一项旨在减少儿科重症监护环境中虐待性头部创伤漏诊的整群随机试验。
A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings.
机构信息
Department of Pediatrics, Penn State College of Medicine, Penn State Health Children's Hospital, Hershey, PA.
University of Texas Health Sciences Center at San Antonio, San Antonio, TX.
出版信息
J Pediatr. 2021 Sep;236:260-268.e3. doi: 10.1016/j.jpeds.2021.03.055. Epub 2021 Mar 31.
OBJECTIVE
To estimate the impact of the PediBIRN (Pediatric Brain Injury Research Network) 4-variable clinical decision rule (CDR) on abuse evaluations and missed abusive head trauma in pediatric intensive care settings.
STUDY DESIGN
This was a cluster randomized trial. Participants included 8 pediatric intensive care units (PICUs) in US academic medical centers; PICU and child abuse physicians; and consecutive patients with acute head injures <3 years (n = 183 and n = 237, intervention vs control). PICUs were stratified by patient volumes, pair-matched, and randomized equally to intervention or control conditions. Randomization was concealed from the biostatistician. Physician-directed, cluster-level interventions included initial and booster training, access to an abusive head trauma probability calculator, and information sessions. Outcomes included "higher risk" patients evaluated thoroughly for abuse (with skeletal survey and retinal examination), potential cases of missed abusive head trauma (patients lacking either evaluation), and estimates of missed abusive head trauma (among potential cases). Group comparisons were performed using generalized linear mixed-effects models.
RESULTS
Intervention physicians evaluated a greater proportion of higher risk patients thoroughly (81% vs 73%, P = .11) and had fewer potential cases of missed abusive head trauma (21% vs 32%, P = .05), although estimated cases of missed abusive head trauma did not differ (7% vs 13%, P = .22). From baseline (in previous studies) to trial, the change in higher risk patients evaluated thoroughly (67%→81% vs 78%→73%, P = .01), and potential cases of missed abusive head trauma (40%→21% vs 29%→32%, P = .003), diverged significantly. We did not identify a significant divergence in the number of estimated cases of missed abusive head trauma (15%→7% vs 11%→13%, P = .22).
CONCLUSIONS
PediBIRN-4 CDR application facilitated changes in abuse evaluations that reduced potential cases of missed abusive head trauma in PICU settings.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03162354.
目的
评估 PediBIRN（儿科脑损伤研究网络）4 变量临床决策规则（CDR）对儿科重症监护环境中虐待评估和漏诊虐待性头部创伤的影响。
研究设计
这是一项聚类随机试验。参与者包括美国学术医疗中心的 8 个儿科重症监护病房（PICU）；PICU 和儿童虐待医生；以及连续患有急性头部损伤<3 岁的患者（干预组 n=183，对照组 n=237）。根据患者数量对 PICU 进行分层，配对匹配，然后平均随机分为干预组或对照组。对生物统计学家隐瞒了随机化。以医生为导向的、集群级别的干预措施包括初始和强化培训、获得虐待性头部创伤概率计算器的使用权，以及信息会议。结果包括对“高风险”患者进行全面的虐待评估（进行骨骼检查和视网膜检查）、潜在的漏诊虐待性头部创伤病例（缺乏任何一种评估的患者），以及漏诊虐待性头部创伤的估计（在潜在病例中）。使用广义线性混合效应模型进行组间比较。
结果
干预组医生更全面地评估了更大比例的高风险患者（81% vs 73%，P=.11），并且潜在的漏诊虐待性头部创伤病例较少（21% vs 32%，P=.05），尽管漏诊虐待性头部创伤的病例估计数没有差异（7% vs 13%，P=.22）。从基线（之前的研究）到试验，全面评估的高风险患者人数发生了显著变化（67%→81% vs 78%→73%，P=.01），潜在的漏诊虐待性头部创伤病例数也发生了显著变化（40%→21% vs 29%→32%，P=.003）。我们没有发现漏诊虐待性头部创伤的估计病例数（15%→7% vs 11%→13%，P=.22）有显著差异。
结论
PediBIRN-4 CDR 的应用促进了虐待评估的改变，减少了儿科重症监护环境中潜在的漏诊虐待性头部创伤病例。
试验注册
ClinicalTrials.gov：NCT03162354。
Zotero 插件