Benefit and risk information for medications in multiple sclerosis

Other measures (1)

Background and study aims Multiple sclerosis is a condition affecting the brain and/or spinal cord that causes problems with vision, arm or leg movement, sensation and balance. Although multiple sclerosis can't currently be cured, there are medicines that can help to reduce the number and severity of relapses in some people, called disease-modifying medications. Patients with multiple sclerosis are faced with complicated information about the risks and benefits of disease-modifying medications. It is important that patients are able to understand and make decisions with confidence about these medications during consultations with health professionals. The aim of this study is to compare a new way of presenting risk and benefit information with the currently used presentation method. It is hoped that this will improve patients' understanding of the risks and benefits of medications and improve their confidence in their decision to choose a medication. Who can participate? Adult patients with relapsing-remitting multiple sclerosis (where patients have distinct attacks of symptoms which then fade away either partially or completely) What does the study involve? Participants are given the information about medication risks and benefits using the following four methods in a random order: 1. Currently used method, verbally 2. Currently used method, in a leaflet 3. New method, verbally 4. New method, in a leaflet All medication information provided to participants is hypothetical but is similar to the risks and benefits of disease-modifying medications in multiple sclerosis. To measure their understanding, participants are asked a few questions about the information they receive. They are also asked to choose between the medications they are given and are asked a few questions about their confidence in their decision. Participants are also asked to complete a few questionnaires and tasks to measure their symptoms, characteristics and skills, to see how these factors may influence their understanding of information about medication risks and benefits. What are the possible benefits and risks of participating? The possible benefits are clearer presentation of risk-benefit information for medications, allowing for effective shared decision-making between patients and health professionals. Potential risks include questions requesting sensitive information, and causing psychological and physical discomfort such as fatigue since study sessions may last up to 2 hours. However, patients may omit any questions they do not wish to answer and are encouraged to take regular breaks when taking part in the study. Other similar studies have not encountered such problems. Where is the study run from? 1. King's College Hospital NHS Foundation Trust (UK) 2. Lewisham and Greenwich NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? September 2014 to March 2017 Who is funding the study? 1. Biogen Idec (USA) 2. Royal Holloway, University of London (UK) Who is the main contact? 1. Miss Gurpreet Reen (public) Gurpreet.reen.2014@live.rhul.ac.uk 2. Dr Dawn Langdon (scientific) d.langdon@rhul.ac.uk