MGUSP-RODS
Research type
Research Study
Full title
The development of a Monoclonal Gammopathy of Undetermined Significance Polyneuropathy Rasch-Built Disability Scale (the MGUSP-RODS)for clinical and trial use.
IRAS ID
199071
Contact name
M.P.T. Lunn
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2016/03/114, UCL Data Protection Registration Number
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Monoclonal gammopathy of undetermined significance polyneuropathy (MGUSP) is a slowly progressive disease of the nerves accompanied by an increased protein in the blood. It has differential effects in individuals ranging from mild foot numbness and minor imbalance to severe neuropathic pain and sensory and motor dysfunction. These symptoms lead to functional deficit and reduced quality of life. International consensus on how to assess functional deficits in patients with MGUSP is lacking. A new MGUSP-specific and more sensitive patient-based outcome measure needs to be constructed. This outcome measure could serve to assess the natural course of the disease and as the primary outcome in future trials. This study aims to develop an MGUSP-specific outcome measure using obtained knowledge on modern scientific scales construction in other peripheral neuropathies. Approximately 100 patients with MGUSP in the National Hospital for Neurology and Neurosurgery in London will be included. Patients will be asked to fill in a questionnaire containing 146 questions concerning activities of daily living twice, with an interval of 2-4 weeks. Modern statistical analysis will be used in order to construct the final questionnaire fulfilling all modern clinimetric requirements, like being simple, valid, reliable, and responsive.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
16/NW/0901
Date of REC Opinion
17 Oct 2017
REC opinion
Further Information Favourable Opinion