Stage 1 validation of a PROM for PMR. Version 1.
Research type
Research Study
Full title
Development of a patient reported outcome measure for polymyalgia rheumatica: Stage 1 psychometric evaluation - item reduction and formation of questionnaire structure
IRAS ID
241085
Contact name
Helen Twohig
Contact email
Sponsor organisation
Keele University
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
A questionnaire survey to test and refine a patient reported outcome measure for polymyalgia rheumatica (PMR).
PMR affects people in older age groups causing pain, stiffness and disability. It is mainly treated with steroid medication which itself can cause significant side effects and health problems. It is an under-researched
condition and there are wide variations in treatment. More research is needed to inform clinical practice and improve patient care.
Patient reported outcome measures (PROMs) are widely used in other conditions to guide assessment and
treatment and to support aspects of care that patients value. PMR is particularly well suited to being assessed
by patient based outcomes given the effects of the condition, its varied presentation and course and the often
difficult balance between benefits versus side effects of treatment. A provisional set of outcome measures to
be used in clinical trials for PMR has recently been published and highlights the limited ability of the
existing measures to assess the effects of PMR on patients’ lives. We therefore aim to develop a PROM specifically for PMR to fill this gap.
We carried out a study of patient experiences of having PMR and used data from this to develop potential questions (items) for a PROM. This draft PROM now needs testing and refining to develop a final measure that is valid and reliable.
This study is the first stage of this testing process. The questionnaire will be sent to a large number of people who have been diagnosed with PMR in the last 2 years, recruited from primary care. Responses will be analysed using statistical methods that allow the structure of the questionnaire to be decided and items that aren't useful to be removed.
This refined questionnaire will then be tested in different ways in a further study which will be the subject of a separate application.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0140
Date of REC Opinion
19 Apr 2018
REC opinion
Favourable Opinion