Informed consent has been established for ethical, medical and legal reasons.
· Ethically, it is better for the patient and the surgeon to have a shared decision regarding the decision to proceed to an operation.
· Medically, a patient should be aware of the potential immediate, early and late health outcomes after an operation, and the risks involved.
· Legally, consent is required to enable fair consideration of liability should complications arise or patient expectations not be met.
The legal aspect underpinning informed consent can be viewed as risk management against a potential law suit should problems arise. Based on this view, if the goal of informed consent is simply risk-management, then consent forms should be encyclopaedic, informing the patient of every conceivable risk associated with the surgery. This is not currently true, due to the balance that has to be struck between the ethical aims of the informed consenting process and the potential negative consequences of overloading patients with information.
There is no clear definition of how much information is required for consent to be sufficiently informed. Commonly it is loosely defined by what a reasonable person would need to make an appropriate decision. This is subjective, and thus provides sufficient greyness that can be sometimes exploited by legal prosecution teams on behalf of naturally dissatisfied patients.
In legal cases, claimants frequently state that they would not have proceeded, if only the risk of the complication they have subsequently suffered from been explained to them. These claims are difficult to validate. This would also imply that the more risks patients are informed about, the more patients will decline the procedure due to fear of the risks.
Additionally in recent practice, even when a patient has said that they would have proceeded if they had been informed of the complication that they ultimately suffered, if they have not been told before the operation about this risk, then the surgeon may have been negligent.
Despite the legal stance, patients frequently report that they do not want to be overburdened with information about very rare risks, and that this information makes them more anxious about their procedure. Increased anxiety before a procedure has been shown to correlate with worse outcomes afterwards, so it could be argued that the legal premise of listing and explaining every single known risk, however rare, could actually be harmful.
This study aims to assess if explaining more risks to patients before receiving a spinal injection leads to more patients withdrawing consent due to concerns about those risks. Patient’s anxiety status and anxiety traits will also be assessed.
Any patient over the age of 18 year, of any gender, receiving a day case spinal injection, who has capacity and is able to complete their questionnaires, will be included in the trial. The trial will occur at Taunton & Somerset NHS Foundation trust, UK; main contact Mr Paul Thorpe (Consultant Spinal Surgeon and trial Chief Investigator). The intervention in the trial will be the use of a consent form with an encyclopaedic list of the risks (55 risks) involved (and an explanation sheet for those risks) in spinal injections, based on a review of all known complications that have happened. The control consent form has 13 more common or serious risks on it.
Patients’ care will be otherwise unaffected except for them completing questionnaires; one at home and one on the day of their injection. There are no anticipated risks associated with enrolling in the trial, except for a potential increase in anxiety levels; any patients found to be very anxious will be offered referral to their general practitioner for on-going management of this. Enrolled patients will benefit by having more information about their procedure and by helping to inform future consenting practices both related to spinal injections and in general.
We are recruiting 220 patients in total, (110 per consent form type) over a 9 month period. The trial has been sponsored by Taunton & Somerset NHS Foundation Trust and has been given a financial grant by the Bristol Orthopaedic Trust.