Danish Multiple Sclerosis Registry

Variables Collected

In Denmark public hospitals perform the majority of neurological services. All thirteen Departments of Neurology treating multiple sclerosis (MS) report data into the online notification system on their entire MS-patient-population being treated with disease modifying therapies (DMT).

Registration in our database starts when MS is diagnosed and then at each visit in the MS clinic. With the introduction of DMT’s in 1996 it became mandatory to regularly report data on all patients in treatment. While on treatment patients are monitored in the MS clinics at regular intervals with recording of demographic, clinical and paraclinical data, as well as Expanded Disability Status Score (EDSS), relapses, and side effects. All patients are informed about their data being recorded.

According to directives given by the Danish Data Inspection, there is no requirement for informed consent from the patient for inclusion in the DMSR. The DMSR has to uphold strict security rules for data storage, and the data cannot be used for other purposes than science and statistics.

Variables

Personal data

ID number
Date of birth
Gender

Basic disease data

Disease course
Time of disease onset
Time of diagnosis
Symptoms at onset
Past disease activity

Paraclinical data

CSV results at diagnosis (IgG index, oligoclonal bands)
Neutralizing antibodies for interferons-beta and natalizumab
JCV status, semiannually for patients treated with natalizumab

Patient reported outcomes (PRO)

Quality of Life
Fatigue

Relapses (every 6-12 months)

Date of relapses
Steroid treatment

Disability /collected at each visit (every 6-12 months)

Expanded Disability Status Score (EDSS)
Functional System Score (FSS)

Treatments

Start and end dates of past treatments
Current disease-modifying therapies
Start date of current treatment
Reason for discontinuation of treatment

MRI

MRI date
T2/FLAIR lesions
Number of T2/FLAIR lesions
Number of new T2/FLAIR since previous scan
T1 with Gadolinium
Number of enhancing lesions
Number of new enhancing lesions since previous scan

Adverse events

ICD codes
Date of event
Seriousness and course
Consequence regarding treatment