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Cancer (clinical) DSS Metadata Online Registry (METeOR)

- 03-08-16 - 1 Formulier, 16 Itemgroepen, 65 Data-elementen, 1 Taal
Itemgroepen: Chemotherapy for cancer cluster, Hormone therapy for cancer cluster, Immunotherapy for cancer cluster, Radiotherapy for cancer cluster, Surgery for cancer cluster, Systemic therapy procedure for cancer cluster, Cancer staging, Cancer treatment, Date, Establishment, Healthcare provider, Patient, Person (address), Person (name), Person with cancer, Person
Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Cancer (clinical) DSS The purpose of the Cancer (clinical) data set specification (C(C)DSS) is to define data standards for the national collection of clinical cancer data so that data collected is consistent and reliable. Collection of this data set specification is not mandated but it is recommended as best practice if clinical cancer data are to be collected. It will facilitate more consistent data collection while enabling individual treatment centres or health service areas to develop data extraction and collection processes and policies that are appropriate for their service settings. Mandatory reporting regulations have enabled population-based cancer registries in Australia to collect standard information on all incident cases of cancer apart from non-melanoma skin cancers, from which incidence, mortality and overall survival have been determined and trends monitored. The Cancer (clinical) data set specification provides a framework for the collection of more detailed and comprehensive clinical data such as stage of cancer at diagnosis, other prognostic characteristics, cancer treatment and patient outcomes. The Cancer (clinical) data set specification will support prospective data collection from the time a person with cancer symptoms is referred or first presents to a hospital or specialist through the entire duration of their illness. The majority of data items in the Cancer (clinical) data set specification are applicable to most solid tumours while many are also relevant to the haematopoietic malignancies such as leukaemia and lymphoma. Data set specifications for specialist tumour streams are also under development and these will contain supplementary data elements that will capture the special features of specific cancer types. The definitions used in this data set specification are designed to capture the provision of cancer care on a day-to-day level. They relate to the cancer care pathway and the need to optimise care by correctly diagnosing, evaluating and managing patients with cancer. In addition, end-points and patterns of care can be monitored to understand both the appropriateness and effectiveness of cancer care. The data elements specified provide a framework for: • promoting the delivery of evidence-based care to patients with cancer • facilitating the ongoing improvement in the quality and safety of cancer management in treatment settings • improving the epidemiological and public health understanding of cancer • informing treatment guidelines and professional education • guiding resource planning and the evaluation of cancer control activities They will facilitate the aggregation of data across different treatment centres. The underlying long-term goal is to provide data support to improve outcomes for patients by increasing the quality and length of life. For example, a comparison of the actual management of patients with best practice guidelines may identify shortfalls in treatment and limitations in access to treatment modalities for some patients. The working group formed under the stewardship of Cancer Australia was diverse and included representation from the following organisations: Cancer Australia, University of Sydney-Department of Gynaecological Oncology, Westmead Institute for Cancer Research, Cancer Council Victoria, Royal Brisbane & Women’s Hospital, National Breast and Ovarian Cancer Centre, The Royal Women's Hospital, Queensland Health, Ministry of Health, NSW Health, TROG Cancer Research, and the Cancer Institute NSW. To ensure the broad acceptance of the data set specification, the proposed list of data items was circulated to members of Cancer Australia’s National Cancer Data Strategy Advisory Group, a multidisciplinary group with a broad spectrum of epidemiological knowledge and expertise, and the inter-governmental Strategic Forum, comprising clinicians and senior health department officials from the Australian Government and from each state and territory government, and with strong community representation. The working group also sought consultation from cancer registry data managers, clinical leaders, pathologists, medical oncologists and radiation oncologists to achieve consensus when required. The Cancer (clinical) data set specification is intended to only describe data collected in relation to the initial course of cancer treatment. The initial course of treatment includes all treatments administered to the patient from diagnosis and before disease progression or recurrence. © Australian Institute of Health and Welfare 2015 Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

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/

Cancer Treatments Protocol PhenX Toolkit

- 26-04-16 - 1 Formulier, 1 Itemgroep, 18 Data-elementen, 1 Taal
Itemgroep: PhenX - cancer treatment protocol
These questions start by asking if the respondent has had cancer. For respondents who have had cancer, detailed follow-up questions ask about the type of cancer treatment, including surgery, chemotherapy, radiation, and hormone therapy. 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.

Cancer: Personal and Family History Protocol PhenX Toolkit

- 20-09-21 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: PhenX - cancer - personal and family history protocol
This protocol is used to assess if the respondent and his or her biological parents, siblings, and children have had cancer. This protocol also obtains information about vital status, age, type of cancer, age at first diagnosis, and any additional cancer diagnoses. 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.

quality management AQUA breast surgery breast cancer - quality management

- 27-09-21 - 1 Formulier, 9 Itemgroepen, 69 Data-elementen, 2 Talen
Itemgroepen: Mammachirurgie, Basis, Brust, Operation, Komplikationen, pTpN, Art der erfolgten Therapie, Weiterer Behandlungsverlauf, Entlassung
quality management forms, with friendly permission, (http://www.sqg.de/downloads/2013/SR3/Dokumentationsboegen/18-1.pdf) AQUA - Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen GmbH

ICHOM Lung Cancer - Baseline - Patient-Reported Form

- 30-04-20 - 1 Formulier, 4 Itemgroepen, 22 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Demographic factors, Baseline Clinical factors, Degree of health
ICHOM Lung 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. For Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains the Baseline - Patient-Reported Form. It depicts first doctor's visit. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

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.

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