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Satisfaction and anxiety are improved with the use of an easy-to-read informed consent document: a randomized multi-group study

Li Liu, MD

University of Pennsylvania Cancer
Last Modified: May 12, 2001

Presenter: P. C. Raich
Affiliation: AMC Cancer Research Center, Denver, CO

Background:

Informed consent is a process in which the patient is given all the information needed to decide whether to participate in a clincal trial. The signing of the informed consent document by both the patient and the investigator is the written verification of this process. Readability of most of the consents remains a problem for the US population in which half has reading skills at an 8th grade level or below.

Materials and Methods:

• 226 patients who were randomly assigned to either standard consent form (13th grade level) or an easy to read form (8th grade level) were evaluated
• Multiple institution study including 46 sites involved with three clinical trials from the NCCTG, ECOG, and CALGB.
• Comprehension of the consent, anxiety associated with the process, and satisfaction with the process were all evaluated.

Results:

• Comprehension of consent content was similar between two groups
• More satisfaction and decreased anxiety were observed in easy
• to
• read group

Authors' Conclusions

• Easy readability was associated with enhanced satisfaction and reduced anxiety
• Participation of clinical trials maybe enhanced by patient's satisfaction and less anxiety with informed consent process

Clinical/Scientific Implications:

• The signing of the informed consent form does not, however, end the process of consent
• The investigator is obligated to continue to provide relevant information to the subject, answer questions, and ensure understanding throughout the duration of the study
• Continued education of patients who are enrolled in the clinical trials may also play a positive role in patient's satisfaction