Standardized Reporting Guidelines for Studies Evaluating Risk Stratification of ED Patients with Potential Acute Coronary Syndromes

Researchers evaluating patients with potential acute coronary syndromes (ACS) 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 (EM-CREG-I) initiated an effort to standardize operational definitions and reporting of studies involving emergency department (ED) patients with potential ACS.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. DEVELOPMENT OF THE CRITERIAMembers 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 prior to 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 individual studies.After discussion, the working group determined whether each criterion should be considered a core reporting criterion, considered a supplemental reporting criterion, or not further considered.Ten broad areas were defined, and a subcommittee was assigned to further review the core and supplemental designations and prepare supporting documentation for the consensus recommendations.The document was then distributed to the full EMCREG-I working group and was discussed in detail at a face-toface meeting in May 2003.The document was distributed to Society for Academic Emergency Medicine (SAEM), the American College of Emergency Physicians (ACEP), the American Heart Association (AHA), and the American College of Cardiology (ACC).Representatives were named from each of the four respective organizations.