Assessment of skin pigmentation-related bias in pulse oximetry readings among adults.
Assessment of skin pigmentation-related bias in pulse oximetry readings among adults.
复制标题
评估成人脉搏血氧饱和度读数中与皮肤色素沉着相关的偏差。
DOI：
10.1007/s10877-023-01095-1
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发表时间：
2024
影响因子：
2.2
通讯作者：
Yapici,HalitO
中科院分区：
文献类型：
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作者：
Khanna,AshishK;Beard,John;Lamminmäki,Sakari;Närväinen,Johanna;Antaki,Nicholas;Yapici,HalitO
目的：最近有报道称，脉搏血氧仪可能会高估肤色较深的个体的血氧饱和度，这引起了监管机构对种族偏见的关注。我们调查了TruSignal SpO 2传感器（通用电气医疗，赫尔辛基，芬兰）在成人不同的皮肤pigmentation.MethodsA回顾性研究的性能进行了使用一组汇总评估SpO 2/SaO 2测量从9项研究，以评估偏见，准确性（武器），和精度TruSignal传感器在健康成人诱导缺氧。根据血氧饱和度水平进行亚组分析（1带≥ 70且≤ 80%，2带> 80且≤ 90%;结果在131名个体的10 800个数据点中，分别有8 202个（75 9%）和2 598个（24 1%）被分配到亮色素组和暗色素组。总体偏倚为0.14%，氧合带间偏倚小于1%。在SpO 2 ≥ 70和≤ 80%的低氧带，深色和浅色色素组之间的偏倚差异具有统计学显著性（分别为+ 0.58%和+ 0.30%; p = 0.0035）。在整个饱和度范围内，Arms在浅色组中为1.64%，在深色组中为1.71%，均在器械规格和法规要求范围内。氧合是逐步方差分析模型中的主导因素。混合模型还表明，偏见是强烈的影响，由oxygenationrange.ConclusionTruSignal传感器表现出较高的偏见，在较低的氧饱和度，色素组之间的差异小于0.5%。这些发现提出了新的问题，例如如何在具有挑战性的临床条件下改善脉搏血氧测量，包括低灌注。
PurposeRecent reports that pulse oximeters may overestimate oxygen saturation in individuals with darker skin pigmentation have prompted concerns from regulatory authorities regarding racial bias. We investigated the performance of TruSignal SpO2 sensors (GE Healthcare, Helsinki, Finland) in adults with varying skin pigmentation.MethodsA retrospective study was conducted using a set of pooled assessments of SpO2/SaO2 measurements from nine studies to assess bias, accuracy (Arms), and precision of TruSignal sensors in healthy adults under induced hypoxia. Subgroup analyses were performed based on oxygen saturation levels (band 1, ≥ 70 and ≤ 80%; band 2, > 80 and ≤ 90%; band 3, > 90 and ≤ 100%).ResultsOf the 10,800 data points from 131 individuals, 8,202 (75.9%) and 2,598 (24.1%) were assigned to the light and dark pigment groups, respectively. Bias was 0.14% overall and less than 1% across oxygenation bands. The difference in bias between dark and light pigment groups was statistically significant at the low oxygenation band with SpO2 ≥ 70 and ≤ 80% (+ 0.58% and + 0.30% respectively; p = 0.0035). Throughout the saturation range, Armswas 1.64% in the light and 1.71% in the dark pigment group, within device specifications and regulatory requirements. Oxygenation was the dominating factor in stepwise ANOVA modeling. The mixed model also showed that bias was strongly affected by the oxygenation range.ConclusionTruSignal sensors demonstrated higher bias at lower oxygen saturation, with less than 0.5% difference between pigment groups. These findings raise new questions, such as ways to improve pulse oximetry measurements during challenging clinical conditions, including low perfusion.