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The Nuances of Informed Consent

Modern medical ethics are built upon the concept of informed consent. This is not, however, as straightforward a concept as it may seem.

Physicians and health care providers have a duty to provide informed consent to their patients or their patients’ guardians, which means that they have to inform them appropriately about the risks and benefits of their recommendations and interventions. This includes informing them about the risks of not treating an illness.

This principle is, in turn, based largely upon the principle of autonomy – people have the right to control their own lives, and one cannot have control without information.

This is all simple enough, but where it becomes tricky is in deciding how much information to give patients, and how to present it. (more…)

Posted in: Critical Thinking, Medical Ethics, Science and Medicine

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Beyond Informed Consent: Shared Decision-Making

Happy New Year to all our readers! Today marks the completion of 5 years of SBM and the beginning of year 6. My contributions, at one a week, have now reached a total of 260. My first post on this blog, 5 years ago, was a review of an important book about science and alternative medicine, Snake Oil ScienceThis year I’d like to start with an important book about communicating medical science to patients, Critical Decisions,  by Peter A. Ubel, M.D.

I was wrong about informed consent. I thought informed consent was a matter of explaining the risks and benefits of treatments to patients so they could decide what they wanted to do.  That was naïve, simplistic, and misguided. Ubel’s book has radically changed my thinking about how doctors should interact with patients.

Paternalism in medicine is dead. Patient autonomy rules. We respect the right of patients to determine their own treatments, even if their choices seem unwise to us. Patients should do what they want. But there’s a problem: patients may not know what they really want. Emotions and unconscious and irrational forces influence their medical decisions. Preferences can change from one moment to the next, and they can shift with subtle changes in how treatments are described and how the issues are framed. Doctors need to develop a better understanding of what is going on in their patients’ minds, of how the way they present treatment options can inadvertently influence patients, and of how they can participate with patients in a process of shared decision-making. It’s possible to provide direction without paternalism. (more…)

Posted in: Book & movie reviews, Medical Ethics

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True Informed Consent Is Elusive

Most of us would agree that doctors should not treat patients without their consent, except in special cases like emergency care for an unconscious patient.  It’s not enough for doctors to ask “Is it OK with you if I do this?” They should get informed consent from patients who understand the facts, the odds of success, and the risk/benefit ratio of treatments. The ethical principle of autonomy requires that they accept or reject treatment based on a true understanding of their situation and on their personal philosophy. Numerous studies have suggested that patients are giving consent based on misconceptions. There is a failure of communication: doctors are not doing a good job of providing accurate information and/or patients are failing to process that information. I suspect it is a combination of both.

An article in The New England Journal of Medicine reports that while the great majority of patients with advanced lung cancer and colorectal cancer agree to chemotherapy, most of them have unreasonable expectations about its benefits. For some cancers chemotherapy can be curative, but for metastatic lung or colorectal cancer it can’t. For these patients, chemotherapy is only used to prolong life by a modest amount or to provide palliation of symptoms. Patients were asked questions like “After talking with your doctors about chemotherapy, how likely did you think it was that chemotherapy would… help you live longer, cure your cancer, or help you with problems you were having because of your cancer?” A whopping 69% of lung cancer patients and 81% of colorectal cancer patients believed it was likely to cure their cancer, and most of these thought it was very likely. (more…)

Posted in: Cancer, Medical Ethics, Pharmaceuticals

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Chiropractic Strokes Again: An Update

The risk of stroke with neck manipulation has been addressed on SBM before by Dr. Crislip, by myself, by chiropractor Samuel Homola, and by Jann Bellamy. I have listed the links at the end of this article for the convenience of interested readers. Recent studies merit a followup.

A case report published in the Annals of Internal Medicine July 17, 2012, describes a 37 year old nurse who had a history of chronic neck pain. She had been getting neck manipulations from her chiropractor once a month for 12-15 years! (One can only conclude that the manipulations had not accomplished much.) She developed a new symptom (pain when turning her head up and to the right), and at her 4th visit in a week, during neck manipulation, she heard a loud pop and immediately had the sensation that the room was spinning. She developed visual disturbances, vomited, and had a loss of balance, persistently falling to the left. The chiropractor failed to recognize her symptoms as signs of a stroke. Instead of rushing her to the ER, he performed an  “occipital adjustment” in an attempt to relieve her symptoms. She went to the ER 1.5 hours after the event and was found to have a cervical artery dissection. She was discharged from the hospital after 48 hours but has residual symptoms. The authors’ conclusion:

Although incidence of cervical artery dissection precipitated by chiropractic neck manipulation is unknown, it is an important risk. Given that risk, physical therapy exercises may be a safer option than spinal manipulation for patients with neck pain.

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Posted in: Chiropractic

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California Bill AB 2109: The Antivaccine Movement Attacks School Vaccine Mandates Again

Of all the preventative treatments ever developed through science- and evidence-based medicine, vaccines have arguably saved more lives, prevented more illness and disability, and in general alleviated more suffering than any single class of treatments or preventative measures throughout history. Given the obvious and incredible success of vaccines at decreasing the incidence of infectious diseases that used to ravage populations, it seems incredible that there would be such a thing as an antivaccine movement, but there is. Indeed, when I first encountered antivaccine zealots on the Usenet newsgroup misc.health.alternative about ten or twelve years ago, as a physician I really had a hard time wrapping my head around the fact that such people existed. No doubt the same is true of many physicians, who take the scientific evidence for the safety and efficacy for vaccines for granted. However, I am a cancer surgeon, and I do not treat children; so until I discovered antivaccine rhetoric on the Internet I was blissfully ignorant that such views even existed. Other health care professionals knew better. Pediatricians, nurses, and any health care professionals who deal with children and the issue of vaccinations know better, because they face antivaccine views on a daily basis. It is because of the incredible importance of vaccination and the danger to public health the antivaccine movement represents that we at Science-Based Medicine write so frequently about vaccines and the antiscientific, pseudoscientific, and misinformation-packed fear mongering about vaccines that is so prevalent today.

The success of vaccination campaigns has recently been endangered by a number of factors, in particular the antivaccine movement. Because of various groups opposed to vaccination, either for philosophical reasons or because they incorrectly believe that vaccines cause autism, neurodevelopmental disorders, sudden infant death syndrome, and autoimmune diseases, among others, one of the most potent tools for encouraging high rates of vaccine uptake, school vaccine mandates, have come under attack. Alternatively, increasing numbers of parents have taken advantage of religious or philosophical exemptions in order to avoid the requirement to have their children vaccinated prior to entry to school. As a result, of late some states with lax vaccination requirements have begun to try to tighten up requirement for non-medical vaccine exemptions. The arguments used by the antivaccine movement against such legislation are highly revealing about their mindset, in particular their attitude towards issues of informed consent, which I will discuss a bit. But first, here’s a little background.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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South Dakota’s Abortion Script: The Hijacking of Informed Consent

In a previous post, I suggested that informed consent could sometimes be misused. South Dakota has provided a clear example of such misuse and has set a frightening precedent reminiscent of Big Brother in George Orwell’s 1984.

A law went into effect in July, 2008, requiring that any woman seeking an abortion in South Dakota must be told that she is terminating the life of “a whole, separate, unique, living human being” with whom she has an “existing relationship” and that abortion terminates “her existing constitutional rights with regards to that relationship.”

It requires that doctors give patients information about medical risks, but it doesn’t leave anything to chance: it specifies what the risks are, including depression, suicide, danger to subsequent pregnancies, and death. The current state of development of the fetus must be described, and the woman must be asked if she wants to see a sonogram of the fetus. All of this must be done in writing, and the woman must sign each page of documentation. Physicians who fail to comply can lose their license or be charged with a misdemeanor. (more…)

Posted in: Politics and Regulation, Surgical Procedures

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Paternalism Revisited

Paternalism is out of fashion. Doctors used to have a parent-child relationship with their patients: they concealed the truth if they thought it was in the patient’s best interest, they dictated the treatment and did not have to justify it to the patient. “You have to take this pill because I’m the expert and I know what’s best; don’t ask questions.” Sort of like “You have to go to bed now – because I said so and because I’m the mommy.”

Some time in the 20th century we evolved to a different doctor-patient relationship, an adult-adult one in which the doctor shared expert knowledge and information with the patient and they cooperated to decide on the best treatment plan. The principle of patient autonomy became paramount and the patient gave informed consent to the chosen treatment.

It is generally accepted that this is all for the good. But is it really? In his book Intern: A Doctor’s Initiation, Sandeep Jauhar says, “Over time, my views on informed consent have evolved. I no longer view paternalism as suspiciously as I once did. I now believe that it can be a core component of good medical care.” (more…)

Posted in: Medical Ethics

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