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

Alina Doina Tănase1,2, Raluca Mioara Cosoroabă1, Alexandra-Denisa Semenescu3,4

  • 1Department of Professional Legislation in Dental Medicine, Faculty of Dental Medicine, "Victor Babes" University of Medicine and Pharmacy, Eftimie Murgu Square No. 2, 300041 Timisoara, Romania.

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Patients generally understood informed consent (IC) information well, but their perceived understanding didn't always match actual comprehension. Self-perceived understanding significantly predicted objective comprehension, emphasizing communication strategies.

Keywords:
decision-makinghealth literacyinformed consentpatient comprehension

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Area of Science:

  • Medical Ethics
  • Patient Communication
  • Health Literacy

Background:

  • Informed consent (IC) is crucial in medical practice.
  • Patient comprehension of medical information presents challenges.
  • Assessing both objective and self-perceived understanding in IC is vital.

Purpose of the Study:

  • To evaluate objective and self-perceived comprehension of IC information.
  • To identify factors influencing patient understanding in an IC scenario.
  • To explore the relationship between self-perceived and objective comprehension.

Main Methods:

  • Cross-sectional study with 275 adult participants in Romania.
  • Anonymous online questionnaire with a standardized IC scenario and comprehension questions.
  • Objective scores (0-8) and Likert scale for self-perceived comprehension; statistical analyses included correlations, t-tests, ANOVA, and regression.

Main Results:

  • Mean objective comprehension score was 6.81 ± 1.48, indicating high understanding.
  • Moderate positive correlation between objective and self-perceived comprehension (ρ = 0.35, p < 0.001).
  • Self-perceived comprehension was a significant independent predictor of objective scores (β = 0.381, p < 0.001).

Conclusions:

  • While overall comprehension was high, discrepancies between perceived and objective understanding exist.
  • Patient-centered communication and active verification of understanding are essential for informed decision-making.
  • Findings underscore the need to bridge the gap between patient perception and actual comprehension in IC.