NRCM 2017 Meeting
RISCS 2 – Risks in spinal consenting for surgery 2: Consent withdrawal rates for major spinal operations based on the awareness of risks
SARCO: Severn Audit & Research Collaborative in Orthopaedics ,
Patient centred consent is enshrined in GMC Guidance and the Montgomery ruling. However, a recent trial involving spinal injections has shown that current assumptions regarding patient decisions are incorrect. Patient decisions are uninfluenced by the severity of risks for minor procedures whilst encyclopaedic risk explanation may be harmful as it generates increased anxiety. Further work is warranted with more invasive procedures to confirm these findings to best inform clinical practice.
We propose a multicentre, noninferiority, controlled trial randomising 500 patients receiving spinal surgery (requiring a general anaesthetic) to either a medical centred consent process (control) involving material and frequently occurring risks for that procedure, or a legally centred consent process (intervention), involving all associated risks found in the literature.
The primary end point is consent withdrawal. Secondary endpoints include questionnaires assessing if anxiety levels change due to either process. This is scheduled to take twelve months.
This trial will challenge the stance generated by Chester vs Asfhar and help refine where consenting processes should be to account for patient expectations and their benefit. It will ensure that consenting processes are fit for purpose whilst maximising patient benefit and minimising unnecessary anxiety.
How to Cite:
Severn Audit & Research Collaborative in Orthopaedics S, Fletcher J. RISCS 2 – Risks in spinal consenting for surgery 2: Consent withdrawal rates for major spinal operations based on the awareness of risks. International Journal of Surgery: Protocols. 2019;15:16. DOI: http://doi.org/10.29337/j.isjp.2019.03.015
17 Jun 2019.