[The Quality of Hand Surgery Informed Consent Discussions: a Prospective Randomised Study].

Abstract

Background: A preoperative informed consent discussion is an essential element of surgical treatment. Suspected errors in informed consent are frequently the subject of medical liability cases. To ensure a comprehensive documentation of the informed consent discussion, commercial documentation forms are available. Thanks to their comprehensiveness, they are increasingly replacing conventional, typically self-designed forms. In this study, the quality of informed consent discussions was evaluated based on the retrievable knowledge of the informed patients. Informed consent discussions based on self-designed forms were compared with those based on a commercial form.

Materials and methods: A monocentric, prospective, randomised, controlled, clinical longitudinal study was performed with 261 patients. Study participants were randomised into two groups. Informed consent discussions held in group A were documented using a self-designed form, while a commercial form (Thieme Compliance) was used for group B. Data collection was conducted through interviews using a standardised questionnaire, which each participant completed twice: once immediately after the medical informed consent discussion, and again on the morning of the surgery. The average time interval between the informed consent discussion and the surgery was 19 days.

Results: In both groups, the results were approximately the same. Overall, 98% of the respondents felt well or very well informed after the informed consent discussion and were satisfied with the manner of communication and the time frame. Accordingly, 77% of the respondents were not or only slightly nervous about the upcoming surgery. 85% of the participants correctly stated their diagnosis, and 80% correctly identified the planned surgery. However, 24% of the respondents were unable to actively name any of the complications mentioned in the discussion. Preoperatively, this percentage increased to 35%. Following the informed consent discussion, 44% of the respondents were able to list one to two complications, 27% were able to list three to four, and 5% were able to list five or more. Patients in group A tended to perform slightly better.

Conclusion: Similar results can be achieved even if different consent forms are used. Patients are well-informed immediately before hand surgery procedures. High patient satisfaction can be achieved through individualised design and documentation.