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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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- 6/8/21 - 1 form, 46 itemgroups, 320 items, 1 language
Itemgroups: Baseline: SARS-CoV-2, Virological testing types, Baseline: PCR: Site of first detected SARS-CoV-2, Baseline: PCR: Tested target at first positive SARS-CoV-2 testing, BL: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, Baseline: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, Baseline: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, Baseline: Laboratory values, Baseline: Blood Count, Baseline: Other laboratory results, Baseline: Urine test, UC: SARS-CoV-2, Virological testing types, UC: PCR Sites, UC: PCR pharyngeal swab at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, UC: Viral coinfections, UC: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, UC: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, UC: Laboratory values, UC: Blood count, UC: Other laboratory results, CO: SARS-CoV-2, Virological testing, CO: PCR Sites, CO: PCR pharyngeal swab at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, CO: Viral coinfections, CO: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, CO: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, CO: Laboratory values, CO: Blood count, CO: Other laboratory results, CR: SARS-CoV-2, Virological testing types, CR: PCR Sites, CR: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, CR: Viral coinfections, CR: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, CR: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, CR: Laboratory values, CR: Blood count, CR: Other laboratory results, RC: SARS-CoV-2, Virological testing types, RC: PCR Sites, RC: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, RC: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, RC: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, RC: Laboratory values, RC: Blood count, RC: Other laboratory results, Diagnostics: Is data entry for this section finished?
- 4/19/21 - 1 form, 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
- 4/13/21 - 1 form, 8 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Disutility of care, Symptoms, functioning and quality of life, Frailty, Time spent in hospital, Overall survival, Place of death
ICHOM Older Person data collection Version 1.0.4 Revised: July 12, 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. For Older Persons, the following treatment approaches are covered by our Standard Set. Treatment approaches: These have not been defined due to the wide range of management options and interventions for an older population. A number of potentially inappropriate medications have been listed as ‘medication variables’. This document contains the Baseline - Clinician- and Administrative-reported form. It has to be filled in at patient's entry into the set. Collecting Patient-Reported Outcome Measures: Medical Outcomes Study: 36-Item Short Form Survey Instrument Version 1 (SF-36). http://www. rand.org/health/surveys_tools/mos/mos_ core_36item_survey.html UCLA 3-Item Loneliness Scale. Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT (2004) A short scale for measuring loneliness in large surveys: Results from two population-based studies. Res Aging 26(6):655–672. Barthel Index. Mahoney FI, Barthel D. “Functional evaluation: the Barthel Index.” Maryland State Med Journal 1965;14:56-61. ASCOT Toolkit. As a license agreement is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Canadian Study on Health & Aging Clinical Frailty Scale. As a permission is needed for use of this questionnaire, only the total score will be included in this version oh the standard set. Reference: Akpan A, Roberts C, Bandeen-Roche K, et al. Standard set of health outcome measures for older persons. BMC Geriatr. 2018;18(1):36. Published 2018 Feb 2. doi:10.1186/s12877-017-0701-3 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797357/) The Standard set of ICHOM was supported by NHS England. For this version of the standard set, semantic annotation with UMLS CUIs has been added.
- 4/13/21 - 1 form, 44 itemgroups, 314 items, 2 languages
Itemgroups: Header Module, Registration Header, Submission Details, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynecological status, Patient Status, ECG, Cardiac Monitoring, Local Her2 Results, Hormonal Receptor Status, History Of Primary Breast Cancer, History Of Primary Cancer (continued), Sentinel Node Sampling, Most Extensive Primary Surgery, Axillary Node Dissection, Chemotherapy, Previous Or Current Cardiovascular Disease, ECG, Translational Research, Central Her2 Testing Form - FISH, Central Her2 Testing Form - IHC, Radiotherapy, Hormone therapy, Concomitant Treatment, Administration of Study Drug, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, Patient Status, Cardiac Monitoring, Mammogram, Hematoly and Biochemistry, Survival Follow-Up, Treatment Completion, Additional Comments , Death Form
- 4/13/21 - 1 form, 47 itemgroups, 279 items, 2 languages
Itemgroups: ChecklistDemographics, Header Module, Registration Header, Registration characteristics, Contact Person For Pathology Results, Patient Demographics, Eligibility Screening Form, Randomization, Informed consent, Gynaecological examination, Patient Status, ECG, Cardiac Monitoring, Local Her2 Results, Hormonal Receptor Status, History Of Primary Breast Cancer, History Of Primary Cancer (continued), Sentinel Node Sampling, Most Extensive Primary Surgery, Axillary Node Dissection, Chemotherapy, Previous Or Current Cardiovascular Disease, ECG, Translational Research, Central Her2 Testing Form - FISH, Central Her2 Testing Form - IHC, Radiotherapy, Hormonetherapy, Concomitant Treatment, Administration of Study Drug, Post-Event-Treatment, Chemotherapy, Targeted Therapy, Hormonetherapy, Radiotherapy, Surgery, Adverse Event (AE), Second Primary Malignancy and Contralateral Breast Cancer, On Study - Years 6, 7, 8, 9, and 10, Patient Status, Cardiac Monitoring, Mammogram, Hematoly and Biochemistry, Survival Follow-Up, Treatment Completion, Additional Comments , Death Form
- 3/15/21 - 1 form, 16 itemgroups, 106 items, 2 languages
Itemgroups: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Randomisierung, Laborwerte, Molekularbiologie, BCR-ABL-Transkripte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Vor- und Begleiterkrankungen, Medikamente, Knochenmarkanalyse, Zytogenetik, Unterschrift
- 3/15/21 - 1 form, 16 itemgroups, 106 items, 2 languages
Itemgroups: Adiminstrative Daten I, Geburtsdatum, Adiminstrative Daten II, Randomisierung, Laborwerte, Molekularbiologie, BCR-ABL-Transkripte, Quality of Life, klinischer Befund I, Blutdruck, klinischer Befund II, Vor- und Begleiterkrankungen, Medikamente, Knochenmarkanalyse, Zytogenetik, Unterschrift
- 3/15/21 - 3 forms, 25 itemgroups, 116 items, 2 languages
Itemgroups: Ein-Ausschlusskriterien, Patientendaten, Krankheitsspezifische Angaben, EDSS-Score vor 12 Monaten, Heutige Scores der Funktionssysteme, Frühere verlaufsmodifizierende MS-Therapien, Aktuelle MS-Therapie, WeitereErkrankungen, Herz- / Kreislauferkrankungen, Stoffwechselerkrankungen, Infektionserkrankungen, Gastrointestinale Erkrankungen, Neurologische / Psychiatrische Erkrankungen, Allergien, Urogenitale Erkrankungen, Autoimmunerkrankungen, Blutbild / Labor, Allgemeine Symptome, Operation, Krebserkrankungen, Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?, Andere Erkrankung, Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt, Schwangerschaft, Biologisches Material (z.B. Blut)

Baseline Pregnancy Part 1

5 itemgroups, 24 items

Baseline Pregnancy Part 2

5 itemgroups, 21 items
- 3/15/21 - 1 form, 6 itemgroups, 62 items, 1 language
Itemgroups: Administrative Data, Lifestyle interventions measured, Baseline health status, Health status measured at baseline, Long-term consequences of disease, Complications of treatment
ICHOM Atrial Fibrillation data collection Version 1.0.0 Published: 3rd April 2019 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. The following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Atrial Fibrillation Population: An adult (≥ 18 years) diagnosed with atrial fibrillation (including symptomatic patients) Treatment approaches: Management of cardiovascular risk factors and institution of preventive therapy | Pharmacological management| Non-Pharmacological management Excluded populations: Children and Young persons below 18 years Excluded conditions: Patients diagnosed with cardiotoxic acute atrial fibrillation This document contains the Baseline – Clinical Form. It has to be filled in at index event. Collecting Patient-Reported Outcome Measure: PROMIS Global Health. As there is an official distribution site, the questions of this questionnaire will not be included in this version of the standard set. For more information see: https://bit.ly/29aOZu9 Alternatively Optum SF-12, AFEQT, AFSS or WPAI:GH may be used. Montreal Cognitive Assessment Test. For more information see: https://www.mocatest.org/ The Standard set of ICHOM was supported by the BigData@Heart organization. Publication: Seligman WH, Das-Gupta Z, Jobi-Odeneye AO, Arbelo E, Banerjee A, Bollmann A, et al. Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group. Eur Heart J. 2020 Jan 29; 10.1093/eurheartj/ehz871 For this version of the standard set, semantic annotation with UMLS CUIs has been added.