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
|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.