2017 AHA/ACC Key Data Elements and Definitions for Ambulatory Electronic Health Records in Pediatric and Congenital Cardiology: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards
Table of Contents
1. Introduction 3
2. Methodology 5
2.1. Writing Committee Composition 5
2.2. Relationships With Industry and Other Entities 5
2.3. Development of Terminology Concepts 5
2.4. Consensus Development 5
2.5. Relation to Other Standards 5
2.6. Peer Review and Public Review 5
3. Data Elements and Definitions 5
3.1. History of Present Illness 6
3.2. Risk Factors 6
3.3. Past Medical History 6
3.4. Physical Examination 6
3.5. Common Cardiac Diagnoses 6
Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2017 AHA/ACC Key Data Elements and Definitions for Ambulatory Electronic Health Records in Pediatric and Congenital Cardiology 8
Appendix 2. Reviewer Relationships With Industry and Other Entities—2017 AHA/ACC Key Data Elements and Definitions for Ambulatory Electronic Health Records in Pediatric and Congenital Cardiology 10
Appendix 3. History of Present Illness 11
Appendix 4. Risk Factors 27
Appendix 5. Past Medical History 40
Appendix 6. Physical Examination 50
A. Vital Signs 50
B. Cardiac Examination 51
C. Extracardiac Examination 66
Appendix 7. Common Cardiac Diagnoses 73
The American College of Cardiology (ACC) and the American Heart Association (AHA) support their members’ goal to improve the care of patients with cardiovascular disease through professional education, research, and development of guidelines and standards and by fostering policies that support optimal patient outcomes. The ACC 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.
Clinical data standards strive to define and standardize data relevant to clinical concepts, with the primary goal of facilitating uniform data collection by providing a platform of clinical terms with corresponding definitions and data elements. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across clinical trials to promote interoperability with electronic health records (EHRs) and to assess the applicability of research to clinical practice. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary to accomplish the ACC’s mission of fostering optimal cardiovascular care and disease prevention and the AHA’s mission of building healthier lives, free of cardiovascular diseases and stroke.
The specific goals of clinical data standards are:
To establish a consistent, interoperable, and universal clinical vocabulary as a foundation for both clinical care and clinical research, including clinical trials
To promote the ubiquitous use of EHRs and facilitate the exchange of data across systems through harmonized, standardized definitions of key data elements
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 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 ACC/AHA Task Force on Clinical Data Standards (Task Force) selects cardiovascular conditions and procedures that will benefit from creation of a standard dataset. Subject matter experts are selected to examine/consider existing standards and develop a comprehensive, yet not exhaustive, standard dataset. When a data collection effort is undertaken, 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 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 standards. Writing committees are instructed to consider adopting or adapting existing nationally and internationally recognized data standards if the definitions and characteristics are useful and applicable to the set under development. In addition, the ACC 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 each patient grants specific permission. These fields are indicated as protected health information in the data standards.
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 protocol, case report forms, and clinical event committee charters. 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.
Biykem Bozkurt, MD, PhD, FACC, FAHA
Chair, ACC/AHA Task Force on Clinical Data Standards
This document creates the first extensive data dictionary, with data elements and definitions, specifically for use in the outpatient—or ambulatory—domain of pediatric and congenital cardiology. It is 1 of 16 domains of mutual interest identified in pediatric cardiology and congenital cardiac disease necessary to build a framework that enables the goal of interoperable data exchange to occur. The other domains include: congenital heart defect nomenclature, adult congenital heart disease, critical care, cardiomyopathy, cardiac transplantation, pulmonary hypertension, congenital cardiac surgery, echocardiography, diagnostic and interventional catheterization, exercise stress testing and physiology, electrophysiology, cardiac magnetic resonance imaging, fetal physiology, perfusion, and cardiac anesthesia. The reason that this domain was chosen first was that there are other nascent data dictionaries that capture, or at least overlap with, other domains in our field. However, outpatient cardiology previously has had limited, if any, attention to its data structure, despite the fact that patients spend the vast majority of their life in this area of care.
The need for a master set of data elements and definitions is of topical interest for the pediatric and congenital heart disease clinician where data sharing is critical to identify best practices, develop evidence-based guidelines, and determine statistical significance in our patient populations. There is a wide range of disease processes across a relatively small set of patients in pediatric and congenital heart disease; this fact is in contrast to adult cardiac disease where there is a large population of patients who experience a more homogenous set of disease processes. In a year, a cardiac center in adult medicine is likely to treat thousands of patients who present with one of only a few disease processes. Adult cardiac medicine has successfully built clinical decision support tools, established data registries, and achieved data pooling because of the large distribution of patients across these disease processes, and because there are common data standards. There are limited large-scale observational data that can be used for evidence-based decisions and for cardiac research in outpatients with pediatric and congenital heart disease.2 Getting to outcome measures in pediatric cardiology and cardiac surgery is challenging; attaining evidence-based decision-making has been challenging, if not even more challenging, although groups such as the Pediatric Heart Network and the National Pediatric Cardiology Quality Improvement Collaborative3 have been breaking down this barrier. There are many obstacles within standardizing and sharing data in pediatric cardiac surgery—including variation in surgical techniques and skills, variations in perioperative care, variation in underlying anatomy, adequate risk stratification, nonavailability of natural history of unoperated patients in the present era, and insufficient patient numbers—from which to draw statistically significant conclusions.4
Pediatric and congenital cardiology and cardiovascular surgery comprise a wholly separate set of diagnoses and procedures compared with those of adult cardiology. Pediatric and congenital cardiac care begins at fetal cardiology through congenital as well as acquired pediatric cardiac disease, leads up to and through adult congenital cardiac disease states, and also incorporates some aspects of adult cardiac care. Several efforts to list congenital cardiac disease, surgical interventions, and complications have been accomplished over the past 15 years including efforts from the Association for European Paediatric and Congenital Cardiology, The Society of Thoracic Surgeons, and the European Association for Cardio-Thoracic Surgery. The combination of the data elements published by the Association for European Paediatric and Congenital Cardiology with the set of data elements created by The Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery5 to give the IPCCC (International Paediatric and Congenital Cardiac Code) was a historic effort in delineating and mapping the various nomenclatures used in the field. Common nomenclature serves as an important linkage across clinical data registries and for EHR data warehousing. Specifically, a number of terms used in this data dictionary harmonize with the living document that is the IPCCC. The IPCCC has not determined the details of all of the terms and definitions associated with the ambulatory environment. Thus, further harmonization will be important as this work progresses.
At this juncture, evidence-based guidelines for the inpatient and outpatient care of children with congenital heart disease are generally lacking, and pediatric cardiologists are often “on their own” when trying to deliver the best quality of care to these children. Compounding this problem, there are often insufficient patients at any one heart center to accumulate sufficient evidence to define optimal patient care. Clinical outcome measures to determine the effect of inpatient and outpatient care are evolving slowly, and there is no universal standardized clinical record to monitor a patient’s course, long-term outcomes, and comorbidities or quality-of-life indicators. Collaborative multi-institutional efforts are required to improve the quality of care for children with congenital heart disease; several have already begun, including the IMPACT (Improving Pediatric and Adult Congenital Treatments) registry, the Pediatric Heart Network and the National Pediatric Cardiology Quality Improvement Collaborative. Clinical data registries, which use data for comparative benchmarking, translational research, and quality improvement, have provided a useful model to improve care and to measure clinical outcomes. Many of these societal and multi-institutional database registries exist in the specialty fields of pediatric and congenital heart disease. Much of our work in defining the minimum data set for the pediatric and congenital heart disease patient will be through “harmonization” and identification of gaps and overlaps in these already existing registries. The multiple societal registries and multi-institutional clinical data registries will provide much of the foundation elements to the data dictionary as needed for the pediatric and congenital heart disease patient. The Multi-Societal Database Committee for Pediatric and Congenital Heart Disease began some of this work in developing strategies to link registries and databases. This committee was established in 2005 with the goal of providing the infrastructure, spanning geographic and subspecialty boundaries, and creating collaboration between healthcare professional interested in the analysis of outcomes of treatments provided to patients with congenital cardiac disease. Through a supplemental document published in Cardiology in the Young5 and a series of annual meetings, this committee offers definitions as standards across the multiple registries in pediatric and congenital heart disease. There are >36 organizations and professional societies that are invited and participate in these meetings and activities. Many of these organizations and societies provide these proceedings or meeting agenda topics to their respective clinical boards. As a result, many of the clinical registries in pediatric and congenital heart disease share clinical nomenclature for disease classification and procedural coding.
We use the term “EHR” as not only referring to the generic concept of such computer-based systems, but includes the idea that a patient’s medical information and discrete data capture may be stored in multiple systems, with clinical data standards enabling the appearance of a single repository. One of the greatest inefficiencies of the current approach to measuring clinical quality indicators and clinical and translational research is the absence of a unifying infrastructure with streamlined, one-time data collection, common data terms, and cooperative use of data shared among institutions and researchers. Clinical quality outcomes assessment and research processes typically occur as independent, parallel endeavors. For example, clinical evaluation findings and management decisions, with accompanying test results, can be documented in a clinic note, dictated into a letter for communication with others, coded for reimbursement, keyed into multiple web-based systems for quality reporting, regulatory activities, and clinical trials, and later be extracted from patient records to support additional clinical or research needs. If uniform data standards and terms supported by an EHR and across all these disparate systems were in place, the data could be captured once in the clinical workflow and be made available to all stakeholders. The current writing committee understands that the entry of information into the EHR is performed by numerous medical personnel, many of whom are not trained in the skills of accurately and consistently entering data in a structured fashion. This data entry is a fundamental source of data error within the EHR. Nevertheless, the hope is to leverage this data by creating structured elements and definitions that can be incorporated into the EHR, and thus used in the future in a routine manner.
Taking a holistic view of the terminologies used in the care of cardiac diseases, we look to the “ACCF/AHA 2011 Key Data Elements and Definitions of a Base Cardiovascular Vocabulary for Electronic Health Records”6 as our guide in thinking about how our field approaches this requirement. However, there is need to create a separate data set for pediatric and congenital disease patients. Children have unique developmental needs and their parent-caregivers have informational needs that are different from those of adults. Pharmacodynamic and metabolic factors make processes in pediatric patients different than in adults. During early childhood, a child is more likely to have multiple visits to the physician’s office, and children see multiple specialists throughout childhood. Thus, there are indeed many characteristics of pediatric care that differ from adult care. In addition to the adult and pediatric differences in medical care, there is also difference both in respective EHR design and in respective data collection points. And, these characteristics often need to be captured differently in EHR systems so that pediatricians and specialty providers benefit from the automation of clinical and developmental child health information.
We therefore suggest the need to compile through the EHR the collective-comparative needs of the many clinical, medical, and surgical domains in the care of pediatric and congenital heart disease patients. Our approach takes us from cardiology clinic to cardiac diagnostic imaging to interventional to cardiac critical care to cardiac care programs. Within each of these domains, we present the cohort perspective and/or clinical prevalence, the presence of current data registry and/or “shareability” of clinical data, and outline of future directions. We see this plan as a first step toward achieving EHR data exchange for the continuity of clinical care of the pediatric and congenital heart disease patient. As for future steps, we see the need for aligning the ACC and AHA pediatric data set to the adult data set and for aligning the ACC and AHA pediatric data set to US Meaningful Use data standards. To do so, immediate next steps for the Task Force will involve further mapping of existing clinical data registries and clinical domain needs to better understand issues around common data standards, overlaps, and gaps in data content.
2.1. Writing Committee Composition
The Task Force selected a writing committee chair and facilitated the selection of members for the writing committee. The writing committee consisted of 31 individuals who are experts in cardiovascular medicine, HER technologies, and medical informatics, and included representation from pediatric and congenital cardiovascular medicine and surgery.
2.2. Relationships With Industry and Other Entities
The Task Force 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 reviewed by the Task Force and 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 an online supplement. 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. Development of Terminology Concepts
The terminology for this document has been derived from 2 primary sources. The first was a set of data elements created by the chair of this writing committee for use specifically in an outpatient clinical practice that could be scalable for use. The second comes from the International Society for Nomenclature of Paediatric and Congenital Heart Disease that initially created a set of data elements to make the IPCCC more complete. However, it had not specifically included definitions. These 2 source documents were then harmonized and divided into smaller sections, consistent with the typical method of documentation within the medical record. These smaller sections included the history of the present illness, risk factors, the past medical history, the physical examination, and common cardiac diagnoses. Our subject matter experts then reviewed and refined these data elements and definitions to derive a data dictionary that would be complete for the majority of patients seen in the outpatient setting.
2.4. Consensus Development
The Task Force established the writing committee according to the processes described in the Task Force’s methodology statement.7 The responsibility of the writing committee was to review and refine the list of the candidate terms identified for ambulatory EHR for pediatric and congenital cardiology, and to harmonize the attributes and other informatics formalisms required to attain interoperability of the terms. The writing committee’s work was accomplished through series of teleconferences and extensive e-mail correspondences. The vetted set of terminology resulted in the tabular data elements and definitions in Appendixes 3-7.8–37
2.5. Relation to Other Standards
The writing committee reviewed the “ACCF/AHA 2011 Key Data Elements and Definitions of a Base Cardiovascular Vocabulary for Electronic Health Records”6 along with available published ACC/AHA clinical data standards. Key sources such as the National Cancer Institute Enterprise Vocabulary Services,38 the Logical Observation Identifiers Names and Codes (LOINC),39 and the Clinical Data Interchange Standards Consortium (CDISC)40 were also reviewed. Most existing published definitions were adopted, and a few were adjusted to eliminate verbiage and improve definitions. New definitions were also proposed by the writing committee for terminology that needed to be defined. Through this consensus work, the writing committee anticipates that this vocabulary set will facilitate uniform adoption of these terms by the various clinical, research, and EHR communities.
2.6. Peer Review and Public Review
This document—“2017 AHA/ACC Key Data Elements and Definitions for Ambulatory Electronic Health Records in Pediatric and Congenital Cardiology”—was reviewed by official reviewers nominated by the ACC and AHA. To increase its applicability further, the document was posted on the ACC website for a 30-day public comment period from July 22, 2016, to August 22, 2016. This document was approved for publication by the ACC Board of Trustees on May 25, 2017, by the AHA Science Advisory and Coordinating Committee on June 7, 2017, and by the AHA Executive Committee on June 30, 2017. The writing committee anticipates that these data standards will require review and updating in the same manner as other published clinical practice guidelines, performance measures, and appropriate use criteria. The writing committee will therefore review the set of data elements periodically, beginning with the first anniversary of publication of the standards, to ascertain whether modifications should be considered.
3. Data Elements and Definitions
The writing committee identified pediatric and congenital terms for EHRs. This document outlines these terms in Appendixes 3–7:
History of Present Illness
Past Medical History
Common Cardiac Diagnoses
3.1. History of Present Illness
The history of the present illness is the portion of the clinical evaluation that brings the patient into the physician’s office for assessment. It can be an initial visit or for follow-up after either observation or intervention. The content and degree of documentation in this section is what drives the remainder of the examination as well as the assessment and the decision-making process, and thus heavily influences subsequent reimbursement. Almost all medical and surgical specialties have a set of typical or frequently seen diagnoses. This section helps to organize historical factors required to correctly assess these diagnoses.
3.2. Risk Factors
The concept of risk factors includes those issues that may exist in the patient, arise in the patient, or be conferred by family history that increase the risk of further cardiac disease or complications associated with the heart.
3.3. Past Medical History
Information gathered in the past medical history section has an important part in the evaluation of the patient as it gives the background of medical and surgical conditions against which the present illness exists. A patient with a negative past medical history may be evaluated differently from that of a patient who presents in the context of multiple complex set of medical and/or surgical problems. Ensuring appropriate delineation of these problems is vital.
3.4. Physical Examination
The physical examination in cardiology can be one of the most diagnostic patient evaluations, giving information that can lead directly to a diagnosis, or at least to a relatively narrow differential diagnosis. Similarly, the combination of descriptors used to document the examination can communicate a clear picture of the cardiac assessment to another provider.
3.5. Common Cardiac Diagnoses
As mentioned previously, these “typically seen” diagnoses are specific to the practice of pediatric cardiology, specifically in the outpatient setting. These are in addition to the large variety of congenital cardiac defects, arrhythmias, and other pathologic processes that will be further delineated and defined in subsequent documents.
Presidents and Staff
American College of Cardiology
Mary Norine Walsh, MD, FACC, President
Shalom Jacobovitz, Chief Executive Officer
William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publishing
Lara E. Slattery, MHS, Team Leader, ACC Scientific Reporting
Michael Simanowith, Team Leader, Terminology and Standards
Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing
American College of Cardiology/American Heart Association
Katherine Sheehan, PhD, Director, Guideline Strategy and Operations
Maria Lizza D. Isler, BSMT, Associate, Clinical Data Standards
American Heart Association
Steven R. Houser, PhD, FAHA, President
Nancy Brown, Chief Executive Officer
Rose Marie Robertson, MD, FAHA, Chief Science and Medicine Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations
Jody Hundley, Production Manager, Scientific Publishing, Office of Science Operations
The opinions expressed in this document are those of the authors and do not reflect the official position of the Agency for Healthcare Research and Quality, the National Heart, Lung, and Blood Institute, or the US Department of Health and Human Services.
This document was approved by the American College of Cardiology Board of Trustees on May 25, 2017, the American Heart Association Science Advisory and Coordinating Committee on June 7, 2017, and the American Heart Association Executive Committee on June 30, 2017.
The Comprehensive RWI Data Supplement table is available with this article at http://circoutcomes.ahajournals.org/lookup/suppl/doi:10.1161/HCQ.0000000000000027/-/DC1.
The American Heart Association requests that this document be cited as follows: Boris JR, Béland MJ, Bergensen LJ, Colan SD, Dangel J, Daniels CJ, Davis C, Everett AD, Franklin R, Gaynor JW, Gray DT, Hirsch-Romano JC, Jacobs JP, Jacobs M, Jeffries H, Krogmann ON, Lomotan EA, Lopez L, Marelli A, Martin GR, Matherne GP, Mavroudis C, McCardle K, Pearson GD, Rosenthal G, Scott JS, Serwer GA, Seslar SS, Shaddy R, Slesnick T, Vener DF, Walters HL 3rd, Weinberg PM. 2017 AHA/ACC key data elements and definitions for ambulatory electronic health records in pediatric and congenital cardiology: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards. Circ Cardiovasc Qual Outcomes. 2017;10:e000027. doi: 10.1161/HCQ.0000000000000027.
This article has been copublished in the Journal of the American College of Cardiology.
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