Informed Consent on Paper, but Not in Reality
Over the long weekend I caught up on some reading. One article* stands out. It’s on informed consent, and the stunning disconnect between physicians’ and patients’ understanding of a procedure’s value.
The study, published in the Sept 7 Annals of Internal Medicine, used survey methods to evaluate 153 cardiology patients’ understanding of the potential benefit of percutaneous coronary intervention (PCI, or angioplasty). The investigators, at Baystate Medical Center in Massachusetts, compared patients’ responses to those of cardiologists who obtained consent and who performed the procedure. As outlined in the article’s introduction, PCI reduces heart attacks in patients with acute coronary syndrome – a more unstable situation than is chronic stable angina, in which case PCI relieves pain and improves quality of life but has no benefit in terms of recurrent myocardial infarction (MI) or survival.
The main result was that, after discussing the procedure with a cardiologist and signing the form, 88% of the patients, who almost all had chronic stable angina, believed that PCI would reduce their personal risk for having a heart attack. Only 17% of the cardiologists, who completed surveys about these particular patients and the potential benefit of PCI for patients facing similar scenarios, indicated that PCI would reduce the likelihood of MI.
This striking difference in patients’ and doctors’ perceptions is all the more significant because 96% of the patients “felt that they knew why they might undergo PCI, and more than half stated that they were actively involved in the decision-making.”
What we have, here, is a study of informed consent, set up in a way that the doctors knew the study was ongoing – because they and their patients were participating, all in one division of one hospital – and, presumably, spent if anything more time and not less than usual talking with patients and answering questions about the procedure. (Note: this particular point is an assumption on my part, supported by the reported fact that 83% of the patients reported that their questions had been answered.)
The central finding is a failure of communication between doctors and patients about the potential benefit of the procedure: 88% of the patients, who’d signed consent, thought that PCI would prevent heart attacks and only 17% of the cardiologists at the same medical center thought the same. This matters, first, because over a million people in the U.S. undergo angioplasty each year and, more broadly, because it represents an everyday outgrowth of the phenomenon of therapeutic misconception – when patients think a procedure has a greater potential benefit than it does.
The concept of therapeutic misconception, as was initially defined narrowly in the context of clinical trials, applies to all areas of medicine. In cancer treatment it’s a big deal but, in my experience, under-addressed. A common misconception among breast cancer patients, for example, concerns the benefit of adjuvant chemotherapy, which generally reduces the odds of recurrence by about a third. So if you have a stage II tumor with good molecular features and the odds of recurrence are somewhere around 15%, that comes down to around 10% with the treatment, which does bear significant side effects and risks. Another fairly common misunderstanding in oncology is in the area of Phase I clinical trials, in which the drugs are tested for toxic effects in humans, and to see how much people can withstand, and not for therapeutic effect.
This topic is worthy of lots more discussion than I can afford here. I do recommend reading the full article, including the methods about how the survey was done, and the editorial* in the Annals, which accompanied the paper, which like so many other provocative and significant reports in the medical literature, didn’t get much attention in the lay press.
One point the editorial considers is that, perhaps, the PCI consent form used by the study authors and said to be at a 12th grade reading level, should instead be provided at an 8th grade level, as some institutions recommend and require. I’m not so sure about this, because I think a lot of medical ideas and decisions simply cannot be communicated at a lower level without loss of content, i.e. nuanced information.
I’m eager for readers’ views on this – how often is it that doctors effectively convey why a procedure should be done or a treatment be given, and what might be done to improve the process?
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At grand rounds we heard a similar study. A long document was required by IRB. In the middle of the document a sentence was inserted saying that it was not necessary to read any further but just exit the program. ONly 1% of volunteers stopped at this point. The surmise was that few subjects read the documents.
Marc
Thanks Marc,
Your story reminds me of a story a researcher told me, about someone who said he inserted an entire paragraph about baseball into his grant proposal, that received funding. That was long ago, of course –
I am known as being one of the most informed consumer patient advocates around but I recently had an experience that reminded me of just how different a providers view is vs a patients. Who knew that a “mask” meant a ventilator? Or that sleepy means you are on a ventilator?
Recently I was scheduled for a simple hysterscopic myomectomy (fibroid removal) with a spinal or walking epi. Goth my father and grandfathers hearts stopped (my Grand-dad passe) just prior to surgery during induction and it wasn’t worth the risk. I found videos of the operative procedure but I wasn’t too concerned about the spinal.
I was very clear that I didn’t want a general to both the surgeon and the anesthesia team in the week leading up tot he procedure but at the last moment I was told I would be more comfortable with a nice mask with some gas to make me sleepy..and someone said to tip my head back so they could measure it for the tube. I was simultaneously given Midazolam, and although I asked to talk to someone I was taken to the OR and quickly given Fentanyl, Propofol and Lidocaine in rapid succession and the mask placed over my face. This was apparently followed by equally rapid ePHEDrine when my BP and HR bottomed out but I wasn’t around to discuss my options.
The “mask” was a laryngal mask which providers all probably realize is actually a 6 inch tube they place into your throat and inflate and the sleepy meant once my respiration became depressed I was placed on a ventilator but I didn’t know about either or those two.
In my anesthesia intake it clearly stated that I didn’t the surgery if it meant I had to intubated and technically since I only got LMA they had my informed consent.. It is interesting to read the records that blow in a templated form that says they discussed the benefits and risks of the anesthesia with me 5 minutes after I was given the Midazolam. I should be glad that the procedure was successful but I feel like I wasn’t informed nor that I really consented..
Since then I have discovered that there isn’t any really any solid evidence to show that the procedure I got is effective for long term resolution of fibroids nor in preserving fertility. The bill? Hospital alone is over $8,000.
Anytime you receive a spinal or an epidural, general anesthesia is always a possibility. There is always the possibility that the spinal or epidural’s level can go too high, causing what is known as a “total spinal”. With a total spinal, you cannot breath on your own, and ventilation (by mask, LMA or endotracheal tube) is indicated, or you could die. There is also the possibility that the surgery goes on longer than anticipated or that the spinal or epidural fails/wears off during the surgery. This may necessitate general anesthesia, or you could feel extreme pain. Intubation is often chosen as it is safest way to protect the airway during a general anesthetic. These things are unusual, but do occur occasionally, and perhaps that is what happened with your case. In any event, a patient must consent to the possibility of general anesthesia if they are to consent to a regional anesthesic. It sounds like your anesthesia provider failed in communicating this to you both preoperatively and postoperatively.