Variables collected

After the patient’s consensus, each center involved collects a minimum data set consisting in selected and mandatory information about principal personal features and clinical conditions that are periodically uploaded. In addition, the clinician can insert further optional information to have a more complete framework about patient’s health.

The following table lists variables collected. No supplementary visits or exams are required to multiple sclerosis subjects to take part in this project and only data by currently clinical practiceare collected

 

Section	Sub-Section	Description
	Clinical Centers	Identification
Baseline	Patient	Identification and Encryption of Personal Data, State of Life, Record Creation Date
	Onset MS	Date, Symptoms, Course (including RIS)
	Diagnosis	Date, Mc Donald Criteria (2010)
Follow up	Visits	Date, EDSS, Course
	Relapses	Date, Duration, Functional Systems involved, Severity, Recovery, Steroid treatment
	Treatments	Start Date, End Date, Dosage, administration routes, symptomatic or specific, Discontinuation cause (if applicable)
	Adverse Events	Reporting Adverse Events
Paraclinical Tests	MRI	Date, CNS region, T2 and T1 lesions, T1 Gd+ lesions, McDonald's Criteria for Spatial Dissemination
	CSF	Date, Routine, Oligoclonal band (presence/absence)
	Evoked Potentials	Date, VEP, SEP, BAEP, MEP
	Laboratory Tests	Date, Routine, Hematologic, Virological, Immunologic, Thyroid Function
Clinical Events	History	Family history, Pregnancies, Comorbidity, Adverse Events

 

FISM and UNIBA are data’s owners that will share all data analysis with centers participating, patients and all scientific communities publishing the results and news.