The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects

Area of Science:

• Clinical Research Methodology
• Informed Consent Process
• Patient Comprehension Assessment

Background:

• Effective informed consent is crucial for ethical clinical trial participation.
• Assessing patient comprehension of complex trial information presents significant challenges.
• Existing methods for evaluating informed consent understanding may be insufficient.

Purpose of the Study:

• To develop and validate a reliable instrument for measuring comprehension of informed consent information.
• To evaluate the psychometric properties of the Deaconess Informed Consent Comprehension Test (DICCT).
• To compare subjects' self-rated understanding with objective test scores.

Main Methods:

• Developed the Deaconess Informed Consent Comprehension Test (DICCT).
• Administered the DICCT to 275 adults enrolling in ambulatory trials.
• Assessed interrater reliability and correlated DICCT scores with WAIS-R vocabulary and WRAT-R reading scores.

Main Results:

• The DICCT demonstrated high interrater reliability (0.84).
• DICCT scores showed significant correlations with vocabulary (r=0.44) and reading (r=0.39) scores, indicating preliminary validity.
• 70% of subjects rated their understanding as thorough, yet DICCT scores revealed a mean score of 20.4 +/- 3.9.

Conclusions:

• The DICCT is a reliable and valid instrument for assessing informed consent comprehension.
• Patient self-assessment of understanding may overestimate actual comprehension.
• The DICCT can aid researchers in ensuring adequate patient understanding in clinical trials.