Tavender Emma, Eapen Nitaa, Wang Junfeng, Rausa Vanessa C, Babl Franz E, Phillips Natalie
Emergency Research, Murdoch Children's Research Institute, Melbourne, Australia.
Departments of Paediatrics and Critical Care, University of Melbourne, Melbourne, Australia.
Cochrane Database Syst Rev. 2024 Mar 22;3(3):CD011686. doi: 10.1002/14651858.CD011686.pub3.
Paediatric cervical spine injury (CSI) after blunt trauma is rare but can have severe consequences. Clinical decision rules (CDRs) have been developed to guide clinical decision-making, minimise unnecessary tests and associated risks, whilst detecting all significant CSIs. Several validated CDRs are used to guide imaging decision-making in adults following blunt trauma and clinical criteria have been proposed as possible paediatric-specific CDRs. Little information is known about their accuracy.
To assess and compare the diagnostic accuracy of CDRs or sets of clinical criteria, alone or in comparison with each other, for the evaluation of CSI following blunt trauma in children.
For this update, we searched CENTRAL, MEDLINE, Embase, and six other databases from 1 January 2015 to 13 December 2022. As we expanded the index test eligibility for this review update, we searched the excluded studies from the previous version of the review for eligibility. We contacted field experts to identify ongoing studies and studies potentially missed by the search. There were no language restrictions.
We included cross-sectional or cohort designs (retrospective and prospective) and randomised controlled trials that compared the diagnostic accuracy of any CDR or clinical criteria compared with a reference standard for the evaluation of paediatric CSI following blunt trauma. We included studies evaluating one CDR or comparing two or more CDRs (directly and indirectly). We considered X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) of the cervical spine, and clinical clearance/follow-up as adequate reference standards.
Two review authors independently screened titles and abstracts for relevance, and carried out eligibility, data extraction and quality assessment. A third review author arbitrated. We extracted data on study design, participant characteristics, inclusion/exclusion criteria, index test, target condition, reference standard and data (diagnostic two-by-two tables) and calculated and plotted sensitivity and specificity on forest plots for visual examination of variation in test accuracy. We assessed methodological quality using the Quality Assessment of Diagnostic Accuracy Studies Version 2 tool. We graded the certainty of the evidence using the GRADE approach.
We included five studies with 21,379 enrolled participants, published between 2001 and 2021. Prevalence of CSI ranged from 0.5% to 1.85%. Seven CDRs were evaluated. Three studies reported on direct comparisons of CDRs. One study (973 participants) directly compared the accuracy of three index tests with the sensitivities of NEXUS, Canadian C-Spine Rule and the PECARN retrospective criteria being 1.00 (95% confidence interval (CI) 0.48 to 1.00), 1.00 (95% CI 0.48 to 1.00) and 1.00 (95% CI 0.48 to 1.00), respectively. The specificities were 0.56 (95% CI 0.53 to 0.59), 0.52 (95% CI 0.49 to 0.55) and 0.32 (95% CI 0.29 to 0.35), respectively (moderate-certainty evidence). One study (4091 participants) compared the accuracy of the PECARN retrospective criteria with the Leonard de novo model; the sensitivities were 0.91 (95% CI 0.81 to 0.96) and 0.92 (95% CI 0.83 to 0.97), respectively. The specificities were 0.46 (95% CI 0.44 to 0.47) and 0.50 (95% CI 0.49 to 0.52) (moderate- and low-certainty evidence, respectively). One study (270 participants) compared the accuracy of two NICE (National Institute for Health and Care Excellence) head injury guidelines; the sensitivity of the CG56 guideline was 1.00 (95% CI 0.48 to 1.00) compared to 1.00 (95% CI 0.48 to 1.00) with the CG176 guideline. The specificities were 0.46 (95% CI 0.40 to 0.52) and 0.07 (95% CI 0.04 to 0.11), respectively (very low-certainty evidence). Two additional studies were indirect comparison studies. One study (3065 participants) tested the accuracy of the NEXUS criteria; the sensitivity was 1.00 (95% CI 0.88 to 1.00) and specificity was 0.20 (95% CI 0.18 to 0.21) (low-certainty evidence). One retrospective study (12,537 participants) evaluated the PEDSPINE criteria and found a sensitivity of 0.93 (95% CI 0.78 to 0.99) and specificity of 0.70 (95% CI 0.69 to 0.72) (very low-certainty evidence). We did not pool data within the broader CDR categories or investigate heterogeneity due to the small quantity of data and the clinical heterogeneity of studies. Two studies were at high risk of bias. We identified two studies that are awaiting classification pending further information and two ongoing studies.
AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the diagnostic test accuracy of CDRs to detect CSIs in children following blunt trauma, particularly for children under eight years of age. Although most studies had a high sensitivity, this was often achieved at the expense of low specificity and should be interpreted with caution due to a small number of CSIs and wide CIs. Well-designed, large studies are required to evaluate the accuracy of CDRs for the cervical spine clearance in children following blunt trauma, ideally in direct comparison with each other.
钝性创伤后小儿颈椎损伤（CSI）虽罕见，但后果严重。临床决策规则（CDR）已被制定用于指导临床决策，尽量减少不必要的检查及相关风险，同时检测出所有严重的 CSI。已有多个经过验证的 CDR 用于指导成人钝性创伤后的影像学决策，并且已提出一些临床标准作为可能的儿科特异性 CDR。关于其准确性的信息知之甚少。
评估和比较 CDR 或临床标准集单独或相互比较时，对评估儿童钝性创伤后 CSI 的诊断准确性。
本次更新中，我们检索了 CENTRAL、MEDLINE、Embase 以及其他六个数据库，检索时间为 2015 年 1 月 1 日至 2022 年 12 月 13 日。由于我们扩大了本次综述更新的索引测试纳入标准，我们检索了上一版综述中排除的研究以确定其是否符合纳入标准。我们联系了领域专家以识别正在进行的研究以及检索可能遗漏的研究。没有语言限制。
我们纳入了横断面或队列设计（回顾性和前瞻性）以及随机对照试验，这些研究比较了任何 CDR 或临床标准与评估小儿钝性创伤后 CSI 的参考标准的诊断准确性。我们纳入了评估一个 CDR 或比较两个或更多 CDR（直接和间接）的研究。我们将颈椎的 X 线、计算机断层扫描（CT）或磁共振成像（MRI）以及临床排除/随访视为适当的参考标准。
两位综述作者独立筛选标题和摘要以确定相关性，并进行纳入标准、数据提取和质量评估。第三位综述作者进行仲裁。我们提取了关于研究设计、参与者特征、纳入/排除标准、索引测试、目标疾病、参考标准和数据（诊断四格表）的数据，并计算并在森林图上绘制敏感性和特异性，以直观检查测试准确性的差异。我们使用诊断准确性研究质量评估版本 2 工具评估方法学质量。我们使用 GRADE 方法对证据的确定性进行分级。
我们纳入了五项研究，共 21379 名参与者，发表时间为 2001 年至 2021 年。CSI 的患病率在 0.5%至 1.85%之间。评估了七个 CDR。三项研究报告了 CDR 的直接比较。一项研究（973 名参与者）直接比较了三项索引测试的准确性，NEXUS、加拿大颈椎规则和 PECARN 回顾性标准的敏感性分别为 1.00（95%置信区间（CI）0.48 至 1.00）、1.00（95%CI 0.48 至 1.00）和 1.00（95%CI 0.48 至 1.00）。特异性分别为 0.56（95%CI 0.53 至 0.59）、0.52（95%CI 0.49 至 0.55）和 0.32（95%CI 0.29 至 0.35）（中等确定性证据）。一项研究（4091 名参与者）比较了 PECARN 回顾性标准与 Leonard 从头模型的准确性；敏感性分别为 0.91（95%CI 0.81 至 0.96）和 0.92（95%CI 0.83 至 0.97）。特异性分别为 0.46（95%CI 0.44 至 0.47）和 0.50（95%CI 0.49 至 0.52）（分别为中等和低确定性证据）。一项研究（270 名参与者）比较了两项英国国家卫生与临床优化研究所（NICE）头部损伤指南的准确性；CG56 指南的敏感性为 1.00（95%CI 0.48 至 1.00），而 CG176 指南的敏感性为 1.00（95%CI 0.48 至 1.00）。特异性分别为 0.46（95%CI 0.40 至 0.52）和 0.07（95%CI 0.04 至 0.11）（非常低确定性证据）。另外两项研究为间接比较研究。一项研究（3065 名参与者）测试了 NEXUS 标准的准确性；敏感性为 1.00（95%CI 0.88 至 1.00），特异性为 0.20（95%CI 0.18 至 0.21）（低确定性证据）。一项回顾性研究（12537 名参与者）评估了 PEDSPINE 标准，发现敏感性为 0.93（95%CI 0.78 至 0.99），特异性为 0.70（95%CI 0.69 至 0.72）（非常低确定性证据）。我们未在更广泛的 CDR 类别内汇总数据，也未因数据量少和研究的临床异质性而调查异质性。两项研究存在高偏倚风险。我们确定两项研究在等待进一步信息以进行分类，还有两项正在进行的研究。
没有足够的证据来确定 CDR 检测儿童钝性创伤后 CSI 的诊断测试准确性，特别是对于八岁以下的儿童。尽管大多数研究具有较高的敏感性，但这通常是以低特异性为代价实现的，并且由于 CSI 数量少和置信区间宽，应谨慎解释。需要设计良好的大型研究来评估 CDR 对儿童钝性创伤后颈椎排除的准确性，理想情况下应相互直接比较。
