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 MacDonald3
To cite: Dickinson R, Raynor DK, Knapp P, et al. 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. BMJ Open 2016;6:e012000. doi:10.1136/bmjopen-2016- 012000
? Prepublication history and additional material is available. To view please visit the journal (http://dx.doi.org/ 10.1136/bmjopen-2016- 012000).
Received 22 March 2016 Revised 3 November 2016 Accepted 8 November 2016
1School of Healthcare, University of Leeds, Leeds, UK 2Department of Health Sciences and The Hull York Medical School, University of York, York, UK 3Medicines and Healthcare Products Regulatory Agency, London, UK
Correspondence to Dr Rebecca Dickinson; r.dickinson@leeds.ac.uk
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 5592. 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 patients 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.
INTRODUCTION For patients to take their medicines safely and effectively, it is important that they receive good quality information about their treatments. Across the European Union, all
licensed medicines are required to be pro- vided with written medicines information in the form of a patient information leaflet (PIL). Frequently, the PIL is the only written information a patient will receive about their medicines.1 PILs provide information about medicines such as: 1. What X is and what it is used for 2. What you need to know before you take X 3. How to take X 4. Possible side effects 5. How to store X 6. Contents of the pack and other
information. PILs are available on http://www.
medicines.org.uk.2 3 Information about side effects (adverse effects) is presented in the format of a qualitative descriptor for five bands of risk alongside a natural frequency (such as commonaffects less than 1 in 10
Strengths and limitations of this study
? This study recruited actual users of medicines in order to explore their opinions on the inclusion of benefit information about their own treat- ments. Previous studies have generally used hypothetical samples or hypothetical medicines and situations.
? The participants recruited to this study were broadly representative of the general practice population who take simvastatin.
? We found that patients overestimated the benefits of statins and expressed surprise at the numer- ical information. Without information about the benefits and harms of their medicines, patients are not in a position to make informed choices about them.Identify whether a generic qualitative approach or a phenomenological approach was used, and describe the characteristics of the research that provide evidence to support your identification.
Identify the key phenomena under investigation.
Describe the data collection process, including the role of the researcher.
Describe the qualitative approach to analyzing the data in this study.
Evaluate the scientific merit of the selected approach. How did the approach used (either phenomenology or generic qualitative) help the researcher answer the research question? How might you have designed this study differently?
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