Informed consent
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.
Exceptions to informed consent
In a few specific circumstances, a physician can bypass the need to acquire informed consent. Several important exemptions to informed consent include the following [3, 4]:
1 Emergency waiver: The patient's critical condition incapacitates them from providing informed consent, and delay in performing the procedure can result in unnecessary harm to the patient.
2 Waiver of self‐determination: A patient waives his/her right of informed disclosure and assigns his/her physician the right for decision‐making.
3 Legal mandate: A judge or court orders a necessary medical therapy for a patient without their consent.
4 Incompetence: A patient cannot make a decision and thus this responsibility is given to an assigned third party (legal guardian).
5 Therapeutic privilege: A physician can withhold information regarding the procedure because of perceived harm to the patient. This is a difficult exception and one that can be perceived as an excuse for not informing the patient. Unless there is a clear and compelling evidence of psychological vulnerability, it is best to avoid use of this exception.
Informed refusal
Patients who refuse a procedure must do so in a well‐informed way. The physician should document that she/he has explained the purpose of the examination and the consequences of deferring the procedure.
Lack of informed consent
If there is no consent or the procedure goes beyond the scope of obtained consent, a charge of battery could be brought upon the physician. Unlike medical malpractice suits, which are a civil offense retributed monetarily, a charge of battery is a criminal allegation. Therefore, when obtaining consent, it may be reasonable to expand the extent of the consent to include foreseeable complications (i.e., surgery in the setting of perforation or blood transfusion in the setting of bleeding). Most malpractice insurances do not cover battery and a physician can be held personally liable. Additionally, a charge of battery can result in restriction of hospital privileges [10].
Documentation
“If you didn't write it, you didn't do it.” This often quoted phrase holds true in litigation. A simple note confirming that discussions occurred regarding the nature of the procedure, alternatives, risks (highlighting the major ones), sedation, and an opportunity was given for patient to ask questions (aka “PARQ”—procedure, alternatives, risks, questions) can confirm a discussion took place with the patient and holds up as an important legal record of the exchange.
Preoperative clinical assessment: focused history and physical exam
Understanding the preoperative health and medical limitations of the patient undergoing a therapeutic procedure is a necessary prerequisite to the successful undertaking of the procedure. The risks of sedation can be assessed using the American Society of Anesthesiologists (ASA) score (Table 3.2) [11]. The ASA score correlates with sedation‐related complications during endoscopy and is helpful in determining the need for anesthesiology support. The cardiopulmonary risks of sedation correlate with the depth of sedation, and for that reason, the sedation plan (minimal, moderate, deep, or general anesthesia) should be specified before the procedure begins [12, 13]. In minimal sedation, previously referred to as “anxiolysis,”