2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease
2013; Lippincott Williams & Wilkins; Volume: 127; Issue: 9 Linguagem: Inglês
10.1161/cir.0b013e3182831a11
ISSN1524-4539
AutoresChristopher P. Cannon, Ralph G. Brindis, Bernard R. Chaitman, David J. Cohen, J. Thomas Cross, Joseph P. Drozda, Francis M. Fesmire, Dan J. Fintel, Gregg C. Fonarow, Keith A.A. Fox, Darryl T. Gray, Robert A. Harrington, Karen A. Hicks, Judd E. Hollander, Harlan Krumholz, Darwin R. Labarthe, Janet B. Long, Alice M. Mascette, Connie Meyer, Eric D. Peterson, Martha J. Radford, Matthew T. Roe, James B. Richmann, Harry P. Selker, David M. Shahian, Richard E. Shaw, Sharon Sprenger, Robert A. Swor, James Underberg, Frans Van de Werf, Bonnie H. Weiner, William S. Weintraub,
Tópico(s)Antiplatelet Therapy and Cardiovascular Diseases
ResumoHomeCirculationVol. 127, No. 92013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUB2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery DiseaseA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Acute Coronary Syndromes and Coronary Artery Disease Clinical Data Standards) Christopher P. Cannon, MD, FACC, Ralph G. Brindis, MD, MPH, FACC, Bernard R. Chaitman, MD, FACC, David J. Cohen, MD, MSC, J. Thomas CrossJr, MD, MPH, Joseph P. DrozdaJr, MD, FACC, Francis M. Fesmire, MD, FACEP, Dan J. Fintel, MD, FACC, Gregg C. Fonarow, MD, FACC, FAHA, Keith A. Fox, MB, ChB, Darryl T. Gray, MD, ScD, FAHA, Robert A. Harrington, MD, FACC, FAHA, Karen A. Hicks, MD, FACC, Judd E. Hollander, MD, FACEP, Harlan Krumholz, MD, SM, FACC, Darwin R. Labarthe, MD, MPH, PhD, Janet B. Long, MSN, ACNP, FAHA, Alice M. Mascette, MD, FACC, FAHA, FACP, Connie Meyer, MICT, AAS, Eric D. Peterson, MD, FACC, FAHA, Martha J. Radford, MD, FACC, FAHA, Matthew T. Roe, MD, MHS, FACC, James B. Richmann, RN, BS, MHA, CEN, Harry P. Selker, MD, MSPH, FAHA, David M. Shahian, MD, FACC, FAHA, Richard E. Shaw, MA, PhD, FACC, FAHA, Sharon Sprenger, RHIA, CPHQ, MPA, Robert Swor, DO, FACEP, James A. Underberg, MD, Frans Van de Werf, MD, FACC, Bonnie H. Weiner, MD, MSEC, MBA and William S. Weintraub, MD, FACC, FAHA Christopher P. CannonChristopher P. Cannon , Ralph G. BrindisRalph G. Brindis , Bernard R. ChaitmanBernard R. Chaitman , David J. CohenDavid J. Cohen , J. Thomas CrossJrJ. Thomas CrossJr *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Joseph P. DrozdaJrJoseph P. DrozdaJr *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Francis M. FesmireFrancis M. Fesmire *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Dan J. FintelDan J. Fintel *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Gregg C. FonarowGregg C. Fonarow , Keith A. FoxKeith A. Fox , Darryl T. GrayDarryl T. Gray *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Robert A. HarringtonRobert A. Harrington , Karen A. HicksKaren A. Hicks *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Judd E. HollanderJudd E. Hollander *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Harlan KrumholzHarlan Krumholz , Darwin R. LabartheDarwin R. Labarthe *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Janet B. LongJanet B. Long *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Alice M. MascetteAlice M. Mascette *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Connie MeyerConnie Meyer *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Eric D. PetersonEric D. Peterson , Martha J. RadfordMartha J. Radford , Matthew T. RoeMatthew T. Roe , James B. RichmannJames B. Richmann *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Harry P. SelkerHarry P. Selker *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , David M. ShahianDavid M. Shahian *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Richard E. ShawRichard E. Shaw , Sharon SprengerSharon Sprenger *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Robert SworRobert Swor *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , James A. UnderbergJames A. Underberg *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ , Frans Van de WerfFrans Van de Werf , Bonnie H. WeinerBonnie H. Weiner *, †, ‡, §, ‖, ¶, #, **, ††, ‡‡, §§, ‖‖, ¶¶, ##, ***, †††, ‡‡‡, ‖‖‖, ¶¶¶ and William S. WeintraubWilliam S. Weintraub Originally published28 Jan 2013https://doi.org/10.1161/CIR.0b013e3182831a11Circulation. 2013;127:1052–1089Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2013: Previous Version 1 Table of ContentsPreamble 10531. Introduction 10542. Methodology 10552.1. Writing Committee Composition 10552.2. Relationships With Industry and Other Entities 10552.3. Review of Literature and Existing Data Definitions 10552.4. Defining Data Elements 10552.5. Relation to Other Standards 10562.6. Consensus Development 10562.7. Peer Review, Public Review, and Board Approval 10562.8. Considerations for ACS and CAD Data Standards 10563. ACS and CAD Clinical Data Standard Elements and Definitions 10593.1. Demographic and Admission Data Elements 10593.2. History and Risk Factors Data Elements 10593.3. Clinical Presentation Data Elements 10633.4. Diagnostic Procedure Data Elements 10653.5. Invasive Therapeutic Intervention Data Elements 10653.6. Medications Table of Data Elements 10653.7. Outcomes Data Elements 1065References 1084Appendix 1. Author Relationships With Industry and Other Entities 1086Appendix 2. Peer Review Relationships With Industry and Other Entities 1089PreambleThe American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) support their members' goal to improve the prevention and care of cardiovascular diseases through professional education, research, and development of guidelines and standards and by fostering policy that supports optimal patient outcomes. The ACCF and AHA recognize the importance of the use of clinical data standards for patient management, assessment of outcomes, and conduct of research, and the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, or quality-improvement initiatives.Hence, clinical data standards strive to define and standardize data relevant to clinical topics in cardiology, with the primary goal of assisting data collection by providing a platform of data elements and definitions applicable to various conditions. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across studies to promote interoperability of electronic health records (EHRs) and to assess the applicability of research to clinical practice. The increasing national focus on adoption of certified EHRs along with financial incentives for providers to demonstrate "meaningful use" of those EHRs to improve healthcare quality render even more imperative and urgent the need for such definitions and standards. Therefore, the ACCF and AHA have undertaken to define and disseminate clinical data standards—sets of standardized data elements and corresponding definitions—to collect data relevant to cardiovascular conditions. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary to accomplish the ACCF/AHA mission of fostering optimal cardiovascular care and disease prevention and building healthier lives, free of cardiovascular diseases and stroke.The specific goals of clinical data standards areTo establish a consistent, interoperable, and universal clinical vocabulary as a foundation for both clinical care and clinical researchTo promote the ubiquitous use of EHRs and facilitate the exchange of data across systems through harmonized, standardized definitions of key data elementsTo facilitate the further development of clinical registries, quality- and performance-improvement programs, outcomes evaluations, and clinical research, including the comparison of results within and across these initiativesThe key elements and definitions are a compilation of variables intended to facilitate the consistent, accurate, and reproducible capture of clinical concepts; standardize the terminology used to describe cardiovascular diseases and procedures; create a data environment conducive to the assessment of patient management and outcomes for quality and performance improvement and clinical and translational research; and increase opportunities for sharing data across disparate data sources. The ACCF/AHA Task Force on Clinical Data Standards selects cardiovascular conditions and procedures that will benefit from creation of a data standard set. Experts in the subject are selected to examine/consider existing standards and develop a comprehensive, yet not exhaustive, data standard set. When undertaking a data collection effort, only a subset of the elements contained in a clinical data standards listing may be needed, or conversely, users may want to consider whether it may be necessary to collect some elements not listed. For example, in the setting of a randomized clinical trial of a new drug, additional information would likely be required regarding study procedures and drug therapiesThe ACCF and AHA recognize that there are other national efforts to establish clinical data standards, and every attempt is made to harmonize newly published standards with existing standards. Writing committees are instructed to consider adopting or adapting existing nationally recognized data standards if the definitions and characteristics are useful and applicable to the set under development. In addition, the ACCF and AHA are committed to continually expanding their portfolio of data standards and will create new standards and update existing standards as needed to maintain their currency and promote harmonization with other standards as health information technology and clinical practice evolve.The Health Insurance Portability and Accountability Act privacy regulations, which went into effect in April 2003, have heightened all practitioners' awareness of our professional commitment to safeguard our patients' privacy. The Health Insurance Portability and Accountability Act privacy regulations1 specify which information elements are considered "protected health information." These elements may not be disclosed to third parties (including registries and research studies) without the patient's written permission. Protected health information may be included in databases used for healthcare operations under a data use agreement. Research studies using protected health information must be reviewed by an institutional review board or a privacy board.We have included identifying information in all clinical data standards to facilitate uniform collection of these elements when appropriate. For example, a longitudinal clinic database may contain these elements because access is restricted to the patient's caregivers. Conversely, registries may not contain protected health information unless specific permission is granted by each patient. These fields are indicated as protected health information in the data standards.The ACCF/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing committee were required to submit a disclosure form showing all such relationships that might be perceived as real or potential conflicts of interest. These statements were reviewed by the ACCF/AHA Task Force on Clinical Data Standards, reported orally to all members of the writing panel at the first meeting, and updated as changes occur.In clinical care, caregivers communicate with each other through a common vocabulary. In an analogous fashion, the integrity of clinical research depends on firm adherence to prespecified procedures for patient enrollment and follow-up; these procedures are guaranteed through careful attention to definitions enumerated in the study design and case report forms. When data elements and definitions are standardized across studies, comparison, pooled analysis, and meta-analysis are enabled, thus deepening our understanding of individual studies.The recent development of quality-performance measurement initiatives, particularly those for which the comparison of providers is an implicit or explicit aim, has further raised awareness about the importance of data standards. Indeed, a wide audience, including nonmedical professionals such as payers, regulators, and consumers, may draw conclusions about care and outcomes. To understand and compare care patterns and outcomes, the data elements that characterize them must be clearly defined, consistently used, and properly interpreted, now more than ever before.Robert C. Hendel, MD, FACC, FAHA Chair, ACCF/AHA Task Force on Clinical Data Standards1. IntroductionIn the field of cardiology, large-scale clinical trials and registries have provided a wealth of data on the treatment and outcomes for hundreds of thousands of patients. Many of these efforts have focused on patients with acute coronary syndromes (ACS), which range from ST-segment elevation myocardial infarction (STEMI) to non–ST-segment elevation myocardial infarction (NSTEMI) to unstable angina (UA). These data have been used to evaluate the effectiveness of the pharmacological and interventional management of these patients, define new therapies, and guide clinical care through evaluation of both the process and the quality of care and outcomes for patients with ACS.The ACCF and AHA, in conjunction with other professional medical organizations and government agencies, recognize the importance of using clinical data and, to that end, have aimed to establish a series of datasets in the major areas of cardiology.2–7 In 2001, a dataset was established for the field of ACS; a working group developed a list of key data elements to characterize patients with ACS. This document served as the basis for data definitions for many data elements in the ACTION Registry–Get With The Guidelines (AR-G), Get With The Guidelines–CAD (GWTG-CAD), and other trials and registries. To date, this document has been cited in 255 publications.Given the overlap of ACS and coronary artery disease (CAD), it was decided to update this list of data elements and expand it to include CAD. The current group of organizations also has been expanded to include as many organizations with an interest in clinical data standards for ACS/CAD as could be identified. In addition, the cardiac catheterization/percutaneous coronary intervention (Cath/PCI) registry of the National Cardiovascular Data Registry also includes patients with ACS and CAD, and as such the elements overlap as well. Thus, the goal was to create definitions that could serve registries in all these areas and in particular those that matched between AR-G and Cath/PCI.The writing committee hopes that this set of data elements and definitions for patients with ACS and CAD will help facilitate research and assessment of quality of care, thereby advancing the practice of medicine.2. Methodology2.1. Writing Committee CompositionThe process undertaken in developing these clinical data standards began with the ACCF/AHA Task Force on Clinical Data Standards, which identified ACS as an important area in which to standardize definitions and registries. A writing committee was formed that included a select group of physicians who have been involved in large-scale ACS clinical trials or registries and who are recognized experts in the field. The committee also included members who are considered to be experts in the diagnosis and treatment of stable CAD. Additionally, the writing committee includes several international members to ensure balance in the data elements and the type of practice worldwide that would be reflected by the data collected in this dataset. The writing committee also included representatives from the American College of Chest Physicians, American College of Emergency Physicians, American College of Physicians, American College of Preventive Medicine, American Medical Association, Emergency Nurses Association, National Association of Emergency Medical Technicians, National Association of EMS Physicians, Preventive Cardiovascular Nurses Association, Society for Academic Emergency Medicine, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Patient Care, Society of General Internal Medicine, and Society of Thoracic Surgeons.2.2. Relationships With Industry and Other EntitiesDisclosure of all relationships with industry and other entities (RWI) is required of every member of ACCF/AHA data standards writing committees and peer reviewers. This writing effort was initiated before the implementation of the updated ACCF and AHA policy on relationships with industry and other entities, which requires that a majority of the writing committee plus the writing committee chair have no relationships with industry and other entities relevant to the document. Relevant relationships disclosed by writing committee members and peer reviewers are listed in Appendixes 1 and 2, respectively. The work of the writing committee was supported exclusively by the ACCF and AHA (and the other partnering organizations) without commercial support. Writing committee members volunteered their time for this effort. Meetings of the writing committee were confidential and attended only by committee members and staff.Appendix 1. Author Relationships With Industry and Other Entities—2013 Accf/Aha Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery DiseaseCommittee MemberEmployer/TitleConsultantSpeakerOwnership/ Partnership/ PrincipalResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessChristopher P. Cannon, ChairBrigham and Women's Hospital—Principal Investigator, TIMI Study Group• Alnylam• Automedics Medical Systems• Bristol-Myers Squibb• CSL Behring• PfizerNone• Automedics Medical Systems• Accumetrics• AstraZeneca• Aventis-Bristol-Myers Squibb• Essentialis• GlaxoSmithKline• Merck• Merck-Schering Plough• Regeneron/Sanofi• Schering Plough• TakedaNoneNoneRalph G. BrindisOakland Kaiser Medical Center—Senior Regional Advisor for Cardiovascular DiseasesNoneNoneNoneNoneNoneNoneBernard R. ChaitmanSt. Louis University School of Medicine–Core ECG Laboratory—Director, Cardiovascular Research• AstraZeneca• CV Therapeutics• Eli Lilly• Merck• Pfizer• Sanofi-aventis• AstraZeneca• CV Therapeutics• PfizerNone• CV Therapeutics• MerckNoneNoneDavid J. CohenSt. Luke's Medical Center—Director, Cardiovascular Research• Boehringer Ingelheim• Eli Lilly• Medtronic• Daiichi Sankyo• Eli LillyNone• AstraZeneca• Boston Scientific• Daiichi Sankyo• Edwards Lifesciences• Eli Lilly• Medtronic• St. Jude MedicalNoneNoneJ. Thomas Cross, JrMedStudy Corporation—Director of Medical EducationNoneNoneNoneNoneNoneNoneJoseph P. Drozda, JrMercy Health—Director of Outcomes ResearchNoneNoneNoneNoneNoneNoneFrancis M. FesmireUniversity of Tennessee Health Science Center—Associate ProfessorNoneNoneNoneNoneNoneNoneDan J. FintelNorthwestern University Feinberg School of Medicine—Professor of Medicine• Merck-Schering Plough• Sanofi-aventis• Schering Plough• AstraZeneca• Merck-Schering Plough• Sanofi-aventis• Schering PloughNoneNone• Merck-Schering Plough• Sanofi-aventis• Schering PloughNoneGregg C. FonarowAhmanson-UCLA Cardiomyopathy Center Division of CardiologyNone• AstraZeneca• Aventis Bristol-Myers Squibb• Bristol-Myers Squibb Sanofi• GlaxoSmithKline• Guidant• Medtronic• Merck-Schering Plough• Nitromed• Pfizer• St. JudeNone• GlaxoSmithKline• MedtronicNoneNoneKeith A. FoxEdinburgh University Chancellor's Building—President, British Cardiac SocietyNoneNoneNoneNoneNoneNoneDarryl T. GrayAgency for Healthcare Research Quality—Medical OfficerNoneNoneNoneNoneNoneNoneRobert A. HarringtonDuke Clinical Research Institute, Duke University Medical Center—Professor of Medicine, DirectorNoneNoneNoneNoneNoneNoneKaren A. HicksUS Food and Drug Administration—Medical OfficerNoneNoneNoneNoneNoneNoneJudd E. HollanderUniversity of Pennsylvania Department of Emergency MedicineNoneNoneNone• Abbott• Allere• Brahms• Nanosphere• SiemensNoneNoneHarlan KrumholzYale University School of Medicine—Professor of Medicine• Alere• Amgen• United Health• VHA, IncNoneNone• American College of Cardiology• Colorado Foundation for Medical CareNoneNoneDarwin R. LabartheCenters for Disease Control and Prevention—retiredNoneNoneNoneNoneNoneNoneJanet B. LongRhode Island Cardiology Center—Nurse PractitonerNone• AstraZenecaNoneNoneNoneNoneAlice M. MascetteNational Heart, Lung, and Blood Institute Division of Cardiovascular Sciences—Senior Clinical Science AdvisorNoneNoneNoneNoneNoneNoneConnie MeyerJohnson County Med-Act (Olathe, KS)—Emergency Medical Services CaptainNoneNoneNoneNoneNoneNoneEric D. PetersonDuke Clinical Research Institute, Duke University Medical Center—Professor of Medicine; Director, Cardiovascular OutcomesNoneGenentechNone• Aventis-Bristol-Myers Squibb• Corgentech• CV Therapeutics• Merck• Schering PloughNoneNoneMartha J. RadfordNew York University Hospitals Center—Professor of Medicine, Chief Quality OfficerNoneNoneNoneNoneNoneNoneMatthew T. RoeDuke Clinical Research Institute, Duke University Medical Center—Associate Professor of Medicine• Genentech• Novartis• Aventis-Bristol-Myers Squibb• Daiichi Sankyo• KAI Pharmaceuticals• Schering PloughNone• Aventis-Bristol-Myers Squibb• Daiichi Sankyo• Eli Lilly• KAI Pharmaceuticals• Schering PloughNoneNoneJames B. RichmannBluejay Consulting—ConsultantNoneNoneNoneNoneNoneNoneHarry P. SelkerTufts Medical Center—Executive Director of the Institute for Clinical Research and Health Policy Studies; Tufts University—Dean of Tufts Clinical and Translational Science InstituteNoneNoneNoneNoneNoneNoneDavid M. ShahianMassachusetts General Hospital—Associate Director of the Codman Center for Clinical Effectiveness in SurgeryNoneNoneNoneNoneNoneNoneRichard E. ShawCalifornia Pacific Medical Center—Director–Research, Quality and EducationNoneNoneNone• Duke Clinical Research Institute• Schering PloughNoneNoneSharon SprengerThe Joint CommissionNoneNoneNoneNoneNoneNoneRobert SworWilliam Beaumont HospitalNoneNoneNoneNoneNoneNoneJames A. UnderbergNYU Langone Center for Cardiovascular Disease Prevention; Bellevue Hospital Lipid Clinic—Director• Genzyme• Liposcience• Aboott• AstraZeneca• Daiichi Sankyo• DiaDexus• Eli Lilly• GlaxoSmithKline• KowaNone• KowaNoneNoneFrans Van de WerfUniversity Hospitals Leuven—Professor of CardiologyNoneNoneNoneNoneNoneNoneBonnie H. WeinerSt. Vincent Hospital Worcester Medical Center—Director of Interventional Cardiology ResearchNoneNoneNoneNoneNoneNoneWilliam S. WeintraubChristiana Care Health System—Section Chief, Cardiology• AstraZeneca• Bayer• Bristol-Myers Squibb• Cardionet• Eli Lilly• Pfizer• ShionogiNoneNone• Abbott• AstraZeneca• Bristol-Myers Squibb• Otsuka• Sanofi-aventisNone• 2011—Oral contraceptive litigation—represented defendant for general epidemiologic testimony• 2009—Aprotinin litigation—represented defendant as an expert witness for AprotininThis table represents the relationships of committee members with industry and other entities that were reported by authors 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 ≥$10000 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. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted.Appendix 2. Peer Review Relationships With Industry and Other Entities—2013 Accf/Aha Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery DiseasePeer ReviewerRepresentationConsultantSpeakerOwnership/Partnership/PrincipalResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessRobert A. GuytonACCF—Board of TrusteesNoneNoneNone• National Institutes of HealthNone• 2011—Represented defendant—aortic dissection during coronary bypassJafna L. CoxACCF—Board of Governors• AstraZeneca• Bayer• Boehringer-Ingelheim• Sanofi-aventisNoneNoneNone• Heart and Stroke Foundation of Nova ScotiaNoneLloyd KleinAmerican Heart AssociationNoneNoneNoneNoneNoneNoneBiykem BozkurtACCF/AHA Data Standards Task Force Lead ReviewerNoneNoneNone• Forest Pharmaceuticals• Amgen• Corthera• National Institutes of Health• NovartisNoneDarice AllardOfficial Reviewer—Society of Chest Pain Centers and ProvidersNoneNoneNoneNoneNoneNoneLes R. BeckerOfficial Reviewer—National Association of Emergency Medical TechniciansNoneNoneNoneNoneNoneNoneDeborah DiercksOfficial Reviewer—American College of Emergency PhysiciansNoneNoneNoneNoneNoneNoneRobert S. GibsonOfficial Reviewer—American College of PhysiciansNoneNoneNoneNoneNoneNoneDiane GurneyOfficial Reviewer—Emergency Nurses AssociationNoneNoneNoneNoneNoneNoneJane Nelson-WorelOfficial Reviewer—Preventive Cardiovascular Nurses AssociationNoneNoneNoneNoneNoneNoneRichard L. PragerOfficial Reviewer—Society of Thoracic SurgeonsNoneNoneNoneNoneNoneNoneClyde B. SchecterOfficial Reviewer—American College of Preventive MedicineNoneNoneNoneNoneNoneNoneDavid K. TanOfficial Reviewer—National Association of EMS PhysiciansNoneNoneNoneNoneNoneNoneShari TargumOfficial Reviewer—Food and Drug AdministrationNoneNoneNoneNoneNoneNoneMichael D. BrownContent ReviewerNoneNoneNoneNoneNoneNoneAngus JamesonContent ReviewerNoneNoneNoneNoneNoneNoneRobert L. McNamaraContent Reviewer• Boehringer-Ingelheim• Ortho-McNeillNoneNoneNoneNoneNoneMark MenegusContent ReviewerNoneNoneNoneNoneNoneNoneJoyce L. RossContent ReviewerNoneNoneNoneNoneNoneNoneThomas TsaiContent ReviewerNoneNoneNoneNoneNoneNoneThis table represents the relevant relationships with industry and other entities that were disclosed by reviewers 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 $10000 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. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Participation in the peer review process does not imply endorsement of this document.2.3. Review of Literature and Existing Data DefinitionsWriting committee members compiled and reviewed case report forms, data elements, and data definitions from national and international ACS registries and previous or ongoing clinical trials to develop an initial set of data elements. Examples of these data sources included in the first round are the NRMI (National Registry of Myocardial Infarction),8 GRACE (Global Registry of Acute Coronary Events),9 TIMI (Thrombolysis in Myocardial Infarction),10–12 and the GUSTO (Global Use of Streptokinase and Tissue Plasminogen Activator to Open Occluded Arteries)13–15 trials, and in this update, the definitions for the Cath/PCI and AR-G, CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress Adverse outcomes with Early implementation of the ACC/AHA Guidelines),16 and ACTION Registry-GWTG17 were reviewed in detail.This document also considered data elements and how they pertain to the emergency department,16 the prehospital setting, and Mission: Lifeline.182.4. Defining Data ElementsThe data elements reflect an ongoing review of the medical literature to focus on new developments. Current scientific evidence provided the basis for the selection and definition of appropriate data elements required to evaluate and manage patients with ACS and stable CAD. Therefore, data elements and definitions were linked whenever possible to evidence-based national guidelines. For the purposes of these clinical data standards, the writing committee chose to review and cite several ACCF/AHA guidelines, including but not limited to the "ACCF/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction"19,20 and the "ACCF/AHA Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction."21 Data element definitions, particularly in the Outcomes section, were also matched to the upcoming Food and Drug Administration (FDA) definitions for major cardiovascular endpoints. In addition, the writing committee adopted the definition of myocardial infarction (MI) as published in a European Society of Cardiology/ACCF/AHA/World Heart Federation consensus document on the universal definition of MI.22 On a few occasions, data elements and definitions were linked to other national guidelines, such as the National Cholesterol Education Program (NCEP III) guidelines.23The writing committee members reviewed the list of
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