The impact of benefit information in medicines leaflets.
Research type
Research Study
Full title
What is the impact of providing benefit information about medicines in a patient information leaflet on the attitudes and beliefs that real-life users of medicines hold about their treatments?
IRAS ID
126373
Contact name
Rebecca Dickinson
Contact email
Sponsor organisation
University of Leeds
Research summary
The study invites patients receiving a prescription for simvastatin from a GP practice to participate in an interview. The main aim of the study is to explore the impact of providing benefit information about medicines in a medicine leaflet on the attitudes and behaviours that users of medicines hold about their treatments.
25-35 participants who receive a prescription for simvastatin will be recruited from a consenting GP practice. These will be patients who have a prior disease category of myocardial infarction (heart attack) or other coronary heart disease, including angina, unstable angina, CABG and angioplasty.
Participants will be identified from a GP practice database search.
Participants will be invited to take part in a semi-structured interview lasting approximately 1 hour. Participants will be shown leaflets containing 3 different formats of benefit information relating to simvastatin [1] a textual statement [2] a positively framed natural frequency [3] a number needed to treat. (2 & 3 are different methods of using statistics to present the benefit of treatments) [see exemplar leaflets]A topic guide will be used to stimulate discussion on [1] ‘Typical’ medicine taking behaviour and beliefs about medicines [2] opinions on and experiences of ‘typical’ PILs [3] opinions on and preferences for different formats of benefit information[4] and the potential impact that the provision of benefit info in a PIL might have on medicine-taking behaviour, beliefs about medicines and relationships with healthcare professionals.
The interviews will be audio-taped and transcribed verbatim. Data will be analysed using the Framework Analysis approach. The aim of the research is to understand more about the impact of providing benefit information about medicines in a PIL on the attitudes and beliefs that users of medicines hold about their treatments and enhance the existing evidence-base on the provision of benefit information in their medicines leaflets.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0180
Date of REC Opinion
22 May 2013
REC opinion
Favourable Opinion