Special ContributionStandardized reporting guidelines for studies evaluating risk stratification of emergency department patients with potential acute coronary syndromes
Introduction
Researchers evaluating patients with potential acute coronary syndromes have incorporated a wide range of eligible patients, historical factors, and outcome parameters into their studies. This has led to difficulty comparing results and conclusions of diagnostic and prognostic studies. The patient selection criteria, time intervals, and positive test and outcome definitions vary greatly between studies and investigators. As a result, Emergency Medicine Cardiac Research and Education Group–International (EMCREG-I) initiated an effort to standardize operational definitions and reporting of studies involving emergency department (ED) patients with potential acute coronary syndromes. These recommendations balance scientific rigor with practicality in an effort to increase the likelihood of obtaining scientifically valid data that may impact care of emergency cardiac patients. The goal of this group was not to develop an ideal study. It was to convene a multidisciplinary consensus panel to develop standardized reporting criteria that would more easily allow for comparison of studies.
Section snippets
Development of the criteria
Members of the Standardized Reporting Criteria Working Group of EMCREG-I first met in October 2001 to draft an initial set of criteria to be considered for incorporation into this document. The draft document was circulated to members of the working group and continually modified before a face-to-face meeting in May 2002. During this meeting, committee members methodologically discussed each proposed criterion and how critical knowledge of the individual parameter would be to interpretation of
Integration with other key publications
In constructing these reporting guidelines, every effort was made to review consensus documents and organizational publications that might overlap with these guidelines. We did not attempt to define all of the variables that we recommend reporting. The ACC has defined Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Acute Coronary Syndromes.1 The Standardized Reporting Guidelines is complementary to the ACC Key Data Elements document. The
Proper use of this document
Bold items are core components. These items should be reported in essentially all risk-stratification studies of ED patients. Investigators planning clinical studies that involve risk stratification of ED patients with acute coronary syndromes should report the items that are considered core components. These items are those that represent the minimal amount of information necessary to allow readers to compare studies with respect to patient enrollment, patient description, and clinical
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Supported, in part, by Aventis Pharmaceuticals by an unrestricted educational grant and by the Emergency Medicine Cardiac Research and Education Group–International.
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Affiliations are listed at the end of the article.
This article is being simultaneously published in Academic Emergency Medicine.