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Study SHIP-TREND_TREND1_PIA - t1.signinfect2

- 26.10.24 - 26 Formulare, 1 Itemgruppe, 6 Datenelemente, 2 Sprachen
Itemgruppe: t1.signinfect2
SHIP Study https://doi.org/10.1093/ije/dyac034

t1.pia_sf12

1 Itemgruppe 12 Datenelemente

t1.symptomresp1

1 Itemgruppe 32 Datenelemente

t1.allergyresp

1 Itemgruppe 24 Datenelemente

t1.pia_solidar

1 Itemgruppe 7 Datenelemente

t1.piacontact

1 Itemgruppe 37 Datenelemente

t1.pia_impact

1 Itemgruppe 75 Datenelemente

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - Module 2: Daily Case Report Form (CRF)

- 18.01.21 - 1 Formular, 5 Itemgruppen, 108 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Signs and symptoms Part 1, Therapy, Signs and symptoms - Part 3, Laboratory Results
This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Complete on the day of admission or first COVID-19 investigation, and on the first day of ICU admission (if different from day of admission). In addition, depending on available resources, complete every day for a maximum of 14 days, or for days when biochemical results are available. 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/

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

- 03.08.21 - 1 Formular, 10 Itemgruppen, 188 Datenelemente, 1 Sprache
Itemgruppen: 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.

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

- 11.08.21 - 1 Formular, 7 Itemgruppen, 195 Datenelemente, 1 Sprache
Itemgruppen: 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.

Virus finder - F.1

- 24.06.22 - 1 Formular, 5 Itemgruppen, 57 Datenelemente, 3 Sprachen
Itemgruppen: Screening Tool, Symptoms, Optional Questions, Data use for future research, Informed Consent
Mischung Beispielfragebogen von Virusfinder und Screening-Tool-Vorschläge von COMPASS vom 22 Okt. 2020, vs3.1 https://www.virus-finder.de Research study of Heidelberg University Hospital and Heidelberg University New Corona testing strategies for the general public Die Studie wurde von einem Team der Universität Heidelberg im Rahmen des bundesweiten Forschungsnetzes zur angewandten Surveillance und Testung durchgeführt, das wiederum zum Nationalen Forschungsnetzwerk der Universitätsmedizin zu Covid-19 gehört. Sie wurden von den örtlichen Gesundheitsämtern unterstützt und vom Bundesministerium für Bildung und Forschung finanziert. "Das neuartige Coronavirus, wissenschaftlich SARS-CoV-2 genannt, stellt uns alle vor große Herausforderungen und wir mussten uns alle in den letzten Monaten wegen der Pandemie stark einschränken. Aktuell wird auf steigende Fallzahlen in der Regel mit einer Verschärfung der Maßnahmen reagiert. Das liegt vor allem daran, dass auch viele Personen ohne Symptome das Virus unerkannt weitertragen und damit nicht rechtzeitig lokal begrenzt reagiert werden kann. Dafür bräuchte es eine Strategie, die frühzeitig auch infizierte Personen ohne Symptome erkennen kann. Mit der Corona-Forschungsstudie erproben wir neue Verfahren hierzu. Im Zeitraum vom 18. November bis 08. Dezember [2020] werden ca. 28.000 Einwohner im Rhein-Neckar-Raum von uns ein Einladungsschreiben zur Teilnahme der Studie erhalten. Die Einladungen werden dabei gleichmäßig verteilt über die Tage verschickt. Sollten Sie in diesem Zeitraum kein Einladungsschreiben erhalten, können Sie leider nicht an der Studie teilnehmen und wir bitten Sie, von Anfragen rund um eine mögliche Teilnahme an der Studie abzusehen. Die Probandinnen und Probanden, d. h. die Menschen, die an der Corona-Forschungsstudie teilnehmen können, wurden dafür zufällig aus den Einwohnermeldeämtern der Gemeinden im Rhein-Neckar-Raum ausgewählt. Solche sogenannten Einwohnermeldestichproben sind nach §46 des Bundesmeldegesetzes zulässig, falls die Studie im öffentlichen Interesse stattfindet." Vielen Dank an Dr. Andreas Deckert für die Erlaubnis zum Upload.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Fatal outcome details

- 28.06.21 - 1 Formular, 4 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Place of death, Contacts in context of death phase, Autopsy, 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: 21.03.2021 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 context of death. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Immunosuppressive premedication

- 07.05.21 - 1 Formular, 31 Itemgruppen, 90 Datenelemente, 1 Sprache
Itemgruppen: Antibodies: Anti-CD20, Antibodies: CD-22, Antibodies: CD-38, Antibodies: CD-52, Antibodies: Anti-CD79b, Antibodies: BLyS, Antibodies: CD19-BiTE, Antibodies: Complement inhibitors, Antibodies: Integrin antagonists, Antibodies: Interleukin inhibitors, Antibodies: TNF-alpha inhibitors, Other Antibodies, Inhibitors: Co-stimulation inhibitors, Inhibitors: Calcineurin inhibitors, Inhibitors: Interleukin inhibitor, Inhibitors: JAK inhibitors, Inhibitors: mTOR inhibitors, Inhibitor: PDE-4-inhibitor, Other Inhibitors, Recent: Checkpoint inhibitors, Chemotherapeutics: Antimetabolites, Chemotherapeutics: Cytostatics, Other Chemotherapeutics, Corticosteroids, Other immunosuppressive regimens: Fumarate, Other immunosuppressive regimens: Immunoglobulines, Other immunosuppressive regimens: Interferon, Immunosuppressive regimens: Other Multiple Sclerosis drugs, Other immunosuppressive regimens, Immunosuppressive drugs: Underlying disease, 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 immunosuppressive premedication. If a text field can't be filled out, note 'ND'.

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

- 01.07.21 - 1 Formular, 6 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: Chronic pulmonary disease other than asthma and copd, Oxygen ventilation/ oxygen support before SARS-CoV-2 detection, Regular use of inhaler, Prior pulmonary function (Spirometrie) before COVID-19, Pulmonary function (Spirometrie) at diagnosis of COVID-19, 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: 21.03.2021 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 pulmonary sub-cohort. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Ethics and palliative care details

- 29.06.21 - 1 Formular, 8 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: 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?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 21.03.2021 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 ethics and palliative care details. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Emergency care details

- 29.06.21 - 1 Formular, 11 Itemgruppen, 43 Datenelemente, 1 Sprache
Itemgruppen: 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?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 21.03.2021 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 Emergency care details. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Diabetes mellitus sub-cohort

- 28.06.21 - 1 Formular, 11 Itemgruppen, 26 Datenelemente, 1 Sprache
Itemgruppen: 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?
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 Diabetes mellitus sub-cohort. If a text field can't be filled out, note 'ND'.

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

- 28.06.21 - 1 Formular, 3 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Drugs at time of SARS-CoV-2 detection (Baseline), Heart failure, 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 cardiovascular sub-cohort. If a text field can't be filled out, note 'ND'.

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