A protocol for tracking outcomes post intensive care.

BACKGROUND: Critically ill patients are more likely to survive intensive care than ever before due to advances in treatment. However, a proportion subsequently experiences post-intensive care syndrome (PICS) incurring substantial personal, social, and economic costs. PICS is a debilitating set of physical, psychological, and cognitive sequelae but the size and characteristics of the affected population have been difficult to describe, impeding progress in intensive care rehabilitation. AIMS AND OBJECTIVES: The aim of this protocol is to describe recovery after admission to intensive care unit (ICU) and the predictors, correlates, and patient-reported outcomes for those experiencing PICS. The study will support the development of screening, diagnostic, and outcome measures to improve post-ICU recovery. DESIGN: A prospective, multi-site observational study in three ICUs in Brisbane, Australia. Following consent, data will be collected from clinical records and using validated self-report instruments from 300 patients, followed up at 6 weeks and 6 months post ICU discharge. METHODS: TOPIC is a prospective, multi-site observational study using self-report and clinical data on risk factors, including comorbidities, and outcomes. Data will be collected with consent from hospital records and participants 6 weeks and 6months post ICU discharge. RESULTS: The main outcome measures will be self-reported physical, cognitive, and psychological function 6 weeks and 6 months post-ICU discharge. RELEVANCE TO CLINICAL PRACTICE: This protocol provides a methodological framework to measure recovery and understand PICS. Data analysis will describe characteristics associated with recovery and PICS. The subsequent prediction and screening tools developed then aim to improve the effectiveness of post-ICU prevention and rehabilitation through more targeted screening and prediction and found a program of research developing a more tailored approach to PICS.

The new Vancouver Chest Pain Rule using troponin as the only biomarker: an external validation study.

OBJECTIVES: To externally evaluate the accuracy of the new Vancouver Chest Pain Rule and to assess the diagnostic accuracy using either sensitive or highly sensitive troponin assays. METHODS: Prospectively collected data from 2 emergency departments (EDs) in Australia and New Zealand were analysed. Based on the new Vancouver Chest Pain Rule, low-risk patients were identified using electrocardiogram results, cardiac history, nitrate use, age, pain characteristics and troponin results at 2 hours after presentation. The primary outcome was 30-day diagnosis of acute coronary syndrome (ACS), including acute myocardial infarction, and unstable angina. Sensitivity, specificity, positive predictive values and negative predictive values were calculated to assess the accuracy of the new Vancouver Chest Pain Rule using either sensitive or highly sensitive troponin assay results. RESULTS: Of the 1635 patients, 20.4% had an ACS diagnosis at 30 days. Using the highly sensitive troponin assay, 212 (13.0%) patients were eligible for early discharge with 3 patients (1.4%) diagnosed with ACS. Sensitivity was 99.1% (95% CI 97.4-99.7), specificity was 16.1 (95% CI 14.2-18.2), positive predictive values was 23.3 (95% CI 21.1-25.5) and negative predictive values was 98.6 (95% CI 95.9-99.5). The diagnostic accuracy of the rule was similar using the sensitive troponin assay. CONCLUSIONS: The new Vancouver Chest Pain Rule should be used for the identification of low risk patients presenting to EDs with symptoms of possible ACS, and will reduce the proportion of patients requiring lengthy assessment; however we recommend further outpatient investigation for coronary artery disease in patients identified as low risk.

Comparison of high sensitivity troponin T and I assays in the diagnosis of non-ST elevation acute myocardial infarction in emergency patients with chest pain.

OBJECTIVES: Concentrations of troponin measured with high sensitivity troponin assays are raised in a number of emergency department (ED) patients; however many are not diagnosed with acute myocardial infarction (AMI). Clinical comparisons between the early use (2h after presentation) of high sensitivity cardiac troponin T (hs-cTnT) and I (hs-cTnI) assays for the diagnosis of AMI have not been reported. DESIGN AND METHODS: Early (0 h and 2 h) hs-cTnT and hs-cTnI assay results in 1571 ED patients with potential acute coronary syndrome (ACS) without ST elevation on electrocardiograph (ECG) were evaluated. The primary outcome was diagnosis of index AMI adjudicated by cardiologists using the local cTnI assay results taken ≥6 h after presentation, ECGs and clinical information. Stored samples were later analysed with hs-cTnT and hs-cTnI assays. RESULTS: The ROC analysis for AMI (204 patients; 13.0%) for hs-cTnT and hs-cTnI after 2h was 0.95 (95% CI: 0.94-0.97) and 0.98 (95% CI: 0.97-0.99) respectively. The sensitivity, specificity, PLR, and NLR of hs-cTnT and hs-cTnI for AMI after 2h were 94.1% (95% CI: 90.0-96.6) and 95.6% (95% CI: 91.8-97.7), 79.0% (95% CI: 76.8-81.1) and 92.5% (95% CI: 90.9-93.7), 4.48 (95% CI: 4.02-5.00) and 12.86 (95% CI: 10.51-15.31), and 0.07 (95% CI: 0.04-0.13) and 0.05 (95% CI:0.03-0.09) respectively. CONCLUSIONS: Exclusion of AMI 2h after presentation in emergency patients with possible ACS can be achieved using hs-cTnT or hs-cTnI assays. Significant differences in specificity of these assays are relevant and if using the hs-cTnT assay, further clinical assessment in a larger proportion of patients would be required.

Validation of high-sensitivity troponin I in a 2-hour diagnostic strategy to assess 30-day outcomes in emergency department patients with possible acute coronary syndrome.

OBJECTIVES: The study objective was to validate a new high-sensitivity troponin I (hs-TnI) assay in a clinical protocol for assessing patients who present to the emergency department with chest pain. BACKGROUND: Protocols using sensitive troponin assays can accelerate the rule out of acute myocardial infarction in patients with low-risk (suspected) acute coronary syndrome (ACS). METHODS: This study evaluated 2 prospective cohorts of patients in the emergency department with ACS in an accelerated diagnostic pathway integrating 0- and 2-h hs-TnI results, Thrombolysis In Myocardial Infarction (TIMI) risk scores, and electrocardiography. Strategies to identify low-risk patients incorporated TIMI risk scores= 0 or ≤ 1. The primary endpoint was a major adverse cardiac event (MACE) within 30 days. RESULTS: In the primary cohort, 1,635 patients were recruited and had 30-day follow-up. A total of 247 patients (15.1%) had a MACE. The finding of no ischemic electrocardiogram and hs-TnI ≤ 26.2 ng/l with the TIMI = 0 and TIMI ≤ 1 pathways, respectively, classified 19.6% (n = 320) and 41.5% (n = 678) of these patients as low risk; 0% (n = 0) and 0.8% (n = 2) had a MACE, respectively. In the secondary cohort, 909 patients were recruited. A total of 156 patients (17.2%) had a MACE. The TIMI = 0 and TIMI ≤ 1 pathways classified 25.3% (n = 230) and 38.6% (n = 351), respectively, of these patients as low risk; 0% (n = 0) and 0.8% (n = 1) had a MACE, respectively. Sensitivity, specificity, and negative predictive value for TIMI = 0 in the primary cohort were 100% (95% confidence interval [CI]: 98.5% to 100%), 23.1% (95% CI: 20.9% to 25.3%), and 100% (95% CI: 98.8% to 100%), respectively. Sensitivity, specificity, and negative predictive value for TIMI ≤ 1 in the primary cohort were 99.2 (95% CI: 97.1 to 99.8), 48.7 (95% CI: 46.1 to 51.3), and 99.7 (95% CI: 98.9 to 99.9), respectively. Sensitivity, specificity, and negative value for TIMI ≤ 1 in the secondary cohort were 99.4% (95% CI: 96.5 to 100), 46.5% (95% CI: 42.9 to 50.1), and 99.7% (95% CI: 98.4 to 100), respectively. CONCLUSIONS: An early-discharge strategy using an hs-TnI assay and TIMI score ≤ 1 had similar safety as previously reported, with the potential to decrease the observation periods and admissions for approximately 40% of patients with suspected ACS. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE] Study, NCT00470587; A 2 hr Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker [ADAPT]: a prospective observational validation study, ACTRN12611001069943).

A cross-sectional analysis of patterns of obesity in a cohort of working nurses and midwives in Australia, New Zealand, and the United Kingdom.

OBJECTIVE: The aim of this study was to examine the prevalence of overweight and obesity and the association with demographic, reproductive work variables in a representative cohort of working nurses and midwives. DESIGN: A cross sectional study of self reported survey data. SETTINGS: Australia, New Zealand and the United Kingdom. METHODS: Measurement outcomes included BMI categories, demographic (age, gender, marital status, ethnicity), reproductive (parity, number of births, mother's age at first birth, birth type and menopausal status) and workforce (registration council, employment type and principal specialty) variables. PARTICIPANTS: 4996 respondents to the Nurses and Midwives e-Cohort study who were currently registered and working in nursing or midwifery in Australia (n=3144), New Zealand (n=778) or the United Kingdom (n=1074). RESULTS: Amongst the sample 61.87% were outside the healthy weight range and across all three jurisdictions the prevalence of obesity in nurses and midwives exceeded rates in the source populations by 1.73% up to 3.74%. Being overweight or obese was significantly associated with increasing age (35-44 yrs aOR 1.71, 95% CI 1.41-2.08; 45-55 yrs aOR 1.90, 95%CI 1.56-2.31; 55-64 aOR 2.22, 95% CI 1.71-2.88), and male gender (aOR 1.46, 95% CI 1.15-1.87). Primiparous nurses and midwives were more likely to be overweight or obese (aOR 1.37, 95% CI 1.06-1.76) as were those who had reached menopause (aOR 1.37, 95% CI 1.11-1.69). Nurses and midwives in part-time or casual employment had significantly reduced risk of being overweight or obese, (aOR 0.81, 95% CI 0.70-0.94 and aOR 0.75, 95% CI 0.59-0.96 respectively), whilst working in aged carried increased risk (aOR 1.37, 95% CI 1.04-1.80). CONCLUSION: Nurses and midwives in this study have higher prevalence of obesity and overweight than the general population and those who are older, male, or female primiparous and menopausal have significantly higher risk of overweight or obesity as do those working fulltime, or in aged care. The consequences of overweight and obesity in this occupational group may impact on their workforce participation, their management of overweight and obese patients in their care as well as influencing their individual health behaviours and risks of occupational injury and chronic disease.

A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study.

BACKGROUND: Patients with chest pain contribute substantially to emergency department attendances, lengthy hospital stay, and inpatient admissions. A reliable, reproducible, and fast process to identify patients presenting with chest pain who have a low short-term risk of a major adverse cardiac event is needed to facilitate early discharge. We aimed to prospectively validate the safety of a predefined 2-h accelerated diagnostic protocol (ADP) to assess patients presenting to the emergency department with chest pain symptoms suggestive of acute coronary syndrome. METHODS: This observational study was undertaken in 14 emergency departments in nine countries in the Asia-Pacific region, in patients aged 18 years and older with at least 5 min of chest pain. The ADP included use of a structured pre-test probability scoring method (Thrombolysis in Myocardial Infarction [TIMI] score), electrocardiograph, and point-of-care biomarker panel of troponin, creatine kinase MB, and myoglobin. The primary endpoint was major adverse cardiac events within 30 days after initial presentation (including initial hospital attendance). This trial is registered with the Australia-New Zealand Clinical Trials Registry, number ACTRN12609000283279. FINDINGS: 3582 consecutive patients were recruited and completed 30-day follow-up. 421 (11.8%) patients had a major adverse cardiac event. The ADP classified 352 (9.8%) patients as low risk and potentially suitable for early discharge. A major adverse cardiac event occurred in three (0.9%) of these patients, giving the ADP a sensitivity of 99.3% (95% CI 97.9-99.8), a negative predictive value of 99.1% (97.3-99.8), and a specificity of 11.0% (10.0-12.2). INTERPRETATION: This novel ADP identifies patients at very low risk of a short-term major adverse cardiac event who might be suitable for early discharge. Such an approach could be used to decrease the overall observation periods and admissions for chest pain. The components needed for the implementation of this strategy are widely available. The ADP has the potential to affect health-service delivery worldwide. FUNDING: Alere Medical (all countries), Queensland Emergency Medicine Research Foundation and National Health and Medical Research Council (Australia), Christchurch Cardio-Endocrine Research Group (New Zealand), Medquest Jaya Global (Indonesia), Science International (Hong Kong), Bio Laboratories Pte (Singapore), National Heart Foundation of New Zealand, and Progressive Group (Taiwan).

Comparison of high specificity with standard versions of a quantitative latex D-dimer test in the assessment of community pulmonary embolism: HaemosIL D-dimer HS and pulmonary embolism.

BACKGROUND: D-dimer assays are sensitive but have poor specificity. False positive results lead to extra imaging and hospital admissions. OBJECTIVES: To make a pilot comparison of the diagnostic accuracy of the standard quantitative latex HemosIL D-dimer assay with a newer HemosIL D-dimer HS version designed to have improved specificity. PATIENTS / METHODS: Consecutive patients presenting from the community to an Emergency Department that were investigated for suspected pulmonary embolism using a D-dimer test were included in the study. Standard and D-dimer HS tests were performed. Pulmonary Embolism was diagnosed on the basis of imaging studies or post-mortem at any time from presentation to 90 days thereafter. RESULTS: The prevalence of Pulmonary Embolism was 4.5% (18/402). The sensitivity, specificity, negative predictive value, and positive predictive value for the standard quantitative D-dimer test was 100% (81.5 - 100.0), 49.2% (44.1 - 54.3),100% (98.1 - 100.0), and 8.5% (5.1 - 13.0), respectively, and 100% (81.5 - 100.0), 58.3% (53.2 - 63.3),100% (98.4 - 100.0), and 10.1% (6.1 - 15.5), for the D-dimer HS test. There were 35 (16%) fewer 'false positives' using the D-dimer HS assay compared with the standard assay. CONCLUSIONS: D-dimer HS has superior specificity to the standard quantitative D-dimer test without any loss of sensitivity. The generation of fewer false positive results should lead to less unnecessary diagnostic imaging; the use of which is associated with increased hospital admissions and length of stay. The HS assay may therefore have significant health economic benefits.