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LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Liver cirrhosis sub-cohort

- 06/05/21 - 1 modulo, 10 itemgroups, 48 elementi, 1 linguaggio
Itemgroups: Etiology of liver cirrhosis, Hepatic decompensation (Ascites, Variceal bleeding, Hepatic encephalopathy), Reasons of consultation / hospitalisation, Liver transplantation waiting list, Recent bacterial infection, Child-Pugh Score at Baseline, MELD Score, Acute-on-chronic liver failure during the SARS-CoV-2 infection, Recent medication, Is data entry for this section finished?
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/. This document is for the liver cirrhosis sub-cohort. If a text field can't be filled out, note 'ND' (for not determined).

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Liver cirrhosis sub-cohort

- 16/07/21 - 23 moduli, 10 itemgroups, 48 elementi, 1 linguaggio
Itemgroups: Etiology of liver cirrhosis, Hepatic decompensation (Ascites, Variceal bleeding, Hepatic encephalopathy), Reasons of consultation / hospitalisation, Liver transplantation waiting list, Recent bacterial infection, Child-Pugh Score at Baseline, MELD Score, Acute-on-chronic liver failure during the SARS-CoV-2 infection, Recent medication, Is data entry for this section finished?
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).

Baseline I

39 itemgroups 280 elementi

Diagnostics (General virological and laboratory findings for all phases)

46 itemgroups 320 elementi

Immunosuppressive premedication

31 itemgroups 90 elementi

HIV sub-cohort

13 itemgroups 55 elementi

Diabetes mellitus sub-cohort

11 itemgroups 26 elementi

Cardiovascular sub-cohort

3 itemgroups 9 elementi

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Critical Phase

- 23/06/21 - 1 modulo, 32 itemgroups, 188 elementi, 1 linguaggio
Itemgroups: CR: Cardiovascular findings, CR: Respiratory findings, CR: Other severe organ damage, CR: Fever, CR: Vitals, CR: Lung ultrasound, CR: worst chest CT result, CR: Antivirals, CR: Antibiotics, CR: Antifungals, CR: Immunomodulators, CR: Cardiovascular medication, CR: Non-oral anticoagulants, CR: Oral anticoagulants, CR: Platelet aggregation inhibition, CR: Further anticoagulation / platelet aggregation inhibition, CR: Other COVID-19 related therapy, CR: ICU treatment, CR: Mechanical ventilation, CR: Other extracorporeal support, CR: Co/Superinfections, CR: Antibacterial treatment: Betalactams, CR: Antibacterial treatment: Macrolides, CR: Other antibacterial treatment, CR: Complications, Thrombotic and thromboembolic manifestations, CR: Complications, Neurological, Ischemic stroke: TOAST classification, Ischemic stroke: NIHSS score in acute phase, CR: Complications, Other, Acute kidney injury (KDIGO criteria), CR: SOFA score, CR: Is data entry for this section finished?
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/. This document is for data aggregated in the critical phase. If a text field can't be filled out, note 'ND'. 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, i.e. those recorded after turning off life-support or heart rate "0" after death of the patient.

Study SHIP-TREND_TREND1_PIA - t1.gastro

- 26/10/24 - 26 moduli, 1 ItemGroup, 22 elementi, 2 lingue
ItemGroup: t1.gastro
SHIP Study https://doi.org/10.1093/ije/dyac034

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 2: OUTCOME CASE REPORT FORM

- 11/08/21 - 1 modulo, 7 itemgroups, 195 elementi, 1 linguaggio
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.

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 1: PRESENTATION/ADMISSION CASE REPORT FORM

- 03/08/21 - 1 modulo, 10 itemgroups, 188 elementi, 1 linguaggio
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.

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