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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
    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
Selected data models

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- 4/30/20 - 1 form, 2 itemgroups, 35 items, 1 language
Itemgroups: Administrative Data, 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 Treatment-specific variables, clinical or administrative. To be collected 6-monthly or annually. 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.
- 11/11/20 - 1 form, 4 itemgroups, 41 items, 1 language
Itemgroups: Administrative Data, Chest X-ray, Cultures and clinical findings, Treatment and Outcome
Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Chest X-ray, Cultures and Clinical Findings, Treatment and Outcome) is to be filled out whenever applicable. In case of suspected pneumonia, pneumonia diagnosis must be confirmed by chest X-ray. Confirmed diagnosis of pneumonia must be recorded as an Adverse Event. A chest X-ray should be obtained for subjects who experience a lower respiratory tract infection requiring treatment with antibiotics for determination of the presence of pneumonia. Ancillary data should represent symptoms from initial presentation.
- 6/16/15 - 1 form, 8 itemgroups, 48 items, 1 language
Itemgroups: Header, Patient demographics, Data amendment, Section I - Surgery and Staging, Pathologic Tumor Staging, Section II - Surgical Complications, Section III - Lymph Node Dissection, Footer
- 6/8/15 - 1 form, 12 itemgroups, 65 items, 1 language
Itemgroups: Header, Patient demographics, Data amendment, Section I - Vital Status, Section II - Patient Characteristics, Section III - Therapy Administered, Dose Modifications, Assessment of medication, Dose Modifications, Section IV - Blood Pressure, MUGA Scanning, Section VI - Non-Protocol Therapy
- 1/1/15 - 1 form, 10 itemgroups, 78 items, 1 language
Itemgroups: Header section, Vital Status, Patient Characteristics, Therapy Administered - Melphalan, Therapy Administered - Prednisone, Therapy Administered - Thalidomide, Therapy Administered - Prophylaxis Treatment, Therapy Administered - Lenalidomide, Non-Protocol Therapy, Comments

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