Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding.
OBJECTIVE
To examine whether a consent document modified to conform with the federal guidelines for readability and processability would result in greater parental understanding compared with a standard form.


METHODS
Randomized clinical study.


METHODS
The preoperative waiting area of a larger tertiary care children's hospital.


METHODS
A total of 305 parents of children scheduled for minor elective surgical procedures.


METHODS
Parents were randomized to receive information about a clinical study in 1 of 4 ways: (1) standard consent form alone, (2) standard consent form with verbal disclosure, (3) modified form alone (standard form modified to meet the federal guidelines for readability and processability), and (4) modified form with verbal disclosure.


METHODS
Parents were interviewed to determine their understanding of 11 elements of consent, including study purpose, protocol, risks, benefits to child (direct), benefit to others (indirect), freedom to withdraw, alternatives, duration of study, voluntariness, confidentiality, and whom to contact. Their responses were scored by 2 independent assessors.


RESULTS
Understanding of the protocol, study duration, risks, and direct benefits, together with overall understanding, was greater among parents who received the modified form (P<.001). Additionally, parents reported that the modified form had greater clarity (P = .009) and improved layout compared with the standard form (P<.001). When parents were shown both forms, 81.2% preferred the modified version.


CONCLUSIONS
Results suggest that a consent form written according to federal guidelines for readability and processability can improve parent understanding and thus will be important in enhancing the informed consent process.
Tait
Alan R
AR
Department of Anesthesiology, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, MI 48109, USA. atait@umich.edu
Voepel-Lewis
Terri
T
Malviya
Shobha
S
Philipson
Sandra J
SJ
D000328:Adult; D016009:Chi-Square Distribution; D002648:Child; D032882:Comprehension; D032962:Consent Forms; D006801:Humans; D033282:Parental Consent; D018709:Statistics, Nonparametric