Unfortunately, even after
signing a consent form, many patients still do not understand
basic information about the risks, benefits and alternatives
of their proposed treatment options. There are many potential
reasons for this failure of truly informed consent and the
ongoing lack of understanding. Patient factors may include
low health literacy, limited English proficiency, cognitive
impairments, learning disabilities, hearing
or vision impairments, confusion about the purpose of the
consent process, a feeling of intimidation, and stress or
time pressure. In addition to the acknowledged low rates
of health literacy and English proficiency seen in an increasingly
diverse American society (See below: “Informed
Consent: What Did the Doctor Say?”), the other
less well documented human factors that may negatively influence
the patient’s comprehension of medical information
include memory, education level, and also the timing of
the informed consent session. On the provider side, the
factors may include lack of time for up-front patient education,
overly complex or overly broad written materials, lack of
support with interpreters, and wrong assumptions about patient
comprehension.
Whatever the reason, the consequences of a lack of truly informed consent can be serious. Beyond the fundamental breach of the ethical and legal duties to inform the patient, there is also the increased potential for medical errors and malpractice claims. For example, recent discussions of consent-related legal problems have stemmed from situations such as:
A doctor who felt the patient “really needed”
the catheterization procedure to avoid a heart attack
and so may not have fully explained the procedural risks
or emphasized that the patient had a right to refuse;
A woman with limited English proficiency who refused
surgery, scared that she had not given her doctor a complete
medical history because her husband was interpreting for
her;
A patient with complications following cosmetic surgery
who claims she was never told about the potential side
effects in her numerous initial discussions with nurses
and doctors—and who says that she signed the informed
consent form describing the full risks only when she was
on her way to surgery and too medicated to comprehend;
A young agricultural worker who speaks only Vietnamese
and was so intimidated by authority figures in the hospital
that he felt he must sign the poorly translated informed
consent form agreeing to an invasive diagnostic test in
order to get access to pain relief for his emergency condition.
Informed Consent: “What Did the
Doctor Say?”
This question is the title of a 2007 publication from
the Joint Commission on improving health literacy
to protect patient safety. [Joint Commission 2007]
Many of the facts cited by the Joint Commission also
support the need for improved informed consent. For
example:
“Approximately 21 million people in the U.S.
speak English ‘less than very well.’”
“... substantially higher rates of blacks, Hispanics,
and Asians reported having ‘communication problems
with their physicians’ than did white patients.”
“One study of health literacy in relation to
colorectal cancer screening found that many participants
with low health literacy did not know the meaning
of commonly used terms, such as ‘polyp,’
‘tumor,’ lesion,’ or ‘blood
in the stool.’ None of the participants knew
what the colon or bowel was nor where it was located.”
“... it is estimated that 75 percent of people
with chronic physical or mental illness have limited
health literacy skills.”
“In the Joint Commission’s sentinel event
database, 65 percent of the identified adverse events
have been found to have communication failures as
the underlying root cause.”
“... among patients who sign an informed consent
form, 44 percent do not know the exact nature of the
operation to be performed, and most—60 to 70
percent—did not read or did not understand the
information contained in the form.”
From “What Did the Doctor Say?:” Improving
Health Literacy to Protect Patient Safety. 2007.
The Joint Commission, Oakbrook Terrace, Illinois www.jointcommission.org
Developed with a grant from the Robert Wood Johnson Foundation
