Missing data in emergency care: a pitfall in the interpretation of analysis and research based on electronic patient records.

Electronic patient records (EPRs) are potentially valuable sources of data for service development or research but often contain large amounts of missing data. Using complete case analysis or imputation of missing data seem like simple solutions, and are increasingly easy to perform in software packages, but can easily distort data and give misleading results if used without an understanding of missingness. So, knowing about patterns of missingness, and when to get expert data science (data engineering and analytics) help, will be a fundamental future skill for emergency physicians. This will maximise the good and minimise the harm of the easy availability of large patient datasets created by the introduction of EPRs.

The effect of relative hypotension on 30-day mortality in older people receiving emergency care.

Research has observed increased mortality among older people attending the emergency department (ED) who had systolic pressure > 7 mmHg lower than baseline primary care values. This study aimed to (1) assess feasibility of identifying this 'relative hypotension' using readily available ED data, (2) externally validate the 7 mmHg threshold, and (3) refine a threshold for clinically important relative hypotension. A single-centre retrospective cohort study linked year 2019 data for ED attendances by people aged over 64 to hospital discharge vital signs within the previous 18 months. Frailty and comorbidity scores were calculated. Previous discharge ('baseline') vital signs were subtracted from initial ED values to give individuals' relative change. Cox regression analysis compared relative hypotension > 7 mmHg with mean time to mortality censored at 30 days. The relative hypotension threshold was refined using a fully adjusted risk tool formed of logistic regression models. Receiver operating characteristics were compared to NEWS2 models with and without incorporation of relative systolic. 5136 (16%) of 32,548 ED attendances were linkable with recent discharge vital signs. Relative hypotension > 7 mmHg was associated with increased 30-day mortality (HR 1.98; 95% CI 1.66-2.35). The adjusted risk tool (AUC: 0.69; sensitivity: 0.61; specificity: 0.68) estimated each 1 mmHg relative hypotension to increase 30-day mortality by 2% (OR 1.02; 95% CI 1.02-1.02). 30-day mortality prediction was marginally better with NEWS2 (AUC: 0.73; sensitivity: 0.59; specificity: 0.78) and NEWS2 + relative systolic (AUC: 0.74; sensitivity: 0.63; specificity: 0.75). Comparison of ED vital signs with recent discharge observations was feasible for 16% individuals. The association of relative hypotension > 7 mmHg with 30-day mortality was externally validated. Indeed, any relative hypotension appeared to increase risk, but model characteristics were poor. These findings are limited to the context of older people with recent hospital admissions.

Measuring health-related quality of life of older people with frailty receiving acute care: feasibility and psychometric performance of the EuroQol EQ-5D.

BACKGROUND: Although outcome goals for acute healthcare among older people living with frailty often include Health-Related Quality of Life (HRQoL) and other patient-reported outcome measures (PROMs), current quality metrics usually focus on waiting times and survival. Lay and patient review have identified the EuroQol EQ-5D as a candidate measure for this setting. This research appraised the EQ-5D for feasibility, psychometric performance, and respondents' outcomes in the acute frailty setting. METHODS: People aged 65 + with Clinical Frailty Scale (CFS) 5-8 were recruited from eight UK hospitals' emergency care and acute admissions settings. They completed the five-level EQ-5D and the EQ-VAS. Feasibility was assessed with completion times and completeness. For reliability, response distributions and internal consistency were analysed. Finally, EQ-Index values were compared with demographic characteristics and service outcomes for construct validity. RESULTS: The 232 participants were aged 65-102. 38% responded in emergency departments and 62% in admissions wards. Median completion time was 12 (IQR, 11) minutes. 98% responses were complete. EQ-5D had acceptable response distribution (SD 1.1-1.3) and internal consistency (Cronbach's alpha 0.69). EQ-VAS demonstrated a midpoint response pattern. Median EQ-Index was 0.574 (IQR, 0.410) and was related positively with increasing age (p = 0.010) and negatively with CFS (p < 0.001). Participants with higher CFS had more frequent problems with mobility, self-care, and usual activities. CONCLUSIONS: Administration of the EQ-5D was feasible in these emergency and acute frailty care settings. EQ-5D had acceptable properties, while EQ-VAS appeared problematic. Participants with more severe frailty had also poorer HRQoL.

Improving communications in PPE: a solution for 'landline' telephone communication.

BACKGROUND: Emergency care staff wearing elastomeric respiratory personal protective equipment (PPE) report difficulties in communicating by telephone. We developed and tested an affordable technological solution aimed at improving telephone call intelligibility for staff wearing PPE. METHODS: A novel headset was created to enable a throat microphone and bone conduction headset to be used in combination with a standard hospital 'emergency alert' telephone system. Speech intelligibility of an ED staff member wearing PPE was compared between the proposed headset and current practice by simultaneously recording a version of the Modified Rhyme Test and a Key Sentences Test. Recordings were played back to a group of blinded ED staff listening to pairs of recordings under identical conditions. The proportion of correctly identified words was compared using a paired t-test. RESULTS: Fifteen ED staff correctly identified a mean of 73% (SD 9%) words for speech communicated via the throat microphone system, compared with only 43% (SD 11%) of words for standard practice (paired t-test, p<0.001). CONCLUSIONS: Introduction of a suitable headset could significantly improve speech intelligibility during 'emergency alert' telephone calls.

Comparison of trauma care structures, processes and outcomes between the English National Health Service and Quebec, Canada.

BACKGROUND: Comparisons across trauma systems are key to identifying opportunities to improve trauma care. We aimed to compare trauma service structures, processes and outcomes between the English National Health Service (NHS) and the province of Quebec, Canada. METHODS: We conducted a multicentre cohort study including admissions of patients aged older than 15 years with major trauma to major trauma centres (MTCs) from 2014/15 to 2016/17. We compared structures descriptively, and time to MTC and time in the emergency department (ED) using Wilcoxon tests. We compared mortality, and hospital and intensive care unit (ICU) length of stay (LOS) using multilevel logistic regression with propensity score adjustment, stratified by body region of the worst injury. RESULTS: The sample comprised 36 337 patients from the NHS and 6484 patients from Quebec. Structural differences in the NHS included advanced prehospital medical teams (v. "scoop and run" in Quebec), helicopter transport (v. fixed-wing aircraft) and trauma team leaders. The median time to an MTC was shorter in Quebec than in the NHS for direct transports (1 h v. 1.5 h, p < 0.001) but longer for transfers (2.5 h v. 6 h, p < 0.001). Time in the ED was longer in Quebec than in the NHS (6.5 h v. 4.0 h, p < 0.001). The adjusted odds of death were higher in Quebec for head injury (odds ratio [OR] 1.28, 95% confidence interval [CI] 1.09-1.51) but lower for thoracoabdominal injuries (OR 0.69, 95% CI 0.52-0.90). The adjusted median hospital LOS was longer for spine, torso and extremity injuries in the NHS than in Quebec, and the median ICU LOS was longer for spine injuries. CONCLUSION: We observed significant differences in the structure of trauma care, delays in access and risk-adjusted outcomes between Quebec and the NHS. Future research should assess associations between structures, processes and outcomes to identify opportunities for quality improvement.

A systematic review and recommendations for prom instruments for older people with frailty in emergency care.

INTRODUCTION: The current service metrics used to evaluate quality in emergency care do not account for specific healthcare outcome goals for older people living with frailty. These have previously been classified under themes of 'Autonomy' and 'Functioning'. There is no person-reported outcome measure (PROM) for older people with frailty and emergency care needs. This study aimed to identify and co-produce recommendations for instruments potentially suitable for use in this population. METHODS: In this systematic review, we searched six databases for PROMs used between 2010 and 2021 by older people living with frailty receiving acute hospital care. Studies were reviewed against predefined eligibility criteria and appraised for quality using the COSMIN Risk of Bias checklist. Data were extracted to map instrument constructs against an existing framework of acute healthcare outcome goals. Instrument face and content validity were assessed by lay collaborators. Recommendations for instruments with potential emergency care suitability were formed through co-production. RESULTS: Of 9392 unique citations screened, we appraised the full texts of 158 studies. Nine studies were identified, evaluating nine PROMs. Quality of included studies ranged from 'doubtful' to 'very good'. Most instruments had strong evidence for measurement properties. PROMs mainly assessed 'Functioning' constructs, with limited coverage of 'Autonomy'. Five instruments were considered too burdensome for the emergency care setting or too specific for older people living with frailty. CONCLUSIONS: Four PROMs were recommended as potentially suitable for further validation with older people with frailty and emergency care needs: COOP/WONCA charts, EuroQol, McGill Quality of Life (Expanded), and Palliative care Outcome Scale.

What matters most in acute care: an interview study with older people living with frailty.

BACKGROUND: Healthcare outcome goals are central to person-centred acute care, however evidence among older people is scarce. Older people who are living with frailty have distinct requirements for healthcare delivery and have distinct risk for adverse outcomes from healthcare. There is insufficient evidence for whether those living with frailty also have distinct healthcare outcome goals. This study explored the nature of acute care outcome goals in people living with frailty. METHODS: Healthcare outcome goals were explored using semi-structured patient interviews. Participants aged over 65 with Clinical Frailty Score 5-8 (mild to very severe frailty) were recruited during their first 72 hours in a UK hospital. Purposive, maximum variation sampling was guided by lay partners from a Patient and Public Involvement Forum specialising in ageing-related research. Qualitative analysis used a blended approach based on framework and constant comparative methodologies for the identification of themes. Findings were validated through triangulation with participant, lay partner, and technical expert review. RESULTS: The 22 participants were aged 71 to 98 and had mild to very severe frailty. One quarter were living with dementia. Most participants had reflected on their situation and considered their outcome goals. Theme categories (and corresponding sub-categories) were 'Autonomy' (information, control, and security) and 'Functioning' (physical, psychosocial, and relief). A novel 'security' theme was identified, whereby participants sought to feel safe in their usual living place and with their health problems. Those living with milder frailty were concerned to maintain ability to support loved ones, while those living with most severe frailty were concerned about burdening others. CONCLUSIONS: Outcome goals for acute care among older participants living with frailty were influenced by the insecurity of their situation and fear of deterioration. Patients may be supported to feel safe and in control through appropriate information provision and functional support.

A high-dose 24-hour tranexamic acid infusion for the treatment of significant gastrointestinal bleeding: HALT-IT RCT.

BACKGROUND: Tranexamic acid reduces blood loss in surgery and the risk of death in trauma patients. Meta-analyses of small trials suggest that tranexamic acid decreases the number of deaths from gastrointestinal bleeding, but these meta-analyses are prone to selection bias. OBJECTIVE: The trial provides reliable evidence of the effect of tranexamic acid on mortality, rebleeding and complications in significant acute gastrointestinal bleeding. DESIGN: A multicentre, randomised, placebo-controlled trial and economic analysis. Patients were assigned by selecting one treatment pack from a box of eight, which were identical apart from the pack number. Patients, caregivers and outcome assessors were masked to allocation. The main analyses were by intention to treat. SETTING: The setting was 164 hospitals in 15 countries, co-ordinated from the London School of Hygiene & Tropical Medicine. PARTICIPANTS: Adults with significant upper or lower gastrointestinal bleeding (n = 12,009) were eligible if the responsible clinician was substantially uncertain about whether or not to use tranexamic acid. The clinical diagnosis of significant bleeding implied a risk of bleeding to death, including hypotension, tachycardia or signs of shock, or urgent transfusion, endoscopy or surgery. INTERVENTION: Tranexamic acid (a 1-g loading dose over 10 minutes, then a 3-g maintenance dose over 24 hours) or matching placebo. MAIN OUTCOME MEASURES: The primary outcome was death due to bleeding within 5 days of randomisation. Secondary outcomes were all-cause and cause-specific mortality; rebleeding; need for endoscopy, surgery or radiological intervention; blood product transfusion; complications; disability; and days spent in intensive care or a high-dependency unit. RESULTS: A total of 12,009 patients were allocated to receive tranexamic acid (n = 5994, 49.9%) or the matching placebo (n = 6015, 50.1%), of whom 11,952 (99.5%) received the first dose. Death due to bleeding within 5 days of randomisation occurred in 222 (3.7%) patients in the tranexamic acid group and in 226 (3.8%) patients in the placebo group (risk ratio 0.99, 95% confidence interval 0.82 to 1.18). Thromboembolic events occurred in 86 (1.4%) patients in the tranexamic acid group and 72 (1.2%) patients in the placebo group (risk ratio 1.20, 95% confidence interval 0.88 to 1.64). The risk of arterial thromboembolic events (myocardial infarction or stroke) was similar in both groups (0.7% in the tranexamic acid group vs. 0.8% in the placebo group; risk ratio 0.92, 95% confidence interval 0.60 to 1.39), but the risk of venous thromboembolic events (deep-vein thrombosis or pulmonary embolism) was higher in tranexamic acid-treated patients than in placebo-treated patients (0.8% vs. 0.4%; risk ratio 1.85, 95% confidence interval 1.15 to 2.98). Seizures occurred in 38 patients who received tranexamic acid and in 22 patients who received placebo (0.6% vs. 0.4%, respectively; risk ratio 1.73, 95% confidence interval 1.03 to 2.93). In the base-case economic analysis, tranexamic acid was not cost-effective and resulted in slightly poorer health outcomes than no tranexamic acid. CONCLUSIONS: Tranexamic acid did not reduce death from gastrointestinal bleeding and, although inexpensive, it is not cost-effective in adults with acute gastrointestinal bleeding. FUTURE WORK: These results caution against a uniform approach to the management of patients with major haemorrhage and highlight the need for randomised trials targeted at specific pathophysiological processes. LIMITATIONS: Although this is one of the largest randomised trials in gastrointestinal bleeding, we cannot rule out a modest increase or decrease in death due to bleeding with tranexamic acid. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11225767, ClinicalTrials.gov NCT01658124 and EudraCT 2012-003192-19. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 58. See the NIHR Journals Library website for further project information.

Acute gastrointestinal bleeding (bleeding from the gut) is a common emergency and an important cause of death and illness worldwide. In the UK, more than 65,000 people each year are admitted to hospital because of acute gastrointestinal bleeding; approximately 10% of them die within 30 days. Gastrointestinal bleeding is also common in low- and middle-income countries. The care of patients with gastrointestinal bleeding has improved in recent decades, but death rates remain high. Gastrointestinal bleeding is often caused by stomach ulcers, but also by liver damage owing to alcohol or hepatitis C infection. An effective and affordable treatment for gastrointestinal bleeding could save many lives and may reduce the need for blood transfusions, which is important because blood is a scarce resource in some health-care settings. Tranexamic acid, also known as TXA, is a cheap drug that reduces bleeding in other conditions. It helps blood to clot, thereby decreasing bleeding. A trial in bleeding accident victims found that tranexamic acid reduced the chances of bleeding to death, without any increase in side effects. We wanted to find out if tranexamic acid safely improves outcomes in patients with gastrointestinal bleeding, particularly to prevent deaths. To investigate this, the HALT-IT (Haemorrhage ALleviation with Tranexamic acid ­ Intestinal system) trial studied 12,009 patients with significant gastrointestinal bleeding in 164 hospitals across 15 countries. Half of the patients received tranexamic acid and the other half received a dummy drug, called a placebo. The treatments were assigned randomly and given in addition to all other treatments needed. Neither the patient nor the doctor knew which treatment a patient received. The trial showed that tranexamic acid did not reduce deaths from gastrointestinal bleeding. Instead, tranexamic acid was linked to an increased risk of complications, including unwanted blood clots (such as deep-vein thrombosis) and seizures. The economic analysis indicated that giving tranexamic acid to patients with gastrointestinal bleeding does not represent value for money for the NHS.

The future of acute and emergency care.

Improved outcomes for acutely unwell patients are predicated on early identification of deterioration, accelerating the time to accurate diagnosis of the underlying condition, selection and titration of treatments that target biological phenotypes, and personalised endpoints to achieve optimal benefit yet minimise iatrogenic harm. Technological developments entering routine clinical practice over the next decade will deliver a sea change in patient management. Enhanced point of care diagnostics, more sophisticated physiological and biochemical monitoring with superior analytics and computer-aided support tools will all add considerable artificial intelligence to complement clinical skills. Experts in different fields of emergency and critical care medicine offer their perspectives as to which research developments could make a big difference within the next decade.

New Horizons in Understanding Appropriate Prehospital Identification and Trauma Triage for Older Adults.

Caring for older people is an important part of prehospital practice, including appropriate triage and transportation decisions. However, prehospital triage criteria are designed to predominantly assess injury severity or high-energy mechanism which is not the case for older people who often have injuries compounded by multimorbidity and frailty. This has led to high rates of under-triage in this population. This narrative review aimed to assess aspects other than triage criteria to better understand and improve prehospital triage decisions for older trauma patients. This includes integrating frailty assessment in prehospital trauma triage, which was shown to predict adverse outcomes for older trauma patients. Furthermore, determining appropriate outcome measures and the benefits of Major Trauma Centers (MTCs) for older trauma patients should be considered in order to direct accurate and more beneficial prehospital trauma triage decisions. It is still not clear what are the appropriate outcome measures that should be applied when caring for older trauma patients. There is also no strong consensus about the benefits of MTC access for older trauma patients with regards to survival, in-hospital length of stay, discharge disposition, and complications. Moreover, looking into factors other than triage criteria such as distance to MTCs, patient or relative choice, training, unfamiliarity with protocols, and possible ageism, which were shown to impact prehospital triage decisions but their impact on outcomes has not been investigated yet, should be more actively assessed and investigated for this population. Therefore, this paper aimed to discuss the available evidence around frailty assessment in prehospital care, appropriate outcome measures for older trauma patients, the benefits of MTC access for older patients, and factors other than triage criteria that could adversely impact accurate prehospital triage decisions for older trauma patients. It also provided several suggestions for the future.

Validation of the BATT score for prehospital risk stratification of traumatic haemorrhagic death: usefulness for tranexamic acid treatment criteria.

BACKGROUND: Tranexamic acid reduces surgical blood loss and reduces deaths from bleeding in trauma patients. Tranexamic acid must be given urgently, preferably by paramedics at the scene of the injury or in the ambulance. We developed a simple score (Bleeding Audit Triage Trauma score) to predict death from bleeding. METHODS: We conducted an external validation of the BATT score using data from the UK Trauma Audit Research Network (TARN) from 1st January 2017 to 31st December 2018. We evaluated the impact of tranexamic acid treatment thresholds in trauma patients. RESULTS: We included 104,862 trauma patients with an injury severity score of 9 or above. Tranexamic acid was administered to 9915 (9%) patients. Of these 5185 (52%) received prehospital tranexamic acid. The BATT score had good accuracy (Brier score = 6%) and good discrimination (C-statistic 0.90; 95% CI 0.89-0.91). Calibration in the large showed no substantial difference between predicted and observed death due to bleeding (1.15% versus 1.16%, P = 0.81). Pre-hospital tranexamic acid treatment of trauma patients with a BATT score of 2 or more would avoid 210 bleeding deaths by treating 61,598 patients instead of avoiding 55 deaths by treating 9915 as currently. CONCLUSION: The BATT score identifies trauma patient at risk of significant haemorrhage. A score of 2 or more would be an appropriate threshold for pre-hospital tranexamic acid treatment.

Diagnostic accuracy of the magnetocardiograph for patients with suspected acute coronary syndrome.

BACKGROUND: We aimed to estimate the diagnostic accuracy of the VitalScan magnetocardiograph (MCG) for suspected acute coronary syndrome (ACS). METHODS: We undertook a prospective cohort study evaluating the diagnostic accuracy of the MCG in adults with suspected ACS. The reference standard of ACS was determined by an independent adjudication committee based on 30-day investigations and events. The cohort was split into a training sample, to derive the MCG algorithm and an algorithm combining MCG with a modified Manchester Acute Coronary Syndrome (MACS) clinical probability score, and a validation sample, to estimate diagnostic accuracy. RESULTS: We recruited 756 participants and analysed data from 680 (293 training, 387 validation), of whom 96 (14%) had ACS. In the training sample, the respective area under the receiver operating characteristic (AUROC) curves were the following: MCG 0.66 (95% CI 0.58 to 0.74), MACS 0.64 (95% CI 0.54 to 0.73) and MCG+MACS 0.70 (95% CI 0.63 to 0.77). MCG specificity was 0.16 (95% CI 0.12 to 0.21) at the threshold achieving acceptable sensitivity for rule-out (>0.98). In the validation sample (n=387), the respective AUROCs were the following: MCG 0.56 (95% CI 0.48 to 0.64), MACS 0.69 (95% CI 0.61 to 0.77) and MCG+MACS 0.64 (95% CI 0.56 to 0.72). MCG sensitivity was 0.89 (95% CI 0.77 to 0.95) and specificity 0.15 (95% CI 0.12 to 0.20) at the rule-out threshold. MCG+MACS sensitivity was 0.85 (95% CI 0.73 to 0.92) and specificity 0.30 (95% CI 0.25 to 0.35). CONCLUSION: The VitalScan MCG is currently unable to accurately rule out ACS and is not yet ready for use in clinical practice. Further developmental research is required.

Barriers and facilitators to implementing trauma registries in low- and middle-income countries: Qualitative experiences from Tanzania.

BACKGROUND: The burden of trauma in low and middle-income countries (LMICs) is disproportionately high: LMICs account for nearly 90% of the global trauma deaths. Lack of trauma data has been identified as one of the major challenges in addressing the quality of trauma care and informing injury-preventing strategies in LMICs. This study aimed to explore the barriers and facilitators of current trauma documentation practices towards the development of a national trauma registry (TR). METHODS: An exploratory qualitative study was conducted at five regional hospitals between August 2018 and December 2018. Five focus group discussions (FGDs) were conducted with 49 participants from five regional hospitals. Participants included specialists, medical doctors, assistant medical officers, clinical officers, nurses, health clerks and information communication and technology officers. Participants came from the emergency units, surgical and orthopaedic inpatient units, and they had permanent placement to work in these units as non-rotating staff. We analysed the gathered information using a hybrid thematic analysis. RESULTS: Inconsistent documentation and archiving system, the disparity in knowledge and experience of trauma documentation, attitudes towards documentation and limitations of human and infrastructural resources in facilities we found as major barriers to the implementation of trauma registry. Health facilities commitment to standardising care, Ministry of Health and medicolegal data reporting requirements, and insurance reimbursements criteria of documentation were found as major facilitators to implementing trauma registry. CONCLUSIONS: Implementation of a trauma registry in regional hospitals is impacted by multiple barriers related to providers, the volume of documentation, resource availability for care, and facility care flow processes. However, financial, legal and administrative data reporting requirements exist as important facilitators in implementing the trauma registry at these hospitals. Capitalizing in the identified facilitators and investing to address the revealed barriers through contextualized interventions in Tanzania and other LMICs is recommended by this study.

The effect of constitutive pigmentation on the measured emissivity of human skin.

BACKGROUND: The measurement of body temperature has become commonplace in the current COVID-19 pandemic. Body temperature can be measured using thermal infrared imaging, a safe, non-contact method that relies on the emissivity of the skin being known to provide accurate readings. Skin pigmentation affects the absorption of visible light and enables us to see variations in skin colour. Pigmentation may also affect the absorption of infrared radiation and thus affect thermal imaging. Human skin has an accepted emissivity of 0.98 but the effect of different skin pigmentation on this value is not known. In this study, we investigated the influence of different skin pigmentation on thermal emissivity in 65 adult volunteers. METHODS: A reference object of known emissivity (electrical tape) was applied to participant's skin on the inner upper arm. Tape and arm were imaged simultaneously using a thermal infrared camera. The emissivity was set on the camera to the known value for electrical tape. The emissivity was altered manually until the skin temperature using thermal imaging software was equal to the initial tape temperature. This provided the calculated emissivity value of the skin. Participants were grouped according to skin pigmentation, quantified using the Fitzpatrick skin phototyping scale and reflectance spectrophotometry. Differences in emissivity values between skin pigmentation groups were assessed by one-way ANOVA. RESULTS: The mean calculated emissivity for the 65 participants was 0.972 (range 0.96-0.99). No significant differences in emissivity were observed between participants when grouped by skin pigmentation according to the Fitzpatrick scale (p = 0.859) or reflectance spectrophotometry (p = 0.346). CONCLUSION: These data suggest that skin pigmentation does not affect thermal emissivity measurement of skin temperature using thermal infrared imaging. This study will aid further research into the application of thermal infrared imaging as a screening or bedside diagnostic tool in clinical practice.

Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial.

BACKGROUND: The CRASH-3 trial hypothesised that timely tranexamic acid (TXA) treatment might reduce deaths from intracranial bleeding after traumatic brain injury (TBI). To explore the mechanism of action of TXA in TBI, we examined the timing of its effect on death. METHODS: The CRASH-3 trial randomised 9202 patients within 3 h of injury with a GCS score ≤ 12 or intracranial bleeding on CT scan and no significant extracranial bleeding to receive TXA or placebo. We conducted an exploratory analysis of the effects of TXA on all-cause mortality within 24 h of injury and within 28 days, excluding patients with a GCS score of 3 or bilateral unreactive pupils, stratified by severity and country income. We pool data from the CRASH-2 and CRASH-3 trials in a one-step fixed effects individual patient data meta-analysis. RESULTS: There were 7637 patients for analysis after excluding patients with a GCS score of 3 or bilateral unreactive pupils. Of 1112 deaths, 23.3% were within 24 h of injury (early deaths). The risk of early death was reduced with TXA (112 (2.9%) TXA group vs 147 (3.9%) placebo group; risk ratio [RR] RR 0.74, 95% CI 0.58-0.94). There was no evidence of heterogeneity by severity (p = 0.64) or country income (p = 0.68). The risk of death beyond 24 h of injury was similar in the TXA and placebo groups (432 (11.5%) TXA group vs 421 (11.7%) placebo group; RR 0.98, 95% CI 0.69-1.12). The risk of death at 28 days was 14.0% in the TXA group versus 15.1% in the placebo group (544 vs 568 events; RR 0.93, 95% CI 0.83-1.03). When the CRASH-2 and CRASH-3 trial data were pooled, TXA reduced early death (RR 0.78, 95% CI 0.70-0.87) and death within 28 days (RR 0.88, 95% CI 0.82-0.94). CONCLUSIONS: Tranexamic acid reduces early deaths in non-moribund TBI patients regardless of TBI severity or country income. The effect of tranexamic acid in patients with isolated TBI is similar to that in polytrauma. Treatment is safe and even severely injured patients appear to benefit when treated soon after injury. TRIAL REGISTRATION: ISRCTN15088122 , registered on 19 July 2011; NCT01402882 , registered on 26 July 2011.

Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double-blind randomised controlled feasibility trial.

INTRODUCTION: Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not using antithrombotic drugs. We aim to assess the feasibility of conducting a randomised controlled testing the safety and efficacy of desmopressin for patients with antiplatelet-associated ICH. METHODS AND ANALYSIS: We aim to include 50 patients within 24 hours of spontaneous ICH onset, associated with oral antiplatelet drug(s) use in at least the preceding 7 days. Patients will be randomised (1:1) to receive intravenous desmopressin 20 µg in 50 mL sodium chloride 0.9% infused over 20 min or matching placebo. We will mask participants, relatives and outcome assessors to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, number of patients receiving allocated treatment, rate of recruitment and adherence to treatment and follow-up. Secondary outcomes include change in ICH volume at 24 hours; hyponatraemia at 24 hours, length of hospital stay, discharge destination, early death less than 28 days, death or dependency at day 90, death up to day 90, serious adverse events (including thromboembolic events) up to day 90; disability (Barthel index, day 90), quality of life (EuroQol 5D (EQ-5D), day 90), cognition (telephone mini-mental state examination day 90) and health economic assessment (EQ-5D). ETHICS AND DISSEMINATION: The Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH) trial received ethical approval from the East Midlands-Nottingham 2 research ethics committee (18/EM/0184). The DASH trial is funded by National Institute for Health and Care Research RfPB grant: PB-PG-0816-20011. Trial results will be published in a peer reviewed academic journal and disseminated through academic conferences and through patient stroke support groups. Reporting will be in compliance with Consolidated Standards of Reporting Trials recommendations. TRIAL REGISTRATION NUMBERS: NCT03696121; ISRCTN67038373; EudraCT 2018-001904-12.

Development and pilot implementation of a standardised trauma documentation form to inform a national trauma registry in a low-resource setting: lessons from Tanzania.

OBJECTIVES: Trauma registries are an integral part of a well-organised trauma system. Tanzania, like many low and middle-income countries, does not have a trauma registry. We describe the development, structure, implementation and impact of a context appropriate standardised trauma form based on the adaptation of the WHO Data Set for Injury (DSI), for clinical documentation and use in a national trauma registry. SETTING: Our study was conducted in emergency units of five regional referral hospitals in Tanzania. PROCEDURES: Mixed methods participatory action research was employed. After an assessment of baseline trauma documentation, we conducted semi-structured interviews with a purposefully selected sample of 33 healthcare providers from all participating hospitals to understand, develop, pilot and implement a standardised trauma form. We compared the number and types of variables captured before and after the form was implemented. OUTCOMES: Change in proportion of variables of DSI captured after implementation of a standardised trauma documentation form. RESULTS: Piloting and feedback informed the development of a context appropriate standardised trauma documentation paper form with carbonless copy that could be used as both the clinical chart and data capture. Among 721 patients (seen by 21 clinicians) during the initial 30-day pilot, overall variable capture was 86.4% of required variables. After modifications of the form and training of healthcare providers, the form was implemented for 7 months, during which the capture improved to 96.3% among 6302 patients (seen by 31 clinicians). The providers reported the form was user-friendly, resulted in less time documenting, and served as a guide to managing trauma patients. CONCLUSIONS: The development and implementation of a contextually appropriate, standardised trauma form were successful, yielding increased capture rates of injury variables. This system will facilitate expansion of the trauma registry across the country and inform similar initiatives in Sub-Saharan Africa.