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.
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References
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use. Official Journal of the European Union, 27 May 2014.
Summary of clinical trial results for laypersons. Clinical trials — major developments. DG Health and Food Safety, European Commission. http://ec.europa.eu/health/human-use/clinical-trials/developments_en. Published 2016.
European Commission. Consultation document: Summary of clinical trial results for lay persons. http://ec.europa.eu/health/sites/health/files/files/clinicaltrials/2016_06_pc_guidelines/gl_3_consult.pdf. Published 2016.
Sless D, Shrensky R. Writing About Medicines for People. Sydney: ASMI; 2006.
Raynor DK. User testing in developing patient medication information in Europe. Res Soc Admin Pharm. 2013;9:640–645.
Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? A randomized controlled trial. BMC Med. 2011;9:89.
Harris E, Enright D. New words for cautionary and advisory labels make them easily understood. Pharm J. 2011;286:278–279.
Raynor DK, Bryant D. European Public Assessment Report (EPAR) summaries for the public: are they fit for purpose? A user-testing study. BMJ Open. 2013;3:e003185.
Raynor DK. Risk management plan lay summaries—how to make them fit for purpose? Paper presented at: DIA European Medical Information and Communications Conference, London 2014.
Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002;32:1020–1028.
Rowlands G, Khazaezadeh N, Oteng-Ntim E. Development and validation of a measure of health literacy in the UK: the newest vital sign. BMC Public Health. 2013;13:16.
Raynor DK, Dickinson D. Key principles to guide development of consumer medicines information. Ann Pharmacother. 2009;43:700–706.
European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. http://ec.europa.eu/health/files/eudralex/vol2/c/2009_01_12_readability_guideline_final_en.pdf.
Hallinan ZP, Getz KA. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372:2370–2371.
Way D, Bouder F, Lofstedt R, Evensen D. Medicines transparency at the EMA in the new information age: the perspective of patients. J Risk Res. 2016;19:1–31.
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Raynor, D.K., Myers, L., Blackwell, K. et al. Clinical Trial Results Summary for Laypersons: A User Testing Study. Ther Innov Regul Sci 52, 606–628 (2018). https://doi.org/10.1177/2168479017753129
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DOI: https://doi.org/10.1177/2168479017753129