Study summary.

BackgroundThe spleen is commonly injured in trauma and this may be managed with a conservative approach, embolisation or splenectomy. There is uncertainty how splenic embolisation fits into the treatment paradigm and the delivery of IR services remains variable.Aims and objectivesThe primary objectives are to determine if service design significantly affects splenic embolisation (SE) rates in AAST grade 2–5 acute traumatic splenic injuries (ATSI) across the Major Trauma Centres (MTCs) in England and to determine if variation in treatment affects SE outcomes in ATSI.MethodsWe will include 5 years of data from traumatic splenic injury patients in the MTCs from 01/01/2016 to 31/12/2020 available from the Trauma Audit and Research Network (TARN) database. Inclusion Criteria will be all patients with ATSI registered with TARN. Those without a CT available to grade radiologically will be excluded. Data available from the TARN database and then correlated with data that will be collected at each MTC, where detail as to the embolisation technique, specific injury pattern, imaging based follow up and patient survival will be available. A short service-based questionnaire will be sent to each centre to establish centre-specific details such as on call rota, IR response activation, reporting practices and capture data around routine decision-making at that site. Data will be collected on an anonymised (REDCap) database. This project will evaluate the impact of service design on embolisation rates and outcomes, as well as evaluating the impact of the variation upon treatment selection and outcomes. Logistic regression will be used to identify factors associated with treatment selection and mortality at 30 days.

研究背景 脾脏在创伤中常受损伤，其治疗可采用保守疗法、脾栓塞术或脾切除术。目前学界对于脾栓塞术在创伤性脾损伤治疗体系中的定位尚存不确定性，且介入放射学（Interventional Radiology, IR）服务的实施模式仍存在较大差异。
研究目标 本研究的首要目标是明确，在英格兰各大创伤中心（Major Trauma Centres, MTCs）内，服务模式设计是否会显著影响美国创伤外科协会（AAST）分级2~5级的急性创伤性脾损伤（Acute Traumatic Splenic Injuries, ATSI）患者的脾栓塞术（Splenic Embolisation, SE）实施率；其次旨在探究急性创伤性脾损伤患者的治疗方案差异是否会对脾栓塞术的治疗结局产生影响。
研究方法 本研究将纳入2016年1月1日至2020年12月31日期间，来自创伤审计与研究网络（Trauma Audit and Research Network, TARN）数据库的5年英格兰各创伤中心创伤性脾损伤患者数据。纳入标准为所有在TARN注册的急性创伤性脾损伤患者；排除无法通过计算机断层扫描（CT）进行放射学分级的病例。首先提取TARN数据库中已有的相关数据，随后将其与各创伤中心自行采集的补充数据进行关联分析，补充数据将涵盖栓塞操作技术细节、具体损伤类型、影像学随访情况以及患者生存状况等信息。此外，本研究将向每家中心发放一份简短的服务模式相关调查问卷，以获取该中心的特异性信息，包括值班排班制度、介入放射学响应启动流程、报告规范以及该中心日常诊疗决策相关的记录数据。所有数据将存储于匿名化的REDCap数据库中。本项目将评估服务模式设计对脾栓塞术实施率及治疗结局的影响，同时分析治疗方案差异对治疗选择与结局的作用。本研究将采用逻辑回归分析法，以筛选出与治疗方案选择及30天死亡率相关的影响因素。