Developing a PROM for people with NMO 2
Research type
Research Study
Full title
The development and validation of a patient reported outcome measure (PROM) for people with Neuromyelitis Optica (NMO)
IRAS ID
184695
Contact name
P Moore
Contact email
Sponsor organisation
The Walton Centre NHS Foundation Trust
Duration of Study in the UK
2 years, 7 months, 1 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). Currently, we have conducted semi-structured interviews with 15 people with NMO to evaluate the first draft PROM questionnaire. The next stages, detailed throughout the present application for ethical approval, will involve up to 100 patients with NMO completing the draft measure to obtain data for traditional psychometrics and advanced Rasch analysis.
At present, a first draft PROM has been constructed. In order to further modify and validate this PROM according to internationally accepted PROM development guidelines, traditional psychometrics must be completed. In addition to this, modern advanced analysis will be completed using Rasch analysis. The power calculation for these analyses indicated that a sample size of 64 would give 95% confidence.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0572
Date of REC Opinion
13 Jul 2015
REC opinion
Favourable Opinion