Lecky Fiona Elizabeth, Russell Wanda, McClelland Graham, Pennington Elspeth, Fuller Gordon, Goodacre Steve, Han Kyee, Curran Andrew, Holliman Damian, Chapman Nathan, Freeman Jennifer, Byers Sonia, Mason Suzanne, Potter Hugh, Coats Timothy, Mackway-Jones Kevin, Peters Mary, Shewan Jane
Centre for Urgent and Emergency Care Research (CURE) Group, Health Services Research, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
Trauma Audit and Research Network, Centre for Occupational and Environmental Health, Institute of Population, University of Manchester, Manchester, UK.
BMJ Open. 2017 Oct 5;7(10):e016355. doi: 10.1136/bmjopen-2017-016355.
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.
Two English Ambulance Services.
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.
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.
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.
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)%).
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.
ISRCTN68087745.
重新配置创伤服务，将创伤性脑损伤（TBI）患者直接转运至专科神经科学中心（SNC），而不经过非专科急症医院（NSAH），可能会改善治疗结果。然而，与从最近的NSAH选择性二次转运至SNC相比，气道、呼吸和循环（ABC）稳定的延迟可能会使结果恶化。我们进行了一项试点整群随机对照试验，以确定绕过疑似TBI患者直接进入SNC产生可测量效果的可行性和合理性。
两家英国救护车服务机构。
74个整群（救护站）在根据重要特征匹配后成对随机分组。整群纳入头部受伤的成年人，这些成年人在距离NSAH最近的地方受伤，具有国际公认的TBI危险因素且ABC稳定。我们排除了由直升机紧急医疗服务救治的参与者，或距离最近的SNC超过1小时车程受伤的参与者。
干预组参与者直接转运至SNC，不经过最近的NSAH；对照组参与者转运至最近的NSAH，并选择性二次转运至SNC。
主要可行性结果为试验招募率（目标每年n = 700）和CT扫描显示TBI的百分比（目标80%）。次要结果为30天死亡率、6个月扩展格拉斯哥预后量表和生活质量。
56个救护站整群在12个月内招募了293名患者。试验组在年龄、意识水平和损伤严重程度方面相似。招募患者中不到25%的CT显示有TBI（n = 70），7%（n = 20）需要神经外科手术。完整病例分析显示，两个试验组的30天死亡率相似（对照组=8.8（2.7 - 14.0）%，干预组=9.4（2.3 - 14.0）%）。
将疑似TBI患者绕过NSAH直接转运至SNC进行神经外科干预的过度分诊（假阳性）比例为13:1，TBI为4:1。因此，对绕过NSAH后进行早期神经科学护理的全面试验产生可测量效果的可能性不大。
ISRCTN68087745。
