Informed consent is an important issue in surgery. It is important that the patient has the correct information to allow them to make an informed incision about the treatment of their condition.
Patients need for information varies- some patients need a lot and some patients don't want to know too much but would rather "get to the point". Some conditions and treatment needs are fairly straightforward and others are very complex. During the consultation I try to provide all the information that I think will help the patient come to an informed decision and I am happy to answer any questions a patient or his or her family members may have.
At other times a question can arise at a later date as to what actually was said during the consultation. One way to do this would be to record the consultation but I don't do that and I don't know any doctors who do. The way I approach this problem is to have a duplicate copy of a form that I write in at the time I am explaining the operation to the patient and their family if present. At the end I sign and date and the patient signs and dates. It records the important aspects of the consent process that were discussed and if the question arises later on about what was discussed then the record is there.
There are seven aspects to an informed consent and these are the headings on the forms:
1. Diagnosis: The diagnosis for the condition being treated is recorded.
2. Recommended Treatment: This is where I record the treatment process that I recommend to the patient based on the advantages and disadvantages and risk/benefit ratios of the various treatment options. The Risk Benefit ratio is the balance of the risks of a procedure versus the potential benefits. Sometimes very Risky procedures are performed (eg heart surgery) because the Benefit (saving the patients life) is greater than the risk ( dying from complications). Sometimes it can be the opposite and we don't recommend a procedure because the risk of a serious complication is high and the potential benefit is only minor or has a low probability of successs.
3. Alternatives: There is a saying that there is "more than one way to skin a cat" and this is often true in surgery. Sometimes there are valid alternatives- either other types of surgery or non-operative treatment such as physical therapy or injections for example and this is where I would have discussed why I recommended one treatment approach over other alternatives.
4. Natural History: This is where I discuss what is likely to happen if NOTHING IS DONE. For example the pain and stiffness from arthritis may worsen with time unless something is done.
5. Potential Complications: The risks associated with a particular procedure and how best to inform a patient properly is a difficult area of obtaining an informed consent. There is an obligation to talk about risks that have a high chance of occurring and risks that might be rare but are serious and therefore may influence your decision to go ahead( for example understanding there is a small risk of dying under an anaesthetic- even though that is extremely rare some patients may not realize it can happen at all and when they do realize it may make them question how much they really want the surgery and sometimes they may decide that it isn't bad enough at this stage to even take that small risk- the Risk Benefit Ratio)
Complications fit into two areas:
- Anaesthetic Complications
- Surgical Complications
My Anesthetist Dr Carlo Vernier will have a discussion with you about the anaesthetic but I tell all patients that there is a risk of dying under an anaesthetic or having a major stroke or heart attack. That risk is small but it does vary between patients. Patients that smoke or have medical conditions like diabetes etc do have a higher risk of complications. I would have made a review of your general health and taken this into consideration when we disuss this area.
There are surgical complications common to almost all procedures. They are the risk of:
Infection: As surgeons we always worry about the risk of infection and particularly in Orthopaedic Surgery because we are often implanting metal implants that need to come out if deep infection occurs. We take many precautions against infection including antibiotics at the time of surgery and meticulous sterile technique during surgery and careful handling of soft tissues as well as careful wound closure.
DVT/PE: Deep Venous Thrombosis and Pulmonary Embolism can complicate any surgery. There is a higher risk in procedures like joint replacement. This is because there is often a combination of venous stasis. Hypercoagulability( ie a greater tendency to clot as a normal response to surgery) and sometimes injury to vessel walls because of positioning of the limbs required during surgery( for example hip replacement surgery where we need to dislocate the hip). We take a number of precautions to prevent this- one is a subcutaneous injection that thins out the blood called Clexane. We use calf compressors during the surgery- they are cuffs that go around your calfs and intermittently inflate during the surgery and help keep the blood flowing. TED stockings help reduce swelling and keep the blood flowing. We try to get the patient up and going as soon as possible after the surgery. In the postoperative period if there is a suggestion of increased swelling or calf pain then we get a Doppler Ultrasound and if that shows a clot then it is treated. It is treated with clexane injections and then Warfarin which is a blood thinning tablet and all this is done as a outpatient through a local hospital. If DVT's are picked up early and treated then they dissolve over time and everything is fine but if they are not picked up then they enlarge and can break off and travel to the lungs - this is when they are called Pulmonary Emboli- they can cause chest pain and shortness of breath but in the worst circumstances it can lead to sudden death.
Nerve or Blood Vessel Injury: The risk nerve injury is higher than blood vessel injury in orthopaedic surgery. Blood vessel injury can lead to increased bleeding either during or after the surgery and this can increase the need for blood transfusion or wound complications and increased pain.
There are large nerves which can be injured with sometimes permanent effects such as numbness or loss of movement but the more common nerve injury is to CUTANEOUS NERVES that supply feeling to the skin. When we do any surgery we are always thinking about the local nerves related to the incision and sometimes by necessity they are quite close. With some incisions numbness around the wound is common and unavoidable- this is particularly true of midline anterior incisions around the knee - the sort of incision that is done for a knee replacement.
The problem with a cutaneous nerve injury is that it an cause numbness- this is not always a major problem although if it occurs on the fingers or the soul of the foot then it can be a big problem. The injured nerve can also get caught up in the scar tissue of the incision and become a painful focus called a NEUROMA.
Haemarthrosis: This is excessive bleeding into a joint and this most commonly affects the knee joint. If this occurs then there is more pain and stiffness and muscle wasting particularly of the thigh muscle and this slows down the recovery. Sometimes the blood needs to be aspirated to reduce the swelling and facilitate rehab.
Stiffness: This can complicate any surgery on or around a joint and if it is permanent it can affect a patients gait and ability to do things. That is why physiotherapy is often an important part of the rehabilitation following surgery.
Amputation: This is obviously a very rare complication but sometimes it is necessary to salvage a very bad situation. Serious complications can occur in seemingly innocuous routine and minor surgery such a "little toe surgery" that becomes complicated by "gangrene" that spreads rapidly and the only way to save the patients life is to amputate the limb. The aim of this description is not to scare patients unnecessarily but rather to illustrate the point that there is a very small risk of serious complications with even routine surgery that means that no procedure is risk free.
I often use the analogy with patients about crossing the road. There is a risk with crossing a road that you will be run over and killed by a car or truck. When you are standing at the side of the road you can reduce that risk by looking left and right and crossing only when there is no visible traffic. You can reduce the risk further by crossing at a set of lights or a pedestrian crossing. If it is a busy road and there are no lights you may question your need to cross the road and if it isn't important you may decide not to cross the road because the risk isn't worth it( Risk/benefit ratio)- you may still take the risk if it is really important( your child is in danger on the other side of the road)- the decision to have an operation is a similar process and as your doctor it is my job to help provide the information necessary for you to make that decision.
6. Outcomes: This is where I outline the major aims of the surgery. It is often to relieve pain. That is usually the main aim of any surgery- sometimes it is to correct deformity such as a leg length discrepancy or to restore stability to a joint as in ACL reconstruction surgery. It is important that the surgeon and the patient understand what the main realistic goals of the surgery are because if the patient has different expectations to the surgeon and those expectations are not met then that can understandably be a source of an unhappy surgical experience.
7. Costs: This is in terms of TIME and MONEY
Time means the expected recovery time and return to work. Money is an understanding of the costs involved if any to the patient- this is part of INFORMED FINANCIAL CONSENT and my secretary will go through a detailed costing so you know before the surgery what the cost will be.
As you can see there is a lot to informed consent. I have described in this paper my approach to this aspect of surgical practice. It is not meant to be a definitive medicolegal dissertation on the subject but hopefully can give the patient some background and understanding.
Dr Tim O'Carrigan
- Click here to download the consent form