Cost-effectiveness of out-of-hospital continuous positive airway pressure for acute respiratory failure: decision analytic modelling using data from a feasibility trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Sport Concussion Assessment Tool: Fifth Edition Normative Reference Values for Professional Rugby Union Players.

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.

Should Adults With Mild Head Injury Who Are Receiving Direct Oral Anticoagulants Undergo Computed Tomography Scanning? A Systematic Review.

STUDY OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Evaluation of World Rugby's concussion management process: results from Rugby World Cup 2015.

OBJECTIVE: To evaluate World Rugby's concussion management process during Rugby World Cup (RWC) 2015. DESIGN: A prospective, whole population study. POPULATION: 639 international rugby players representing 20 countries. METHOD: The 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. RESULTS: Players 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. CONCLUSIONS: This study supports the implementation of a multimodal, multitime-based concussion evaluation process to ensure that immediate and late developing concussions are captured.

Long-Term Survival Following Traumatic Brain Injury: A Population-Based Parametric Survival Analysis.

BACKGROUND: Long-term mortality may be increased following traumatic brain injury (TBI); however, the degree to which survival could be reduced is unknown. We aimed at modelling life expectancy following post-acute TBI to provide predictions of longevity and quantify differences in survivorship with the general population. METHODS: A population-based retrospective cohort study using data from the Rochester Epidemiology Project (REP) was performed. A random sample of patients from Olmsted County, Minnesota with a confirmed TBI between 1987 and 2000 was identified and vital status determined in 2013. Parametric survival modelling was then used to develop a model to predict life expectancy following TBI conditional on age at injury. Survivorship following TBI was also compared with the general population and age- and gender-matched non-head injured REP controls. RESULTS: Seven hundred and sixty nine patients were included in complete case analyses. The median follow-up time was 16.1 years (interquartile range 9.0-20.4) with 120 deaths occurring in the cohort during the study period. Survival after acute TBI was well represented by a Gompertz distribution. Victims of TBI surviving for at least 6 months post-injury demonstrated a much higher ongoing mortality rate compared to the US general population and non-TBI controls (hazard ratio 1.47, 95% CI 1.15-1.87). US general population cohort life table data was used to update the Gompertz model's shape and scale parameters to account for cohort effects and allow prediction of life expectancy in contemporary TBI. CONCLUSIONS: Survivors of TBI have decreased life expectancy compared to the general population. This may be secondary to the head injury itself or result from patient characteristics associated with both the propensity for TBI and increased early mortality. Post-TBI life expectancy estimates may be useful to guide prognosis, in public health planning, for actuarial applications and in the extrapolation of outcomes for TBI economic models.

Sport Concussion Assessment Tool: baseline and clinical reference limits for concussion diagnosis and management in elite Rugby Union.

OBJECTIVES: Rugby Union has adapted the Sports Concussion Assessment Tool (SCAT) into an abridged off-field concussion screen and the complete SCAT is used during diagnostic screens performed after head impact events. No firm guidelines exist as to what should be considered "abnormal" and warrant further evaluation. This study evaluates SCAT performances in 13,479 baseline SCAT assessments, and proposes clear reference limits for each sub-component of the SCAT5. Baseline reference limits are proposed to guide management of baseline testing by identifying abnormal sub-tests, enhancing the clinical validity of baseline screens, while clinical reference limits are identified to support concussion diagnosis when no baseline is available. DESIGN: Cross sectional census sample. METHODS: 13,479 baseline SCATs from 7565 elite male rugby players were evaluated. Baseline reference limits were identified for each sub-test as the sub-test result achieved by approximately 5% of the population, while clinical references limits corresponded to the sub-test score achieved by as close as possible to 50% of the cohort. RESULTS: Players reported symptoms 35% (95% CI 1.29-1.42) more frequently during SCAT5 than SCAT3 baseline assessments (mean 1.4±2.7 vs 1.0±2.4). Ceiling effects were identified for many cognitive sub-tests within the SCAT. Baseline and Clinical reference limits corresponding to the worst performing 5th percentile and 50th percentile were described. CONCLUSIONS: Targeted baseline re-testing should be repeated when abnormal sub-tests are identified according to proposed baseline reference limits, while a more conservative clinical reference limit supports concussion diagnosis during screens in diagnostic settings.

Prehospital continuous positive airway pressure for acute respiratory failure: the ACUTE feasibility RCT.

BACKGROUND: 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. OBJECTIVES: 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. DESIGN: (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. SETTING: Four West Midlands Ambulance Service hubs, recruiting between August 2017 and July 2018. PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. LIMITATIONS: 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. CONCLUSIONS: 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. FUTURE WORK: A definitive clinical effectiveness trial of continuous positive airway pressure in the NHS is not recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12048261. 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. 7. See the NIHR Journals Library website for further project information.

Acute respiratory failure is a life-threatening medical emergency. It occurs when heart or lung disease suddenly develops, or deteriorates, and leads to the patient being unable to maintain oxygen levels in their blood. Continuous positive airway pressure is a potentially useful treatment that could be used by paramedics. It involves delivering oxygen under increased pressure through a tight-fitting face mask. However, it is uncertain whether or not it could work effectively in NHS ambulance services, or if it represents value for money. The Ambulance continuous positive airway pressure (CPAP): Use, Treatment Effect and economics (ACUTE) trial investigated whether or not it is possible and worthwhile to undertake a full-scale study comparing continuous positive airway pressure with normal paramedic treatment. Paramedics identified adults with acute respiratory failure when attending 999 emergency calls. Half were randomly assigned to receive continuous positive airway pressure, whereas the other half were treated normally. Patients were then followed up to see what happened to them. Fewer patients than expected were entered into the trial, but paramedics were able to provide treatment with continuous positive airway pressure, and most patients were successfully followed up. It therefore seems possible to do a full-scale trial. A cost-effectiveness model also showed that it is uncertain whether or not continuous positive airway pressure represents value for money for the NHS, so further research might be worthwhile, if continuous positive airway pressure is thought to be effective. However, examination of patients recruited to the trial uncovered important doubts about whether or not continuous positive airway pressure would help them. One-quarter of patients were not able to tolerate the tight continuous positive airway pressure mask. Some of the patients had conditions that are not usually treated by continuous positive airway pressure, or had severe underlying disease that could not be helped by this treatment. Others had collapsed lungs that could have been made worse by continuous positive airway pressure. This means that, although a full-scale trial may be possible, it is difficult to see how continuous positive airway pressure could save enough lives to make a trial worthwhile.

The diagnostic accuracy of pre-hospital assessment of acute respiratory failure.

INTRODUCTION: Acute respiratory failure (ARF) is a common medical emergency. Pre-hospital management includes controlled oxygen therapy, supplemented by specific management options directed at the underlying disease. The aim of the current study was to characterise the accuracy of paramedic diagnostic assessment in acute respiratory failure. METHODS: A nested diagnostic accuracy and agreement study comparing pre-hospital clinical impression to the final hospital discharge diagnosis was conducted as part of the ACUTE (Ambulance CPAP: Use, Treatment effect and Economics) trial. Adults with suspected ARF were recruited from the UK West Midlands Ambulance Service. The pre-hospital clinical impression of the recruiting ambulance service clinician was prospectively recorded and compared to the final hospital diagnosis at 30 days. Agreement between pre-hospital and hospital diagnostic assessments was evaluated using raw agreement and Gwets AC1 coefficient. RESULTS: 77 participants were included. Chronic obstructive pulmonary disease (32.9%) and lower respiratory tract infection (32.9%) were the most frequently suspected primary pre-hospital diagnoses for ARF, with secondary contributory conditions recorded in 36 patients (46.8%). There was moderate agreement between the primary pre-hospital and hospital diagnoses, with raw agreement of 58.5% and a Gwets AC1 coefficient of 0.56 (95% CI 0.43 to 0.69). In five cases, a non-respiratory final diagnosis was present, including: myocardial infarction, ruptured abdominal aortic aneurysm, liver failure and sepsis. CONCLUSIONS: Pre-hospital assessment of ARF is challenging, with limited accuracy compared to the final hospital diagnosis. A syndromic approach, providing general supportive care, rather than a specifically disease-orientated treatment strategy, is likely to be most appropriate for the pre-hospital environment.

Guidelines for community-based injury surveillance in rugby union.

OBJECTIVES: The vast majority of rugby union ('rugby') participants are community-based players; however, the majority of injury surveillance studies reported relate to the elite, professional game. A potential reason for this dearth of studies could be the perceived difficulty of using the consensus statement for injury recording at the community level. The aim of this study was to identify areas where the consensus statement could be adapted for easier and more appropriate implementation within the community setting. DESIGN: Round-table discussion. METHODS: All community-based injury surveillance issues were discussed during a 2-day facilitated round-table meeting, by an 11-person working group consisting of researchers currently active in rugby-related injury surveillance, sports medicine and sports science issues. The outcomes from the meeting were summarised in a draft guidance document that was then subjected to an extensive iterative review prior to producing methodological recommendations. RESULTS: Each aspect of the rugby-specific consensus statement was reviewed to determine whether it was feasible to implement the standards required in the context of non-elite rugby and the resources available within in a community setting. Final recommendations are presented within a community-based injury report form. CONCLUSIONS: It is recommended that whenever possible the rugby-specific consensus statement for injury surveillance studies be used: this paper presents an adapted report form that can be used to record injury surveillance information in community rugby if suitable medical support is not available.

Pre-hospital CPAP for acute respiratory failure: the ACUTE feasibility and pilot randomised controlled trial.

INTRODUCTION: Acute respiratory failure (ARF) is a common and life-threatening medical emergency. Continuous positive airway pressure (CPAP) is a potentially beneficial alternative treatment; however, it is uncertain whether this could improve important outcomes in NHS ambulance services. The ACUTE study aimed to assess the feasibility of a large-scale pragmatic trial of pre-hospital CPAP. METHODS: The study was a pilot randomised controlled trial of the O-Two system CPAP mask versus standard oxygen therapy, with concealed allocation 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 endpoint was 30-day mortality. Ancillary studies included an ARF incidence study, ARF diagnostic agreement study, clinician perceptions of CPAP mixed methods study and investigation of allocation concealment. RESULTS: Over 12 months, 77 patients were enrolled (target 120). CPAP was fully delivered in 74% (target 75%). There were no major protocol violations/non-compliances. Full data were available for all key outcomes (targets ≥ 90%). Thirty-day mortality was 27.3%. Of deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital NIV and critical care. CONCLUSION: The ACUTE trial recruitment rate was below the target rate and feasibility was not demonstrated. Identification of patients who might benefit from pre-hospital CPAP was challenging. It appeared difficult to exclude conditions where CPAP would not work, or might be harmful, and to select appropriate patients where there was a meaningful chance of success, or where the potential advantages of pre-hospital CPAP would outweigh the burdens of more advanced and aggressive treatment. The limited compliance with CPAP, and the difficulty in identifying patients who could benefit from CPAP, indicate that pre-hospital CPAP is unlikely to materially reduce mortality. A definitive effectiveness trial of CPAP in the NHS is therefore not recommended.

The Use of Sideline Video Review to Facilitate Management Decisions Following Head Trauma in Super Rugby.

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.

Correction to: The Use of Sideline Video Review to Facilitate Management Decisions Following Head Trauma in Super Rugby.

In the original article [1] reference was made to the Hawk-Eye system having been used as the sideline operating system during the 2015 season.

The ACUTE (Ambulance CPAP: Use, Treatment effect and economics) feasibility study: a pilot randomised controlled trial of prehospital CPAP for acute respiratory failure.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN12048261. Registered on 30 August 2017. http://www.isrctn.com/ISRCTN12048261.

National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations.

Through a partnership with the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, and Department of Defense, the development of Sport-Related Concussion (SRC) Common Data Elements (CDEs) was initiated. The aim of this collaboration was to increase the efficiency and effectiveness of clinical research studies and clinical treatment outcomes, increase data quality, facilitate data sharing across studies, reduce study start-up time, more effectively aggregate information into metadata results, and educate new clinical investigators. The SRC CDE Working Group consisted of 32 worldwide experts in concussion from varied fields of related expertise divided into three Subgroups: Acute (<72 h post-concussion), Subacute (3 days-3 months post-concussion) and Persistent/Chronic (>3 months post-concussion). To develop CDEs, the Subgroups reviewed various domains, then selected from, refined, and added to existing CDEs, case report forms and field-tested data elements from national registries and funded research studies. Recommendations were posted to the NINDS CDE Website for Public Review from February 2017 to April 2017. Following an internal Working Group review of recommendations, along with consideration of comments received from the Public Review period, the first iteration (Version 1.0) of the NINDS SRC CDEs was completed in June 2017. The recommendations include Core and Supplemental-Highly Recommended CDEs for cognitive data elements and symptom checklists, as well as other outcomes and end-points (e.g., vestibular, oculomotor, balance, anxiety, depression), and sample case report forms (e.g., injury reporting, demographics, concussion history) for domains typically included in clinical research studies. The NINDS SRC CDEs and supporting documents are publicly available on the NINDS CDE website www.commondataelements.ninds.nih.gov . Widespread use of CDEs by researchers and clinicians will facilitate consistent SRC clinical research and trial design, data sharing, and metadata retrospective analysis.