Resuscitation Outcomes Consortium (ROC) Trauma Epidemiologic Registry (Trauma Epistry) (ROC-Trauma Epistry-BioLINCC)

<b style="text-decoration-line: underline;">Data Access NOTE</b>: Please refer to the "Authorized Access" section below for information about how access to the data from this accession differs from many other dbGaP accessions.

<u style="font-weight: bold;">Available Data</u>: This dataset only includes traumatic injury participants. For ROC cardiac arrest Epistry data please see: [ROC-Cardiac Epistry 1 and 2](https://biolincc.nhlbi.nih.gov/studies/roc_cardiac_epistry_1_2/) and [ROC-Cardiac Epistry 3](https://biolincc.nhlbi.nih.gov/studies/roc_cardiac_epistry_3/).

<u style="font-weight: bold;">Objectives</u>: To build a prospective population-based registry of participants with out-of-hospital traumatic injury responded to by Emergency Medical Services (EMS). Specific aims included: to establish whether the results of Resuscitation Outcomes Consortium (ROC) trials can be generalized to the larger population of people that experience traumatic injury; to more fully establish the burden of traumatic injury; and to examine the relationships between variation in EMS structure and process, regional and periodic factors, and participant outcomes.

<u style="font-weight: bold;">Background</u>: Traumatic injury is a major public health problem generating substantial morbidity, mortality, and economic burden on society. The majority of seriously injured persons are initially evaluated and cared for by prehospital providers, however the effect of EMS systems, EMS clinical care, and EMS interventions on trauma patient outcomes is largely unknown. EMS factors such as service level, number of responding providers, use of procedures or drugs in the field, training, quality assurance/feedback, and response time intervals also vary significantly by region.

The Resuscitation Outcomes Consortium (ROC) was established in 2004 to conduct clinical research in the areas of cardiopulmonary arrest and life-threatening traumatic injury with the overall goal of improving resuscitation outcomes. Previous trauma registries have generally focused primarily on hospitalized patients with limited prehospital information. Registries may also exclude trauma cases at far ends of the spectrum, such as those who die in the field or in a non-trauma center and/or patients that are treated and released. These limitations do not allow for detailed, outcome-based assessments of EMS system factors necessary to define prehospital resuscitation best practices. Therefore there was a need for standardized data collection of out-of-hospital traumatic injuries matched to hospital-based outcomes in diverse geographic locations in order to identify the independent effects of prognostic or treatment factors accounting for variations in survival.

<u style="font-weight: bold;">Participants</u>: The registry included 13,830 traumatic events from 264 EMS agencies transporting to 287 acute care hospitals from the following regional centers: Birmingham, Alabama; Dallas, Texas; Iowa City, Iowa; Milwaukee, Wisconsin; Pittsburgh, Pennsylvania; Portland, Oregon; San Diego, California; Seattle/King County, Washington; Ottawa, Ontario; Toronto, Ontario; and Vancouver, British Columbia.

<u style="font-weight: bold;">Design</u>: ROC Epistry collected standardized data regarding episode-specific factors, participant demographics, clinical information, pre-hospital interventions and disposition, hospital information, and participant outcome for all out-of-hospital traumatic injuries in the ROC regions. Cases were identified through review of emergency response system records including dispatch centers, EMS ground agencies, and air medical services. Out-of-hospital data were extracted from existing databases whenever possible and augmented with targeted review of EMS reports. Hospital data were abstracted directly from the hospital file in most cases. Sites submitted data using a web-based interface or batch uploads (Newgard, et al., 2008, [PMID: 18482792](https://pubmed.ncbi.nlm.nih.gov/18482792/)).

<u style="font-weight: bold;">数据访问须知</u>: 请参阅下文的“授权访问”章节，了解本次收录数据集的访问方式与其他多数dbGaP收录数据集的差异。

<u style="font-weight: bold;">可用数据</u>: 本数据集仅纳入创伤性损伤受试者。如需获取ROC心搏骤停急诊登记数据，请参阅：[ROC心脏骤停登记数据集1和2](https://biolincc.nhlbi.nih.gov/studies/roc_cardiac_epistry_1_2/) 与 [ROC心脏骤停登记数据集3](https://biolincc.nhlbi.nih.gov/studies/roc_cardiac_epistry_3/)。

<u style="font-weight: bold;">研究目标</u>: 构建一项基于人群的前瞻性登记库，纳入急诊医疗服务（Emergency Medical Services, EMS）处置的院外创伤性损伤受试者。具体研究目标包括：验证复苏结局联盟（Resuscitation Outcomes Consortium, ROC）试验的结果能否外推至更大范围的创伤性损伤人群；全面明确创伤性损伤的疾病负担；探究急诊医疗服务的结构与流程、区域及周期性因素与受试者结局之间的关联。

<u style="font-weight: bold;">研究背景</u>: 创伤性损伤是一项重大公共卫生问题，会造成大量发病、死亡及社会经济负担。多数重伤患者最初由院前急救人员进行评估与救治，但急诊医疗服务体系、急诊医疗临床服务及急诊医疗干预措施对创伤患者结局的影响目前尚不明确。急诊医疗服务的相关因素，如服务等级、出诊急救人员数量、现场操作或药物使用情况、培训情况、质量保证与反馈机制及响应时间间隔，也存在显著的区域差异。

复苏结局联盟（Resuscitation Outcomes Consortium, ROC）于2004年成立，旨在开展心搏骤停及危及生命的创伤性损伤领域的临床研究，总体目标是改善复苏结局。既往创伤登记库通常主要关注住院患者，且院前信息有限；部分登记库还会排除极端病例，如现场死亡或在非创伤中心死亡的患者，以及经治疗后出院的创伤患者。这些局限性使得无法对定义院前复苏最佳实践所需的急诊医疗服务体系因素开展详细的基于结局的评估。因此，亟需在不同地理区域开展院外创伤性损伤的标准化数据采集，并匹配院内结局，以明确影响生存率差异的预后或治疗因素的独立效应。

<u style="font-weight: bold;">受试者情况</u>: 本登记库共纳入来自264家急诊医疗服务机构的13830例创伤事件，这些机构将患者转运至以下区域中心的287家急诊医院：阿拉巴马州伯明翰市、德克萨斯州达拉斯市、艾奥瓦州艾奥瓦城、威斯康星州密尔沃基市、宾夕法尼亚州匹兹堡市、俄勒冈州波特兰市、加利福尼亚州圣迭戈市、华盛顿州西雅图/金县、加拿大安大略省渥太华市、加拿大安大略省多伦多市及加拿大不列颠哥伦比亚省温哥华市。

<u style="font-weight: bold;">研究设计</u>: ROC急诊登记库（Epistry）针对ROC区域内的所有院外创伤性损伤病例，收集事件特异性因素、受试者人口学信息、临床资料、院前干预措施与处置情况、医院信息及受试者结局的标准化数据。通过审阅应急响应系统记录（包括调度中心、地面急诊医疗服务机构及航空医疗服务的记录）识别病例。尽可能从现有数据库提取院外数据，并辅以针对性审阅急诊医疗服务报告。多数情况下，医院数据直接从医院档案中提取。研究站点通过基于网页的界面或批量上传提交数据（Newgard等，2008，[PMID: 18482792](https://pubmed.ncbi.nlm.nih.gov/18482792/)）。