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dataset CPCTR CDE Prostata Cancer prostate cancer - dataset

- 15-03-21 - 1 Formulier, 24 Itemgroepen, 94 Data-elementen, 2 Talen
Itemgroepen: Demographics, Clinical History, Prostatic specific Antigen (PSA), Diagnostic PSA, PSA Matrix, Histological Characteristics of Prostatectomy, Prostatectomy: Primary Gleason Grade, Prostatectomy: Secondary Gleason Grade, Prostatectomy: Gleason Sum Score, Histological Characteristics of Prostatectomy II, Regional Lymph node status at the time of Prostatectomy, Recurrence/Metastasis Status, Clinical verified tissue recurrence/metastasis, Staging, Pathological staging, Clinical Staging, Vital Status/Follow Up Date, Therapy Matrix, Type of Therapy, Overall Needle Biopsy Attributes, Biopsy: Primary Gleason Grade, Biopsy: Secondary Gleason Grade, Biopsy: Gleason Sum Score, Overall Needle Biopsy Attributes II
with friendly permission, ODM derived from PDFs attached to the paper: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1236914/

ICHOM Localized Prostate Cancer - Clinical Form annually after treatment initiation

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 52 Data-elementen, 1 Taal
Itemgroepen: Patient ID, Treatment Variables, Acute Complications of Treatment, Survival and Disease Control
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 annually after salvage treatment initiation. 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.

ICHOM Localized Prostate Cancer - Clinical Form within 6 months after treatment initiation

- 20-09-21 - 1 Formulier, 3 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Patient ID, Treatment Variables, Acute Complications of Treatment
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 6 months after primary treatment initiation. Surveys 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. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Advanced Prostate Cancer - Baseline Patient-reported Form

- 30-04-20 - 1 Formulier, 4 Itemgroepen, 67 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Demographic factors, Baseline Clinical Factors, Degree of health
ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 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. Conditions: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains patient-reported variables, to be assessed at baseline. Questionnaires used in this form: 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 (according to ICHOM). 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-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Advanced Prostate Cancer - Follow-Up Patient-reported Form

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 39 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Degree of health
ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 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. Conditions: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains patient-reported outcome variables. To be assessed 6 months and 1 year post (initial) treatment and annually for life from then on. Questionnaires used in this form: 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 (according to ICHOM). 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-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Advanced Prostate Cancer - Baseline Clinical Form

- 30-04-20 - 1 Formulier, 5 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Demographic Factors, Baseline clinical factors, Baseline Tumor Factors, Treatment Factors
ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 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. Conditions: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains clinical varibales to be assessed at baseline (Baseline index event: diagnosis of advanced Disease: Diagnosed with LPC, progresses to biochemical recurrence and is not eligible for salvage thearpy or has been treated with salvage thearpy; Diagnosed with LPC, progresses to metastatic disease; Diagnosed with metastatic disease at time of diagnosis). Questionnaires used in this standard set: 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 (according to ICHOM). 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-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Advanced Prostate Cancer - Follow-Up Clinical Form

- 30-04-20 - 1 Formulier, 5 Itemgroepen, 66 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Treatment Variables, Acute Complications of Treatment, Degree of Health, Survival and disease control
ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 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. Conditions: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains clinical and administrative variables. To be assessed 1 year post (initial) treatment and annually for life from then on. Questionnaires used in this standard set: 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 (according to ICHOM). 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-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Localized Prostate Cancer - Patient-Reported Form (Questionnaires)

- 30-04-20 - 1 Formulier, 3 Itemgroepen, 35 Data-elementen, 1 Taal
Itemgroepen: Patient ID, EPIC-26, Libido Questions
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 Patient-reported Health Status. To be used before treatment, 6 months after treatment and annually up to ten years after treatment. Surveys 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 (according to ICHOM). This standard set uses questions 2 and 3 a-e. 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 verbatim in this Version of the questionnaire. This standard set uses only question 50. 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.

ICHOM Localized Prostate Cancer - Clinical Form after primary or salvage surgery

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Patient ID, Pathological Information
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.

ICHOM Localized Prostate Cancer - Baseline Clinical Form

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Patient ID, Baseline Tumor Factors
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 Baseline Clinical Form. To be used at baseline, i.e., post-diagnosis, pre-treatment. 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 this 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.

ICHOM Localized Prostate Cancer - Baseline Patient-reported Form

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Patient ID, Patient Factors
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 Baseline Patient-reported Form. To be used at baseline, i.e., post-diagnosis, pre-treatment. Excluding the Patient Reported Outcome questionnaires (separate form, as asked at multiple timepoints). 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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