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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Baseline Main Sheet

- 9/20/21 - 9 forms, 25 itemgroups, 116 items, 2 languages
Itemgroups: Ein-Ausschlusskriterien,Patientendaten,Krankheitsspezifische Angaben,EDSS-Score vor 12 Monaten,Heutige Scores der Funktionssysteme,Frühere verlaufsmodifizierende MS-Therapien,Aktuelle MS-Therapie,WeitereErkrankungen,Herz- / Kreislauferkrankungen,Stoffwechselerkrankungen,Infektionserkrankungen,Gastrointestinale Erkrankungen,Neurologische / Psychiatrische Erkrankungen,Allergien,Urogenitale Erkrankungen,Autoimmunerkrankungen,Blutbild / Labor,Allgemeine Symptome,Operation,Krebserkrankungen,Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?,Andere Erkrankung,Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt,Schwangerschaft,Biologisches Material (z.B. Blut)
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.

Baseline Pregnancy Part 1

25 itemgroups 116 items

Follow Up Main Sheet

25 itemgroups 116 items

Follow Up Medication Change

25 itemgroups 116 items

NINDS CDE Demographics Multiple Sclerosis - Demographics

- 3/15/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: Demographics
NINDS Common Data Elements, Multiple Sclerosis Demographics Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069 - Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

- 5/24/16 - 4 forms, 7 itemgroups, 31 items, 1 language
Itemgroups: Administration and Instructions for CRF Completion,Demographic Data,Blood pregnancy test,Testing for JC virus antibodies,Medical History,MS Medical History,MS Treatment History
Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

NON-MS Treatment and symptomatic MS Treatment

7 itemgroups 31 items

Blood samples for safety laboratory tests

7 itemgroups 31 items

Eligibility

7 itemgroups 31 items

Multiple Sclerosis - Patient Questionnaire (REGIMS)

- 12/9/14 - 1 form, 15 itemgroups, 119 items, 2 languages
Itemgroups: General information,First Symptoms,Diagnostic procedure within the past 12 months,Fatigability Multiple Sclerosis,Course,Aid, manufactured,Medical benefits,Medical benefits past 12 months,Treatment satisfaction,Family history,Symptoms within past 12 months,Medication within last 7 days,Demographics,Doctor visit,Quality of life
Patientenfragebogen Multiple Sklerose REGIMS http://epi.uni-muenster.de

Timed 25-Foot Walk (EHR Archetype) - openEHR-EHR-OBSERVATION.timed_25_foot_walk.v1

- 7/10/17 - 1 form, 1 itemgroup, 11 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.timed_25_foot_walk.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Timed 25-Foot Walk test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite (MSFC) assessment, but may be performed independently. The patient is directed to one end of a clearly marked 25-foot (7,62 m) course. Then he is instructed to walk this course as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Assistive devices (in general, customary walking devices) may be used when doing this task. Use the MSFC Manual for detailed administration instructions. The test should only be administred by a suitably trained person.

Paced Auditory Serial Addition Test (EHR Archetype) - openEHR-EHR-OBSERVATION.paced_auditory_serial_addition_test.v1

- 7/10/17 - 1 form, 1 itemgroup, 16 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.paced_auditory_serial_addition_test.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Paced Auditory Serial Addition Test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite, but may be performed independently. 61 single-digit numbers are presented to the subject one by one. During PASAT-3'' a new number is presented every three seconds, in the optional PASAT-2'' every two seconds. In each case the subject is asked to respond with the sum of the last two digits (not the running total). That is, there is a maximum of 60 possible correct sums. Use the MSFC Manual for detailed administration instructions. Prior to the recording of the actual tests at least one practice trial has to be performed (this training sequence is part of the PASAT). If less than three correct answers were given, the practice trial should be repeated (up to three times). If more than two correct answers were given, the PASAT-3'' can be administered (the patient should have understood the task sufficiently). To obtain additional information about the cognitive functions, the PASAT-2'' can be performed optionally after the 3'' test. The tests should only be administered by a suitably trained person.

Nine Hole Peg Test (EHR Archetype) - openEHR-EHR-OBSERVATION.nine_hole_peg_test.v1

- 7/10/17 - 1 form, 1 itemgroup, 18 items, 3 languages
Itemgroup: openEHR-EHR-OBSERVATION.nine_hole_peg_test.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Nine Hole Peg Test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite (MSFC) assessment, but may be performed independently. Both the dominant and non-dominant hand of the patient are tested twice (two consecutive trials of the dominant hand, followed by two consecutive trials of the non-dominant hand). For each trial nine pegs are picked one by one from a container, placed in the holes on a pegboard and then separately returned to the container. The subject may only use one hand at each trial, but may hold the pegboard with the free hand. This archetype covers variations of the test. According to Mathiowetz et al. (1985) an untimed practice trial should be administered prior to the timed trial for each hand. The MSFC Manual stipulates two timed trials for each hand, but no practice trial. Use the MSFC Manual or see Mathiowetz et al. (1985) for detailed administration instructions. The test should only be administered by a suitably trained person.

MSFC Score (EHR Archetype) - openEHR-EHR-OBSERVATION.msfc_score.v1

- 7/9/17 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.msfc_score.v1.xml
Derived from www.openehr.org . Use to record the MSFC Score and the reference data set, as well as links to the measured results of the three individual tests (Timed 25-Foot Walk, Nine Hole Peg Test and Paced Auditory Serial Addition Test). The MSFC Score is a computed value based on the average of each test result, adjusted to the reference population. I.e. MSFC Score = 1/3 * (Z_arm,avg. + Z_leg,avg. + Z_cognitive), where Z_x = Z-score of each test result. This score has to be computed externally, only the resulting value is to be recorded here. Use the MSFC Manual for further scoring instructions, formulas and background information.

REGIMS - SUE Report

- 9/27/21 - 1 form, 10 itemgroups, 43 items, 2 languages
Itemgroups: SUE,Patientenangaben,SUE: Beschreibung,SUE: Behandlung,SUE: Ausgang,SUE: MS-Medikation,SUE: Begleitmedikation,SUE: Relevante Vorerkrankung / Sypmtome,Ergebnisse der relevanten Diagnostischen Untersuchungen,Kontaktdaten des Berichterstatters
Schwerwiegendes unerwünschtes Ereignis (SUE) in der Therapie SUE Berichtsformular Bitte ausfüllen und faxen oder senden an: Westfälische Wilhelms-Universität Münster, Institut für Epidemiologie und Sozialmedizin, Albert-Schweitzer-Campus 1, Gebäude 03, 48149 Münster Fax: (0251) 83-55300, E-Mail: regims@uni-muenster.de http://epi.uni-muenster.de

Multiple Sclerosis - Base Sheet (REGIMS)

- 1/19/15 - 1 form, 9 itemgroups, 38 items, 2 languages
Itemgroups: General information,Disease-specific information,Current Symptoms Multiple Sclerosis,Past treatment Multiple Sclerosis,Current Therapy Multiple Sclerosis,Cortisone,MRT,Disease history,Pregnancy, current
Medizinischer Basisbogen Multiple Sklerose http://epi.uni-muenster.de

Multiple Sclerosis - In-/Exclusion Criteria (REGIMS)

- 12/12/14 - 1 form, 3 itemgroups, 8 items, 2 languages
Itemgroups: Inclusion criteria,Exclusion criteria,Comments
REGIMS Multiple Sklerose-Register http://epi.uni-muenster.de

Discharge Letter Items Neuroinflammatory Demyelinating Diseases - Discharge Letter Items -18546 Multiple Sclerosis

- 9/27/21 - 12 forms, 25 itemgroups, 146 items, 3 languages
Itemgroups: Administrative Data,Principal Diagnosis,Risk Stratification of Therapy with Natalizumab,Secondary Diagnosis,Reason for Admission,Medical History,Medication on Admission,Neurological Examination: Cranial Nerves,Neurological Examination: Motor,Neurological Examination: Reflexes,Neurological Examination: Sensibility ,Neurological Examination: Coordination and Gait,Neurological Examination: On Discharge,Laboratory Results Urine,Laboratory Results Urine Analysis FACS, Laboratory Results Pregnancy,Laboratory Results Serum,Laboratory Results Small EDTA,Laboratory Results Differential EDTA,Laboratory Results Blood coagulation tests,Laboratory Results Thyroid Function Tests,Laboratory Results Calculated,Laboratory Results Cellular Immune State,Summary and Procedures,Medication on Discharge
Discharge Letter Items for semantic analysis in discharge letters of patients diagnosed with Multiple Sclerosis, Neuromyelitis optica spectrum disease or Acute Disseminated Encephalomyelitis from Neurology Department of University Hospital Muenster provided by Prof. Dr. Luisa Klotz.

Discharge Letter Items 1146404369 Multiple Sclerosis

25 itemgroups 146 items

Discharge Letter Items 1146401133 Multiple Sclerosis

25 itemgroups 146 items

Discharge Letter Items 1229450930 Multiple Sclerosis

25 itemgroups 146 items

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