Early exercise in blunt chest wall trauma: protocol for a mixed-methods, multicentre, parallel randomised controlled trial (ELECT2 trial).

INTRODUCTION: Chronic pain and disability are now well-recognised long-term complications of blunt chest wall trauma. Limited research exists regarding therapeutic interventions that can be used to address these complications. A recent feasibility study was completed testing the methods of a definitive trial. This protocol describes the proposed definitive trial, the aim of which is to investigate the impact of an early exercise programme on chronic pain and disability in patients with blunt chest wall trauma. METHODS/ANALYSIS: This mixed-methods, multicentre, parallel randomised controlled trial will run in four hospitals in Wales and one in England over 12-month recruitment period. Patients will be randomised to either the control group (routine physiotherapy input) or the intervention group (routine physiotherapy input plus a simple exercise programme completed individually by the patient). Baseline measurements including completion of two surveys (Brief Pain Inventory and EuroQol 5-dimensions, 5-Levels) will be obtained on initial assessment. These measures and a client services receipt inventory will be repeated at 3-month postinjury. Analysis of outcomes will focus on rate and severity of chronic pain and disability, cost-effectiveness and acceptability of the programme by patients and clinicians. Qualitative feedback regarding acceptability will be obtained through patient and clinician focus groups. ETHICS/DISSEMINATION: London Riverside Research Ethics Committee (Reference number: 21/LO/0782) and the Health Research Authority granted approval for the trial in December 2021. Patient recruitment will commence in February 2022. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. TRIAL REGISTRATION NUMBER: ISRCTN65829737; Pre-results.

Prehospital Management of Traumatic Brain Injury across Europe: A CENTER-TBI Study.

BACKGROUND: Prehospital care for traumatic brain injury (TBI) is important to prevent secondary brain injury. We aim to compare prehospital care systems within Europe and investigate the association of system characteristics with the stability of patients at hospital arrival. METHODS: We studied TBI patients who were transported to CENTER-TBI centers, a pan-European, prospective TBI cohort study, by emergency medical services between 2014 and 2017. The association of demographic factors, injury severity, situational factors, and interventions associated with on-scene time was assessed using linear regression. We used mixed effects models to investigate the case mix adjusted variation between countries in prehospital times and interventions. The case mix adjusted impact of on-scene time and interventions on hypoxia (oxygen saturation <90%) and hypotension (systolic blood pressure <100mmHg) at hospital arrival was analyzed with logistic regression. RESULTS: Among 3878 patients, the greatest driver of longer on-scene time was intubation (+8.3 min, 95% CI: 5.6-11.1). Secondary referral was associated with shorter on-scene time (-5.0 min 95% CI: -6.2- -3.8). Between countries, there was a large variation in response (range: 12-25 min), on-scene (range: 16-36 min) and travel time (range: 15-32 min) and in prehospital interventions. These variations were not explained by patient factors such as conscious level or severity of injury (expected OR between countries: 1.8 for intubation, 1.8 for IV fluids, 2.0 for helicopter). On-scene time was not associated with the regional EMS policy (p= 0.58). Hypotension and/or hypoxia were seen in 180 (6%) and 97 (3%) patients in the overall cohort and in 13% and 7% of patients with severe TBI (GCS <8). The largest association with secondary insults at hospital arrival was with major extracranial injury: the OR was 3.6 (95% CI: 2.6-5.0) for hypotension and 4.4 (95% CI: 2.9-6.7) for hypoxia. DISCUSSION: Hypoxia and hypotension continue to occur in patients who suffer a TBI, and remain relatively common in severe TBI. Substantial variation in prehospital care exists for patients after TBI in Europe, which is only partially explained by patient factors.

Evaluating the impact of cycle helmet use on severe traumatic brain injury and death in a national cohort of over 11000 pedal cyclists: a retrospective study from the NHS England Trauma Audit and Research Network dataset.

OBJECTIVES: In the last 10 years there has been a significant increase in cycle traffic in the UK, with an associated increase in the overall number of cycling injuries. Despite this, and the significant media, political and public health debate into this issue, there remains an absence of studies from the UK assessing the impact of helmet use on rates of serious injury presenting to the National Health Service (NHS) in cyclists. SETTING: The NHS England Trauma Audit and Research Network (TARN) Database was interrogated to identify all adult (≥16 years) patients presenting to hospital with cycling-related major injuries, during a period from 14 March 2012 to 30 September 2017 (the last date for which a validated dataset was available). PARTICIPANTS: 11 patients met inclusion criteria. Data on the use of cycling helmets were available in 6621 patients. OUTCOME MEASURES: TARN injury descriptors were used to compare patterns of injury, care and mortality in helmeted versus non-helmeted cohorts. RESULTS: Data on cycle helmet use were available for 6621 of the 11 192 cycle-related injuries entered onto the TARN Database in the 66 months of this study (93 excluded as not pedal cyclists). There was a significantly higher crude 30-day mortality in un-helmeted cyclists 5.6% (4.8%-6.6%) versus helmeted cyclists 1.8% (1.4%-2.2%) (p<0.001). Cycle helmet use was also associated with a reduction in severe traumatic brain injury (TBI) 19.1% (780, 18.0%-20.4%) versus 47.6% (1211, 45.6%-49.5%) (p<0.001), intensive care unit requirement 19.6% (797, 18.4%-20.8%) versus 27.1% (691, 25.4%-28.9%) (p<0.001) and neurosurgical intervention 2.5% (103, 2.1%-3.1%) versus 8.5% (217, 7.5%-9.7%) (p<0.001). There was a statistically significant increase in chest, spinal, upper and lower limb injury in the helmeted group in comparison to the un-helmeted group (all p<0.001), though in a subsequent analysis of these anatomical injury patterns, those cyclists wearing helmets were still found to have lower rates of TBI. In reviewing TARN injury codes for specific TBI and facial injuries, there was a highly significant decrease in rates of impact injury between cyclists wearing helmets and those not. CONCLUSIONS: This study suggests that there is a significant correlation between use of cycle helmets and reduction in adjusted mortality and morbidity associated with TBI and facial injury.

A multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL Trial.

OBJECTIVE: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). The aim of this trial is to assess the feasibility and acceptability of a definitive impact trial investigating the clinical and cost-effectiveness of a new prognostic model for the management of patients with blunt chest wall trauma in the ED. DESIGN: Stepped wedge feasibility trial. SETTING: Four EDs in England and Wales. PARTICIPANTS: Adult blunt chest wall trauma patients presenting to the ED with no concurrent, life-threatening injuries. INTERVENTION: A prognostic model (the STUMBL score) to guide clinical decision-making. OUTCOME MEASURES: Primary: participant recruitment rate and clinicians' use of the STUMBL score. Secondary: composite outcome measure (mortality, pulmonary complications, delayed upgrade in care, unplanned representations to the ED), physical and mental components of quality of life, clinician feedback and health economic data gathering methodology for healthcare resource utilisation. RESULTS: Quantitative data were analysed using the intention-to-treat principle. 176 patients were recruited; recruitment targets were achieved at all sites. Clinicians used the model in 96% of intervention cases. All feasibility criteria were fully or partially met. After adjusting for predefined covariates, there were no statistically significant differences between the control and intervention periods. Qualitative analysis highlighted that STUMBL was well-received and clinicians would support a definitive trial. Collecting data on intervention costs, health-related quality of life and healthcare resource use was feasible. DISCUSSION: We have demonstrated that a fully powered randomised clinical trial of the STUMBL score is feasible and desirable to clinicians. Minor methodological modifications will be made for the full trial. TRIAL REGISTRATION NUMBER: ISRCTN95571506; Post-results.

Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial.

OBJECTIVE: Reconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)-bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI -directly into SNCs-producing a measurable effect. SETTING: Two English Ambulance Services. PARTICIPANTS: 74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults-injured nearest to an NSAH-with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC. INTERVENTIONS: Intervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC. OUTCOMES: Trial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes. RESULTS: 56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7-14.0)% vs intervention=9.4(2.3-14.0)%). CONCLUSION: Bypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely. TRIAL REGISTRATION NUMBER: ISRCTN68087745.