Patient understanding of Risk - MTX and Anti-TNF V1.0
Research type
Research Study
Full title
Patient Understanding of the Risks of Methotrexate and Anti-TNF Therapy - The UMA Study
IRAS ID
232320
Contact name
Robert Marshall
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Aim: The overall aim of this study is to evaluate what percentage of participants treated with methotrexate and/ or an anti-TNF therapy for rheumatoid arthritis can correctly identify both common and rare side effects of their medication by means of a questionnaire.
Design: This is a cross-sectional single group study using a mixed-methods questionnaire to collect qualitative and quantitative data from participants.
Sample: Three hundred adult patients with a diagnosis of rheumatoid arthritis currently prescribed methotrexate and/ or an anti-TNF biologic therapy receiving treatment at a large tertiary centre who have attended an outpatient appointment within the previous 18 months will be invited to participate.
Recruitment: Participants on Methotrexate are identified through pharmacy's list of patients who received a Methotrexate prescription within the last 18 months. Participants on anti-TNF therapy are identified through nurse specialist's list of patients on anti-TNF therapy, whom attended clinic in the last 18 months. A random sample of these two lists are taken to total 100 patients on Methotrexate, 100 patients on anti-TNF therapy and 100 patients on combination therapy. Invitation to participate will be by post. The research team have chosen an inclusion duration of 3 months, with non-responders being telephoned after 1 month.
Data Analysis: Quantitative data will be analysed using descriptive analysis. Qualitative data will be analysed using framework analysis.
Projected outputs: It is anticipated that this study will generate data which can be used to produce journal publications, oral and poster presentations.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0157
Date of REC Opinion
14 Jun 2018
REC opinion
Further Information Favourable Opinion