The Randomised Assessment of Treatment using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department

Abstract

Objectives To determine whether using a point-of-care cardiac biomarker panel would increase the rate of successful discharge home after emergency department assessment, and affect the use of cardiac tests and treatments, subsequent attendance at or admission to hospital and major adverse events. Design and setting Pragmatic multicentre randomised controlled trial in six acute hospitals in the UK. Participants Patients attending with acute chest pain due to suspected myocardial infarction (N¼2243).Interventions Diagnostic assessment using a point-ofcare biomarker panel consisting of creatine kinase, myocardial type, myoglobin and troponin I measured at baseline and 90 min compared with standard care without the point-of-care panel.

Methodological Issues Surrounding the Use of Baseline Health-Related Quality of Life Data to Inform Trial-Based Economic Evaluations of Interventions Within Emergency and Critical Care Settings: A Systematic Literature Review

“…The mean time horizon for the withintrial component of the economic evaluations in the remaining 18 studies was 8 months (median 9 months and range 1 to 12 months). Some studies extrapolated outcomes beyond the trial follow-up period using decision analytic modelling methods [25,26,28] with up to 60 months [25] and lifetime [15,16,28,29] extrapolations beyond the study follow-up periods. Most economic evaluations were conducted from the perspective of the UK National Health Service (NHS) (n=4) or the NHS/Personal Social services (n=9) in accordance with NICE guidance for appraising health technologies [30].…”

“…Most of the economic evaluations did not discount costs and effects in line with the relatively short time horizons of the within-trial analyses. Where studies had extrapolated cost and effects beyond the trial follow-up, discount rates of between 3.0% [25] and 3.5% [16,28,29,33] per annum were applied to both costs and effects. In terms of study quality, all 19 (100%) studies reported using a randomisation process that was assessed as adequate according to the criteria described in Appendix B in the supplementary online material; 16 (84%) were un-blinded and 9 (47%) reported ≥80% completion rates for the primary outcome at end of follow-up.…”

“…Even where trial participants are conscious, the nature of some health conditions (for example cardiac arrest and serious traumatic injury) around the time of randomisation can often raise ethical objections to collecting patient-reported outcome data. Solutions adopted by previous trialbased economic evaluations within emergency and critical illness settings have included delaying the time at which health-related quality of life is assessed until patients are well enough to complete questionnaires [15], [16], [17] , asking patients to retrospectively recall [18] their pre-randomisation health state and use of proxies such as patients' next of kin or health professionals [19]. The impact of this heterogeneity of method upon the findings of economic analyses is unclear.…”

Triage of acute onset chest pain: now a biochemical rule-out test?

“…This triage can be achieved very rapidly. Two large studies, one a randomised controlled trial 37 and the other an observational study, 38 have shown that failure of troponin to increase during the two-hour period following admission defines a low-risk group which can be safely discharged. Triage of acute onset chest pain is now a biochemical rule-out test based on troponin because it is fast and accurate.…”

“…Ischaemia modified albumin in particular appeared hopeful, with reasonable sensitivity and negative predictive value for early detection of ACS as well as providing additional diagnostic and prognostic information to troponin. [34][35][36][37] It is the only biomarker for myocardial ischaemia to have been approved by the US Federal Drugs Administration for clinical use. However both markers are hindered by a lack of cardio-specificity and sufficient clinical evidence, and the IMA test was recently withdrawn from commercial sale.…”