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Late-Breaking Clinical Trials |
From the Division of Cardiovascular Diseases (W.K.S., J.M.T., K.M.B., A.J., P.A.B., T.M.M., B.J.G., S.C.H., R.L.F.), the Department of Emergency Medicine (W.W.D., P.A.S., D.G.G., A.E.W.), and the Division of Biostatistics (D.O.H.), Mayo Clinic, Rochester, Minn.
Reprint requests to Dr Win Shen, Mayo Clinic, 200 First St SW, Rochester, MN 55905. E-mail wshen{at}mayo.edu
Received October 7, 2004; revision received October 22, 2004; accepted October 22, 2004.
Background The primary aim and central hypothesis of the study are that a designated syncope unit in the emergency department improves diagnostic yield and reduces hospital admission for patients with syncope who are at intermediate risk for an adverse cardiovascular outcome.
Methods and Results In this prospective, randomized, single-center study, patients were randomly allocated to 2 treatment arms: syncope unit evaluation and standard care. The 2 groups were compared with
2 test for independence of categorical variables. Wilcoxon rank sum test was used for continuous variables. Survival was estimated with the Kaplan-Meier method. One hundred three consecutive patients (53 women; mean age 64±17 years) entered the study. Fifty-one patients were randomized to the syncope unit. For the syncope unit and standard care patients, the presumptive diagnosis was established in 34 (67%) and 5 (10%) patients (P<0.001), respectively, hospital admission was required for 22 (43%) and 51 (98%) patients (P<0.001), and total patient-hospital days were reduced from 140 to 64. Actuarial survival was 97% and 90% (P=0.30), and survival free from recurrent syncope was 88% and 89% (P=0.72) at 2 years for the syncope unit and standard care groups, respectively.
Conclusions The novel syncope unit designed for this study significantly improved diagnostic yield in the emergency department and reduced hospital admission and total length of hospital stay without affecting recurrent syncope and all-cause mortality among intermediate-risk patients. Observations from the present study provide benchmark data for improving patient care and effectively utilizing healthcare resources.
Key Words: syncope diagnosis prognosis
Related Article:
Circulation 2004 110: 3621-3623.
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