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A brief measure of perceived understanding of informed consent in a clinical trial was validated
- Source :
-
Journal of Clinical Epidemiology . Jun2006, Vol. 59 Issue 6, p608-614. 7p. - Publication Year :
- 2006
-
Abstract
- Abstract: Background and Objective: To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial. Methods: The study was embedded in a Department of Veterans Affairs randomized clinical trial of Gulf War veterans' illnesses (CSP#470). The trial was initiated in May 1999 at 20 hospitals and concluded in September 2001; 1,092 participants were enrolled and followed for 12 months. The reliability and validity sample included 1,086 participants evaluated at baseline, 906 at 3 months, 929 at 6 months, and 910 at 12 months. The psychometric evaluations included tests of acceptability (based on missing data, endorsement frequencies, and floor/ceiling effects), item reduction, internal consistency, and construct validity (based on Cronbach's alpha coefficients, item-total correlations, and principal components analysis). Results: The ICQ had >5% missing information on some questions at baseline, indicating poor acceptability prior to the initiation of the trial; however, the scale had good acceptability at each of the follow-up visits. Psychometric evaluation following standard item reduction techniques confirmed the reliability and validity of a four-item subscale of the ICQ (ICQ-4). Conclusions: The ICQ-4 is a simple and psychometrically sound self-report measure of perceived understanding of informed consent. [Copyright &y& Elsevier]
Details
- Language :
- English
- ISSN :
- 08954356
- Volume :
- 59
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Journal of Clinical Epidemiology
- Publication Type :
- Academic Journal
- Accession number :
- 20923325
- Full Text :
- https://doi.org/10.1016/j.jclinepi.2005.11.009