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CDASH ECG – Scenario 2 (local processing) - ECG – Scenario 2 (local processing)

- 20.06.18 - 1 Formular, 3 Itemgruppen, 16 Datenelemente, 2 Sprachen
Itemgruppen: General information, ECG Information (Local processing), ECG Results
modified from http://www.cdisc.org

NINDS CDE Cardiac End Points Friedreich´s Ataxia - Cardiac End Points

- 04.05.16 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: Cardiac End Points
NINDS Common Data Elements (Cardiac End Points; Friedreich´s Ataxia) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

CDASH ECG – Scenario 3 - ECG – Scenario 3 (central information processing)

- 20.06.18 - 1 Formular, 3 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: General information, ECG Information (Central processing), ECG Results
modified from http://www.cdisc.org

CDASH ECG - Scenario 1 - ECG – Scenario 1

- 20.06.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: General information, ECG
modified from http://www.cdisc.org

ICHOM Heart Failure - Baseline Characteristics, at time of index event

- 30.04.20 - 1 Formular, 5 Itemgruppen, 62 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Demographic Factors, Baseline health status, Treatment variables, Burden of Care
HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 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: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains baseline characteristics. It should be filled in at the time of the index event. The index event represents the entry into the set. This could either be after diagnosis/first encounter in an outpatient setting, or at discharge from hospital if the initial presentation was severe enough to require admission. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Coronary Artery Disease - Peri-Inverventional Clinical Form

- 30.04.20 - 1 Formular, 8 Itemgruppen, 46 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic factors, Baseline health status, Prior Treatments, TREATMENT VARIABLES, Acute complications of treatment, Major surgery complications, Major interventional cardiology complications
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 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: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains peri-interventional clinical items. The items cover a timespan from prior to the intervention (e.g. PCI or CABG) until 30 days after it. They should be assessed at the entry event and at any new index event (e.g. new revascularization procedure or new diagnosis of ACS). Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

QMMI score

- 27.09.21 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache
Itemgruppe: QMMI score
In the context of the Quality Measurement and Management Initiative (QMMI) Coronary Revascularization Project, this "clinical prediction rule for in-hospital major adverse outcomes, defined as death, renal failure, reinfarction, cardiac arrest, cerebrovascular accident, or coma, in patients who underwent coronary artery bypass grafting (CABG)", was developed. Reference: Fortescue, E. B., Kahn, K., & Bates, D. W. (2001). Development and validation of a clinical prediction rule for major adverse outcomes in coronary bypass grafting. The American journal of cardiology, 88(11), 1251-1258.

CHA2DS2-VASc score

- 27.09.21 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: CHADS2
The CHA2DS2-VASc is a simple stroke risk stratification schema for patients with atrial fibrillation which is based on a risk factor approach and provides some improvement in predictive value for TE over the CHADS 2 schema. Reference: Lip, G. Y., Nieuwlaat, R., Pisters, R., Lane, D. A., & Crijns, H. J. (2010). Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest Journal, 137(2), 263-272.

Kardiovaskulaere Anamnese MS University Hospital Muenster (UKM)

- 20.09.21 - 1 Formular, 3 Itemgruppen, 48 Datenelemente, 2 Sprachen
Itemgruppen: Cardiovascular Risks, Cardiovascular history, Other
Hospital Routine Documentation Form at the University Hospital Muenster. Original Form name: Kardiovaskulaere Anamnese MS.

ICHOM Coronary Artery Disease - Baseline Clinical Form

- 30.04.20 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic factors, Baseline health status
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 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: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains baseline clinical items. Some of the items may additionally be reported from administrative sources. It may be filled out in an outpatient setting in case of diagnosis of a stable angina or at diagnosis in an inpatient setting. Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Coronary Artery Disease - Follow-Up Administrative Form

- 30.04.20 - 1 Formular, 4 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic Factors, Cardiovascular disease progression, Survival
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 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: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains administrative follow-up items. They should be assessed at 1 and 5 years after entry event or 1 and 5 years after a new index event (e.g. new revascularization procedure or a new diagnosis of ACS). Given that longitudinal data capture is based on administrative data, this can continue to be collected and analyzed for either the original or subsequent index events. Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Coronary Artery Disease - Patient-reported Form (Baseline and Follow-up)

- 30.04.20 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic factors, Patient-Reported Health Status
CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 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: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains the patient-reported Outcome questionnaires. They should be assessed at the entry event, 30 days after it and annually for 5 years. A new revascularization procedure or a new diagnosis of ACS constitutes a new index event, and tracking of patient-reported health status should reset from this point, tracking again at +30 days, and then annually for 5 years. Questionnaires used in this Form: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

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