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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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24412 Search results.

eWundbericht (electronic wound report) - Body - Therapie (therapy)

- 5/23/17 - 4 forms, 9 itemgroups, 26 items, 2 languages
Itemgroups: Treatment goals, Treatment plan, Equipment and Resources, Healing and therapy process, Hygiene activity, Wound protection, Therapy, causal, Education of patient and relatives, Treatment results, preliminary
eWundbericht Prof. Dr. Ursula Hübner Forschungsgruppe Informatik im Gesundheitswesen Hochschule Osnabrück Fakultät Wirtschafts- und Sozialwissenschaften http://wiki.hl7.de/index.php/EWundbericht_(Projekt)

Body - Anamnese (medical history)

11 itemgroups, 36 items

Body - Diagnose (diagnosis)

2 itemgroups, 6 items

Header

3 itemgroups, 18 items

GSK 100262 Clinical Study Report Demography

- 5/17/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Date of assessment, Demography
GSK 100262 Clinical Study Report Demography

Eligibility Leukemia, Myeloid NCT00611247

- 3/7/17 - 1 form, 2 itemgroups, 20 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00611247

Eligibility Dementia NCT00294307

- 3/1/17 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers; ODM derived from: https://clinicaltrials.gov/show/NCT00294307

NRS pain

- 4/13/21 - 1 form, 1 itemgroup, 3 items, 2 languages
Itemgroup: Pain NRS
Numerical Rating Scale Pain

NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template - 2748814v1.0 - NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template

- 4/13/21 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Mandatory Adverse Event Questions, Conditional Adverse Event Questions, Optional Adverse Event Questions, Optional Serious Adverse Event Questions
The collection of CDEs used in the Adverse Events/Serious Adverse Events module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4D0BC7DD-57DD-63BE-E044-0003BA3F9857

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069 - Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

- 5/24/16 - 4 forms, 7 itemgroups, 31 items, 1 language
Itemgroups: Administration and Instructions for CRF Completion, Demographic Data, Blood pregnancy test, Testing for JC virus antibodies, Medical History, MS Medical History, MS Treatment History
Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

NON-MS Treatment and symptomatic MS Treatment

4 itemgroups, 19 items

Blood samples for safety laboratory tests

4 itemgroups, 16 items

Eligibility

3 itemgroups, 31 items

Quality assurance Heart Transplant Heart Assist Devices Artificial Heart - Transplant (AQUA)

- 3/17/16 - 1 form, 8 itemgroups, 49 items, 2 languages
Itemgroups: Heart Transplant Heart Assis Devices Artificial Heart - Transplant, Empfängerdaten, Risikoprofil, Immunsuppression initial, Spenderdaten, Befunde Spender, Operation, Postoperativer Verlauf
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: HTXM-T Specification 2015 V02

EHR4CR data inventory for patient identification and recruitment

- 5/21/15 - 1 form, 10 itemgroups, 150 items, 2 languages
Itemgroups: Demographics, Medical History, Medical device, Diagnosis, Procedure, Findings, Laboratory Findings, Medication, Scores&Classifications, Patient Characteristics
EHR4CR data inventory for patient identification and recruitment Referenced by https://www.ncbi.nlm.nih.gov/pubmed/25991199

Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 1/9/15 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Header, Endocrine therapy, Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

ICHOM Coronary Artery Disease - Peri-Inverventional Clinical Form

- 4/30/20 - 1 form, 8 itemgroups, 46 items, 1 language
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.

register Finish Cancer Registry cancer - register

- 3/15/21 - 1 form, 6 itemgroups, 49 items, 2 languages
Itemgroups: CancerRegistry, Previous cancer, Current Neoplasm, Treatment, surgery, radiotherapy
Data set from the Finish cancer registry, with friendly permission (http://www.cancer.fi/syoparekisteri/en/registration/forms-and-instructions/)