Cynthia Papendick1, Andrew Blyth2, Anil Seshadri3, Michael J R Edmonds2, Tom Briffa4, Louise Cullen5, Stephen Quinn6, Jon Karnon1, Anthony Chuang3, Adam J Nelson1, Matthew Horsfall2, Erin Morton7, Derek P Chew8. 1. School of Medicine, University of Adelaide, Adelaide, Australia. 2. South Australian Department of Health, Adelaide, Australia. 3. School of Medicine, Flinders University of South Australia, Adelaide, Australia; South Australian Department of Health, Adelaide, Australia. 4. School of Population and Global Health, University of Western Australia, Perth, Australia. 5. Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Public Health, Queensland University of Technology, Brisbane, Australia; School of Medicine, University of Queensland, Brisbane, Australia. 6. Department of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia. 7. School of Medicine, Flinders University of South Australia, Adelaide, Australia. 8. School of Medicine, Flinders University of South Australia, Adelaide, Australia; South Australian Department of Health, Adelaide, Australia. Electronic address: derek.chew@flinders.edu.au.
Abstract
BACKGROUND: Protocols incorporating high-sensitivity troponin to guide decision making in the disposition of patients with suspected acute coronary syndromes (ACS) in the emergency department have received a lot of attention. Traditionally, patients with chest pain have required long periods of observation in emergency department before being deemed safe for discharge. In an era of limited health service resources, a protocol that could discharge patients safely within an hour of presentation is extremely attractive. Unfortunately, despite incorporation into some guidelines, these protocols have not been subjected to randomized comparisons evaluating safety, effectiveness, and cost-effectiveness. OBJECTIVE: This study is designed to provide the evidence required to allow key decision makers to implement these protocols: specifically, to provide evidence that a decision rule based on 0- and 1-hour high-sensitivity troponin T (hs-TnT) is safe, provides noninferior outcomes in all patients with suspected ACS, and that implementation of a rapid troponin protocol leads to efficient care. DESIGN: This prospective pragmatic trial (n=5,400, 5 hospitals) randomly allocates patients with suspected ACS to either a 0/1-hour hs-TnT protocol as advocated in clinical guidelines, versus usual care of standard troponin reporting evaluated at 3 and 6hours. The primary effectiveness composite end points of this study are all-cause death and new/recurrent ACS within 30days. To evaluate cost-effectiveness, follow-up will determine clinical events, quality of life, and resource utilization within 12 months. SUMMARY: Demonstrating that a 0/1-hour hs-TnT protocol improves the effectiveness and efficiency of care within a robust comparative study will fill an evidence gap that currently limits the translation of more precise hs-TnT testing into better patient and health service outcomes. Crown
RCT Entities:
BACKGROUND: Protocols incorporating high-sensitivity troponin to guide decision making in the disposition of patients with suspected acute coronary syndromes (ACS) in the emergency department have received a lot of attention. Traditionally, patients with chest pain have required long periods of observation in emergency department before being deemed safe for discharge. In an era of limited health service resources, a protocol that could discharge patients safely within an hour of presentation is extremely attractive. Unfortunately, despite incorporation into some guidelines, these protocols have not been subjected to randomized comparisons evaluating safety, effectiveness, and cost-effectiveness. OBJECTIVE: This study is designed to provide the evidence required to allow key decision makers to implement these protocols: specifically, to provide evidence that a decision rule based on 0- and 1-hour high-sensitivity troponin T (hs-TnT) is safe, provides noninferior outcomes in all patients with suspected ACS, and that implementation of a rapid troponin protocol leads to efficient care. DESIGN: This prospective pragmatic trial (n=5,400, 5 hospitals) randomly allocates patients with suspected ACS to either a 0/1-hour hs-TnT protocol as advocated in clinical guidelines, versus usual care of standard troponin reporting evaluated at 3 and 6hours. The primary effectiveness composite end points of this study are all-cause death and new/recurrent ACS within 30days. To evaluate cost-effectiveness, follow-up will determine clinical events, quality of life, and resource utilization within 12 months. SUMMARY: Demonstrating that a 0/1-hour hs-TnT protocol improves the effectiveness and efficiency of care within a robust comparative study will fill an evidence gap that currently limits the translation of more precise hs-TnT testing into better patient and health service outcomes. Crown
Authors: Denise Burtenshaw; Brian Regan; Kathryn Owen; David Collins; David McEneaney; Ian L Megson; Eileen M Redmond; Paul Aidan Cahill Journal: Front Cell Dev Biol Date: 2022-06-01
Authors: Edward Hyun Suh; Aleksandr M Tichter; Lauren S Ranard; Andrew Amaranto; Betty C Chang; Phong Anh Huynh; Alexander Kratz; Rebekah Jihae Lee; LeRoy E Rabbani; Dana Sacco; Andrew J Einstein Journal: J Am Coll Emerg Physicians Open Date: 2022-05-05
Authors: Anthony Ming-Yu Chuang; Mau T Nguyen; Ehsan Khan; Dylan Jones; Matthew Horsfall; Sam Lehman; Nathaniel R Smilowitz; Kristina Lambrakis; Martin Than; Julian Vaile; Ajay Sinhal; John K French; Derek P Chew Journal: PLoS One Date: 2021-03-12 Impact factor: 3.240
Authors: Ming-Yu Anthony Chuang; Emmanuel S Gnanamanickam; Jonathan Karnon; Kristina Lambrakis; Matthew Horsfall; Andrew Blyth; Anil Seshadri; Mau T Nguyen; Tom Briffa; Louise A Cullen; Stephen Quinn; John K French; Derek P Chew Journal: Int J Cardiol Heart Vasc Date: 2021-12-29