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OBJECTIVES: Currently, there are no explicit guidelines for informed consent for vascular surgical interventions. Unfortunately,there is evidence to suggest that consent deficiencies occur. The objective of this survey was to catalogue current peer-practice and collate consensus relating to vascular surgery patient consent.
METHODS: A prospective anonymous online survey was administered using Survey Monkey™ to members of the Society for Clinical Vascular Surgery in June 2013. Following completion of provider demographic details,each member evaluated general and procedural specific complications for both arterial and venous interventions which should be discussed with patients during the informed consent process. Greater than 75% reporting for a specific complication was deemed the threshold for consensus opinion.
RESULTS: 179/1210(14.8%) members completed the survey. The majority of respondents were staff surgeons(85.5%) followed by vascular fellows(11.2%). Both groups considered vascular fellows competent to obtain consent. The majority of patients were consented primarily by the staff surgeons(67.6%) within twenty-four hours of surgery(43%).This was done in either the out-patient(67.4%) or pre-operative holding areas(66%). A procedural specific,pre-printed consent form was used in 95% of patients with additional written documentation provided in 59.7%. General complications discussed prior to arterial surgery included bleeding(94.9%),cardiac(94.9%),cerebrovascular(92.6%),wound infection(90.4%),respiratory(78.7%) and thromboembolic(76%) events. Although respondents provided consent consensus for a number of core vascular procedures,in patients undergoing open aortic surgery,10.2%, 14.4% and 13.6% reported no discussion of bleeding, impotence or lower limb ischemia respectively. Endoleak(5.6%), follow-up surveillance(14.0%), graft occlusion/lower limb ischemia(8.4%) and reintervention possibilities(10.3%) were additionally not documented during EVAR consent by survey respondents. Surprisingly,cranial nerve injury and restenosis were not discussed by 6.5% and 18.7% of vascular surgeons performing carotid endarterectomy. For patients undergoing limb bypass procedures, graft occlusion, limb loss, edema and procedural failure were not discussed in 5% to 9.9% of cases. General complications described during venous procedures included bruising(90%),bleeding(86%), thromboembolic events(87%) and wound infections(81.8%) However, nerve injury,failure to improve symptoms,scarring and recurrence were omitted from discussion by 17.7%, 11.5%, 22.2% and 12.5% of respondents. Only 37% and 5.8% of vascular centres provided informal and formal consent training respectively.
CONCLUSIONS: The informed consent process presently utilized by most providers is non-standardized and inadequate. Recognized complications for procedures are frequently not discussed during the informed consent process. Opportunities for standardization and enhancement of the informed consent process should be pursued by consensus groups.