How to Proficiently Acquire Consent in Surgery.
Introduction
The consent form is a critical aspect of surgery. Before doing any major and minor procedures, the patient must consent to that particular surgical procedure. It is a valuable medical document as no surgeries will be performed; however, there are exceptions when consent is not necessarily needed (such as in an emergency setting). In addition, the consent form helps the patient understand the procedure, how it is basically done, its benefits, harms, alternatives, and complications.
For consent to be successful, a patient should have it early as it gives time to think about risks, benefits and alternatives. Patients can also write questions and bring them to the next consult. Remember, consent is ongoing; it is not just about when they are signed. Patients can change their minds right up before they go under anaesthesia. Consent must be given voluntarily and not under intimidation as it is quite common for the doctor to directly or indirectly persuade the patient into a decision they were not sure about. Regardless of where the patient is (less so in an outpatient clinic), the patient needs to express the capacity to consent. This includes understanding, retaining, weighing up and communicating their decisions. If a patient needs help, involve the family and see the hospital rules.
As the beautiful poem mentioned below, it is the doctor's duty and responsibility to respect the patient's choice regardless of how irrational it may be. The right to refuse treatment is a fundamental right and is one of the pillars of medicine, that is, autonomy. Moreover, accepting their decision solidifies the doctor's and patients' trust in the field of medicine, even when there is death looming close by.
“Theirs not to make reply,
Theirs not to reason why,
Theirs but to do and die.”
Basic consent template
STEP 1 - WHY THE PROCEDURE
Begin to explain why the recommended procedure needs to be performed. Just like any conversation in medicine, it is always preferable to use simple and effective wording; in other words, avoid jargon. The proposed treatment or test must be clearly understood. Describe who will be involved and who will be operating. Mention the probability of success of that procedure. Ask if the patient's had prior experience with this procedure.
STEP 2 - HOW IT WILL BE DONE
Next, explain simply the procedure. This involves a general description of what that procedure entails. Describe step-by-step the procedure, including what happens before, during, and after. Again, it doesn't have to be complicated. Keep it brief and easy to remember.
STEP 3 - RISKS VS BENEFITS & COMPLICATIONS
An essential aspect of consenting for the procedure is to explain the benefit of having the procedure. In medicine, any procedure comes with risks of harm. Provide the risks of undergoing the procedure, including the following:
Common side effects of the procedure.
General anaesthesia risks: broken teeth, allergies, acute myocardial infarction, death.
General procedure risks: bleeding, infection, scars, damage to local structures, pain, procedural failure, DVT/PE, death.
Specific risks to that procedure: for example, the conversion to a laparotomy from a laparoscopy.
Any complications during the procedure had to be escalated into a different procedure.
Any complications that can occur straight after the procedure include pyrexia, confusion, hypoxia, decreased urine output, nausea/vomiting, et cetera.
Any long-term complications, such as adhesions after a laparotomy.
Any contraindication that may occur on the day such as ongoing inflammation. Contraindications before the procedure would warrant the procedure not to go forward.
STEP 4 - ALTERNATIVES
There is always an alternative to procedures regardless of the situation. Thus, it is essential to empower patients with other options. When doctors have been training (for a very long time) in a unique field doing a particular technique in surgery, they grow to have an insatiable urge to perform that specific technique dutifully. As mentioned to me by a surgeon in a passing conversation, "when you are trained to be a scissor, for example, all of a sudden everything looks like paper… and you just want to snip, cut and do your job well. Sometimes, it's not the best outcome or solution for that patient, but you just did it because you knew you could do it [the procedure] remarkably well". Thus, avoid biases. Doing nothing such as watch-and-wait is an acceptable alternative. However, do mention drawbacks on alternatives as the choice might not be the best course of action. Describe each alternative method's allocated consequences, risks, benefits, complications, and success probability. As long as the patient knows and is aware of the risks, benefits, and alternatives, you have provided information adequately for the patient to decide.
STEP 5 - UNDERSTANDING
Use the teach-back method to check understanding with the patient. Remember, medicine is a field that can be a completely foreign language to many people. Check if the patient understands the procedure and correct any misunderstanding. For example, it is challenging and unethical to perform a consent form for a patient that does not understand the language used to communicate. Organise a translator if needed.
STEP 6 - OBTAIN CONSENT
After all information has been given, obtain written consent from the patient. A signature is often needed along with the date on the consent form. The consent form gets handed to the front desk and is processed. From my experience with surgery, the consent form will resurface during a Time-Out. Time-Out occurs a few minutes before the patient goes under anaesthesia. It is the final hurdle before the procedure. The patient has the opportunity to check the consent form, check that it is indeed their signature, and agree to the procedure. Time-Out is extremely important as it involves the surgical, anaesthetic, and nursing team to all agree that they have the right patient, consent to the procedure, and have no other current problems. Time-Out helps everyone be on the same page a final time before the procedure.
STEP 7 - INFORMATION LEAFLET
Provide the patient with a leaflet that describes the procedure, the benefits and harm, and the alternative to the procedure. Most of the time, most patients can't remember much from a consultation; hence it is vital to provide a leaflet. Patients can then use the leaflet with other family members to discuss the procedure.
STEP 8 - DOCUMENT
Document in the notes about the consent being approved along with patient's worry/questions and so on.
FINALLY
When getting consent, ask yourself:
Am I the right person to perform a consent form?
Do I have the right patient?
Do they have capacity?
Have I used easy and straightforward terms, and did they understand the procedure (including harm, benefit, alternatives and complications)?
Have I given them a diagram or leaflet to take home?
Have I taken steps for illiterate, other spoken languages and physically disabled patients?
FOR PATIENTS
It is ideal for patients to take on an active role by researching the procedure. Learn about its standard method, success rate, alternatives and so on. Taking an active role enables the patient to come up with questions that can be discussed at the next consult if needed. Discuss with your family to hear other points of view and opinions or different past experiences that other family members may have gotten. If there are doubts, you can always get a second opinion if needed. As always, your consent is not a contract. You do not have to go through with the procedure; if at any time you want to pull out, by all means, do it.
Consent example: colonoscopy
A 55-year-old male presents with fresh blood in his stool for the past week. He describes constant bowel habit changes and mentions his dad had bowel cancer. He has never done an FOBT screening test. He has been referred by his GP, and the consultant recommends a colonoscopy.
STEP 1 - WHY THE PROCEDURE
To diagnose or exclude any insidious conditions such as bowel cancer.
To take samples for testing if needed (polyps) or control any source of bleeding (ulcers).
Screen for malignancy.
STEP 2 - HOW IT WILL BE DONE
Ask for any prior experience.
General description of the colonoscopy may include:
A flexible tube with a camera attached goes up into the back passage and into the colon/bowel.
The surgeon will look for any abnormalities, sampling may be required, or removal of tissues may occur.
Describe step-by-step the procedure before, during and after.
Before: a bowel preparation is necessary to be taken 24 hours before the procedure. We recommend standing near a toilet as it is incredibly effective and unpredictable. Talk about what happens when the bowel prep is not done correctly (such as not seeing anything and missing essential areas that may have pathologies or that the procedure will have to be postponed - waste money and time). Only drink clear fluids before the colonoscopy.
During: include the duration and possible pain. The procedure will take between 15-30 minutes, and in some cases, up to 1-2 hours if it is difficult. You will be under twilight anaesthesia (not general) where you won't feel pain or remember the procedure.
After: recover from the sedation and go home. It is unsafe to drive after sedation; hence ask someone to pick you up. Follow up the results with the doctor at the clinic.
STEP 3 - RISKS VS BENEFITS & COMPLICATIONS
Benefits of undergoing the procedure:
Able to diagnose cancer early increase the chance of prognosis. Pre-cancerous polyps can be removed and avoid further future cancer growth.
Risks of undergoing the procedure:
Common side effects of the procedure: abdominal discomfort, discomfort defecating after a short while.
General procedure risks: bleeding, infection, damage to local structures, pain, procedural failure.
General anaesthesia risks: broken teeth, allergies, acute myocardial infarction, death.
Specific risks to that procedure: perforation (1/1000), not finding the source of bleeding, missing source of cancer.
Risks of not undergoing the procedure:
Cancer may go under detected and thus untreated. Increase late cancer diagnosis that may have spread (stage 4). Possible polyps not being taken out may progress into cancer.
Any complications that can occur straight after the procedure include pyrexia, confusion, hypoxia, decreased urine output, nausea/vomiting, et cetera.
Contraindication:
Active inflammatory bowel disease or other acute colitis.
Co-morbid conditions that the anaesthesia team has denied.
STEP 4 - ALTERNATIVES
Virtual colonoscopy (CT).
Double-contrast barium enema.
Not undergoing any procedures.
STEP 5 - UNDERSTANDING
Use the teach-back method to check understanding with the patient. A patient's understanding is a crucial step in obtaining consent.
STEP 6 - OBTAIN CONSENT
Obtain the consent form that has been done correctly, hand the consent form to the front desk for the process to start.
STEP 7 - INFORMATION LEAFLET
Provide the patient with a leaflet that describes the procedure, the benefits and harm, and the alternative to the procedure.
STEP 8 - DOCUMENT
Document in the notes about the consent being approved along with patient's worry/questions and so on.
Published 15th December 2021. Last reviewed 5th March 2022.
Reference
Better Health Channel authors. Informed consent for medical treatment. Better Health Channel website. https://www.betterhealth.vic.gov.au/health/servicesandsupport/informed-consent-for-medical-treatment. Reviewed August 31, 2014. Accessed February 20, 2022.
Wheeler R. Consent in surgery. Ann R Coll Surg Engl. 2006;88(3):261-264. doi:10.1308/003588406X106315
Wilkinson I, Raine T, Wiles K, Goodhart A, Hall C, O’Neill H. Oxford handbook of clinical medicine. 10th ed. Published in the United States by Oxford University Press Inc., New York.
