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Friday, December 14, 2007

Informed Consent

How 'informed?' How specific need it be? This comes up in multiple threads.

191 comments:

Joel Sherman said...

I intend to look at this in greater depth as it appears to be a major variable in protecting patient privacy. Do you think a general consent is adequate for the more egregious examples we've seen, such as pelvic exams done by students under anesthesia for teaching purposes and the filming of exposed patients in emergency rooms?

The usually more patient oriented AMA has this to say about it:

H-320.951 AMA Opposition to "Procedure-Specific" Informed Consent
Our AMA opposes legislative measures that would impose procedure-specific requirements for informed consent or a waiting period for any legal medical procedure. (Res. 226, A-99; Reaffirmed: Res. 703, A-00)

That would for example mean that the AMA opposes specific consent mandates for photography etc. Anyone agree with that approach?

Joel Sherman said...

It occurs to me that it would be highly beneficial if all hospitals made their consent forms available online so that patients could read them before checking in, and not have to sign fine print forms in 30 seconds. I looked to see if any of my local hospitals did this. They do not, only mentioning in passing that forms need to be signed as part of the admission procedure. Yale New Haven Hospital did somewhat better supplying the following information, but not the forms themselves so that a patient can't come prepared to cross out what they want:

"Surgical consent form and policy changes
YNHH has recently adopted a new surgical consent form to comply with new federal guidelines. A copy of the new form is included. The changes include:

* Written informed consent is required for any procedure coded as “surgical,” including certain bedside procedures such as central line placement, lumbar puncture, thoracentesis, etc.
* Documentation of informed consent must always be recorded on a form rather than a note in the chart.
* The date and time of the patient’s signature must be on the consent form.
* The process must include a discussion of procedure-specific risks, benefits and alternatives, with all material risks being documented on the consent form.
* The form now mentions that YNHH is a teaching hospital and that trainees will be involved in portions of the procedure.
* The form also includes a statement that if someone other than the medical team will be present in the OR (such as a vendor or an observer) that the doctor has discussed this with them (separate written permission should be obtained).
* The new form also includes a permission for photographs to be taken for medical, research or educational purposes.

Physicians or patients may cross out provisions that they believe do not apply. As in the past, in the event of an emergency, no informed consent form is necessary (though when possible, obtain consent from the patient, a legal representative or next of kin, even via telephone). A new Section C has been added to the form to allow for documentation of emergency circumstances."


These guidelines are advertised for physicians, but are available to anyone on their website. I am not on their staff. One has to search the website to come up with this. They don't make it easy to find.

I'd be interested in what other hospitals do. Making these forms available on their website could certainly be taken up by JCAHO as one standard of quality.

Joel Sherman said...

P.S. Please lookup your local hospital's website and comment on whether they outline anything about their consent procedures.
You don't have to identify the hospital by name.

Anonymous said...

Dr. Sherman, I read the thread and while disquested, was not surprised. I think the basic underlying thought process of many of posters (future providers) is at the root of many of our complaints. The belief that the right of providers overides it is more important than the rights of the patients. Many of the posters felt thier right to learn took precedence over the patients wishes for their own bodies. They felt justified actions that would never be acceptable in other segments of society. For those who have not read it among other things various posters justified:
1. Acts of omission, suggesting that you shouldn't tell patients (in this case female surgery patients) that numerous students would be doing procedures (pelvic exams) strictly for educational purposes becasue they had signed a consent form for surgery, therefore it was OK to do the exams
2. Having multiple students do pelvic exams for strictly for their personal education was no different than the student doing the exam as part of the surgery (they did not differentiate between exams for the patients benefit or theirs)
3. They justified doing exams on patients even though they knew the patient might not agree by saying this action would further their abilities and benefit future patients.
4. One even made the statement about "patient rights bulls**t.

The subject actually touches on several areas. But to the point of this section, consent was more inportant to many of the posters purely from a liablity issue, it was a formality to protect them and one they obviously found to be bothersome and an intrusion. They are doing it becasue the have to but only for complience not for the benefit of the patient.

I find this true from my own experience, I was in for surgery and presented a clip board full of forms while I was on the prep table, in a gown, IV in. Among the forms was consent for filming. Consent, and informed consent are two different things, I feel informed consent is a rare thing in the medical community and once again ir falls on the patient to take the lead to get the "informed" part.

The basic phylosophy seems to permiate the whole medical community. The view that the thoughts and attitudes of the provider over ride, or at a minimum make their actions justifiable if it differs from the feelings of the paitent. I.E. its OK I am a professional over rides a patients desires for a same gender provider. In this case the providers felt their rights to education over rides the patients wishes. On a side note, funny how the people on allnurse objected so strongly to practicing on each other in class, even in swimsuits, the the providers justify violating an unconcious patient and become not only self rightous, but hositle to those who question them. It was a truely disturbing read.

Joel Sherman said...

Anonymous, as you refer to it, I will add the reference to the medical student blog on pelvic exams under anesthesia. But of course you are right, that many responders treat informed consent as a legal nuisance to be minimized and only important to avoid liability. Needless to say our whole society is like that, not just medicine. I could give many examples. But that's not a valid excuse. Concern over liability is an overriding problem in American medicine. But we all agree that concern for patients and their rights must be paramount.
I would like to suggest to JCAHO and others my above proposal, that informed consent forms be made available prior to coming in the hospital either online or sent with other preadmission material so that a patient can read it over carefully. I would also like to suggest what areas should not be covered by general consent forms, but require individual consent forms, such as photography and the use of students or residents doing procedures. I would like others thoughts on what topics should require separate consent forms.

lady patient said...

I recently had gynecologic cancer surgery at a major private hospital in Los Angeles. The hospital is a teaching hospital with ties to one of the universities here. During the 7 am admissions process right before my surgery, I was handed a stack of papers by a clerk, all with the signature pages open. I received no guidance except "this one is for billing your insurance", "this is permission to for us to operate", etc. As my surgery was scheduled in 2 hours, and there was a line of patients behind me, I signed everything so as not to miss my surgery queue. It would have taken an hour to read through everything and there would be no one around who could answer any questions. Plus I was really nervous about the surgery, so just trusted them. And quite frankly, even though I was in a teaching hospital, I never in a million years would have assumed that I just consented to my body being used for teaching pelvic exams to students.

This is how the hospital's consent form reads regarding teaching:

"Patient acknowledges that the Hospital is a teaching hospital and as such the training of physicians and surgeons, nurses and other health care personnel takes place at the Hospital. Patient understands that nurses, physicians and other health care personnel in training may participate in the operation or special diagnostic or therapeutic procedures specified above under a supervising physician or suregon, and Patient hereby consents thereto."

Some months later, out of curiousity, I questioned the hospital if I could add or delete some provisions in the consent form. I was told that if anything was crossed out or changed, the consent would be invalid. It was suggested that I bring my concerns to the attending physician, and it was up to him to comply or not to my wishes.

My question is, how can a patient opt out of practice intimate exams without causing resentment for meddling? If I verbally told the circulating nurse my wishes (isn't she the patient advocate in the O.R.?) would she be obligated to stop the medical students? What if I wrote out my wishes and taped it to my abdomen before the operation? Could the surgeon override my wishes? Afterall, I'm sedated, so how would I know. My fear is that if I had to make an issue of this, my care might be compromised.

Joel Sherman said...

Lady patient, your post typifies the uninformed consent that hospitals force on us. Two questions: Do you know that this hospital permitted pelvic exams under anesthesia for student purposes and if so, was one done? Or was it just a fear of yours? If the latter, talking it over with your physician before hand could easily have solved the problem. You might have found out that it wasn’t done in that institution. If it turned out that it was a practice at this hospital, it’s likely that your physician could have stopped the practice for you. If the physician couldn’t guarantee it, then you’d have the real option to go to another hospital.
But the point of this thread is that you don’t truly have many options if this first comes up a few hours before the scheduled surgery, as is usually the case. The clerk who shoves the papers at you likely knows nothing about it and could not answer questions. Amending the form by adding statements or crossing others out would likely cause a delay or even cancellation of your surgery. Not many patients would be willing to do this. This is exactly why I’d like to see all these forms made available to patients beforehand. The idea is not radical. In fact most surgeons nowadays hand patients forms in the office prior to surgery to explain possible complications. There’s no reason why a hospital couldn’t do the same to explain their procedures. Maybe a few do, but I haven’t found them yet.
What can you do after the fact? Well the options are limited. If a student did do a pelvic under anesthesia for teaching purposes only, you could contact a lawyer and consider suing. If successful, the practice would surely cease promptly. Only a knowledgeable attorney could tell you if a lawsuit has a chance of success in California; my guess is it would. Lesser options would be to complain after the fact to your attending, the hospital, and the state stressing that any permission you gave was in fact uninformed and essentially forced consent made under pressure. This could well help change their future practices in this area.
Your other questions: I don’t know what is meant by the consent being ‘invalid’ if you changed something. Certainly if the clerk took it, the consent would be presumed to be valid. There is no person in the OR who could be considered a patient advocate. That is not their job though I’m sure most would be willing to listen, but it’s really too late for a procedural change. If you discussed the matter with your surgeon beforehand and he agreed, he would be legally bound by it though of course unless you have it in writing you might have different opinions as to what was meant. I don’t think your care would be compromised if you spoke up beforehand and ironed any issues out. Hope this helps.
Good luck. Please add any follow up.

Anonymous said...

Lady Patient -- What was the position of the person who told you that were you to change the consent form, it would invalidate it? Invalidate in this context means "having no legal force." This statement appears to me to be preposterous on its face. If you signed the document and threated litigation for being used as a teaching tool without your consent, you can bet your booties hospital representatives would point to your signature. Similarly, if you simply crossed out and initialed or signed the change and your wishes were violated, you could do the same in a court of law, it seems to me. However, I'm not an attorney and I doubt if the person at the hospital was one either. You might contact the New York-based "People Against Non-Consensual Pelvic Exams," or "Non-Con" if it is still viable. The executive director used to be and may still be Gabrielle Lichterman. Someone in that organization may be able to help answer your questions or refer you to someone who could. -- Ray

Anonymous said...

Lady Patient,

I posted this on Dr. Bernstein's blog:

With regard to non-consensual pelvic exams, you might find of interest the article "Using Tort Law to Secure Patient Dignity", by Robin Fretwell Wilson. Here is the

link



CLW

Joel Sherman said...

Nice legal reference CLW. I have no doubt that legal action is possible and would achieve the most permanent results. I note that the paper is from 2004, and there may well be further cases since then. The article states that Harvard requires separate permission for these pelvic exams. I previously looked at Massachusetts General Hospital's website, Harvard's main hospital, and found nothing pertinent. Though I think they have a separate woman's hospital. I've also quickly searched for the AMA's policy that they refer to, but haven't found it.
One of the article's points is that studies show that there would be sufficient numbers of women who would agree to the procedure using fully informed consent. That is important. No subterfuge is needed.

Anonymous said...

I'll have to go to my office computer to download the article, but as I read Joel's post about it, I was reminded that it was at Harvard Med. School several years ago, I believe, that medical students protested non-consensual pelvic exams on anesthetized patients and convinced the powers that be to stop the practice. I was impressed by the gumption of the students (although I suspect that there may have been some faculty behind the movement) but disheartened that the faculty and hospital administrators allowed it to happen in the first place. The students have a right to be proud of what they did but the faculty should be ashamed that the impetus did not come from them. -- Ray

lady patient said...

Thank you for the responses.

To clarify, when I questioned the hospital if I could add or delete anything on the consent form, it was hypothetical, as my operation was performed some months previously. I was just curious if a patient at this hospital had that right, and wanted to be prepared should I have another operation. When I was told it would be "invalid", I took it to mean that an altered consent form would not be accepted, thus my operation could be called off.

>>"Two questions: Do you know that this hospital permitted pelvic exams under anesthesia for student purposes and if so, was one done? Or was it just a fear of yours?"

I knew nothing about practice pelvic exams before my operation, and only became aware through reading doctor blogs and medical forums months later. I then became suspicious after I accessed my operation report and read a note that said "pre-op teaching done". What happened that would have necessitated such a note to be recorded?

Also, whenever there was a thread on doctor blogs debating unauthorized pelvic exams, most of the comments (by medical people, I suspect) vigorously defended the practice. "how will the next generation learn? "go to a community hospital if you don't like it" "we can't be expected to explain every procedure in the O.R. to the patient" "if a patient complains about this, it's a foot in the door, what else will the patient demand?" "the patient is sedated, no harm, no foul". The comments seemed to acknowledge that these exams are commonplace in teaching hospitals. Take it or leave it. None of the posters accepted or cared that most women aren't aware that these pelvic exams goes on. No concern or conscience was expressed that in reality they were done in secret.

>>"What was the position of the person who told you that were you to change the consent form, it would invalidate it? "

When I called the hospital, I was transferred several times until I got someone in "Patient Relations". When I persisted with more questions, I was referred to someone in Risk Management. I think Risk Mgmt. is manned by lawyers. I didn't follow through, I became intimidated as I was still an outpatient at the hospital.

Regarding the last post about Harvard medical students protesting non-consensual exams: I wonder what prompted them to ask if the exams were consented to. Do students look at patient consent forms? They were pretty brave, as their refusal to participate in essence was passing judgment on the ethics of their superiors who condone the practice.

Joel Sherman said...

Thanks lady patient. A brief late night response:
My guess is that the statement that pre-op teaching was done does mean a 'practice' pelvic was done by one or more physicians or students. If your doctor won't tell you, the only thing you can do is to ask to see your operative report where it should be listed, but may not be. If they won't give it to you, you'll need a lawyer and a subpoena.
Risk Management is their damage control department to avoid liability and lawsuits, so they are already afraid of what may be coming down the road. They may not be forthcoming. Hiring an attorney may be the only way of pursuing it.
If you want to see it through, that is the best course. Honestly though if you need ongoing cancer care, it may not be worth it for you. Once you hire an attorney, it will be difficult (though not impossible) to return to the same physician and hospital. I wouldn't do it in your position if you need continuing medical care more than legal entanglements at this point in your life.

lady patient said...

Well, with all my internet searching on the subject, I just now found this link which seems to
indicate that a California Assembly bill was passed in 2004 that mandates informed consent for
practice pelvic exams.

http://www.leginfo.ca.gov/pub/03-04/bill/asm/ab_0651-0700/ab_663_bill_20031001_chaptered.html

But cynic that I am, I'm wondering if the wording in Section 2, 2281 provides loopholes in favor
of the practice exams without consent.

Joel Sherman said...

To my medical mind lady patient, if you want to bring a legal case there are two questions or problems:
1.) Proving that a practice pelvic exam actually took place. That could take extended discovery motions.
2.) Convincing a judge/jury that what you signed was not informed consent. The statute is a good find, but that would be the assumption in any event, i.e. that informed consent is needed. In any case you likely need an attorney to pursue it.

Anonymous said...

The dilemma in which you find yourself, "lady patient," provides anecdotal confirmation of the need for advocates (usually family members) chosen by patients to accompany them wherever they go in hospitals. Not only can it reduce the likelihood of abberant behavior by healthcare providers, it can also save a life. I'm convinced, for example, that if my wife, a nurse and attorney, did not advocate for my daughter during the time she was in several hospitals a few years back, we'd have one fewer daughters today. -- Ray

TT said...

Dr Joel,

This is a link to an article that may be of interest on this topic.

http://www.chass.utoronto.ca/~gsreeniv/4models.pdf

It outlines four different approaches to the physician/patient relationship and how they affect informed decision making (informed consent) with regard to course of medical treatment. While it may be a little dated (1992), I think it does a pretty good job of comparing them - not sure I agree with their conclusions though......

Joel Sherman said...

Thanks TT,
The paper is a very formal discourse on the subject. It's really geared to complex decisions regarding major illnesses and courses of therapy. Don't think that much analysis is needed to ask a patient if she wants a queue of medical students doing a pelvic on her under anesthesia. In that situation, there is little to ponder for most people, it's either yes or no. The only pertinent point is that the patient be clearly asked for permission.
Not sure that there's any easy answer for the larger question. I tend to give patients the possible alternatives for therapy, the 'informative approach,' but then I usually make a specific recommendation telling them what I would do in that situation or what I'd recommend for my family. But every patient is different. Some want to be told what to do or say that they come to me because they value my opinion. Others want a second opinion immediately or start their own research project. One approach doesn't work with everyone. What did you disagree with in their conclusion?

Anonymous said...

Jimmy Here,

It's been awhile since I last posted, I've been recovering from a torn knee meniscus. I'd like to add to this discussion.

First, as I've stated elsewhere. All forms should be signed ahead of time including the surgery forms. There's no reason for this not to happen, especially if it's a scheduled procedure. I ran into the same thing that lady patient did except I only signed the insurance forms at the clerks desk. I kept the surgery forms with me to review and sign and was allowed ample time to review. I then gave those forms to my pre-op nurse. There were three items that I disagreed with and the nurse tried to change my mind two of them. The first was photos/filming of my procedure. Since my surgeon likes to take pictures of what was repaired and I'm the type of person that appreciates detail, I did allow that but only after I said it could only be pictures and noted it on my form. The other was with allowing students/techs be present during my procedure, she said that this wasn't a teaching hospital and that I really didn't have to worry about but I still wouldn't change it. The last one got interesting, it had to do with allowing other technical personnel in the room during my procedure. Her response to me was that these people would be only computer techs or just personnel that took care of the equipment. That was of no comfort to me and I finally asked her when they actually needed someone for that. She responded by saying rarely but sometimes SALES REPS are present for some cases. Needless to say, that fired me up and my answer didn't change. I asked my wife who is a CFO at our local hospital if this was common and she said that it is mostly for Orthopedic and Gynocologic cases. They are there to answer any questions that the surgeon may have with the equipment or just teaching how to use it.

The forms need to be more specific! Imagine how many patients would decline if the forms stated that a SALES REP may be present during your procedure, don't hide it in the technical reference of the form. They should give a detail list AHEAD of time of what/who could be included in each section of the form. The forms you sign are so vague, you really don't get a good idea of what you just signed. How could have lady patient had known from what she signed that a practice pelvic exam be included with her treatment?

I still have my survey and plan to send it back to the facility along with some added comments. I can't find their website so I'm not sure if this form is available online or not, I'll post once I know. I had a great experience and was quite pleased with everyone involved in my care. When I fill out my survey, I plan to add a letter stating how this shouldn't have been hid and they should add a section on their forms for this.

For those that would like to know: JK is Jimmy.

Joel Sherman said...

Hope you're recovering Jimmy.
It's nice that you were given some time to read over the informed consent forms in your leisure. I think lady patient's experience is far more typical however. It is unusual that there was actually someone there to explain the forms. That is what is really vital, and missing most places.
I'm sure I would have signed these forms as they were explained to you. I agree that sales reps don't belong there, though I think most of them really are more technical representatives than salesmen when they're present. Unfortunately some medical procedures and equipment are so complicated nowadays that they can be really needed, in fact the procedure may not be able to be done without them. We're all adjusting to the increasing presence of technicians, whether working for the hospital or commercial companies, whose role can be vital.
But there is unquestionably the possibility of abuse. I have heard the story, which I believe but can't independently verify, of NCAA college physicals upon which scholarships depend, of guys having to stand around nude in large rooms where all kinds of mixed gender onlookers were present including sales reps. They of course did not have the power to refuse or the opportunity to question any of this.

Anonymous said...

Joel,

I hate to be argumentative, but I’d like to add a few points on this subject based on your last response. I do respect your opinion but I think you’ve missed my point. I apologize if I wasn’t clear on my last post.

First, no one explained anything to me; I understood the forms upfront because of this blog and the others that I’ve read. When I asked the pre-op nurse my questions, you could tell by her hesitant responses that she normally didn’t get these questions and even have to deal with all the “I do not consent” remarks that I had on my form.

Second, I made time to read over the forms. I came in an hour early from the time that they asked me to be there so I would have time to read the fine print. It’s always been my practice to be way early than to late. That may be part of the reason why I haven’t run into any surprises during my procedures?

Finally, the comment that some procedures won’t be done without the representatives is really unfair to any patient. The consent form is the only control we the patient has and there shouldn’t be any exceptions. I’d also question the surgeon’s skills if he has to have one of these representatives present during a procedure. Do they not go through basic training on this equipment before using it on a patient? If the equipment has an operating system, there a remote control tools available to where they can access and make configuration changes as needed, most hospital equipment is on a network from my experience. Again, this shows how little respect that they have toward the patient. If the patient marks NO, end of discussion!!!!

All this really boils down to knowledge and the fact that providers don’t cover all the details. I honestly feel like they do this on purpose so people will remain dumb to the fact. They should take the time to provide all the patients with all the facts, I don’t care how long or how much more work it would require.

One question and this may not be the appropriate place for this. What do you think would happen if all the patients at your hospital spent the time to read over this blog and Dr.Bernstein’s? Do you really believe it would be business as usual or do you think you would get a rash of request or just more patients questioning what they are provided to sign?

Jimmy

Joel Sherman said...

Hi Jimmy. No I didn't understand that the explanations you were given came from an OR nurse and not from the office where the papers were given to you. Like lady patient, it's too late then to really change anything.
I agree that hospitals make these forms as vague as they can to cover as many sins as possible. After all, these forms usually are reviewed by lawyers at some point. The goal is to protect the hospital as much as possible.
My point about sales reps you may have misunderstood. Sales reps and technical representatives who really can be necessary may be the same person. I know that is the case in my field. I doubt that pure sales reps are ever routinely present. Some surgical procedures use equipment that is just so complicated that a technical person needs to be on hand. They may work for the hospital or the manufacturer may send them. Complicated electronic equipment like some robotics used in a few procedures are well beyond the purview of most physicians or surgeons. You might as well ask the surgeon to be responsible for running the x-equipment which may be present. For some surgery there might well be multiple technicians present in the OR, most of whom likely work for the hospital. If I was having something complicated, like open heart surgery, I wouldn't dream of trying to keep them out.
If even a small fraction of patients read over blogs like these, it could not be business as usual at most hospitals. I've certainly become sensitized to these issues from these blogs. I don't have any available statistics, but the average patient doesn't worry about these matters. Some don't even want to know, and will refuse to listen to explanations of possible complications

Anonymous said...

Comments about sales reps being present during surgeries remined me of a case I read about years ago. By golly, I was able to google it and have included it below. What the "Nurseweek" article fails to report is that the patient had no idea that the Johnson and Johnson sales rep. would be running the machine that contributed to her death. One could reasonably argue the woman's death was not only a consequence of the refusal of physicians to listen to nurses, physicians' willingness to allow a sales rep. to run the machine, and the ignorance of the sales rep. regarding the negative consequences of his actions. It was also the consequence of the refusal of physicians to follow basic ethical guidelines regarding informed consent. -- Ray


Patient dies after equipment demonstration during surgery
Posted 11-16-98

Despite repeated warnings from operating room nurses, physicians at Beth Israel Medical Center in New York allowed a salesperson to demonstrate equipment on a patient during surgery to remove a noncancerous uterine fibroid tumor, resulting in her death.

The November 1997 surgery was attended by two surgeons, two OR nurses, an anesthesiologist, and a Johnson & Johnson salesperson.

The nurses’ warnings came as the patient’s abdomen swelled excessively from saline solution being pumped into it. As the procedure progressed, a surgeon shut off the saline outflow to "get a good picture," a report from the New York State Health Department states, allowing the fluid buildup that later caused the patient to go into cardiac arrest. The physicians were using the Versapoint Bipolar Hysteroscopy Electrosurgery System, a product of the Ethicon Division of Johnson & Johnson designed to allow for easier removal of tumors. The salesperson operated the machine’s controls.

"Clearly the fact that the surgeons ignored the nurses was a major factor in the patient’s death," said Frances Tarlton, a Department of Health spokesperson.

Beth Israel notified the Department of Health of the incident as required by law and filed the required follow-up report. As the investigation of the surgeons was launched, however, the Department of Health found discrepancies that led it to begin an independent investigation.

"The hospital’s report was missing key facts, like the sales representative operating the machine’s controls, the OR nurses’ repeated warnings, and the fact that the surgeons had not been trained on the equipment, which wasn’t even approved for use in the hospital," Tarlton said.

The Department of Health fined Beth Israel $30,000. The hospital suspended the surgeons’ privileges, and the circulating OR nurse was fired as a result of the incident and others that had happened on her watch, according to Jim Mandler, hospital spokesperson. The Johnson & Johnson salesperson has been referred for investigation for practicing medicine without a license, Tarlton said.

Related Sites
Beth Israel Medical Center in New York
Ethicon Division of Johnson & Johnson
American Nurses Association

Joel Sherman said...

This is a little off topic, but it's important to recognize that informed consent can be used against patient interests by making valid research difficult to impossible. This reference is to a Johns Hopkins study about using a simple checklist to protect patients from hospital acquired infection. The results were very positive, yet the government czar disallowed the study because informed consent wasn't obtained for such routine recommendations as washing your hands between patients. There were 5 parts to the checklist, though all of them are not referenced in the article unfortunately.
Informed consent is a major tool to protect patient privacy, but it can be used to hinder valid research.

Anonymous said...

Joel -- I think Atul Gawande is being a bit deceptive here. He comflates the Johns Hopkins' healthcare program meant to reduce hospital born infections with the research designed to test the effects of the program. He writes, "A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. . . The Office for Human Research Protections shut the program down. . . Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island." The OHRP does not have the authority to shut any healthcare program down. It has the authority only to stop research which it considers in violation of ethical guidelines. And, in all cases with which I am familiar, once the researchers put ethical guidelines in place, the research can resume. In Johns Hopkins case, this would mean getting consent from the physicians who use the checklist and their I.C.U. patients or their next of kin if patients are incapacitated. It would seem to me that this would not cause researchers much more inconvenience than getting the checklist into the hands of the physicians who use them.

Given the 1000s of publications that demonstrate the importance of sterile protocol and the findings by Johns Hopkins researchers whose unit of analysis was every I.C.U. in the state of Michigan, I see no reason why the research must be replicated in other states. There appears to be enough evidence -- concomitant with common sense -- to recommend that every I.C.U. use the five-step checklist. If Johns Hopkins researchers believe differently, then I guess they will have to conform to the same ethical guidelines to which I and my colleagues must conform when conducting research that uses checklists.

Just a note,research at Johns Hopkins has been curtailed on a number of occasions because of the failure of its researchers to obtain informed consent, one following the death of a healthy college student about whom I wrote in Bernstein's blog. Johns Hopkins also failed to obtain informed consent from patients or next of kin before allowing ABC to film them when they were in the most vulnerable and humiliating of circumstances. Its CEO or president (I can't remember which one) defended doing so by implying that the education of the public trumped the rights of patients to privacy and both failed to conceptually distinguish between consent to film and consent to broadcast. If you recall, I also wrote about this. When I add up all this information, I can't help but conclude that there are some people at Johns Hopkins who have little more than contempt for the principle of informed consent.

I have as nagging feeling that Gawande left important information out of his report. When I and my colleagues conduct research using checklists, we are expected to obtain informed consent from subjects or their guardians. If we decline to do so, our research proposal is not approved by our Internal Review Board (IRB). I bet you ten-to-one that Johns Hopkins' researchers' proposal that went the IRB included provisions for informed consent and was approved on that basis, but once in the field, informed consent was overlooked. If not, the problem not only lies with the researchers but also with Johns Hopkins' IRB. -- Ray

Joel Sherman said...

Ray, as I posted I was uncomfortable that the article did not list the 5 steps. Quite possibly the other four were far more controversial than washing your hands and if so the rejection could be appropriate. I'm also quite aware that newspaper articles can be poorly researched, biased or both, including articles from the New York Times.
I think you are possibly inconsistent though in suggesting that the research doesn't need to be duplicated if it is self evident. If it is self evident, I'm not sure why the study needed to be done or informed consent required. Something about the study was not self evident, including determining whether it really achieved results.
I'm all in favor of informed consent, but it can be taken to extremes and be an impediment to valid research. There are lots of complaints about research being hindered by it, not just from Johns Hopkins.

Anonymous said...

Joel: Thanks for keeping me on my toes. This topic seems less pertinent to informed consent as it pertains to medical privacy from a clinical point of view and more to informed consent as it pertains to scientific research. So, I'll send my response by e-mail and if you consider it apropos to what you had in mind for this blog, then by all means go ahead and post it here. -- Ray

Joel Sherman said...

Here's a good online booklet from the federal Agency for Healthcare Research and Quality about what you need to know and ask before having surgery. I recommend it.

Joel Sherman said...

Ray, I've been meaning to discuss your comment that individual informed consent was different from consent for research. There are differences. Usually for an individual they are signing consent for a procedure or operation. A research consent may involve new surgery but more commonly is for an unproven or experimental drug or therapy. (This excludes from consideration the general consent for treatment that you sign when you enter a hospital, which is a different matter.) A research protocol has to be approved by an IRB (Institutional Review Board); a standard procedure or operation does not need separate approval.
But they all boil down to giving a patient a choice as to whether or not he wants to submit to the procedure or therapy involved. Usually risks are summarized. Alternative therapies may be mentioned.
In the Johns Hopkins case mentioned above, I still don't know why informed consent was needed as no experimental procedures or therapies were involved. They were just documenting the effectiveness of the 5 combined accepted guidelines.

Anonymous said...

Joel: Generally, but not always, standards for ethical research documents, federal guidelines, and IRBs require informed consent not only for experiments but also for surveys and field studies which use human subjects. It doesn't matter from what discipline the researchers come. Johns Hopkins conducted survey research. They were not "just documenting the effectiveness of the 5 completed guidelines," they implemented the study and tested the effects of the completed guidelines.

It may indeed be true, as I suggested in my e-mail to you, that the OHRP was being overzealous in the application of the informed consent criterion in this case, and maybe refusing to permit Johns Hopkins researchers to replicate the study elsewhere was unwarranted. I'd have to read the OHRP report first before I am satisfied one way or another and I can't find it. I certainly won't take Gawande's report as fact since I don't believe he wrote the truth, the whole truth, and nothing but the truth.

Ironically, if the hospital ICUs studied had themselves implemented the procedures or protocols including use of the checklists and stored what was documented, Johns Hopkins researchers could have, with the permission of the hospitals only, requested the data and conducted their study without informed consent of patients. In this case, they'd be conducting an analysis of existing data. It would be incumbent on the hospitals to get patients' consent to use information collected about them for research purposes, something which all research hospitals do on their intake forms. Also, if information was taken from patient files, Johns Hopkins' IRB would probably require researchers to explain how they would insure that patients remain anonymous. -- Ray

Anonymous said...

Joel,

Getting back to one of my earlier responses. I've looked through the surgery center's website that I used and was unable to find the consent form. I did take the time to search the meaning of "Informed Consent" though their website and this is the medical definition:

"consent to surgery by a patient or to participation in a medical experiment by a subject after achieving an understanding of what is involved"

How can anyone ever achieve an understanding if no one explains what is involved? It's strange to me that the nurse took the time to explain what I was signing only after I didn't consent to certain things. If they would take the time to explain then, why not be upfront with patients in the beginning? This is why this form needs to become these forms, to give the patient a better understanding how what REALLY occurs during their procedure and who's involved. Jimmy

Joel Sherman said...

Jimmy, hospitals used blanket informed consents written by lawyers to cover themselves to the fullest. They are useless in terms of explaining anything in depth. That's why I recommended above that these consents be made available to the patient before they arrive, so they would know what to ask or modify. It's probably not going to happen as it would complicate matters for hospitals. Only patients who ask questions and demand to know can change the system. The rest of society is no better. Just think of all the agreements we check on without looking when we're downloading something online. You can be sure you've just clicked all your rights away.

Ray, I'm sure you're right that OHRP requires consent for surveys and field studies. I just don't understand the rationale for the requirement which hinders important studies. Here's the reference to the Gawande paper.

Joel Sherman said...

Proper informed consent can be done. Here's a reference from a center for bariatric (weight loss) surgery which includes a video you can watch, and then review and sign the informed consent online. This should be a general model, not just applied to individual higher risk procedures.

Joel Sherman said...

Here's an interesting case about a man suing a hospital for a rectal exam he was forced to undergo after he refused permission.
I'm personally unclear as to why they needed a rectal exam to evaluate a head injury, but then one can never be sure that the article got the details of the case right.

Joel Sherman said...

Here's two interesting articles about the above case complete with some medical and legal opinions.
Here's an especially interesting quote from the Wall Street Journal law review:

According to the original article, this man was driven to the hospital by his friend and walked into the ER. Clearly this patient was in full control of his faculties. The patient was arrested after “assaulting” the doctor or who ever it was forcing this rectal exam on him. In twenty eight years as a surgeon treating thousands of head injured patients, I have never seen a combative head injured patient arrested and jailed for assault. Therefore, if this patient liable for the assault, its a tacit admission by the treating hospital he was in control of his faculties and well within his rights to refuse a rectal exam. If this man was alert, oriented, moving all for extremities, the yield on a rectal exam in my experience would about zero percent. That this patient was forced into this procedure, then paralyzed and intubated after refusing is the Advanced Trauma Life Support protocol carried too far. If I were the hospital attorneys, I would recommend apologizing to the patient and settle as quickly as possible.
Comment by Trauma Surgeon - January 17, 2008 at 9:59 am


A second good article from Slate.

Anonymous said...

If the facts are correct, it looks as though the healthcare providers involved indicted themselves.

I wonder if anyone has ever sworn out a warrant for the arrest of healthcare providers for battery in such cases. After all, insurance companies tend to cover the cost of suits won by plaintiffs; thus offenders remain largely unaccountable for their actions. That's not much of a specific or general deterrent. We in the U.S. seem to live comfortably with an irony; we tend to threaten with criminal sanctions those who are the least deterrable because they have the least to lose (e.g., low-income individuals) while relying on the internal controls (e.g., conscience) and informal controls (e.g., fear of disapproval by significant others) to discourage the criminal behavior of those who are the most deterrable because they have the most to lose.

The argument given in the quotation you contributed, Joel, was well constructed. I was impressed. The plaintiff's attorney should employ the writer.

I also appreciated the comment by "Jessica" -- "It's unlikely he had a spinal cord injury if he was able to walk in and deck the attending." -- and "P.S."If the guy had the capacity to form the requisite intent to commit assault, he had the capacity to decline the procedure. You can't have it both ways. It was self defense."

Given acceptance of the facts given, the ignorance exhibited by some (alleged) physicians, such as "GOOD DR," was palpable. As I read a couple of his posts, I couldn't help think that a physician who called himself "GOOD DR" could be likened to a used car salesman who called himself "HONEST JOHN."

Next to the person you quoted, I was most impressed with "Trauma Surgeon" who wrote:

"The other consideration is the inherent risks in paralyzing and intubating a patient. While it is generally safe, injuries can and do occur, to the mouth, teeth, to the trachea, to the vocal cords. In addition there is a small but definite risk of lung trauma when a patient is connected to positive pressure ventilation. More remotely, but still possible, is the inability to intubate or ventilate the patient, once the patient is paralyzed. This could lead to hypoxia and brain injury. I’ve seen all of these complications occur.

To make it clear, the purpose of doing a rectal exam is to assess for a spinal cord injury, not a brain injury. An unconscious BRAIN injured patient can have a normal rectal tone.

It wouldn’t even occur to me to a rectal in this patient, much less subject him to the risk of an intubation.

This scenario seems to be medical incompetence piled on top of arrogance."

Ray

Anonymous said...

One comment on the above case:

One important piece of information seems to have been left out that could paint a clearer picture of what happened. Would be interested to know what prompted the doctor to feel the need to sedate this patient. There had to have been a conversation between the two on the course of treatment. As much as I'd like to get on the band wagon and hope the doctor and hospital have to pay, I can't understand why anyone in a hospital would call for help with sedation of a patient over just a rectal exam? Can't say that I see the need for a rectal exam for a head injury but what do I know, I've been fortunate enough to have never had one, let alone being forced? I'm sure there's more to this case than being reported so I'll just save my opinion. I hope they keep the public informed on how this turns out, this has made even my local news. If he did win, do you guys think it will hurt/help the informed consent process? I can see it going either way. Jimmy

Anonymous said...

I wonder why the man was intubated. Would it be that those who sedated him feared that they gave him too much sedation and he would asphyxiate?

"Law Student," whom you cited in your blog, Joel, suggests that having the patient arrested is a "tacit admission by the treating hospital he was in control of his faculties as well as his right to refuse a rectal exam." This argument sounds pretty good on the surface but could result in what appears to be a defense with which comedians around the country would have a ball -- "Well, our initial assessment of the patient provided sufficient evidence of possible brain damage that could render the patient incompetent to make decisions for himself, thus warranting a coerced rectal exam. However, the rectal exam resulted in data that belied our original suspicion, thereby suggesting the patient was, in fact, fully capable of making decisions for himself including the decision to assault and batter a physician. Thus, his arrest was also warranted."

Ray

Joel Sherman said...

Jimmy and Ray,
I think that the presumption is strong that they sedated the patient because they thought he was out of control, and not for any medical reason per se. Why did they think that? Because he attacked the physician even though he may have had great provocation. I think the whole scenario is outrageous, especially when the patient walked in and had no evidence for a spinal cord injury if we're getting full details. On one blog, a person commented that he was suing for a million. My guess is that it's worth more than that, especially if punitive damages are awarded. Ray I don't think a rectal exam could provide any evidence about the patient's mental competence, one way or another.

Anonymous said...

Joel -- I know that a rectal exam does not provide evidence about a patient's mental competence. But, that's the way comedians might present the defendant's rebuttal to the plaintiff's argument that if they thought he was incompetent they would not have had him arrested. I'm afraid I don't have the wit to present it in the way comedians would.

Whatever the case, if the suit goes to trial, the defense might have to come up with some reasonable rebuttal for the argument presented by "Law Student."

I'm still wondering why he had to be intubated. -- Ray

Anonymous said...

I must concur with the many comments here regarding surgical consent forms. We personally experienced much anger regarding a procedure involving the genital area. After the surgery we obtained the medical file. Only then did we see that in the small print it allowed people to stand in, pictures and video taping. This is absurd. Also, the entire ordeal of the skin preparation and cleanse is not discussed with the patient and it SHOULD BE!!! When there are opposite sex nurse performing these procedures it should be discussed with the patient with ALL elective procedures. That is not too much to ask.

Joel Sherman said...

Anonymous,
If you look under the videos and pictures thread, you will find the JCAHO guidelines for consent for pictures. They consider a general consent form adequate if the pictures are only to be used internally in the institution. I don't agree with that and it is why I recommend that all consent forms be made available beforehand so that patients can actual read them. You can protest to the hospital and make your displeasure known. That can have an effect, but they haven't violated any national standards if no pictures were released elsewhere.
In terms of who prepped you, gender is never covered in consent forms and you would always have to insist on your wishes with the surgeon well ahead of time. They may or may not be willing to accommodate you. That's not likely to change in the near future. Sorry.

Joel Sherman said...

For the sake of thoroughness, this is how JCAHO defines informed consent:

Informed consent Agreement or permission accompanied by full notice about what is being consented to. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment.

AMA guidelines aren't any more helpful:

H-140.989 Informed Consent and Decision-Making in Health Care
(1) Health care professionals should inform patients or their surrogates of their clinical impression or diagnosis; alternative treatments and consequences of treatments, including the consequence of no treatment; and recommendations for treatment. Full disclosure is appropriate in all cases, except in rare situations in which such information would, in the opinion of the health care professional, cause serious harm to the patient.


Neither one specifies that the patient should not only consent, but have the time to read over what they consent to. Neither one says that the patient has to understand what they consent to! JCAHO is applicable to hospitals and institutions. AMA guidelines are more applicable to the physician or surgeon doing a treatment or a procedure.

Anonymous said...

Anonymous and Joel,

I'm guessing that you were the recent poster on Dr.Bernstein's blog, if not, my mistake. It sounds as though you took all the steps neccessary to protect your husband but just as Joel has pointed out, that sometimes isn't good enough. In the end, they'll do what's in their best interest.

What can be done in the future? I can tell you that with the last procedure I had done, I noted it in my chart. I was never questioned about the subject. If they had done anything other than what was noted, I'd see a lawyer. I know that's not the right thing to do, but that's really the only way that I see one can protect themself or their loved ones.

Of greater concern to me is the silence by all the agencies that you reported the incident with. Would you care to elaborate on those that you contacted and by what means? On the privacy blog we've been discussing, it has been noted to report those facilities to the appropriate institutions or government agencies. Your the second poster that has done this not to receive any kind of response(one on Dr.B's blog as well)? How is anything ever going to change if they ignore our pleas? Is there another route to take that we've not discussed yet? Jimmy

Anonymous said...

Some years ago, I phoned JCAHO and spoke to a representative about their standard for patient consent regarding filming patients in emergency situations without their consent. I was told by a spokeswoman that it was sufficient for the hospital to post a notice of its intent in the emergency room. I'm not 100% certain, but she may have added that the hospital also needed to put a notice in the local paper of its intent. Patients brought to the emergency room were considered, ipso facto, to be giving their consent to be filmed, even if they did not, in fact, give their consent. Is the standard still the same, do you know?

The government is colluding with some amenable hospitals to conduct experimental research on the effects of substitute blood using a similar approach. All the hospitals have to do is advertise what they are doing in a local paper and they won't have to get consent from patients. If patients happen to read the advertisement and don't want to participate, they can purchase a wrist band that indicates their refusal. The best evidence suggests that no one in the communities in which the experiment is being conducted know anything about it. Physicians who run the program, nevertheless, adamantly cling to the belief that no ethical guideline is violated. -- Ray

Joel Sherman said...

This is only marginally related to informed consent and patient privacy, but is a very interesting article claiming that living wills are ineffective in practice. If you want your ultimate wishes carried out, better to have your surrogate know exactly what you want rather than rely on what's written down. Though no method is fool proof.

TT said...

Ray,

Actually there are currently at least three FDA approved studies that I know of being conducted under the auspices of ROC's (resuscitation outcome committees) in quite a few areas throughout the US. The theory is that it allows EMS crews to use experimental protocols in the field on patients without their informed consent - primary reason is that patients who meet the criteria for the experimental treatment are typically unconscious & unable to give consent.

The study you refer to is for a product called polyheme, which is a hemoglobin based substitute for whole blood. The theory is that unlike whole blood, which is very perishable and for that reason not practical to carry om EMS vehicles, these synthetic substitutes could be used in the field to potentially save lives in cases of severe blood loss. It is well known that synthetic hemoglobin based substitutes irritate the blood vessels. There have been a number of documented cases of MI in patients where the substitutes were used compared to the control group where there were none.

A second study involves administering a one time 250ml hypertonic saline to certain patients - control group gets normal saline (standard protocol). This one is a blind study & field EMS crews don't know which they are actually administering.

The 3rd involves a mechanical device that is inserted in series with a CPR mask, bag or ETT that affects the ventilation pressure & pattern, - supposedly improves the efficiency of ventilation during CPR.

You can easily do a web search using the appropriate key words and find out which hospitals are participating. If one or more facilities in your area is participating and you want to opt out, you simply need to contact the coordinating ROC for the local participating facility and they will send you a stainless steel bracelet engraved with "NO STUDY". The bracelet is free - there is no cost. I know this for fact - I'm wearing one. Wearing the bracelet will automatically opt you out of all ROC field studies.

TT said...

Correction yo my previous post: ROC stands for "Resuscitation Outcome Consortium", not committee....my bad!

TT said...

For those interested, this url provides more info on the ROC, including participating cities.

http://www.nih.gov/news/pr/mar2006/nhlbiv1-24.htm

It includes the rationale and required process for exception from normal informed consent requirements. Take a look at who some of the funding agencies are....interesting....

lady patient said...

I'm sorry if these are repeats, but just in case, here are 2 reports of patients bodies being used for experiments without informed consent:

1 - Junior doctors 'practice' on dying patients without consent:

http://www.wddty.com/03363800370518816742/junior-doctors-practice-on-dying-patients.html

2 - clinical trial on blood substitute allowed on ambulance patients without consent:

http://www.slhhn.org/body.cfm?id=768

Joel Sherman said...

My thanks to all the posters for those interesting references. It's a subject I wasn't aware of. Here's the url to the actual FDA guidelines which were available through lady patient's post. I personally think the guidelines are quite reasonable, even strict, given that these are emergency situations with very ill patients where usual protocols just won't serve. Anyone disagree?
I'd be surprised Ray if they apply to ER filming unless there is a similar approved study going on. Presumably it wouldn't suffice for filming TV shows where at least JCAHO standards are reasonably strict, though the few hospitals that do film apparently don't feel bound by JCAHO.

Jimmy, once again we need to emphasize that if you complain to JCAHO or most state regulatory boards, you are not likely to get any immediate satisfaction. These agencies aren't primarily disciplinary in nature. If the issue is a clear violation of their standards, they may start an investigation, but probably won't tell the complainant about it. If it is not a violation, such as refusal to provide same gender care, they will do nothing more than note the complaints. Even this doesn't mean the complaint is wasted. If enough people complain the institutions will get the message. If the complaint is a rare one, little will change.

Anonymous said...

Interesting information TT. I'll have to dig out some documentation from my office and read your references before I can respond. The stuff I read is over a year old so some of the ethical issues may have been ironed out by now, but based on what you've written, I'm suspect.

Given you have a "No Study" bracelet, I assume you're not convinced that substitue blood is a good alternative for you or is there some other reason you have one. -- Ray

TT said...

Joel,

I agree that the requirements are fairly reasonable from a patient safety perspective. I would like to see added a formal requirement for an opt-out process, as right now that is left up to the whims of the local IRB. The other thing that bothers me, at least in our area, is that the "public notification" process has been pretty much low key and very few folks heard anything about it. As a result, when a local reporter got wind of it and did a "Hey, did you they are doing this without your consent?" article it caused a PR backlash.

IMHO they would be better off being proactive with the public notification process - use the media to get the word out: "This is what we propose and this is why we think it's a good thing. We hope you agree and will help us in this research. Here's were you can get more information.." When you do it on the QT it makes it look like you're trying to hide something, and that makes people suspicious.

TT said...

Ray,

Our local IRB declined to participate in the polyheme study, primarily over questions on how to implement an effective opt-out procedure. They are participating in the hypertonic saline study, and will be in the CPR valve as well.

The polyheme study is now over and the preliminary report shows no improvement in survivability with polyheme vs the standard NS.

Given that these hemoglobin based substitutes expose the patient to the same risks of blood borne pathogens like HIV & hepatitis as whole blood, I have a serious problem in giving it to patients without their informed consent.

The other problem I have with the polyheme study is how it was implemented. There was apparently an earlier trial by the manufacturer that was stopped due to some serious problems (I believe this is where the MI's surfaced), and this information was not given to the ROC when they made their pitch for the more recent study.

In the actual implementation of the the study there were also some problems with giving the required prompt notification to the patient or their representative on reaching the hospital and giving them the opportunity to opt out at that point. There were instances where notification was significantly delayed and the patient was continued on the substitute even though whole blood products were available. Whether this was intentional or from carelessness, it's inexcusable, and the safeguards need to be tightened up to make sure those implementing the study comply 100% with the guidelines.

I personally wear the "No Study" bracelet for a couple of reasons:
1. I don't believe that patients should be subject to experimental treatment protocols without their informed consent.
2. While I firmly believe that the intent of the majority of health care professionals is in the right place, there are enough of them out there that tend to play "fast and loose" with the rules that I don't trust them to comply with the study safeguards.

Joel Sherman said...

Jimmy,
I know little about the polyheme study, but I find it hard to believe that its use would expose recipients to a significant risk of HIV infection greater than they would get from any screened blood products (which is very small) which they were very likely to get anyway.
If you know differently please post it. I can't imagine anyone agreeing to the use of a product which would increase their risk of AIDS unnecessarily.

TT said...

Joel,

The risk of exposure to blood borne pathogens from the blood substitute products (which are derived from hemoglobin) is the same as it would be for screened blood products (whole blood, packed cells, etc.), while the standard field intervention (normal saline) does not have that risk. Screening is not perfect, and even with screening there still exists a possibility of exposure to blood borne pathogens such the HIV & hepatitis viruses. The more instances of exposure, the higher the statistical risk.

Since the study results indicate that polyheme showed no increase in survivability, and in fact the death rate for patients receiving it was higher than those in the control group receiving NS, I see no justification for it's further use or approval. Further, O-neg (universal donor) blood can be administered to almost anyone, and the logistics of refrigerating it in the field are not insurmountable, so while a blood substitute might be convenient, there are realistic ways around it.

What I find really disturbing is that one of the major sponsors of the research is the DOD. The battlefield is one area where substitute blood products would be of great value. I have no problem with researching that objective, but I find the use of vulnerable private citizens to conduct that research without their informed consent both reprehensible and highly unethical...in my opinion of course. - TT

Anonymous said...

TT -- Thanks for your posts. Very high quality. Very informative.

I'm in the process of writing up what little I know about the project and the ethical issues surrounding it after I refreshed my old and failing memory this morning. I also contacted my cousin's husband John Ferrugia in Denver, one of the study sites. He's a 7NEWS Investigative Reporter in Denver and has frequent contacts with the head (former head, now, I guess) of the Denver-based study Dr. Ernest Moore who was featured on a 20-20 investigative report a few years back that I taped. John is the reporter who broke the story about the sexual assaults at the U.S. Air Force Academy a few years back. He had some interesting things to write.

The two studies I read about found that the use of PolyHeme was actually counterproductive. Each time, however, Northfield Labs debunked its own study and after the Phase III study sought to reanalyze the data to find a positive effect. Based on what I know about probability theory vis-a-vis the random assignment of subjects to experimental treatment groups, had they found a positive effect, it would have suggested something fatally wrong about their methodology. The second study involved reducing the sample size, which could explain why they failed to find an effect, as you suggest.

Based on what you've written, maybe what I have written is moot and superfluous. But I think I'll post it anyway -- maybe tomorrow. It'll give me something to do. And, I'll fool myself into believing that all that work was not in vain. -- Ray

Joel Sherman said...

I still haven't come across the actual details of the polyheme study. Maybe TT or Ray has them. But from what I can gather medically the study is very reasonable. TT saline is not a substitute for blood in an emergency situation where the patient is in shock from blood loss. Blood just can't be practically given in ambulances or on the scene. Saline is just an attempt to keep the patient alive until blood products are available. Polyheme seemed like it could improve survival in this situation. It was certainly a reasonable hypothesis. I would have agreed to receive it under emergency circumstances.
It's a different question if the study was negative. Have the results been released? But I certainly agree that commercial abuse of research is rampant. See the Amgen articles under the HIPAA thread I believe for an egregious alleged example.

TT said...

Joel & Ray,

The following is a url to the report on the study results published in Nov 2007 by UTHSC in San Antonio, one of the participating facilities.

http://www.universityhealthsystem.com/news/DOCS/PR-11-07-07.pdf

The following are direct quotes from the report:

"Every second counts for severely injured and bleeding patients, so finding the safest and quickest way to stabilize those suffering from massive blood loss is a top priority for emergency responders and trauma surgeons. For this reason, University Hospital and Brooke Army Medical Center (BAMC) were two of 32 Level I trauma Centers across the United States taking part in a study involving the use of PolyHeme®, an investigational blood substitute, in trauma patients suffering shock due to massive blood loss."

"Today, The University of Texas Health Science Center and U.S. Army trauma surgeons, heading up the San Antonio arm of this national study, released results which indicate that patients receiving PolyHeme did about the same as patients who received the current standard of care for shock – saline solution given intravenously. However, after analyzing the national data, they
conclude PolyHeme may have some increased risks when compared to blood."

"Nationally, a greater number of heart attacks were reported in patients who received PolyHeme (11) than those who received saline
(3)."

If you go back to the original proposal for the study, one of the reasons given is to improve survivability rates in trauma victims.

The reported results pretty much speak for themselves:
1. No improvement in survivability when compared to current standard of care.
2. Evidence suggests that Polyheme may have some increased risks compared to blood.

Doesn't sound like something I'd want to take a chance on.....again, just my $0.02

TT

TT said...

Ray,

All I've seen from the ethics standpoint is the little I referenced earlier - and I found that fairly disturbing. I'd definitely be interested in anything you come up with.

TT

Anonymous said...

Jimmy Here,

Not sure how many of you guys go to MSN but here's a recent article that was posted on their homepage, can go along with the conversation on the Johns Hopkins study:

http://www.msnbc.msn.com/id/22827499

Atleast some people a starting to recognize some of the every day errors that happen. Nice to see it where it could get some attention.

Joel Sherman said...

Jimmy,
I'm not sure how a patient is supposed to know if their provider washed their hands. Most hospital rooms don't have a utility sink and you don't want to use the patient's bathroom. One hospital I know of is always urging providers to wash their hands, but trying to figure out where to wash them is a different problem. We used to use the soiled utility rooms, but then the state ordered them to be kept locked because of some rather ordinary supplies stored inside. There are no utility sinks in the hall on most floors. I've complained to hospital authorities, but so far nothing has changed. They need to install sinks in the hall. I wouldn't be surprised if they need some state OK to do that too.

Joel Sherman said...

TT,
Thanks for the reference. It is a public statement to the community as mandated by the release from the informed consent requirement. It says the results have been presented at a conference. I don't know if they've been published yet.
At any rate, the results are clearly stated to show no benefit. That is medically disappointing as it could have been an important life saving therapy. But I doubt that the possible hazards were significant. All you can usually talk about is identifying some possible trends when you're dealing with low numbers, such as a few heart attacks. I'm sure the published results will include all the info.

Anonymous said...

Joel,

I provided that reference just because it had many of the same points as what was discussed earlier in this topic concerning the 5 steps checklist. I honestly don't know how OR's are layed out or where the sinks are. I would've guessed that they were at the end of each suite but I guess I'm wrong. Here's the opening sentence from the reference that you provided:

"A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves."

Again, just thought it had value to what was already said here. Jimmy

Joel Sherman said...

Jimmy, just for clarity I would think the reference you gave is not about OR's, but regular patient rooms. Everyone in an OR suite has to scrub and wash their hands. It's only a question on the floors.
Just thought I'd point out how the crazy mix of conflicting rules and regulations can give you unintended results that make even seemingly trivial policies problematic in practice.

Anonymous said...

Joel,

Thanks for the clarity, I see your point and I can see how that is valid. Most rooms that I've been in do have sinks in them but in the two outpatient facilities I've been to, only one bathroom for all the patients and most of the time your already on an IV so that's not to sanitary as well. Sinks in the hallway would do alot of good. Jimmy

Joel Sherman said...

A New York Times editorial follow up on the Johns Hopkins 'handwashing' study.

Anonymous said...

Back to the PolyHeme study -- I contacted members of my family who live in Denver to find out if any of them knew of the PolyHeme study that was conducted there. As I suspected, the only one who did was my cousin's husband, John Ferrugia. So, in spite of the fact that it was widely publicized and in spite of the less than charitable assessment of it in a 20-20 report in Denver several years ago, none but the investigative reporter in the family had ever heard of it. He personally knows the ex-head of the Denver study Dr. Ernest Moore and has "interviewed him many times over the years." He writes, "It is a very well known study in the medical community. . . especially the military where blood products expire quickly, especially in a warm environment." He remembers that the "initial results of the study were discouraging as mortality was greater in the aggregate among the patients who were given polyheme" and remembers that Northfield Labs stock dropped precipitously after the report of the results were made public. "However," he writes, "later there was an article noting that the product had been used on some patients who were not eligible, thereby skewing the results negatively." He did not, however, know about the wrist band opt-out option.

I responded to his e-mail message and pointed to some of the ethical issues associated with the study which were mentioned by TT and about which I read. Aside from the ethics of the research, there was also some shady behavior on the part of Northfield Labs such as announcing that it had provided data from the Phase I study to a well-known Johns Hopkins medical researcher who would verify publicly that there was no causal connection between PolyHeme and the 10 MIs and two deaths. The physician and Johns Hopkins forced Northfield to recant because it had not, in fact, provided the scientist with all the data from the study.

In John's last communique to me, he noted, "My cursory reading of material seems to indicate the product is to be used in only certain cases that were outlined in the study . . . and some doctors did not follow the protocol." As far as I could tell, I responded, there was only one systematic omission that occurred across sites which carried ethical implications; viz., the failure to inform the public (in ads and at community meetings) and subjects or their kin (when patients receiving PolyHeme were admitted to the hospital) of the results of the Phase I study. And I had no evidence that potential participants or participants/family were informed about the results of the Phase III study published in December, 2006.

John added, "I have not called Dr. Moore about this because I have neither heard nor seen any facts to refute the authenticity of the study."

So I did a little analysis of what, from my reading, aided by the report sent to me by TT, was the science of the study. I have included below what I e-mailed John. -- Ray


When I first came across information about the study in 2000, it appears that Phase I was a methodological catastrophe – There was no control group. Because 10 people out of 81 experienced MIs and two died, the study was halted and then begun again, this time using what appears to be a post-test only control group experimental design with random assignment of subjects to different treatment groups. Both studies appear to have been authentic, but the latter was (or, at least, started out to be) more methodologically rigorous than the former. One thing that confuses me at this time, however, is that it appears there was only one dependent variable – death rate. It would seem advisable to have other dependent variables (e.g., side effect variables) that could favor use of PolyHeme or saline solution/blood if no difference was found. It also appears that researchers did not plan to follow patients over some period of time to see if there were any differences between the control and experimental groups on the dependent variables. I have addresses and telephone numbers to contact sources that will allow me to do more digging in the future if I’m so inclined.

On November 7, 2007 it was reported by San Antonio’s University Hospital that the Phase III national study showed that “patients receiving PolyHeme did about the same as patients who received the current standard of care for shock – saline solution given intravenously. However, after analyzing the national data, [researchers] concluded PolyHeme may have some increased risks when compared to blood.”

The report does not give findings comparing PolyHeme to blood. The results comparing PolyHeme to saline solution were as follows – “46 [13.2%] of the 349 patients who were treated with PolyHeme died, and 36 [9.9%] of the 365 patients who received saline solution died.”

I conducted a statistical analysis on these figures and, indeed, failed to find a significant difference. However, there is a methodological anomaly; viz., random assignment of subjects to treatment necessarily results in an equal number of subjects in the experimental and control groups. The PolyHeme study ended up with an unequal number in each group. That probably occurred in December, 2006 when researchers found, as you noted, subjects included in both groups who had been ineligible for the study so their data were excluded from the study (20% of subjects from the experimental group and 15% from the control). Without going into detail, the problem with dropping subjects out of treatment groups in this manner is that it can defeat the purpose of random assignment and render a study internally invalid making the legitimate use of inferential statistics tenuous at best. It didn’t have that effect in this study, I don’t think, as I explain below.

So here is what appears to have happened. A Wikipedia publication titled “PolyHeme” reported, “On December 19, 2006, Northfield Labs released preliminary results of the trial, and the mortality data was [sic.] disappointing:13.2 percent of patients receiving PolyHeme died versus 9.6 percent among the control group.” I conducted a statistical analysis and failed to find significance between 13.2% and 9.6% at the .05 level.

The article goes on to report, as you recalled in your e-mail to me, “This news led to Northfield shares plummeting more than 50%.” However, the company remains optimistic, noting that of the 712 randomized treatment patients, 20% [n = 72] of the PolyHeme group and 15% [n = 54] of the control group were protocol violations, leaving a valid total of 586 patients.” Here’s where Northfield seems to be grasping at straws. The purpose of random assignment is to, probabilistically speaking, equalize experimental and control groups. In other words, if random assignment is done correctly, there should be no significant difference between the experimental and control groups on any variable. Consequently, if there is a statistically significant difference between the two groups on the dependent variable (e.g., mortality rate) at the end of the experiment, that difference cannot be due (statistically speaking) to differences between the experimental and control groups except that one received the experimental stimulus (e.g., PolyHeme) and the other did not. In other words, if random assignment was conducted correctly in the PolyHeme study, there should have been no significant difference between experimental and control group members’ ages, genders, intelligence quotients, ability to leap tall buildings in a single bound, and protocol violating characteristics. To test this proposition, I conducted an analysis on the significance of difference between the 20% of PolyHeme subjects and 15% of the control who were dropped from the study because they were protocol violations and found none. In other words, the random assignment did what it was supposed to do; equalize the experimental and control groups (probabilistic speaking) on protocol violating characteristics.

I also did some simple arithmetic and found that after the 126 subjects were dropped another 126 were added over the next eleven months. So, why did Northfield Labs drop 126 subjects from the study if it really didn’t make any scientific sense? Maybe it was ignorance. Then, again, maybe Northfield Labs was playing fast and lose with the rules of science so its representatives could justify their reportedly “optimistic” outlook to reduce the negative impact of its “shares plummeting more than 50%.”

There’s no reason for me to believe that the study was not methodologically sound. Given its methodological robustness, there was absolutely no scientific reason to extend the study for another year except to follow up with subjects; to do so was a waste of time and money and was possibly based on the pipe dream that the findings would, by some statistical miracle, turn around. Of course, those who criticize the study on ethical grounds might point to the scientifically unnecessary extension of the study as putting the public at unnecessary risk. They might also criticize the study on ethical grounds if researchers failed to inform the public (especially in information distribution sessions) and subject patients/kinfolk (after victims arrived at the hospital) about the results of the Phase III study.

On the other hand, after all the time I’ve put into my analysis and speculations, maybe you, I and others were duped into believing that Northfield Labs actually did drop the “protocol violations” from the study. After all, the figures from December, 2006 and November, 2007 are so close as to suggest that Northfield Labs, for some reason, may have sat on the results for almost a year. To be charitable, they may have sat on the results while doing follow-ups on subjects to determine if the mortality rate changed in either test groups. If so, the figures suggest that all of the subjects who were alive in December, 2006 were also alive in November, 2007. That is certainly possible, but difficult for me to believe. Further reading may quell my skepticism.

Whatever the case, it is, in my opinion, ethically obligatory for Northfield Labs to follow-up for at least a year with test subjects to find out if there were any delayed effects of using PolyHeme over saline solution and blood. This follow-up may be taking place but in the best of circumstances, it will take me some time to find out since I haven’t read yet if the study has been or will be published in any professional journal.

Joel Sherman said...

If anyone is still interested here's the AMA's take on the Johns Hopkins infection study promoting the use of a 5 point checklist. It's a good summary of medical opinion I believe.

TT said...

Ray,

Another url with info on the Polyheme trials you may find of interest...

http://www.circare.org/subjects/polyhemetrial.htm

TT

Joel Sherman said...

Thanks TT,
Good reference. The additional info it gives, that the polyheme was continued 12 hours after arrival at the hospital changes the whole character of the trial. It may even have been at least partly responsible for its failure.
As a patient, I would have agreed to polyheme in the ambulance, but not afterwards without clear proof of efficacy.

Anonymous said...

The principle of informed consent may today require some refinement in medicine and other areas, but I can't help but think about how far this nation has come.

A couple of years ago, I read a book by Edwin Black about the eugenics movement that gained popularity among members of the leisure class (including President Wilson, Henry Ford, and Oliver Wendell Holmes) from the late 19th century into the 1930s. The book is entitled "War Against the Weak." Black spends three pages or so writing about Kirksviille, where I teach school, and an osteopathic physician named Laughland (I forgot his first name.) who became one of the medical leaders of the movement. A hospital here was named after the guy.

Thousands of people were gathered up and underwent coerced sterilization. In Appalacian states, scores of "hill billies" disappeared while they were walking, working, and fishing; they returned days or weeks later after having been sterilized against their will by government-paid physicians.

Adolph Hitler modeled his early program after the American eugenics movement and gave speaches which contained phrases borrowed from Henry Ford who was as rabid an antiSemite as Wilson was a white supremicist. And, Josef Mengele's eugenic experiments with twins were financed by the Rockefeller Foundation.

The U.S. eugenics movement began to die out a few years after the incipiency of the Tuskegee syphilis experiment in 1932. The program was actually started to treat blacks with syphilis in Macon County Alabama. It was only funded after Congress was persuaded by government physicians that if syphilis was not stopped in black communities, it would filter into white communities. The program was threatened when money began to run out. However, because the only research on syphilis at the time was conducted in Scandanavia with white subjects and because people of color were considered to be inherently syphilitic, medical scientists wanted to find out if syphilis would operate on black folk in the same way it did on white folk, so the program was salvaged but without the arsenic-based interventions (which apparently had some effect in destroying the syphilis spirochete, if it didn't kill the patient). Thus began the experiment on untreated syphilitic blacks, publications about which can be found in early copies of the JAMA. Govenment doctors ran the show and a black nurse by the name of Eunis Rivers was used to attract black men (about 400 of them) with syphilis into the program with the promise of meals, payment, and a $50 burial fee in return for agreeing to an autopsy after they died. The U.S. military, churches, schools, and the government all conspired to prevent subjects from making informed decisions about their treatment. The 400 or so subjects were told they were receiving treatment when, in fact, they received placebos; they underwent spinal taps after being told that a spinal tap was a "very special treatment" rather than a diagnostic procedure; when they went for treatment, Nurse Rivers tracked them down and threatened to withdraw benefits if they received treatment; the military would not allow them to join because it provided treatment that would screw up the experiment; when penicillin became commonplace, it was not offered to any of the men.

The experiment, which was to run for only a few years, lasted until 1972 when the government, recognizing the parallel to Nazi experiments, terminated it.

The U.S. eugenics movement gave the U.S. one black eye and the Tuskegee syphilis experiment blackened the other; and, not only did the science stink, it didn't tell us anything we didn't already know.

The experiment is detailed in a book entitled "Bad Blood" by Jones. A excellent film, "Ms. Ever's [instead of Rivers] Boys" dramatizes what occurred over those 40 years. -- Ray

Joel Sherman said...

I think I'd put the stress on how our concepts of ethical experiments have changed over the years more than just on informed consent. Nobody would consider an experiment such as the Tuskegee syphilis experiment today even if you could get 'informed' consent for such a proposal.
In the 19th century physicians experimented on themselves. The transmission of yellow fever by mosquito vectors was found by experimenting on subjects who in part were told the risk, and several of the physicians involved inoculated themselves with some deaths resulting. The Frenchman Jenner experimented with smallpox vaccines by injecting his infant son repetitively, probably leading to the boy’s sickly youth and early demise. In the early 20th century, the first cardiac catheterization was done by a German Werner Forssmann on himself. He threaded the catheter in his own arm and then walked to x-ray so he could take a picture to prove it was in his heart. He was fired for his achievement, though later won a Nobel Prize.
So we've come a long way in the design and ethics of medical research, not all of it for the good. No one volunteers to be their own guinea pig nowadays.

Anonymous said...

Joel -- Intersting. I heard about self-experimentation in the "olden" days but had not, until now, read any examples.

I have read about and do have a video tape about CIA human experimentation during the Cold War. It occurred at least through the '60s but most of what I read is from the '50s. It's chilling.

In the video, there's a depiction of a British scientist who is shown taking LSD and then describing what he was experiencing. In my mind's eye, I still see his facial expressions as he was taking his "trip." -- Ray

Joel Sherman said...

Sometimes I think that the Wall Street Journal should be called the Wall Street Journal of Medicine. As the health industry gets more and more commercial, more medical news can be found in the WSJ than in most medical journals.
Here's an article on informed consent for drug trials and what most patients don't know, that if something goes wrong, the patient may be left footing the major bill for it. Makes you think. (BTW, I don't know how long this article will be freely available online; most of the WSJ online is subscription only.)

Anonymous said...

Well, this article reiterates in one sentence what many have said about the consent forms:

"But the wording in these consent forms is often confusing and vague."

Something hit me as I was reading this. I was nervous through my last procedure because it was going to be the first time under general anesthesia. I knew the risk because I studied what it does to your body and it always mentioned the side affects. During the day of my procedure, none of this was covered by the doctor? I did get the form and sign stating that they would use general anesthesia but it was right before I went back for the procedure, it was a two page document so I didn't want to delay any longer. I'm just wondering if this was explained to this person or if they even covered any of the potential side-affects with her. I realize that it was a trial but surely they could've taken an educated guess as to what it may do? Just think about all the drug commercials on TV, they always end with the risk portion and say to discuss with your doctor if you experience any of these symptoms.

Whether patients agree or not, we're going to have to be proactive in our care to prevent things like this from happening. It may slow the process down, but it could prevent many issues. Jimmy

Joel Sherman said...

Here's more alleged drug company malfeasance of a company accused of testing new medicines without authorization or informed consent. It's hard to judge how balanced a presentation this is, but there's certainly no lack of accusations against big pharma for these kinds of violations.
The drug is called Providex and is apparently for 'sore relief.' It's so investigational that no other info appears available.

Joel Sherman said...

Another good article from the Wall Street Journal on informed consent stressing the need for understandable forms. Of interest, it states that The Centers for Medicare and Medicaid Services have issued new guidelines stressing understandable forms. I'll see if I can find these.

Joel Sherman said...

Here's an interesting academic article which involves informed consent in part, but is really a discussion of the whole patient/physician interaction in a larger sense.
It's worth reading if you can wade through it.

Joel Sherman said...

How does one go about getting informed consent when a patient comes in unconscious or incompetent, sometimes without even identifying information?
Here's an article which addresses that problem. It's one I haven't had to consider much, but happens in ERs all the time.

Joel Sherman said...

The feds via OHRP (the Office for Human Research Protections) has relented in the Johns Hopkins and Michigan Hospitals study controversy outlined above and decided that the protocol can continue without informed consent.
All it took for them to come to their senses was some overwhelmingly bad publicity as documented above in major newspapers. Added later was criticism by the prestigious NEJM. If it takes that much, it’s not often that stupid and counterproductive federal measures will be overthrown.

Joel Sherman said...

This quote from a commercial site outlines perhaps the most stringent requirement of informed consent that's been suggested, that patients be able to repeat back what they've been told.

In its recent landmark report, "Making Healthcare Safer," the Agency for Healthcare Research and Quality (AHRQ) identified missed, incomplete or not-fully-comprehended informed consent as a clear opportunity for improving patient safety. Specifically, the report recommends that health care organizations require patients to recall and restate the information that was shared with them during the informed consent process to ensure they completely understand their conditions and the corresponding procedures.

It certainly sounds as if this is the most fool proof test of whether a patient really understands, but it also has practical problems with many elderly patients who are still legally competent or patients for whom English is not their primary language.

Joel Sherman said...

Here's a nice summary of what a patient should know before entering a hospital with the emphasis on informed consent.
My guess is that only a very small percentage of patients are familiar with everything they ideally need to be to make an informed decision. Not many people have the time and energy to do this, and many are just not well enough.

Joel Sherman said...

Here's the AMA's take on the case of Brian Persaud who underwent the forced rectal exam in NYC. The summary emphasizes only one of the issues though, that is whether informed consent was necessary in an emergency situation. It ignores the real question as to whether he actually needed a rectal exam as he had no evidence of a spinal chord injury. It also ignores the exceedingly bad judgment of the hospital in having the patient arrested.

Joel Sherman said...

Here's a good article describing what patients need to do with informed consent when they check into a hospital. Unfortunately the vast majority of patients aren't capable of doing this when they check in for surgery or for an urgent illness. The only practical solution is to mandate that whenever possible the informed consent papers be made available to patients before hospitalization so that they can read it preferably with a family member well before they have to sign anything.

Joel Sherman said...

This post is equally appropriate under the HIPAA thread.
Electronic prescribing has benefits, but also great privacy dangers. Under HIPAA, all kinds of companies have the right to access your records and 'data mine' them. You have lost the right to be asked for informed consent about this under updated HIPAA regulations.
Here's an editorial on the subject.

To be fair, here’s an opposing point of view from a New York physician. He’s right that protecting privacy will involve more paper work, but physicians’ offices already do this with HIPAA and it wouldn’t be an unfamiliar burden. I don’t think New York’s proposed legislation goes anywhere near far enough though. A one time informed consent isn’t good enough. For example, a pharmaceutical company that wanted to access medical records should have to get informed consent each time. And the burden should be on them to obtain it, not the physician’s office. It’s the company that wants to make profits on this, not the physician.

TT said...

I ran across an article that I feel is an excellent treatise on the whole issue of informed consent. To me it both clearly outlines the problems and limitations of the existing process, and offers constructive recommendations on how it can be improved that benefits both physicians and patients.

The article can be found here:
http://www.informedmedicaldecisions.org/pdfs/shared_med_decisions.pdf

Be forewarned, it's 70+ pages, but I feel it's well worth the read to anyone interested in this issue.

TT

TT said...

OOPS!

The url was truncated - here is is broken into 2 lines........

http://www.informedmedicaldecisions.org/
pdfs/shared_med_decisions.pdf

Joel Sherman said...

Thanks for that scholarly reference TT. It'll take me awhile to digest it.

Here's the reference in one piece.

Joel Sherman said...

Here's an interesting post (which may scroll down)from Minnesota saying that the state wants to eliminate the need for informed consent to take DNA samples from all infants born in that state. The state has been doing that for some years apparently through pro forma consent. I haven't seen a good description of what these genetic samples are used for, but apparently some have been sent to the Home Security Administration and kept on file. If true, it's certainly a topic that needs to be brought out into the open.
A side box on this website recommends that patients not sign HIPAA consent forms at their doctors offices or hospitals saying that it's not required, doesn't give you any extra protection, and in fact helps indemnify the institution if other 'covered entities' spread your information. Sounds like a good idea, though as physicians we are required to give these notices to patients.

Joel Sherman said...

Here's an update on the forced rectal exam that's going to trial soon. They're asking for 36 million in damages. We already knew he had an aggressive lawyer. Not sure how the case got to the NY Supreme court. What happened in lower courts?
At any rate, I await the outcome with interest.
I still believe that the patient, Brian Persaud, has an excellent case.

Joel Sherman said...

Here's a National Cancer Institute guide for informed consent as concerning clinical trials. It's clearly idealized and doesn't really match what happens in the real world. But it's still a somewhat useful guide to what should be done.

Joel Sherman said...

Here's a variation on the substitute blood experiment in emergencies using saline. But the ethical conundrum is the same. The study is not feasible if you need to get informed consent from urgent accident victims so by federal law you have to opt out before hand by wearing a bracelet, which is a preposterous idea. How many people will bother to do that?
I have no answer for this quandary. I certainly don't trust pharmaceuticals to make decisions for me, and the government can't always be trusted either. These questions are mostly related to traumatic injuries and the army has the biggest stake in it. Seems to me that they could answer most of these questions on the battlefield.

Here’s another reference which gives more medical details as to what was used and done.

Joel Sherman said...

Here's another article referencing Minnesota's project of obtaining DNA from all newborns. The issue is that now you have to opt out of it to prevent it. There is a new bill which modifies the informed consent options parents have.
I'm not fully clear on what the benefits to the individual are of this program, as opposed to research opportunities. Don't know how you can give valid informed consent to a project which might entail your DNA being used for who knows what purpose decades down the road.

Joel Sherman said...

This may be the final follow up to the forced rectal exam case in Manhattan. A trial jury voted against Brian Persaud and gave him nothing. Don't know what the reasons were though his lawyer clearly was overreaching asking for 36 million. Still a very interesting case.

Anonymous said...

The 36 million is the only reason why he lost this case. If anything, maybe this case brought awareness to other doctors that may try this in the future. I certainly wouldn't want that forced upon me and don't believe for one second that the jury thought it was necessary. He just got greedy and this was a good decision based upon today's health care cost crisis. Jimmy

Joel Sherman said...

Jimmy, I think there's another aspect to the case as well. If you read the NY Times article, it mentions for the first time that I've seen that the plaintiff, Persaud, was not a sympathetic character, but an immigrant with a prior criminal record. This undoubtedly also colored the jury’s thinking, especially in view of a 36 million claim for damages.

Joel Sherman said...

An article in JAMA pretty much sounding the death knell for emergency blood substitutes in emergencies (although I note the article is a meta-analysis which I never fully believe to be reliable).
At any rate you can add me to the list of non-believers in this therapy. I would not volunteer. Glad my area was not part of any of these studies which were excused from the requirement of informed consent.

Joel Sherman said...

Here's an anesthesiologist's opinion on informed consent, that she doubts whether it can ever be fully informed. That's correct of course in the sense that a patient will never be as informed as the physician and it's hard to know how much information is necessary or even wise. Every patient is different, some want to know everything, others want the physician to decide for them. I try to explain the alternatives to patients, but I always feel I should also give them a recommendation. If they come to me, hopefully my opinion carries some weight with them. I usually will say what I would do if I was the patient or what I would recommend to my family in the same situation.

Joel Sherman said...

I found this story on a lady's blog interesting. It certainly exemplifies all that can be wrong with the process of informed consent and affirms some of the complaints in this thread. Most of this is found in the first paragraph though she says more about how her modesty was disrespected by the nurse involved. Basically she was asked to sign a blanket consent form which she ultimately refused. She received no adequate instruction. She's lucky that they proceeded with the test.
Most places you would be asked to sign a specific procedural consent form, usually by the physician doing it, but then the hospital may well ask you to sign a general consent form which gives you no rights. It's the latter that is the problem. If they should refuse to proceed, I believe you would have a valid complaint which could be filed with a state regulatory commission or with JCAHO.

Anonymous said...

I FOUND THIS ON THE NET. THOUGHT
IT SHOULD BE POSTED HERE.
KYLE


Leffell DJ, Berwick M, Bolognia J.
Department of Dermatology, Yale School of Medicine, New Haven, CT 06510.

BACKGROUND. Public skin cancer screening has become increasingly common in recent years. However, currently there is no standardized procedure for these screenings. Full body skin examination as opposed to examination of sun-exposed areas offers several advantages, including the opportunity to diagnose early melanoma in areas normally covered by clothing. Disadvantages of full body skin examination include patient resistance because of inconvenience and concerns about privacy and modesty. The additional time involved in full body skin examination may also be an impediment. OBJECTIVE. In a randomized double-armed study, we studied whether patients were more likely to develop a positive attitude towards full body skin examination if they were advised beforehand, in writing, of the logic underlying the need for a complete examination. METHODS. Patients presenting to a public skin cancer screening were divided into two groups. Group A (N = 111) received a written explanation of the need for full body skin examination and Group B (N = 175) received no information. Patients were then surveyed, after the screening, about their attitudes towards full body skin examination. RESULTS. Those who received pre-education were less likely (P < .05) to be concerned about a genital examination. Those who were concerned about a genital exam were compared with those who were not concerned about a genital exam, the former patients were: 1) younger (P < .05); 2) more concerned about privacy (P < .001); and 3) preferred a physician of the same sex (P < .001). CONCLUSION. Providing patients with information about the need for full body skin examination decreases concern about undergoing a skin genital exam and may minimize resistance to full body skin examination in public skin cancer screenings.

PMID: 8349904 [PubMed - indexed for MEDLINE]

Anonymous said...

I'd also like to comment on the article, "Frida Writes", linked above.

In my experience this is so typical of hospitals and medical
testing procedures.

The patient is assumed to know
nothing and expected to do exactly
as told. If you refuse to go
along, they will make your life
difficult. It often reminds me
of the effect generated by arguing with a cop over a ticket.
In fact, for me, the atmosphere
in a hospital often appears to
reflect the para-military atmosphere of a police station.
Ever ask a police officer a
question in a police station.
They are coarse, cold, rude,
always in your face, immediately, to put you on the defensive about
the slightest enquiry. Argue with
a cop or a desk nurse and you'll
notice that protective
elements start to form-up on the
fringe, just in case you try
pushing too far. Great atmosphere
to get well in. Generally speaking, I hate medicine and medical personnel as much as
most cops I must deal with.
KYLE

Joel Sherman said...

Thanks for the reference Kyle. I'll try to look up that reference when I get back. I'd be interested in the actual percentages of young people who preferred same gender exams.

Joel Sherman said...

Here's a particularly egregious example of abusive informed consent if the details are accurate. This is a personal account written by a California litigation attorney.
Needless to say, consent papers are supposed to be signed prior to any procedure. After the procedure has started the validity of informed consent is easily open to question.

Anonymous said...

Well, I'm glad that I've never had to experience anything like what was stated in the above blog. Just had an EGD this week, completed all registration papers weeks before the procedure and read over the consent forms while waiting for someone to take me to the procedure room. The only form I didn't sign was the anesthesia form, which I waited because I wanted to speak to him about the bad reactions that I have after anesthesia. I don't know how much you can really fault hospitals/doctors offices because for it to become SOP, that means that no resistance (or not enough) has been met. Do the research in advance, you can call ahead and get your forms in advance if it's not an emergency. That will prevent this type thing from happening. Jimmy

Joel Sherman said...

I admit that I have seen many examples of consent forms signed at the last minute. Most of these occurred years ago when it wasn't a major issue. Now most hospitals are much more careful. But it still happens, often when a hospital has changed forms and an older form is signed, or the patient is given the wrong form to sign to begin with. But consents signed after sedation is given or the procedure has started may be worse than useless.
Most doctors have consent forms signed in the office where there is lots of opportunity to ask questions and explain, but most hospitals have not yet gotten to the point where the necessary forms are sent to the patient before coming to the hospital.

Joel Sherman said...

Apparently the Mayo Clinic didn't believe in informed consent, at least not enough to put it in writing. I find it amazing in this litigious age that they could have practiced these policies for years without a major lawsuit based on it. Maybe people aren't as lawsuit prone as I thought. Without signed consent, the physician has to write a long inclusive note documenting what was said. They should do it anyway, but it's time consuming and most don't usually take the trouble to write a detailed note.

Joel Sherman said...

This anonymous post has been copied from another thread.

I would be very curious to know how many of you are familiar with the "Informed Consent for Surgery" form where it says:
"I consent to the admission of 'observers' into the procedure for the purpose of medical education or science."
"I further agree that photographs and a narrative of my case may be utilized for medical or science, including publication in a professional journals and medical books."
"I understand that photographs and movies may be taken of this operation, and that they may be viewed by 'various' personnel undergoing training or indoctrination at this or any other facilities."
From here on, beware of what you sign - cross out these paragraphs if you object to them and initial them.
I for one wouldn't want a bunch of "observers" standing around 'learning' how to insert a Foley' or any other handling of my private parts - or photographing them with their cell phone cameras for 'entertainment' later on at one of their socials.
If I ever thought that was what they did and could prove it, I would have some licenses decorating my wall.
These statements are not standard but are common in many hospitals, especially teaching hospitals. They should specify that the patient will not be identifiable. I would not want to sign a statement that doesn't specifically guarantee that. But it would be rare that the teaching materials would be abused to provide entertainment. For instances of abuse look thru the thread of 'taking videos and pictures without permission.

MER said...

Joel:

Is there such a thing as a standard form for Informed Consent for Surgery? I had some minor surgery recently and I didn't see the kind of rights granting that this anonymous poster mentions. I'm sure it's on some forms. Maybe we could go to a few hospital sights that publish these forms and look to see what they are really saying. I don't recall seeing anything about film, educational use or observers on the form I signed. If I had seen it, I would have crossed it out.

Joel Sherman said...

MER, there are no standard forms, though probably JCAHO makes some suggestions.
But every hospital has somewhat different needs. Large teaching hospitals would include clauses to cover students and residents being present. Small rural hospitals likely don't need such clauses. Same goes for filming. A very few hospitals video all OR procedures and these may be controlled by technicians with little medical training. Some hospitals aren't equipped to film anything routinely and that may be where your experience is from.
A few hospitals put their permission forms online and you can search them.

cjahobson said...

Hi I came across tghis site in Queensland (a State in Australia). They have listed a series of secific consent forms as well of a general one. The thing I noticed is the comment about being filmed. I gather that these forms are made available for specific facilities to use. Whilst I am in a different State in Austrlia, I wonder what would happen if the patient deleted any of the clauses for example?
This is the link: http://www.health.qld.gov.au/informedconsent/default.asp

Chris

Joel Sherman said...

I found that site interesting Chris. It's too bad that there are no similar sites available for the US that I know of.
It would be useful indeed if the feds or AMA would put out a series of consent forms for all procedures in this country which could constitute a legal and medical standard.

Sam said...

Informed consent has always been ignored with cervical cancer screening.
Doctors in the UK & Australia are paid to reach screening targets which has caused some very unethical conduct. (particularly in the UK)
I believe screening targets are in direct conflict with a doctors obligation to obtain informed consent.
In the UK the situation reached serious levels...doctors pressuring, harassing, coercing, frightening, intimidating - two doctors pressuring one patient, women being asked to leave a practice unless she agreed to testing, being labeled defaulters and refusers, opportunistic screening...so women couldn't see a Dr for a cold without being pressured...doctors asking women to sign disclaimers.
Also, totally inappropriate testing is a problem around the world - testing virgins & pushing women who've had complete hysterectomies for non-cancerous conditions into testing.
Thousands of women are being forced into testing and/or being tested unnecessarily...and we're talking about a VERY invasive exam.
It was also fairly common for doctors to refuse the Pill without testing - cancer screening has nothing to do with contraception - I doubt any of our doctors do that now - women are more aware.
In the States however, severe medical barriers prevent access to the Pill. (pelvic, rectal and breast exams and annual screening)
My US colleagues receive their medical care in HK and avoid US doctors - they regard these requirements as totally unnecessary and therefore, unethical and even abusive. Informed consent is once again, totally disregarded...even though many US medical associations (follow the rest of the world) and say these requirements are unnecessary, the doctors still persist with their requirements preventing access.

The UK General Medical Council have finally made a stand...
Dr's must now disclose they have a conflict of interest, admit the woman has a low chance of benefiting from the testing (uncommon cancer) and a fairly high chance of an incorrect test result and that a false positive leads to biopsies which can be harmful. (unreliable test)
The Dr MUST obtain informed consent and respect and accept the woman's decision.
A Dr can offer a test, but that's all - they can't recommend or anything else.

The truth behind this test is eye-opening - Dr Angela Raffles (UK cancer screening expert)released some statistics - 1000 women need regular testing for 35 years to save ONE woman from cervical cancer.
Armed with the facts, ALL of them, (and considering your risk profile) many women may choose not to have testing or have it less often...
Until recently, it was impossible to make an informed decision - women were given misleading information and no risk information - a scare campaign was used to force compliance.

Smoking cigarettes is a FAR, FAR greater risk factor for cancer than choosing not to have an unreliable test for an uncommon cancer - a test more likely to harm you, than help you.

A report by RM DeMay published in 2000 in the American Jnl of Clinical Pathology, "Should we abandon pap smear testing" says that of the 1% of women who'll get this cancer, ONE THIRD will have a false negative test result and may delay seeing a Dr for symptoms, reassured by the test result and therefore, face a later diagnosis - so this group may be disadvantaged by testing...that leaves 0.66% of women to benefit from screening.
Apply your risk profile and your chance of benefit may be tiny.

The other fact - two yearly testing means almost 78% of women will have biopsies, with only a very small number having any sign of cancer - annual screening means 95% will have biopsies - three yearly 65% (L.Koutsky, Cancer Prevention, Fall 2004, Issue 4 & DeMay Article)
A false positive causes enormous anxiety and biopsies are very unpleasant and painful - some women take weeks or months to heal and some are left with permanent damage that can cause problems with fertility and during pregnancy.
I'm grateful I was alerted to the real facts 30 years ago...and now I see the same deception with breast screening.
I would never agree to mammograms - yet most women have no idea of the significant risks.
The Nordic Cochrane Institute have just announced that the breast screening brochures should be redrafted because they don't provide risk information - just the upside of screening.
How disrespectful to women and how arrogant - to take chances with our health by keeping us ignorant, afraid and deliberately misleading us?
When did medicine become so dishonest?
Cancer screening is offered to healthy people - IMO doctors are morally and ethically obliged to present all the facts and leave the decision to the patient.
We are all prepared to accept different types and levels of risk in our life.
Informed consent - don't ask a Dr - most have never heard of it or consider themselves above it...

Joel Sherman said...

Thanks for the post Sam. Informed consent is indeed not generally taken seriously for what are considered screening procedures which are non-invasive, that is not requiring any surgery or anesthesia. -Though clearly many women think of pap smears as invasive. Like the post above suggests, we should have standard informed consent forms for all procedures that are in widespread use. I personally don't know the up to date recommendations for pap smears (not my field) but I understand they are indeed loosening. What you describe in the UK and Australia is outrageous in that doctors are being pressured to do them. But we are not far from that. The quality controls that the present administration would like to pass could indeed include guidelines for physician payments that are equally objectionable. I don't know where it will go.
I personally get yearly prostate screening and DREs because I have a family history of prostate cancer. If it weren't for the family history, I might well go longer than a year. I also got a screening colonoscopy which is quite invasive, but if all is well, it is only recommended every 10 years which is acceptable. I'd think twice if it was every year.
Health screening and preventive medicine is a mantra in US medicine, but it is not always evidence based. Of course most of medical practice is not evidence based and can be challenged. The more patients research their own medical care, the better off they are.

Hexanchus said...

Joel,

The definition of an invasive procedure is "A medical procedure which penetrates or breaks the skin or a body cavity".

Hence a PAP, DRE, etc are all invasive procedures by definition and should require informed consent.

Hexanchus

Joel Sherman said...

I don't doubt that you found that definition Hexanchus, but your definition would also include putting a tongue blade in a mouth or even a speculum in an ear.
In practice I know of no one who gets written informed consent for entering readily accessible cavities when no cutting, punctures or anesthesia is needed. That includes pelvics, DRE's, and what I mentioned above.

Hexanchus said...

Joel,

The definition I provided is the accepted standard - can be found on many "official" sites, including NIH, NCI, AMA, etc.

Informed consent takes many forms - doesn't have to be written for exams, simple procedures, injections, etc. That said, for any invasive procedure, at the minimum the provider should explain to the patient what they are going to do and why, give the patient an opportunity to ask questions, and get consent from the patient (either verbal or by action) before proceeding.

Joel Sherman said...

I agree with your comments Hexanchus. But when an exam is considered routine and without significant risk, very few doctors take the time to explain it thoroughly, the reasons for doing the test, and alternatives. Agreement to have the test is taken to be consent.
Not saying that's ideal, but most doctors would tell you that they don't have time for long explanations for routine parts of the physical such as pelvic and rectal exams. Ideal would be to have pamphlets available on all the procedures for those who wanted more details.

MER said...

"Routine" is one of those catch words. It needs to be understood in context. All professions get into routines, and as I've stated before on other threads, routines are neither good nor bad. They can be both. It's one thing for a pilot to go through his routine checklist before he takes off. I hope he does. That's a good routine. In operating rooms they go through checklists, too, before starting. All good uses of routine.
But doctors need to understand both intellectually and emotional that pelvic and rectal exams, although routine parts of the exam for them, and not routine for the patient. That's why doctors need to really assess whether they can take short cuts here. For some patients it's okay. for others it isn't. It's not a question of having enough time. It's a question of getting in touch with the patient's needs.

Joel Sherman said...

MER, I don't disagree with your comments but I view it more as Dr 'Chill' did on Bernstein. It is impractical to take 10-15 min to fully discuss the pros and cons of doing a rectal or pelvic exam every time you do one. Especially nowadays when most doctors aren't their own boss and are paid or graded on their productivity. That's not the way it should be, but it's far more likely to get worse before it gets better. That's why I recommended having brochures available that fully explain the pros and cons of these tests.
But certainly most patients know what to expect and don't need lengthy explanations. They are certainly a 'routine' part of my exams and my wife's. If I had questions I would do the research on my own. It's not hard to do nowadays on the web.

MER said...

I think we basically agree, Joel. I'm not suggesting these discussions go on every time for every patient. But there may be some patients, probably a small number, who need the personal touch. And this is where physicians must make sure they deal with individual social and psychological needs and not just look at the clock and follow a routine checklist.

Anonymous said...

Frankly I believe this idea of "consent" in a medical setting is a misnomer. The patient who actually does considerable research and then proceeds to discuss it with the doctor or other medical worker, is often in my experience resented or patronised. What actually happens in discusssion about even major medical procedures, is the doctor explains what they think is the issue and then says: "now here's what we are going to do" or similar. The power relationship is not equal, the information is not equal and the patient who suggests alternatives is not really wanted.
My experience anyway.
Chris

Joel Sherman said...

Your experience is likely common, Chris, but certainly not universal. Especially with major procedures or operations that can go badly, it is to the doctors interest to explain it fully to the patient including pros and cons. If something goes wrong, the patient will be much more understanding and less likely to sue. My tact is to give alternatives when feasible, but always to state my own preference as if I was considering it for myself or for my family.
If your doctors won't explain, best to find someone who will. Of course I'm referring to major procedures. Almost no one will take 15 minutes to talk you into a rectal exam for example; it's not worth any physician's time.

Anonymous said...

When the doctors discuss proedures with the patient before surgery they should also discuss things like pre op shaving, catheters, who will be in the OR, what things will happen to them while they are unconscious, etc. Why do those things always have to be a surprise to inexperienced patients?

I think if many patients knew that while they were unconscious one or more people of the opposite gender will be fiddling with their genitals, shaving their pubic hair, undressing them and redressing them etc. they would have second thoughts about having the procedure done, at least in that particular hospital where they are not shown any respect whatsoever.

Joel Sherman said...

Anonymous, it's hard for the doctor to discuss this because in large measure it's not under his/her control. It's really much more under the hospital's control.
In terms of general procedures used in the OR, the hospital really needs to send out brochures to all patients in advance to describe to them what to expect. Even then it would be difficult because many of the procedures vary and the personnel is always differing.

KN said...

Sam is right.
I was pressured to have routine gyn exams from age 18 and always refused. I didn't need birth control so couldn't be forced.
I lived with fear and worry...every twinge was cancer.
I'm on an exchange scheme and currently living in Amsterdam.
I was surprised to find they don't recommend routine gyn exams AT ALL here and cervical screening isn't even offered until you're 30 and then only every 5 years. Virgins are not offered screening at any age.
I was SO relieved and happy and also very angry that our doctors treat us so badly.
I don't go to doctors at home because these horrible exams always dominate the consult.

I was brave enough to see a Dr recently for bad headaches after finding out Dutch women are not pressured or forced into stirrups at every consult or at all.
I felt comfortable with a doctor for the first time.
I asked the Doctor about this screening and she said, "it's not a perfect test by any means and cervical cancer is not a common cancer...I'll give you some information and the risk factors when you hit 30 and you can make your own decision whether you'd like to have the Test"...
I was shocked...MY decision.
A Dr speaking honestly and giving me a choice.
I asked whether birth control is withheld if you don't have the test. She looked surprised and said, "Of course not"...
In the States that always happens...no exams and test (including pelvic, breast and often a rectal plus pap smears every year) then no birth control.
Many of my friends manage with condoms rather than go through all of that. No wonder we have so many unplanned pregnancies.
Why are our health care systems so different?
I read on another forum that in this country womanhood is treated like a disease and we're all just a collection of our reproductive organs....that's certainly the way many of us feel.
I'm pleased that I'm away from all that and upon my return, I'll be armed with facts. I know our lives don't have to be dominated by these horrible exams and tests.
Hopefully, I'll be able to find a doctor who'll respect my wishes and still treat me for asthma, a sprain and give me birth control without insisting on all the invasive exams and tests.
It seems like a ridiculous thing, but it happens every day to thousands of women in our country.
My friend was denied antibiotics until she agreed to a pelvic and pap - she refused and made a fuss and eventually got her script. Women need to do more of that...stand up to our abusers.
I think it's sad that so many of us regard doctors as abusers.
Your Dr is supposed to work with you, not take advantage of you.

Joel Sherman said...

Apparently guidelines for routine pap smears have loosened in this country and now every two years is considered adequate in many instances. It's not my field but I would doubt that there is a compelling reason for a pelvic exam more frequently than that. Of course, a routine exam is likely the only way that uterine or ovarian cancer can potentially be picked up early, but that risk is obviously acceptable to some women. I don't know whether a pelvic exam is truly needed to start hormonal therapy, but it is apparently controversial.
I'd think it would be possible to find a physician willing to prescribe bc pills without an exam. Might help if you brought along the pertinent literature.
I think the reason physicians are reluctant to accede is in case there are problems, it would be harder to defend in case of a lawsuit.

Sam said...

Pap smears every two years means almost 78% of women will endure the ordeal of biopsies in her lifetime - it should therefore be each woman's choice whether she puts her hand up for that gamble.
(L. Koutsky, Cancer prevention, Fall 2004, Issue 4)
That's why informed consent is vitally important when you're pushing healthy people into cancer screening.
A few doctors in the UK have been very outspoken about the dangers and real value of screening. This is a brave act as the vested interests in screening run deep...it's a rich source of income.
Professor Michael Baum, a very senior UK breast cancer surgeon has been very outspoken.
He helped set up the fist breast screen centres and now believes they're doing more harm than good. He strongly disapproves of the misleading and incomplete information given to women.
To give you one example - in the UK, there was a scare campaign started by Breast Screen, "One in 9 women will get breast cancer, have your mammogram today!"....
I wondered about this 1 in 9 and went further...
This figure is based on the assumption that women will live into their mid 90's...in fact, most of us are gone by 82...if you adjust the figure, it comes down to one in 65....
Why is there so much dishonesty with screening?
I believe it's because doctors are rewarded for any drop in the death rate and are not penalized for the thousands of patients harmed in the process. Keep us ignorant and afraid and hopefully, compliant.
Informed consent and patient bodily privacy gets in the way.

Routine pelvic exams should also be the woman's choice - they are NOT recommended or carried out in other developed countries. How can they be vitally important to US women when they're not recommended or carried out in other developed countries?

If we choose to accept the small chance (even for high risk women) of this uncommon cancer and not risk an invasive and unreliable test, if we choose to accept a fairly high chance of disease through smoking or risk of injury doing adventure sport - that's our choice.
BTW the HOPE program at Planned Parenthood (US)now makes it possible to access birth control pills without an exam (apart from a history and blood pressure check)
They see that women are using less reliable methods and risking pregnancy, rather than giving in to medical barriers. It is also IMO, an acknowledgement that the risks of pregnancy are far greater than the risk associated with choosing not to have these exams.
I spoke to a senior Australian gynecologist recently at a staff dinner and he said that routine pelvic exams are of low clinical value and performed routinely usually cause more harm, than good.
If you look at the US, their women have more pelvic exams and pap smears than any other women in the world. Many more during pregnancy, required for birth control (except the HOPE scheme) required for HRT, recommended annually from your late teens.

I saw a chart recently that showed US women have more than 50-55 smears on average over their lifetimes - the country with the lowest rates of cervical cancer also, has the lowest rates of biopsies. (55%) Finland.
They don't screen women before 30 (young women have a high chance of false positives and extremely low risk for cancer) and then only every 5 years until 50, 55 or 60 (depending on risk profile)...5 to 7 tests in total.

US women need to ask themselves why all of this is being done - is it really about women's health?
In other countries, pelvic exams are only carried out on symptomatic women.
If you google routine pelvic exams there is a great article by Heather Dixon.
KN, go to Planned Parenthood upon your return and use the HOPE program. No exams or tests - I've heard they do pressure you after a while to have these exams, but that hasn't happened to any of my friends. If it did, they have their references to hand.
I agree Dr, that's the answer - we must be informed and protect our own health.

Joel Sherman said...

Thanks Sam. I have copied all these recent posts to the women's privacy thread, as I believe more women will look there first.

Anonymous said...

Isn't it dangerous for doctors to ignore informed consent?
If something goes wrong, they'd be wide open liability wise.
If the system is set up so that women (and men) can't make an informed decision...by the use of unethical strategies (like tying birth control with screening) wouldn't then the medical associations be in trouble as well.
It seems like a hazardous approach and I would have thought their insurance companies would be concerned (if they were aware)
You can't force an optional extra on a patient that might harm them or decide not to tell them the risks of the test.
It's astonishing that no one has challenged these barriers in a court of law.
It seems like it would be a simple matter and have fair reaching and immediate consequences.
TD

Joel Sherman said...

Of course informed consent is a big legal issue TD. Both lawyers and doctors are well aware of it. No physician would do a significant procedure or operation without written signed consent.
But having said that, the possible permutations are endless. What's significant? Were all possible complications and alternatives explained? Should a 1 in a thousand chance of a serious complication be explicitly explained? There's lots of legal room to bring suit, although not always easy for a lawyer to win.

Sam said...

I've been seriously concerned about the ethics and legality of screening practices for decades.
There is lots of evidence to show that screening authorities made a conscious and deliberate decision NOT to disclose to women anything that might deter them from screening.
They also devised strategies to force screening...totally ignoring the need for informed consent.
In countries where doctors are paid large sums to screen 85% of their eligible female patients...this conflicts with the need to obtain informed consent and has led to very unethical tactics and practices.
Also, in the States...where almost all doctors make it a pre-requisite for birth control simply to force screening. It has nothing to do with birth control.
This amounts to coercion, in my opinion...
Personally, I believe no woman can give informed consent at the moment, apart from the few that work in the area or have researched the topic. Any woman harmed by this testing would IMO, have a solid case against the Dr, the medical association and the screening authorities.
I believe that's why they're very reluctant to tell women the truth...when you've been misleading and harming women for years and ignoring the need for informed consent, it's then very dangerous to come clean.
I think a class action might not be far away.
Hazel Thornton, ONE woman, has forced change in the UK...forcing the authorities to release risk information to every woman in that country. It was a fight and it continues....
They have still withheld a lot of risk and statistical information...so the fight goes on.
It shocks me that women have been treated in this way, for so long.
Professor Michael Baum and others have said it's disrespectful...that's putting it lightly!
For those interested there is an article that was published in Australia recently that cautiously discusses some of these issues (authors need to be careful with this topic...any criticism provokes a rapid and savage reaction)
You'll find it at: www.racgp.org.au/afp/200904/200903trevena.pdf

Bree said...

I agree...we are given no choice about smears and gyn checks...we're TOLD, DIRECTED, it's INSISTED upon or just done...
Only the strongest women can avoid them.
I just stay away from doctors and rely on the pharmacist to meet my needs.
I'm happier and healthier than all of my friends that go through the annual cancer-checking process...they often take Xanax to get through the exams and then there is the awful things that usually follow...vaginal ultrasounds and biopsies. The extreme fear and anxiety, the humiliation and degrading nature of the procedures.
They have all (but one)had bits carved out of the cervix, or burnt off or frozen off...you can't tell me that all of these 20-something women had cancer or were in real danger of it.
Everything seems to be pre-cancer - it seems all of us are pre-cancer except for those of us who walk away from this shocking "treatment".
All of my friends who've been convinced of the need for this exam or were pushed into it carry the scars and they're only in their mid to late 20's. Several have been told they'll need special care if they get pregnant because they now have an incompetent cervix.
What are we doing to our healthy women?
It never seemed right to me...our grandmothers and great-aunts didn't live like this and in most cases, they lived into their 80's.
I think this obsession with cancer has turned our lives into a suspended state - the assumption is we all have cancer until proved otherwise...by checking, cutting, burning and freezing.
I will never live my life with that slant...
My fear of that life is far greater than my fear of cancer.

Joel Sherman said...

I have copied this post to the women's privacy thread and commented on it there.

Joel Sherman said...

Here's a brief story concerning the use of informed consent in ERs and the need for patient participation in the process. It concerns the ordering of an unnecessary test.
I find it quite valid.

John Culhane said...

I'm the person with the story linked by the previous comment. You can find my blog here: wordinedgewise.org. As you'll see, I link to an earlier post where I tell of another trip to the ER where I DID undergo the CT scan procedure that I avoided this time.

I'm currently at work on a law review article that traces, analyzes and critiques the law of informed consent from a comparative perspective. When I've posted a working draft (within a few weeks), I will notify the readers of this site.

Hexanchus said...

John,

You might find the following article useful:

THE HISTORY OF INFORMED CONSENT
Peter M. Murray, M.D.
University of Iowa
Department of Orthopaedics
Iowa City, Iowa

It was published in the Iowa Orthopedic Journal

Joel Sherman said...

Copied from the mass media thread:

Will said...

The thing that is totally disregarded in many countries including the States.
Cancer screening is supposed to be an optional extra...yet words like MUST, WILL & SHOULD are usually used implying no choice or at least, no responsible person would object...and it's your fault if you don't screen and you get cancer.
This makes no sense to me...
ALL screening has risks...high risk individuals may readily accept those risks, but very low risk may feel differently...yet doctors roll us all into the same risk category....we're ALL at risk, when that's often not true.
It's actually quite hard to access risk information or even to find a balanced account of the test...all the medical brochures are biased in favour of testing.
It's a common dilemma with screening...give patients all the information and some will choose not to screen, give then very little, add a scare campaign, add some tactics and strategies to force compliance and hopefully, you'll catch more people.
The aim is coverage for the common good (less cancer hopefully) rather than an offer to healthy individuals and we have an opportunity to consider our position and make a decision to screen or not.
My reading suggests the latter is required by law and that any person harmed by a false positive and a biopsy that goes wrong...could sue the doctor, medical association and the government, if they have sponsored the program.
I think the ad is highly offensive by the way...I actually don't care for the pressure that accompanies these screening programs...they all add to the medicalization of our lives and IMO, that's a bad thing.
None of these tests become "offers", but further demands on our bodies, dignity, comfort and often our mental and physical well-being.
August 26, 2009 9:35 AM

Joel Sherman said...

Copied from the mass media thread:

August 26, 2009 9:35 AM
Anonymous said...

I can smoke if I want, I can eat big mac's three meals a day, ride my motorcylce without a helmet, sky dive, drink to excess, I can make all sorts of decisions that put be at risk.........why does the medical community think they can make a policy or choice for me that goes against what I want just becasue they think it is in my best interest.......if my modesty kills me....isn't that just as much my choice as lighting a smoke and hopping on a harley with no helmet....alan
August 26, 2009 4:36 PM
Will said...

Exactly...in fact, I'll wager your Dr is far less likely to mention those things...even though they are more likely and in some cases (smoking) MUCH more likely to harm you in the long run.
I also hate the constant reinforcement that screening is the sensible thing to do...
Then why give us a choice?
Why even mention informed consent when it's acceptable for the profession to totally ignore it?
I've heard doctors talk about certain cancer patients and then add, "she/he didn't have any screening...shame, this could have been avoided"....
BUT no mention is made of the patients who end up regretting the test...the men left with problems after a false positive with the PSA blood test or the people who die or face radical treatment after a false negative reassures them all is well.
We don't hear about those people, yet I suspect there are more of those people than there are people saved by screening.
A workmate has been left with problems after a prostate biopsy...he was given absolutely no risk information, just told the test was life-saving with no risks.
No competent doctor would make those claims about cancer screening...there are always risks....and whether those risks are worth it...can only be judged by the patient.
The dishonesty and bullying that accompanies screening...the psychological games...the ad campaigns...
I just don't understand how they're able to get away with it...
I can only assume by keeping us ignorant and convinced of the benefits of these tests, we don't question...even when we're left with problems.
We're relieved we don't have cancer...even though that means we're now incontinent or impotent.
The older I get, the less inclined I am to listen to doctors...the dishonesty and scare tactic mentality is so disrespectful...I can't bear to listen to them anymore...
I've reached the point...if my Dr says it's a harmless test...I assume the worst.
I know his strategy is to get us to screen...get the numbers up there...with no regard for the fact the test may harm or disadvantage me.
Their only concern is to bring down the death rate...no one cares or counts the number of adverse outcomes.
Well, I care....
It means it's up to us to protect our health...
I hate the outrage by doctors when patients choose not to screen...and their repeated efforts to get us on board.
In their minds, no one died from screening (well, not many) whereas many die from cancer.
So, it's better to accept the risk of incontinence, than die of cancer.
Yet surely that has to be MY decision...incontinence severely detracts from your quality of life.
No, I'll make my own decisions.
It's the safest approach.
August 26, 2009 8:14 PM

Joel Sherman said...

Copied from the mass media thread:

Joel Sherman said...

Doctors are in a bind. If they don't offer screening and the worst happens, they can easily be up against an indefensible lawsuit.
I don't deal with cancer, but I certainly offer many patients tests which are screening tests. I tell them the risks and if they refuse I document it. But I could still be sued if they refuse and something horrible does happen. The only difference is that the patient's chance of winning is reduced.
It's a no win situation for a doctor. And please note that Obamacare doesn't offer any hope for a solution to the malpractice and defensive medicine problem.
August 26, 2009 8:33 PM


Anonymous said...

I honestly think most Dr.s push screening in good faith. Its what they are taught, err on the safe side. And while I have no fcts to back it, I would bet more lives are saved than lost due to screening. That said it is still our choice and no one elses. And while I understand Dr's can be sued even if they suggest and patients don't follow it...you can be sued for anything....doesn;t mean they will win...alan
August 26, 2009 9:03 PM

Joel Sherman said...

Copied from the mass media thread:

Will said...

I have no objection to an "offer" of screening...but that rarely happens...
We're told to have screening or the doctor just starts the test or writes up the referral...
It's that attitude I hate...
Also, the refusal to accept even the soundest of reasons for refusing a test...
I hate the total lack of risk information provided and doctors generally presenting an exaggerated upside of screening.
If I go into screening, it should be my decision and I face the risks head-on...I accept the possible consequences...that doesn't happen at the moment IMO...
We're often pushed or bullied into screening and we live with any negative outcome...doctors hide behind the mass recommendation.
I find that offensive and unacceptable.
I'm happy to sign a waiver - I know we live in a litigious world and I'd even accept the scare mongering speech ONCE...
but not every year without fail.
There are risks with testing and there may be risks with no testing....but we can't know for sure how the numbers stack up...because we receive no information as to the number of patients that have a negative outcome. They're ignored...
It's all so one-sided...
I think screening has it's place, but to say all screeening is a good thing for all people and leave it at that is far too simplistic IMO....
August 26, 2009 11:28 PM

Jess said...

I've refused prostate screening for a few years now....locked in indecision.
Fortunately (unlike women) we can simply say "No" or "Not yet"....
I know women are forced into screening or they don't get birth control...which I strongly disagree with...
I accompanied my GF to PP to sort out this issue...women also have the right to choose and consider their position.
It astonishes me that we even need to have that discussion in 2009 and it's shameful that this is only an issue in this country.
We all should decide for ourselves whether we want screening.
An unplanned pregnancy carries far more serious consequences than choosing not to screen.

I've seen this man's name on a few forums...Professor Michael Baum.
He's very concerned about women being screened for breast cancer in total ignorance...having been presented with one side of the story only.
He has had more to say about prostate screening over the last few years.
Men are harder to round up and the ad campaigns are becoming more frequent. I tend to turn off when they exaggerate and try to frighten us.
I've attached an article by Baum where he talks about prostate screening (after his concerns about breast cancer screening)

I've never heard a US doctor criticize any screening program...so it's hardly surprising that any man would be poorly prepared for a bad outcome and as I've mentioned, women don't even have the opportunity to consent or consider....(if they want birth control or see a Dr for anything else and are unable to resist the enormous pressure)
My sister was actually refused mild sleeping tablets (she wasn't sleeping leading up to finals...she's gone back to college in her 30's) until she agreed to a smear.
How can doctor's possibly justify that sort of conduct?
My sister was inconvenienced, upset and angry...she left that consult and saw another Dr the following day for her insomnia.
Many of her friends have been treated in the same manner.
I think these doctors should be disciplined by the Licensing Board...no doctor has the right to force you into screening and ignore your right to choose.
My sister has lodged a complaint.

All of these tests have a downside...even if that goes unmentioned and I'm certain doctors would not agree to accept responsibility for the negative outcomes that may flow from tests they've forced onto patients.
I do think pressure is mounting on us as well...maybe my Dr will refuse me meds in the future if I continue to refuse.
I'd be on the phone to the Licensing Board and my lawyer so fast...No doctor has that right.
I wish more women would refuse and take matters further...there is no doubt the conduct of some doctors amounts to grossly unprofessional conduct.
I make decisions every day that may affect my health...but it's my right to choose and make those decisions.
Doctors can advise or offer, but they can never stand in my shoes.

Joel Sherman said...

Thanks for the references Jess. The value of screening can always be questioned. As I see it for prostate cancer, it's solely a matter of your personal risk including age and family history. I personally am at high risk and get annual screening, but if I was under 50 without a family history I might well follow a different course.
I'm not very familiar with the issues related to breast cancer screening. Here's a link to Dr Baum who you mentioned for anyone who wants further info. I do note his opinions are controversial and the British NHS has criticized them.

Olivia said...

The NHS criticize him, but they won't discuss or "take on board" his concerns.
They just trot out the same old stuff...avoid, deny, read our brochure....screening is a good thing is the starting and finishing point.
If there was nothing in his concerns...then let's hear their side of the story.
Instead they react aggressively to close scrutiny and criticism.
How dare anyone question the value of screening?
I think when screeners become so arrogant they can ignore the concerns of an eminent breast cancer surgeon, a leader in the area...we're all in trouble.
We need to fear the testing, not the cancer.
I applaud Dr Baum...it would have been far easier to let them keep screening women in complete ignorance...put them through multiple biopsies and terrify them with false positives, remove breasts or start them on chemo for DCIS, but his professional concerns won't let him do that...he felt morally and ethically obliged to speak out...to make sure women have the facts and actualy choose to screen with that knowledge.
Keep talking Professor Baum - we're all listening here in Oxford!

Emily L said...

I took myself off the Breast Screen Registry this year.
My first mamogram at age 50 was a complete nightmare.
I still carry anxiety and fear as a result....5 months later.
My mammogram showed an "area of concern"...an area!
I was sure that meant death was around the corner.
I had 24 hours of pure hell...repeat mammograms, ultrasounds, CBE's and multiple biopsies.
It was nothing...normal breast tissue that looked suspicious on the mammogram...so, a false positive.
It was an ordeal...a frightening experience that I'll carry through life.
I feel like I had a cancer scare, but there was no cancer or health scare...the test was just plain wrong.
It was then that I went looking for answers.
No more mammograms for me.

It's not just Michael Baum...there is also quite a lot of research into DCIS and the Nordic Cochrane Institute played a part in some research which showed regular mammograms may INCREASE the risk of breast cancer...perhaps, the radiation exposure or damage to delicate breast tissue or the compression turns DCIS into an aggressive tumour. Their research continues...
Anyway, I've heard enough to call it quits until my questions and fears are answered.
If I get breast cancer, so be it...but I can't ignore these risks to my health.

Lyn J said...

I think that Prof Baum's views were once considered "controversial", but that's no longer the case.
The last few years have seen more and more medical people coming forward and supporting Baum.
There are many articles in medical journals that support Prof Baum's concerns.
Women around the world should be grateful to this man for putting his neck on the line for our benefit.
Dr Baum is not saying, "Don't screen"...he's saying, "before you screen women, give them all the risk information"...
Why would that outrage the screening authroities if as they say, the benefits greatly exceed the risks?
My GP said he was tied by the recommendations of his medical authority, but he did have concerns about all cancer screening and felt there needed to be more honesty and patients being informed of the possible negative consequences of screening...rather than consenting in ignorance.
He said he struggled with this issue...if you dissuade a woman and she gets cancer, you may be held responsible...if you say nothing, push screening and there is a poor or bad outcome, you may be held responsible or at least, feel guilty or uncomfortable recommending that test unreservedly in the future.
He tends to mention screening, it's overall risks and benefits and leave it to the patient.
He said he has never pressured a woman to have cervical or breast screening.
He said when a woman has a firm view either way...it makes his day a bit easier.

MER said...

Interesting discussion on informed consent on allnurses. A nurse complains that nurses are often asked to get informed consent from patients for procedures, etc., something the doctor should do. She says often the patient doesn't know what's going on.
You'll find it at:
http://allnurses.com/general-nursing-discussion/informed-consent-435733.html

Joel Sherman said...

MER, like all things in medicine, the theory is easier than the practice. Years ago, formal consent was only obtained for major procedures and clearly the surgeon was responsible for doing it. Nowadays informed consent is needed for minor low risk procedures such as stress tests. And nurses do obtain permission for those. In fact in many laboratories, the test may be done without a physician even being present.
But there are 2 parts to every informed consent, the indications for the procedure and the risks of the procedure. The providers doing the procedure can only attest to the latter. For example, an ER physician orders a CT scan with contrast. The radiologist can discuss with the patient the risks of the test, but there is no feasible way he/she can know if the test was truly indicated without spending an hour reviewing the case including history, physical and lab data. In short, truly informed consent is legally one person's responsibility most of the time, but in actuality it requires the collaboration of multiple providers and sometimes nurses to review it all. In practice many minor procedures are explained by nurses and the physician will then ask only if the patient has any unanswered questions. But if the patient wants to know why the test has been ordered, the doctor doing the test may have to refer the patient back to the physician who requested the test.

Rev.FRED said...

Dr., this is my first post. Perhaps, my question needs to be discussed with an attorney. Am I as a patient, legally permitted to write a postscript to my signature that declares: "Agreement contingent, upon same gender provider, for possible intimate exams, discussion, procedures, scans, and care"? If I have made this expectation knowN, what assurity do I have that it will be honored? Can you advise?-REV.FRED

Joel Sherman said...

I'm not competent to give you legal advice Reverend, but I would think that you're entitled to add anything you want to papers you sign, and if accepted they would be binding. There's no guarantee they would be accepted.
Hopefully you will discuss this first with your physician and not just surprise an admitting office with an addendum to their routine papers they ask you to sign. I certainly can't tell you what the chances are your wishes would be respected. If your physician is willing to inform the institution of your wishes, they probably would be except perhaps in an emergency. Bear in mind also that the simpler the procedure and the less people involved, the more likely it that your wishes will be respected. If you need ultrasound for example it would usually be feasible to arrange for a male tech, but if you need major surgery, few hospitals would be able to guarantee that all personnel would be same gender. That applies for women as well.

Violet to Blue said...

http://www.theglobeandmail.com/life/health/time-to-end-pelvic-exams-done-without-consent/article1447337/

think this is the right thread for this topic, if not I'm sure Dr Sherman will move appropriately...

Joel Sherman said...

Violet, there are some posts concerning this in various places. I think the practice has pretty much ended in the US without formal permission being given.
Didn't know it was still considered proper in Canada.

Anonymous said...

Not done in Australia - we use people who are paid to act as patients.

Anonymous said...

The New York State Nursing Association's position statement on informed consent. Specifically, look at # 5. Seems pretty clear to me as applies to the reasonable requests for modesty or same gender care.
MER

http://www.nysna.org/practice/positions/position18_04.htm

Anonymous said...

MER,

I read that nurses policy and I suspect you would find in fact that nurses would not regard that as applying to the issue of for example same gender care. I suspect that the issue as they would see it relates to the patients consent to a particular procedure, not the gender of the nurse. I hope I am wrong. I am not in the US, but perhaps someone should write to them and ask for an "interpretation".

In addition, I wonder how the nursing profession would reconcile their role as "the patient advocate", against their rights to provide care regardless of the nurse or the patients gender and the patients preferences. Taken to its logical conclusion, nurse say female, would have to argue on behalf of say male patient, in an advocacy role, that the same nurse should not be providing nursing care as that is the patients preference.
I suspect that we are as likely to see this as we say in Aus, as 'pigs flying backwards".

Chris

Joel Sherman said...

I agree with Chris. Statement 5 is so broad as to be meaningless in application. It's just another platitude that makes a good sound bite. It's like most patient privacy statements in that regard.

Anonymous said...

5)"Each patient has a right to
freedom from the imposition of another's belief or judgemental
attitudes."

I assume this is the standard we're talking about.

When a policy statement is as vague as that one is, it can be interpreted many ways. If it's going to exclude certain certain things, it had better say what's excluded.
Otherwise, the patient's interpretation is as good as the institution's interpretation. Be vague on purpose, and you just open the door.
How would you define a "belief" or a "judgmental attitude?" If a man asks for same gender care because it's his belief or value, and the caregiver refuses or gives him a hard time, isn't the caregiver or institution being "judgmental" about a patient's beliefs?

Of course these are platitudes -- until they are challenged.

Caregiver: "I'm sorry, but we don't include same gender care as part of patient privacy or dignity."

Patient: "Would you show me where that's written in your hospital policy?"

Caregiver: "Well, it's not written down. It's just the way we do things."

Patient: "Would you show me where in hospital policy you have a specific definition of what constitutes patient dignity and respect and privacy?"

Caregiver: "Sorry, we don't have it in writing?"

Patient: "See, here's the problem. I do have a definition of what I consider to be my privacy and dignity. And my definition includes my right to same gender care. So, since you have nothing in writing, except that vague #5 statement, we'll then go with my definition."

Caregiver: "Well, we do have definitions. We just don't write them down."

Patient: "Let's get your supervisor in here and let's, all of us, go over the core values of this institution as well as the Patient Rights form. Let's discuss this."

etc. etc. etc.

Remember, "meaningless" doesn't just mean it has no meaning. "Meaningless" also means it can have any meaning. Vague polices like these are used, not to communicate, but to prevent communication.
So, as patients, let's force the system to communicate.
MER

Joel Sherman said...

Here's an issue I mentioned at least a year ago. It apparently has not been resolved. Many states still collect DNA on all infants and enter it in a database which is kept forever. This is done without informed consent. Most places parents aren't even asked if they want to participate. Some parents have been shocked to be queried about their child's results years later.

Joel Sherman said...

An interesting approach, an Australian group devised an interactive computer program for patients pre-op for prostatectomy. You had to pick the correct answer before moving on to the next question so it was very informative and required all patients to have a solid base of info about the procedure.
A wide spread adoption of this approach would perhaps solve most problems of informed consent.

Anonymous said...

The computer test option for informed consent is an interesting idea. With the right questions, I can see it working. What I think may be lacking in the whole informed consent process is detailed patient input. I know it's time consuming, but the ideal would be to gather experienced and inexperienced patients into focus groups led by doctors and nurses, and together come up with the kinds of questions that need to be addressed with informed consent procedures. I'm not convinced this is being done. I think the whole idea of informed consent today is based upon legal considerations rather than what may be in the best interest of the patient's physical and psychological health.
MER

Anonymous said...

In relation to the issue of the computer program as reported for Australia, there is it seems to me a big problem with that and that is the issue of deciding between the different treatment options.
Being from Austrlai myself I would like to see the various groups work together and create an informed consent tool that covers surgery, radiotheraphy (various types) and of course "watchful waiting". I supect that the various rival views beween different specialists would make this almost impossible.
Chris

Hexanchus said...

Joel,

I ran across a site you might want to add to the links on your main page:

http://www.informedmedicaldecisions.org/

Take a look at it and let me know what you think........

Joel Sherman said...

Thanks Hexanchus. I haven't had time to fully review the site as there is a lot there.
But it certainly looks worthwhile. I have added it to my links.

Joel Sherman said...

Here is a long thorough position paper from the Patient Privacy Rights organization concerning informed consent and how it is needed to protect your electronic medical records in this digital age. It is worth reading through.

Anonymous said...

I have some questions about informed consent. It seems that leaving out specific important details about what will happen to us after we're unconscious aren't included under informed consent. Details such as having a catheter inserted or that one or more teenaged girls will be exposing us to do humiliating things to our privates to prep us for surgery. Apparently they don't believe that informing us of those details is important and keeping it a secret is for our own good.

What I want to know is if we (the patients) ask specific questions about what will happen are they (the hospital employees) required to answer the questions truthfully? Are they then required to do exactly what they said they would do? For example if I ask who will prep me for surgery and what exactly will be done and who could possibly witness it are they legally required to tell me the entire truth? Will they then be legally required to to do exactly what they promised me they would do? If I'm told beforehand that a male and only a male will be prepping me could I still be stuck with a female and there's nothing I could do about it since I would already be unconscious? Can they make that kind of decision behind my back (assuming it's not an emergency)?

If I'm promised an all male team and one of them calls in sick and there's not another male to fill in for him will they honor my request to cancel the surgery at that point? If I learn that there's only a female to fill in for him and I'm still conscious I would cancel the surgery myself, but if I'm unconscious can I count on them to do the right thing and re-schedule for another day? Of all the unethical things that are done to patients I believe lying to us is among the worst.

GR

Joel Sherman said...

GR, it would be rare for teenagers to be part of any hospital procedure. They would have to be there in an unofficial observer capacity and you should be asked ahead of time if their presence was acceptable.
I'm not a lawyer, but the hospital would be bound by what employees tell you if you ask specific questions. But unless you have it in writing, it would be a difficult point to prove. They could easily say you misunderstood. They are required to tell you all pertinent facts, but 'pertinent' is subject to interpretation and so you really have to ask and then have the employees write down their answer. Needless to say, this is hard to accomplish and very very few patients will do it. But if you do, your request will certainly get serious attention.

Anonymous said...

Thanks for the advice Dr Sherman. It's incredible how you can do all the important things you do and still find the time to discuss our problems and answer our questions.

When I mention teenagers I refer to young CNAs who I've been told do many very intimate procedures the nurses are too lazy or too arrogant to do. My sister was a certified nurse's assistant at age 16. I assumed that 18 year olds and sometimes even younger are allowed to do those things.

GR

Joel Sherman said...

GR, every state is different in terms of how they regulate CNAs. Often they have to be high school graduates and/or 18 to be licensed (if they need a license in your state). Most hospitals won't hire high school kids, but they may be there as volunteers or as part of vocational programs. In either event, your permission should be obtained for them to be present.
Honestly though, hospitals don't use CNAs because nurses are arrogant or lazy; they use them because they are much cheaper than nurses who get starting salaries varying from $60000 to $80000 depending on region.

Anonymous said...

Watching many crime shows, real and fictional I see that it is legal for cops to lie all they want during an interrogation in order to try and force a confession. Do medical professionals legally have that power? If not, how can they get away with it? I've heard of countless cases and experienced one myself where the "professionals" lie to patients because they believe it's for their own good. I'm sure there have also been many cases where they lie to the patients just because they need their business. Shouldn't informed consent keep that from happening?

Joel Sherman said...

That question is easy. Doctors have no legal protection if they lie to patients. In past decades it was common for doctors to mislead patients about their prognosis. Often the family wanted to 'protect' the patient from the knowledge of a a death causing illness. This is no longer considered ethical.
But many patients don't want to hear bad news. If that's the case, I don't force it on them. Informed consent applies to explaining treatment options and therapies, not so much to giving a full explanation of an illness. That info is readily available nowadays to nearly everyone.

Joel Sherman said...

This was sent to me by email as posting failed:

My wife went into a local hospital (Spokane, Washington) in January 2011 for replacement of her second hip joint (the first was done at the same hospital in July 2010, when the hospital accepted the blanket consent form with "students" and "photos" clauses stricken or X'd out). At the admitting desk, at 7:00 a.m., on the consent forms, she X'd out the student consent paragraph and the photos/videos paragraph, just as she had in July 2010 . . . and the clerk advised that "we will not accept an altered form." We discussed that she especially did not want students involved in her care; the answer two more times was "we will not accept an altered form." Having no other choice, we left the hospital. The surgeon, with whom all of this had been cleared ahead of time and who was fine with the "no students" business, had his office manager call a few hours later and advise that he was "greatly inconvenienced", and would no longer treat my wife, and she would have to go back to her primary doctor for a referral to another orthopedic surgeon.

First question, which perhaps would be to a legal mind as well as to an ethical mind: The law generally invalidates contracts of adhesion. Isn't a blanket consent form, signed under the circumstances that it is a "take it or leave it" proposition, a contract of adhesion and therefore unenforceable? Aren't the hospitals doing this "shooting themselves in the foot" in the long run, because when it really counts, the court will throw that blanket consent form out as unenforcable?

Second: Everything I read (and discussions with that hospital's personnel since January 2011) indicate that all at that hospital are in agreement that a patient has the right to NOT consent to students being involved in their care. This "right" is a very hollow one, however, if you cannot be admitted to the hospital without giving up this right as the "price" of admission. This ties in to the question of "contract of adhesion", of course.

Among poor results in the past had been a surgery in 2007 at a different hospital wherein the anesthesiologist, even though the student participation clause had been X'd out, and unknown to my wife ahead of time, allowed a paramedic student from the local community college to attempt (unsuccessfully, two times) the intubation procedure upon my wife during the anesthesia process, causing some damage. Although not nearly as "personal" as the pelvic exams, to us it was an equally egregious violation of the patient's rights. This anesthesiologist estimated to my wife in discussions afterward that in about 15% of general anesthesia procedures, paramedic/EMT students participate in the intubation procedures; I would suggest to you that this is equally unknown to the general population as is the pelvic examination.

Aren't there any laws protecting patients? Aren't there any hospital associations, or accreditation agencies, or somebody, looking out for patients?

Joel Sherman said...

This post raises several important questions. First, the poster is correct that it is a common practice for trainees to take part in intubation procedures presumably under guidance from an anesthesiologist. But only the person doing the intubation has any real control. As an intern decades ago, I once broke a patient's tooth attempting an intubation. Concern about procedures done by students, first year residents etc is valid although there is no real alternative to teaching some procedures under real settings.
Although you have the right to refuse any procedure or provider, it is indeed an empty right if the hospital won't admit you under those conditions. I would think they can legally do that in most states, though law varies in each state. JCAHO which inspects hospitals may have specific regulations concerning the use of students. My guess is that they would uphold the right of a patient to refuse students. Their regulations are not posted online so I cannot check it. The AHA (Am. Hosp. Ass.) may also post guidelines for member hospitals. I'm not a lawyer and cannot give a legal opinion, but I'd think that making patients agree to all this at the moment of admission is a form of duress which could be challenged.
The taking of pictures and videos is another topic. I would not agree to blanket permission for this unless it was sufficiently qualified to protect patient privacy. Don't know how this statement in question read.

Joel Sherman said...

I meant also to add that insisting on the acceptance of students is far more likely to occur at teaching or public hospitals. Smaller private hospitals are more likely to accommodate your wishes.

Anonymous said...

For all of my surgeries in a large public and teaching hospital in Australia I put on my Consent Form, that is not the form signed on admission, but the form I signed with the Doctor before, "no students without prior permission".

This was always respected and students then had to come and see me to request permission, which I then gave. (Though in reading the post about medical students performing rectals etc on patients in Australia without their consent, next time I will say students as observers only, when or if I give permission).

Its true though that unless you make this clear, yourself the right will not be offered to you, even though this is on their Patients Charter of Rights for that Hospital.
In Aus on admission the person at the desk is often an administrative person and I suspect that they don't have any authority to exercise discretion; that's why I use the Consent Form.

Chris

Joel Sherman MD said...

This comment has been copied here from the video thread:

Anonymous has left a new comment on your post "Taking of Videos and Pictures Without Permission":

I have worked in hospitals for my entire career, but only recently had become a patient and I was surprized at how a patient is coerceed into "consenting" to filming, unauthorized observers etc. During my last outpatient surgery I read the consent carefully and crossed out all references to allowing filming or to allow observers, residents, drug company reps or visitors in the OR while my surgery was being done. My surgeon had promised that he would personally do the case, bier block only, no sedation, but everyone tried to get me to agree to the possibility of gen anes (crossed it out) and to allow observers (crossed it out) and had the surgeon and anesthesiologist sign the modified consent. After the pre-surgery "time out" I asked each person in the OR to identify themselves; incredibly there were 2 residents, a student nurse and a premed student! I blasted the surgeon who lied to me (he kicked them out) and I told him that I was withdrawing my consent unless he had a damned good excuse for lying to me. He didn't and a long discussion ensued resulting in me tossing my paper hat on the floor and hopping off the table and leaving. Good thing that I had made the anesthesia doc sign the "no general or no sedation" addendum on the consent..I'm sure that they would have drugged me and claimed that this didn't happen. During my colonoscopy a year later, my endo doc asked my permission for 2 nursing students to observe; she was worried that I might not agree since I wasn't getting any drugs (don't trust anesthesia anymore). I agreed because she ASKED first. I hope that my prolonged farting in front of these pretty girls was entertaining. I eventually got an apology from the first doctor who lied to me, but not before I told everyone at the hospital of the incident. Patients should not be viewd as pieces of meat who sign away their rights just because a clerk says: "sign her so we can treat you" Thats not informed consent.


Most patients would be unable to get their surgeon and anesthesiologist to sign the hospital consent forms as they are nowhere around when the clerk gives you a form to sign. In your case it was likely only feasible because you discussed it with your physician beforehand. That should be routine, but almost never is.

I note that most violations recorded on these threads are concerned with gender issues, but that need not be the case. It is perfectly reasonable to object to any unneeded personnel no matter what their gender is.

Doug Capra said...

I see a potential patient strategy for patients here. Make note on the consent forms that any students, observers or non medical personnel in the OR must introduce themselves to you before the procedure and get your permission. This way you are not outright refusing. At the time of the introductions you may then make your decision. It's less likely you'll be challenged a this point, but if you are, you have the upper hand since everyone is ready for the procedure. This goes for filming or photographs too, Write on the form that you must be informed, meet whomever is doing the filming or photography, and give permission at that time. Then, at the time, can deny permissions if you wish.
Doug/MER

Hexanchus said...

I write on the consent form "I expressly forbid the use of general anesthesia, sedation, any drug known to have amnesic properties and endotracheal intubation under any circumstances for any reason."

There are two other things to watch out for on the surgical consent form.
1. Often there will be a statement that says the surgeon may delegate part or all of the surgical procedure to be performed by others (residents, students, etc.). I always cross this out and initial it, and point out to the surgeon that my consent is limited specifically to them only and may not be delegated without my written consent.
2. You'll also find a statement something to the effect that you consent to having the surgical procedure described, or any other procedure the surgeon may feel is medically necessary. I always cross that out & initial it as well, then point it out to the surgeon. My consent is for a specific procedure only. If during the course of that procedure the surgeon discovers something, then we need to discuss it before he does anything - if that means terminating the procedure and addressing it at a future date, so be it.

Doug Capra said...

Hex:
Interesting. Now, with all that up front, how often do you think surgeons might just refuse to treat a patient?
Doug/MER

Hexanchus said...

Doug,

I have done this for many years, over the course of which I've had several surgeries and it's never been an issue. All were done with either local or regional anesthesia and no sedation at my request. Had an anesthesiologist pitch a fit once, but have never had any objections from the surgeon. In fact, one surgeon told me most patients would be better off if they did the same, as there are some really nasty potential side effects from some of the drugs used for sedation.

I think it helps that I'm not rude or aggressively confrontational about it - I simply explain that while I'm confident in their abilities, the same trust does not extend to the residents/interns/students and I am not comfortable letting them perform parts of the surgery.

As to choice of anesthesia, it doesn't hurt that I have a well documented history of family members that had really bad reactions to general anesthesia.

Several states, including mine, have laws that require the surgeon who obtained the consent to actually perform the surgery unless they tell the patient otherwise in advance.

Bottom line, they refuse and they lose the fee - and there's always someone else that will do it if they won't.

StayingFit said...

I am curious how the context of the informed consent can, or should, factor in to what a surgeon can do, either legally or ethically. My question arises from a recent decision in a Kentucky case, where a man was taken into surgery for a circumcision. The surgeon discovered cancer, and removed a portion of the man's penis.

The jury decided against awarding damages to the man, primarily because he had signed a consent form. According to the article:

“Seaton (the patient) signed a consent form for a routine circumcision. Within the signed forms, a disclaimer included language that recognized Patterson's (the surgeon) right to perform any further surgery he deemed necessary if unforeseen conditions arose”.

Here is a link to that story:

http://abcnews.go.com/Health/jury-backs-doctor-penis-amputation-trial/story?id=14373288


It seems to me that the interpretation of this consent is overly broad. In the context of a circumcision, granting the surgeon the right to perform other surgeries deemed necessary, would not include the right to amputate the patient's penis, in my opinion. Just as, this consent would not allow him to perform open heart surgery, or to amputate the patient's foot.

Had emergency surgery been indicated, the surgeon would have a stronger argument. However, I find it hard to believe that a delay of a day, or even a week or so, would have made any difference.

I am curious what the other folks on this board think of this case, and the broader question of context, as it relates to informed consent.

Joel Sherman MD said...

Stayingfit, the case you linked to is not unique. From the description there was a reasonable likelihood that cancer would be found. I don't know if the surgeon was a urologist or a general surgeon, but a urologist should know that a general consent form was questionable for a penectomy. Some men would indeed rather die a painful death from cancer than undergo this kind of surgery. The surgeon would indeed have been prudent to use a specific consent form rather than a general one. But medically what he did was correct in my opinion.

Anonymous said...

From my understanding whilst surgery is the normal practice in these cases, it is my further understanding in selected cases, radiotheraphy is possible; so that at the very least, the patient should have been given the opportunity to explore all options.

Without of course seeing all the scans and tests which would be done in the context of evaluating the best treatment option, I would have thought it would have been difficult for both the patient and his surgeon to make an informed treatment decision.

I am Australian based, so I don't know the rules in the US, but I would have thought that in Australia the patient would have been able to raise a complaint against the surgeon and/or the hopital. Especially as I understand that penile cancer and a possible penectomy was not mentioned in the discussion or documentation. (If not to the courts at least to our State based Health Services Commissions, which can also investigate and impose sanction on matters such as these).

I just think that this does go to a "god like" belief by some surgeons that they can decide in surgery that they can undertake a procedure that could be traumatic for the patient which the patient should have the opportunity to decide on beforehand.(I also understand that most penile ca is pretty slow growing so that a few days or a weeks delay, would not likely increase the risks)

Chris

Joel Sherman MD said...

Can't really answer Chris as this is a rare cancer and I'm not a urologist. Never heard of radiation therapy for it, but I'm sure its feasibility would depend on the type of cancer it was on biopsy.
You might be right but I haven't anywhere near enough information to judge whether the physician acted appropriately or not based on that article. Maybe more is available online.

chrish said...

Hi Joel,

I was responding in part to your comment:

"But medically what he did was correct in my opinion."

Chris

chrish said...

Hi Joel,

Attached in a summary of penile cancer treatment options, from what I believe is a reputable site.

Radiotheraphy is an option listed which the patient should have been able to consider.

http://www.cancer.gov/cancertopics/pdq/treatment/penile/Patient/page5

Chris

Joel Sherman MD said...

Thanks Chris. That site certainly does list radiation therapy as an option which this patient almost certainly would have preferred.

Informed consent works best when the patient also takes responsibility to inform themselves and knows what to ask. I still can't judge the malpractice case; the doctor may well have claimed that all possibilities were discussed with the patient. The jury must have had some reason for acquitting.

chrish said...

This study suggests that increased informed consent in relation to patients being given actual information on exactly what training surgeons will be doing, leads to a dramatic reduction in the % of those who give consent. According to the authors this presents a problem in that it leads to less trained surgeons.

To me it raises a number of issues. In particular, rather than giving less information, how about actually spending the time educating patients about the need for training of sugeons, get the patient to meet the patient etc; rather than make the consent so vague that the patient does not understand exactly what is involved. What do others think?

http://archsurg.ama-assn.org/cgi/content/full/archsurg.2011.235

Anonymous said...

Great website: I never thought about privacy concerns; I fly airliners for a living (my wife is the doc in the family) and we came to the USA from the UK...A while back I had a colonoscopy and the onsultant asked if several nurses/students could be observe my procedure...I agreed and it went well; since I don't get drugs I remember it and it wasn't terrible. They asked to see my naked backside and this was fine with me). Fast forward many years back to the USA; same procedure. I was assured that unsedated colonoscopy could be done; when I arrive they try to basically badger me into signing a "sedation consent". I do not. I was told that if I wanted sedation that an anesthesiologist would do it; but only a CRNA (nurse) was available and she tried to strong-arm me into signing an anesthesia consent. this is all while I'm in a backless gown with no fewer that 6 observers. in front of 6 observers I was basically yelled at for not agreeing to sedation; so after 2 hours, IV fluids and raising my BP, the doc wanted to start my colonoscopy. I reminded her that we had agreed to: "no sedation"..she agreed that she had promised me this, but: "everyone wants sedation/amnesia drugs" sign here and all will be well. I joked with the 6 observers; "at least you get to see a perfect a-hole",,but the doc stopped laughing when she learned that I refused to sign a general consent including sedation. At this point, I stopped being a nice patient. I dismissed the observers and asked the doc if she would keep her work (no sedation). Her answer was totally detached..she made me feel unreasonable, so I hopped up and got dressed, much to the chagrin of the staff. As I was walking out one of the nurses advised me to be aware of being treated like a piece of meat and to demand decent care.

Joel Sherman MD said...

Anon, that whole episode appears to be the doctor's fault, though likely not intentional. She should have checked with the hospital as to what their policy was regarding no sedation with colonoscopy.
But given that there was no excuse for them badgering you. Walking out is appropriate.

Doug Capra said...

Anonymous -- At what point does harassment involving informed consent cross the line from an unethical action to an illegal one? I think you may be describing such an incident. I'm no lawyer -- but when a doctor promises someone a specific procedure done a certain way, then gets them in a vulnerable, powerless position and tries to force them into a procedure they don't want -- that seems to me to rise above mere harassment.
I would hope you reported or report this, if not for yourself, but to help prevent others from going through such treatment. The sad fact is that most patients don't have the stamina or self-confidence to stand up to such treatment and will just go along with it out of fear and powerlessness. It was good to see the nurse back you up as you left -- but, unfortunately, you needed support and advocacy during the harassment and, unfortunately again, in a toxic culture like the one you describe, anyone challenging that doctor would be dead meat.
Thanks for sharing your story.
Doug Capra

Joel Sherman MD said...

Here's an article that some may be interested in concerning a Canadian woman's fight to obtain full informed consent in labor and delivery. She has set up a website as well.

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