This trial will address the research question of whether there are increased rates of consent withdrawal for patients receiving spinal injections when using a legal centred consent form compared to a medical centred consent form. A recent legal case means that doctors should no longer decide how much and what information a patient should be given by their doctor prior to a procedure; all information may be relevant to the patient should something go wrong. This change in the consenting process has not been widely adopted by the surgical profession mainly due to a concern of over burdening a patient with incredibly rare risks.
This single centre trial will randomise patients having elective spinal injections to have either a standard ‘medical centred’ consent form (control) or a trial ‘legal centred’ consent form (intervention), the latter having 5 times as many risks stated on it. The primary end point is rates of consent withdraw, with the trial of 220 patients (110 per group) expected to last 9 months.
Research kindly supported by the Bristol Orthopaedic Trust