Abstract
Study designProspective, multi-centre, multi-specialty medical notes review and patient interview.PurposeThe consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall.MethodsConsent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall.ResultsThe written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P < 0.0005), highest in infection (96.1%) and lowest in recurrence (52.3%). For patient recall of these risks, there was no inter-centre variation. Patients’ recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients <65 years old recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to <2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade.ConclusionOverall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.
Highlights
The process of consent is an important method to communicate all aspects of the proposed procedure, including benefits and risks, as well as having medico-legal importance
Patients consented [14 days compared to \2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%)
Patient recall was independent of consenter grade
Summary
The process of consent is an important method to communicate all aspects of the proposed procedure, including benefits and risks, as well as having medico-legal importance. Sidaway v The Bethlem and Maudsley Hospitals (1985) reaffirmed that the standard of information given during consent should be judged using the Bolam Criteria [2, 3]; Lord Scarman dissented with this judgement, arguing that disclosure of a risk should occur ‘where the risk is such that in the court’s view, a prudent person in the patient’s situation would have regarded it as significant’ [3, 4]. Lord Woolf stated that doctors were responsible to disclose to the patient any ‘significant risk, which would affect the judgement of a ‘reasonable patient’’. In the case of Chester v Afshar (2004), Mr Afshar was found negligent due to his failure to inform of the risk of cauda equina syndrome during the procedure, even though he was found to have performed the operation adequately [5,6,7]. The decision emphasized the requirement for written documentation of all risks, as Mr Afshar claimed that he had consented for the risk of cauda equina syndrome, the failure to document led to the judgement in favour of Miss Chester
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