Do the numbers stack up? Getting to the heart of the matter with statins

confused_guy_holding_medicineProfessor Theo Raynor, co-founder and academic advisor to Luto Research supported a recently published study by Lead Author Rebecca Dickinson titled, 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.  The study formed part of Rebecca’s PhD and was co-funded by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Other aspects of Rebecca’s PhD involved user testing of headline sections in Patient Information Leaflets which were carried out at Luto.

What is a statin?

Statins help prevent heart attacks by lowering fats (‘cholesterol’) in the blood and relaxing blood vessels, which lowers blood pressure.

Side effects

Over the years there has been a lot of publicity regarding statins, the majority of it being negative and relating to the long list of side effects.  Some of which are listed  below:

More common:

  • feeling dizzy
  • fainting
  • fast or uneven heartbeat

Less common:

  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain.

However, in 2014 The National Institute for Health and Care Excellence (NICE) recommended statins to be used more widely. The starting point of Rebecca’s PhD was that without information about the likely level of benefits, patients are not able to make an informed decision about their medicine.

In a previous research paper, ‘It’s for your benefit: exploring patient’s opinions about the inclusion of textual and numerical benefit information in medicine leaflets’.  Hamrosi et.al found that Patient Information Leaflets are too focused on side effects whereas they should also include information about their potential benefits. Patient Leaflets or package leaflets are crucial as they enable the patient to take their medicines safely and effectively.

The aim of Rebecca’s PhD study was to investigate the impact of providing additional information about the benefits of Simvastatin in Patient Leaflets.

Study design

21 participants were provided with leaflets showing 1 of 3 types of additional benefits information, in the form of:

  • a statement which contained no data or statistics
  • a number needed to treat (NNT) (contains numbers from real life scenarios, for example, if 17 people take this medicine 1 will be prevented from heart attack)
  • natural frequency (contains numbers from scenarios, for example, in 100 people like you who do not take this medicine 28 will have a heart attack).

Results

  • Patients preferred worded statements over the other 2 forms which focused on numbers.
  • Patients were surprised at the benefits of statins and felt this was underestimated.
  • NNTs proved to be very difficult to understand.
  • The results indicated barriers such as certain participants claiming they would not read the Patient Leaflet as they feel they take the medicine because they need it. They felt there was a lack of relevance.
  • Participants wanted the information in the Patient Leaflet to be positive to stress the benefits of the medicine.

NICE recommends that doctors provide clear information to patients about the benefits of their medicine. This can be very complex for doctors to communicate as some patients struggle to understand benefits information from numerical data. This highlights the importance of clear and easy to understand Patient Leaflets.

How Luto can help?

Over the years we have enhanced the readability and written hundreds of Patient Leaflets for our clients. There are many things to consider when producing a Patient Leaflet, labelling or packaging for medicines.

Luto can review and enhance the readability of your Patient Leaflet text. Luto can also originate a Patient Leaflet from the Summary of Product Characteristics (SmPC). We ensure that the Patient Leaflet is compliant with the Quality Review of Documents (QRD) template for EU leaflets and can offer advice on how to comply with the QRD template.

Find out more about Patient Leaflets and User Testing.