Abstract
Background
In the European Union (EU), all medicines are mandated to be provided with a patient information leaflet (PIL). Many patients express concerns about the length and complexity of some PILs, and this can be a disincentive for patients to read the PILS. In order to address this, the UK’s regulatory body (Medicine and Healthcare products Regulatory Agency [MHRA]) suggested leaflets might include a headline section—information presented prominently at the beginning of a leaflet that summarizes key safety messages about a drug.
Objective
To explore the extent to which readers used a headline section in a PIL, using a form of diagnostic testing called user-testing, which examines how readers find and understand key information.
Methods
The study used a cross-sectional design to user-test a PIL with a headline section in a target sample of 20 participants. Participants were provided with an exemplar PIL, and the performance of the PIL was evaluated by a questionnaire and semistructured interview.
Results
The results showed that a headline section was used just over one-third of the time (39%); 90% of participants used the headline section to find information when they initially began the user-test. The qualitative findings suggested that the participants valued the presence of the headline section.
Conclusion
The research suggests there does not appear to be any negative impact from including a headline section in a PIL, and it is a technique that is highly valued by the consumers of medicines information.
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Dickinson, R., Raynor, D.K., Knapp, P. et al. Do Patients Use a Headline Section in a Leaflet to Find Key Information About Their Medicines? Findings From a User-Test Study. Ther Innov Regul Sci 50, 581–591 (2016). https://doi.org/10.1177/2168479016639080
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DOI: https://doi.org/10.1177/2168479016639080