MD News: Techniques to Obtain and Codify Informed Consent Discussions and Limit the Risk of Medical Malpractice Claims Based on a Lack of Informed Consent

by | Nov 7, 2016 | Medical Malpractice | 0 comments

By Michael A. Sonkin and Michelle A. Frankel

Monday, November 7, 2016

Category: EthicsLegalPractice ManagementRegulatory & ComplianceRisk Management

Specialty: Critical Care

The discussion between physician and patient prior to an invasive diagnostic procedure or surgery is a critically important aspect of care and treatment. This discussion is particularly important prior to an elective test or procedure to ensure the patient’s understanding of the reasonably foreseeable risks, benefits and alternatives to that test or procedure. Doing so helps to manage the patient’s expectations effectively, as well as to satisfy the physician’s obligations to obtain the patient’s informed consent for that test or procedure.

Pattern Jury Instruction 2:150A states that a doctor has a duty to provide certain information about what he/she proposes to do and discuss the alternatives and reasonably foreseeable risks before obtaining a patient’s consent. At trial, a jury must decide whether informed consent was obtained by answering three questions: (1) did the doctor, before obtaining the patient’s consent, provide appropriate information; (2) would a reasonably prudent person in the patient’s position at the time consent was given have consented if given appropriate information; and (3) was the operation or procedure a substantial factor in causing the injury to the patient. A claim for lack of informed consent may be refuted if the patient’s counsel failed to prove the aforementioned.

While consent forms must be signed prior to the invasive test or procedure, effective discussions between physicians and patients regarding the nature of that test or procedure, as well as its reasonably foreseeable risks, benefits and alternatives, culminates in the obtainment of informed consent. Further, there should be an opportunity for questions to be raised and answered. This discussion should be substantiated not only by the consent form, but ideally by a separate notation in the patient’s chart.

In the context of planned endoscopy or colonoscopy procedures for example, the aforementioned informed consent techniques can be used to document that a physician discussed the risks of perforation, bleeding and infection. Still, despite a detailed discussion, the patient may believe that endoscopy or colonoscopy procedures pose limited or no risk as they are frequently performed uneventfully. For this reason, some practitioners have also considered using the “teach-back” method to help ensure and document their patient’s understanding of the reasonably foreseeable risks, benefits and alternatives. This technique engages the patient in the educational process by having patients document in their own words their diagnosis, a description of the proposed test or treatment, and the risks, benefits and alternatives of that treatment or test. This technique affirms the patient’s choice and thereby makes it more difficult for him/her to later claim that he/she would not have undergone the treatment if more fully informed. Video-aided informed consent tools may also be used as interactive forums with questions after each significant sequence. This method may further enhance comprehension and retention, which is important because some studies have shown that 60 percent of patients do not understand the information on consent forms despite signing them. This alleged lack of understanding may be used to support a claim that the patient would not have undergone the test or procedure if more fully informed. Thus, additional documentation of the patient’s personal reasons for undergoing the test or procedure, especially those that identify heightened expectations, as well as records of questions asked and answered, may refute a lack of informed consent claim and be persuasive to a jury.

Source: MD News November 2016, Long Island Edition