Bioethics Discussion Blog: Patient Informed Consent from Partially Uninformed Physicians

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Wednesday, March 05, 2014

Patient Informed Consent from Partially Uninformed Physicians







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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