Variables collected

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.