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(Circulation. 2004;109:3223-3243.)
© 2004 American Heart Association, Inc.

ACC/AHA Clinical Data Standards

ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Atrial Fibrillation

A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Data Standards on Atrial Fibrillation)

WRITING COMMITTEE MEMBERS: Robert L. McNamara, MD, MHS, FACC, Chair; Lawrence M. Brass, MD, FAHA; Joseph P. Drozda, Jr, MD, FACC; Alan S. Go, MD; Jonathan L. Halperin, MD, FACC, FAHA; Charles R. Kerr, MD, FACC; Samuel Lévy, MD, FACC, FAHA; David J. Malenka, MD, FACC; Suneet Mittal, MD, FACC; Frank Pelosi, Jr, MD, FACC; Yves Rosenberg, MD; Daniel Stryer, MD; D. George Wyse, MD, PhD, FACC, FAHA

TASK FORCE MEMBERS: Martha J. Radford, MD, FACC, FAHA, Chair; David C. Goff, Jr, MD, PhD, FAHA; Frederick L. Grover, MD, FACC; Paul A. Heidenreich, MD, FACC; David J. Malenka, MD, FACC; Eric D. Peterson, MD, FACC, FAHA; Rita F. Redberg, MD, MSc, FACC, FAHA

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Endorsed by the Mediterranean Society of Pacing and Electrophysiology

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An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 

Preamble 3224

I. Introduction 3225

   A. Purpose 3225

II. Methodology 3225

   A. Writing Committee Composition 3225

   B. Review of Literature and Existing Data Definitions 3225

   C. Prioritizing Data Elements 3225

   D. Defining Data Elements 3225

   E. Writing Considerations for Use 3226

   F. Consensus Development 3226

   G. Peer Review, Public Comment, and Board Approval 3226

   H. Document Format 3226

III. General Considerations of the AF Clinical Data Standards 3226

   A. Patient-Oriented Format 3226

   B. Balance Between Focus and Comprehensiveness 3226

   C. Dates 3226

   D. Varied Clinical Presentations 3226

   E. Balance Between Primary and Summary Data Elements 3226

   F. Atrial Fibrillation-Specific Elements 3226

   G. Quality of Life 3227

   H. Atrial Flutter and Other Atrial Tachycardias 3227

IV. Atrial Fibrillation Clinical Data Elements and Definitions 3227

   A. Retrospective and Concurrent Data (collected at or near the time of study initiation) 3228

   B. Prospective Data (collected after enrolling in study) 3234

Appendix A: External Peer Reviewers 3242

References 3243

	Preamble

 
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 will improve 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, . . . [Full Text of this Article]

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