or in the case where you want to test all stools we still run into problems.

The problems with doing urine dips and hemoccults are that for any lab procedure (which is what they are trying to say these are) you must record all the tests and results in a central log and prove that periodic control testing is done. They also don't like it that the reagent (peroxide, a substance so highly toxic it can only be purchased in every grocery and drug store) is usually not under lock and key. So to stay in compliance you can either use your actual lab which is presumably already certified, certify the whole hospital as a lab which is not realistic or apply for various waivers which is also difficult. Hospitals deal with it in various ways from ignoring it completely to requiring that all guiac cards go to the lab.
One hospital I work at has just decided that everytime I do a guiac I must take the card to the charge nurse, we must "interpret it together along with the control." Then we are to log the test, patient and result in a log book that is to be kept in the ER. If during the course of interpretation we disagree about the result we must call the JACHO high command so that they can dispatch arbiters to the scene and wager on the outcome as we battle to the death in a cage match to determine the winner. Seriously though, I and most of the other docs, have just decided not to do guiacs. I not going to turn a 2 minute procedure into a marathon of carrying a feces stained card about the ED for 20 minutes to find the charge and then discuss the results and log them in a book. In the ER all I really care about is if there is gross blood on the exam. The guiac is a courtesy to the patient and the admitting doc so it doesn't have to get done later but if the hospital makes that too difficult then so be it.

 

[docB]

As for my previous post I'm not trying to derail the discussion of informed consent to harp on guiacs so mea culpa.

'Informed consent is a process, not a form'.

This is true but the question is how should docs in the real world document informed consent. Again this is not actually about acheiving informed consent. It's about how you prove comprehension by the patient months to years after the fact after all sides have lawyered up.

 

[Apollyon]

One of our attendings was telling me a story about a pt he had at his last job - crushing chest pain, sudden onset, STEMI in progress. Consent, checklist, thrombolytics - and the pain goes away, the EKG normalizes, and the patient says, "I feel better - can I go home now?". The attending says that he already had cardiology on board, CCU bed ready, the whole deal. But the patient wouldn't budge - she said "I'm all right now - I'm leaving". He explained to her - in plain terms - that she was thisclose to being dead, and that she needs to be observed and tested, but she would not have any of it, since she was now "fixed". He said that he never documented as profusely or tightly as on that AMA.

 

[f_w]

This is true but the question is how should docs in the real world document informed consent. Again this is not actually about acheiving informed consent. It's about how you prove comprehension by the patient months to years after the fact after all sides have lawyered up.

Well, as we all know, a pre-printed generic surgical consent that leaves 2 lines to 'describe procedure in laymans terms' signed by the patient is not sufficient. In their quest to make it all inclusive, the hospital attorneys try to pack everything in there, making the document unreadable in the process (photography, disposal of body parts, blood transfusions etc.).

Key is to document the discussion aspect of the consent process in the pre-procedure consult. Read your radiation oncologists consult letters if you want to see how to document these things. They go at great lengths to document their discussions. You will find sentences like 'The possibility of skin burns, hair loss, nausea and death where explained to Mr X who had the opportunity to ask questions. Mr X asked questions regarding the likelihood of skin burns and it was quoted to him to be in the range of Y%'
They will also in many cases leave a couple of days between the consultation/simulation appointment and the start of treatments. That way, the patient has the option to not start treatment. Do they get sued ? Sure. Do they get sued often in relation to the relatively invasive treatments they prescribe ? I don't think so.

Many physicians essentially do away with consent. Patients show up in places like the GI lab, change into a gown, a patient care tech shoves a piece of paper in front of them 'sign here' and the piece of paper gets filed away as only documentation of the consent process. They just make themselves an easy target for insufficient consent type suits.

 

[edmadison]

Wow, where to start. First, the case brought up by the OP is 15 years old and was decided by a relatively minor court. The doctor won the case at trial, but this was reversed on appeal and a new trial was ordered. There were two issues that the plantiff/patient prevailed on. These were based on procedural grounds due to improper jury instructions. I'd be happy to get into the legal issues of the case more, but I don't want to put you all to sleep. In essence, the court held with prevailing legal theory that the physician bears the responsibility of ensuring that the patient understands what's going on. However, the burden of proof at trial in on the Plaintiff to prove that the physican failed to provide the appropriate information.

In terms of informed consent, I never cease to be amazed how few physicians understand this concept. Informed consent does not relieve a physican of negligence. It merely relieves him or her from failure to warn of the risks of the procedure. The consent form is merely documentation of the processess. f_w hit the nail on the head. Consent is a process, the form merely memorializes the discussion. A signed form without that process is as good as toilet paper. This is why the Docs position in the Hawaii case was untenable (or at least the jury thought so). Anyone that sends an intern or nurse in to do consent is an idiot. You might as well right the check. That is both my medical and legal opinion.

Ed

 

[CatsandCradles]

There are many groups that do this. When I worked for Congress this year, one of my jobs was to keep many of these medical lobbyists off my boss' back - that was a lot of fun As I did this, I learned how truly fragmented the medical lobby is. Turf wars within the medical field are just as strong as wars between medicine and other professions. Sometimes its physicians fighting against each other to keep their larger share of the pie as medicare/medicaid reimbursement declines - go look at the history of the development of the RBRVS... that was an ugly set of battles Other times, its home-health care groups fighting hospitals fighting physicians to maintain payments and avoid additional oversight. So when all is said and done, precious little lobbying is done for the advancement of the medical field in general, and the bit that is done for doctors is not very effective (ask a professional staffer in congress what they think of the AMA - they'll either laugh, scoff, or both).

wow, guess we're a divided crowd of people than I thought.

 

[RuralMedicine]

The problems with doing urine dips and hemoccults are that for any lab procedure (which is what they are trying to say these are) you must record all the tests and results in a central log and prove that periodic control testing is done. They also don't like it that the reagent (peroxide, a substance so highly toxic it can only be purchased in every grocery and drug store) is usually not under lock and key. So to stay in compliance you can either use your actual lab which is presumably already certified, certify the whole hospital as a lab which is not realistic or apply for various waivers which is also difficult. Hospitals deal with it in various ways from ignoring it completely to requiring that all guiac cards go to the lab.

We do have to log them when we do them (it takes a few seconds if that). Our dirty utility rooms apparently double as "lab satellites" on our various units. Control testing on the hemoccults is on each individual test. The charge nurse does UA controls (and UPT and will be doing glucometer controls when they magically appear in the ICU next month---yes they all go to the lab--well lab comes bedside and does them but apparently no longer in the ICU). I think we're in JCAHO compliance we just had our lab reaccredited and apparently did very well.





To get back on topic I think the point that informed consent is a process is the most important take home piece. If your documentation reflects the process then you will be most likely to be able to defend yourself with or without a form. Our consent forms provide space to document part of the process (ie your consent discussion with patient) and this works well for bedside procedures like central lines, LPs etc although if it's something outside of the norm [like the central line in the lady with an INR of 22 and Hgb of 7.1 (yes that's the INR not the PT--she truly had no other access and needed blood and FFP--it actually went well without complications, even no hematoma although she definitely got a nice pressure dressing and sandbag at the insertion site for several hours) that I put in on call the other weekend] I will do additional documentation on a progress note or dictate it into the procedure note at the beginning.