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.