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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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GECCO - German Corona Consensus - Covid-19 Research-Dataset - Studieneinschluss/Einschlusskriterien

- 28/10/20 - 13 moduli, 1 ItemGroup, 3 elementi, 1 linguaggio
ItemGroup: Studieneinschluss/Einschlusskriterien
This version of the GECCO dataset is mainly based on https://art-decor.org/art-decor/decor-datasets--covid19f- on the "final" version published mid to end September 2020. 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. Additional source: https://simplifier.net/ForschungsnetzCovid-19/ResearchDatasetGECCO/~overview 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.

Krankheitsbeginn / Aufnahme

1 ItemGroup, 1 elemento

Epidemiologische Faktoren

1 ItemGroup, 1 elemento

Outcome bei Entlassung

1 ItemGroup, 3 elementi

Komplikationen

1 ItemGroup, 8 elementi
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Smart Device System Meta Data Definitions - PD NMS

- 03/09/20 - 7 moduli, 1 ItemGroup, 1 elemento, 2 lingue
ItemGroup: PD NMS
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

Neurologic Examination

1 ItemGroup, 6 elementi

Demography

2 itemgroups, 5 elementi

Medical History

1 ItemGroup, 9 elementi

Family History

1 ItemGroup, 2 elementi
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DIVI Kerndatensatz Intensivmedizin 2010 - Entlassung von der Intensivtherapiestation

- 19/03/20 - 5 moduli, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: DNR (do not resuscitate) / AND (allowed natural death), Procedures and complications
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

Strukturdaten

1 ItemGroup, 28 elementi

Entlassung aus dem Krankenhaus

1 ItemGroup, 2 elementi

Tägliche Datenerhebung

2 itemgroups, 25 elementi

Aufnahmestatus

2 itemgroups, 37 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

Paragraph 21 Datensatz 2017 - Paragraph 21 medical data

- 20/07/19 - 1 modulo, 6 itemgroups, 55 elementi, 1 linguaggio
Itemgroups: Case data, Medical Department data, Diagnosis details, Procedure Details, PIA-Documentation of services, Modell project
Medizinische Daten des Behandlungsfalls

ICHOM Coronary Artery Disease - Peri-Inverventional Clinical Form

- 30/04/20 - 1 modulo, 8 itemgroups, 46 elementi, 1 linguaggio
Itemgroups: Administrative Data, Demographic factors, Baseline health status, Prior Treatments, TREATMENT VARIABLES, Acute complications of treatment, Major surgery complications, Major interventional cardiology complications
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://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: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains peri-interventional clinical items. The items cover a timespan from prior to the intervention (e.g. PCI or CABG) until 30 days after it. They should be assessed at the entry event and at any new index event (e.g. new revascularization procedure or new diagnosis of ACS). Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Type 2 Diabetes NCT00641251

- 21/04/18 - 1 modulo, 2 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00641251

Eligibility Type 2 Diabetes NCT00508599

- 21/04/18 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00508599

EHR4CR CTE Data Inventory

- 21/04/18 - 1 modulo, 14 itemgroups, 133 elementi, 1 linguaggio
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Eligibility Leukemia, Myeloid NCT00512083

- 10/01/18 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00512083

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

- 07/12/17 - 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 Pregnancy Part 1

5 itemgroups, 24 elementi

Follow Up Medication Change

3 itemgroups, 11 elementi

Follow Up Pregnancy Part 2

5 itemgroups, 21 elementi
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Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 14/11/17 - 1 modulo, 10 itemgroups, 71 elementi, 2 lingue
Itemgroups: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)