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Table of contents
  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
Selected data models

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- 12/7/17 - 9 forms, 14 itemgroups, 50 items, 2 languages
Itemgroups: Angaben zum unerwünschtes Ereignis, Weitere Angaben zum unerwünschtes Ereignis, Einstufung des Ereignisses, Ausgang, Kausalität (UE & MS-Medikation), MS-Medikation, Kausalität (UE & Begleitmedikation), Begleitmedikation, Schwerwiegende unerwünschte Ereignisse, Patientenangaben, Behandlung, Relevante Vorerkrankung / Symptome, Ergebnisse der relevanten Diagnostischen Untersuchungen, Kontaktdaten des Berichterstatters
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.
- 11/2/15 - 1 form, 5 itemgroups, 16 items, 19 languages
Itemgroups: Identity, Diagnosis, Therapy, Study, Follow-up
- 3/20/14 - 1 form, 6 itemgroups, 49 items, 2 languages
Itemgroups: CancerRegistry, Previous cancer, Current Neoplasm, Treatment, surgery, radiotherapy
- 8/5/16 - 1 form, 29 itemgroups, 267 items, 1 language
Itemgroups: Medical History (PGID 272) , Diseases, conditions , Treatment, Indication for treatment, Treatment target, Involved sites, Risk Factors, APACHE Score, Immunosuppressants, Types of isolation, Other Antifungals BEFORE initiation, Other Antifungals AFTER initiation, Temperature, Diagnostic procedures, Sites of Mycosis, CT finding, Sites of Mycosis, MRT finding, Sites of Mycosis, Sonography finding, Sites of Mycosis, Fundoscopy finding, Sites of Mycosis, microbiological culture finding, Sites of Mycosis, Tissue specimen finding, Method of biopsy, Micafungin Treatment (PGID 280), CYP450 inductors DURING treatment, Breakthrough Infections (PGID 281), Adverse Events, Laboratory Parameters (PGID 283) , Outcome Micafungin (PGID 284) , Other Antifungal, Outcome Final Antifungal Treatment (PGID 286), Follow Up (PGID 287)
- 5/7/13 - 1 form, 2 itemgroups, 12 items, 2 languages
Itemgroups: Unfallgeschehen, Straßenverkehr
- 4/4/14 - 1 form, 7 itemgroups, 38 items, 2 languages
Itemgroups: Patient data, Treating Clinic, General practitioner, Patient Characteristics, Professional career, Comments, Signature
- 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
- 6/25/15 - 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
- 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
- 5/30/20 - 1 form, 8 itemgroups, 33 items, 2 languages
Itemgroups: Administrative Documentation, Administrative Documentation of Care Receiver, Relation to your loved one, Your health, Time spent caring for your loved one, How difficult is the care for you, Quality of life for yourself, Conclusion
You are caring for your partner, a family member, a friend or a loved one. This list contains questions about what this care means for you as a caregiver. Your answers will be used in research aimed at improving elderly care and informal care. The more information there is about these types of care, the more they can be taken into consideration. For example, when changing the facilities, regulations or legislation for care and wellbeing. Therefore, your experiences are also valuable for other caregivers. Instructions: - Completing this questionnaire will take approximately twenty minutes. - If you read ‘your loved one’, then the question refers to the person for whom you are a caregiver. - Read each question through completely before answering. - Some questions may appear to be ‘repeated’, but please answer all questions. They are intended to view your situation again from a different angle. - When you are done, please check that you have not forgotten any questions. The Older Persons and Informal Caregivers Survey Minimum DataSet (TOPICS-MDS) is a public data repository which contains information on the physical and mental health and wellbeing of older persons and informal caregivers across the Netherlands. The database was developed in part to ensure uniform collection of outcomes measures, thus promoting comparability between studies. To date, 53 different research projects have contributed data to this initiative, resulting in a pooled dataset >44,000 older persons and >9,000 informal caregivers. This form contains the version of TOPICS-MDS 2017. More information can be found at https://topics-mds.eu