PDF(Pubmed)
Abstract：
Advances in diagnostic microbiology allow for the rapid identification of a broad range of enteropathogens; such knowledge can inform care and reduce testing. We conducted a randomized, unblinded trial in a tertiary-care pediatric emergency department. Participants had stool (and rectal swabs if stool was not immediately available) tested using routine microbiologic approaches or by use of a device (BioFire FilmArray gastrointestinal panel), which identifies 22 pathogens with a 1-h instrument turnaround time. Participants were 6 months to <18.0 years and had acute bloody diarrhea. Primary outcome was performance of blood tests within 72 h. From 15 June 2018 through 7 May 2022, 60 children were randomized. Patients in the BioFire FilmArray arm had a reduced time to test result (median 3.0 h with interquartile range [IQR] of 3.0 to 4.0 h, versus 42.0 h (IQR 23.5 to 47.3 h); difference of -38.0 h, 95% confidence interval [CI] of -41.0 to -22.0 h). Sixty-five percent (20/31) of participants in the BioFire FilmArray group had a pathogen detected-most frequently enteropathogenic Escherichia coli (19%), Campylobacter (16%), and Salmonella (13%). Blood tests were performed in 52% of children in the BioFire FilmArray group and 62% in the standard-of-care group (difference of -10.5%, 95% CI of -35.4% to 14.5%). There were no between-group differences in the proportions of children administered intravenous fluids, antibiotics, hospitalized, or who had diagnostic imaging performed. Testing with the BioFire FilmArray reduced the time to result availability by 38 h. Although statistical significance was limited by study power, BioFire FilmArray use was not associated with clinically meaningful reductions in health care utilization or improved outcomes. IMPORTANCE Advances in diagnostic microbiology now allow for the faster and more accurate detection of an increasing number of pathogens. We determined, however, that in children with acute bloody diarrhea, these advances did not necessarily translate into improved clinical outcomes. While a greater number of pathogens was identified using a rapid turnaround multiplex stool diagnostic panel, with a reduction in the time to stool test result of over 1.5 days, this did not alter the practice of pediatric emergency medicine physicians, who continued to perform blood tests on a large proportion of children. While our conclusions may be limited by the relatively small sample size, targeted approaches that educate clinicians on the implementation of such technology into clinical care will be needed to optimize usage and maximize benefits.
摘要：
诊断微生物学的进步允许快速识别广泛的肠病原体；这些知识可以为护理提供信息并减少测试。我们做了一个随机的,在三级护理儿科急诊科进行的非盲试验。参与者使用常规微生物学方法或使用设备（BioFireFilmArray胃肠道面板）测试粪便（如果粪便不能立即可用，则为直肠拭子）。在1小时的仪器周转时间内识别出22种病原体。参与者在6个月至<18.0岁时出现急性血性腹泻。主要结果是72小时内的血液检查。从2018年6月15日至2022年5月7日，60名儿童被随机分配。BioFireFilmArray组患者的测试时间缩短(中位数3.0h,四分位距[IQR]为3.0至4.0h,与42.0小时(IQR23.5至47.3小时)；差异为-38.0小时，95%置信区间[CI]为-41.0至-22.0h)。BioFireFilmArray组的参与者中有65％（20/31）检测到病原体-最常见的是肠致病性大肠杆菌（19％），弯曲杆菌（16%），沙门氏菌（13%）。在BioFireFilmArray组中，有52％的儿童进行了血液检查，在标准护理组中，有62％的儿童进行了血液检查（差异为-10.5％，95%CI为-35.4%至14.5%）。儿童静脉输液的比例没有组间差异，抗生素,住院,或进行诊断成像的人。使用BioFireFilmArray进行的测试将结果可用时间缩短了38小时。尽管统计显著性受到研究能力的限制，BioFireFilmArray的使用与临床上有意义的医疗保健利用率降低或预后改善无关。重要性诊断微生物学的进步现在允许更快，更准确地检测越来越多的病原体。我们决心,然而,在患有急性血性腹泻的儿童中，这些进展并不一定意味着临床结局的改善.虽然使用快速周转多重粪便诊断小组确定了更多的病原体，粪便测试结果的时间减少了1.5天以上，这并没有改变儿科急诊医生的做法，他们继续对大部分儿童进行血液检查。虽然我们的结论可能受到相对较小的样本量的限制，需要有针对性的方法来教育临床医生在临床护理中实施此类技术，以优化使用并最大化收益。
