Journal of Clinical Research

ISSN: 2795-6172

Open Access

Tracy Moitt

Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, United Kingdom

  • Research Article   
    Does a Re-designed Patient Consent Form Result in Fewer Completion Errors? A Study within a Trial (SWAT)
    Author(s): Peter Knapp*, Peter Bower, Jenny Roche, Caroline Fairhurst, Lola Awoyale and Tracy Moitt

    Background: Consent form completion errors may invalidate consent and waste participant and research time. The aim of this study was to compare error rates in an existing trial consent form with a revised version, developed through information design and user testing Method: Study within a trial (SWAT) conducted within the ISDR trial of diabetic screening intervals. Using a sequential groups design, participants completed either the original trial consent form or a version that had been revised through iterative user testing and information design principles. Results: Forms for 1,027 participants were analyzed: 307 revised forms and 720 original forms. Major error rates were low and similar in the two groups (1.0% in original forms; 0.6% in revised forms; p=0.61). Minor error rates were lower in revised forms (11.0.. Read More»

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