PDF(Pubmed)
Abstract：
BACKGROUND: Injury is a global health concern, and injury-related mortality disproportionately impacts low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries shows that trauma education programs, such as the Rural Trauma Team Development Course (RTTDC), increase clinician knowledge of injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of the RTTDC on process and patient outcomes in LMICs.
OBJECTIVE: This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident-related injuries in an African low-resource setting.
METHODS: This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident-related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police.
RESULTS: The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024.
CONCLUSIONS: This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs.
BACKGROUND: Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763.
UNASSIGNED: DERR1-10.2196/55297.
OBJECTIVE: This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident-related injuries in an African low-resource setting.
METHODS: This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident-related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police.
RESULTS: The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024.
CONCLUSIONS: This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs.
BACKGROUND: Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763.
UNASSIGNED: DERR1-10.2196/55297.
摘要：
背景：伤害是一个全球性的健康问题，与伤害相关的死亡率对低收入和中等收入国家(LMICs)的影响不成比例。来自高收入国家的观察性研究的有力证据表明，创伤教育计划，例如农村创伤团队发展课程(RTTDC)，增加临床医生对损伤护理的认识。缺乏来自对照临床试验的此类证据来证明RTTDC对LMIC中的过程和患者结果的影响。
目的：这项多中心整群随机对照临床试验旨在研究RTTDC对非洲低资源环境中与摩托车事故相关伤害相关的过程和患者预后的影响。
方法：这是一个双臂，平行,多周期,集群随机化，控制,乌干达的临床试验，农村创伤团队发展培训不是常规进行的。我们将招募地区转诊医院,并包括与摩托车事故有关的受伤病人,实习生,医疗学员,和道路交通执法专业人员。干预组（RTTDC）和对照组（标准护理）各包括3家医院。主要结果将是从事故到入院的间隔以及从转诊决定到出院的间隔。次要结果将是损伤后90天与神经和骨科损伤相关的全因死亡率和发病率。所有结果将作为最终值进行测量。我们将比较干预组和对照组之间个体和集群水平的基线特征和结果。我们将使用混合效应回归模型来报告任何绝对或相对差异以及95%CI。我们将进行亚组分析，以评估和控制由于损伤机制和损伤严重程度造成的混淆。我们将与社区交警协商，建立摩托车创伤结果（MOTOR）注册表。
结果：该试验于2019年8月27日获得批准。第一位患者参与者的实际招募于2019年9月1日开始。最后一次随访是在2023年8月27日。审判后护理，包括与临床的联系，社会支持,和转介服务，将于2023年11月27日完成。数据分析将在2024年春季进行，结果预计将在2024年秋季发布。
结论：该试验将揭示在基础设施和人力资源有限的情况下，当地背景农村创伤团队发展计划如何影响组织效率。此外，该试验将揭示农村创伤团队协调如何影响临床结果，如与神经和骨科损伤相关的死亡率和发病率，这是在院前护理处于早期阶段的LMIC中加强创伤系统的关键目标。我们的结果可以为设计提供信息，实施，以及LMICs未来农村创伤团队和创伤教育计划的可扩展性。
背景：泛非临床试验注册（PACTR202308851460352）;https://pactr。Samrc.AC.za/TrialDisplay。aspx?试验ID=25763。
■DERR1-10.2196/55297。
目的：这项多中心整群随机对照临床试验旨在研究RTTDC对非洲低资源环境中与摩托车事故相关伤害相关的过程和患者预后的影响。
方法：这是一个双臂，平行,多周期,集群随机化，控制,乌干达的临床试验，农村创伤团队发展培训不是常规进行的。我们将招募地区转诊医院,并包括与摩托车事故有关的受伤病人,实习生,医疗学员,和道路交通执法专业人员。干预组（RTTDC）和对照组（标准护理）各包括3家医院。主要结果将是从事故到入院的间隔以及从转诊决定到出院的间隔。次要结果将是损伤后90天与神经和骨科损伤相关的全因死亡率和发病率。所有结果将作为最终值进行测量。我们将比较干预组和对照组之间个体和集群水平的基线特征和结果。我们将使用混合效应回归模型来报告任何绝对或相对差异以及95%CI。我们将进行亚组分析，以评估和控制由于损伤机制和损伤严重程度造成的混淆。我们将与社区交警协商，建立摩托车创伤结果（MOTOR）注册表。
结果：该试验于2019年8月27日获得批准。第一位患者参与者的实际招募于2019年9月1日开始。最后一次随访是在2023年8月27日。审判后护理，包括与临床的联系，社会支持,和转介服务，将于2023年11月27日完成。数据分析将在2024年春季进行，结果预计将在2024年秋季发布。
结论：该试验将揭示在基础设施和人力资源有限的情况下，当地背景农村创伤团队发展计划如何影响组织效率。此外，该试验将揭示农村创伤团队协调如何影响临床结果，如与神经和骨科损伤相关的死亡率和发病率，这是在院前护理处于早期阶段的LMIC中加强创伤系统的关键目标。我们的结果可以为设计提供信息，实施，以及LMICs未来农村创伤团队和创伤教育计划的可扩展性。
背景：泛非临床试验注册（PACTR202308851460352）;https://pactr。Samrc.AC.za/TrialDisplay。aspx?试验ID=25763。
■DERR1-10.2196/55297。
