ID
40646
Descripción
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.
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Versiones (4)
- 24/7/19 24/7/19 -
- 30/7/19 30/7/19 -
- 2/8/19 2/8/19 - Sarah Riepenhausen
- 30/4/20 30/4/20 - Sarah Riepenhausen
Titular de derechos de autor
ICHOM
Subido en
30 de abril de 2020
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Creative Commons BY-NC 4.0
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ICHOM Macular Degeneration
Each Clinical Visit - Clinical Form
- StudyEvent: ODM
Descripción
Clinical status
Alias
- UMLS CUI-1
- C0449440
Descripción
INCLUSION CRITERIA: ALl patients TIMING: Baseline, Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0024437
- UMLS CUI [1,2]
- C0332307
Descripción
SUPPORTING DEFINITION: Geographic atrophy is defined as an area of hypopigmentation or hyperfluorescence of at least 250 μm in its minimum linear dimension with 2 of the 3 following characteristics: (i) circular shape, (ii) sharp borders, or (iii) visibility of choroidal vessels within the area of geographic atrophy INCLUSION CRITERIA: ALl patients TIMING: Baseline, Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1536085
Descripción
SUPPORTING DEFINITION: Abnormal thickening of the subretinal tissue complex (material between Bruch's membrane and outer retina) anywhere in the macular area INCLUSION CRITERIA: ALl patients TIMING: Baseline, Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0423434
Descripción
SUPPORTING DEFINITION: Discrete elevations of the retinal pigment epithelium (RPE) anywhere in the macular area with solid (fibrovascular or haemorrhagic PED) or fluid (serous PED) matter below the corresponding retinal pigment epithelium INCLUSION CRITERIA: ALl patients TIMING: Baseline, Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0339546
Descripción
SUPPORTING DEFINITION: Solid (fibrovascular or haemorrhagic) or fluid (Serous) PED below the corresponding retinal pigment epithelium INCLUSION CRITERIA: All patients If answered '1' or '2' on Pigment epithelial detachment (PED) TIMING: Baseline, Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0339546
- UMLS CUI [1,2]
- C0332307
Descripción
Other ocular treatments
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0015392
Descripción
INCLUSION CRITERIA: ALl patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2939459
Descripción
INCLUSION CRITERIA: All patients If answered 'yes' on cataract surgery (CATSURGTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2939459
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0579255
Descripción
INCLUSION CRITERIA: All patients If answered 'yes' on YAG laser capsulotomy (YAGLASERTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0579255
Descripción
SUPPORTING DEFINITION: i.e. for macular edema or diabetic retinopathy INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0438670
Descripción
INCLUSION CRITERIA: All patients If answered 'yes' on retinal laser (RETLASERTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0438670
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single Answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0042903
Descripción
INCLUSION CRITERIA: All patients If answered 'yes' on vitrectomy (VITRTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042903
Descripción
SUPPORTING DEFINITION: i.e. graft, pterygium INCLUSION CRITERIA: All patients TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Single Answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0197402
Descripción
INCLUSION CRITERIA: All patients If answered 'yes' on corneal surgery (CORNSURGTX) TIMING: Each clinical visit to check for change REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0197402
Descripción
Treatment variables
Alias
- UMLS CUI-1
- C0087111
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0549184
- UMLS CUI [1,2]
- C0087111
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2,1]
- C0013216
- UMLS CUI [2,2]
- C1566537
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2,1]
- C0013216
- UMLS CUI [2,2]
- C0796392
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2,1]
- C0013216
- UMLS CUI [2,2]
- C1531015
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2,1]
- C0013216
- UMLS CUI [2,2]
- C1134659
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2]
- C1444685
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2]
- C0940918
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2]
- C0441510
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2,1]
- C0035331
- UMLS CUI [2,2]
- C1522449
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2,1]
- C0442379
- UMLS CUI [2,2]
- C0879037
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0087111
- UMLS CUI [2]
- C0197770
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0087111
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical or administrative data TYPE: Multiple answers Separate multiple entries with "";""
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0439673
- UMLS CUI [1,2]
- C0087111
Descripción
Burden of treatment
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C2828008
Descripción
Complications of treatment
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0009566
Descripción
Severe intra-ocular inflammation within 3 months of last intra-ocular treatment, due to infectious or non-infectious causes INCLUSION CRITERIA: Neovascular macular disease patients receiving treatment TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0014236
Descripción
Disease activity
Alias
- UMLS CUI-1
- C0544450
Descripción
SUPPORTING DEFINITION: Presence of intraretinal or subretinal fluid or hemorrhage that is attributable to activity of the neovascular lesion as determined by the treating ophthalmologist. This could be based on clinical examination or imaging INCLUSION CRITERIA: Neovascular macular disease patients receiving treatment TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0242420
- UMLS CUI [2]
- C0035317
Descripción
Visual functioning and health related quality of life
Alias
- UMLS CUI-1
- C4279947
- UMLS CUI-2
- C0042792
Descripción
SUPPORTING DEFINITION: Distance visual acuity (best of uncorrected, corrected using glasses or contact lenses, or pinhole) in the affected eye INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: Numerical value preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. Please refer to page 13 for a Snellen to LogMAR conversion table. Change in distance visual acuity should be calculated from baseline and previous visual acuity assessments.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0429537
Descripción
SUPPORTING DEFINITION: Results preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: Numerical value preferably reported in LogMAR. Snellen may be used but needs to be converted to LogMAR. Please refer to page 13 for a Snellen to LogMAR conversion table. Change in distance visual acuity should be calculated from baseline and previous visual acuity assessments.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1302978
- UMLS CUI [1,2]
- C0429537
Descripción
INCLUSION CRITERIA: All patients TIMING: Each clinical visit REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: Record details of the distance at which visual acuity is measured
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0429537
- UMLS CUI [1,2]
- C0012751
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