Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial.

INTRODUCTION: Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician's discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice. Chest drains carry a high risk of complications such as bleeding and infection. The default to invasive treatment may be causing potentially avoidable pain, distress and complications. We are evaluating the clinical and cost-effectiveness of an initial conservative approach to the management of patients with traumatic pneumothoraces. METHODS AND ANALYSIS: The CoMiTED (Conservative Management in Traumatic Pneumothoraces in the Emergency Department) trial is a multicentre, pragmatic parallel group, individually randomised controlled non-inferiority trial to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness and quality of life. We aim to recruit 750 patients from at least 40 UK National Health Service hospitals. Patients allocated to the control (invasive management) group will have a chest drain inserted in the emergency department. For those in the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation. The primary outcome is a binary measure of the need for one or more subsequent emergency pleural interventions within 30 days of randomisation. Secondary outcomes include complications, cost-effectiveness, patient-reported quality of life and patient and clinician views of the two treatment options; participants are followed up for 6 months. ETHICS AND DISSEMINATION: This trial received approval from the Wales Research Ethics Committee 4 (reference: 22/WA/0118) and the Health Research Authority. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN35574247.

A national study of 23 major trauma centres to investigate the effect of a geriatrician assessment on clinical outcomes in older people admitted with serious injury in England (FiTR 2): a multicentre observational cohort study.

BACKGROUND: Older people are at the greatest risk of poor outcomes after serious injury. Evidence is limited for the benefit of assessment by a geriatrician in trauma care. We aimed to determine the effect of geriatrician assessment on clinical outcomes for older people admitted to hospital with serious injury. METHODS: In this multicentre observational study (FiTR 2), we extracted prospectively collected data on older people (aged ≥65 years) admitted to the 23 major trauma centres in England over a 2·5 year period from the Trauma Audit and Research Network (TARN) database. We examined the effect of a geriatrician assessment within 72 h of admission on the primary outcome of inpatient mortality in older people admitted to hospital with serious injury, with patients censored at discharge. We analysed data using a multi-level Cox regression model and estimated adjusted hazard ratios (aHRs). FINDINGS: Between March 31, 2019, and Oct 31, 2021, 193 156 patients had records held by TARN, of whom 35 490 were included in these analyses. Median age was 81·4 years (IQR 74·1-87·6), 19 468 (54·9%) were female, and 16 022 (45·1%) were male. 28 208 (79·5%) patients had experienced a fall from less than 2 m. 16 504 (46·5%) people received a geriatrician assessment. 4419 (12·5%) patients died during hospital stay, with a median time from admission to death of 6 days (IQR 2-14). Of those who died, 1660 (37·6%) had received a geriatrician assessment and 2759 (62·4%) had not (aHR 0·43 [95% CI 0·40-0·46]; p<0·0001). INTERPRETATION: Geriatrician assessment was associated with a reduced risk of death for seriously injured older people. These data support routine provision of geriatrician assessment in trauma care. Future research should explore the key components of a geriatrician assessment paired with a health economic evaluation. FUNDING: None.

COVID-19 emergency response assessment study: a prospective longitudinal survey of frontline doctors in the UK and Ireland: study protocol.

INTRODUCTION: The COVID-19 pandemic is putting an unprecedented strain on healthcare systems globally. The psychological impact on frontline doctors of dealing with the COVID-19 pandemic is currently unknown. This longitudinal professional survey aims to understand the evolving and cumulative effects of working during the COVID-19 outbreak on the psychological well-being of doctors working in emergency departments (ED), intensive care units (ICU) and anaesthetics during the pandemic. METHODS AND ANALYSIS: This study is a longitudinal questionnaire-based study with three predefined time points spanning the acceleration, peak and deceleration phases of the COVID-19 pandemic.The primary outcomes are psychological distress and post-trauma stress as measured by the General Health Questionnaire-12 (GHQ-12) and Impact of Events Scale-Revised (IES-R). Data related to personal and professional characteristics will also be collected. Questionnaires will be administered prospectively to all doctors working in ED, ICU and anaesthetics in the UK and Ireland via existing research networks during the sampling period. Data from the questionnaires will be analysed to assess the prevalence and degree of psychological distress and trauma, and the nature of the relationship between personal and professional characteristics and the primary outcomes. Data will be described, analysed and disseminated at each time point; however, the primary endpoint will be psychological distress and trauma at the final time point. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Bath, UK (ref: 4421), and Children's Health Ireland at Crumlin, Ethics Committee. Regulatory approval from the Health Regulation Authority (UK), Health and Care Research Wales (IRAS: 281944).This study is limited by the fact that it focuses on doctors only and is survey based without further qualitative interviews of participants. It is expected this study will provide clear evidence of the psychological impact of COVID-19 on doctors and will allow present and future planning to mitigate against any psychological impact. TRIAL REGISTRATION NUMBER: ISRCTN10666798.

Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol.

INTRODUCTION: Observational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%-60% of ED patients with chest pain. This is done using an 'undetectable' cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients. METHODS AND ANALYSIS: This is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate. ETHICS AND DISSEMINATION: The study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients. TRIAL REGISTRATION NUMBER: ISRCTN86184521; Pre-results.

Assessment of the 2016 National Institute for Health and Care Excellence high-sensitivity troponin rule-out strategy.

OBJECTIVE: We aimed to evaluate the limit of detection of high-sensitivity troponin (hs-cTn) and Thrombolysis In Myocardial Infarction (TIMI) score combination rule-out strategy suggested within the 2016 National Institute for Health and Care Excellence (NICE) Chest Pain of Recent Onset guidelines and establish the optimal TIMI score threshold for clinical use. METHODS: A pooled analysis of adult patients presenting to the emergency department with chest pain and a non-ischaemic ECG, recruited into six prospective studies, from Australia, New Zealand and the UK. We evaluated the sensitivity of TIMI score thresholds from 0 to 2 alongside hs-cTnT or hs-cTnI for the primary outcome of major adverse cardiac events within 30 days. RESULTS: Data were available for 3159 patients for hs-cTnT and 4532 for hs-cTnI, of these 376 (11.9%) and 445 (9.8%) had major adverse cardiac events, respectively. Using a TIMI score of 0, the sensitivity for the primary outcome was 99.5% (95% CI 98.1% to 99.9%) alongside hs-cTnT and 98.9% (97.4% to 99.6%)%) alongside hs-cTnI, identifying 17.9% and 21.0% of patients as low risk, respectively. For a TIMI score ≤1 sensitivity was 98.9% (97.3% to 99.7%)%) alongside hs-cTnT and 98.4% (96.8% to 99.4%)%) alongside hs-cTnI, identifying 28.1% and 35.7% as low risk, respectively. For TIMI≤2, meta-sensitivity was <98% with either assay. CONCLUSIONS: Our findings support the rule-out strategy suggested by NICE. The TIMI score threshold suggested for clinical use is 0. The proportion of patients identified as low risk (18%-21%) and suitable for early discharge using this threshold may be sufficient to encourage change of practice. TRIAL REGISTRATION NUMBERS: ADAPT observational study/IMPACT intervention trial ACTRN12611001069943.ADAPT-ADP randomised controlled trial ACTRN12610000766011. EDACS-ADP randomised controlled trial ACTRN12613000745741. TRUST observational study ISRCTN no. 21109279.

A Risk Assessment Score and Initial High-sensitivity Troponin Combine to Identify Low Risk of Acute Myocardial Infarction in the Emergency Department.

OBJECTIVES: Early discharge of patients with presentations triggering assessment for possible acute coronary syndrome (ACS) is safe when clinical assessment indicates low risk, biomarkers are negative, and electrocardiograms (ECGs) are nonischemic. We hypothesized that the Emergency Department Assessment of Chest Pain Score (EDACS) combined with a single measurement of high-sensitivity cardiac troponin (hs-cTn) could allow early discharge of a clinically meaningful proportion of patients. METHODS: We pooled data from four patient cohorts from New Zealand and Australia presenting to an emergency department with symptoms suggestive of ACS. The primary outcome was major adverse cardiac events (MACE) within 30 days of presentation. In patients with a nonischemic ECG we evaluated the sensitivity for MACE and percentage low risk of every combination of high-sensitivity cardiac troponin T (hs-cTnT) concentration and high-sensitivity cardiac troponin I (hs-cTnI) concentration with EDACS. We used a standard smoothing technique on the probability density function for hs-cTn and EDACS and applied bootstrapping to determine the optimal threshold combinations, namely, the combination that maximized the percentage low risk with ≥98.5% sensitivity for MACE. RESULTS: From 2,536 patients, 2,258 presented without an ischemic ECG of whom 272 (12.1%) had a MACE within 30 days. The optimal threshold for hs-cTnI was 7 ng/L combined with an EDACS threshold of 16 (36.8% patients low risk). The optimal thresholds for hs-cTnT were 8 ng/L combined with an EDACS threshold of 15 (30.2% patients low risk). CONCLUSION: Single measurements of both hs-cTnI and hs-cTnT at presentation combined with EDACS to identify over 30% of patients as low risk and therefore eligible for safe early discharge after only one blood draw.

Beyond triage: the diagnostic accuracy of emergency department nursing staff risk assessment in patients with suspected acute coronary syndromes.

OBJECTIVES: To establish the accuracy of emergency department (ED) nursing staff risk assessment using an established chest pain risk score alone and when incorporated with presentation high-sensitivity troponin testing as part of an accelerated diagnostic protocol (ADP). DESIGN: Prospective observational study comparing nursing and physician risk assessment using the modified Goldman (m-Goldman) score and a predefined ADP, incorporating presentation high-sensitivity troponin. SETTING: A UK District ED. PATIENTS: Consecutive patients, aged ≥18, with suspected cardiac chest pain and non-ischaemic ECG, for whom the treating physician determined serial troponin testing was required. OUTCOME MEASURES: 30-day major adverse cardiac events (MACE). RESULTS: 960 participants were recruited. 912/960 (95.0%) had m-Goldman scores recorded by physicians and 745/960 (77.6%) by nursing staff. The area under the curve of the m-Goldman score in predicting 30-day MACE was 0.647 (95% CI 0.594 to 0.700) for physicians and 0.572 (95% CI 0.510 to 0.634) for nursing staff (p=0.09). When incorporated into an ADP, sensitivity for the rule-out of MACE was 99.2% (95% CI 94.8% to 100%) and 96.7% (90.3% to 99.2%) for physicians and nurses, respectively. One patient in the physician group (0.3%) and three patients (1.1%) in the nursing group were classified as low risk yet had MACE. There was fair agreement in the identification of low-risk patients (kappa 0.31, 95% CI 0.24 to 0.38). CONCLUSIONS: The diagnostic accuracy of ED nursing staff risk assessment is similar to that of ED physicians and interobserver reliability between assessor groups is fair. When incorporating high-sensitivity troponin testing, a nurse-led ADP has a miss rate of 1.1% for MACE at 30 days. TRIAL REGISTRATION NUMBER: Controlled Trials Database (ISRCTN no. 21109279).