Myasthenia Gravis Development of a PRO Strategy
Research type
Research Study
Full title
Myasthenia Gravis (MG) Development of a Patient Reported Outcome (PRO) Strategy
IRAS ID
189357
Contact name
Angus Gunn
Contact email
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
UCB, a pharmaceutical company is considering drug development for several rare autoimmune diseases, including Myasthenia Gravis (MG) and wishes to explore MG symptoms and daily impact from the patient’s perspective, and to use this information in the assessment of new treatments. UCB has commissioned Modus Outcomes LTD, an independent outcomes research and consulting firm to conduct a research study regarding this. As such, a study has been designed to investigate the range of symptoms experienced by adult MG patients and the spectrum of daily impact of MG with the aim of conceptualising “treatment benefit” in MG.
Trained Modus Outcomes interviewers will conduct two rounds telephone interviews with a total of 60 people living with MG. Interviews will last approximately 60 minutes and will be audiotaped. NO personal information about participants will be shared with the pharmaceutical company.
The first round of interviews will be exploratory aiming to elicit the concepts important to patients in relation to their condition and assess the comprehensiveness and applicability of newly develop MG impairment index items in a UK sample (MG Impairment Index has recently been developed in Canada and is currently in press). Qualitative analysis will be used to map out aspects of treatment benefit in MG (including symptoms and general impact), review the items and suggest modifications and/or additions. The second round of interviews will be semi-structured aiming to assess the comprehensiveness of the ”treatment benefit” conceptual framework and to cognitive debrief the newly modified items suggested by the analysis of the first round interviews.
This study will enhance knowledge of MG highlighting concepts which are most important to patients and further propose a treatment benefit conceptual framework and draft item stems which could form the basis for the assessment of treatments in MG.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0366
Date of REC Opinion
21 Sep 2015
REC opinion
Further Information Favourable Opinion