Acute respiratory failure is a life-threatening emergency. Standard prehospital management involves controlled oxygen therapy. Continuous positive airway pressure is a potentially beneficial ...alternative treatment; however, it is uncertain whether or not this treatment could improve outcomes in NHS ambulance services.
To assess the feasibility of a large-scale pragmatic trial and to update an existing economic model to determine cost-effectiveness and the value of further research.
(1) An open-label, individual patient randomised controlled external pilot trial. (2) Cost-effectiveness and value-of-information analyses, updating an existing economic model. (3) Ancillary substudies, comprising an acute respiratory failure incidence study, an acute respiratory failure diagnostic agreement study, clinicians perceptions of a continuous positive airway pressure mixed-methods study and an investigation of allocation concealment.
Four West Midlands Ambulance Service hubs, recruiting between August 2017 and July 2018.
Adults with respiratory distress and peripheral oxygen saturations below the British Thoracic Society's target levels were included. Patients with limited potential to benefit from, or with contraindications to, continuous positive airway pressure were excluded.
Prehospital continuous positive airway pressure (O-Two system, O-Two Medical Technologies Inc., Brampton, ON, Canada) was compared with standard oxygen therapy, titrated to the British Thoracic Society's peripheral oxygen saturation targets. Interventions were provided in identical sealed boxes.
Feasibility objectives estimated the incidence of eligible patients, the proportion recruited and allocated to treatment appropriately, adherence to allocated treatment, and retention and data completeness. The primary clinical end point was 30-day mortality.
Seventy-seven patients were enrolled (target 120 patients), including seven patients with a diagnosis for which continuous positive airway pressure could be ineffective or harmful. Continuous positive airway pressure was fully delivered to 74% of participants (target 75%). There were no major protocol violations/non-compliances. Full data were available for all key outcomes (target ≥ 90%). Thirty-day mortality was 27.3%. Of the 21 deceased participants, 14 (68%) either did not have a respiratory condition or had ceiling-of-treatment decision implemented that excluded hospital non-invasive ventilation and critical care. The base-case economic evaluation indicated that standard oxygen therapy was probably cost-effective (incremental cost-effectiveness ratio £5685 per quality-adjusted life-year), but there was considerable uncertainty (population expected value of perfect information of £16.5M). Expected value of partial perfect information analyses indicated that effectiveness of prehospital continuous positive airway pressure was the only important variable. The incidence rate of acute respiratory failure was 17.4 (95% confidence interval 16.3 to 18.5) per 100,000 persons per year. There was moderate agreement between the primary prehospital and final hospital diagnoses (Gwet's AC1 coefficient 0.56, 95% confidence interval 0.43 to 0.69). Lack of hospital awareness of the Ambulance continuous positive airway pressure (CPAP): Use, Treatment Effect and economics (ACUTE) trial, limited time to complete trial training and a desire to provide continuous positive airway pressure treatment were highlighted as key challenges by participating clinicians.
During week 10 of recruitment, the continuous positive airway pressure arm equipment boxes developed a 'rattle'. After repackaging and redistribution, no further concerns were noted. A total of 41.4% of ambulance service clinicians not participating in the ACUTE trial indicated a difference between the control and the intervention arm trial boxes (115/278); of these clinician 70.4% correctly identified box contents.
Recruitment rate was below target and feasibility was not demonstrated. The economic evaluation results suggested that a definitive trial could represent value for money. However, limited compliance with continuous positive airway pressure and difficulty in identifying patients who could benefit from continuous positive airway pressure indicate that prehospital continuous positive airway pressure is unlikely to materially reduce mortality.
A definitive clinical effectiveness trial of continuous positive airway pressure in the NHS is not recommended.
Current Controlled Trials ISRCTN12048261.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
; Vol. 25, No. 7. See the NIHR Journals Library website for further project information.
Background
Sideline video review has been increasingly used to evaluate risk of concussive injury during match play of a number of collision sports, with the view to reducing the incidence of match ...play concussion injuries. The purpose of this study was to evaluate the effectiveness of sideline video review for identifying and evaluating head impact events in Rugby Union.
Methods
All Australian teams’ 2015 Super Rugby season matches were studied. Meaningful head impact events (HIEs) were identified, comprising events identified and acted upon during matches and events identified through a post-season retrospective review. Video footage of each HIE was coded by two experienced independent sports medicine clinicians to evaluate management decisions made by match-day (MDD) and team doctors (TD). HIE incidences for matches with and without sideline video were compared, and the agreement between game-day video interpretation and the independent clinician opinion calculated.
Results
Seventy HIEs were identified in 83 matches (47 identified during matches and 23 identified post-season), equating to 42.5 HIEs per 1000 player match hours. When video review was available, an unnoticed HIE occurred once every 4.3 matches, compared to once every 2.3 matches when the sideline video review was unavailable. Of the 47 identified in-match HIEs evaluated by TD and MDD during the season, 18 resulted in an immediate and permanent removal, 28 resulted in temporary removal for an off-field assessment, and one resulted in the player continuing the game. Game-day head injury assessment process video decisions agreed with the independent clinician view in 72% of cases,
κ
= 0.49 (95% CI 0.38–0.59, weak agreement).
Conclusions
These findings suggest that access to sideline video review is an important supplementary component to identify potential concussions; however, there is a critical need for improved systems and processes to reduce the likelihood of missing an incident.
Standard prehospital management for Acute respiratory failure (ARF) involves controlled oxygen therapy. Continuous positive airway pressure (CPAP) is a potentially beneficial alternative treatment, ...however, it is uncertain whether this could improve outcomes and provide value for money. This study aimed to evaluate the cost-effectiveness of prehospital CPAP in ARF.
A cost-utility economic evaluation was performed using a probabilistic decision tree model synthesising available evidence. The model consisted of a hypothetical cohort of patients in a representative ambulance service with undifferentiated ARF, receiving standard oxygen therapy or prehospital CPAP. Costs and quality adjusted life years (QALYs) were estimated using methods recommended by NICE.
In the base case analysis, using CPAP effectiveness estimates form the ACUTE trial, the mean expected costs of standard care and prehospital CPAP were £15,201 and £14,850 respectively and the corresponding mean expected QALYs were 1.190 and 1.128, respectively. The mean ICER estimated as standard oxygen therapy compared to prehospital CPAP was £5685 per QALY which indicated that standard oxygen therapy strategy was likely to be cost-effective at a threshold of £20,000 per QALY (67% probability). The scenario analysis, using effectiveness estimates from an updated meta-analysis, suggested that prehospital CPAP was more effective (mean incremental QALYs of 0.157), but also more expensive (mean incremental costs of £1522), than standard care. The mean ICER, estimated as prehospital CPAP compared to standard care, was £9712 per QALY. At the £20,000 per QALY prehospital CPAP was highly likely to be the most cost-effective strategy (94%).
Cost-effectiveness of prehospital CPAP depends upon the estimate of effectiveness. When based on a small pragmatic feasibility trial, standard oxygen therapy is cost-effective. When based on meta-analysis of heterogeneous trials, CPAP is cost-effective. Value of information analyses support commissioning of a large pragmatic effectiveness trial, providing feasibility and plausibility conditions are met.
OBJECTIVE:To describe distributions and establish normative ranges for new or changed subcomponents of the Sports Concussion Assessment Tool (SCAT)-5.
DESIGN:Cross-sectional study.
SETTING AND ...PARTICIPANTS:Professional Rugby Union players performing 2017 preseason baseline SCAT-5 testing.
INDEPENDENT VARIABLES:Subcomponent tests newly introduced or changed in the SCAT-5.
MAIN MEASUREMENTS:The 10-word immediate and delayed recall tests and the rapid neurological screen.
RESULTS:Thousand two hundred three players were included in complete case analyses. The 10-word immediate recall test median score 15, interquartile range (IQR) 15-22, range 3-30 showed an asymmetrical, bimodal distribution. The delayed recall test (median score 7, IQR 5-9, range 0-10) demonstrated a left skewed distribution. The diplopia and reading/following instruction tests of the neurological screen were performed normally by virtually all participants (98.5% and 99.6%, respectively). Normative classification ranges for each SCAT-5 subcomponents of interest were determined.
CONCLUSIONS:The increased spread of scores, with improved midrange centering, suggests that the increase to 10-word list lengths should improve the performance of immediate and delayed recall tests. Normative ranges will provide a distribution against which postinjury SCAT-5 scores can be compared and interpreted.
Acute respiratory failure (ARF) is a common and life-threatening medical emergency. Standard prehospital management involves controlled oxygen therapy and disease-specific ancillary treatments. ...Continuous positive airway pressure (CPAP) is a potentially beneficial alternative treatment that could be delivered by emergency medical services. However, it is uncertain whether this treatment could work effectively in United Kingdom National Health Service (NHS) ambulance services and if it represents value for money.
An individual patient randomised controlled external pilot trial will be conducted comparing prehospital CPAP to standard oxygen therapy for ARF. Adults presenting to ambulance service clinicians will be eligible if they have respiratory distress with peripheral oxygen saturation below British Thoracic Society (BTS) target levels, despite titrated supplemental oxygen. Enrolled patients will be allocated (1:1 simple randomisation) to prehospital CPAP (O_two system) or standard oxygen therapy using identical sealed boxes. Feasibility outcomes will include incidence of recruited eligible patients, number of erroneously recruited patients and proportion of cases adhering to allocation schedule and treatment, followed up at 30 days and with complete data collection. Effectiveness outcomes will comprise survival at 30 days (definitive trial primary end point), endotracheal intubation, admission to critical care, length of hospital stay, visual analogue scale (VAS) dyspnoea score, EQ-5D-5L and health care resource use at 30 days. The cost-effectiveness of CPAP, and of conducting a definitive trial, will be evaluated by updating an existing economic model. The trial aims to recruit 120 patients over 12 months from four regional ambulance hubs within the West Midlands Ambulance Service (WMAS). This sample size will allow estimation of feasibility outcomes with a precision of < 5%. Feasibility and effectiveness outcomes will be reported descriptively for the whole trial population, and each trial arm, together with their 95% confidence intervals.
This study will determine if it is feasible, acceptable and cost-effective to undertake a full-scale trial comparing CPAP and standard oxygen treatment, delivered by ambulance service clinicians for ARF. This will inform NHS practice and prevent inappropriate prehospital CPAP adoption on the basis of limited evidence and at a potentially substantial cost.
ISRCTN12048261. Registered on 30 August 2017. http://www.isrctn.com/ISRCTN12048261.
Patients receiving direct oral anticoagulant medications commonly undergo computed tomography head scanning after mild traumatic brain injury, regardless of symptoms or signs. International ...guidelines have noted a lack of evidence to support management decisions for such patients. This systematic review aims to identify, appraise, and synthesize the current evidence for the risk of adverse outcome in patients receiving direct oral anticoagulants after mild head injury.
A protocol was registered with PROSPERO and review methodology followed Cochrane Collaboration recommendations. Studies of adult patients with mild head injury (Glasgow Coma Scale score 13 to 15) and who were receiving direct oral anticoagulants that reported the risk of adverse outcome after the head injury were eligible for inclusion. A comprehensive range of bibliographic databases and gray literature was examined with a sensitive search strategy. Selection of eligible studies, data extraction, and risk of bias were evaluated independently by separate reviewers. A random-effects meta-analysis was used to provide a pooled estimate of the risk of adverse outcome. The overall quality of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation Working Group approach.
A total of 4,886 articles were screened for inclusion, of which 7 cohort studies including 346 patients met inclusion criteria. All studies were at high or unclear risk of bias as a result of selection and information bias. Estimates of adverse outcome (any death, intracranial hematoma, or neurosurgery) ranged from 0.0% to 8.3%. A random-effects meta-analysis showed a weighted composite outcome risk of 3.7% (95% confidence interval 1.7% to 5.8%; I2=3.3%). The overall quality of the body of evidence was low as a result of imprecision, indirectness, and risk of bias.
There are limited data available to characterize the risk of adverse outcome in patients receiving direct oral anticoagulants after mild traumatic brain injury. A sufficiently powered prospective cohort study is required to validly define this risk, identify clinical features predictive of adverse outcome, and inform future head injury guidelines.
ObjectiveTo evaluate World Rugby's concussion management process during Rugby World Cup (RWC) 2015.DesignA prospective, whole population study.Population639 international rugby players representing ...20 countries.MethodThe concussion management process consisted of 3 time-based, multifaceted stages: an initial on-pitch and/or pitch-side assessment of the injury, a follow-up assessment within 3 hours and an assessment at 36–48 hours. The initial on-pitch assessment targeted obvious signs of concussion, which, if identified, lead to a ‘permanent removal from play’ decision and a diagnosis of concussion. If the on-pitch diagnosis was unclear, a 10-min off-pitch assessment was undertaken for signs and symptoms of concussion leading to a ‘suspected concussion with permanent removal from play’ or a ‘no indication of concussion with return to play’ decision. Evaluations at 3 and 36–48 hours postmatch lead to diagnoses of ‘confirmed concussion’ or ‘no concussion’. Medical staff's decision-making was supported during each stage by real-time video review of events. Players diagnosed with confirmed concussion followed a 5-stage graduated-return-to-play protocol before being allowed to return to training and/or competition.ResultsPlayers were evaluated for concussion on 49 occasions, of which 24 resulted in diagnoses of concussion. Fourteen players showing on-pitch signs of concussion were permanently removed from play: 4 of the 5 players removed from play following off-pitch medical room evaluation were later diagnosed with a confirmed concussion. Five players not exhibiting in-match signs or symptoms of concussion were later diagnosed with concussion. The overall incidence of concussion during RWC 2015 was 12.5 concussions/1000 player-match-hours.ConclusionsThis study supports the implementation of a multimodal, multitime-based concussion evaluation process to ensure that immediate and late developing concussions are captured.
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