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Table 2 Data acquisition plan for TRUST

From: Design of TRUST, a non-interventional, multicenter, 3-year prospective study investigating an integrated patient management approach in patients with relapsing-remitting multiple sclerosis treated with natalizumab

Documented items Baseline (visit #1) Approximately every 3 months (visits #2–13) until month 36
Definition of investigator’s infrastructure x  
Informed consent x  
Patient demographic characteristics x  
History (medical, MS): x  
First MS diagnosis
Other underlying diseases
History of EDSS score
History of relapses
History of (previous) MS therapy
MRI status at baseline
Opportunistic infections before start of natalizumab treatment
History of natalizumab treatment x  
Status of current treatment   x
Current EDSS score x x
Relapse(s) since last visit (number, date)   x
AE at/since (last) visit (yes, no) x continuously
Anti-JCV serostatus   x
Other biomarkers collected or evaluated (e.g. anti-JCV antibody index)   x
Resources used (nurse contact, other HCP, clinic)   x
Lymphocytes and other critical laboratory parameters in association with natalizumab treatment x x
Opportunistic infections   x
TSQM-9 (treatment satisfaction) x every 12 months
FSMC (fatigue) x every 12 months
MSIS-29 (MS-related quality of life) x every 12 months
HADS (depression) x every 6 months
SDMT (cognitive function) x every 6 months
WPAI (productivity) x every 6 months
Expert advice requested   if available
MRI results x if available
  1. Due to the non-interventional character of the study, only data collected within the routine clinical practice are documented
  2. TSQM-9 Treatment Satisfaction Questionnaire for Medication, FSMC Fatigue Scale for Motor and Cognitive Functions, MSIS-29 Multiple Sclerosis Impact Scale-29 items, HADS Hospital Anxiety and Depression Scale, SDMT Symbol Digit Modality Test, WPAI Work Productivity and Activity Impairment Questionnaire