Informed Consent for Treatments: Operations and Injections

Information for patients at The Spine Surgery London

Introduction

Before you have a procedure of any kind, however trivial you may feel it to be, you must be fully aware of the possible and likely consequences. You have to sign a consent form in which you state that you are fully aware. Do not sign any consent form for a procedure with us unless you feel fully informed of its aims and risks as well as the alternatives and you are fully content with everything set out below.

What does “fully informed” mean? For you, as a patient of ours, it means you have read this, asked for and read any of the other information sheets we provide which are of relevance to your condition, remembered the details of our conversations in out-patients in addition to any conversations you may have had with our anaesthetist and assistants and that you have understood it all.

We have a duty to provide you with the information and you have a duty to take the time to make sure you take it all in, fully understand it and accept the implications of any procedure you consent to.  If in any doubt do not have the operation. Book another appointment instead. We would much rather delay an admission or even an operating list, if doubts remain in your mind. You should not book things unless you are entirely content to sign the consent form. However, if you have booked do not proceed unless you are clear and content that you are signing the consent form “fully informed” on every aspect of that which follows below.

How informed consent works

Before any operation is booked we will have told you about:-

• The aims of a procedure – what it is meant to do but might not
• The risks of a procedure – what it is not meant to do but might
• The likely natural history of the condition you suffer – what happens if nothing is done
• The possible impact of alternative treatments – can another treatment be done instead
• The usual logistics of the post-procedure recovery and the possible variance from this.

The following will happen:-

• We will give you written information on the procedure unless it is very unusual. However, you are all different and this is not a substitute for listening carefully to the specifics we tell you about in out-patients and reading below.
• We will often arrange for a second person to talk to you; either Dr Visram if it is an injection we are both to have a part in or one of our assistants if it is a neurosurgical operation. It may be they or us who do the written consent with you. In addition you may speak with our Specialist Nurse.
• You will sign a written consent. This is a detailed enough document. However, it is only a summary and extract of all the information you are given. In signing it you agree to the whole package of the operation and its aims and risks as outlined here, in the specific information sheets, in our conversations and on the form. Do not sign the consent form unless you are entirely happy with all the information received and that all the elements we describe here have indeed been covered to your satisfaction.

The aim of this system is for you to have had information from more than one source and in several different forms.

The risks of a procedure

Obviously you must know what these are. We will document in the notes that we have explained certain risks to you. Do not sign the consent form if you feel we have not.

We will write something like this in your notes:- make sure you feel it is true

“I have explained the aims and risks of the procedure including those to life and limb (ie. death paralysis and disaster), of failure (the procedure does not work), recurrence (you get better but it comes back) and deterioration, (you are made worse), of death, paralysis, wound problems, of nerve/ nerve root injury, as well as the likely natural history of the condition (what happens if nothing is done), the possible impact of alternative managements and treatments, along with the usual post procedure recovery and its variants (i.e., how much time off from work, what help you will need at home, what the wound care is).”

These are all things you will need to have had covered. Again, do not sign the consent if you are not sure

Any procedure, however small, carries a risk to life i.e., of you dying. Any procedure on the brain its spine or the peripheral nerves may result in paralysis of arms, legs bowel and or bladder. Any operation on a part of the nervous system may result in mental incapacity. i.e., you are not the same person you were, are in coma or have speech, visual and hearing problems. However safe we make modern medicine no procedure is not associated with these devastating complications to some degree.

However, remember for most routine spinal operations the likelihood of you dying or being paralysed is very, very low. Most of you will have no problem but if you are the unlucky one you will need to have known that the risk you took was sensible.
 
Remember too that most patients, when tested, apparently remember little of what was said or hear different things from that which was intended.

The aims of a procedure

It is equally important to be aware of the aim of the operation. This needs to match precisely your needs if there is to be any chance of your expectations being met.

For example:-

Broadly, operations on the spine may be divided into two categories- those that relieve back pain and those that relieve leg pain. Which is it you need? Most of you will have some of each. Do you need an operation aimed primarily at the relief of back pain or at the relief of leg pain?  Most spinal operations for leg pain will not relieve back pain.

In regard to a tumour (brain or spine) is the operation to get tissue for a diagnosis (a biopsy), to palliate or to cure the tumour? These three are all very different. A biopsy will not make a tumour better, indeed it can do harm. The aim is to get a diagnosis and allow a plan for treatment to be made.  A palliative operation will not stop the eventual progression of a tumour but may either delay its growth or relieve some of the symptoms it produces. Any operation aimed at a cure may fail so you need understand what the chances of failure are.

Just as we cannot cure everything with surgery not all the symptoms a patient may suffer may be relieved. .If you have more than one symptom some may be more likely to respond than others. Make sure that the operation addresses the issues you need it to.

* All copyright reserved for The Spine Surgery London. The information sheets provided by TSSL are intended for use by patients undergoing active treatment and only following the conversations they will have had with team members. It is not advised that they are used outside of this context.