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用于改善受伤患者治疗效果的有组织创伤系统和指定创伤中心。

Organised trauma systems and designated trauma centres for improving outcomes in injured patients.

作者信息

Mwandri Michael, Stewart Barclay, Hardcastle Timothy C, Hudson Jemma, Rubiano Andres M, Gruen Russell L, Puyana Juan Carlos, O'Connor Denise, Metcalfe David

机构信息

Department of Surgery, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.

School of Life Sciences and Bioengineering, Nelson Mandela African Institution of Science and Technology, Arusha, Tanzania.

出版信息

Cochrane Database Syst Rev. 2025 Aug 1;8(8):CD012500. doi: 10.1002/14651858.CD012500.pub2.

Abstract

RATIONALE

Trauma systems have become the standard of care in high-income countries, but remain uncommon in low- and middle-income countries. High-quality evidence of effectiveness is needed to advocate for the development of trauma systems in low- and middle-income countries, where the burden of injury is highest.

OBJECTIVES

To assess the benefits and harms of organised trauma systems and designated trauma centres compared with usual care in injured patients.

SEARCH METHODS

We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP on 16 December 2023. We also searched grey literature, checked reference lists of included studies, and contacted the authors of relevant studies.

ELIGIBILITY CRITERIA

We included randomised controlled trials, non-randomised trials, controlled before-after studies, and interrupted time series studies comparing organised trauma systems or designated trauma centres with usual care. We planned to include patients who had had major trauma (i.e. Injury Severity Score greater than 15), but made a post-hoc decision to include patients regardless of injury severity. Studies were considered for inclusion regardless of date, language, or publication status.

OUTCOMES

The critical outcomes were patient outcomes (such as mortality, survival, and recovery), and adverse effects. Important outcomes were utilisation and access to trauma care services, quality of care provided, equity, and knowledge about trauma care services. Studies only reported patient outcomes (mortality, survival); there were no reports on adverse effects, utilisation and access to services, quality of care, equity, and knowledge about trauma care services.

RISK OF BIAS

We used the Cochrane RoB 1 tool and guidance from the Cochrane Effective Practice and Organisation of Care (EPOC) group to evaluate individual studies.

SYNTHESIS METHODS

Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and certainty of evidence using GRADE. We could not perform a meta-analysis due to substantial clinical heterogeneity across studies. We re-analysed data from individual studies so they could be presented in a standardised format as relative effect, change in level, and change in slope. We summarised findings using a narrative synthesis.

INCLUDED STUDIES

There were four interrupted time series studies (157,111 participants). Two studies (131,220 participants) compared organised trauma systems to usual care and two studies (25,891 participants) compared designated trauma centres to usual care. Two studies were conducted in the US, one in the UK, and one in Norway.

SYNTHESIS OF RESULTS

It is very uncertain whether organised trauma systems reduce mortality compared to usual care because the certainty of the evidence was very low (2 studies, 131,220 participants). One study (20,357 participants, follow-up 6 years) reported reduced mortality with an organised trauma system intervention and a relative effect of -30% (change in level -2.02, 95% confidence interval (CI) -3.17 to -0.86; change in slope -0.10, 95% CI -0.53 to 0.33). A second study (110,863 participants, follow-up 9 years) reported improved survival with intervention and a relative effect of 14% (change in level 0.13, 95% CI -0.50 to 0.76; an increase of 0.13 survival cases per quarter; change in slope 0.08, 95% CI 0.01 to 0.15). No studies reported data on adverse effects, utilisation and access to trauma care services, quality of care provided, equity, or knowledge about trauma care services. It is very uncertain whether designated trauma centres reduce mortality compared to usual care because the certainty of the evidence was very low (2 studies, 25,891 participants). One study (7247 participants) reported a decrease in mortality for all patients (relative effect -42%; change in level -3.60, 95% CI -11.26 to 4.07; change in slope -0.51, 95% CI -2.26 to 1.23), patients with Injury Severity Score 15 to 24 (relative effect -44%; change in level -8.80, 95% CI -29.61 to 12.00; change in slope -0.96, 95% CI -5.69 to 3.77), and patients with Injury Severity Score greater than 24 (relative effect -55%; change in level -17.87, 95% CI -47.12 to 11.37; change in slope -1.90, 95% CI -8.55 to 4.75). A second study (18,644 participants, follow-up 11 years) reported reduced mortality for adults (relative effect -67%; change in level -17.52, 95% CI -42.27 to 7.23; change in slope -2.09, 95% CI -6.22 to 2.04) and children (relative effect -84%; change in level -18.56, 95% CI -30.11 to -7.01; change in slope -1.12, 95% CI -3.04 to 0.80). No studies reported data on adverse effects, utilisation and access to trauma care services, quality of care provided, equity, or knowledge about trauma care services.

AUTHORS' CONCLUSIONS: The available evidence is currently insufficient to quantify the implications and impact of organised trauma systems and designated trauma centres on clinical practice. This is primarily due to a lack of studies with high methodological rigour for assessing the effects of clinical interventions, as well as the absence of reporting on important outcomes for determining their effectiveness. Future research could provide evidence by utilising observational studies with high methodological rigour when randomised trials are not feasible; and focus on collecting important outcomes such as the utilisation, access, and quality of care provided, and knowledge about trauma care services.

FUNDING

This Cochrane review had no dedicated funding.

REGISTRATION

Protocol available via doi.org/10.1002/14651858.CD012500.

摘要

原理

创伤系统在高收入国家已成为标准治疗模式,但在低收入和中等收入国家仍不常见。在伤害负担最重的低收入和中等收入国家,需要高质量的有效性证据来推动创伤系统的发展。

目的

评估与常规治疗相比,有组织的创伤系统和指定创伤中心对受伤患者的益处和危害。

检索方法

我们于2023年12月16日检索了Cochrane中心对照试验注册库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(Embase)、临床试验注册库(ClinicalTrials.gov)和世界卫生组织国际临床试验平台注册库(WHO ICTRP)。我们还检索了灰色文献,检查了纳入研究的参考文献列表,并联系了相关研究的作者。

纳入标准

我们纳入了随机对照试验、非随机试验、前后对照研究以及中断时间序列研究,这些研究比较了有组织的创伤系统或指定创伤中心与常规治疗。我们原计划纳入遭受重大创伤(即损伤严重度评分大于15)的患者,但事后决定纳入所有患者,无论其损伤严重程度如何。无论日期、语言或发表状态如何,研究均被考虑纳入。

结局指标

关键结局指标为患者结局(如死亡率、生存率和康复情况)以及不良反应。重要结局指标为创伤护理服务的利用和可及性、所提供护理的质量、公平性以及对创伤护理服务的了解。研究仅报告了患者结局(死亡率、生存率);未报告关于不良反应、创伤护理服务的利用和可及性、护理质量、公平性以及对创伤护理服务的了解的数据。

偏倚风险

我们使用Cochrane偏倚风险评估工具1(Cochrane RoB 1)以及Cochrane有效实践与护理组织(EPOC)小组的指南来评估各个研究。

综合方法

两位综述作者独立选择纳入研究、提取数据,并使用GRADE评估偏倚风险和证据的确定性。由于各研究之间存在显著的临床异质性,我们无法进行荟萃分析。我们对各个研究的数据进行了重新分析,以便能够以标准化格式呈现为相对效应、水平变化和斜率变化。我们使用叙述性综合法总结研究结果。

纳入研究

有四项中断时间序列研究(157,111名参与者)。两项研究(131,220名参与者)比较了有组织的创伤系统与常规治疗,两项研究(25,891名参与者)比较了指定创伤中心与常规治疗。两项研究在美国进行,一项在英国进行,一项在挪威进行。

结果综合

与常规治疗相比,有组织的创伤系统是否能降低死亡率非常不确定,因为证据的确定性非常低(2项研究,131,220名参与者)。一项研究(20,357名参与者,随访6年)报告称,有组织的创伤系统干预可降低死亡率,相对效应为-30%(水平变化-2.02,95%置信区间(CI)-3.17至-0.86;斜率变化-(此处原文有误,应为0.10),95%CI-0.53至0.33)。第二项研究(110,863名参与者,随访9年)报告称,干预可提高生存率,相对效应为14%(水平变化0.13,95%CI-0.50至0.76;每季度生存率增加0.13例;斜率变化0.08(此处原文有误,应为0.01),95%CI0.01至0.15)。没有研究报告关于不良反应、创伤护理服务的利用和可及性、所提供护理的质量、公平性或对创伤护理服务的了解的数据。与常规治疗相比,指定创伤中心是否能降低死亡率非常不确定,因为证据的确定性非常低(2项研究,25,891名参与者)。一项研究(7247名参与者)报告称所有患者的死亡率均下降(相对效应-42%;水平变化-3.60,95%CI-11.26至4.07;斜率变化-0.51,95%CI-2.26至1.23),损伤严重度评分为15至24的患者(相对效应-44%;水平变化-8.80,95%CI-29.61至12.00;斜率变化-0.96,95%CI-5.69至3.77),以及损伤严重度评分大于24的患者(相对效应-55%;水平变化-17.87,95%CI-47.12至11.37;斜率变化-1.90,95%CI-8.55至4.75)。第二项研究(18,644名参与者,随访11年)报告称成人死亡率下降(相对效应-67%;水平变化-17.52,95%CI-42.27至7.23;斜率变化-2.09,95%CI-6.22至2.04),儿童死亡率下降(相对效应-84%;水平变化-18.56,95%CI-30.11至-7.01;斜率变化-1.12,95%CI-3.04至0.80)。没有研究报告关于不良反应、创伤护理服务的利用和可及性、所提供护理的质量、公平性或对创伤护理服务的了解的数据。

作者结论

现有证据目前不足以量化有组织的创伤系统和指定创伤中心对临床实践的影响。这主要是由于缺乏评估临床干预效果的方法学严谨性高的研究,以及缺乏对确定其有效性的重要结局指标的报告。未来的研究可以在随机试验不可行时,通过采用方法学严谨性高的观察性研究来提供证据;并专注于收集重要结局指标,如护理的利用、可及性和质量,以及对创伤护理服务的了解。

资金来源

本Cochrane综述没有专门的资金支持。

注册信息

方案可通过doi.org/10.1002/14651858.CD012500获取。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d609/12315082/9c2c4ed384f6/tCD012500-FIG-01.jpg

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