Much of what happens to you in the hospital in the name of diagnosing and healing is invasive. Depending on what ails you, a doctor may need to ream out an artery to get more blood to your heart, or flood your body with a poison to kill cancerous cells, or saw through the bones of your leg to replace a crumbling hip or a worn-out knee. If a stranger came at you with a scalpel or syringe in a back alley, you would consider it assault and battery. But in a hospital most of us willingly schedule an appointment and pay big money to be precision-poked and carved because we trust our doctor’s skill and knowledge and assume the alternatives—illness, incapacity or early death—are surely worse.

But how many patients truly understand the alternatives or the risks and benefits of the test or treatment they are undergoing? One of the guiding principles of modern health care is that, except in an emergency, doctors must get the patient’s permission before the start of any invasive medical procedure. That “informed consent” is supposed to be based on an earlier conversation during which physicians make sure patients understand what the procedure will and will not do, along with its benefits and risks relative to other options.

Unfortunately, what typically happens in hospitals and clinics across the U.S. is far from ideal: On the way into surgery or some test or treatment, a nurse or technician slips the patient a clipboard of legalese to sign. In most cases, that piece of paper is either a vague permission slip acknowledging that the patient has been “informed” about the procedure, or it reads like a legal waiver—a laundry list of every single side effect and rare complication that could possibly go wrong. These badly written, hastily signed forms are meaningless or worse, health literacy experts say. Research consistently confirms that the flawed permission slips do not improve the patient’s understanding or safety. Nor do they protect hospitals or doctors from misguided malpractice suits.

In hopes of filling the gap, a growing number of medical centers are now turning to technology—specifically, interactive computer programs that are designed to get beyond the one-size-fits-no-one consent form. These software solutions vary widely in approach and targeted audience. Some are aimed at doctors, others at patients. Some are meant to be reviewed with a health care provider during an office visit; others can be watched with family members at home. Health researchers still debate each approach’s effectiveness. Rigorous outside testing of them has barely begun. But everyone lauds the goals these new approaches share. First, the programs aim to help make the discussion of the relative pros and cons of every invasive procedure—from angioplasty to tonsillectomy—more meaningful for the patient. Second, they aim to get doctors talking about benefits and risks much earlier in the diagnostic and treatment process so that patients can make truly informed choices about their own health care.

Strong evidence that traditional consent forms fail to inform patients or improve their care has been growing for more than a decade, says Harlan M. Krumholz of Yale University, who studies the ways the system goes wrong. One of the most telling nationwide investigations, he says, was a review published in 2000 of 540 forms collected from 157 randomly selected U.S. hospitals by a public health team led by Melissa M. Bottrell, then at New York University and now with the U.S. Department of Veterans Affairs. Its analysis revealed a haphazard mess: Some forms were short and vague; others were long and confusing. Many contained legalistic language that muddied the decision-making character of the consent process. Only about one in four of the forms went beyond a basic description of the procedure to include common risks, benefits and alternatives.

In nearly 60 percent of the documents studied, protecting “against liability” was the rationale given for using the permission slips, according to the hospitals submitting the forms. Too often, Krumholz says, the informed consent process has deteriorated into “largely a risk management tool for hospitals—a way to try to avoid malpractice suits—instead of a way to promote good decisions. And that seems to me a real shame.”

6 Comments

1. 1. croller23 02:27 PM 2/25/11

   I disagree with Deborah Franklin's position as it is presented in this article. I believe that the options discussed to further inform patients would not have the same beneficial effects in practice as it does in theory. It is a theory that would benefit far fewer than she seems to indicate in her article. I believe the effect of more information about procedures and side effects would prevent majority of people away from receiving proper medical attention.
   
   The idea of surgery is frightening enough to most patients. For a patient to then be required to undergo a tutorial about the process and be specifically informed of everything that could possibly go wrong would most certainly make the physician’s job more difficult as well as hinder the decision making by the patient.
   
   Contrary to the article, malpractice law suits would more than likely increase. Such a vigorous informed process would make a patient feel completely informed about everything that is going to happen and everything that could happen.
   
   The practice of medicine is a practice of helping others based on odds. What can happen during a procedure is unknown to even the physician himself, and making the patient feel more confident with "what is going to happen" may ultimately be a legal trap for physicians. This may further hinder healthcare because a physician may hesitate to help a patient as best as he can because a necessary procedure (from the physician's point of view) may legally be too much of a risk for the physician to take.
   
   Finally, a patient has the ability to ask the physician or a nurse for more information before they sign an informed consent. One reason why many patients do not actively seek more information about procedures is because they may not want the information. A calm, intelligent person must simply say "what is going to be done, how do side effects come about, and why do I need this procedure?" and a nurse of physician will give the patient the information he or she seeks.
   
   A Physician’s primary goal is to help their patients, not run up hospital bills or perform risky procedures at their patient’s expense for their own personal glory. People see doctors when they cannot handle a health issue on their own. Doctors are consultants, but people need to trust that a doctor is acting in their best interest. Doctors are already extremely busy in their day to day lives, and requiring them to spend significantly more time explaining procedures to patients is just not realistic nor do I see any clear benefit in it.

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2. 2. Lind4 02:17 AM 2/26/11

   I'm of the opposite opinion as the previous comment. Nobody want's to be in the hospital unless they are having a baby. The stress level is through the roof because they have no idea of what's going to happen with them. Many hospitals are taking the idea of patient education more seriously because of recent study proving the positive impacts of educating the patients. There is an art to creating effective education designed for patients...they layout, inclusion of art work, reading level.
   
   Patient consent forms, for many hospitals, are nothing about educating or empowering a patient to make choices regarding their health. They are designed to cover the backside of the hospital...no question. How much detail or time needs to be taken is really something that needs to be looked at, but moving away from the "head in the sand" approach is fantastic.
   
   I would dare say that most consent documents are written at a 10th or 11th grade level...at least. A good consent form with patient education included should be done at a 5th-8th grade reading level. Where the average person can read and understand it.
   
   Hospitals can no longer afford to deal with law suits and high readmission rates (soon to be not covered by Medicare).
   
   Great article and right on the money to where the industry is trending!

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3. 3. croller23 11:31 AM 2/27/11

   I agree that consent forms can be written in a more "patient friendly" format. However, the article is suggesting a more involved process, one that does not seem practical. The more involved process would benefit some Americans, I never denied that. I simply believe that "the majority of people," will not be helped by such a process. Keeping this system simple allows physicians to spend their time diagnosing and treating patients as opposed to thoroughly explaining their decisions to patients. A physician or nurse will gladly answer any questions or explain procedures and alternatives before the consent form is signed, if a patient would simply ask for more information. But if a patient does not ask, why should a physician be required to give more information by law? What the article suggests would simply be a more involved consent process to “cover the backside of the hospital.”
   
   The main point of my previous comment was to suggest that the limited studies cited in the article do not provide strong enough evidence to warrant a more involved patient consent process. Again, it is great in theory and a great topic for discussion on ScientificAmerican.com. However, I still fail to see any clear benefit that the "majority of people" would receive by a more informative/involved patient consent process.
   

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4. 4. mfvk63 12:57 PM 2/27/11

   I like the idea of being able to review videos of a potential procedure. When was to have an aortic valve replaced in 2001 we (my wife and I) went on the web to find out what this was all about. By the time I gave my consent I had a pretty good idea of what I was in for.
   
   On the other hand I recently need to see a urologist. The first one really did not explain much and some form I couldn't decipher was put in front of me. It really did not comprehend what they were going to do and how. After a very painful diagnostic procedure I went elsewhere and was advised I needed some other test. This was even more painful and actually failed (they could get the test to work they way it was supposed to). Although this this second doctor did a much better job of trying to explain what was to be done, I don't think I was really informed.
   
   Part of the problem is you don't want to look stupid when you are in the office and usually you can'
   t think of an intelligent question to ask other that "could you repeat that because I don't get it". With an interactive video you get time to think, rethink, and formulaqte questions you can then ask the doctor.
   
   I hope more clinics and hospitals use this tool.

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5. 5. bucketofsquid in reply to croller23 10:38 AM 3/16/11

   "A physician or nurse will gladly answer any questions or explain procedures and alternatives before the consent form is signed, if a patient would simply ask for more information."
   
   My personal experience does not match your vague generalization. I have had some medical professionals that would but many were simply too worn out or too busy to give useful answers. Then there were a couple of them that were offended by my asking questions. In a perfect world your scenario would be correct. In the real world it is not.
   
   If patients choose to give up their right to an informed decision they surely may do so. Having medical professionals take that right away from them arbitrarily is simply wrong.

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6. 6. croller23 in reply to bucketofsquid 02:21 PM 3/16/11

   You have it backwards. The article presents a situation that "in a perfect world" would be correct, but would not "in the real world". By requiring medical professionals who are already "worn out or too busy" to give a patient useful answers would either require more physicians which would increase costs, or require the physicians to spend more time answering the patients questions instead of practicing medicine, thereby lowering the quality of the care they provide. If a patient has a chance, they can do their own research like mfvk63 did when he needed an aortic arch replaced. If you can not, take the physicians advice and sign the form. You can always choose the alternative, refusing medical attention.
   
   Implied consent (when a patient is unconscious it is assumed that they would accept medical attention) is proof that the law is on the side of the physicians. No one, not even the spouse of a patient, can prevent the care of a person who is unconscious (the only exception is when a patient is under the age of 18 a parent must be asked). The law and healthcare systems are not going to change their opinions on this matter anytime soon, and there is no where near enough proof to show any benefit in a different system.
   

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