Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.
OBJECTIVE
Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual.


METHODS
A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes.


RESULTS
Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups.


CONCLUSIONS
Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.
Coyne
Cathy A
CA
Department of Community Medicine, School of Medicine, West Virginia University, Morgantown, WV 26506, USA. ccoyne@hsc.wvu.edu
Xu
Ronghui
R
Raich
Peter
P
Plomer
Kathy
K
Dignan
Mark
M
Wenzel
Lari B
LB
Fairclough
Diane
D
Habermann
Thomas
T
Schnell
Linda
L
Quella
Susan
S
Cella
David
D
D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D032882:Comprehension; D032962:Consent Forms; D004522:Educational Status; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D010344:Patient Advocacy; D010358:Patient Participation; D011932:Reading