gms | German Medical Science

Background: Informed consent is a legal requirement for any medical intervention. Recent studies have shown, however, that the informed consent talk is not sufficient for understanding the possible complications and consequences of treatment. The aim of our investigation was to assess the perception of informed consent talks by vascular surgery patients and to analyse associated factors.

Materials and methods: During the first half of 2015, 43 vascular surgery patients undergoing aortic (N=9) or inguinal (N=7) surgery or transfemoral endovascular intervention (N=27) were voluntarily included in an informed consent quality assurance investigation. Beside of age, sex and other demographic and perioperative clinical variables, one questionnaire evaluating the informed consent talk, disease knowledge and treatment expectations was filled out by the patients before surgery. Another questionnaire containing treatment satisfaction was filled out before discharge from hospital.

Results: The treatment groups differed significantly in mean age. Other preoperative variables such as comorbidities and tobacco consumption did not relevantly differ. A standardized informed consent talk took place 7 days (median) before surgery or intervention and continued for 17 minutes (median). Almost all patients expected improvements of life quality and maximal walking distance independent from the planned intervention. They remembered the correct diagnoses, planned procedures and incision localisations in more than 2/3 of cases, but none of the possible complications could be remembered by 37,5 % of aortic surgery, 29 % of inguinal surgery and 58 % of angiography patients. Possible minor complications were remembered in only 37,5%, 43 % and 32 % of cases respectively and major complications in 62,5 %, 57,1% and 26,3%, respectively. An improvement of complains was reported by 60%, 100% and 40% of patients respectively after treatment, and all but one patient would agree to undergo the same procedure again if necessary. A multiple regression analysis on remembering no possible complication before intervention was performed and age was found as the only contributing factor.

Conclusion: Signing of the standardized informed consent talk protocol before surgery does not necessarily mean that patients would be able to understand the potential risks and benefits of planned procedures. Growing age showed an impact on recapitulation of the talk. In addition to a single talk continuous patient education is necessary in order to influence the understanding of the disease, behaviour (i.e. smoking cessation) and compliance.