11 Informed Consent, Complication Assessment, Quality Control, and Documentation Obtaining informed consent from the patient is an important process within the patient–doctor relationship. The goal of the informed consent is to educate the patient about potential complications or side-effects. Informed consent is necessary in situations where a reasonable patient would not be aware of the potential consequences of a given treatment decision without obtaining specific information from the treating physician (Mock, 2003). The requirement that physicians obtain informed consent from their patients before treatment codifies a belief predominant in Western culture that people have a basic right to control their own lives and bodies (Howard, 2005). However, there are distinctions between countries with a legal tradition based upon civil law (“Roman” law) and those with common law (“English”). What follows is discussion based upon a common law perspective. The requirement for informed consent not only varies from state to state but is also inherently dependent on the nature of the work the physician performs. Furthermore, not every patient assesses the risks and potential outcomes, including the disastrous ones, in the same manner. Some patients may find any risk whatsoever unacceptable and will not proceed with having the procedure or treatment performed. Another patient may feel, in his or her assessment of the overall possibilities, that the risks should be taken as a matter of “trust,” no matter what could happen. In order to obtain informed consent that is acceptable to the courts and that meets the ethical obligations, the following information must be provided (AMA, 1998): • The nature of the disease and the proposed treatment or surgery. • The chances of success based on medical knowledge. • The risks of the proposed treatment. • Adverse effects of the proposed treatment or procedure. • Reasonable alternatives and their chances of success, risks, and adverse effects. • The consequences of deciding not to proceed with the recommended course of treatment. The process of informed consent requires that ultimately the patient be provided with the following (Howard, 2005): • A working or presumed diagnosis. • Differential diagnoses. • The purpose and risks of any planned tests. • Options to treatment recommendations. • Prognosis. • An estimate of the current level of severity of the patient’s condition. In order to fulfill the above obligations, one of the points in the discussion of providing informed consent is the question of what is “sufficient” or what is “going overboard.” While in theory many of these considerations can be implemented, in the end—and in the “real world”—it is practicality and the availability of time that may be the overall deciding factors. Howard (2005) provides a rationale for full and complete disclosure, a disclosure that informs the patient of “everything.” This recommendation is based first on the premise that patient autonomy “means that the values that lead to the patient’s decision must be respected.” He states secondly that in preparing a comprehensive list only the most obscure possibilities are excluded. “A conscientiously prepared list excludes only a few risks that are highly unlikely and occur in fewer than 1 per 100 000 cases. Therefore, the chances of such an event both occurring and being absent from the list is much less than 1 per 100 000 cases
Informed Consent within Patient Care
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