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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 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 Breast Cancer - Baseline - Patient-reported

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Demographic factors, Baseline clinical factors, Degree of health
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 - Patient-reported form. It has to be filled in before first doctor's visit. 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.

ICHOM Breast Cancer - Follow-up, 1+2 years post treatment - Patient-reported

- 30-04-20 - 1 Formulier, 3 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Treatment variables, Degree of health
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 Follow-up, 1+2 years post treatment - Patient-reported form. It has to be filled in 1+2 years after the begin of a new therapy. Annual follow-up reassessed from date of surgery or start of a new therapy (e.g. for recurrence) so that it will run parallel with annual outpatient visit. At least 10 years post surgery/start of treatment. Distinction for long-term follow-up: Local disease: Up to 10 years follow-up; Metastatic disease: Annually for life 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.

ICHOM Breast Cancer - Follow-up, 6 month, 3-10 years post treatment - Patient-reported

- 30-04-20 - 1 Formulier, 4 Itemgroepen, 33 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Baseline clinical factors, Treatment variables, Degree of health
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 Follow-up, 6 month, 3-10 years post treatment - Patient-reported form. It has to be filled in 6 month and annually for 3-10 years after each begin of a new therapy. Annual follow-up reassessed from date of surgery or start of a new therapy (e.g. due to recurrence) so that it will run parallel with annual outpatient visit. At least 10 years post surgery/start of other therapy. Distinction for long-term follow-up: Local disease: Up to 10 years follow-up; Metastatic disease: Annually for life 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.

ICHOM Lung Cancer - Follow-up - Patient reported

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 4 Data-elementen, 1 Taal
Itemgroepen: Administrative data, 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 Follow-up - Patient reported form. It covers: 3 months post initiation of treatment, 6 months post initiation of treatment, 1 year post initiation of treatment, 2 years post initiation of treatment and 3 years post initiation of treatment. 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.

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