Читать книгу Successful Training in Gastrointestinal Endoscopy - Группа авторов - Страница 47

Informed consent

Оглавление

Obtaining an informed consent is a process that requires more than the attainment of a patient's signature. It involves mutual communication, disclosure of procedural limitations, and setting realistic expectations. When done effectively, it is an important risk management tool, transferring the responsibility of risk for an imperfect procedure to a competent patient who acknowledges and accepts that well‐performed endoscopies can have adverse or limited outcomes [4, 5]. Much of our approach to informed consent has been shaped by the culture we live in and the judicial system. In a landmark 1914 ruling “Every human being of adult years and sound mind has a right to determine what is done with his body,” the focus of informed consent shifted to a patient‐centered approach of self‐determination [6]. It is the physician's responsibility to disclose as much information as a reasonable patient would wish to know when making a decision [7]. Determining “reasonable” is not a precise science and the physician must simultaneously balance the need to avoid overwhelming the patient with providing pertinent risk information [8]. Certain states, such as Louisiana, have assisted the physician by providing a list of material risks for common medical procedures [9]. It is important to know the legal requirements where you practice [10]. Many physicians use brochures or website‐guided tutorials as tools for informed consent. While these instruments can augment informing a patient of a procedure, they should not substitute for the individual conversation between the patient and provider. Although state law varies on who can legally obtain informed consent, most experts recommend that the physician do so personally [1, 4].

Table 3.1 Preprocedure quality indicators.

Indication for procedure The indication is specified, and if a nonstandard indication, the reason is documented
Informed consent Proper informed consent documenting “PARQ” is documented
Focused history and physical exam Document any cardiovascular disease, medications, allergies, vital signs, heart and lung exam, and airway assessment
Preprocedure risk assessment Document ASA and/or Mallampati score
Appropriate use of prophylactic antibiotics As per published guidelines
Management of anticoagulants and antiplatelet agents Plan as to whether and when to stop them and when to resume is documented
Sedation plan Specify the depth of sedation planned: minimal, moderate, deep, or general anesthesia
Team pause Ensure that the proper patient is undergoing the proper procedure

The process of informed consent requires a thoughtful exchange of seven essential elements between the physician and patient. The consent form should be timed and dated and, if possible, witnessed by a third party.

There are seven elements that require discussion in nontechnical terms and should be appropriately documented. These include the following:

1 Nature of procedure.

2 Benefits.

3 Material risks and complications of the procedure, including their likely incidences and severity.

4 Alternatives (including nontreatment).

5 Limitations of procedure.

6 Conflict of interest/research evaluation: A physician who has either financial or research gain in enrolling a patient into a specific study or medication must be direct about these affiliations.

7 Opportunity given for patient to ask questions.

Successful Training in Gastrointestinal Endoscopy

Подняться наверх