ID

40524

Description

LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 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: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains a Clinical Form to be used after primary or salvage surgery. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 . ICHOM was supported for the Localized Prostate Cancer Standard Set by the Movember Foundation. Publication: Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460‐467. doi:10.1016/j.eururo.2014.08.075 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

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www.ichom.org

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Versions (2)
  1. 21/08/2018 21/08/2018 - Sarah Riepenhausen
  2. 30/04/2020 30/04/2020 - Sarah Riepenhausen
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ICHOM

Téléchargé le

30 avril 2020

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Licence

Creative Commons BY-NC 4.0
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ICHOM Localized Prostate Cancer

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Clinical Form after primary or salvage surgery

1 Formulaires  
Patient ID
Description

Patient ID

Alias
UMLS CUI-1
C1269815
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical TYPE: Numerical RESPONSE OPTIONS: According to institution

Type de données

integer

Alias
UMLS CUI [1]
C1269815
Pathological Information
Description

Pathological Information

Alias
UMLS CUI-1
C0205469
Indicate the pathological tumor stage (per AJCC 7th)
Description

Pathologic staging preferred, if available pT2: if not able to select T2a, T2b or T2c: Organ confined pT2a: Unilateral, one-half of one side or less pT2b: Unilateral, involving more than one-half of side but not both sides pT2c: Bilateral disease pT3: if not able to select T3a, T3b: Extraprostatic extension pT3a: Extraprostatic extension or microscopic invasion of bladder neck pT3b: Seminal vesicle invasion pT4: Invasion of rectum, levator muscles, and/or pelvic wall pTX: Primary tumor cannot be assessed INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: After primary or salvage surgery REPORTING SOURCE: Clinical TYPE: Single answer

Type de données

integer

Alias
UMLS CUI [1,1]
C0441915
UMLS CUI [1,2]
C0205469
UMLS CUI [1,3]
C0600139
Indicate the pathological nodal stage (per AJCC 7th)
Description

Pathologic staging preferred, if available pN0: No positive regional nodes pN1: Metastases in regional node(s) pNX: Regional nodes not sampled INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: After primary or salvage surgery REPORTING SOURCE: Clinical TYPE: Single answer

Type de données

integer

Alias
UMLS CUI [1,1]
C0456532
UMLS CUI [1,2]
C0441915
UMLS CUI [1,3]
C0205469
UMLS CUI [1,4]
C0600139
Indicate margin status
Description

INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: After primary or salvage surgery REPORTING SOURCE: Clinical TYPE: Single answer

Type de données

integer

Alias
UMLS CUI [1,1]
C1269830
UMLS CUI [1,2]
C0600139
Indicate if margin status is focal or multi-focal
Description

INCLUSION CRITERIA: Patients who undergo surgical interventions; If answered 'positive' to margin status (MARGIN) TIMING: Before treatment REPORTING SOURCE: Clinical TYPE: Single answer

Type de données

integer

Alias
UMLS CUI [1,1]
C1269830
UMLS CUI [1,2]
C1446409
UMLS CUI [1,3]
C0439792
If yes, indicate the primary Gleason score based upon surgical pathology
Description

INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: After primary or salvage surgery REPORTING SOURCE: Clinical TYPE: Numerical value

Type de données

integer

Alias
UMLS CUI [1,1]
C1273604
UMLS CUI [1,2]
C0033573
If yes, indicate the secondary Gleason score based upon surgical pathology
Description

INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: After primary or salvage surgery REPORTING SOURCE: Clinical TYPE: Numerical value

Type de données

integer

Alias
UMLS CUI [1,1]
C1273605
UMLS CUI [1,2]
C0033573
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Similar models

Clinical Form after primary or salvage surgery

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient ID
C1269815 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Item Group
Pathological Information
C0205469 (UMLS CUI-1)
Item
Indicate the pathological tumor stage (per AJCC 7th)
integer
C0441915 (UMLS CUI [1,1])
C0205469 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Clinical tumor stage
Code List
Indicate the pathological tumor stage (per AJCC 7th)
CL Item
pT2 (1)
C1709725 (UMLS CUI-1)
(Comment:en)
CL Item
pT2a  (2)
C1709726 (UMLS CUI-1)
(Comment:en)
CL Item
pT2b  (3)
C1709727 (UMLS CUI-1)
(Comment:en)
CL Item
pT2c  (4)
C1709728 (UMLS CUI-1)
(Comment:en)
CL Item
pT3 (5)
C1709729 (UMLS CUI-1)
(Comment:en)
CL Item
pT3a  (6)
C2982627 (UMLS CUI-1)
(Comment:en)
CL Item
pT3b  (7)
C1709731 (UMLS CUI-1)
(Comment:en)
CL Item
pT4 (8)
C2982628 (UMLS CUI-1)
(Comment:en)
CL Item
pTX (9)
C0332395 (UMLS CUI-1)
C0600139 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate the pathological nodal stage (per AJCC 7th)
integer
C0456532 (UMLS CUI [1,1])
C0441915 (UMLS CUI [1,2])
C0205469 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Clinical nodal stage
Code List
Indicate the pathological nodal stage (per AJCC 7th)
CL Item
pN0  (0)
C1709722 (UMLS CUI-1)
(Comment:en)
CL Item
pN1 (1)
C1709723 (UMLS CUI-1)
(Comment:en)
CL Item
pNX  (2)
C1709724 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate margin status
integer
C1269830 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Margin status
Code List
Indicate margin status
CL Item
Negative (0)
C0205160 (UMLS CUI-1)
(Comment:en)
CL Item
Positive (1)
C1446409 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate if margin status is focal or multi-focal
integer
C1269830 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0439792 (UMLS CUI [1,3])
Margin status focality
Code List
Indicate if margin status is focal or multi-focal
CL Item
Focal (1)
CL Item
Multi-focal (2)
CL Item
Unknown (999)
Pathological Gleason grade: Primary
Item
If yes, indicate the primary Gleason score based upon surgical pathology
integer
C1273604 (UMLS CUI [1,1])
C0033573 (UMLS CUI [1,2])
Pathological Gleason grade: Secondary
Item
If yes, indicate the secondary Gleason score based upon surgical pathology
integer
C1273605 (UMLS CUI [1,1])
C0033573 (UMLS CUI [1,2])
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