Improving Surgical Informed Consent: Unanswered Questions

Area of Science:

• Medical Ethics
• Clinical Trial Methodology
• Patient Autonomy

Background:

• Informed consent is a cornerstone of ethical medical practice, evolving with patient care.
• Defining and measuring the effectiveness of interventions to improve surgical informed consent remains a challenge.
• Ethical imperatives of autonomy, beneficence, and social justice guide the informed consent process.

Purpose of the Study:

• To review randomized clinical trials (RCTs) evaluating interventions aimed at improving the informed consent process.
• To assess the impact of various interventions on patient comprehension, satisfaction, and mental state.
• To identify gaps in research regarding the social justice dimensions of informed consent.

Main Methods:

• A literature search identified 70 RCTs on informed consent interventions.
• Data on demographics, interventions, and assessments were tabulated.
• Interventions were categorized into printed matter, audiovisual tools, and interactive multimedia.

Main Results:

• Improvement in patient comprehension was documented in 46 of 65 trials.
• Enhanced satisfaction was observed in 13 of 33 trials; anxiety decreased in 3 of 30.
• Few studies assessed primary language, literacy, learning needs, or cost, highlighting a gap in social justice considerations.

Conclusions:

• No single intervention effectively improved all three ethical principles of informed consent (autonomy, beneficence, social justice).
• Validated interventions and assessments demonstrated a greater impact on outcomes.
• Future research should prioritize social justice aspects, including language, literacy, learning needs, and cost, to ensure equitable informed consent.