Understanding Informed Consent: A Cross-Sectional Study of Objective and Self-Perceived Comprehension in Romania

Background/Objectives: Informed consent (IC) is an essential component of medical practice; however, patients' understanding of medical information remains challenging. This study aimed to assess both objective and self-perceived comprehension of information presented in an IC scenario and to identify factors associated with understanding. Methods: A cross-sectional study was conducted using an anonymous online questionnaire with 275 adult participants in Romania. The questionnaire included a standardized IC scenario followed by comprehension assessment questions. Each correct answer was assigned one point, generating a total comprehension score ranging from 0 to 8. Self-perceived comprehension was evaluated using a Likert scale. Statistical analyses included descriptive statistics to summarize participant characteristics and questionnaire responses, Spearman's correlations to examine associations between self-perceived comprehension and objective comprehension scores, independent samples t-tests and ANOVA to compare comprehension scores across participant groups, and multiple linear regression to identify independent predictors of comprehension. Results: The mean comprehension score was 6.81 ± 1.48, indicating a generally high level of understanding. A moderate positive correlation was observed between objective and self-perceived comprehension (ρ = 0.35, p < 0.001). Non-healthcare participants achieved slightly higher scores than healthcare field participants (p = 0.046), while educational level was not significantly associated with comprehension score (p = 0.566). Multiple linear regression analysis identified self-perceived comprehension as a significant independent predictor of the comprehension score (β = 0.381, p < 0.001). Conclusions: Although the overall level of comprehension was high, discrepancies between self-perceived comprehension and objective comprehension were identified. These findings highlight the importance of patient-centered communication strategies and the need to actively verify patient understanding during the informed consent process to support truly informed decision-making.