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Sommario
  1. 1. Test clinico
  2. 2. Documentazione di routine
  3. 3. Registro / studio di coorte
  4. 4. Garanzia di qualità
  5. 5. Dati Standard
  6. 6. Risultato segnalato dal paziente
  7. 7. Specialità mediche
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Telephone notes Pediatric Hematology and Oncology UK Muenster

- 13/04/21 - 1 modulo, 3 itemgroups, 24 elementi, 2 lingue
Itemgroups: Telephone notes, Laboratory, Current Medication
Freigabe zur Verarbeitung durch Frau Prof. Rössig, Quellenangabe: "Pädiatrische Hämatologie und Onkologie, UKM" Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Münster Released for adaption by Frau Prof. Rössig Source:Pediatric Hematology und Oncology, University hospital Münster

REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Follow Up Adverse Events

- 15/03/21 - 9 moduli, 14 itemgroups, 50 elementi, 2 lingue
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.

Follow Up Main Sheet

4 itemgroups, 15 elementi

Follow Up Medication Change

3 itemgroups, 11 elementi

Follow Up Multiple Sclerosis Progression

2 itemgroups, 8 elementi

Follow Up Pregnancy Part 1

5 itemgroups, 24 elementi
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NINDS CDE Demographics Multiple Sclerosis - Demographics

- 15/03/21 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio
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.

GECCO - German Corona Consensus - Covid-19 Research-Dataset - Vitalparameter

- 03/02/21 - 13 moduli, 1 ItemGroup, 11 elementi, 1 linguaggio
ItemGroup: Vitalparameter
Disclaimer: Der „GECCO - German Corona Consensus - Covid-19 Research-Dataset“ Inhalt, der auf dem Portal für medizinische Datenmodelle (MDM Portal) zu finden ist, ersetzt nicht den GECCO Datensatz auf simplifier.net. Für die Nutzung von GECCO-FHIR-Profilen verwenden Sie bitte die auf https://simplifier.net/ForschungsnetzCovid-19/ verfügbaren Profile. Der FHIR-Download auf MDM erzeugt lediglich eine FHIR-Fragebogenresource. This version of the GECCO logical model is based on https://art-decor.org/art-decor/decor-datasets--covid19f- on the "final" version published mid to end September 2020. For actual use of FHIR profiles, please use the profiles available on https://simplifier.net/ForschungsnetzCovid-19/ResearchDatasetGECCO/~overview (FHIR download on MDM is only a FHIR questionnaire resource). A few items implicated by comments/descriptions of items on art-decor have been added: "Datum der letzten Impfung" (date of last vaccination for all listed vaccinations), "Schweregrad" (Severity of Kidney Diseases), "Ort" (Location of vacation in the last 14 days), "Befund bildgebender Verfahren im Rahmen von COVID-19" added separately for all types of imaging procedures listed, "Symptom Schweregrad" (Severity of Symptoms) for each symptom listed, and an "NCT-/EudraCT-Nummer" item for Study participation. Official German text from http://cocos.team/datasets.html: Zur Bewältigung der aktuellen Pandemie und der damit einhergehenden Behandlung von Patienten fördert das Bundesministerium für Bildung und Forschung (BMBF) ein nationales Netzwerk der Universitätsmedizin im Kampf gegen COVID-19. Unter anderem soll das Netzwerk die Daten der behandelten COVID-19 Patienten systematisch erfassen und bündeln. Die Forschenden sollen die Behandlung der COVID-19-Patienten standardisiert erheben, verfolgen und analysieren. Die hohe Bedrohungslage hat zu intensiver wissenschaftlicher Aktivität zu COVID-19 geführt, wozu zahlreiche regionale, nationale und internationale epidemiologische Erhebungen und Registerstudien zählen. Der Konsensusdatensatz gibt der Wissenschaft um COVID-19 eine gemeinsame Sprache und Arbeitsgrundlage. Inofficial translation: In order to cope with the current pandemic and the associated treatment of patients, the Federal Ministry of Education and Research (BMBF) is funding a national network of university medicine in the fight against COVID-19. Among other things, the network will systematically collect and bundle the data of the treated COVID-19 patients. The researchers are to collect, track and analyze the treatment of COVID-19 patients in a standardized way. The high threat level has led to intensive scientific activity on COVID-19, including numerous regional, national and international epidemiological surveys and register studies. The consensus data set provides a common language and working basis for the science around COVID-19. Not yet integrated: Items for "Data Absent Reason", "Certainty of Presence", "Uncertainty of Presence", and "Certainty of absence"; "therapeutic intention", "Medication Statement Status", "EventStatus"; longer versions of the ValueSets published separately from the variables in art-decor.

Medical History/Risk factors (Anamnese/Risikofaktoren)

1 ItemGroup, 88 elementi

Demographie

1 ItemGroup, 8 elementi

Bildgebung

1 ItemGroup, 6 elementi

Studieneinschluss/Einschlusskriterien

1 ItemGroup, 3 elementi
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EHR4CR data inventory

- 13/04/21 - 1 modulo, 7 itemgroups, 75 elementi, 2 lingue
Itemgroups: Demographics, Medical History, Diagnosis, Procedure, Findings, Laboratory Findings, Medication
Doods J, Botteri F, Dugas M, Fritz F; EHR4CR WP7. A European inventory of common electronic health record data elements for clinical trial feasibility. Trials. 2014 Jan 10;15:18 http://www.ncbi.nlm.nih.gov/pubmed/24410735

Sepsis Case Report Form MEDUSA project - SAPS II- Score Report Form

- 17/11/20 - 1 modulo, 2 itemgroups, 8 elementi, 1 linguaggio
Itemgroups: Header module, SAPS II- Score
The MEDUSA project (medical education for sepsis source control and antibiotics) is a scientific study of the integrated research and treatment center "Center for Sepsis Control and Care" (CSCC) of the University Hospital Jena, Thuringia, Germany. Its aim is to investigate whether a multimodal and interdisciplinary training concept for the early recognition and standardized treatment of patients with sepsis improves time to administration of first antibiotic and survival of patients. Original forms obtained from: http://www.medusa.uniklinikum-jena.de/Datenerfassung.html

Smart Device System Meta Data Definitions - Neurologic Examination

- 03/09/20 - 7 moduli, 1 ItemGroup, 6 elementi, 2 lingue
ItemGroup: Neurologic examination
Metadata definitions for the Smart Device System for Movement Disorders. Clinical Protocol and Registration Information available on: https://clinicaltrials.gov/ct2/show/NCT03638479 Principal Investigator: Julian Varghese Description for Assessment Steps for Neurologic Examination are available under: Varghese J, Niewöhner S, Soto-Rey I, et al. A Smart Device System to Identify New Phenotypical Characteristics in Movement Disorders. Front Neurol. 2019;10:48. doi:10.3389/fneur.2019.00048

Demography

2 itemgroups, 5 elementi

Medical History

1 ItemGroup, 9 elementi

Medication

1 ItemGroup, 3 elementi

Vital Signs

1 ItemGroup, 1 elemento
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ICHOM Heart Failure - Baseline Characteristics, at time of index event

- 30/04/20 - 1 modulo, 5 itemgroups, 62 elementi, 1 linguaggio
Itemgroups: Patient ID, Demographic Factors, Baseline health status, Treatment variables, Burden of Care
HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains baseline characteristics. It should be filled in at the time of the index event. The index event represents the entry into the set. This could either be after diagnosis/first encounter in an outpatient setting, or at discharge from hospital if the initial presentation was severe enough to require admission. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Physician referral letter

- 15/03/21 - 1 modulo, 21 itemgroups, 341 elementi, 2 lingue
Itemgroups: Current episode, Transfer diagnosis, Other Diagnoses, Beta blocker, Calcium Channel Blockers, Angiotensin 2 Receptor Blocker, ACE inhibitors, Diuretics, Cardiac drugs, Antikoagulanzien, Antidiabetics , Antidepressive Agents, Neuroleptic Drugs, Hormonal contraceptives, Bronchodilator Agents, Antilipemic agent, Analgesics, Anti-Infective Agents, Antiparkinson Agents, Glucocorticoids, Other medication
derived from http://www.arztbriefmanager.de/ (Dr. Wolfram Arends, Tutzing, Germany)

Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 24/03/20 - 1 modulo, 5 itemgroups, 90 elementi, 2 lingue
Itemgroups: Logistics , Physical examination, ECG, 6MWT, Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

DIVI Kerndatensatz Intensivmedizin 2010 - Strukturdaten

- 19/03/20 - 5 moduli, 1 ItemGroup, 28 elementi, 1 linguaggio
ItemGroup: Hospital and intensive care unit structure data
Kerndatensatz Intensivmedizin 2010 der DIVI und DGAI (nur patientenbezogene Daten, ohne Strukturdaten der Intensivtherapiestation und der Klinik ). Deutsche interdisziplinaere Vereinigung fuer Intensiv und Notfallmedizin DIVI (German interdisciplinary association for intensive and emergeny medical care), http://www.divi.de/images/Dokumente/Empfehlungen/Strukturempfehlungen/2010_KerndatensatzIntensivmedizin.pdf

Aufnahmestatus

2 itemgroups, 37 elementi

Entlassung von der Intensivtherapiestation

2 itemgroups, 16 elementi

Entlassung aus dem Krankenhaus

1 ItemGroup, 2 elementi

Tägliche Datenerhebung

2 itemgroups, 25 elementi

Quality assurance Follow-up Heart Transplant (AQUA) - Quality assurance Follow-up Liver Transplant (AQUA)

- 27/09/19 - 1 modulo, 2 itemgroups, 16 elementi, 2 lingue
Itemgroups: Follow-up(auszufüllen nach 1, 2 und 3 Jahren), Überlebensstatus des Empfängers
Documentation form for quality assurance in German Health Care by the Institute for Applied Quality Improvement and Research in Health Care (Aqua), https://www.aqua-institut.de/en/home. Internal Aqua form version: HTXFU Specification 2015 V02