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  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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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ICHOM Chronic Kidney Disease - Baseline Characteristics, Baseline Condition Factors and Treatment-specific Variables (administrative / clinical)

- 4/30/20 - 1 modulo, 4 itemgroups, 43 elementi, 1 linguaggio
Itemgroups: Patient ID, Baseline Characteristics, Baseline Condition Factors, Treatment-specific
CHRONIC KIDNEY DISEASE DATA COLLECTION REFERENCE GUIDE Version 1.0.0 Revised October 25th, 2017 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: Chronic Kidney Disease Stage G3a/A3 | Chronic Kidney Disease StageG 3b/A2/A3 | Chronic Kidney Disease Stage G4 | Chronic Kidney Disease Stage G5 (KDIGO 2012 Stages) Treatment Approaches: Pre-RRT = Pre-Renal Replacement Therapy | HD = Haemodialysis | PD = Peritoneal Dialysis | Tx = Renal Transplantation | CC = Conservative Care This ODM-file contains Baseline Characteristics, Baseline Condition factors and Treatment-specific variables, clinical or administrative. To be collected at Baseline Visit. Surveys used: The OptumTM SF-36v2® Health Survey: The SF-36v2 Health Survey requires a license agreement prior to the use or reprodution of the tool. Information on how to obtain a license can be found here: bit.ly/SF36LIC . The scoring guide for the SF36v2 is only available upon a license agreement being made. Due to the requirement of a license the Score cannot be found in this version of the standard set. PROMIS-Global Health and PROMIS-29: Free for use in clinical practice and a license is not required. Information http://www.nihpromis.org/measures/translations . The scoring guides for the two PROMIS Scores can be found at bit.ly/PROMISGLOBALSCORE and bit.ly/PROMIS29SCORE . RAND-36: Free for use in clinical practice and a license is not required. The RAND-36 is available in English and Arabic. https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html . The Scoring guide can be found at bit.ly/RAND36Score . Publication: Verberne WR, Das-Gupta Z, Allegretti AS, et al. Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease: A Report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. American Journal of Kidney Diseases. Volume 73, Issue 3, 2019, Pages 372-384, ISSN 0272-6386, https://doi.org/10.1053/j.ajkd.2018.10.007 ICHOM was supported for the Chronic Kidney Disease Standard Set by NSW Agency for Clinical Innovation, Providence Health and Services, ERCPA, santeon and Dutch Kidney Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Baseline Genzyme Chronic Kidney Disease EudraCT 2005-003233-41

- 9/16/16 - 1 modulo, 7 itemgroups, 41 elementi, 1 linguaggio
Itemgroups: Patient administration, Inclusion criteria, Vital signs, Physical Exam, Laboratory Evaluations, Concomitant Medication, Adverse Events
An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis Name of Sponsor: Genzyme Europe BV Country: Netherlands https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A

ICHOM Lung Cancer - Baseline - Clinical Form

- 4/30/20 - 1 modulo, 5 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Administrative data, Demographic factors, Baseline Clinical Factors, Baseline tumor factors, Degree of health
ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 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 Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains Baseline - Clinical Form. It depicts first doctor's visit. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaire. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Lung Cancer - Baseline - Patient-Reported Form

- 4/30/20 - 1 modulo, 4 itemgroups, 22 elementi, 1 linguaggio
Itemgroups: Administrative Data, Demographic factors, Baseline Clinical factors, Degree of health
ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 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 Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains the Baseline - Patient-Reported Form. It depicts first doctor's visit. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Multiple Myeloma and Plasma Cell Neoplasm null Follow-Up - S0522 Baseline AND Follow-up Tumor Assessment Form for Multiple Myeloma - 2456693v1.0 - S0522 Baseline AND Follow-up Tumor Assessment Form for Multiple Myeloma

- 1/9/15 - 1 modulo, 6 itemgroups, 39 elementi, 1 linguaggio
Itemgroups: Header, Serum M-Protein, Urine M-Protein, Bone Marrow Plasmacytosis, Bone Disease and Anemia, Comments
S0522 Baseline AND Follow-up Tumor Assessment Form for Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EE5FB2C-6B6F-0581-E044-0003BA3F9857

Response - Multiple Myeloma - Baseline Disease Assessment Form - 2274587v3.0 - Multiple Myeloma - Baseline Disease Assessment Form

- 1/9/15 - 1 modulo, 8 itemgroups, 71 elementi, 1 linguaggio
Itemgroups: CRF Header, Myeloma: Form Administration, Myeloma: Assessment Reporting Interval, Myeloma: Protein Studies, Myeloma: Peripheral Blood Hematology/Chemistry, Myeloma: Bone and Marrow Assessment, Myeloma: Soft Tissue Plasmacytoma, Comments
Multiple Myeloma - Baseline Disease Assessment Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6E3244C-90DF-56DA-E034-0003BA12F5E7

Baseline Laboratory test form pancreatic cancer SWOG S0205 NCT00075686

- 9/24/15 - 1 modulo, 2 itemgroups, 35 elementi, 1 linguaggio
Itemgroups: Header, BASELINE LAB TEST RESULTS
BASELINE LABORATORY TEST RESULT FORM - 2307541v3.0 SOUTHWEST ONCOLOGY GROUP S0205 BASELINE LABORATORY TEST RESULT FORM S0205 Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F2FD3D46-E071-663C-E034-0003BA3F9857

E4A08 Baseline Disease Assessment Form NCT01078454

- 6/16/15 - 1 modulo, 15 itemgroups, 111 elementi, 1 linguaggio
Itemgroups: Header, Data amendment, Protein Measurements, Urine Sample, Serum Quantitative Immunoglobins, Other Biopsy, Bone Marrow, Bone Involvement, Cardiac Assessment, Liver Assessment, GI Tract Assessment, Nerve Assessment, Kidney Assessment, Peripheral Blood Chemistry, Comments
E4A08 Baseline Disease Assessment Form NCT01078454 Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7BCCA614-5186-15BB-E040-BB89AD4326D3

Initial assessment Leukemia AML-AZA in elderly patients NCT00915252

- 9/20/21 - 1 modulo, 10 itemgroups, 80 elementi, 2 lingue
Itemgroups: Patient data, Clinical findings, Comorbidities, Differential blood count, Clinical Chemistry, Knochenmarkuntersuchung, Zytologie, FAB-Klassifikation, Molekulargenetik, Unterschrift
A randomized, multi-center phase II trial to assess the efficacy of 5-azacytidine added to standard primary therapy in elderly patients with newly diagnosed AML NCT00915252

Bogen 1 Einschluss Randomisierung DRKS00005243 NCT01657604 Chronic Myeloid Leukemia - Bogen 1 Einschluss Randomisierung

- 9/20/21 - 1 modulo, 16 itemgroups, 106 elementi, 2 lingue
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
http://clinicaltrials.gov/ct2/show/NCT01657604

NSABP PROTOCOL C-08: BASELINE HYPERTENSION STATUS FORM NCT00096278

- 6/9/15 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Header, Blood pressure assessment
NSABP PROTOCOL C-08: BASELINE HYPERTENSION STATUS FORM NCT00096278 Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7FA2647-04C2-625B-E034-0003BA12F5E7

Leukemia NCT01041703 Treatment - E2906 Baseline Data Form - Step 3 - 3177877v1.0 - E2906 Baseline Data Form - Step 3

- 1/9/15 - 1 modulo, 8 itemgroups, 61 elementi, 1 linguaggio
Itemgroups: Header Module, Reporting Period, Header, Pre-registration Evaluation, Bone Marrow, Pre-registration Hematology/Chemistry, Baseline Abnormalities, Footer Module
E2906 Baseline Data Form - Step 3 Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9805CBE8-D299-9B64-E040-BB89AD431E80

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