Informed consent: Use it to improve care, reduce risk

Unfortunately, a complete informed consent remains a rare phenomenon. A landmark study in JAMA (1999; 282:2313-20) documented that fully comprehended informed consent occurs in only 9% of patients' charts. A number of organizations have taken steps to address this issue. In September 2005, the National Quality Forum provided guidelines on the informed consent process, which suggest that physicians document that each patient be able to recount what he/she was told during the informed consent discussion. The guidelines also provide specific recommendations for using a "teach back" strategy to verify patient understanding through specific questioning.

Documentation

What type of consent forms do you use in your practice: a single, general consent-to-treat form, a fill-in-the-blank form, or a set of detailed, procedure-specific forms? A study published in the Archives of Surgery (2000; 135:26-33) reviewed 540 written consent forms from 157 hospitals. That analysis found that the necessary elements of informed consent-purpose, risks, benefits, and alternatives-were present in only 26% of the documents.

Even in our specialty, authors of a study of 95 radical prostatectomy patients found that 41.8% of the informed consent documents failed to mention any alternative therapies (J Urol 2006; 176:694-9).

While a well-executed informed consent document may not by itself provide adequate protection against a claim involving lack of informed consent, an effective consent should contain the alternatives to treatment and the risks of not having the procedure you recommend. Consider a case in Pennsylvania in which a patient claimed that she was not advised of non-surgical alternatives for the treatment of urinary incontinence. The patient did not allege surgical negligence, only that she had not been informed of less-invasive alternatives. The urologist was unable to provide documentation supporting his claim that he reviewed non-surgical alternatives with the patient. A jury awarded the patient $150,000.

An effective informed consent also contains a list of the risks associated with a given procedure. Such a list should include both risks and complications that are common, meaning known adverse events, and those that are uncommon but material, such as risks that might affect the decision-making process of a reasonable person.

For example, a patient underwent spinal surgery to treat sciatic pain. The patient was not advised of the potential risks of neurogenic bladder and the need for self-catheterization. The patient suffered those complications-neither of which was disclosed on the signed consent form-and a general consent-for-treatment form had been used. A New Jersey jury awarded that plaintiff $1.8 million.