ACC/AHA 2013 methodology for developing clinical data standards: A report of the American college of cardiology/American heart association task force on clinical data standards

TY - JOUR

T1 - ACC/AHA 2013 methodology for developing clinical data standards

T2 - A report of the American college of cardiology/American heart association task force on clinical data standards

AU - Hendel, Robert C.

AU - Bozkurt, Biykem

AU - Fonarow, Gregg C.

AU - Jacobs, Jeffrey P.

AU - Lichtman, Judith H.

AU - Smith, Eric E.

AU - Tcheng, James E.

AU - Wang, Tracy Y.

AU - Weintraub, William S.

N1 - Funding Information: Appendix 1 Author Relationships With Industry and Other Entities (Relevant)—ACC/AHA 2013 Methodology for Developing Clinical Data Standards Name Employment Consultant Speaker Ownership/ Partnership/ Principal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Robert C. Hendel ( Chair) University of Miami Miller School of Medicine—Director of Cardiac Imaging and Outpatient Services None None None None None None Biykem Bozkurt Michael E. DeBakey VA Medical Center—Chief, Cardiology Section None None None None None None Gregg C. Fonarow Ahmanson−UCLA Cardiomyopathy Center Division of Cardiology—Director; Professor of Medicine None None None None • Steering Committee—GWTG (AHA) ∗ • Steering Committee Chair AR-G ∗ None Jeffrey P. Jacobs All Children’s Hospital and Florida Hospital for Children—Cardiovascular and Thoracic Surgeon None None None None None None Judith H. Lichtman Yale School of Public Health—Associate Professor of Epidemiology None None None None None None Eric E. Smith Calgary Stroke Program Department of Clinical Neurosciences—Associate Professor of Neurology None None None None None None James E. Tcheng Duke University Medical Center—Director, Duke Translational Medicine Institute, Biomedical Informatics Core; Professor of Medicine; Professor of Community and Family Medicine • Cardiovascular Systems, Inc. None None • Duke University Medical Center—Philips Medical Systems † None Tracy Y. Wang Duke University Medical Center—Associate Professor of Medicine None None None None None None William S. Weintraub Christiana Care Health System—Chief of Cardiology None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Please refer to http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees. According to the ACC/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document ; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document , or makes a competing drug or device addressed in the document ; or c) The person or a member of the person’s household , has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document . ACC indicates American College of Cardiology; AHA, American Heart Association; AR-G, ACTION Registry−Get With The Guidelines; GWTG, Get With The Guidelines; and VA, Veterans Affairs. ∗ No financial benefit. † Significant relationship. Appendix 2 Peer Reviewer Relationships With Industry and Other Entities—ACC/AHA 2013 Methodology for Developing Clinical Data Standards Name Representation Employment Consultant Speaker Ownership/ Partnership/ Principal Research Institutional, Organizational, or Other Financial Benefit Expert Witness John E. Brush ACC—Board of Trustees Cardiology Consultants None None None None None None Geetha Raghuveer ACC—Board of Governors Children’s Mercy Hospital None None None None None None Alice M. Mascette American Heart Association NHLBI/NIH Division of Cardiovascular Sciences—Senior Clinical Science Advisor, Office of Special Projects None None None None None None Nancy Albert Content Reviewer Cleveland Clinic Foundation—Senior Director of Nursing Research and CNS, Kaufman Center for Heart Failure • Gambro • BG Medicine • Medtronic None None None None None William B. Borden Content Reviewer Weill Cornell Medical College • US Department of Health and Human Services † None None • Robert Wood Johnson Foundation † None None Virginia Howard Content Reviewer University of Alabama at Birmingham—Professor, Department of Epidemiology, School of Public Health • Bayer Healthcare † None None • NIH—Principal Investigator † None • Defendant, Chantix and risk of adverse events, 2012 Mark D. Huffman Content Reviewer Northwestern University Feinberg School of Medicine—Assistant Professor Hani Jneid Content Reviewer Baylor College of Medicine—Assistant Professor of Medicine; Director of Interventional Cardiology Research, Division of Cardiology None None None None None None Suzanne Judd Content Reviewer University of Alabama at Birmingham—Associate Professor None None None None None None Dariush Mozaffarian Content Reviewer Brigham and Women's Hospital and Harvard Medical School— Co-Director, Program in Cardiovascular Epidemiology, and Associate Professor of Medicine and Epidemiology • Bunge, Pollock Institute, Quaker Oats, Life Sciences Research Organization, and Nutrition Impact • Foodminds, McKinsey Health Systems Institute • Patent ∗ • UpToDate • GlaxoSmithKline, Sigma Tau, Pronova, and NIH † • Unilever North America Scientific Advisory Board Peter Tilkemeier Content Reviewer Warren Alpert Medical School of Brown University—Associate Professor of Medicine None None None None None None Salim Virani Content Reviewer Baylor College of Medicine—Assistant Professor None None None • Merck • NFL Medical Charities • Roderick D. MacDonald Research Fund † None None This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Please refer to http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees. ACC indicates American College of Cardiology; NFL, National Football League; NHLBI, National Heart, Lung, and Blood Institute; and NIH, National Institutes of Health. ∗ No financial benefit. † Significant relationship. Appendix 3 Sample Data Element and Definition: Myocardial Infarction (6) Terminology Concept (Data Element) Concept Definition Permissible Values Permissible Values Definitions Additional Notes References Myocardial infarction, acute Clinical syndrome where there is evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia Yes Thygesen K, Alpert JS, Jaffe AS, et al; the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60:1581-98. Myocardial infarction, acute Type of myocardial infarction Type 1: Spontaneous Spontaneous clinical syndrome related to atherosclerotic plaque rupture, ulceration, fissuring, erosion, or dissection, with resulting intraluminal thrombus and leading to decreased myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis. This classification requires a) detection of a rise and/or fall of cardiac biomarker values (preferably cTn) with at least 1 value >99th percentile of the URL and b) at least 1 of the following: – Symptoms of myocardial ischemia – New or presumed new significant ST–T changes or new LBBB on the ECG – Development of pathological Q waves on the ECG – Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality – Identification of an intracoronary thrombus by angiography or autopsy cTn—I or T—is the preferred biomarker. If a cTn assay is not available, the best alternative is CKMB (measured by mass assay). One or more coronary arteries may be involved. The patient may have underlying severe coronary artery disease but on occasion may have nonobstructive or no coronary artery disease. Type 2: Ischemic imbalance Spontaneous clinical syndrome where a condition other than coronary artery disease contributes to an imbalance between myocardial oxygen supply and/or demand (e.g., coronary endothelial dysfunction, coronary artery spasm, coronary embolism, tachy-/bradyarrhythmias, anemia, respiratory failure, hypotension, and hypertension with or without left ventricular hypertrophy). This classification requires detection of a) rise and/or fall of cardiac biomarker values (preferably cTn) with at least 1 value >99th percentile of the URL and b) at least 1 of the following: – Symptoms of myocardial ischemia – New or presumed new significant ST–T changes or new LBBB on the ECG – Development of pathological Q waves on the ECG – Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. cTn—I or T—is the preferred biomarker. If a cTn assay is not available, the best alternative is CKMB (measured by mass assay). Type 3: Death, no biomarkers Death where symptoms suggestive of myocardial ischemia are present and with (presumed) new ischemic changes or new LBBB on ECG but where death occurs before cardiac biomarkers can be obtained or before cardiac biomarker values could rise. Type 4a: PCI related Myocardial infarction associated with and occurring within 48 h of PCI, with elevation of cardiac biomarker values to >5× 99th percentile of the URL in patients with normal baseline values (≤99th percentile URL) or a rise of cardiac biomarker values ≥20% if the baseline values are elevated and are stable or falling. This classification also requires at least 1 of the following: – Symptoms of myocardial ischemia – New ischemic ECG changes or new LBBB – Angiographic loss of patency of a major coronary artery or a side branch or persistent slow- or no-flow or embolization – Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. cTn—I or T—is the preferred biomarker. If a cTn assay is not available, the best alternative is CKMB (measured by mass assay). Type 4b: Stent thrombosis Myocardial infarction associated with stent thrombosis as detected by coronary angiography or at autopsy, where symptoms suggestive of myocardial ischemia are present, and with a rise and/or fall of cardiac biomarkers values, with at least 1 value >99th percentile of the URL. cTn—I or T—is the preferred biomarker. If a cTn assay is not available, the best alternative is CKMB (measured by mass assay). Type 4c: Stent restenosis Myocardial infarction associated with stent restenosis as detected by coronary angiography or at autopsy, occurring >48 h after PCI, without evidence of stent thrombosis but with symptoms suggestive of myocardial ischemia, and with elevation of cardiac biomarker values to >99th percentile of the URL. This classification also requires the following: – Does not meet criteria for any other classification of myocardial infarction – Presence of ≥50% stenosis at the site of previous successful stent PCI. cTn—I or T—is the preferred biomarker. If a cTn assay is not available, the best alternative is CKMB (measured by mass assay). Type 4c is described in the Third Universal Definition of MI. Type 5: CABG related Myocardial infarction associated with and occurring within 48 h of CABG surgery, with elevation of cardiac biomarker values to >10× 99th percentile of the URL in patients with normal baseline cardiac biomarker values (≤99th percentile URL). This classification also requires at least 1 of the following: – New pathologic Q waves or new LBBB on ECG – Angiographic new graft or new native coronary artery occlusion – Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. cTn—I or T—is the preferred biomarker. If a cTn assay is not available, the best alternative is CKMB (measured by mass assay). ACC indicates American College of Cardiology; AHA, American Heart Association; CABG, coronary artery bypass graft; CKMB, creatine kinase MB; cTn, cardiac troponin; ECG, electrocardiogram; ESC, European Society of Cardiology; LBBB, left bundle-branch block; PCI, percutaneous coronary intervention; ST–T, ST-segment–T wave; URL, upper reference limit; and WHF, World Heart Federation. Appendix 4 ACC/AHA Clinical Data Standards Document Approval and Publication Process ACC indicates American College of Cardiology; AHA, American Heart Association; BOT, Board of Trustees; and SACC, Science Advisory and Coordinating Committee.

PY - 2014/6/3

Y1 - 2014/6/3

KW - ACC/AHA Data Standards

KW - controlled vocabulary

KW - healthcare data interoperability

KW - methodology

UR - http://www.scopus.com/inward/record.url?scp=84901610625&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84901610625&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2013.11.006

DO - 10.1016/j.jacc.2013.11.006

M3 - Article

C2 - 24246166

AN - SCOPUS:84901610625

VL - 63

SP - 2323

EP - 2334

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 21

ER -