The development of an immunoglobulin (Ig) burden of treatment question
Research type
Research Study
Full title
The development of an immunoglobulin (Ig) burden of treatment questionnaire
IRAS ID
164178
Contact name
Deborah McClean
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The overall objective of this study is to develop a new questionnaire that can be used to measure the burden of immunoglobulin (Ig) treatment and its impact upon the quality of life of patients with primary immunodeficiency (PID): lg Burden of Treatment Questionnaire.
Primary immunodeficiency disorders (PIDs) consist of a group of rare, mainly genetic disorders characterised by an absent or poor immune system. People affected will experience a range of mild to severe ailments e.g. frequent infections, pneumonia to heart problems. Ig treatment is the main mode of therapy for most patients, administered either directly into the vein (in hospital) or through the skin (in hospital or at home).
We propose a four stage study to develop the Ig Burden of Treatment Questionnaire. This will involve:
Stage 1) Obtaining ethics and research governance and generating the items for the questionnaire using Sheffield Teaching Hospitals (STH) patients (7 months)
Stage 2) Reviewing the items with STH patients (1 month)
At this point, the long-form questionnaire will be ready to use by the funder of the study (Baxter Healthcare). The remaining analyses below will be carried out using data collected by Baxter in a large scale European survey. Once this data is received, we anticipate a further 2 months of work to complete the development of the instrument.
Therefore, only stage 1 and 2 will be carried out with STH patients. The remaining statistical analyses will be carried out using large scale anonymous international survey data collected by Baxtor and thus will not require NHS ethics or R&D approval for the research.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
14/YH/1247
Date of REC Opinion
31 Oct 2014
REC opinion
Favourable Opinion