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
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.
Comprehension of consent content was similar between two groups
More satisfaction and decreased anxiety were observed in easy
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
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
Dec 8, 2011 - A randomized controlled trial of hepatocellular carcinoma (HCC) screening is not feasible for informed patients with cirrhosis; and small HCC detection is not improved by ultrasonographic screening every three versus six months, according to two studies published in the December issue of Hepatology.