Peter Knapp|David K. Raynor|Jonathan Silcock|Brian Parkinson
Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial
University of York|University of Leeds|University of Bradford
participant information sheet pis provided potential trial participants critical part process valid consent however longstanding concern lengthy complex documents fitforpurpose supported recently application performancebased approach testing improving readability called user testing method widely used improve patient medicine leafletsdetermining whether people find understand key facts study applied first time controlled design determine whether pis developed user testing improved readability original using sheet uk trial acute myeloid leukemia aml16in first phase performance original pis tested people target group trial three rounds testing including 50 people totalwith information revised according performance first 2 rounds second phase revised pis compared original parallel groups randomised controlled trial rct total 123 participants recruited randomly allocated read one version pis find show understanding 21 key factsthe first developmental phase produced revised pis significantly altered wording layout second trial phase 66 participants read revised pis able show understanding aspects trial compared 15 reading original version odds ratio 112 chisquare 315 p 001 asked state preference 871 participants chose revised pis sign test p 001the original pis aml16 trial may enabled valid consent combining performancebased user testing expertise writing patients information design led significantly improved preferred information sheet user testing efficient method indicating strengths weaknesses trial information research ethics committees institutional review boards consider requesting testing ensure pis fitforpurpose