Informed consent forms for clinical and research imaging procedures: how much do patients understand?

Area of Science:

• Radiology
• Medical Ethics
• Health Literacy

Background:

• Informed consent is crucial in diagnostic radiology, especially for invasive procedures and research.
• Patient comprehension of information in informed consent forms remains uncertain.
• Assessing the readability of these forms is essential for effective communication.

Purpose of the Study:

• To evaluate the readability of clinical and research informed consent forms used in diagnostic radiology.
• To determine how easy or difficult these forms are for the average patient to understand.

Main Methods:

• Solicited clinical and research informed consent forms from active members of the Association of University Radiologists.
• Digitized 549 unique forms from 156 institutions.
• Utilized computer programs with readability formulas (Flesch-Kincaid, Flesch, Fog) to assess comprehension levels.

Main Results:

• Clinical consent forms, though shorter, were statistically harder to understand than research forms (p < 0.005).
• The average readability score for clinical forms required 15 years of education, compared to 12 for research forms.
• Generic surgical or procedure consent forms from hospitals were the most complex, needing a college education to understand.

Conclusions:

• Most radiology informed consent forms are too complex for the average patient.
• Increased complexity in clinical forms may stem from less attention, bureaucratic/legal demands, and limited physician input.
• Improving the readability of consent forms is vital for patient comprehension and ethical practice.