title: Study design of embracing high-sensitivity troponin effectively: the value of more information: a randomized comparison.
abstract: BACKGROUND
  The development of troponin assays with increased diagnostic sensitivity and greater analytic precision has improved the diagnosis of myocardial infarction in high risk patients. However for those patients at intermediate or low risk in whom a small troponin rise is detected, a cascade of clinical decisions and investigations could result; potentially having uncertain impact on recurrent ischemic events and increasing bleeding risk and resource utilization. Clinical equipoise remains as to the clinical utility of high sensitivity troponin.
  
  
  METHODS
  We designed a pragmatic randomized clinical trial to evaluate the short and long term clinical impact and resource implications of high sensitivity 5th generation troponin T reporting compared with 4th generation troponin T reporting. Two thousand patients presenting with a suspected acute coronary syndrome were randomized and risk stratified in 5 metropolitan emergency departments in South Australia, Australia. Clinical events occurring after the first 24 h and within 30 days were assessed as the primary endpoint with subsequent events evaluated at 6 and 12 months.
  
  
  CONCLUSIONS
  The true translational benefits of innovations in diagnostic testing need to be evaluated in robust clinical trials as they can be costly to introduce and the adoption process often focuses on sensitivity and specificity at the expense of measuring improvements in clinical outcome. The results of this study will provide valuable information on contemporary patterns of troponin utilization on the heterogeneous population of chest pain patients presenting to emergency departments, while providing important information from the clinical practice setting for health administrators, government and policy makers.
authors.affiliation: SA Health, Flinders University, SA, Australia. Electronic address: Carolyn.astley@health.sa.gov.au.
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Astley
authors.affiliation: The Queen Elizabeth Hospital, University of Adelaide, SA, Australia.
authors.forename: John F
authors.initials: JF
authors.lastname: Beltrame
authors.affiliation: The Queen Elizabeth Hospital, University of Adelaide, SA, Australia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Zeitz
authors.affiliation: Royal Adelaide Hospital, University of Adelaide, SA, Australia.
authors.forename: Matthew
authors.initials: M
authors.lastname: Worthley
authors.affiliation: SA Pathology, SA, Australia.
authors.forename: Penelope
authors.initials: P
authors.lastname: Coates
authors.affiliation: Lyell McEwin Hospital, University of Adelaide, SA, Australia.
authors.forename: Alistair
authors.initials: A
authors.lastname: Murray
authors.affiliation: Lyell McEwin Hospital, University of Adelaide, SA, Australia.
authors.forename: Margaret
authors.initials: M
authors.lastname: Arstall
authors.affiliation: Flinders University, SA, Australia.
authors.forename: Hugh
authors.initials: H
authors.lastname: Grantham
authors.affiliation: Royal Adelaide Hospital, University of Adelaide, SA, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Dunn
authors.affiliation: Flinders University, SA, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Quinn
authors.affiliation: Flinders Medical Centre, SAHMRI, Flinders University, SA, Australia.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Aylward
authors.affiliation: Flinders Medical Centre, SAHMRI, Flinders University, SA, Australia.
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
mesh_terms: D000367:Age Factors; D015415:Biomarkers; D004562:Electrocardiography; D004636:Emergency Service, Hospital; D006779:Hospitals, Public; D006801:Humans; D009203:Myocardial Infarction / Q000097:blood*; D012107:Research Design; D012307:Risk Factors; D012680:Sensitivity and Specificity; D013021:South Australia; D020107:Troponin T / Q000097:blood*
chemical_list: D015415:Biomarkers; D020107:Troponin T
keywords: Clinical outcomes; Electronic data capture; Measuring innovations; Pragmatic clinical trial; Rigorous methods