Could Computed Tomography Coronary Angiography Replace Invasive Coronary Angiography as a First-Line Diagnostic Investigation in Suspected Acute Coronary Syndromes? A Decision-Analytic Model.

BACKGROUND: The implementation of high-sensitivity cardiac troponin (hs-cTn) assays into clinical practice has resulted in the identification of a novel cohort of patients with modestly increased troponin concentrations. Subsequent increases in rates of coronary angiography have been observed, without significant increases in rates of coronary revascularisation. Computed tomography coronary angiography (CTCA) is a non-invasive investigation that offers the opportunity to decouple investigation from the impetus to revascularise, and may provide an alternative, more risk-appropriate initial investigative strategy for the cohort with low to moderate hs-cTn increases. This analysis seeks to define the threshold of pre-test probability of coronary revascularisation in patients with suspected acute coronary syndrome at which a strategy of initial CTCA is safe and a more cost-effective approach than standard invasive coronary angiography (ICA). METHODS: A cost-benefit evaluation was conducted using a decision-analytic model. The primary outcome measure was the incremental cost-effectiveness ratio (ICER) of CTCA in comparison with ICA as an initial diagnostic investigation for patients with hs-cTnT levels between 5 and 100 ng/L. Secondary outcome measures of costs, patient outcomes, and quality-adjusted life years were analysed. RESULTS: Median base case ICER over 1,000 trials was $17,163 AUD but demonstrated large variability. Sensitivity analysis demonstrated that CTCA was cost-effective until the probability of requiring revascularisation was ∼60%, beyond which point CTCA was associated with higher costs and poorer outcomes than ICA. CONCLUSIONS: Computed tomography coronary angiography may be a cost-effective first-line investigation for patients with moderate hs-cTnT rises until/up to a 60% pre-test probability for receiving coronary revascularisation. To objectively assess the optimal circumstances of cost-effectiveness, prospective evaluation incorporating the estimated probability of revascularisation will be required.

Chest Pain Management Using Prehospital Point-of-Care Troponin and Paramedic Risk Assessment.

Importance: Prehospital point-of-care troponin testing and paramedic risk stratification might improve the efficiency of chest pain care pathways compared with existing processes with equivalent health outcomes, but the association with health care costs is unclear. Objective: To analyze whether prehospital point-of-care troponin testing and paramedic risk stratification could result in cost savings compared with existing chest pain care pathways. Design, Setting, and Participants: In this economic evaluation of adults with acute chest pain without ST-segment elevation, cost-minimization analysis was used to assess linked ambulance, emergency, and hospital attendance in the state of Victoria, Australia, between January 1, 2015, and June 30, 2019. Interventions: Paramedic risk stratification and point-of-care troponin testing. Main Outcomes and Measures: The outcome was estimated mean annualized statewide costs for acute chest pain. Between May 17 and June 25, 2022, decision tree models were developed to estimate costs under 3 pathways: (1) existing care, (2) paramedic risk stratification and point-of-care troponin testing without prehospital discharge, or (3) prehospital discharge and referral to a virtual emergency department (ED) for low-risk patients. Probabilities for the prehospital pathways were derived from a review of the literature. Multivariable probabilistic sensitivity analysis with 50 000 Monte Carlo iterations was used to estimate mean costs and cost differences among pathways. Results: A total of 188 551 patients attended by ambulance for chest pain (mean [SD] age, 61.9 [18.3] years; 50.5% female; 49.5% male; Indigenous Australian, 2.0%) were included in the model. Estimated annualized infrastructure and staffing costs for the point-of-care troponin pathways, assuming a 5-year device life span, was $2.27 million for the pathway without prehospital discharge and $4.60 million for the pathway with prehospital discharge (incorporating virtual ED costs). In the decision tree model, total annual cost using prehospital point-of-care troponin and paramedic risk stratification was lower compared with existing care both without prehospital discharge (cost savings, $6.45 million; 95% uncertainty interval [UI], $0.59-$16.52 million; lower in 94.1% of iterations) and with prehospital discharge (cost savings, $42.84 million; 95% UI, $19.35-$72.26 million; lower in 100% of iterations). Conclusions and Relevance: Prehospital point-of-care troponin and paramedic risk stratification for patients with acute chest pain could result in substantial cost savings. These findings should be considered by policy makers in decisions surrounding the potential utility of prehospital chest pain risk stratification and point-of-care troponin models provided that safety is confirmed in prospective studies.

Implementation and prospective evaluation of the Country Heart Attack Prevention model of care to improve attendance and completion of cardiac rehabilitation for patients with cardiovascular diseases living in rural Australia: a study protocol.

INTRODUCTION: Despite extensive evidence of its benefits and recommendation by guidelines, cardiac rehabilitation (CR) remains highly underused with only 20%-50% of eligible patients participating. We aim to implement and evaluate the Country Heart Attack Prevention (CHAP) model of care to improve CR attendance and completion for rural and remote participants. METHODS AND ANALYSIS: CHAP will apply the model for large-scale knowledge translation to develop and implement a model of care to CR in rural Australia. Partnering with patients, clinicians and health service managers, we will codevelop new approaches and refine/expand existing ones to address known barriers to CR attendance. CHAP will codesign a web-based CR programme with patients expanding their choices to CR attendance. To increase referral rates, CHAP will promote endorsement of CR among clinicians and develop an electronic system that automatises referrals of in-hospital eligible patients to CR. A business model that includes reimbursement of CR delivered in primary care by Medicare will enable sustainable access to CR. To promote CR quality improvement, professional development interventions and an accreditation programme of CR services and programmes will be developed. To evaluate 12-month CR attendance/completion (primary outcome), clinical and cost-effectiveness (secondary outcomes) between patients exposed (n=1223) and not exposed (n=3669) to CHAP, we will apply a multidesign approach that encompasses a prospective cohort study, a pre-post study and a comprehensive economic evaluation. ETHICS AND DISSEMINATION: This study was approved by the Southern Adelaide Clinical Human Research Ethics Committee (HREC/20/SAC/78) and by the Department for Health and Wellbeing Human Research Ethics Committee (2021/HRE00270), which approved a waiver of informed consent. Findings and dissemination to patients and clinicians will be through a public website, online educational sessions and scientific publications. Deidentified data will be available from the corresponding author on reasonable request. TRIAL REGISTRATION NUMBER: ACTRN12621000222842.

Cost effectiveness of a 1-hour high-sensitivity troponin-T protocol: An analysis of the RAPID-TnT trial.

BACKGROUND: To understand the economic impact of an accelerated 0/1-hour high-sensitivity troponin-T (hs-cTnT) protocol. OBJECTIVE: To conduct a patient-level economic analysis of the RAPID-TnT randomised trial in patients presenting with suspected acute coronary syndrome (ACS). METHODS: An economic evaluation was conducted with 3265 patients randomised to either the 0/1-hour hs-cTnT protocol (n = 1634) or the conventional 0/3-hour standard-of-care protocol (n = 1631) with costs reported in Australian dollars. The primary clinical outcome was all-cause mortality or new/recurrent myocardial infarction. RESULTS: Over 12-months, mean per patient costs were numerically higher in the 0/1-hour arm compared to the conventional 0/3-hour arm (by $472.49/patient, 95% confidence interval [95 %CI]: $-1,380.15 to $2,325.13, P = 0.617) with no statistically significant difference in primary outcome (0/1-hour: 62/1634 [3.8%], 0/3-hour: 82/1631 [5.0%], HR: 1.32 [95 %CI: 0.95-1.83], P = 0.100). The mean emergency department (ED) length of stay (LOS) was significantly lower in the 0/1-hour arm (by 0.62 h/patient, 95 %CI: 0.85 to 0.39, P < 0.001), but the subsequent 12-month unplanned inpatient costs was numerically higher (by $891.22/patient, 95 %CI: $-96.07 to 1,878.50, P = 0.077). Restricting the analysis to patients with hs-cTnT concentrations ≤ 29 ng/L, mean per patient cost remained numerically higher in the 0/1-hour arm (by $152.44/patient, 95 %CI:$-1,793.11 to $2,097.99, P = 0.988), whilst the reduction in ED LOS was more pronounced (by 0.70 h/patient, 95 %CI: 0.45-0.95, P < 0.001). CONCLUSIONS: There were no differences in resource utilization between the 0/1-hour hs-cTnT protocol versus the conventional 0/3-hour protocol for the assessment of suspected ACS, despite improved initial ED efficiency. Further refinements in strategies to improve clinical outcomes and subsequent management efficiency are needed.

Comparative overview of ST-elevation myocardial infarction epidemiology, demographics, management, and outcomes in five Asia-Pacific countries: a meta-analysis.

The aim of this study is to gain insight into the differences in demographics of ST-elevation myocardial infarction (STEMI) patients in Asia-Pacific, as well as inter-country variation in treatment and mortality outcomes. Systematic review of published studies and reports from known registries in Australia, Japan, Korea, Singapore, and Malaysia that began data collection after the year 2000. Supplementary self-report survey questionnaire on public health data answered by representative cardiologists working in these countries. Twenty studies comprising of 158 420 patients were included in the meta-analysis. The mean age was 61.6 years. Chronic kidney disease prevalence was higher in Japan, while dyslipidaemia was low in Korea. Use of aspirin, P2Y12 inhibitors, and statins were high throughout, but ACEi/ARB and ß-blocker prescriptions were lower in Japan and Malaysia. Reperfusion strategies varied greatly, with high rates of primary percutaneous coronary intervention (pPCI) in Korea (91.6%), whilst Malaysia relies far more on fibrinolysis (72.6%) than pPCI (9.6%). Similarly, mortality differed, with 1-year mortality from STEMI was considerably greater in Malaysia (17.9%) and Singapore (11.2%) than in Korea (8.1%), Australia (7.8%), and Japan (6.2%). The countries were broadly similar in development and public health indices. Singapore has the highest gross national income and total healthcare expenditure per capita, whilst Malaysia has the lowest. Primary PCI is available in all countries 24/7/365. Despite broadly comparable public health systems, differences exist in patient profile, in-hospital treatment, and mortality outcomes in these five countries. Our study reveals areas for improvements. The authors advocate further registry-based multi-country comparative studies focused on the Asia-Pacific region.

Objective Risk Assessment vs Standard Care for Acute Coronary Syndromes: A Randomized Clinical Trial.

Importance: Although international guidelines recommend use of the Global Registries of Acute Coronary Events (GRACE) risk score (GRS) to guide acute coronary syndrome (ACS) treatment decisions, the prospective utility of the GRS in improving care and outcomes is unproven. Objective: To assess the effect of routine GRS implementation on guideline-indicated treatments and clinical outcomes of hospitalized patients with ACS. Design, Setting, and Participants: Prospective cluster (hospital-level) randomized open-label blinded end point (PROBE) clinical trial using a multicenter ACS registry of acute care cardiology services. Fixed sampling of the first 10 patients within calendar month, with either ST-segment elevation or non-ST-segment elevation ACS. The study enrolled patients from June 2014 to March 2018, and data were analyzed between February 2020 and April 2020. Interventions: Implementation of routine risk stratification using the GRS and guideline recommendations. Main Outcomes and Measures: The primary outcome was a performance score based on receipt of early invasive treatment, discharge prescription of 4 of 5 guideline-recommended pharmacotherapies, and cardiac rehabilitation referral. Clinical outcomes included a composite of all-cause death and/or myocardial infarction (MI) within 1 year. Results: This study enrolled 2318 patients from 24 hospitals and was stopped prematurely owing to futility. Of the patients enrolled, median age was 65 years (interquartile range, 56-74 years), 29.5% were women (n = 684), and 62.9% were considered high risk (n = 1433). Provision of all 3 measures among high-risk patients did not differ between the randomized arms (GRS: 424 of 717 [59.9%] vs control: 376 of 681 [55.2%]; odds ratio [OR], 1.04; 95% CI, 0.63-1.71; P = .88). The provision of early invasive treatment was increased compared with the control arm (GRS: 1042 of 1135 [91.8%] vs control: 989 of 1183 [83.6%]; OR, 2.26; 95% CI, 1.30-3.96; P = .004). Prescription of 4 of 5 guideline-recommended pharmacotherapies (GRS: 864 of 1135 [76.7%] vs control: 893 of 1183 [77.5%]; OR, 0.97; 95% CI, 0.68-1.38) and cardiac rehabilitation (GRS: 855 of 1135 [75.1%] vs control: 861 of 1183 [72.8%]; OR, 0.68; 95% CI, 0.32-1.44) were not different. By 12 months, GRS intervention was not associated with a significant reduction in death or MI compared with the control group (GRS: 96 of 1044 [9.2%] vs control: 146 of 1087 [13.4%]; OR, 0.66; 95% CI, 0.38-1.14). Conclusions and Relevance: Routine GRS implementation in cardiology services with high levels of clinical care was associated with an increase in early invasive treatment but not other aspects of care. Low event rates and premature study discontinuation indicates the need for further, larger scale randomized studies. Trial Registration: anzctr.org.au Identifier: ACTRN12614000550606.

The Asia-Pacific Society of Cardiology (APSC) Expert Committee Consensus Recommendations for Assessment of Suspected Acute Coronary Syndrome Using High-Sensitivity Cardiac Troponin T in the Emergency Department.

The Asia-Pacific Society of Cardiology (APSC) high-sensitivity troponin T (hs-TnT) consensus recommendations and rapid algorithm were developed to provide guidance for healthcare professionals in the Asia-Pacific region on assessing patients with suspected acute coronary syndrome (ACS) using a hs-TnT assay. Experts from Asia-Pacific convened in 2 meetings to develop evidence-based consensus recommendations and an algorithm for appropriate use of the hs-TnT assay. The Expert Committee defined a cardiac troponin assay as a high-sensitivity assay if the total imprecision is ≤10% at the 99th percentile of the upper reference limit and measurable concentrations below the 99th percentile are attainable with an assay at a concentration value above the assay's limit of detection for at least 50% of healthy individuals. Recommendations for single-measurement rule-out/rule-in cutoff values, as well as for serial measurements, were also developed. The Expert Committee also adopted similar hs-TnT cutoff values for men and women, recommended serial hs-TnT measurements for special populations, and provided guidance on the use of point-of-care troponin T devices in individuals suspected of ACS. These recommendations should be used in conjunction with all available clinical evidence when making the diagnosis of ACS.

A Randomized Trial of a 1-Hour Troponin T Protocol in Suspected Acute Coronary Syndromes: The Rapid Assessment of Possible Acute Coronary Syndrome in the Emergency Department With High-Sensitivity Troponin T Study (RAPID-TnT).

BACKGROUND: High-sensitivity troponin assays promise earlier discrimination of myocardial infarction. Yet, the benefits and harms of this improved discriminatory performance when incorporated within rapid testing protocols, with respect to subsequent testing and clinical events, has not been evaluated in an in-practice patient-level randomized study. This multicenter study evaluated the noninferiority of a 0/1-hour high-sensitivity cardiac troponin T (hs-cTnT) protocol in comparison with a 0/3-hour masked hs-cTnT protocol in patients with suspected acute coronary syndrome presenting to the emergency department (ED). METHODS: Patients were randomly assigned to either a 0/1-hour hs-cTnT protocol (reported to the limit of detection [<5 ng/L]) or masked hs-cTnT reported to ≤29 ng/L evaluated at 0/3-hours (standard arm). The 30-day primary end point was all-cause death and myocardial infarction. Noninferiority was defined as an absolute margin of 0.5% determined by Poisson regression. RESULTS: In total, 3378 participants with an emergency presentation were randomly assigned between August 2015 and April 2019. Ninety participants were deemed ineligible or withdrew consent. The remaining participants received care guided either by the 0/1-hour hs-cTnT protocol (n=1646) or the 0/3-hour standard masked hs-cTnT protocol (n=1642) and were followed for 30 days. Median age was 59 (49-70) years, and 47% were female. Participants in the 0/1-hour arm were more likely to be discharged from the ED (0/1-hour arm: 45.1% versus standard arm: 32.3%, P<0.001) and median ED length of stay was shorter (0/1-hour arm: 4.6 [interquartile range, 3.4-6.4] hours versus standard arm: 5.6 (interquartile range, 4.0-7.1) hours, P<0.001). Those randomly assigned to the 0/1-hour protocol were less likely to undergo functional cardiac testing (0/1-hour arm: 7.5% versus standard arm: 11.0%, P<0.001). The 0/1-hour hs-cTnT protocol was not inferior to standard care (0/1-hour arm: 17/1646 [1.0%] versus 16/1642 [1.0%]; incidence rate ratio, 1.06 [ 0.53-2.11], noninferiority P value=0.006, superiority P value=0.867), although an increase in myocardial injury was observed. Among patients discharged from ED, the 0/1-hour protocol had a negative predictive value of 99.6% (95% CI, 99.0-99.9%) for 30-day death or myocardial infarction. CONCLUSIONS: This in-practice evaluation of a 0/1-hour hs-cTnT protocol embedded in ED care enabled more rapid discharge of patients with suspected acute coronary syndrome. Improving short-term outcomes among patients with newly recognized troponin T elevation will require an evolution in management strategies for these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au. Unique identifier: ACTRN12615001379505.

The appropriateness of coronary investigation in myocardial injury and type 2 myocardial infarction (ACT-2): A randomized trial design.

BACKGROUND: Elevated troponin level findings among patients presenting with suspected acute coronary syndrome (ACS) or another intercurrent illness undeniably identifies patients at increased risk of mortality. Whilst enhancing our capacity to discriminate risk, the use of high-sensitivity troponin assays frequently identifies patients with myocardial injury (i.e. troponin rise without acute signs of myocardial ischemia) or type 2 myocardial infarction (T2MI; oxygen supply-demand imbalance). This leads to the clinically challenging task of distinguishing type 1 myocardial infarction (T1MI; coronary plaque rupture) from myocardial injury and T2MI in the context of concurrent acute illness. Diagnostic discernment in this context is crucial because MI classification has implications for further investigation and care. Early invasive management is of well-established benefit among patients with T1MI. However, the appropriateness of this investigation in the heterogeneous context of T2MI, where there is high competing mortality risk, remains unknown. Although coronary angiography in T2MI is advocated by some, there is insufficient evidence in existing literature to support this opinion as highlighted by current national guidelines. OBJECTIVE: The objective is to evaluate the clinical and economic impact of early invasive management with coronary angiography in T2MI in terms of all-cause mortality and cost effectiveness. DESIGN: This prospective, pragmatic, multicenter, randomized trial among patients with suspected supply demand ischemia leading to troponin elevation (n=1,800; T2MI [1,500], chronic myocardial injury [300]) compares the impact of invasive angiography (or computed tomography angiography as per local preference) within 5 days of randomization versus conservative management (with or without functional testing at clinician discretion) on all-cause mortality by 2 years. Randomized treatment allocation will be stratified by baseline estimated risk of mortality using the Acute Physiology, Age, and Chronic Health Evaluation (APACHE) III risk score. Cost-effectiveness will be evaluated by follow-up on clinical events, quality of life, and resource utilization over 24 months. SUMMARY: Ascertaining the most appropriate first-line investigative strategy for these commonly encountered high-risk T2MI patients in a randomized comparative study will be pivotal in informing evidence-based guidelines that lead to better patient and health care outcomes.

TEXT messages to improve MEDication adherence and Secondary prevention (TEXTMEDS) after acute coronary syndrome: a randomised clinical trial protocol.

BACKGROUND: Identifying simple, low-cost and scalable means of supporting lifestyle change and medication adherence for patients following a cardiovascular (CV) event is important. OBJECTIVE: The TEXTMEDS (TEXT messages to improve MEDication adherence and Secondary prevention) study aims to investigate whether a cardiac education and support programme sent via mobile phone text message improves medication adherence and risk factor levels in patients following an acute coronary syndrome (ACS). STUDY DESIGN: A single-blind, multicentre, randomised clinical trial of 1400 patients after an ACS with 12 months follow-up. The intervention group will receive multiple weekly text messages that provide information, motivation, support to adhere to medications, quit smoking (if relevant) and recommendations for healthy diet and exercise. The primary endpoint is the percentage of patients who are adherent to cardioprotective medications and the key secondary outcomes are mean systolic blood pressure (BP) and low-density lipoprotein cholesterol. Secondary outcomes will also include total cholesterol, mean diastolic BP, the percentage of participants who are adherent to each cardioprotective medication class, the percentage of participants who achieve target levels of CV risk factors, major vascular events, hospital readmissions and all-cause mortality. The study will be augmented by formal economic and process evaluations to assess acceptability, utility and cost-effectiveness. SUMMARY: The study will provide multicentre randomised trial evidence of the effects of a text message-based programme on cardioprotective medication adherence and levels of CV risk factors. ETHICS AND DISSEMINATION: Primary ethics approval was received from Western Sydney Local Health District Human Research Ethics Committee (HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15). Results will be disseminated via peer-reviewed publications and presentations at international conferences. TRIAL REGISTRATION NUMBER: ACTRN12613000793718; Pre-results.

A randomized trial of a 1-hour troponin T protocol in suspected acute coronary syndromes: Design of the Rapid Assessment of Possible ACS In the emergency Department with high sensitivity Troponin T (RAPID-TnT) study.

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.

Cost effectiveness of high-sensitivity troponin compared to conventional troponin among patients presenting with undifferentiated chest pain: A trial based analysis.

BACKGROUND: Patients with low and intermediate risk chest pain features comprise the greatest proportion presenting to emergency services for evaluation of suspected acute coronary syndromes (ACS). The efficient and timely identification of patients with these features remains a major challenge within clinical practice. Troponin assays are increasingly being used for the determination of risk among patients presenting with chest pain potentially facilitating more appropriate care. To date, no economic evaluation comparing high-sensitivity troponin T (hs-TnT) reporting to standard troponin T (c-TnT) reporting in the routine management of suspected ACS and based on longer-term clinical outcomes has been conducted. METHODS AND RESULTS: An economic evaluation was conducted with 1937 participants randomized to either hs-TnT (n=973) or c-TnT (n=964) with 12month follow-up. The primary outcome measure was the number of cumulative combined outcomes of all-cause mortality and new or recurrent ACS avoided. Mean per participant Australian Medicare costs were higher in the hs-TnT arm compared to the c-TnT arm (by $1285/patient). Mean total adverse clinical outcomes avoided were higher in the hs-TnT arm (by 0.0120/patient) resulting in an incremental cost-effectiveness ratio (ICER) of $108,552/adverse clinical outcome avoided. An ICER of $49,030/adverse clinical outcome avoided was obtained when the analysis was restricted to patients below the threshold of normal Troponin testing (actual c-TnT levels <30ng/L). CONCLUSIONS: hs-TnT reporting leads to fewer adverse clinical events but at a high ICER. For the routine implementation of hs-TnT to be more cost-effective, substantial changes in clinical practice will be required. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12614000189628). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365726.

Screening for important unwarranted variation in clinical practice: a triple-test of processes of care, costs and patient outcomes.

Objective Unwarranted variation in clinical practice is a target for quality improvement in health care, but there is no consensus on how to identify such variation or to assess the potential value of initiatives to improve quality in these areas. This study illustrates the use of a triple test, namely the comparative analysis of processes of care, costs and outcomes, to identify and assess the burden of unwarranted variation in clinical practice. Methods Routinely collected hospital and mortality data were linked for patients presenting with symptoms suggestive of acute coronary syndromes at the emergency departments of four public hospitals in South Australia. Multiple regression models analysed variation in re-admissions and mortality at 30 days and 12 months, patient costs and multiple process indicators. Results After casemix adjustment, an outlier hospital with statistically significantly poorer outcomes and higher costs was identified. Key process indicators included admission patterns, use of invasive diagnostic procedures and length of stay. Performance varied according to patients' presenting characteristics and time of presentation. Conclusions The joint analysis of processes, outcomes and costs as alternative measures of performance inform the importance of reducing variation in clinical practice, as well as identifying specific targets for quality improvement along clinical pathways. Such analyses could be undertaken across a wide range of clinical areas to inform the potential value and prioritisation of quality improvement initiatives. What is known about the topic? Variation in clinical practice is a long-standing issue that has been analysed from many different perspectives. It is neither possible nor desirable to address all forms of variation in clinical practice: the focus should be on identifying important unwarranted variation to inform actions to reduce variation and improve quality. What does this paper add? This paper proposes the comparative analysis of processes of care, costs and outcomes for patients with similar diagnoses presenting at alternative hospitals, using linked, routinely collected data. This triple test of performance indicators extracts maximum value from routine data to identify priority areas for quality improvement to reduce important and unwarranted variations in clinical practice. What are the implications for practitioners? The proposed analyses need to be applied to other clinical areas to demonstrate the general application of the methods. The outputs can then be validated through the application of quality improvement initiatives in clinical areas with identified important and unwarranted variation. Validated frameworks for the comparative analysis of clinical practice provide an efficient approach to valuing and prioritising actions to improve health service quality.

Clinical care standards: appropriate care everywhere - acute coronary syndromes as an example.

Audit data show that despite clinical practice guidelines, some patients miss out on evidence-based care, which is not explained by individual needs or preferences. Clinical care standards are small sets of concise recommendations that focus on known gaps in evidence-based care for a particular clinical condition. They aim to ensure that all patients with the same clinical condition are offered appropriate care, regardless of their location. Clinical care standards are nationally agreed standards and are developed to maximise engagement of consumers, clinicians, health services, and state and territory health departments and agencies. They complement clinical practice guidelines and other initiatives for improving quality of health care. As an example, the Acute Coronary Syndromes (ACS) Clinical Care Standard is a significant step forward in supporting clinicians and health services to realise all of the gains promised by the ACS evidence base. The ACS Clinical Care Standard focuses on the areas of care that are known to be most associated with variation in outcome. It supports patient involvement in critical decisions that affect their care, refocuses clinicians on the priority areas of ensuring appropriate ACS care, and informs health services about the systems required to deliver evidence-based care.

Randomized Comparison of High-Sensitivity Troponin Reporting in Undifferentiated Chest Pain Assessment.

BACKGROUND: High-sensitivity troponin T (hs-TnT) assays promise greater discrimination of evolving myocardial infarction, but the impact of unguided implementation on the effectiveness of care is uncertain. METHODS AND RESULTS: We evaluated the impact of hs-TnT reporting on care and outcome among chest pain patients presenting to 5 emergency departments within a multicenter randomized trial. Patients were allocated to hs-TnT reporting (hs-report) or standard reporting (std-report; Roche Elecys). The primary end point was death and new or recurrent acute coronary syndrome by 12 months. A total of 1937 patients without ST-segment elevation were enrolled between July 2011 and March 2013. The median age was 61 (interquartile range, 48-74) years, and 46.3% were women. During the index hospitalization, 1466 patients (75.7%) had maximal troponin <30 ng/L within 24 hours. Randomization to hs-report format did not alter the admission rate (hs-report: 57.7% versus std-report: 58.0%; P=0.069). There was no difference in angiography (hs-report: 11.9% versus std-report: 10.9%; P=0.479). The hs-reporting did not reduce 12-month death or new/recurrent acute coronary syndrome in the overall population (hs-report: 9.7% versus std-report: 7.2% [hazard ratio, 0.83 (0.57-1.22); P=0.362]). However, among those with troponin levels <30 ng/L, a modest reduction in the primary end point was observed (hs-report: 2.6% versus std-report: 4.4%, [hazard ratio, 0.58; 95% confidence interval, 0.34-0.1.00; P=0.050). CONCLUSIONS: High-sensitivity troponin reporting alone is associated with only modest changes in practice. Clinical effectiveness in the adoption of high-sensitivity troponin may require close coupling with protocols that guide interpretation and care. CLINICAL TRIAL REGISTRATION: URL: http://www.ANZCTR.org.au. Unique identifier: ACTRN12611000879965.

Variation in coronary angiography rates in Australia: correlations with socio-demographic, health service and disease burden indices.

BACKGROUND: Variation in the provision of coronary angiography is associated with health care inefficiency and inequity. We explored geographic, socio-economic, health service and disease indicators associated with variation in angiography rates across Australia. METHODS: Australian census and National Health Survey data were used to determine socio-economic, health workforce and service indicators. Hospital separations and coronary deaths during 2011 were identified in the National Hospital Morbidity and Mortality databases. All 61 Medicare Locals responsible for primary care were included, and age- and sex-standardised rates of acute coronary syndrome (ACS) incidence, coronary angiography, revascularisation and mortality were tested for correlations, and adjusted by Bayesian regression. RESULTS: There were 3.7-fold and 2.3-fold differences between individual Medicare Locals in the lowest and highest ACS and coronary artery disease mortality rates respectively, whereas angiography rates varied 5.3-fold. ACS and death rates within Medicare Locals were correlated (partial correlation coefficient [CC], 0.52; P < 0.001). There was modest correlation between ACS and angiography rates (CC, 0.31; P = 0.018). The proportion of patients undergoing angiography who proceeded to revascularisation was inversely correlated with the total angiogram rate (CC, -0.71; P < 0.001). Socio-economic disadvantage and remoteness were correlated with disease burden, ACS incidence and mortality, but not with angiography rate. In the adjusted analysis, the strongest association with local angiography rates was with admissions to private hospitals (71 additional angiograms [95% CI, 47-93] for every 1000 admissions). CONCLUSION: Variation in rates of coronary angiography, not related to clinical need, occurs across Australia. A greater focus on clinical care standards and better distribution of health services will be required if these variations are to be attenuated.

A cluster randomized trial of objective risk assessment versus standard care for acute coronary syndromes: Rationale and design of the Australian GRACE Risk score Intervention Study (AGRIS).

BACKGROUND: Assessing risk and weighing the potential benefits from evidence-based therapies are essential in the clinical decision making process of optimizing care and outcomes for patients presenting with acute coronary syndromes (ACS). Such practices are advocated in international clinical guidelines of ACS care. While the GRACE risk score (GRS) is a guideline advocated, well-validated risk stratification tool, its utility in improving care and outcomes remains unproven, and its application has been limited in routine clinical practice. OBJECTIVE: This study will assess the effectiveness using the GRS tool and treatment recommendations during patient assessment on improving the application of guideline-recommended therapies in ACS care. DESIGN: This study employs a PROBE (prospective cluster [hospital-level] randomized open-label, blinded endpoint) design to evaluate objective measures of hospital performance, with clinical events adjudicated by a blinded event committee. This randomized study is nested within the established CONCORDANCE registry of ACS patients, with existing methods for data collection and monitoring of care and clinical outcomes. The hospital-level intervention is the integration of the GRS into routine ACS patient assessment process. The study will assess the use of early invasive management, prescription of guideline recommended pharmacology and referral to cardiac rehabilitation by hospital discharge; with the key composite clinical endpoint of cardiovascular death, new or recurrent myocardial infarction, in-hospital heart failure or cardiovascular readmission at 12 months. Health economic impacts of risk stratification implementation will also be evaluated. The study will recruit 3000 patients from 30 hospitals. SUMMARY: The AGRIS trial will establish the effect of routine objective risk stratification using the GRACE risk score on ACS care and clinical outcomes.

The Heart Health Study - increasing cardiovascular risk assessment in family practice for first degree relatives of patients with premature ischaemic heart disease: a randomised controlled trial.

BACKGROUND: This study aimed to increase cardiovascular disease (CVD) risk assessment in adult first degree relatives of patients with premature ischaemic heart disease (PIHD) using written and verbal advice. DESIGN: A prospective, randomised controlled trial. SETTING: Cardiovascular wards at three South Australian hospitals. Cardiovascular risk assessments were performed in general practice. PARTICIPANTS: Patients experiencing PIHD (heart disease in men aged <55 years or women aged < 65 years) and their first degree relatives. INTERVENTION: Patients distributed either general information about heart disease and written advice to attend their general practitioner (GP) for CVD risk assessment or general information about heart disease only, to their first degrees relatives. MAIN OUTCOME MEASURE: The primary outcome was the proportion of relatives who attended their GP for CVD risk assessment within 6 months of the patients' PIHD event. RESULTS: One hundred forty four patients were recruited who had 541 eligible relatives; 97/541 (18 %) of relatives agreed to participate. A larger number of intervention 41/55 (75 %) than control group 9/42 (21 %) [difference 53 %, 95 % CI 36 % - 71 %] relatives attended their GP for a CVD assessment, and 34 % of these had moderate to very high 5-year absolute risk for CVD. CONCLUSION: This low cost intervention demonstrates that individuals who have a family history of PIHD and are at moderate or high risk of CVD can be targeted for early intervention of modifiable risk factors. Further research is required to improve the uptake of the intervention in relatives. TRIAL REGISTRATION: The trial was registered with the Australian Clinical Trials Registry (ACTRN), Registration ID 12613000557730 .