Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes

BMC Neurology

Table 2 Data collection by time points

Modules	Baseline	Months 1,2,4,5,7,8, 10,11,13,14 16,17,19,20, 22,23	Months 3,9,15,21	Months 6, & 18	Months 12 & 24
Demographic characteristics	X
Co-morbidities baseline/updates	X		X	X	X
MS history	X
MS therapies & concomitant drug history/updates	X		X	X	X
Relapses, history and current	X
Current DMT		X	X	X	X
Current MS status (relapse)		X^f	X^f	X^f	X
Targeted events ^a	X	X	X	X	X
Quality of Life (SF-12v.2™)	X		X	X	X
Disability: Self-Assessed Kurtzke	X			X	X
Fatigue Severity Scale (FSS)	X		X	X	X
Patient Health Questionnaire (PHQ-9) ^b	X		X	X	X
Perceived Deficits Questionnaire (PDQ-5) ^c	X			X	X
Work Productivity and Activity Impairment: General Health (WPAI:GH)	X		X	X	X
Drug shipment data for compliance & persistence ^d	X	X	X	X	X
Termination ^e					X
Termination ^e					24 months

DMT, Disease-modifying therapy; SF-12v.2™, Short Form Health Survey, 12 items, version 2, [14].
^aMost commonly reported adverse events; Includes reports of pregnancy; ^bDepression screener/severity assessment [17, 18]; ^cCognition screener [19]; ^dShipment data were uploaded electronically to study database; ^eTermination module was asked when a patient left the study or completed follow-up. ^fAt report of relapse, Self-Assessed Kurtzke was completed and repeated in six months [13].

ISSN: 1471-2377