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Do Patients Use a Headline Section in a Leaflet to Find Key Information About Their Medicines? Findings From a User-Test Study

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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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Author information

Authors and Affiliations

  1. School of Healthcare, University of Leeds, Leeds, LS2 9JT, United Kingdom

    Rebecca Dickinson RGN, PhD & David K. Raynor PhD

  2. Department of Health Sciences, University of York and the Hull York Medical School, York, United Kingdom

    Peter Knapp PhD

  3. Medicines and Healthcare Products Regulatory Agency, London, United Kingdom

    Jan MacDonald BSc, MSc, MRPharmS

Authors
  1. Rebecca Dickinson RGN, PhD
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  2. David K. Raynor PhD
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  3. Peter Knapp PhD
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  4. Jan MacDonald BSc, MSc, MRPharmS
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Corresponding author

Correspondence to Rebecca Dickinson RGN, PhD.

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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

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