Can User Testing of a Clinical Trial Patient Information Sheet Make It Fit-for-Purpose? -- a Randomized Controlled Trial
Raynor, David K
BMC medicine 2011 July 21; 9: 89
The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets--determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16).
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Knapp, Peter; Raynor, D.K.; Silcock, J.; Parkinson, B. (2009-09)BACKGROUND: Concern has been expressed about the process of consent to clinical trials, particularly in phase I "first-in-man" trials. Trial participant information sheets are often lengthy and technical. Content-based ...
Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group Coyne, Cathy A.; Xu, Ronghui; Raich, Peter; Plomer, Kathy; Dignan, Mark; Wenzel, Lari B.; Fairclough, Diane; Habermann, Thomas; Schnell, Linda; Quella, Susan; Cella, David (2003-03-01)
Fletcher, Kate; Mant, Jonathan; Holder, Roger; Fitzmaurice, David; Lip, Gregory Y.H.; Hobbs, F.D. Richard (2007-09)