Author + information
- Published online March 5, 2013.
- Christopher P. Cannon, MD, FACC, Chair, Writing Committee,
- Ralph G. Brindis, MD, MPH, FACC, Writing Committee Member,
- Bernard R. Chaitman, MD, FACC, Writing Committee Member,
- David J. Cohen, MD, MSc, Writing Committee Member,
- J. Thomas Cross Jr, MD, MPH, Writing Committee Member*,
- Joseph P. Drozda Jr, MD, FACC, Writing Committee Member†,
- Francis M. Fesmire, MD, FACEP, Writing Committee Member‡,
- Dan J. Fintel, MD, FACC, Writing Committee Member§,
- Gregg C. Fonarow, MD, FACC, FAHA, Writing Committee Member,
- Keith A. Fox, MB, ChB, Writing Committee Member,
- Darryl T. Gray, MD, ScD, FAHA, Writing Committee Member∥,
- Robert A. Harrington, MD, FACC, FAHA, Writing Committee Member,
- Karen A. Hicks, MD, FACC, Writing Committee Member¶,
- Judd E. Hollander, MD, FACEP, Writing Committee Member#,
- Harlan Krumholz, MD, SM, FACC, Writing Committee Member,
- Darwin R. Labarthe, MD, MPH, PhD, Writing Committee Member**,
- Janet B. Long, MSN, ACNP, FAHA, Writing Committee Member††,
- Alice M. Mascette, MD, FACC, FAHA, FACP, Writing Committee Member‡‡,
- Connie Meyer, MICT, AAS, Writing Committee Member§§,
- Eric D. Peterson, MD, FACC, FAHA, Writing Committee Member,
- Martha J. Radford, MD, FACC, FAHA, Writing Committee Member,
- Matthew T. Roe, MD, MHS, FACC, Writing Committee Member,
- James B. Richmann, RN, BS, MHA, CEN, Writing Committee Member∥∥,
- Harry P. Selker, MD, MSPH, FAHA, Writing Committee Member¶¶,
- David M. Shahian, MD, FACC, FAHA, Writing Committee Member##,
- Richard E. Shaw, MA, PhD, FACC, FAHA, Writing Committee Member,
- Sharon Sprenger, RHIA, CPHQ, MPA, Writing Committee Member***,
- Robert Swor, DO, FACEP, Writing Committee Member†††,
- James A. Underberg, MD, Writing Committee Member‡‡‡,
- Frans Van de Werf, MD, FACC, Writing Committee Member,
- Bonnie H. Weiner, MD, MSEC, MBA, Writing Committee Member§§§ and
- William S. Weintraub, MD, FACC, FAHA, Writing Committee Member
- ACCF/AHA Data Standards
- acute coronary syndrome
- coronary artery disease
- data elements
- clinical outcomes
ACCF/AHA Task Force Members
Robert C. Hendel, MD, FACC, FAHA, Chair
Véronique L. Roger, MD, MPH, FAHA, FACC∥∥∥
Biykem Bozkurt, MD, FACC, FAHA
Gregg C. Fonarow, MD, FACC, FAHA
Jeffrey P. Jacobs, MD, FACC
Judith H. Lichtman, MPH, PHD
Pamela N. Peterson, MD, FACC, FAHA¶¶¶
Eric E. Smith, MD, FAHA
James E. Tcheng, MD, FACC
Tracy Wang, MD, FACC, FAHA
William S. Weintraub, MD, FACC, FAHA
Table of Contents
2.1 Writing Committee Composition......995
2.2 Relationships With Industry and Other Entities......995
2.3 Review of Literature and Existing Data Definitions......995
2.4 Defining Data Elements......996
2.5 Relation to Other Standards......996
2.6 Consensus Development......996
2.7 Peer Review, Public Review, and Board Approval......996
2.8 Considerations for ACS and CAD Data Standards......998
3. ACS and CAD Clinical Data Standard Elements and Definitions......1002
3.1 Demographic and Admission Data Elements......1002
3.2 History and Risk Factors Data Elements......1003
3.3 Clinical Presentation Data Elements......1003
3.4 Diagnostic Procedure Data Elements......1003
3.5 Invasive Therapeutic Intervention Data Elements......1003
3.6 Medications Table of Data Elements......1004
3.7 Outcomes Data Elements......1014
Appendix 1. Author Relationships With Industry and Other Entities......1022
Appendix 2. Peer Review Relationships With Industry and Other Entities......1024
The 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 are
1. To establish a consistent, interoperable, and universal clinical vocabulary as a foundation for both clinical care and clinical research
2. To promote the ubiquitous use of EHRs and facilitate the exchange of data across systems through harmonized, standardized definitions of key data elements
3. To 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 initiatives
The 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 therapies.
The 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 regulations (1) 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 Standards
In 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.
2.1 Writing Committee Composition
The 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 Entities
Disclosure 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.
2.3 Review of Literature and Existing Data Definitions
Writing 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- GWTG (17) were reviewed in detail.
2.4 Defining Data Elements
The 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 (23).
The writing committee members reviewed the list of data elements, bearing in mind the intent of their use. For example, some data elements are suitable for use in developing and implementing risk adjustment models, whereas others can be used to construct performance measures. Several data elements can be used for multiple purposes. Additional uses of the data include identification of patient demographics for combining data across registries and disease states, institutional and regional variances that may be addressed in health services research, patient follow-up for evaluation of long-term effects of therapy, and outcomes analysis.
2.5 Relation to Other Standards
The writing committee reviewed other standards, including those developed for heart failure, atrial fibrillation, electrophysiology, and cardiac imaging. It was thought that this writing committee possessed key levels of expertise needed to address issues related to ACS and CAD in a consistent fashion.
2.6 Consensus Development
The writing committee met several times in person and by conference call to refine the data standards to their present form. The overriding goals were to focus on important variables needed to assess patients' characteristics, their treatment with both medication and interventional therapies, and their outcomes. In developing the list of data elements, the writing committee worked to balance the completeness of the dataset in describing ACS with the length of the data element set. The goal was to be as concise as possible to facilitate the use of these variables in real-world registry or trial settings. Standardized definitions for each variable are provided. In assembling these, the writing committee again balanced the increased complexity of obtaining more specific and detailed data required to satisfy more comprehensive definitions against information that can be readily and reliably obtained from medical records to make these definitions more functional and applicable in the various real-world settings in which they may be used.
2.7 Peer Review, Public Review, and Board Approval
The “2013 ACCF/AHA Key Elements and Data Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes and Coronary Artery Disease” was reviewed by official reviewers nominated by the ACCF and AHA, as well as official reviewers designated by collaborating societies. To increase its applicability further, the document was posted on the ACC World Wide Web site for a 30-day public comment period. This document was approved for publication by the ACCF Board of Trustees on October 19, 2012, and AHA Science Advisory and Coordinating Committee on November 30, 2012, and was formally endorsed by the American College of Emergency Physicians, Emergency Nurses Association, National Association of Emergency Medical Technicians, National Association of EMS Physicians, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Patient Care, and Society of Thoracic Surgeons. The writing committee anticipates that these data standards will require review and updating, just as with other published guidelines, performance measures, and appropriateness criteria. The writing committee will review the set of data elements on a periodic basis, starting with the anniversary of publication of the standards, to ascertain whether modifications should be considered.
2.8 Considerations for ACS and CAD Data Standards
There are many goals that this project hopes to fulfill by providing a list of key data elements and standardized definitions in ACS and CAD (Table 1). First, it is hoped that standardized definitions will facilitate better cross-comparison of results and clinical outcomes between different clinical trials and registries. This is particularly true for meta-analyses of clinical trials, where differences in data collection methods and variations in definitions have hampered the validity of these analyses. Furthermore, the standardized definitions would also facilitate the application of research findings that come from the clinical trials and registries, because the key elements needed for assessment of efficacy, safety, and appropriate risk adjustment would be included in the clinical data standards.
Second, the provision of a list of the major variables, outcomes, and definitions should facilitate the development and implementation of future registries at both individual hospital and national levels. The standardized definitions should also standardize and enhance the reporting of research findings coming from the clinical trials and registries, because the key elements needed for assessment of efficacy and safety and for appropriate risk adjustment would be included in the dataset. In fact, the ACS CAD clinical data standards could be used in their entirety to develop a registry. For example, the AR-G includes 81 of the data elements discussed in this document.
Third, the use of standardized definitions and registry data should facilitate quality improvement by collecting data on these data elements as part of a quality-improvement program at a hospital, state, or national level and thereby improve both the process of care and clinical outcomes.
Fourth, these data elements and definitions can be used in the development of performance measures by identifying underutilization of therapies (24–27). They could be used to compare various subgroups of patients in the various performance measures and to identify certain groups for whom medications are underused (e.g., the GWTG age and gender paper). These elements would also fit very well with longitudinal follow-up studies, where the same definitions could be used by hospitals and outpatient providers to monitor a patient's adherence to medication and clinical course.
Fifth, the list of data elements and definitions could become the basis for developing a standardized charting process with the anticipation that medical charting used in the process of delivering care could progressively move toward an electronic format. The specifics of coding elements in EHRs are a large and evolving area. Many other groups are working on this; details are beyond the scope of this document but would need to be provided before implementation.
Sixth, appropriate collection of confounding characteristics will allow adjustment for comorbidities and other variables that may affect outcomes and quality metrics between different providers, hospitals, and geographical networks and ensure scientific comparisons.
Finally, considering the application of these data elements to use in the real-world setting, the writing committee paid close attention to the level of detail required to fully describe certain variables, such as timing of prior cardiovascular events, timing of procedures, specific drug names versus classes of drugs, and types of insurance. The committee agreed that for these or any of the data elements listed, the user can decide to collect more or less information, depending on the circumstance. For example, if a hospital association were compiling a registry to assess the relationship of patient insurance status with use of cardiac procedures and their outcomes, the group might elect to use more subcategorizations than listed in this document. On the other hand, if a pharmaceutical company were doing a study to evaluate the use of a new drug for UA, type of insurance might not matter and could be omitted. A third example would be if a community hospital wished to track its use of new therapies, such as new antiplatelet agents, for which as few as 10 of the listed elements might be collected on patients. Thus, this listing of data elements and definitions could be expanded or condensed to meet the needs of the study or project in which they are being used. However, the users would not want to adapt the individual definitions since that would no longer allow direct comparison of these elements to other studies using these standard definitions.
These data elements could also be expanded to include additional information, such as all the detailed relative contraindications to aspirin or beta blockers or for careful measurement of performance measures, as was done in the Cooperative Cardiovascular Project (28). Expansion of the variables collected would also be expected in the setting of a randomized clinical trial of a new drug, for which more information would be required on additional study procedures and drug therapies. Thus, depending on the intended use of the variables, the number of data elements used could be restricted or expanded. In either case, the definitions provided in this document should assist in standardizing the process. It should also be noted that other data elements and measures may be important in the assessment of patients with ACS. For example, quality-of-life measures such as the Seattle Angina Questionnaire (29) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) (30) have been used extensively in the evaluation of outcome in cardiac patients. Those developing registries and performing clinical trials are encouraged to adopt a similar approach in evaluating and choosing measures so that these efforts will be more easily integrated into future data standards for patients with ACS.
3 ACS and CAD Clinical Data Standard Elements and Definitions
3.1 Demographic and Admission Data Elements
There are 5 demographic data elements that include the patient's sex, date of birth, race, and ethnicity, and the postal code for the patient's residence. It is intended that these elements be collected once for each patient. The race and ethnicity data elements are defined in a way that is consistent with the standard formats suggested by the U.S. Department of Health and Human Services, which includes identification of Hispanic or Latino ethnicity. The postal code for the patient's residence is included to permit geographical analysis of results and comparison with other cardiovascular registry data analyses.
Sixteen data elements and definitions describe the status of care for the current data collection (inpatient or outpatient); for inpatients, details include date of admission, source of admission, information about payment type, information about first medical contact, date and time of arrival and transfer to an outside facility, mode of transport to the local facility, and location and time of first evaluation in the local facility. These data elements define the critical aspects of timing and level of acuity for the presentation of this patient to the healthcare system. They provide the initial elements of information that articulate risk for the patient and the impact of these factors on the entire episode of care and its outcomes. Data elements for admission source and type have been standardized in recent recommendations by the Centers for Medicare & Medicaid Services and The Joint Commission.
3.2 History and Risk Factors Data Elements
Assessment of the patient's cardiovascular and general medical history is necessary for assessing risk and for a fuller understanding of variations in outcome. The information is also critical in applying these results to targeted quality-improvement efforts and for comparison of these data with clinical trial results. Many of the data elements in this section (Table 2) are common to risk models that have been developed to predict outcome in patients undergoing PCI and cardiac surgery (31). The element capturing the history of MI (and all data elements in this dataset referring to MI) incorporates the recent elements for the universal definition of MI (22). Definitions and categorization of stages of heart failure follow recent recommendations proposed by the ACCF/AHA data standards document on heart failure (4). The definitions for peripheral arterial disease were taken from recent work by the Peripheral Atherosclerotic Vascular Disease Data Standards document (32). The writing committee attempted to include only data elements that were pertinent to characterizing the risk of the patient. In addition, specific coding descriptors and detailed definitions have been provided so that medical abstractors should be able to code most of these data elements with information that is available as part of the standard process of documenting the delivery of care. Software and applications are now being developed to automatically pull information on some data elements from EHRs. It would be optimal if the algorithms these programs use could follow the standard definitions.
3.3 Clinical Presentation Data Elements
Clinical presentation data elements (Table 3) include the date and time of symptom onset, the presence of positive biomarkers (troponin I or T, CK-MB, or bedside troponin) within the first 24 hours of initial presentation that exceed the locally defined upper limits of normal, heart failure on first medical contact, height, weight, waist circumference, Killip class, heart rate, systolic blood pressure on first medical contact, angina type with number of episodes and possible secondary causes, and syncope. Presenting symptoms are well described in the data definition and along with the presence of biomarkers are key indicators for defining the patient with ACS. Height and weight are important parameters in calculating body surface area and determining whether pharmacological dosing was therapeutic or above acceptable thresholds. Killip class has been a useful classification system and is included with specific criteria for determination of the appropriate level.
3.4 Diagnostic Procedure Data Elements
Findings on the ECG provide the most important information in stratifying patients as those with STEMI and those with NSTEMI. Because it is becoming more common for emergency medical services personnel to perform a prehospital 12-lead ECG on initial contact with a patient with suspected MI or ACS in the field, data elements are included to track the date, time, and location of the first ECG. The data definition provides detailed criteria for categorizing electrocardiographic findings as ST-segment elevation, new left bundle-branch block, or isolated inferobasal MI. Location of electrocardiographic changes and other pertinent findings (new ST-segment depression, new T-wave inversion, etc.) are collected. Data elements are also included for laboratory tests that are routinely performed on patients with CAD, including total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides. Other laboratory values supporting the evaluation of cardiac function, metabolic syndrome, and liver and renal function (brain natriuretic peptide, glucose, hemoglobin A1c, hematocrit, and creatinine) are collected and provide easily obtained information that characterizes the patient's general status and gives data that can be used to further risk-stratify patient outcomes. Table 4 includes troponin, creatinine kinase (CK) and creatinine kinase–MB isoenzyme (CK-MB) with first and peak levels for these markers. However, if more precision on timing of CK-MB is desired, the full set of these markers could be collected with dates and times so as to ensure being able to distinguish initial biomarker elevation versus post-PCI elevations.
3.5 Invasive Therapeutic Intervention Data Elements
Many clinical trials have been conducted to establish effective therapeutic approaches for the treatment of ACS as well as studies that have identified optimal timing for invasive strategies based on risk stratification of the patient (36–38). The invasive therapeutic interventions section (Table 5) includes data elements covering noninvasive stress testing, results of evaluation of maximum stenosis percent narrowing in the major epicardial systems, assessment of left ventricular ejection fraction and the modality used for this measurement, and results of diagnostic coronary angiography if performed (definition of the culprit artery, TIMI flow in the culprit artery, and stenoses in the major coronary artery systems). Because primary PCI has been established as the preferred revascularization approach for patients with STEMI and an early invasive strategy as the most effective strategy for patients with NSTEMI, data elements are included that capture the time of arrival at the catheterization laboratory, first device activation date, and time for calculating door-to-balloon time for patients with STEMI, which has been related to improved immediate and long-term outcomes in these patients (21,39,40) An important data element for PCI is the type of stent used (bare metal, drug-eluting, or other) and the number of stents used. Data elements are included that provide important modifiers that may occur in the treatment of these patients, including reasons for delay in performing PCI and reperfusion contraindications. Given that other significant therapeutic approaches may occur during hospitalization, data elements are included to track any peripheral vascular or cerebrovascular interventions, requirement for CABG surgery, use of a pulmonary artery catheter, and more advanced therapeutic techniques, including placement of an intra-aortic balloon pump, ventilator, and enhanced external counterpulsation support.
3.6 Medications Table of Data Elements
The efficacy of pharmacological therapy at symptom onset, throughout hospitalization, and at discharge from the hospital has been well established with data from both clinical trials and ACS registries (21). Antiplatelet and anticoagulant therapies are crucial in managing the cascade of thrombotic events that occur with ACS. The complexity of the pathways involved with this cascade has led to the use of multiple therapeutic agents. Aspirin, anticoagulant agents, including heparin and bivalirudin, clopidogrel, and GP IIb/IIIa inhibitors have been established as essential for the management of patients with ACS. The writing committee determined that where possible, collection of detailed data on medications (Table 6) would provide information that is critical to evaluate patient outcomes. The group determined that the important dimensions of medication administration were the type of agent used, timing (given within the first 24 hours, during hospitalization, at discharge, and during the months after hospital discharge), dosage, duration (captured by date and time of starting and stopping the medication), and contraindications. Because thrombolytic therapy is an acceptable mode of reperfusion in cases where PCI is not available, detailed information is collected on type, dosage, and timing of thrombolysis. Data collection for other medications that impact the function of the heart and the impact of coronary disease include nitrates (intravenous, oral, and topical), beta blockers, calcium channel blockers, ranolazine therapy, warfarin/new anticoagulants, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone, diuretics, statins, and other lipid-lowering medications, nonsteroidal anti-inflammatory drugs, insulin, oral hypoglycemics, influenza, and pneumococcal immunizations.
3.7 Outcomes Data Elements
Clinical trials on STEMI, NSTEMI, and UA patients and research published from ACS registries have established well-defined data elements that reflect clinically relevant outcomes in these patient groups. Outcome data elements (Table 7) that have been selected by the writing committee include death during hospitalization (with timing and primary cause being either cardiovascular or noncardiovascular), occurrence of reinfarction (using the universal definition of MI), heart failure, cardiogenic shock, stroke, TIMI major or minor bleeding, GUSTO bleeding, location of the bleeding event, surgical intervention required for bleeding, transfusion required, amount of blood given, thrombocytopenia, cardiac rupture, atrial fibrillation, ventricular arrhythmia, and atrioventricular block. Data elements have been included that capture discharge status, discharge destination, and The Joint Commission discharge core measures reflecting optimal patient care. The availability of long-term outcome data on patients with ACS is essential in determining the efficacy of therapies. Data elements have been selected for patient follow-up after discharge to reflect important aspects of patient status. These include anginal status, need for cardiac catheterization, reinfarction, revascularization (either PCI or coronary artery bypass graft), readmission to the hospital and reason for readmission, important laboratory tests about risk factors (low-density lipoprotein, high-density lipoprotein, hemoglobin A1c, C-reactive protein), occurrence of heart failure and New York Heart Association class, medication use, and death (timing and cause). The timing of collection of outcomes can be determined by the specific registry or trial; for example, in-hospital outcomes versus 30 days versus 1 year.
The writing committee also recognizes the efforts of other groups in standardizing cardiovascular definitions, specifically, the 2012 third universal definition of MI (22) and the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Cardiovascular Trials” (41) from the FDA, which is currently in development. It should also be noted that the writing committee believes that further research is needed from large observational databases to identify the actual trends in duration of UA; however, the timing criteria for UA in this document was revised to ≥10 minutes to align with the FDA's Standardized Definitions for End Point Events in Cardiovascular Trials definition. Future iterations of the ACCF/AHA ACS/CAD data standards data elements and definitions will be harmonized with the work of the universal definition of MI Group, the FDA, and other groups.34
Presidents and Staff
American College of Cardiology Foundation
William A. Zoghbi, MD, FACC, President
Thomas E. Arend, Jr. Esq., CAE, Interim Chief Staff Officer
William J. Oetgen, MD, MBA, FACC, Senior Vice President, Science and Quality
Charlene L. May, Senior Director, Science and Clinical Policy
Melanie Shahriary, RN, BSN, Director, Performance Measures and Data Standards
Erin A. Barrett, MPS, Senior Specialist, Science and Clinical Policy
American College of Cardiology Foundation/American Heart Association
Maria Lizza D. Isler, BSMT, Specialist, Clinical Data Standards
American Heart Association
Donna K. Arnett, PhD, MSPH, BSN, FAHA, President
Nancy Brown, Chief Executive Officer
Rose Marie Robertson, MD, FACC, FAHA, Chief Science Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations
Melanie Turner, MPH, Associate Science and Medicine Advisor, Office of Science Operations
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 Disease
|Committee Member||Employer/Title||Consultant||Speaker||Ownership/ Partnership/ Principal||Research||Institutional, Organizational, or Other Financial Benefit||Expert Witness|
|Christopher P. Cannon, Chair||Brigham and Women's Hospital—Principal Investigator, TIMI Study Group||None||None||None|
|Ralph G. Brindis||Oakland Kaiser Medical Center—Senior Regional Advisor for Cardiovascular Diseases||None||None||None||None||None||None|
|Bernard R. Chaitman||St. Louis University School of Medicine–Core ECG Laboratory—Director, Cardiovascular Research||None||None||None|
|David J. Cohen||St. Luke's Medical Center—Director, Cardiovascular Research||None||None||None|
|J. Thomas Cross, Jr||MedStudy Corporation—Director of Medical Education||None||None||None||None||None||None|
|Joseph P. Drozda, Jr||Mercy Health—Director of Outcomes Research||None||None||None||None||None||None|
|Francis M. Fesmire||University of Tennessee Health Science Center—Associate Professor||None||None||None||None||None||None|
|Dan J. Fintel||Northwestern University Feinberg School of Medicine—Professor of Medicine||None||None||None|
|Gregg C. Fonarow||Ahmanson-UCLA Cardiomyopathy Center Division of Cardiology||None||None||None||None|
|Keith A. Fox||Edinburgh University Chancellor's Building—President, British Cardiac Society||None||None||None||None||None||None|
|Darryl T. Gray||Agency for Healthcare Research Quality—Medical Officer||None||None||None||None||None||None|
|Robert A. Harrington||Duke Clinical Research Institute, Duke University Medical Center—Professor of Medicine, Director||None||None||None||None||None||None|
|Karen A. Hicks||U.S. Food and Drug Administration—Medical Officer||None||None||None||None||None||None|
|Judd E. Hollander||University of Pennsylvania Department of Emergency Medicine||None||None||None||None||None|
|Harlan Krumholz||Yale University School of Medicine—Professor of Medicine||None||None||None||None|
|Darwin R. Labarthe||Centers for Disease Control and Prevention—retired||None||None||None||None||None||None|
|Janet B. Long||Rhode Island Cardiology Center—Nurse Practitoner||None||None||None||None||None|
|Alice M. Mascette||National Heart, Lung, and Blood Institute Division of Cardiovascular Sciences—Senior Clinical Science Advisor||None||None||None||None||None||None|
|Connie Meyer||Johnson County Med-Act (Olathe, KS)—Emergency Medical Services Captain||None||None||None||None||None||None|
|Eric D. Peterson||Duke Clinical Research Institute, Duke University Medical Center—Professor of Medicine; Director, Cardiovascular Outcomes||None||None||None||None|
|Martha J. Radford||New York University Hospitals Center—Professor of Medicine, Chief Quality Officer||None||None||None||None||None||None|
|Matthew T. Roe||Duke Clinical Research Institute, Duke University Medical Center—Associate Professor of Medicine||None||None||None|
|James B. Richmann||Bluejay Consulting—Consultant||None||None||None||None||None||None|
|Harry P. Selker||None||None||None||None||None||None|
|David M. Shahian||Massachusetts General Hospital—Associate Director of the Codman Center for Clinical Effectiveness in Surgery||None||None||None||None||None||None|
|Richard E. Shaw||California Pacific Medical Center—Director–Research, Quality and Education||None||None||None||None||None|
|Sharon Sprenger||The Joint Commission||None||None||None||None||None||None|
|Robert Swor||William Beaumont Hospital||None||None||None||None||None||None|
|James A. Underberg||NYU Langone Center for Cardiovascular Disease Prevention; Bellevue Hospital Lipid Clinic—Director||None||None||None|
|Frans Van de Werf||University Hospitals Leuven—Professor of Cardiology||None||None||None||None||None||None|
|Bonnie H. Weiner||St. Vincent Hospital Worcester Medical Center—Director of Interventional Cardiology Research||None||None||None||None||None||None|
|William S. Weintraub||Christiana Care Health System—Section Chief, Cardiology||None||None||None|
This 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 ≥$10,000 of the fair market value of the business entity; or iffunds 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 Disease
|Peer Reviewer||Representation||Consultant||Speaker||Ownership/ Partnership/ Principal||Research||Institutional, Organizational, or Other Financial Benefit||Expert Witness|
|Robert A. Guyton||ACCF—Board of Trustees||None||None||None||None|
|Jafna L. Cox||ACCF—Board of Governors||None||None||None||None|
|Lloyd Klein||American Heart Association||None||None||None||None||None||None|
|Biykem Bozkurt||ACCF/AHA Data Standards Task Force Lead Reviewer||None||None||None||None|
|Darice Allard||Official Reviewer—Society of Chest Pain Centers and Providers||None||None||None||None||None||None|
|Les R. Becker||Official Reviewer—National Association of Emergency Medical Technicians||None||None||None||None||None||None|
|Deborah Diercks||Official Reviewer—American College of Emergency Physicians||None||None||None||None||None||None|
|Robert S. Gibson||Official Reviewer—American College of Physicians||None||None||None||None||None||None|
|Diane Gurney||Official Reviewer—Emergency Nurses Association||None||None||None||None||None||None|
|Jane Nelson-Worel||Official Reviewer–Preventive Cardiovascular Nurses Association||None||None||None||None||None||None|
|Richard L. Prager||Official Reviewer—Society of Thoracic Surgeons||None||None||None||None||None||None|
|Clyde B. Schecter||Official Reviewer–American College of Preventive Medicine||None||None||None||None||None||None|
|David K. Tan||Official Reviewer—National Association of EMS Physicians||None||None||None||None||None||None|
|Shari Targum||Official Reviewer—Food and Drug Association||None||None||None||None||None||None|
|Michael D. Brown||Content Reviewer||None||None||None||None||None||None|
|Angus Jameson||Content Reviewer||None||None||None||None||None||None|
|Robert L. McNamara||Content Reviewer||None||None||None||None||None|
|Mark Menegus||Content Reviewer||None||None||None||None||None||None|
|Joyce L. Ross||Content Reviewer||None||None||None||None||None||None|
|Thomas Tsai||Content Reviewer||None||None||None||None||None||None|
This 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 $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. 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.
↵* American College of Physicians Representative.
↵† American Medical Association Representative.
↵‡ American College of Emergency Physicians Representative.
↵§ American College of Chest Physicians Representative.
↵∥ Agency for Healthcare Research and Quality Representative. The findings and conclusions in this report are those of the author and do not necessarily represent the official positions of the Agency for Healthcare Research and Quality.
↵¶ Food and Drug Administration Representative. The findings and conclusions in this report are those of the author and do not necessarily represent the official positions of the Food and Drug Administration.
↵# Society for Academic Emergency Medicine Representative.
↵** Centers for Disease Control and Prevention Representative. The findings and conclusions in this report are those of the author and do not necessarily represent the official positions of the Centers for Disease Control and Prevention.
↵†† Preventive Cardiovascular Nurses Association Representative.
↵‡‡ National Heart, Lung, and Blood Institute Representative. The findings and conclusions in this report are those of the author and do not necessarily represent the official positions of the National Heart, Lung, and Blood Institute.
↵§§ National Association of Emergency Medical Technicians Representative.
↵∥∥ Emergency Nurses Association Representative.
↵¶¶ Society of General Internal Medicine Representative.
↵## Society of Thoracic Surgeons Representative.
↵*** The Joint Commission Representative. The findings and conclusions in this report are those of the author and do not necessarily represent the official positions of The Joint Commission.
↵††† National Association of EMS Physicians Representative.
↵‡‡‡ American College of Preventive Medicine Representative.
↵§§§ Society for Cardiovascular Angiography and Interventions Representative.
↵∥∥∥ Former Task Force Chair during this writing effort
↵¶¶¶ Former Task Force Member during this writing effort
Developed in Collaboration with American College of Emergency Physicians, Emergency Nurses Association, National Association of Emergency Medical Technicians, National Association of EMS Physicians, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Patient Care, and Society of Thoracic Surgeons
This document was approved by the American College of Cardiology Foundation Board of Trustees October 19, 2012, and by the American Heart Association Science Advisory and Coordinating Committee November 30, 2012, as well as endorsed by the following societies in November 2012: American College of Emergency Physicians, Emergency Nurses Association, National Association of Emergency Medical Technicians, National Association of EMS Physicians, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Patient Care, and Society of Thoracic Surgeons.
The American College of Cardiology Foundation requests that this document be cited as follows: Cannon CP, Brindis RG, Chaitman BR, Cohen DJ, Cross JT Jr, Drozda JP Jr, Fesmire FM, Fintel DJ, Fonarow GC, Fox KA, Gray DT, Harrington RA, Hicks KA, Hollander JE, Krumholz H, Labarthe DR, Long JB, Mascette AM, Meyer C, Peterson ED, Radford MJ, Roe MT, Richmann JB, Selker HP, Shahian DM, Shaw RE, Sprenger S, Swor R, Underberg JA, Van de Werf F, Weiner BH, Weintraub WS. 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: a 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). J Am Coll Cardiol 2013;61:xxx–xxx, doi:10.1016/j.jacc.2012.10.005.
This article is copublished in Circulation and Critical Pathways in Cardiology.
Copies: This document is available on the World Wide Web sites of the American College of Cardiology (http://www.cardiosource.org) and the American Heart Association (my.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail .
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology Foundation. Please contact.
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- Table of Contents
- 1 Introduction
- 2 Methodology
- 3 ACS and CAD Clinical Data Standard Elements and Definitions
- Presidents 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 Disease
- 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 Disease