Informed Consent is easily misunderstood. It is not, as we so often might think, a piece of paper representing a patient's agreement to a procedure or surgery or program. Quite the opposite. According to the "Bible" of informed consent - Fay Rozovsky's "Consent to Treatment," "Consent is a process, not a form. It is a communications process....a two-way flow of information that helps care providers identify potential risk, and then to design care plans in a way that helps reduce the risk of harm."
Further, Rozovsky writes "Those who wish to litigate subsequent to an adverse or unanticipated outcome may do so regardless of a robust consent process." Frequently, if there is an adverse outcome, litigation is the result. While consent communication can help diffuse litigants, it does not always stop them from litigating on the very issue of informed consent. While consent to treatment is a fundamental component of medicine, it is often poorly executed in the field. The results of poor consent to treatment can be catastrophic for all involved: patient, physician, family, institution. Therefore, whether litigation does result or not, proper consent to treatment is a sine qua non of good medical care.
There are three profound difficulties facing physicians who wish to deliver the best possible informed consent.
1. Consent to treatment means disclosing potentially terrible outcomes. "Yes, and you might die" is not something many physicians wish to say, even if there is a possibility of death. Reason: hope springs eternal in the human breast, and physicians and patients alike find that hope - or "faith" in the healer - is a critical component of the healing process. Fear is its enemy.
2. Consent to treatment is uncompensated. Physicians are generally paid for their time and skill. But no ICD-9 code exists for "informed consent." This creates a problematic psychological barrier to the physician.
3. Good differential diagnosis requires at times that physicians, simply, recognize that they do not know precisely what's going on, but that they make a "best guess" at a diagnosis, and proceed to watch carefully as treatment progresses. Physicians cannot be paid for their services without a core diagnosis. Yet, patients often do not want to return, and often do not call or inform the physician when a treatment isn't having the desired result. So both the billing process, and patient expectations, frustrate the program of differential diagnosis, and thereby also frustrate informed consent.
One of our doctors in the pediatric insurance company I run - a Board-certified emergency pediatrician - reasons this way when presented with an uncertain diagnosis. "What is the worst possible thing this could be? What is the most catastrophic diagnosis? Could this problem, this disease process, this presentation, be this "worst possible thing?" He then considers the "next worst possibility," and so forth.
What does this have to do with informed consent? You cannot readily inform a patient about a treatment for a disease process or procedure, if you are still largely uncertain. "It could be this, it could be that, it could be something else" is difficult for patients to absorb. I mention this to indicate the intimate relationship between consent to treatment and differential diagnosis.
How do lawyers think about informed consent? Here's a set of comments from a major malpractice firm (it specializes in ophthalmological lawsuits):
"...An informed consent waiver is not worth the paper it's written on if a) you should not have had the surgery; b) you were not properly screened or verbally informed of the risks; c) the physician botched your operation. On the other hand, doctors wouldn't make you sign these forms if they didn't offer some protection against lawsuits. ....the strength of any waiver you signed depends on the skill of your attorney to break it....Our experience has been that most victims did not fully understand the risks - a lack of informed consent - because no doctor ever sat down to discuss "the good, the bad, and the ugly."
In order to provide a high-level of patient safety and disclosure, and to make sure that every possible risk has been thoroughly disclosed to patients and their families, it is imperative that providers implement a well-designed Informed Consent Program. A good program provides important disclosures to patients while saving doctors time. Simultaneously, its reporting system assists doctors and patients to focus on the key issues of comprehension or concern. It helps to protect doctors from unreasonable lawsuits, and patients from misinformation.
We believe a well designed Informed Consent Program can almost completely (but not quite, of course) remove the possibility of misunderstandings, mis-communication and misplaced expectations. It also "drives" patient-physician interaction. It sets the stage for a well-understood outcome, even if that outcome is less than desirable. A well designed and consistently implemented Informed Consent Program will achieve the following:
1 To effectively and efficiently deliver critically important information about proposed procedures, surgeries and programs to patients.
2 To save doctors time and the difficulty of remembering every element related to a particular procedure's informed consent.
3 To communicate important items to patients which doctors are uncomfortable saying
4 To offer patients a chance to deeply understand their need for a procedure in a comfortable home environment, and to share the information directly with others.
5 To enhance patient-physician relationships with definitive consent to treatment.
6 To empower patients to understand the consequences of their decisions.
7 To help patients achieve a deeper sense of personal responsibility for their health care.
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