2022 ACC/AHA Key Data Elements and Definitions for Chest Pain and Acute Myocardial Infarction: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Data Standards
2022; Lippincott Williams & Wilkins; Volume: 15; Issue: 10 Linguagem: Inglês
10.1161/hcq.0000000000000112
ISSN1941-7705
AutoresH. Vernon Anderson, Sofia Carolina Masri, Mouin Abdallah, Anna Marie Chang, Mauricio G. Cohen, Islam Y. Elgendy, Martha Gulati, Kathleen LaPoint, Nidhi Madan, Issam Moussa, Jorge Ramirez, April W. Simon, Vikas Singh, Stephen W. Waldo, Marlene S. Williams,
Tópico(s)Cardiovascular Function and Risk Factors
ResumoHomeCirculation: Cardiovascular Quality and OutcomesVol. 15, No. 102022 ACC/AHA Key Data Elements and Definitions for Chest Pain and Acute Myocardial Infarction: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Data Standards Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplementary MaterialsFree AccessReview ArticlePDF/EPUB2022 ACC/AHA Key Data Elements and Definitions for Chest Pain and Acute Myocardial Infarction: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Data Standards H.V. ("Skip") Anderson, MD, FACC, FAHA, Chair, Sofia Carolina Masri, MD, Vice Chair, Mouin S. Abdallah, MD, MHCM, MSc, FACC, Anna Marie Chang, MD, MSCE, Mauricio G. Cohen, MD, FACC, Islam Y. Elgendy, MD, FACC, FAHA, Martha Gulati, MD, MS, FACC, FAHA, Kathleen LaPoint, MS, Nidhi Madan, MD, MPH, Issam D. Moussa, MD, MBA, Jorge Ramirez, MD, FACC, April W. Simon, RN, MSN, Vikas Singh, MD, Stephen W. Waldo, MD, FACC and Marlene S. Williams, MD, FACC H.V. ("Skip") AndersonH.V. ("Skip") Anderson , Sofia Carolina MasriSofia Carolina Masri , Mouin S. AbdallahMouin S. Abdallah , Anna Marie ChangAnna Marie Chang , Mauricio G. CohenMauricio G. Cohen , Islam Y. ElgendyIslam Y. Elgendy , Martha GulatiMartha Gulati , Kathleen LaPointKathleen LaPoint , Nidhi MadanNidhi Madan , Issam D. MoussaIssam D. Moussa , Jorge RamirezJorge Ramirez , April W. SimonApril W. Simon , Vikas SinghVikas Singh , Stephen W. WaldoStephen W. Waldo and Marlene S. WilliamsMarlene S. Williams Originally published30 Aug 2022https://doi.org/10.1161/HCQ.0000000000000112Circulation: Cardiovascular Quality and Outcomes. 2022;15Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: August 30, 2022: Ahead of Print Table of ContentsTop 10 Take-Home Messages...820Preamble...8201. Introduction...8211.1 Abbreviations...8222. Methodology...8222.1 Writing Committee Composition...8222.2 Relationships With Industry and Other Entities...8222.3 Review of Literature and Existing Data Definitions...8222.4 Development of Terminology Concepts...8232.5 Consensus Development...8232.6 Relation to Other Standards...8232.7 Peer Review, Public Review, and Board Approval...8233. Data Elements and Definitions...8233.1 Chest Pain...8233.2. Myocardial Injury...8243.3. Myocardial Infarction...8244. Informatics of Controlled Vocabularies...8245. Future Directions and Areas for Research...825References...826Appendix 1. Author Relationships With Industry and Other Entities (Relevant)...828Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive)...829Appendix 3. Chest Pain...831Appendix 4. Myocardial Injury...854Appendix 5. Myocardial Infarction...856Top 10 Take-Home MessagesThis document presents a clinical lexicon comprising data elements related to chest pain and acute myocardial infarction (MI), in the sense and context of how these terms are used in the recently released guideline: "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain."This lexicon follows the plans contained in the new chest pain guideline. Not all conceivable types and causes of chest pain are considered here.This lexicon is designed to focus on serious cardiovascular causes of chest pain as they might be encountered in emergency departments.Data elements for etiology of chest pain syndromes are enumerated for potentially serious cardiac, as well as certain noncardiac, causes.Data elements are grouped into 3 broad categories as outlined in the new guideline: chest pain, myocardial injury, and myocardial infarction.Data elements for patient demographics, history, cardiovascular risk factors, laboratory testing, and revascularization or other therapies are not included here as they have been the subjects of other published references.The terms "typical" and "atypical" as descriptors of chest pain or anginal syndromes are not used here. In keeping with the new chest pain guideline, the terms "cardiac," "possible cardiac," and "noncardiac" are used for categorizing chest pain syndromes.Data elements for risk stratification scoring according to several common risk scoring algorithms are included.Data elements for procedure-related myocardial injury and procedure-related MI are included.This clinical lexicon and data standard should be broadly applicable in various settings, including patient care, electronic health records (EHRs), quality and performance improvement initiatives, registries, and public reporting programs.PreambleThe American College of Cardiology (ACC) and the American Heart Association (AHA) support their members' goal to improve the prevention and treatment of cardiovascular diseases through professional education, research, the development of guidelines and standards, and by fostering policy that supports optimal patient care and outcomes. The ACC and AHA also recognize the importance of using clinical data standards for patient management, assessment of outcomes, and conduct of research, as well as the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, oversight and regulatory programs, or quality improvement initiatives.Clinical data standards aim to identify, define, and standardize data elements relevant to clinical topics in cardiovascular medicine, with the primary goal of assisting data collection and use by providing a compilation of data elements and definitions applicable to various cardiovascular conditions. Broad agreement on common vocabulary and definitions is needed to pool and compare data from EHRs, clinical registries, administrative datasets, and other databases and to assess whether these data are applicable to clinical practice and research endeavors. Emerging federal standards, such as the US Department of Health & Human Services, Office of the National Coordinator for Health Information Technology, and the US Core Data for Interoperability, support efforts to "promote interoperability" and the more effective use of EHR data to improve health care quality. The purpose of clinical data standards is to contribute to the infrastructure necessary to accomplish the ACC's mission to transform cardiovascular care and improve heart health and the AHA's mission of being a relentless force for a world of longer and healthier lives for all individuals.The specific goals of clinical data standards are:To establish a consistent, interoperable, and universal clinical vocabulary as a foundation for clinical care and researchTo facilitate consistent and equitable exchange of data across systems through harmonized, standardized definitions of key data elementsTo facilitate further development of clinical registries and guidelines, quality and performance improvement programs, public reporting, and clinical research, including the comparison of results within and across these initiativesThe key data 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 implementation of clinical guidelines, 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 AHA/ACC Joint Committee on Clinical Data Standards (Joint Committee) selects cardiovascular conditions, procedures, and other topics related to cardiovascular health and medicine that will benefit from the creation of a clinical data standard set. Experts in the subject area are selected to examine and 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 standard listing may be needed. Conversely, users may want to consider whether it may be necessary to collect and incorporate additional elements. For example, in the setting of a randomized, clinical trial of a new drug, additional information would likely be required regarding study procedures and medical therapies. Alternatively, if a data set is to be used for quality improvement, safety initiatives, or administrative functions, elements such as Current Procedural Terminology (CPT) codes, International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes, or outcomes may be added. The intent of the Joint Committee is to standardize clinical concepts, focusing on the patient and clinical care and not on administrative billing or coding concepts. The clinical concepts selected for development are predominantly cardiovascular-specific and usually encompass areas where a standardized terminology does not already exist. The clinical data standards can, therefore, serve as a guide to develop administrative data sets, and complementary administrative or quality assurance elements can evolve from these core clinical concepts and elements. Thus, rather than forcing the clinical data standards to harmonize with existing administrative codes, such as ICD-10-CM or CPT codes, we envision the administrative codes to follow the lead of the clinical data standards. This approach would allow clinical care to lead standardization of cardiovascular health care terminology.The ACC 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 ones. Writing committees are instructed to consider adopting or adapting existing nationally recognized data standards if the definitions and characteristics are validated, useful, and applicable to the set under development. In addition, the ACC and AHA are committed to continually expanding their portfolio of clinical data standards and will create new standards and update existing ones as needed to maintain their currency and promote harmonization with other standards as health information technology and clinical practice evolve.The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPPA) privacy regulations, which went into effect in April 2003, emphasizes the importance of our professional commitment to safeguard patients' privacy. The HIPPA privacy regulations specify which information elements are considered "protected health information." These elements may not be disclosed to third parties (including registries and research studies) without meeting all relevant privacy sharing requirements. Protected health information may be included in databases used for health care operations under a data use agreement. Research studies using protected health information must be reviewed by an institutional review 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 health care team.In clinical care, health care professionals communicate with each other through a common vocabulary. In an analogous manner, 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. Harmonizing data elements and definitions across studies facilitates comparisons and enables the conduct of pooled analyses and meta-analyses, thus deepening our understanding of individual study results.The recent development of quality performance measurement initiatives, particularly those for which the comparison of health care professionals and institutions is an implicit or explicit aim, has further raised awareness about the importance of clinical data standards. Indeed, a wide audience, including nonmedical professionals such as payers, regulators, and consumers, may draw conclusions about care and outcomes from these comparisons. To understand and compare care patterns and outcomes, the data elements that characterize them must be clearly defined, consistently used, and properly interpreted.Hani Jneid, MD, FACC, FAHAChair, AHA/ACC Joint Committee on Clinical Data Standards1. IntroductionRecently, the ACC/AHA Joint Committee on Clinical Practice Guidelines developed and published a guideline for evaluation and diagnosis of chest pain.1 The intent of the new guideline is to outline a framework for evaluation of acute or stable chest pain syndromes or other anginal equivalents in various clinical settings, but especially in emergency departments, with emphasis on identification of ischemic and other potentially high-risk etiologies.Chest pain is the second most common reason for adults to present to an emergency department in the United States, accounting for >7 million visits annually.2 Although noncardiac causes of chest pain account for a large majority of these cases, there are several dangerous and life-threatening causes of chest pain that must be identified and treated promptly. Distinguishing between serious and nonserious causes of chest pain is an urgent imperative.Our writing committee was established with the charge to develop a set of data elements and definitions that could be used for describing clinical care relevant for chest pain and acute MI, as outlined in the new guideline. Further, the selected elements and definitions are meant to be useful in clinical trials, observational studies, and data registries. They also should advance the mission of achieving interoperability in EHRs and across computer networks.In developing these data elements and definitions, we sought first to identify those items from existing vocabularies and lexicons that would be suitable for this purpose. The intent is to continue ongoing efforts meant to harmonize and synchronize data elements and definitions across multiple standards-based platforms. To that end, we reviewed previous publications related to guidelines, performance measures, data standards, and other documents containing appropriately structured data elements and definitions. Our goal was to employ to the fullest extent possible all existing elements and definitions. New elements and definitions were to be created only if existing ones were found not to be appropriate or useful. Given the expansive nature of a "chest pain" syndrome, this necessarily entailed close examination of previously published work. In particular, the writing committee considered previously published joint ACC/AHA publications, AHA and ACC clinical statements, and other relevant national and international guidelines, registry data dictionaries, standardized health care coding organization documents, and administrative datasets.We did not attempt to create data elements and definitions for all conceivable types and causes of chest pain beyond the intended scope of the guideline. Instead, we deliberately followed the plans contained in the new guideline and focused on potentially serious cardiovascular causes of chest pain as might be encountered in emergency departments.1 Data elements that might be used for the collection of demographic data, history and risk factors, laboratory test results, diagnostic procedures, and cardiovascular complications of other illnesses are beyond the scope of this document. Many of these other items can be found in previous ACC/AHA data standards publications.3,4The data element tables are also included as an Excel file in the Online Data Supplement.1.1. AbbreviationsAbbreviationMeaning/PhraseCPTCurrent Procedural TerminologycTncardiac troponinEHRelectronic health recordICD-10-CMInternational Classification of Diseases, 10th Revision, Clinical ModificationLOINCLogical Observation Identifiers Names and CodesMImyocardial infarctionNSTEMInon–ST-segment elevation myocardial infarctionSNOMED-CTSystematized Nomenclature of Medicine–Clinical TermsSTEMIST-segment elevation myocardial infarctionURLupper reference limit2. Methodology2.1. Writing Committee CompositionMembers of the writing committee were nominated by the Joint Committee, ACC, AHA, American College of Emergency Physicians, and Society for Cardiovascular Angiography and Interventions. Relevant RWI was taken into consideration when finalizing the writing committee, and every effort was made to ensure that the committee was well balanced and diverse with regards to professional expertise and interests, geographic location and institution, sex, ethnicity, and race. The writing committee consisted of 15 individuals with domain expertise in various disciplines: clinical cardiology, interventional cardiology, preventive cardiology, cardiovascular disease in women, emergency medicine, heart failure, coronary physiology, nursing, cardiac imaging, racial and ethnic disparities in cardiovascular outcomes, outcomes research, performance measures, health care quality management, medical informatics, and clinical registries.2.2. Relationships With Industry and Other EntitiesThe Joint Committee makes every effort to avoid actual or potential conflicts of interest that might arise as a result of an outside relationship or a personal, professional, or business interest of any member of the writing committee. Specifically, all members of the writing committee are required to complete and submit a disclosure form showing all such relationships that could be perceived as real or potential conflicts of interest. These statements are updated when changes occur. Authors' and peer reviewers' relationships with industry and other entities pertinent to this data standards document are disclosed in Appendixes 1 and 2, respectively. In addition, for complete transparency, the disclosure information of each writing committee member—including relationships not pertinent to this document—is available as a Supplemental Appendix. The work of the writing committee was supported exclusively by the ACC and AHA 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 DefinitionsA substantial body of literature was reviewed for this manuscript. The primary sources of information were the "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain,"1 "2020 AHA/ACC Key Data Elements and Definitions for Coronary Revascularization,"3 and "Fourth Universal Definition of Myocardial Infarction."5 This information was augmented by multiple peer-reviewed references listed in the tables under the column "Mapping/Source of Definition."2.4. Development of Terminology ConceptsThe writing committee aggregated, reviewed, harmonized, and extended the selected data elements to develop a terminology set that would be usable in as many contexts as possible. As necessary, the writing committee identified contexts where individual terms required differentiation according to their proposed use (ie, research/regulatory versus clinical care contexts).This publication was developed to serve as a common lexicon and base infrastructure by end users to augment ongoing work related to standardization and interoperability including, but not limited to, structural, administrative, and technical metadata development. The resulting appendixes (Appendixes 3 to 5) list the data element in the first column, followed by the clinical definition of the data element. The allowed responses ("permissible values") for each data element in the next column are the acceptable means of recording this information. For data elements with multiple permissible values, a bulleted list of the permissible values is provided in the row listing the data element, followed by multiple rows listing each permissible value and corresponding permissible value definition, as needed. Where possible, clinical definitions (and clinical definitions of the corresponding permissible values) are repeated verbatim as previously published in reference documents.2.5. Consensus DevelopmentThe Joint Committee established the writing committee as described in the Joint Committee on Clinical Data Standards' methodology paper.6 The primary responsibility of the writing committee was to aggregate existing information relevant to the care of patients with chest pain and acute MI from external sources such as the "2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain,"1 "2019 ESC Guidelines for the Diagnosis and Management of Chronic Coronary Syndromes,"7 other national and international guidelines and clinical statements, and cardiovascular subspecialty society statements. The work of the writing committee was accomplished via a series of virtual meetings, along with extensive email correspondence. The review work was distributed among subgroups of the writing committee based on interest and expertise in the components of the terminology set. The proceedings of the workgroups were then assembled, resulting in the vocabulary in Appendixes 3 to 5, and associated descriptive text in Section 3. All members reviewed and approved the final lexicon.2.6. Relation to Other StandardsThe writing committee reviewed the available published data standards, including previous ACC/AHA data standards publications and data dictionaries from the ACC's National Cardiovascular Data Registry.8 Relative to published data standards, the writing committee anticipates that this terminology set will facilitate the uniform adoption of these terms, where appropriate, by the clinical, translational research, regulatory, quality and outcomes, and EHR communities.2.7. Peer Review, Public Review, and Board ApprovalThis document was reviewed by official reviewers nominated by the ACC, AHA, and the collaborating organizations, as well as content reviewers appointed by these organizations and the Joint Committee. To increase its applicability further, the document was posted on the ACC and AHA websites for a 30-day public comment period. This document was approved by the ACC Clinical Policy Approval Committee and AHA Science Advisory and Coordinating Committee in April 2022, and by the AHA Executive Committee in May 2022. The writing committee anticipates that these data standards will require review and updating in the same manner as other published guidelines, performance measures, and appropriate use criteria.3. Data Elements and Definitions3.1. Chest PainThe data elements in Appendix 3 include terminology pertaining to the description of chest pain and its suspected etiologies as used in current clinical practice. Data elements related to history, cardiovascular risk factors, laboratory testing, and invasive and noninvasive testing for chest pain are not discussed here because they have been previously described.3,4Chest pain is one of the leading reasons for emergency department visits among adults in the United States. Patients often report various types of chest discomfort. Traditionally, chest pain symptoms have been categorized as "typical" or "atypical." This classification was primarily aimed at differentiating symptoms relating to myocardial ischemia versus nonischemic etiologies; however, the term "atypical" is often used to describe noncardiac symptoms, as well as cardiac symptoms not representative of myocardial ischemia (eg, pericarditis), thereby creating ambiguity. The recent chest pain guideline, therefore, recommends using "cardiac," "possible cardiac," and "noncardiac" chest pain as the preferred terminology. A comprehensive history and focused physical examination remain pivotal in the evaluation of specific chest pain etiologies and help discern serious cardiovascular causes from more benign ones. Although some patients present with nonclassic or "noncardiac" symptoms, chest pain is still the predominant symptom among men and women who have underlying coronary artery disease. In patients who present with acute chest pain and are thought to have possible acute coronary syndrome (excluding ST-segment elevation myocardial infarction [STEMI]), clinical decision pathways based on risk stratification tools can guide further testing and disposition. Several risk scores have been designed for this purpose (eg, TIMI [Thrombolysis in Myocardial Infarction], GRACE [Global Registry of Acute Coronary Events], HEART [History, ECG, Age, Risk factors and Troponin]).9–13 They include clinical data such as electrocardiographic abnormalities, risk factors, and cardiac biomarkers. In alignment with the recent chest pain guideline, we do not recommend the use of one risk stratification system over others. Risk scores should be used within the clinical context of each patient. Additionally, in Appendix 3, we have identified data elements and permissible values for suspected chest pain etiologies besides atherosclerotic coronary artery disease, dividing them into 4 categories: nonatherosclerotic coronary causes, noncoronary causes, vascular causes, and noncardiac causes. The recent chest pain guideline highlighted the need to reach consensus for the definitions of chest pain to align with clinical practice. This document is aimed at harmonizing related data elements for uniform reporting.3.2. Myocardial InjuryMyocardial injury, acute versus chronic (or acute-on-chronic), is defined by the presence of an elevated cardiac troponin (cTn) concentration above the 99th percentile of the upper reference limit (URL). Myocardial injury is a frequently encountered clinical syndrome and is associated with an adverse prognosis. Myocardial injury is considered acute if there is a rise or fall of cTn concentrations over time and considered chronic when cTn concentrations are persistently elevated.Clinicians must distinguish between one of the MI subtypes and nonischemic myocardial injury. Acute myocardial injury is related to the diagnosis of MI, particularly when accompanied by supportive evidence in the form of symptoms, electrocardiographic abnormalities, or imaging evidence of new regional wall motion abnormalities or new loss of viable myocardium. Nonischemic myocardial injury may arise secondary to cardiac or noncardiac conditions.Appendix 4 focuses on nonischemic myocardial injury, listing the appropriate vocabulary to facilitate uniform reporting.3.3. Myocardial InfarctionMI is the irreversible necrosis of heart muscle. A common cause for infarction is deprivation in myocardial oxygen supply because of interruption of blood flow in ≥1 coronary arteries as a result of plaque rupture, erosion, fissure, or coronary dissection. Additionally, MI can result from inflammatory, metabolic, or toxic insults to the myocardium. Early and accurate detection of MI is important for initiating and maintaining appropriate therapy. In clinical trials, lack of a uniform MI definition can result in low concurrence between the initial clinical and later adjudicated assessments of MI, which will affect accuracy of primary end points and trial outcomes. Thus, uniform definitions are needed to ensure accurate reporting of MI events across clinical trials and registries.The data element set for an MI event requires both subjective and objective findings, including symptoms, cardiac biomarkers, and electrocardiographic abnormalities. The data elements in Appendix 5 were selected based on published peer-reviewed MI definitions developed by national and international cardiovascular subspecialty societies (AHA, ACC, European Society of Cardiology, and Society for Cardiovascular Angiography and Interventions) and are commonly used by regulatory bodies that oversee the conduct of cardiovascular clinical trials. The terminology of STEMI and non-STEMI (NSTEMI) is included because it has practical implications that determine pathways of care, despite the limitations of this terminology in terms of predictive accuracy and lack of optimal correlation with the underlying pathology (occlusive versus nonocclusive culprit vessel). The value of the STEMI/NSTEMI terminology is that it allows for early identification of patients who benefit from immediate coronary revascularization, and it has been universally adopted across multiple medical specialties. Lastly, the writing committee acknowledges the controversy concerning the best definition of MI after coronary revascularization. Inclusion of the 2 most commonly used postcoronary revascularization MI definitions is intended to support continued scientific efforts to decipher the relationship between those definitions and the long-term outcomes of affected patients.4. Informatics of Controlled VocabulariesVarying data definitions, data formats, and data encoding, and lack of a standardized vocabulary for representing clinical concepts in health care information systems, are known barriers that limit the capacity of computer systems to transmit data seamlessly. The ambiguity of clinical concepts and terminologies used in health care data exchange make standardization, harmonization, and maintenance of clinical vocabulary an effortful task that demands considerable time, specialized knowledge, and a specific skill set. The writing committee identified the basic attributes of a standardized vocabulary that allow creation of a clinical data dictionary—data elements, data element definitions, permissible values, permissible value defi
Referência(s)