- 9/15/21 - 13 forms, 26 itemgroups, 78 items, 1 language
Itemgroups: Datum der Laborwerte, CRP, Ferritin, Bilirubin, D-Dimer, Gamma-GT, GOT/AST, LDH, Kardiale Troponine, Hämoglobin, Kreatinin, Laktat, Leukozyten absolut, Lymphozyten absolut, Neutrophile absolut, PTT (Partielle Thromboplastinzeit/Partial Thromboplastin Time), Thrombozyten absolut, INR (International Normalized Ratio), Serum-Albumin, Antithrombin III, Procalcitonin, Interleukin-6, N-terminales B-Typ natriuretisches Peptid, Fibrinogen, SARS-CoV-2-RT-PCR, SARS-CoV-2-Antikörper-Panel
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. Ziel Überarbeitung August 2021: höhere Kompatibilität mit der NUM-COMPASS-App bzw. der Schnittstelle zur zentralen Datenbank; Zwischenstand, gewisse Module sind noch nicht kompatibel mit der Schnittstelle (u.a. Medikation und Laborwerte; Beatmungstherapie ist aktuell doppelt hinterlegt) This version of the GECCO logical model is based on https://art-decor.org/art-decor/decor-datasets--covid19f-, and the implementation for REDCap by the University of Tübingen (3.3.2021), partially updated with https://simplifier.net/guide/GermanCoronaConsensusDataSet-ImplementationGuide/Home information. For actual use of FHIR profiles, please use the actual profiles available on https://simplifier.net/ForschungsnetzCovid-19/ResearchDatasetGECCO/~overview (FHIR download on MDM is only a FHIR questionnaire resource). This version is not compatible with the REDCap to FHIR GECCO converter of the University of Tübingen. It aims at a higher compatibility with the app generated for the NUM-COMPASS project (conversion to COMPASS-compatible FHIR questionnaire necessary) and from there with the central platform of the NUM-CODEX project. A few modules are not yet compatible (e.g. Medication and lab values; ventilation is currently double). 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.

Anamnese/Risikofaktoren

16 itemgroups, 101 items

Medikation

5 itemgroups, 56 items

Krankheitsbeginn / Aufnahme

1 itemgroup, 3 items

Epidemiologische Faktoren

1 itemgroup, 1 item
- 9/20/21 - 1 form, 12 itemgroups, 138 items, 1 language
Itemgroups: Participant Identification, Treatment, Complications, Diagnostics, Biospecimen Testing, Antiviral therapy, Antibiotic therapy, Corticosteroids, Heparin, Antifungal therapy, Other treatments administered for COVID-19, Outcome
This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Module 1 and Module 2 complete on the first day of presentation/admission or on first day of COVID-19 assessment. Module 2 also complete on first day of admission to ICU or high dependency unit. In addition, complete daily for as many days as resources allow up to a maximum of 14 days. Continue to follow-up patients who transfer between wards. Module 3 (Outcome) complete at discharge or death General Guidance: - The CRF is designed to collect data obtained through examination, interview and review of hospital notes. Data may be collected retrospectively if the patient is enrolled after the admission date. - For more detailed guidance on how to complete these forms, please refer to the CRF Completion Guideline - Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number. You can obtain a site code and registering on the data management system by contacting ISARIC. Participant numbers should be assigned sequentially for each site beginning with 0001. In the case of a single site recruiting participants on different wards, or where it is otherwise difficult to assign sequential numbers, it is acceptable to assign numbers in blocks or incorporating alpha characters. E.g. Ward X will assign numbers from 0001 or A001 onwards and Ward Y will assign numbers from 5001 or B001 onwards. Enter the Participant Identification Number at the top of every page. - Printed paper CRFs may be used for later transfer of the data onto the electronic database. - For participants who return for re-admission to the same site, start a new form with a different Participant Identification Number. Please check “YES-admitted previously” in the ONSET & ADMISSION section. Enter as 2 separate entries in the electronic database. - For participants who transfer between two sites that are both collecting data on this form, it is preferred to have the data entered by a single site as a single admission, under the same Participant Identification Number. When this is not possible, the first site should record “Transfer to other facility” as an OUTCOME, and the second site should start a new form with a new patient number and indicate “YES-transferred” in ONSET & ADMISSION. - Complete every line of every section, except for where the instructions say to skip a section based on certain responses. - Mark ‘Not done’ for any results of laboratory values that are not available, not applicable or unknown. - Avoid recording data outside of the dedicated areas. Sections are available for recording additional information. - If using paper CRFs, we recommend writing clearly in ink, using BLOCK-CAPITAL LETTERS. - Place an (X) when you choose the corresponding answer. To make corrections, strike through (-------) the data you wish to delete and write the correct data above it. Please initial and date all corrections. - Please keep all of the sheets for a single participant together e.g. with a staple or participant-unique folder. - ISARIC would like the centers to enter data directly into their electronic data capture system. Please contact ISARIC about access. If your site would like to collect data independently, ISARIC can support you in the estabilishment of locally hosted databases. This version may serve as a basis for locally hosted databases. - Please contact ISARIC, if you need help with databases, have comments or to let ISARIC know that you are using the CRF. - Please let us know if you find any mistakes in the MDM Portal's version. FURTHER GUIDANCE AND DEFINITIONS (from the Completion guideline) Comorbidities: Comorbidities present before the onset of COVID-19 and are still present. Do not include those that developed following the onset of COVID-19 symptoms. More detailed guidance is provided. Hospital admission: For patients who were admitted to hospital with COVID-19 or symptoms consistent with possible COVID-19 infection, please enter details for the date of hospital admission. For patients with a clear alternative diagnosis leading to admission who subsequently acquired COVID-19, original admission date should be provided, but all subsequent references to admission should be taken as referring to day COVID-19 was first clinically suspected (or within the first 24 hours after first day of suspected or confirmed COVID-19 infection). Where a patient was admitted via multiple hospital departments, count admission from the time they came to the first department during the visit that led to their admission (e.g. arrival at the Emergency Department). Oxygen therapy: Include any form of supplemental oxygen received using any methods. Invasive ventilation: Please include any mechanical ventilation delivered following intubation or via a tracheostomy. Do not include patients who are breathing independently via a tracheostomy. Non-invasive ventilation: Please include any positive-pressure treatment given via a tight-fitted mask. This can be continuous positive pressure (CPAP) or bi-level positive pressure (BIPAP). Renal replacement therapy or dialysis: Please include any form of continuous renal replacement therapy or intermittent haemodialysis. Worst result: References to ‘worst result’ refer to those furthest from the normal physiological range or laboratory normal range. Results that were rejected by the clinical team (e.g. pulse oximetry on poorly perfused extremities, haemolysed blood samples, contaminated microbiology results) should not be reported. The following measures should be considered as a single observation and entered together: Blood gas results: Please report the measures from the blood gas with the lowest pH (most acidotic). Blood pressure: Please report the systolic and diastolic blood pressure from the observation with the lowest mean arterial pressure (if mean arterial pressure has not been calculated, report the measurement with lowest systolic blood pressure). Respiratory rate: If both abnormal low and high rate observed, record the abnormally high rate. General information about ISARIC ISARIC has developed a portfolio of resources to accelerate outbreak research and response. All resources are designed to address the most critical public health questions, have undergone extensive review by international clinical experts, and are free to use. ISARIC should be acknowledged and informed if you implement the protocol. Ethical apporval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators. This form refers to the CoV CASE RECORD FORM Version 1.3 25 Aug 2020. See https://isaric.tghn.org/COVID-19-CRF/
- 8/11/21 - 1 form, 7 itemgroups, 195 items, 1 language
Itemgroups: Participant Identification, Summary of clinical features of current illness, Laboratory results, Imaging and pathogen testing, Treatment, Supportive care, Outcome
Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). This Module is to be completed at time of discharge or death.
- 8/3/21 - 1 form, 10 itemgroups, 188 items, 1 language
Itemgroups: Participant Identification, Demographics, Onset of current illness and vital signs, Possible signs and symptoms of multisystem inflammatory syndrome, Other signs and symptoms of multisystem inflammatory syndrome, Recent history, Co-morbidities, past history, Pre-admission and chronic medication, Laboratory results, Imaging and pathogen testing
Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. This Module is to be completed when multisystem inflammatory syndrome is suspected, on admission or in-patients.
- 7/16/21 - 23 forms, 39 itemgroups, 280 items, 1 language
Itemgroups: Sociodemography, Comorbidities, Central nervous system / Neurological disesases, Comorbidities, Cardiovascular diseases, Comorbidities, Pulmonary diseases, Comorbidities, Hematological / oncological diseases, Comorbidities, Rheumatological diseases, Comorbidities, Allergology, Comorbidities, Other internal disorders, Comorbidities, Other conditions, Body-Mass-Index (BMI), Smoking status, Use of e-cigarettes and / or vaporizer?, Pre-existing treatment, Recent immunosuppressive medication, Colonisation with multi-resistant pathogens, Disease limiting life expectancy before positive SARS-CoV-2 testing, Follow-up duration after SARS-CoV-2 diagnosis, Last known status, Diagnosis context, COVID-19 diagnosis details, Complications at baseline: Thrombotic and thromboembolic manifestations, Complications at baseline: Neurological, Complications at baseline: Other severe organ damage, Complications at baseline: Other, Disease course, Duration (days) of..., Symptoms: Please click all symptoms which occurred in the respective clinical phase, Vitals, Lung ultrasound results at SARS-CoV-2 detection, Baseline: Chest CT results at SARS-CoV-2 detection, Heart function, Echocardiography: Ejection fraction (EF) at SARS-CoV-2 detection, Cardiovascular magnetic resonance imaging (CMR) performed in any clinical phase, Neurological diagnostic in various phases, Complementary and/or integrative medicine (CIM) used in any phase, Discussion of limitation of therapy during SARS-CoV-2 infection, Specialist palliative care during SARS-CoV-2 infection, Agreement to share data for scientific purposes, Biomaterial availability for research proposes, Participation in interventional clinical trials
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. Please note that only cases with known outcome are collected! Baseline / diagnosis is defined as the day the sample of the first positive SARS-CoV-2 result was taken. Criteria of the Uncomplicated Phase: Asymptomatic OR Symptoms of upper respiratory tract infection and/or Nausea, emesis, diarrhea and/or Fever Remember: The Uncomplicated Phase ends, if a previously febrile patient has no fever anymore and has completed 14 days of follow-up without entering Complicated or Critical Phase; then move to Recovery Phase. Also, as soon as one of the criteria of the Complicated or Critical Phase are fulfilled, Uncomplicated Phase ends; move over to there. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient. Criteria of the Complicated Phase: * Need for oxygen supplementation (In patients with prior oxygen home therapy, clinically meaningful increase in need for oxygenation.) * paO2 at room air < 70 mmHg * SO2 at room air < 90 % * GOT or GPT > 5x ULN * New cardiac arrhythmia * New pericardial effusion >1cm * New heart failure with pulmonary edema, congestive hepatopathy or peripheral edema Remember: The Complicated Phase ends, if none of the criteria for the Complicated Phase is fulfilled anymore AND the patient is free of fever; then move to Recovery Phase. Also, as soon as one of the criteria of the Critical Phase are fulfilled, Complicated Phase ends; move over to Critical Phase. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient. Criteria of the Critical Phase: * Need for catecholamines * Life-threatening cardiac arrhythmia * Mechanical ventilation (invasive or non-invasive) * Liver failure with Quick< 50% * qSOFA >= 2 * Renal failure in need of dialysis Remember: The Critical Phase ends as soon as none of the criteria for the Critical Phase is fulfilled anymore AND the patient is free of fever. If the patient has died, it ends with the death of the patient. If the patient has died, do not report terminal values, i.e. those recorded after turning off life-support or heart rate "0" after death of the patient. Criteria of the Recovery Phase: *Improvement by at least one phase, i.e. Critical to Complicated or Complicated to Uncomplicated * Defervescence Remember: Uncomplicated asymptomatic patients enter recovery phase after 14 days of observation without disease progression No further progression or re-hospitalization If a text field can't be filled out, note 'ND' (for not determined).
- 6/29/21 - 1 form, 8 itemgroups, 41 items, 1 language
Itemgroups: Reasons for change of therapeutic goals from life-prolonging to palliative, Ethics consultation, Patient declined life-prolonging measures in case of life threatening diseases, Specialist palliative care setting, Specialist palliative care type, Specialist palliative care professionals involved, Drugs prescribed for symptom control (e.g. breathlessness, pain, death rattle), Is data entry for this section finished?
- 6/29/21 - 1 form, 11 itemgroups, 43 items, 1 language
Itemgroups: Lung ultrasound in emergency department for COVID-19 diagnosis, result, Initial therapeutic approaches for COVID-19 treatment in emergency department, respiratory / airway management in the emergency department, Oxygen inhalation, High flow nasal cannula, Mechanical ventilation settings, BIPAP settings, Mechanical ventilation: mean positive endexpiratory pressure (PEEP), Mechanical ventilation: mean fraction of inspired oxygen (FIO2), Information concerning admission at / discharge from emergency department, Is data entry for this section finished?
- 6/28/21 - 1 form, 11 itemgroups, 26 items, 1 language
Itemgroups: Diabetes Mellitus details, Hemoglobin A1c (HbA1c ) in blood, C-peptide in blood, Glucose in blood, C-peptide-to-Glucose Ratio (CGR) in blood, Insulin level in blood, Cortisol level in blood, Insulin treatment before SARS-CoV-2 detection (Baseline), Change of insulin scheme at the time of SARS-CoV-2 detection (Baseline), Oral antidiabetic treatment before SARS-CoV-2 detection (Baseline), Is data entry for this section finished?
- 6/28/21 - 1 form, 15 itemgroups, 80 items, 1 language
Itemgroups: RC: Respiratory findings, RC: Cardiovascular findings, RC: Neurological findings, RC: Further findings, RC: Vitals, RC: Lung ultrasound, RC: worst chest CT result, RC: Co/Superinfections, RC: Antibacterial treatment: Betalactams, RC: Antibacterial treatment: Macrolides, RC: Antibacterial treatment: Other antibacterial treatment, RC: Multiple sclerosis, severity after COVID-19 infection, RC: Pulmonary function test (Spirometry), RC: Deterioration of prior chronic pulmonary disease, RC: Is data entry for this section finished?