Developing and testing a new RA stiffness PROM
Research type
Research Study
Full title
A research study to develop and test the structure of a rheumatoid arthritis (RA) stiffness patient reported outcome measure (PROM)
IRAS ID
156440
Contact name
Serena Halls
Contact email
Sponsor organisation
Faculty of Health and Life Sciences University of the West of England
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory condition. For people with RA, stiffness is a commonly experienced symptom. As such, stiffness is regularly used as an outcome in clinical settings and in research. However, there is currently no standardised or validated way of assessing stiffness. Therefore the aim of this study is to develop and then test the structure of a new RA stiffness patient reported outcome measure (PROM). The potential items for this new stiffness PROM have been developed in three previous studies, according to recent guidelines that encourage the use of qualitative research to capture the relevant concept from the patient perspective (Patrick et al., 2011a; 2011b).
People with a diagnosis of RA (Arnett et al., 1988) who are over the age of 18 are eligible to participate in this study. Potential participants will be identified from NHS patient databases or from clinics at collaborating centres by a member of their direct care team.
The study will consist of completion of a questionnaire pack. The questionnaire pack can be completed while patients wait for their clinic appointment or in patients own homes and will take approximately 20 minutes to complete. In participants who consent, results of their most recent blood test for inflammation (C-reactive protein (CRP) and/or plasma viscosity (PV)) will be recorded. All participants will be asked if they would be happy to repeat a smaller questionnaire pack one week after returning the first. For participants who agree, this will be posted to their home address along with a prepaid envelope. Data analysis will involve two parts. Part one will involve developing the structure and content of the new stiffness PROM (RAST-Q). Part two will then involve preliminary testing of the reliability and validity of the RAST-Q.
REC name
Wales REC 4
REC reference
14/WA/1162
Date of REC Opinion
6 Oct 2014
REC opinion
Further Information Favourable Opinion