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. 2016 Dec 2;6(12):e012000.
doi: 10.1136/bmjopen-2016-012000.

Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs

Rebecca Dickinson  1 , David K Raynor  1 , Peter Knapp  2 , Jan MacDonald  3
Affiliations

Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs

Rebecca Dickinson et al. BMJ Open. .

Abstract

Objective: To explore the impact of providing additional information about the potential benefits of simvastatin in a patient leaflet on attitudes and beliefs.

Design: Interview-based study using a generic qualitative approach and framework analysis.

Participants: 21 participants receiving a prescription for simvastatin were recruited from a general practitioner practice (from a total of 120). 8 participants were women; the age range was 55-92.

Intervention: Participants were provided with leaflets showing one of 3 types of additional benefit information: (1) textual statement, (2) number needed to treat (NNT) or (3) natural frequency. Semistructured interviews explored patient's attitudes and beliefs.

Results: A descriptive narrative of preferences for format suggested patients prefer textual as opposed to numerical benefit information. Significant barriers to the acceptance of numerical benefit information included difficulty in understanding the numbers. Patients overestimated the benefits of statins and expressed surprise at the numerical information.

Conclusions: Textual information was preferred but numerical information, in particular in the form of a natural frequency, may help patients make judgements about their medicines. NNTs were found to be very difficult to understand. This raises the prospect that some patients might reject medicines because of disappointment with the perceived low benefits of their medicines. The self-reported impact on behaviour appeared minimal with reports of intentions to 'do what the doctor tells me'. Further research is needed to explore the impact of such statements on people who are yet to be prescribed a statin.

Keywords: medicines information; patient information; risk benefit communication; risk format.

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Conflict of interest statement

Conflicts of Interest: None declared.

References

    1. Medicines and Healthcare Products Regulatory Agency. Best practice guidance on patient information leaflets. London: Medicines and Healthcare products Regulatory Agency, 2012.
    1. Dickinson D, Raynor DKT. Ask the patients—they may want to know more than you think. BMJ 2003;327:861 10.1136/bmj.327.7419.861-a - DOI - PMC - PubMed
    1. Co-ordination Group for Mutual Recognition and Decentralized Procedures—Human. CMDh annotated QRD template for MC/DC procedures (based on version 8 of the QRD template for CP), 2011. http://www.hma.eu/uploa
    1. Harris K, Dickinson R, Raynor D et al. . Changes in side effect risk communication in patient information leaflets over the past decade: results of a survey. Drug Saf 2015;38:1–11. 10.1007/s40264-014-0249-5 - DOI - PubMed
    1. Hamrosi K, Dickinson R, Knapp P et al. . It's for your benefit: exploring patients’ opinions about the inclusion of textual and numerical benefit information in medicine leaflets. Int J Pharm Pract 2012;21:216–25. 10.1111/j.2042-7174.2012.00253.x - DOI - PubMed

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