Developing a PROM for people with NMO
Research type
Research Study
Full title
Development a preliminary patient reported outcome measure (PROM) for people with neuromyelitis optica (NMO)
IRAS ID
173575
Contact name
P Moore
Contact email
Sponsor organisation
The Walton Centre
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Neuromyelitis Optica (NMO) is a degenerative condition of the central nervous system. It presents with a range of symptoms including blindness, paralysis and incontinence. Despite previously being thought of as a subtype of multiple sclerosis (MS), it is now recognised as a distinct disease.
Patient experience is a key factor in evaluating quality of care. This information is often obtained by patient reported outcome measures (PROMs) which are specific to an illness. Currently there is no PROM specifically for NMO.
The present research aims to develop a PROM for patients with NMO in accordance with international guidelines for PROM development (US Food and Drug Administration 2009 Blazeby 2002; Rothman 2009; Streiner 2003). The process will involve a high level of patient involvement to ensure the measure is designed around and therefore able to assess patient experience.
Systematic reviews will assess the quality of life issues involved in NMO and the necessity for developing a new PROM. The quality of life issues will provide a conceptual framework which will guide further literature searches to identify existing relevant PROMs. Subject experts will review the existing PROMs to identify relevant items and an exhaustive list of items will be achieved. This list will be reduced through expert review of overlap and clarity. Patients will then be contacted by a member of the clinical team and will be invited to take part in a semi-structured interview to review the identified items. Patients will also be asked to rate each item for importance and relevance. The results of these interviews will guide the development of a preliminary measure. Traditional psychometrics and Rasch analysis will be carried out in further stages.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0203
Date of REC Opinion
16 Mar 2015
REC opinion
Favourable Opinion