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DATA STANDARDS

2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS Key Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease

A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic Vascular Disease)

Mark A. Creager, MD, FACC, FAHA, Chair, Writing Committee, Michael Belkin, MD, Writing Committee Member^_*, Edward I. Bluth, MD, FACR, Writing Committee Member, Donald E. Casey, Jr, MD, MPH, FAHA, FACP, Writing Committee Member, Seemant Chaturvedi, MD, FAHA, FAAN, Writing Committee Member, Michael D. Dake, MD, Writing Committee Member, Jerome L. Fleg, MD, FACC, FAHA, Writing Committee Member^||, Alan T. Hirsch, MD, FACC, FAHA, Writing Committee Member, Michael R. Jaff, DO, FACC, Writing Committee Member^¶, John A. Kern, MD, Writing Committee Member^#, David J. Malenka, MD, FACC, FAHA, Writing Committee Member^_**, Edward T. Martin, MD, FACC, FACP, FAHA, Writing Committee Member, Emile R. Mohler, III, MD, FACC, FAHA, Writing Committee Member, Timothy Murphy, MD, FACR, FAHA, FSIR, FSVMB, Writing Committee Member, Jeffrey W. Olin, DO, FACC, FAHA, Writing Committee Member, Judith G. Regensteiner, PhD, FAHA, Writing Committee Member^||||, Robert H. Rosenwasser, MD, FACS, FAHA, Writing Committee Member^¶¶, Peter Sheehan, MD, Writing Committee Member^##, Kerry J. Stewart, EdD, MAACVPR, FAHA, Writing Committee Member^_***, Diane Treat-Jacobson, PhD, RN, FAHA, Writing Committee Member, Gilbert R. Upchurch, Jr, MD, FACS, FAHA, Writing Committee Member^_*, Christopher J. White, MD, FACC, FAHA, Writing Committee Member and Jack A. Ziffer, MD, PhD, FACC, FAHA, FSCCT, Writing Committee Member

Key Words: ACCF/AHA Data Standards • clinical outcomes • peripheral atherosclerotic vascular disease • registries

	ACCF/AHA Task Force on Clinical Data Standards

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

	Table of Contents

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

 

Preamble......295

1 Introduction......296

2 Methodology......297

2.1 Writing Committee Composition......297

2.2 Relationships With Industry and Other Entities......297

2.3 Review of Literature and Existing Data Definitions......297

2.4 Defining Data Elements......297

2.5 Relation to Other Standards......297

2.6 Consensus Development......297

2.7 Peer Review, Public Review, and Board Approval......304

2.8 Intended Use......304

3 PAVD Data Standard Elements and Definitions......304

3.1 General Table of Data Elements......304

3.2 Lower Extremity PAD Table of Data Elements......316

3.3 AAA Table of Data Elements......327

3.4 Renal and Mesenteric Artery Disease Table of Data Elements......327

3.5 Extracranial Carotid and Vertebral Artery Disease Table of Data Elements......340

References......352

Appendix 1: Author Relationships With Industry and Other Entities......354

Appendix 2: Peer Reviewer Relationships With Industry and Other Entities......356

	Preamble

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

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 and to assess the applicability of research to clinical practice. The increasing national focus on adoption of certified electronic health records along with financial incentives for providers to demonstrate "meaningful use" of those electronic health records 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's missions of fostering optimal cardiovascular care and disease prevention and building healthier lives, free of cardiovascular diseases and stroke, respectively.

The specific goals of clinical data standards are

1 To establish a consistent, interoperable, and universal clinical vocabulary as a foundation to both clinical care and clinical research

2 To promote the ubiquitous use of electronic health records 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 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 (HIPAA) privacy regulations, which went into effect in April 2003, have heightened all practitioners' awareness of our professional commitment to safeguard patients' privacy. The HIPAA 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. On the other hand, 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 group were required to submit a disclosure form showing all such relationships that might be perceived as real or potential conflicts of interest. These statements are 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. Writing committee members' relationships with industry or other entities (RWI) are listed in Appendix 1. Official peer reviewers' RWI are listed in Appendix 2.

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, comparisons, 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 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, FASNC, FAHAChair, ACCF/AHA Task Force on Clinical Data Standards

	1. Introduction

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

 
Atherosclerotic vascular disease refers to disorders of the arteries caused by atherosclerosis (2). This document provides data standards for peripheral atherosclerotic vascular diseases (PAVDs), including lower extremity peripheral artery disease (PAD), abdominal aortic aneurysm (AAA), renal and mesenteric artery disease, and extracranial carotid artery disease. It may serve as a companion to the "2005 ACC/AHA Guidelines for the Management of Patients With Peripheral Arterial Disease" (3), the "2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease" (4), and the "2010 ACCF/AHA Performance Measures for Adults With Peripheral Artery Disease" (5). Coronary artery disease is outside the scope of this document. Multiple disciplines are engaged in the evaluation and management of patients with PAVDs, and developments in relevant research and technology are emerging rapidly. Therefore, to ensure optimal documentation and communication among healthcare providers, researchers, policy makers, payers, and industry, the establishment of a uniform set of data elements and definitions for PAVDs could not be more timely and compelling.

The data standards covered in this document are divided into 6 distinct tables. The first table covers general data elements common to all PAVDs, including demographic information, atherosclerotic risk factors, concurrent atherosclerotic diseases, comorbid conditions, medications, the cardiovascular examination, and relevant blood chemistries and hematology. The remaining tables cover data standards specific for lower extremity PAD, AAA, renal artery disease, mesenteric artery disease, and extracranial carotid and vertebral artery disease, respectively. Each of the disease-specific tables includes the following data elements: medical history, physical examination, laboratory testing, diagnostic procedures, invasive therapeutic procedures (both endovascular and open surgical), pharmacological therapy, follow-up, and outcomes.

	2. Methodology

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

 
2.1 Writing Committee Composition.   The ACCF/AHA Task Force on Clinical Data Standards selected members for the Writing Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic Vascular Disease. The writing committee consisted of 23 members who are well versed in the epidemiology, clinical evaluation, medical management, invasive therapy, and/or outcomes assessment of patients with vascular disease and included members with expertise in patient care, clinical investigation, and healthcare services research and delivery. The writing committee included representatives from a broad range of cardiovascular professional societies and organizations to ensure that the content of this document is widely applicable. All partnering and collaborating organizations nominated people to serve on the writing committee.

2.2 Relationships With Industry and Other Entities.   The ACCF/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual, potential, or perceived conflicts of interest that may arise as a result of RWI among members of the writing committee. Specifically, all members of the writing group, as well as peer reviewers of the document, were required to disclose all current relationships and those that existed 24 months before initiation of this writing effort that might be perceived as relevant. These statements were reviewed by the ACCF/AHA Task Force on Clinical Data Standards and by all members during each conference call or meeting of the writing committee and updated when changes occurred. This writing effort was initiated before the implementation of the updated ACCF and AHA policy on RWI, which requires that the writing committee chair plus a majority of the writing committee have no relevant RWI. Relevant RWI disclosed by writing committee members and peer reviewers are listed in Appendixes 1 and 2, respectively. Comprehensive disclosure information for the Task Force is available online at available online at www.cardiosource.org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces.aspx. 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.   The nomenclature used in this document to designate specific PAVDs, including lower extremity PAD, AAA, renal and mesenteric artery disease, and extracranial carotid artery disease, is derived from an AHA conference proceeding (2). The "Peripheral Atherosclerotic Vascular Disease Data Standards" are intended to provide data elements that parallel and complement existing data fields previously reported in ACCF and AHA data standards documents (6–11), along with those used as fields within existing registries, such as those developed by the ACC National Cardiovascular Disease Registry (12). The writing committee also reviewed the "2007 ACC/AHA Methodology for the Development of Clinical Data Standards" (13), the reporting standards formulated by the Society for Vascular Surgery/International Society for Cardiovascular Surgery; the "AHA Guidelines for the Reporting of Renal Artery Revascularization in Clinical Trials" (14); the National Heart, Lung, and Blood Institute CLEVER (Claudication: Exercise Vs Endoluminal Revascularization) Study (15,16); CORAL (Cardiovascular Outcome in Renal Atherosclerotic Lesions) trials (17,18); National Institute of Neurological Disorders and Stroke Common Data Elements (19); and the AHA Get With The Guidelines–Stroke Program (20).

2.4 Defining Data Elements.   The definitions of the data elements developed by the writing committee are broad enough for use in various aspects of data collection but specific enough to promote uniform and simplified interpretation of data. Some elements will require an additional level of specificity by the end user for implementation, which is beyond the scope of this document. Data definitions were linked whenever possible to the evidence-based national guidelines.

To ensure consistency across ACCF/AHA data standards, the writers used existing ACCF/AHA definitions. The writing committee chose not to develop an all-inclusive list of every possible data element that may be used for all aspects of PAVD. Rather, the committee focused on common elements that cross vascular specialty disciplinary boundaries. It is anticipated that some data definitions and elements will need further delineation, likely by subspecialty societies and groups. The purpose of this document is to attempt to harmonize as many common data fields as possible.

2.5 Relation to Other Standards.   As previously noted, the writing committee reviewed other standards, including those developed for heart failure, atrial fibrillation, electrophysiology, acute coronary syndromes, and cardiac imaging. It was thought that members of the writing committee possessed the key levels of expertise needed to address issues relating to PAVD in a consistent manner.

2.6 Consensus Development.   These ACCF/AHA data standards, like other documents developed by the ACCF and AHA, were developed and written as a team effort based on the judgments of experts. The writing committee met >10 times, by telephone and in person, to define and refine the data elements. Throughout the process, consensus was developed through extensive in-person discussion, teleconferences, and e-mail messages.

2.7 Peer Review, Public Review, and Board Approval.   This set of standards and definitions for PAVD was independently reviewed by official appointees from the ACCF, AHA, American College of Radiology, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, and the ACCF/AHA Task Force on Clinical Data Standards, as well as experts from collaborating organizations, namely, the American College of Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; American Academy of Neurology; American Diabetes Association; National Heart, Lung, and Blood Institute; Society of Atherosclerosis Imaging and Prevention; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; and Vascular Disease Foundation. To increase its applicability, this document was posted on the ACC Web site for a 30-day public comment period from September 1, 2010, through October 1, 2010. The document was then approved by the ACCF Board of Trustees and the AHA Science Advisory and Coordinating Committee in June 2011; American Association of Cardiovascular and Pulmonary Rehabilitation, American Academy of Neurology, American Diabetes Association, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, Society of Interventional Radiology, Society of Thoracic Surgeons, Society for Vascular Medicine, Society for Vascular Nursing, and Vascular Disease Foundation in October 2011; the American College of Radiology and Society for Cardiovascular Angiography and Interventions in November 2011; and the Society for Vascular Surgery in December 2011.

The writing committee anticipates that these data standards will require review and updating, as with the ACCF/AHA guidelines, performance measures, and appropriate use criteria. At the anniversary of publication, the writing committee will review the data standards to ascertain whether modifications should be considered.

2.8 Intended Use.   The writing committee anticipates that the "Key Data Elements and Definitions for Peripheral Atherosclerotic Vascular Disease" will prove useful in several settings:

1 Clinical programs in which providers and health plans work in concert to achieve optimal use of procedures pertinent to PAVD. Data standards will assist in the development of structured reporting systems and the organization and design of electronic medical information systems, including clinical database and decision support tools.

2 Clinical research, including prospective registries and randomized controlled trials. Meta-analyses will be particularly strengthened by the use of standardized data for key variables.

3 Quality assessment/performance measurement. Data standards will especially facilitate interpretation for nonmedical users, including payers, regulators, and consumers.

	3. PAVD Data Standard Elements and Definitions

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

 
3.1 General Table of Data Elements.   The general elements listed in Table 1 are applicable to all of the PAVDs included in this document. These include demographic elements, such as sex, age, race, ethnicity, and payer information; elements related to the patient's presentation, such as the primary reason for the encounter and its location; risk factors for atherosclerosis, such as hypertension, dyslipidemia, diabetes mellitus, and cigarette smoking; and evidence of previously established atherosclerotic conditions, such as coronary artery disease, lower extremity PAD, renal/mesenteric artery disease, AAAs, and cerebrovascular disease; and comorbid conditions, such as congestive heart failure, pulmonary insufficiency, and chronic kidney disease. More detailed data elements for each PAVD are provided in the subsequent tables. The general elements table also lists components of the physical examination, such as height, weight, body mass index, vital signs, and aspects of the cardiac and vascular examination. Detailed elements of the examination are provided in subsequent tables as applicable to each PAVD. Common laboratory values are also included, such as the complete blood count, renal and hepatic function tests, lipid levels, cardiac enzymes, markers of inflammation, and tests for inherited and acquired thrombophilia. Additional general elements include current pharmacotherapy, such as antiplatelet/anticoagulant drugs, medications to treat atherosclerotic risk factors, and drugs for comorbid cardiovascular conditions.

	Staff

Top ACCF/AHA Task Force on... Table of Contents Preamble 1. Introduction 2. Methodology 3. PAVD Data Standard... Staff References

John C. Lewin, MD, Chief Executive Officer

Charlene May, Senior Director, Science and Clinical Policy

Melanie Shahriary, RN, BSN, Director, Performance Measures and Data Standards

American College of Cardiology Foundation/American Heart Association

Maria Lizza D. Isler, BSMT, Specialist, Clinical Data Standards

American Heart Association

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

Mark D. Stewart, MPH, Science and Medicine Advisor, Office of Science Operations

Jody Hundley, Production Manager, Scientific Publishing, Office of Science Operations

	Footnotes

 
Developed in Collaboration With the American Association of Cardiovascular and Pulmonary Rehabilitation, American Academy of Neurology, American Association of Neurological Surgeons, American Diabetes Association, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Vascular Disease Foundation

This document was approved by the American College of Cardiology Foundation Board of Trustees and the American Heart Association Science Advisory and Coordinating Committee in June 2011; the Society of Interventional Radiology, Society of Thoracic Surgeons, Society for Vascular Medicine, and Society for Vascular Nursing in October 2011; the American College of Radiology and Society for Cardiovascular Angiography and Interventions in November 2011; and the Society for Vascular Surgery in December 2011.

The American College of Cardiology Foundation requests that this document be cited as follows: Creager MA, Belkin M, Bluth EI, Casey DE Jr, Chaturvedi S, Dake MD, Fleg JL, Hirsch AT, Jaff MR, Kern JA, Malenka DJ, Martin ET, Mohler ER 3rd, Murphy T, Olin JW, Regensteiner JG, Rosenwasser RH, Sheehan P, Stewart KJ, Treat-Jacobson D, Upchurch GR Jr, White CJ, Ziffer JA. 2012 ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/SVS key data elements and definitions for peripheral atherosclerotic vascular disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Peripheral Atherosclerotic Vascular Disease). J Am Coll Cardiol 2012;59:294–357.

This article is copublished in Circulation.

Copies: This document is available on the World Wide Web sites of the American College of Cardiology (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 reprints{at}elsevier.com.

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 Elsevier's permission department at healthpermissions{at}elsevier.com.

^_* Society for Vascular Surgery Representative.

American College of Radiology Representative.

American College of Physicians Representative.

American Academy of Neurology Representative.

^|| National Heart, Lung, and Blood Institute Representative. The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official positions of the National Heart, Lung, and Blood Institute.

^¶ Vascular Disease Foundation Representative.

^# Society of Thoracic Surgeons Representative.

^_** ACCF/AHA Task Force on Data Standards Liaison to the Writing Committee.

Society for Cardiovascular Magnetic Resonance Representative.

Society of Atherosclerosis Imaging and Prevention Representative.

Society of Interventional Radiology Representative.

^|||| Society for Vascular Medicine Representative.

^¶¶ American Association of Neurological Surgeons Representative.

^## American Diabetes Association Representative.

^_*** American Association of Cardiovascular and Pulmonary Rehabilitation Representative.

Society for Vascular Nursing Representative.

Society for Cardiovascular Angiography and Interventions Representative.

Society of Cardiovascular Computed Tomography Representative.

^|||||| Immediate Past Chair of the ACCF/AHA Task Force on Clinical Data Standards.

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