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Assessing Clinical Trial Informed Consent Comprehension In Non-Cognitively-Impaired Adults: A Systematic Review Of Instruments, Laura Buccini, Don Iverson, Peter Caputi, Caroline Jones, Sheridan Gho
Assessing Clinical Trial Informed Consent Comprehension In Non-Cognitively-Impaired Adults: A Systematic Review Of Instruments, Laura Buccini, Don Iverson, Peter Caputi, Caroline Jones, Sheridan Gho
Don C. Iverson
This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults. Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments selected for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test …