Circulation. 2005;112:1888-1916
Published online before print September 14, 2005,
doi: 10.1161/CIRCULATIONAHA.105.170073
(Circulation. 2005;112:1888-1916.)
© 2005 American Heart Association, Inc.
ACC/AHA Heart Failure Clinical Data Standards |
ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Chronic Heart Failure
A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Heart Failure Clinical Data Standards): Developed in Collaboration With the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: Endorsed by the Heart Failure Society of America
WRITING COMMITTEE: Martha J. Radford, MD, FACC, FAHA, Chair;
J. Malcolm O. Arnold, MD, FACC;
Susan J. Bennett, DNS, RN, FAAN, FAHA;
Michael P. Cinquegrani, MD, FACC;
John G. F. Cleland, MD, FACC;
Edward P. Havranek, MD, FACC;
Paul A. Heidenreich, MD, MS, FACC;
John D. Rutherford, MB, CHB, FACC, FAHA;
John A. Spertus, MD, MPH, FACC;
Lynne Warner Stevenson, MD, FACC, FAHA
TASK FORCE MEMBERS: Paul A. Heidenreich, MD, MS, FACC, Chair;
David C. Goff, PHD, FAHA*;
Frederick L. Grover, MD, FACC;
David J. Malenka, MD, FACC*;
Eric D. Peterson, MD, FACC;
Martha J. Radford, MD, FACC, FAHA
;
Rita F. Redberg, MD, MSc, FACC*
*Former Task Force member;
Immediate past Task Force Chair
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Introduction
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Table of Contents
- Preamble 1889
- I. Introduction 1890
- II. Methodology 1890
- A. Writing Committee Composition 1890
- B. Relationships With Industry 1891
- C. Review of the Literature and Existing Data Definitions 1891
- D. Prioritizing Data Elements 1891
- E. Defining Data Elements 1891
- F. Consensus Development 1892
- G. Peer Review, Public Comment, and Board Approval 1892
- H. Considerations for Use of Data Elements and Definitions 1892
- I. Special Considerations and Challenges for HF Data Standards 1892
- Uses for HF Data Standards 1892
- Balance Between Focus and Comprehensiveness 1893
- Balance Between "Primary" and "Summary" Data Elements 1893
- Variety of Disease States Leading to HF 1893
- Acute and Chronic Care, Inpatient and Outpatient Care Venues 1893
- Therapy for HF 1893
- Outcomes Assessment for HF 1893
- III. HF Clinical Data Standards Elements and Definitions 1893
- A. Patient Demographics 1893
- B. Medical History 1895
- C. Patient Assessment: Current Symptoms and Signs 1900
- D. Patient Assessment: Summary Assessment 1901
- E. Laboratory Tests 1903
- F. Diagnostic Procedures 1903
- G. Invasive Therapeutic Procedures 1906
- H. Pharmacological Therapy 1908
- I. End-of-Life Management 1910
- J. Patient Education: Assessment of Status 1910
- K. Patient Education: Intervention and Referral 1911
- Appendix A: Health Status 1912
- Appendix B: Writing Committee Relationships With Industry 1914
- Appendix C: Peer Reviewer Relationships With Industry 1915
- References 1915
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Preamble
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The American College of Cardiology (ACC) and the American Heart
Association (AHA) recognize the importance of refining the lexicon
used to describe the process and outcomes of clinical care,
whether in randomized trials, observational studies, registries,
or quality improvement initiatives. Broad professional agreement
on a common vocabulary with common definitions will facilitate
cross-study comparisons or, when advantageous, combining of
data across studies and improving the assessment of any project’s
generalizability to clinical practice. To further efforts aimed
at standardizing such a lexicon, the ACC and AHA have undertaken
to develop and publish clinical data standards-sets of standardized
data elements and corresponding definitions that can be used
in a variety of data collection efforts for a range of cardiovascular
conditions.
It is hoped that these clinical data standards will:
- Improve cross-comparison of results and clinical outcomes between different trials and registries.
- Facilitate the development and conduct of future registries, at both hospital and national levels, by providing a list of major variables, outcomes, and definitions.
- Facilitate measurement for quality improvement programs.
- Become the basis for a standardized medical documentation process with the anticipation that the medical record will progress to an electronic format.
The ACC/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or a personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the parent task force, reported orally to all members of the writing panel at the first meeting, and updated as changes occur.
The ACC/AHA Task Force on Clinical Data Standards selects cardiovascular conditions and procedures that would benefit from the creation of a standard dataset. Experts in the subject are selected to examine/consider existing data standards and develop a comprehensive, yet not exhaustive, standard dataset. Users should understand that, when undertaking a data collection effort, only a subset may be needed or, conversely, they 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 aim to standardize the language used to describe cardiovascular diseases and procedures, enhance consistency in cardiology, and increase opportunities for sharing data across various data sources. The ultimate goal of ACC/AHA clinical data standards is to contribute to the infrastructure necessary for accomplishing the ACC/AHA’s mission of fostering optimal cardiovascular care and disease prevention.
The ACC and AHA support the goals of their members to improve cardiovascular care and disease prevention through professional education, promotion of research, development of guidelines and standards for cardiovascular care, and fostering a policy that supports optimal patient outcomes. Both the ACC and the AHA recognize the importance of the use of clinical data for patient management, in the assessment of patient outcomes, and in research efforts focused on improving the clinical treatment of patients.
As a component of this objective, the ACC/AHA clinical data standards concentrate on the identification, definition, and standardization of data corresponding with various clinical topics in cardiology. The primary goal of clinical data standards is to assist in the collection of data by providing an initial platform of data elements and corresponding definitions applicable to various disease conditions in cardiology. These key elements and definitions are a compilation of variables applicable in the measurement of patient clinical management and outcomes, and for research and epidemiological assessments.
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 our patients’ privacy. Our goal is to treat every patient’s health information with the same respect and courtesy as
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Footnotes
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This document was approved by the American College of Cardiology
Board of Trustees in August 2005 and the American Heart Association
Science Advisory and Coordinating Committee in August 2005.
When citing this document, the American Heart Association would appreciate the following citation format: Radford MJ, Arnold JM, Bennett SJ, Cinquegrani MP, Cleland JGF, Havranek EP, Heidenreich PA, Rutherford JD, Spertus JA, Stevenson LW. ACC/AHA key data elements and data definitions for measuring the clinical management and outcomes of patients with heart failure: a report of the ACC/AHA Task Force on Clinical Data Standards (Heart Failure Data Standards Writing Committee). Circulation. 2005;112:1888–1916.
Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association (www.americanheart.org). Single copies of this document as published in the September 20, 2005 issue of the Journal of the American College of Cardiology and the September 20, 2005 issue of Circulation are available for $10.00 each by calling 1-800-253-4636 or writing the American College of Cardiology Foundation, Resource Center, at 9111 Old Georgetown Road, Bethesda, MD 20814-1699. To purchase bulk reprints (specify version and reprint number-71-0335 for the published document: Up to 999 copies, call 1-800-611-6083 (U.S. only) or fax 413-665-2671; 1000 or more copies, call 214-706-1789, fax 214-691-6342, or E-mail: pubauth@heart.org.
Permissions: 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 direct requests to copyright_permissions@acc.org.
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Top
Introduction
Preamble
