A Refresher On Obtaining Informed Consent From Patients
- Bradly Bussewitz DPM
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During my podiatric surgical training, I noticed a difference in approaches to surgical informed consent. Some may cut the consent process short to save time whereas others may cut it short to prevent patient worry or stress. Some surgeons may provide an exhaustive list of potential complications, thus overburdening the patient’s ability to process and make decisions.
Clearly, obtaining consent to perform surgery on our patients is a critical process. Accordingly, let us take a closer look at key requirements on informed consent.
A particular institution likely has policies in place that address procedures or treatments that require consent, who is required to obtain consent and the manner of documentation.
Examples include all surgical procedures with general/spinal anesthesia and those procedures with local anesthesia, such as biopsies, excisions and infusions including bone marrow aspirate, blood transfusions and donation. There are separate consent forms for anesthesia from the administering physician) for general/spinal/epidural anesthesia.
It is generally accepted that one discuss the risks, benefits and alternatives to the planned procedure.
Types of information to be disclosed/discussed:
1) Nature of the condition and procedures to be performed
2) Nature and probability of material risks involved
3) Benefits to reasonably expect
4) Inability of the physician to predict results
5) Result of no treatment
6) Available alternatives, including risks and benefits
The medicolegal system understands that this does not apply to all “remotely possibly risks of proposed treatment.” Documentation should be clear and detailed for the patient to understand the information, and have a specific listing of some of the more major material risks. Examples include but are not limited to loss of life, loss of limb function, paralysis, hemorrhage, allergic reactions, nerve injury and blood clots.
Consent forms provide some discreet evidence that the informed consent process has taken place and should include: patient name, contemplated procedure, date, doctor signature and patient signature. If pertinent, the form also includes the potential use of tissue and the participation in the patient’s surgery of physicians in training or other health practitioners.
What Professional Associations Recommend For Informed Consent
Professional medical associations provide guidance for us when it comes to informed consent. Listed below is information from the American Podiatric Medical Association (APMA) and American College of Surgeons.1,2
The American Podiatric Medical Association Statement on Informed Consent. “The doctrine of informed consent is premised upon the right of the patient to exercise control over their body by deciding whether or not to undergo a proposed treatment regimen. The duty of the podiatrist is always to disclose relevant information to the patient and obtain the consent of a competent patient or someone legally authorized to give consent on behalf of the patient before initiating treatment.”1
What a patient needs to know about the proposed treatment. The APMA statement recommends that the podiatrist strive to ensure that the patient is cognizant of the nature of the illness or condition, the treatment proposal or its alternatives with reasonable explanations of expected outcomes, potential complications and the length of recovery.
Disclosure of experience and outcomes. The podiatrist provides truthful representations of his or her experience and previous outcomes from similar surgeries.
Economic interests. The podiatrist strives to ensure that any economic benefit involving services, materials, medications or facilities shall not interfere with his or her primary responsibility for the welfare of the patient. The podiatrist shall comply with applicable legal requirements, according to the APMA.
American College of Surgeons Statement on Informed Consent. “Informed consent is more than a legal requirement. It is a standard of ethical surgical practice that enhances the surgeon/patient relationship and that may improve the patient's care and the treatment outcome. Surgeons must fully inform every patient about his or her illness and the proposed treatment. One must present the information fairly, clearly, accurately and compassionately. The surgeon should listen carefully to understand the patient's feelings and wishes and should answer all questions as accurately a possible.”2
The American College of Surgeons recommends that the informed consent discussion conducted by the surgeon include the following key points.
1) The nature of the illness and the natural consequences of no treatment
2) The nature of the proposed operation, including the estimated risks of mortality and morbidity.
3) The more common known complications, which one should describe and discuss. The patient should understand the risks as well as the benefits of the proposed operation. The discussion should include a description of what to expect during the hospitalization and post-hospital convalescence.
4) Alternative forms of treatment, including non-operative techniques.
The college notes that the surgeon should not exaggerate the potential benefits of the proposed operation or make promises or guarantees. For minors and incompetent adults, parents or legal guardians must participate in the informed consent discussion and provide the signature for elective operations. Any adequately informed, mentally competent adult patient can refuse any treatment including operation. When mentally incompetent patients or the parents (guardians) of minors refuse treatments jeopardizing the patient's best interest, the American College of Surgeons advises that the surgeon can request legal assistance.
When patients agree to an operation conditionally or make demands that are unacceptable to the surgeon, the surgeon may elect to withdraw from the case.
My Approach To Getting Patient Consent For Procedures
During my preoperative appointment, I discuss the surgical procedure and why I recommend it. I briefly revisit other options, such as doing nothing or more conservative care. I talk about the risk of infections and quote the rate of infection depending on pathology and overall health. I mention the risk and rate of recurrence of the deformity or, when applicable, nonunion. I also mention the possibility of continued pain. I quote the known risk of deep vein thrombosis and the potential seriousness of this finding.
Lastly, I briefly describe the risks of anesthesia. I lay out expectations for postoperative course and care. I finish the process by asking if there are any questions about the surgical consent before signing.
My intent is to allow the patient informed consent and ensure that each patient has the knowledge necessary to proceed with the planned procedure.
1. Available at www.apma.org/files/FileDownloads/2013%20Code%20of%20Ethics.pdf .
2. Available at http://www.facs.org/fellows_info/statements/stonprin.html .