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An Australian Based Study On The Readability Of Hiv/Aids And Type 2 Diabetes Clinical Trial Informed Consent Documents, Laura Buccini, Donald Iverson, Peter Caputi, Caroline Jones
An Australian Based Study On The Readability Of Hiv/Aids And Type 2 Diabetes Clinical Trial Informed Consent Documents, Laura Buccini, Donald Iverson, Peter Caputi, Caroline Jones
Don C. Iverson
The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under study where examined to identify whether they had any formal policies/guidelines on the readability of informed consent documents. The two …
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 …