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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
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Personal and Family History of Eye Disease and Treatments Protocol PhenX Toolkit

- 9/27/17 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: PhenX - personal and family history of eye disease and treatments protocol
Questions are asked to determine personal and family history of glaucoma, macular degeneration, cataract, and diabetic retinopathy. Questions are also asked to determine the participant’s history of laser and/or eye surgery for cataract, glaucoma and diabetic retinopathy. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

ICHOM Cataracts - Post-operative Clinical Form - Outcomes

- 4/30/20 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data, Post-operative visual status, Post-operative complications
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 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: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. By Mats Lundström et al. This ODM-file contains the post-operative clinical form. The items are to be filled in with clinical or administrative data, collected within three months after cataract surgery. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Cataracts - Pre- and intraoperative Clinical Form

- 9/20/21 - 1 form, 8 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data, Demographic factors, Baseline visual status, Ocular Comorbidities, Prior ophthalmic interventions, Technical Factors, Treatment Variables, Intra-operative Complications
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 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: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. by Mats Lundström et al. This ODM-file contains the pre-operative and intra-operative clinical Form. The items are to be filled in with clinical or administrative data, collected pre- or intraoperatively. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Cataracts - Patient-Reported Visual Function (pre- and post-operative)

- 4/30/20 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, Patient-reported visual function
CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 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: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. By Mats Lundström This ODM-file contains pre- and post-operative patient froms. To be filled in by patient prior to and within 3 months after surgery. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Macular Degeneration - Each Clinical Visit - Clinical Form

- 4/30/20 - 1 form, 8 itemgroups, 35 items, 1 language
Itemgroups: Administrative Data, Clinical status, Other ocular treatments, Treatment variables, Burden of treatment, Complications of treatment, Disease activity, Visual functioning and health related quality of life
ICHOM Macular Degeneration data collection Version 3.0.1 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 Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Each Clinical Visit - Clinical Form. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Retinal Digital Photography Protocol PhenX Toolkit

- 9/27/17 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: PhenX - retinal digital photography protocol
Two 45¿ digital retinal images (Field 1 and 2) will be taken of each eye of the participant using the Canon Non-Mydriatic Retinal CR6-45NM camera with a digital Canon D60 camera back (6.3 megapixels per image). Field 1 is centered on the optic disc and Field 2 is centered on the macula, providing photographic documentation of the optic disc, macula, and substantial portions of the temporal arcades. These photographs may be graded for retinal microvascular characteristics, including focal arteriolar narrowing, arterio-venous nicking, retinopathy (e.g., microaneurysms, retinal hemorrhages) and other conditions. In addition, generalized arteriolar narrowing is quantified using a computer assisted measure of retinal vascular caliber. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

ICHOM Macular Degeneration - Annually - Clinical Form

- 4/30/20 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Administrative Data, Medical History
ICHOM Macular Degeneration data collection Version 3.0.1 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 Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Annually - Clinical Form. It has to be filled in annually from baseline. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Macular Degeneration - Baseline - Patient-reported

- 4/30/20 - 1 form, 3 itemgroups, 4 items, 1 language
Itemgroups: Administrative Data, Demographics, Visual functioning and health related quality of life
ICHOM Macular Degeneration data collection Version 3.0.1 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 Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Baseline - Patient-reported form. It has to be filled in at Patient's entrance into outcome tracking system for Macular Degeneration. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Macular Degeneration - Follow-up - Patient-reported

- 4/30/20 - 1 form, 2 itemgroups, 3 items, 1 language
Itemgroups: Administrative Data, Visual functioning and health related quality of life
ICHOM Macular Degeneration data collection Version 3.0.1 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 Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Follow-up - Patient-reported form. It has to be filled in annually from baseline. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Macular Degeneration - Baseline - Clinical Form

- 4/30/20 - 1 form, 5 itemgroups, 28 items, 1 language
Itemgroups: Administrative Data, Demographics, Baseline Functional Status, Baseline clinical status, Associated clinical history
ICHOM Macular Degeneration data collection Version 3.0.1 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 Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Baseline - Clinical Form. It has to be filled in at Patient's entrance into outcome tracking system for Macular Degeneration. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

NINDS CDE OCT Analysis – Stratus Retinal Thickness Report Multiple Sclerosis - OCT Analysis – Stratus Retinal Thickness Report

- 7/24/16 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: OCT Retinal Thickness Right orbit, OCT Retinal Thickness Left orbit
NINDS Common Data Elements, Multiple Sclerosis OCT Analysis – Stratus Retinal Thickness Report Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

NINDS CDE OCT Analysis – RNFL Thickness Analysis Multiple Sclerosis - OCT Analysis – RNFL Thickness Analysis

- 7/24/16 - 1 form, 2 itemgroups, 26 items, 1 language
Itemgroups: OCT Nerve fiber layer of right retina, RNFL Thickness Analysis Left orbit
NINDS Common Data Elements, Multiple Sclerosis OCT Analysis – RNFL Thickness Analysis Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

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