TY  - JOUR
T1  - Improving the readability and processability of a pediatric informed consent document: Effects on parents’ understanding
AU  - Tait AR, Voepel-Lewis T, Malviya S, Philipson SJ
Y1  - 2005/04/01
N1  - 10.1001/archpedi.159.4.347
JO  - Archives of Pediatrics & Adolescent Medicine
SP  - 347
EP  - 352
VL  - 159
IS  - 4
N2  - 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.Design 
    Randomized clinical study.Setting 
    The preoperative waiting area of a larger tertiary care children’s hospital.Participants 
    A total of 305 parents of children scheduled for minor elective surgical procedures.Interventions 
    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.Main Outcome Measures 
    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.
SN  - 1072-4710
M3  - doi: 10.1001/archpedi.159.4.347
UR  - http://dx.doi.org/10.1001/archpedi.159.4.347
ER  -