INTRANET    Institutu biostatistiky a analýz
Institut biostatistiky a analýz
LF MU
Kamenice 126/3
625 00 Brno
www.iba.muni.cz

COMPASS

neaktivní

COMPASS

Cross-Cultural adaptation of the Leeds Multiple Sclerosis Quality of Life (Leeds-MSQoL) scale and its validation on patients included in Copaxone Patient Support Programme (PSP) in the Czech Republic and Slovakia.

Quality of life can only be assessed using a Patient Reported Outcome Measure (PROM). Scales are designed to impose as little burden as possible on the patient, short and simple scales are preferable over more extensive scales, even though these are likely to provide a more broad and detailed insight. We therefore selected the Leeds MS Quality of Life Questionnaire (Leeds-MSQoL) and EQ5D-5L as the scales that were ideal for standard use in patients with Multiple Sclerosis (MS).

Patients suffering from MS that are prescribed Copaxone© are given the opportunity to join a Patient Support Program (PSP). The overarching goal of a PSP is to ensure the optimal use of the product for optimal effect and where possible provide advice or ancillary care in order for the patient to achieve the highest possible health benefit and quality of life. Patients from the Czech Republic have been included in the PSP for last 7 years. Patients from Slovakia do not have the chance to be part of the PSP but the PSP will be launched at the same time as start of this study.

This is the opportunity to validate newly adapted versions of LeedMS-QoL and measure the change in the Quality of life of the patients after entrance to the PSP.

COMPASS is a multicentre, non-interventional, prospective project focused on translation and cultural adaptation and evaluation of QoL of patients who are treated with Copaxone© and entered the Patient Support Programme (PSP).

Primary objective of the project:

  • Translation, cultural adaptation and further validation in the Czech and Slovak languages the Leeds-MSQoL

Exploratory objectives of the project:

  • Evaluation of change in QoL measured by MS specific scale Leeds-MSQoL in 6m and 12m compared to baseline in Copaxone© patients (Group A)
  • Evaluation of change in QoL measured by non-specific scale EQ5D-5L in 6m and 12m compared to baseline in Copaxone© patients (Group A)
  • Evaluation of a change in Leeds-MSQoL in patients 6 months after entrance to the PSP (Group B)