Department of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky.
Tufts Clinical and Translational Science Institute, Boston, Massachusetts.
JAMA Netw Open. 2020 Apr 1;3(4):e202275. doi: 10.1001/jamanetworkopen.2020.2275.
Observer-rated scales, such as the Finnegan Neonatal Abstinence Scoring Tool (FNAST), are used to quantify the severity of neonatal abstinence syndrome (NAS) and guide pharmacologic therapy. The FNAST, a comprehensive 21-item assessment tool, was developed for research and subsequently integrated into clinical practice; a simpler tool, designed to account for clinically meaningful outcomes, is urgently needed to standardize assessment.
To identify FNAST items independently associated with the decision to use pharmacologic therapy and to simplify the FNAST while minimizing loss of information for the treatment decision.
DESIGN, SETTING, AND PARTICIPANTS: This multisite cohort study included 424 neonates with opioid exposure who had a gestational age of at least 36 weeks with follow-up from birth to hospital discharge in the derivation cohort and 109 neonates with opioid exposure from the Maternal Opioid Treatment: Human Experimental Research Study in the validation cohort. Neonates in the derivation cohort were included in a medical record review at the Universities of Louisville and Kentucky or in a randomized clinical trial and observational study conducted at Tufts University (2014-2018); the Maternal Opioid Treatment: Human Experimental Research was conducted from 2005 to 2008. Data analysis was conducted from May 2017 to August 2019.
Prenatal opioid exposure.
All FNAST items were dichotomized as present or not present, and logistic regression was used to identify binary items independently associated with pharmacologic treatment. The final model was validated with an independent cohort of neonates with opioid exposure.
Among 424 neonates (gestational age, ≥36 weeks; 217 [51%] female infants), convulsions were not observed, and high-pitched cry and hyperactive Moro reflex had extremely different frequencies across cohorts. Therefore, these 3 FNAST items were removed from further analysis. The 2 tremor items were combined, and 8 of the remaining 17 items were independently associated with pharmacologic treatment, with an area under the curve of 0.86 (95% CI, 0.82-0.89) compared with 0.90 (95% CI, 0.87-0.94) for the 21-item FNAST. External validation of the 8 items resulted in an area under the curve of 0.86 (95% CI, 0.79-0.93). Thresholds of 4 and 5 on the simplified scale yielded the closest agreement with FNAST thresholds of 8 and 12 (weighted κ = 0.55; 95% CI, 0.48-0.61).
The findings of this study suggest that 8 signs of NAS may be sufficient to assess whether a neonate meets criteria for pharmacologic therapy. A focus on these signs could simplify the FNAST tool and may enhance its clinical utility.
观察者评定量表,如 Finnegan 新生儿戒断评分工具(FNAST),用于量化新生儿戒断综合征(NAS)的严重程度,并指导药物治疗。FNAST 是一种全面的 21 项评估工具,专为研究而开发,随后整合到临床实践中;迫切需要一种更简单的工具来评估,该工具旨在考虑有临床意义的结果,以标准化评估。
确定与使用药物治疗决策独立相关的 FNAST 项目,并在最小化信息损失的情况下简化 FNAST,以便做出治疗决策。
设计、地点和参与者:这项多中心队列研究纳入了 424 名有阿片类药物暴露的新生儿,其胎龄至少为 36 周,并在推导队列中从出生到出院进行随访,在验证队列中有 109 名有阿片类药物暴露的新生儿。推导队列中的新生儿纳入了路易斯维尔大学和肯塔基大学的病历回顾或塔夫茨大学进行的随机临床试验和观察性研究(2014-2018 年);母体阿片类药物治疗:人体实验研究于 2005 年至 2008 年进行。数据分析于 2017 年 5 月至 2019 年 8 月进行。
产前阿片类药物暴露。
所有 FNAST 项目均分为存在或不存在,并使用逻辑回归来确定与药物治疗独立相关的二元项目。最终模型在一个有阿片类药物暴露的新生儿独立队列中进行了验证。
在 424 名新生儿(胎龄≥36 周;217[51%]名女婴)中,未观察到惊厥,高尖哭声和亢进的 Moro 反射在不同队列中的频率差异极大。因此,这些 3 个 FNAST 项目被排除在进一步分析之外。2 个震颤项目合并,其余 17 个项目中有 8 个与药物治疗独立相关,曲线下面积为 0.86(95%CI,0.82-0.89),而 21 个项目的 FNAST 为 0.90(95%CI,0.87-0.94)。对 8 个项目进行外部验证,曲线下面积为 0.86(95%CI,0.79-0.93)。简化量表的 4 分和 5 分与 FNAST 的 8 分和 12 分最接近(加权κ=0.55;95%CI,0.48-0.61)。
本研究结果表明,8 种 NAS 体征可能足以评估新生儿是否符合药物治疗标准。关注这些体征可以简化 FNAST 工具,并可能提高其临床实用性。