ID
40621
Beschrijving
ICHOM Breast Cancer data collection Version 1.0.1 Revised: March 30, 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 Breast Cancer, the following treatment approaches (or interventions) are covered by our Standard Set. Conditions*: All patients (men and women) with newly pathologically diagnosed invasive breast cancer (stage I-IV) and ductal carcinoma in situ (DCIS). *Excluded Conditions: Rare tumors (e.g. phyllodes tumor), lobular carcinoma in situ (LCIS) and patients with recurrent disease at baseline will be excluded. Treatment approaches: (Reconstructive) Surgery | Radiotherapy | Chemotherapy | Hormonal Therapy | Targeted Therapy | This document contains the Baseline - Clinical-reported form. It has to be filled in at first doctor's visit of patient and repeated at the beginning of therapies or in case of recurrence. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, EORTC QLQ-BR23, EORTC QLQ-LMC21). As a permission is needed for use of these questionnaires, only the total score of each will be included in this version of the standard set. More information can be found at http://groups.eortc.be/qol/eortc-qlq-c30 BREAST-Q Patient Reported Outcomes Instrument (BREAST-Q). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information, please visit: https:// eprovide.mapi-trust.org/instruments/ breast-q#contact_and_conditions_of_ use Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES). As a permission is needed for use of this questionnaire, only the total score of each will be included in this version of the standard set. For more information see http://www.facit.org/facitorg/ questionnaires. Reference: Ong WL, Schouwenburg MG, van Bommel AC, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677–685. doi:10.1001/jamaoncol.2016.4851 The Standard set of ICHOM was supported by the Dutch Dnstitute for Clinical Auditing, Onderlinge Waarborgmaatschappij Centrale Zorgverzekeraars group, Ramsay Health Care and Karolinska Institute. For this version of the standard set, semantic annotation with UMLS CUIs has been added.
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Versies (5)
- 05-07-19 05-07-19 -
- 05-07-19 05-07-19 -
- 22-07-19 22-07-19 -
- 26-07-19 26-07-19 - Sarah Riepenhausen
- 30-04-20 30-04-20 - Sarah Riepenhausen
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ICHOM
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30 april 2020
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Creative Commons BY-NC 4.0
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ICHOM Breast Cancer
Baseline - Clinical-reported
- StudyEvent: ODM
Beschrijving
Demographic factors
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Baseline clinical factors
Alias
- UMLS CUI-1
- C0449440
- UMLS CUI-2
- C1442488
Beschrijving
Height and weight are used to calculate BMI INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value of height in cm or in
Datatype
float
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beschrijving
Height and weight are used to calculate BMI INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer RESPONSE OPTIONS: Numerical value of weight in kg or lbs
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0925205
- UMLS CUI [1,2]
- C0678222
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0678222
- UMLS CUI [1,2]
- C3172269
Beschrijving
Baseline tumor factors
Alias
- UMLS CUI-1
- C0475752
- UMLS CUI-2
- C1442488
Beschrijving
SUPPORTING DEFINITION: The first time that histology of the tumoris examined, after biopsy or surgery, whichever came first INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Datatype
date
Maateenheden
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0679557
- UMLS CUI [1,2]
- C0011008
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
boolean
Alias
- UMLS CUI [1]
- C0449574
- UMLS CUI [2]
- C1527349
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
boolean
Alias
- UMLS CUI [1]
- C0449574
- UMLS CUI [2]
- C1134719
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
boolean
Alias
- UMLS CUI [1]
- C0449574
- UMLS CUI [2]
- C0279565
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
boolean
Alias
- UMLS CUI [1]
- C0449574
- UMLS CUI [2]
- C0205394
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
boolean
Alias
- UMLS CUI [1]
- C0449574
- UMLS CUI [2]
- C0439673
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline and after 1 year REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0314657
- UMLS CUI [1,2]
- C0678222
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1]
- C1269955
Beschrijving
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0007124
- UMLS CUI [1,2]
- C0919553
Beschrijving
SUPPORTING DEFINITION: Tumor stage (AJCC 5th -7th edition): TX: primary tumor cannot be assessed T0: no evidence of primary tumor Tis: intraepithelial or invasion of lamina propria T1: tumor confined to the submucosa T2: tumor has grown into (but not through) the muscularis propria T3: tumor has grown into (but not through) the serosa T4: tumor has penetrated through the serosa and the peritoneal surface. INCLUSION CRITERIA: All patients that received neoadjuvant therapy TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205210
- UMLS CUI [1,2]
- C1300072
Beschrijving
SUPPORTING DEFINITION: Nodal stage (AJCC 5th -7th edition): NX: lymph nodes were not assessed N0: no lymph nodes contain tumor cells N1: there are tumor cells in up to 3 regional lymph nodes N2: there are tumor cells in 4 or more regional lymph nodes INCLUSION CRITERIA: All patients that received neoadjuvant therapy TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0456532
- UMLS CUI [1,2]
- C0205210
Beschrijving
SUPPORTING DEFINITION: Distant metastasis (AJCC 5th- 7th edition): Mx: presence of metastasis cannot be assessed M0: no metastasis to distant organs M1: metastasis to distant organs INCLUSION CRITERIA: All patients that received neoadjuvant therapy TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1]
- C1275856
Beschrijving
SUPPORTING DEFINITION: Tumor stage (AJCC 5th -7th edition): TX: primary tumor cannot be assessed T0: no evidence of primary tumor Tis: intraepithelial or invasion of lamina propria T1: tumor confined to the submucosa T2: tumor has grown into (but not through) the muscularis propria T3: tumor has grown into (but not through) the serosa T4: tumor has penetrated through the serosa and the peritoneal surface. INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C1521733
Beschrijving
SUPPORTING DEFINITION: Nodal stage (AJCC 5th -7th edition): NX: lymph nodes were not assessed N0: no lymph nodes contain tumor cells N1: there are tumor cells in up to 3 regional lymph nodes N2: there are tumor cells in 4 or more regional lymph nodes INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0456532
- UMLS CUI [1,2]
- C1300072
- UMLS CUI [1,3]
- C0205469
Beschrijving
SUPPORTING DEFINITION: Distant metastasis (AJCC 5th- 7th edition): Mx: presence of metastasis cannot be assessed M0: no metastasis to distant organs M1: metastasis to distant organs INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0807944
- UMLS CUI [1,2]
- C1521733
Beschrijving
INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value; Please enter "999" if size of invasive component is unknown.
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1]
- C0475440
Beschrijving
INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value; Please enter "999" if size of invasive component is unknown.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0728940
Beschrijving
INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value; Please enter "999" if size of invasive component is unknown.
Datatype
integer
Alias
- UMLS CUI [1]
- C0806692
Beschrijving
INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single Answer
Datatype
integer
Alias
- UMLS CUI [1]
- C1516974
Beschrijving
INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single Answer
Datatype
integer
Alias
- UMLS CUI [1]
- C1514471
Beschrijving
SUPPORTING DEFINITION: By immunohistochemistry or ISH, whichever was considered most definitive INCLUSION CRITERIA: If the patient received surgery TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single Answer
Datatype
integer
Alias
- UMLS CUI [1]
- C1512413
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