The exchange of information between doctor and patient is central to good decision making. Good record-keeping of such information is crucial for continuity of care and to justify any decision and action (1). The aim of this study was to assess documentation of the consent process for open and endovenous varicose vein surgery at Leeds Teaching Hospitals NHS Trust (LTHT).

A retrospective analysis of consent documentation for all consecutive patients who underwent varicose vein surgery by Open or Endovenous Laser Therapy (EVLT) between 01/01/2019 and 31/06/2021 at LTHT was undertaken. This comprised analysis of clinic letters and consent forms on the Electronic Patient Records platform PPM+ in use at the Trust. Information extracted included which risks were discussed, who had discussed these risks with the patient and whether a patient information leaflet was documented as being provided. Written approval from Clinical Governance and Caldicott Guardian was obtained.

Three-hundred and fifteen patients underwent treatment for varicose veins either via open surgery or EVLT. There were 117 men (37%) and 198 women (63%) with a median age of 46 years (IQR 36-58). Open surgery and EVLT were performed on 196 patients (62%) and 119 (38%) respectively. A scanned copy of the informed consent signed by the patient and the surgeon was found in the patients' records in 127 cases (40%). For 241 patients (77%), risks and benefits were recorded in the preoperative varicose vein clinic letter sent to the patient and General Practitioner. For a total of 276 patients (88%) it was possible to find documentation of risks either on a signed consent form or in a clinic letter and these are analysed below. One-hundred and seventy-two patients (62%) discussed risks with a consultant, 80 (29%) with a Registrar and 24 (9%) with a Core Trainee. In the patients receiving open surgery, risk of DVT, PE, nerve injury and wound infection were explained to 87%, 72%, 77% and 70% of the patients respectively. In the group receiving EVLT, the same risks were explained in 84%, 50%, 74% and 26 % of the cases respectively. The possibility of a lymphocele, skin bruising, residual veins or new spider veins occurring post-operatively was mentioned only to 5%, 49%, 44% and 2% of the patients receiving open surgery and to 2%, 41%, 54% and 4% of those receiving EVLT respectively. Major vascular injury was touched upon only in 14% of the cases in the open surgery group An information leaflet was documented as being provided in 10% of the cases.

There is considerable variability in the way risks are documented as being discussed with patients prior to varicose vein intervention. Locally we have identified a gap in the proportion of consent forms uploaded to the electronic records. Minimum expected standards may improve consistency and quality of documentation of the consent process. The use of pre-printed consent forms should be considered.

1) General Medical Council, 2020. Decision making and consent. Guidance on professional standards and ethics for doctors. Available from https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent