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

Area of Science:

• Medical Ethics
• Surgical Patient Care
• Informed Consent

Background:

• Preoperative informed consent is crucial for surgical treatment and often a factor in medical liability.
• Commercial documentation forms are increasingly replacing traditional self-designed forms for comprehensive informed consent discussions.
• This study evaluates the quality of informed consent by assessing patient knowledge after using different documentation forms.

Purpose of the Study:

• To compare the quality of informed consent discussions documented by self-designed forms versus a commercial form.
• To assess patient knowledge and satisfaction following informed consent procedures.
• To determine if the type of informed consent form impacts patient understanding and anxiety levels.

Main Methods:

• A monocentric, prospective, randomized, controlled clinical study with 261 patients.
• Participants were randomized into two groups: Group A (self-designed form) and Group B (commercial Thieme Compliance form).
• Data collected via standardized questionnaire interviews immediately after consent and again before surgery, with an average 19-day interval.

Main Results:

• Overall patient satisfaction with information and communication was high (98%).
• Most patients felt informed (98%), had low surgical anxiety (77%), and correctly stated their diagnosis (85%) and planned surgery (80%).
• A significant portion struggled to recall complications (24% initially, rising to 35% preoperatively), with Group A showing slightly better recall.

Conclusions:

• Different informed consent forms yield similar patient outcomes regarding satisfaction and knowledge.
• Patients are generally well-informed prior to surgical procedures.
• Individualized design and documentation of informed consent contribute to high patient satisfaction.