Saturday, November 10, 2012

Informed Consent and Low Literacy

The principle of informed consent—that patients have the right to participate in decisions about their own health care—is a widely accepted tenet of medical ethics and law. The reason implementing informed consent is so challenging may be embedded in the term itself: one of its components—information—comes from the doctor, and the other—consent—comes from the patient. Typically, informed consent has two parts: a process in which the doctor explains the procedure and its risks and its benefits to the patient. Then, the patient signs a legal document called an informed consent form, which becomes a part of his medical record and serves to document that he has given the doctor permission to do the procedure after understanding what it entails. The problem is that consent forms are often long and detailed, and this glut of complicated information rarely facilitates comprehension or informed decision making. Instead of enhancing understanding, informed consent forms often end up overwhelming, confusing, or intimidating patients.

It appears that consent forms are deliberately badly designed. They seem to serve the purpose of protecting the doctor, rather than educating the patient because they are written by lawyers for lawyers. Hospital informed consent forms have virtually no bearing on the patient being truly informed or being aware of what is going to take place. Patients are typically asked to sign informed consent forms minutes before the procedure is to begin, often in a state of stress and fear (on top of being ill). Taking their signature seems to have become a formality, and they are expected to sign the document quickly so that the doctor’s schedule is not affected. Often these forms provide blanket authorisation for doing anything, which protects the hospital, but actually removes informed consent, because it means the surgeon can do anything he sees fit.

With regards to informed consent, low literate patients are a high-risk group – not just because they have a higher chance of suffering a poor outcome, but also because the hospital is at higher risk for being sued for malpractice. Doctors and hospitals can be held liable for adverse outcomes if the information provided to patients was incomprehensible to the patient. Communication failures can lead to adverse events in the courtroom. Courts have held that the patient's inability to read a consent form invalidated signed consent, and have shifted the burden to the physician to prove that informed consent was provided in some other way. Judges have made clear that when a physician is aware of an impediment to patient understanding, such as poor literacy or a communication barrier, the physician has a legal duty to address the impediment in order to obtain informed consent. This is why hospitals are investing in health literacy and patient education systems, thus creating smarter, more engaged patients, who can take better care of themselves. Health literate patients are less likely to have negative outcomes, thus reducing the risk of malpractice suits.

The law can serve as a carrot as well as a stick. If the fact that the doctor used health literacy tools when obtaining informed consent can be used as a defence against the claim that the patient was not educated about possible risks and complications, this would help encourage doctors to use these routinely. Some courts have considered the use of patient-friendly informational materials as proof that the patient provided informed consent.

In order to fix a broken process, clever companies are now using technology to allow patients to provide online digital consent. The web-based iMedConsent solution (@ prepares procedure-specific consent forms, covering more than 2,200 treatments and procedures. The clinical content library includes anatomical images and videos to enhance patient understanding. These resources can be personalised by the doctor, and the patient can review them from the comfort of home, thus saving the doctor’s time as well. The signed documents can be automatically stored, ensuring that critical documents are never lost or misplaced. This is smart use of technology to enhance patient safety and it also reduces the risk of the doctor being sued for malpractice, since it standardises and automates the informed consent processes.

HELP is organizing a conference on “ Putting Patients First Through Health Literacy  “. This will be on Sunday, 2nd December’12 at Nehru Center at 10.30a.m. to 1.p.m.  The website is

The conference will be followed by a health literacy workshop in the afternoon. Helen Osborne, President, Health Literacy, a world renowned  Consultant from US , will be delivering the keynote and conducting the workshop.  Her website is at

At this time, we will be releasing the book, Deciphering Medical Gobbledygook: Promoting Health Literacy to Put Patients First , authored by Dr Aniruddha Malpani and Juliette Siegfried. This is a section from that book

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