The title of this thread clearly sets the topic to be
discussed. Informed consent by a patient
for an examination or medical-surgical procedure is an established ethical and
legal act which has been even more focused throughout the medical profession in
the recent decades when previous professional paternalism behavior dissolved to
patient autonomy. However established
the practice is preached, the act still depends on several factors. With regard
to the patient becoming informed about the details of the examination and
procedure, it requires the patient or patient's surrogate making a decision to
comprehend what is being communicated, understanding the words and implications
of what was learned but also feeling free and comfortable to ask the physician
questions about details told and about information which had not been presented
but which is of concern to the patient.
These details therefore must be presented directly by the healthcare
professional who will be responsible for the exam or procedure and not only by
text on a sheet of paper to be read and signed.
With regard to the professional who provides the details to
the patient, the information presented should be in a form which is the best
for patient understanding and decision-making.
The talk should be comprehensible both in terminology and in how it is
presented. The detailing should not be "rushed through" but slow
enough for the patient to hear clearly what was said but also slow enough for the professional to
stop and monitor by questioning the patient that the words are truly being
understood. An important aspect of the presentation of information from doctor
to patient is to maintain attention to patient autonomy and avoid paternalistic
remarks or possible options which only fit
that physician's own personal interests.
However, even though physicians may have decided upon their own options
or professional decisions and it is appropriate for the doctor to tell the
patient what the doctor has decided is best for the patient's health and
well-being and why, it finally becomes the patients' own decision which is the
primary goal of the informed consent exercise.
For the patient to do that, it requires that the patient actually be
informed.
But, how can informed consent by the patient work if the
patient's doctor is not fully informed? And
perhaps the entire medical profession is not fully informed about the
interpretation of an examination nor the outcome of a procedure. "How can
that be?" you might ask. The answer
is very simple. The medical and surgical profession just doesn't know about
everything it carries out. The
profession knows a lot but it doesn't know everything and that
"thing" it doesn't know may be a "critical thing" for the
best interest of the patient.
Although, in the United States, the Food and Drug
Administration (FDA) attends to prevent medications which have been developed
to be used on patients without careful scientific evaluation of the drug's
safety and efficacy for treatment, there still occurs side-effects and serious
complications that only appear once the drugs are used throughout the whole
patient population and not simply in the preliminary investigative tests of
small numbers of patients. With regard
to surgical instruments and procedures, the government has far less direct
control over studies to evaluate safety and comparative values. Some techniques and procedures may be
informally described in the literature and carried out by surgeons with varying
degrees of experience and unlike the case with the prescription of medications,
each use becomes for that surgeon a learning experience.
An interesting example of a surgical technique and its
developing but still incomplete knowledge of its complications and the best way
to prevent them is the procedure of electric uterine morcellation as described
in a Viewpoint article in the March 5 2014 issue of the Journal of the American
Medical Association. The procedure is a
method for slicing a large organ within the body, in this case the uterus, in
order to remove the organ piecemeal through the very small incisions which are
used to enter the abdomen for a laparoscopic surgical procedure. The advantages of laparoscopic surgery to surgically treat a variety of abdominal
diseases and disorders with a minimum of surgical trauma and a much more rapid
patient recovery period is common knowledge. What isn't common knowledge and is
not fully known at this time by the
surgical profession is the full risks and degree of risks of incorporating
electric morcellation of organs including the uterus. For example, shredding a uterus to facilitate
its removal may also shred and disseminate throughout the abdomen a previously
undetected uterine cancer within the body of the uterus. There are more unknowns about the procedure
including the full risk/benefit ratio as compared with removal of the entire
organ through a standard operative incision.
So how can informed consent be asked from the patient when
the doctor him/herself is not fully informed? The article stresses the
importance and necessity for full information disclosure to the patient and
including detailing the various issues
for which the surgeon is uninformed such as regarding risks which are "vague
and unspecified because of limited data".
It is my opinion that such disclosure requires the risk and benefit information
to be provided in an unhurried manner and so the patient understands them, to
be provided by the surgeon responsible for the surgery and all the alternate
options be presented. However, as noted in the article, with respect to
disclosure of risks and benefits "this is difficult when the risks are
vague or unquantified because of lack of data or rarity of an event. Yet a lack
of data or rarity of an event should not preclude discussion of serious
potential complications".
How would you, as a patient, want the physician to inform you
about the risks and benefits of a procedure to obtain your "informed
consent" when the doctor him/herself is not fully informed? ..Maurice.
Addendum 3-5-2014: The
original graphic obtained from Google Images and modified by me with ArtRage
and Picasa 3 is from an excellent article about the responsibilities of the
doctor toward the autonomy of the patient written by Dr. Faisal Saeed in the
Team Talk website of the ADK Hospital of Male' in the Maldives. I suggest, to supplement what I have written
above, you go to the above link and read Dr. Saeed's article.
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