Raynor, DK orcid.org/0000-0003-0306-5275, Myers, L, Blackwell, K et al. (3 more authors) (2018) Clinical Trial Results Summary for Laypersons: A User Testing Study. Therapeutic Innovation and Regulatory Science, 52 (5). pp. 606-628. ISSN 2168-4790
Abstract
Objective: To apply “user testing” to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary—a new European requirement.
Methods: “User testing” (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version.
Results: In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants’ symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable.
Conclusions: Applying “user testing” resulted in a largely health-literate summary suitable for people across a range of backgrounds.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018, The Author(s). This is an author produced version of a paper published in Therapeutic Innovation & Regulatory Science. Reprinted by permission of SAGE Publications. |
Keywords: | clinical trial, lay summary, user testing, readability, health literacy |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Healthcare (Leeds) > Pharmacy (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 23 Mar 2018 11:31 |
Last Modified: | 09 Oct 2018 06:27 |
Status: | Published |
Publisher: | SAGE Publications |
Identification Number: | 10.1177/2168479017753129 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:128873 |