Is it truly an informed consent when a piece of paper is given to you to sign on your way to the operating room? The first insult is that the Consent Form is presented at an awkward time when you are so scared you do not even know what to ask. Next, the “informed consent form” is written in such a “legalese” you will need a lawyer to interpret what it says – preferably the same one who wrote it! Finally, the consent form goes into such great detail on everything that can go wrong, that if you really start thinking about each one of them, you may choose to suffer than sign that paper!!
It is sad that what should have been done to involve patients in a thoughtful decision making process has been made into a “risk management tool”. These consent forms do not even perform that function well. Evidence accumulated over the past several years has shown that the “informed consent” forms fail to truly inform the patients. They do not help avoid malpractice suits either.
A study that analyzed the consent forms collected from several US hospitals showed that some of them were “short and vague”, some of them “long and confusing”, many of them used legalistic language and only 25% of them went beyond just the description of the procedure to include information on risks, benefits and alternatives.
The status of informed consent was the topic of an essay on “Uninformed Consent” by Ms.Debra Franklin in the March 2011 issue of the Scientific American. She describes new tools of technology that are being developed to include and involve patients in the process of obtaining informed consent. These tools formalize and organize the components of Informed Consent and emphasize “education” of the patient so that when the patient signs a consent, it is truly an “informed” consent. Although these tools have not been tested, this is a good start.
These “software” tools of technology are interactive and are either aimed at doctors or at patients. I looked at two of them, mentioned in the article by Ms.Debra Franklin. They are Emmi Solutions and iMedConsent.
Emmi Solutions is patient centered, interactive, uses images, written at a level most people can understand, is in English and Spanish and is based on input from patients and doctors. The program I opened was on Angioplasty. The topic is presented under seven headings: Your Body, Your Condition, Pre-Procedure information, details of the procedure, Post-procedure recommendations, Risks and benefits and Alternatives.
iMedConsent is for physicians. Templates with details on several hundred procedures are available. They can be modified to suit the specific needs of individual patients. The program I looked at was on Cholecystectomy. This also followed the same format as the Emmi in explaining the body, the condition, preparation, procedure, post-operative instruction, risks and benefits and alternative.
Obviously these tools need testing. Also, what about patients who do not have computers or cannot interact with computers?
Ultimately, face-to-face “communication is essential no matter what the approach”. The computer will help to make sure the conversation did take place and all the elements of truly informed consent were covered. It will also assure us that the interaction is documented. Prudent, “compulsive” clinicians have been doing these all the time. Machine can only formalize the details and the process and inform everyone that it was done.
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