Objective assessment of informed consent quality using a structured patient comprehension–based algorithm
DOI: magyurol.2025.4.beothet.163
Authors:
Beöthe Tamás Zsolt dr. PhD
Budapesti Péterfy Sándor utcai Kórház – Rendelőintézet
Summary
Introduction: Informed consent is one of the fundamental principles of modern medicine, representing both a legal obligation and a bioethical value. Nevertheless, the process of patient information often remains formal and does not ensure true patient understanding. International data indicate that patients are frequently unable to accurately recall the information provided, even though comprehension directly affects cooperation, adherence, and satisfaction. Current legislation does not specify the assessment of information quality. Although the literature discusses the quality of patient information, only few studies directly measure patient understanding. Preoperative counselling is the essence of doctor–patient communication; assessing this process provides insight into the overall effectiveness of communication.
Objective: Our aim was to develop a surgery-specific questionnaire-based algorithm that objectively evaluates patient comprehension and can serve as a tool for assessing the quality of informed consent.
Methods: The algorithm is based on the elements of patient information defined in the Hungarian Health Act (Act CLIV of 1997, Section 13). The questions are not universal but are tailored to each surgical procedure and its corresponding patient information document. The questionnaire was first tested in the context of prostate surgery. Drawing on the principles of the “teach-back” method (which has been shown to enhance understanding through repetition and confirmation), the questionnaire was designed to include closed, knowledge-reinforcing questions, each containing relevant information and excluding misleading (“distractor”) options. Completion is performed independently by the patient on a tablet or computer, while automated data processing provides real-time feedback for both patient and physician. The ratio of fully informed patients to all respondents constitutes an aggregated “information indicator,” applicable for quality assurance purposes.
Results: The algorithm was tested in a pilot group of patients awaiting prostate surgery (n=9). Completion required approximately 10–15 minutes. A total of 56% of patients demonstrated comprehensive understanding, whereas 44% required additional information. Based on physician feedback, question wording and answer options were refined to improve clarity and interpretation.
Conclusion: The developed algorithm is easy to implement, saves valuable physician time, and provides an objective means of assessing patient comprehension. The method contributes to improving the quality of informed consent, strengthening patient safety, and enhancing doctor–patient communication, and may also serve as a quality assurance indicator.