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.
RCT Entities:
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.
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Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Alan R Tait; Terri Voepel-Lewis; Stanley J Chetcuti; Colleen Brennan-Martinez; Robert Levine Journal: Int J Med Inform Date: 2014-02-03 Impact factor: 4.046
Authors: Lynn M Yee; Michael Wolf; Rebecca Mullen; Ashley R Bergeron; Stacy Cooper Bailey; Robert Levine; William A Grobman Journal: Prenat Diagn Date: 2014-03-18 Impact factor: 3.050