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Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials

- 20.09.21 - 1 Formular, 16 Itemgruppen, 122 Datenelemente, 1 Sprache
Itemgruppen: Patient Characteristics, Patient Performance Status, Protocol Design, Surgical Procedures, Pathologic Disease Classification, Pathology: Assessment of Lymph Nodes, Margins, Estrogen Status, Progesterone Status, Pathology: Breast Tumor Markers, Pathology: Assessment of Ductal Carcinoma In Situ (DCIS), Pathology: Assessment of Lobular Carcinoma In Situ (LCIS), Endpoints, Tumor Response, Sites of Progression, Notice of New Primary
Treatment - Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials - 2719861v1.0 Breast Cancer DataMart Common Data Elements for Adjuvant Clinical Trials Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43B3F0AE-1119-0B42-E044-0003BA3F9857

Treatment - Breast Cancer DataMart Common Data Elements Surgical Template - 2723098v1.0 - Breast Cancer DataMart Common Data Elements Surgical Template

- 20.09.17 - 1 Formular, 5 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Tumor Assessment, Assessment of Lymph Nodes, Surgical Procedures, Margins, Breast Reconstruction
Breast Cancer DataMart Common Data Elements Surgical Template Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=443F4BFB-7974-666C-E044-0003BA3F9857

Treatment - Proposed Breast Cancer DataMart Common Data Elements for Pre-Operative Clinical Trials - 2722335v1.0 - Proposed Breast Cancer DataMart Common Data Elements for Pre-Operative Clinical Trials

- 20.09.12 - 1 Formular, 7 Itemgruppen, 53 Datenelemente, 1 Sprache
Itemgruppen: Clinical/Imaging Examination of the Breast, Clinical/Imaging Examination of Lymph Nodes, Pre-operative Surgical Evaluation, Diagnostic Pathology of Breast and Lymph Nodes, Marker Status, Therapeutic Changes, Residual Cancer Burden
Proposed Breast Cancer DataMart Common Data Elements for Pre-Operative Clinical Trials Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43F0A8A5-2CF0-6BFA-E044-0003BA3F9857

Breast cancer (cancer registries) DSS Metadata Online Registry (METeOR)

- 02.04.17 - 1 Formular, 2 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Patient, Person with cancer
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) Breast cancer (cancer registries) DSS This breast cancer data set is not mandated for collection but is recommended as best practice if breast cancer data are to be collected. The data set would allow common, consistent and high quality breast cancer data to be collected by State and Territory cancer registries and collated nationally. This data will help inform research, policy, planning and guideline development work in the breast cancer area. Breast cancer may be used as a forerunner for other cancers in terms of establishing common data collections across cancer registries. This data set includes 20 items, with the inclusion of five new standards and the addition of further detail to several existing standards. © Australian Institute of Health and Welfare 2015 Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

ICHOM Breast Cancer - Baseline - Patient-reported

- 20.09.21 - 1 Formular, 4 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: 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.

Measurement Instrument Database for the Social Science (MIDSS) - Measure of Body Apperception (MBA)

- 21.07.20 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: Measure of Body Apperception (MBA)
Carver, C. S.. (2013). Measure of Body Apperception (MBA). Measurement Instrument Database for the Social Science. Retrieved 21.07.2020 from www.midss.ie Key references: Carver, C. S., Pozo-Kaderman, C., Price, A. A., Noriega, V., Harris, S. D., Derhagopian, R. P., Robinson, D. S., & Moffatt, F. L., Jr. (1998). Concern about aspects of body image and adjustment to early stage breast cancer. Psychosomatic Medicine, 60, 168-174. Petronis, V. M., Carver, C. S., Antoni, M. H., & Weiss, S. (2003). Investment in body image and psychosocial well-being among women treated for early stage breast cancer: Partial replication and extension. Psychology and Health, 18, 1-13. Primary use / Purpose: Measures self-reported appreciation of body. Background: Body image is often thought of in terms of physical appearance, but there is also a body image pertaining to integrity, wholeness, and normal functioning. People who are greatly concerned about either aspect of their body image are vulnerable to poorer psychosocial adjustment when confronting treatment for breast cancer. The poorer adjustment takes a different form, however, depending on the nature of the patient's body-image concern . The Measure of Body Apperception (MBA) is a measure of the investment in, or dependence on, one's body image as a source of the sense of self-worth. It has two scales, which reflect reliance on physical appearance, and reliance on a sense of body intactness or integrity. Psychometrics: For details on psychometrics see: Carver, C. S., Pozo-Kaderman, C., Price, A. A., Noriega, V., Harris, S. D., Derhagopian, R. P., Robinson, D. S., & Moffatt, F. L., Jr. (1998). Concern about aspects of body image and adjustment to early stage breast cancer. Psychosomatic Medicine, 60, 168-174. Web link to tool: http://www.psy.miami.edu/faculty/ccarver/sclMBA.html Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.538 Scoring: Items 1, 3, 6, and 8 constitute the subtotal for investment in appearance Items 2, 4, 7, and 9 constitute the subtotal for investment in body integrity Items 5 and 10 are fillers, not scored.

ICHOM Breast Cancer - Baseline - Clinical-reported

- 30.04.20 - 1 Formular, 4 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic factors, Baseline clinical factors, Baseline tumor factors
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.

ICHOM Breast Cancer - 6 months Follow-up - Clinical-reported

- 30.04.20 - 1 Formular, 3 Itemgruppen, 70 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Treatment variables, Disutility of care
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 6 months Follow-up - Clinical-reported form. It has to be filled in 6 months after treatment (start), also after treatment (start) for 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.

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

- 30.04.20 - 1 Formular, 3 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: 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 - Clinical-reported

- 30.04.20 - 1 Formular, 4 Itemgruppen, 62 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Tumor factors, Treatment variables, Survival and Disease control
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 - Clinical-reported form. Annual follow-up is reassessed from date of surgery or start of chemo-/radiotherapy (also in case of recurrence), so that it will run parallel with annual outpatient visit. 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 Formular, 4 Itemgruppen, 33 Datenelemente, 1 Sprache
Itemgruppen: 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.

Human genetics Senology University Hospital Muenster (UKM) - Checklist for detecting a hereditary burden of breast and / or ovarian cancer

- 14.10.16 - 1 Formular, 6 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: Demographic Information, Score A: Patient and siblings/offspring, Score B: Maternal line, Score C: paternal line, Score D: Higher value from B and C, E: Risk Score
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: Humangenetik Senologie:Checkliste zur Erfassung einer erblichen Belastung für Brust- und/oder Eierstockkrebs

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