Umana Etimbuk, Mills Clare, Norman-Bruce Hannah, Mitchell Hannah, McFetridge Lisa, Lynn Fiona, McKeeman Gareth, Foster Steven, Barrett Michael J, Roland Damian, Lyttle Mark D, Watson Chris, Waterfield Thomas
Wellcome Wolfson Institute of Experimental Medicine, Queen's University Belfast, Belfast, UK.
Mathematical Sciences Research Centre, Queen's University Belfast, Belfast, UK.
EClinicalMedicine. 2024 Nov 27;78:102961. doi: 10.1016/j.eclinm.2024.102961. eCollection 2024 Dec.
Between 1% and 4% of febrile infants, aged from birth to 90 days of age, presenting to hospital will be diagnosed with an invasive bacterial infection (IBI). Traditional teaching has advocated a treat all approach but more recently a number of clinical decision aids (CDA) have been developed to classify febrile infants into lower and higher risk cohorts, with lower risk infants suitable for management without immediate parenteral antibiotics and lumbar puncture. The aim of this study was to apply these CDA to a UK and Irish cohort.
This was a prospective multicentre cohort study of febrile infants presenting to 35 Paediatric Emergency Research in the UK and Ireland (PERUKI) sites between the 6th July 2022 and the 31st August 2023. All infants received standard care as per local policy. IBI was defined as growth of bacterial pathogen in blood or cerebrospinal fluid. The performance of the following CDAs were assessed, National Institute for Health and Care Excellence (NICE) guidelines NG143 (Fever under 5 years), British Society Antimicrobial Chemotherapy (BSAC), Aronson rule and American Academy of Pediatrics (AAP) CDA. A cost comparison of each CDA against a treat all approach was conducted. Trial registration: NCT05259683.
1821 were included in the final analysis. The median age was 46 days (IQR: 30-64 days), with 1108 (61%) being male. Of the 1821 infants, 67 (3.7%) had IBI. The AAP and BSAC CDAs were the most sensitive at 0.99 (95% CI 0.92-1.0) for both with specificities of 0.23 (95% CI 0.21-0.25) and 0.20 (95% CI 0.18-0.22) respectively. The NICE NG143 and Aronson CDA were the most specific CDAs with values of 0.27 (95% CI 0.25-0.30) and 0.30 (95% CI 0.28-0.32) respectively, but their sensitivity was lower. The AAP CDA performed equally well with either procalcitonin (PCT) or C-reactive protein (CRP) as the biomarker of choice. Of the 1821 infants, 77% were admitted, 14% were discharged and 9% were ambulated. All CDAs were cost saving for hospital services when compared to a treat all approach, with the lowest mean cost per patient estimated for Aronson (£1171; bootstrap 95% CI £1129-£1214) and NICE NG143 CDA (£1218; bootstrap 95% CI £1174-£1263).
The AAP and BSAC CDAs are highly sensitive at excluding IBI, with a cost saving to hospital services when compared to a treat all approach. The substitution of CRP for PCT made no difference to the performance of the AAP CDA in this cohort and was more costly.
The Febrile Infant Diagnostic Assessment and Outcome (FIDO) study is funded by Royal College of Emergency Medicine Doctoral Fellowship (RCEM 02/03/2021). Procalcitonin analysis was supported by the Public Health Agency Northen Ireland Grant (HSC R&D-COM/5745/22). The funders played no part in the conception or design of this study.
在出生至90日龄的发热婴儿中,到医院就诊的患儿有1%至4%会被诊断为侵袭性细菌感染(IBI)。传统教学主张采用全面治疗的方法,但最近已开发出一些临床决策辅助工具(CDA),将发热婴儿分为低风险和高风险队列,低风险婴儿适合在不立即使用胃肠外抗生素和进行腰椎穿刺的情况下进行管理。本研究的目的是将这些CDA应用于英国和爱尔兰的队列。
这是一项前瞻性多中心队列研究,研究对象为2022年7月6日至2023年8月31日期间到英国和爱尔兰35个儿科急诊研究(PERUKI)站点就诊的发热婴儿。所有婴儿均按照当地政策接受标准护理。IBI定义为血液或脑脊液中细菌病原体的生长。评估了以下CDA的性能:英国国家卫生与临床优化研究所(NICE)指南NG143(5岁以下发热)、英国抗菌化疗协会(BSAC)、阿伦森规则和美国儿科学会(AAP)CDA。对每种CDA与全面治疗方法进行了成本比较。试验注册:NCT05259683。
1821例纳入最终分析。中位年龄为46天(四分位间距:30 - 64天),其中1108例(61%)为男性。在1821例婴儿中,67例(3.7%)患有IBI。AAP和BSAC CDA的敏感性最高,均为0.99(95%置信区间0.92 - 1.0),特异性分别为0.23(95%置信区间0.21 - 0.25)和0.20(95%置信区间0.18 - 0.22)。NICE NG143和阿伦森CDA是特异性最高的CDA,值分别为0.27(95%置信区间0.25 - 0.30)和0.30(95%置信区间0.28 - 0.32),但敏感性较低。AAP CDA以降钙素原(PCT)或C反应蛋白(CRP)作为首选生物标志物时表现同样良好。在1821例婴儿中,77%入院,14%出院,9%可走动。与全面治疗方法相比,所有CDA对医院服务而言均节省成本,阿伦森CDA估计的每位患者平均成本最低(1171英镑;自展95%置信区间1129 - 1214英镑),NICE NG143 CDA为1218英镑(自展95%置信区间1174 - 1263英镑)。
AAP和BSAC CDA在排除IBI方面具有高度敏感性,与全面治疗方法相比可节省医院服务成本。在该队列中,用CRP替代PCT对AAP CDA的性能无影响,且成本更高。
发热婴儿诊断评估与结果(FIDO)研究由皇家急诊医学院博士奖学金(RCEM 02/03/2021)资助。降钙素原分析得到北爱尔兰公共卫生机构资助(HSC R&D - COM/5745/22)。资助者未参与本研究的构思或设计。