title: The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study.
abstract: BACKGROUND
  Reconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence - with regard to 'early neurosurgery' in this cohort - which we sought to address.
  
  
  METHODS
  Pilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of < 13 in NWAS, GCS score of < 14 in NEAS] and stable ABC, injured nearest to a NSAH were transported either to that hospital (control clusters) or bypassed to the nearest NC (intervention clusters).
  
  
  METHODS
  recruitment rate, protocol compliance, selection bias as a result of non-compliance, accuracy of paramedic TBI identification (overtriage of study inclusion criteria) and pathway acceptability to patients, families and staff. 'Open-label' secondary outcomes: 30-day mortality, 6-month Extended Glasgow Outcome Scale (GOSE) and European Quality of Life-5 Dimensions.
  
  
  RESULTS
  Overall, 56 clusters recruited 293 (169 intervention, 124 control) patients in 12 months, demonstrating cluster randomised pre-hospital trials as viable for heath service evaluations. Overall compliance was 62%, but 90% was achieved in the control arm and when face-to-face paramedic training was possible. Non-compliance appeared to be driven by proximity of the nearest hospital and perceptions of injury severity and so occurred more frequently in the intervention arm, in which the perceived time to the NC was greater and severity of injury was lower. Fewer than 25% of recruited patients had TBI on computed tomography scan (n = 70), with 7% (n = 20) requiring neurosurgery (craniotomy, craniectomy or intracranial pressure monitoring) but a further 18 requiring admission to an intensive care unit. An intention-to-treat analysis revealed the two trial arms to be equivalent in terms of age, GCS and severity of injury. No significant 30-day mortality differences were found (8.8% vs. 9.1/%; p > 0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury.
  
  
  CONCLUSIONS
  Current NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating 'early neurosurgery through bypass' and address the challenge of reliable TBI diagnosis at the scene of injury.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN68087745.
  
  
  BACKGROUND
  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. 20, No. 1. See the NIHR Journals Library website for further project information.
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Lecky
authors.affiliation: Trauma Audit and Research Network, Center of Occupational and Environmental Health, Institute of Population, University of Manchester, Manchester, UK.
authors.forename: Wanda
authors.initials: W
authors.lastname: Russell
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Gordon
authors.initials: G
authors.lastname: Fuller
authors.affiliation: Research and Development Department, North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Graham
authors.initials: G
authors.lastname: McClelland
authors.affiliation: Research and Development Department, North West Ambulance Service, Carlisle, UK.
authors.forename: Elspeth
authors.initials: E
authors.lastname: Pennington
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Goodacre
authors.affiliation: Research and Development Department, North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Kyee
authors.initials: K
authors.lastname: Han
authors.affiliation: Research and Development Department, North West Ambulance Service, Carlisle, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Curran
authors.affiliation: Department of Neurosurgery, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Damien
authors.initials: D
authors.lastname: Holliman
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Freeman
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Nathan
authors.initials: N
authors.lastname: Chapman
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Matt
authors.initials: M
authors.lastname: Stevenson
authors.affiliation: Research and Development Department, North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Sonia
authors.initials: S
authors.lastname: Byers
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Mason
authors.affiliation: Potter Rees Serious Injury Solicitors LLP, Manchester, UK.
authors.forename: Hugh
authors.initials: H
authors.lastname: Potter
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester/University Hospitals of Leicester NHS Trust, Leicester, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Coats
authors.affiliation: Research and Development Department, North West Ambulance Service, Carlisle, UK.
authors.forename: Kevin
authors.initials: K
authors.lastname: Mackway-Jones
authors.affiliation: Research and Development Department, North West Ambulance Service, Carlisle, UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Peters
authors.affiliation: Research and Development Department, Yorkshire Ambulance Services NHS Trust, Wakefield, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Shewan
authors.affiliation: EMRiS Group, Health Services Research, School of Health and Related Research (SCHaRR), University of Sheffield, Sheffield, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Strong
mesh_terms: D000328:Adult; D000488:Allied Health Personnel; D064422:Ambulance Diversion / Q000191:economics*; D000552:Ambulances; D001930:Brain Injuries / Q000191:economics / Q000601:surgery; D003362:Cost-Benefit Analysis; D004739:England; D005240:Feasibility Studies; D015600:Glasgow Coma Scale; D006761:Hospitals; D006801:Humans; D009493:Neurosurgery / Q000191:economics*; D017060:Patient Satisfaction; D012107:Research Design; D013673:Technology Assessment, Biomedical; D014218:Triage / Q000191:economics*