不同条件对智能手机软件拍照估算新生儿胆红素值准确性的影响

Influences on accuracy of automated image-based estimation of neonatal serum bilirubin level using smartphone application under different circumstances

目的研究不同条件对智能手机软件自动拍照估算胆红素(automated image-based bilirubin, AIB)准确性的影响。 方法本研究为前瞻性研究。选择2017年8月至12月东南大学附属徐州医院新生儿科收治的黄疸新生儿179例。当新生儿因病情需要采血检测血清总胆红素(total serum bilirubin, TSB)时,同时测定前胸(36例患儿同时对照测定眉心及目测最黄部位)经皮胆红素(transcutaneous bilirubin, TcB)和AIB。采用OPPO R11智能手机(55例患儿同时对照采用华为Mate 8及iPhone 6),安装新生儿黄疸移动监护软件进行AIB检测。分析AIB与TcB相比的准确性及非劣性、AIB与TSB的相关性及一致性,以及AIB预测TSB的价值。采用非劣效性检验、t检验、方差分析、相关性分析、Bland-Altman图一致性分析及受试者工作特性曲线进行统计学分析。 结果179例患儿的胎龄平均为(36.2±2.1)周,出生体重平均为(2 871±735)g。全部数据的AIB与TSB的差的绝对值(即|AIB-TSB|)与TcB与TSB的差的绝对值(即|TcB-TSB|)之差的均值为0.77 mg/dl(1 mg/dl=17.1 μmol/L),95%CI为0.60~0.95 mg/dl,AIB的准确性不劣于TcB。不同检测时龄、胎龄及检测时段为白天等亚组AIB的准确性也不劣于TcB;检测时段为晚间的亚组|AIB-TSB|与|TcB-TSB|之差的均值为1.47 mg/dl,95%CI为1.08~1.87 mg/dl,AIB的准确性劣于TcB。全部数据AIB与TSB有较好的相关性(r=0.788)和较强的一致性[96.4%(238/247)的样本落在95%的一致性区间(-4.75~5.71 mg/dl)内];不同手机、检测部位、检测时龄、胎龄等亚组AIB与TSB也有较好的相关性及较强的一致性;检测时段为白天时AIB与TSB的相关性(r=0.924)、一致性(98.4%)均明显好于晚间(r=0.727、一致性为87.5%)。目测值与TSB的差的绝对值(即|目测值-TSB|)与|AIB-TSB|之差的均值为2.13 mg/dl,95%CI为1.68~2.58 mg/dl,即AIB的准确性显著好于目测值。AIB预测TSB>10、>15、>20 mg/dl的受试者工作特性曲线下面积分别是0.94、0.89和0.84,敏感性分别为93%、75%和50%,特异性分别为85%、87%和88%。 结论AIB的准确性不劣于TcB,显著好于目测。AIB与TSB相关性较好、一致性很强。不同检测时龄、胎龄、手机、部位等条件对AIB准确性、AIB与TSB相关性及一致性影响不大。但晚间检测对AIB影响较大,建议最好在"白天明亮的自然光线环境中"检测AIB。

ObjectiveTo study the influence factors on the accuracy of a smartphone software application (APP), which is an automated image-based bilirubin (AIB) testing technique for neonatal bilirubin. MethodsThis was a prospective study involving 179 jaundiced neonates admitted to the Department of Neonatology of the Affiliated Xuzhou Hospital of Southeast University from August to December, 2017. If blood sampling was required to determine total serum bilirubin (TSB), the transcutaneous bilirubin (TcB) and AIB on the sternum (glabella or the visible darkest yellow area were tested in 36 cases at the same time) were also tested. The concentrations of AIB were measured using a mobile phone-based neonatal jaundice monitoring APP with images taken by OPPO R11 smartphone (55 cases were also taken by Huawei Mate 8 and iPhone 6). The accuracy and non-inferiority of AIB comparing with TcB, the correlation and consistency between AIB and TSB and the value of AIB in predicting TSB were analyzed. Non-inferiority trial, student's t test, variance analysis, Pearson's correlation analysis, Bland-Altman plots and receiver operating characteristic (ROC) curve were used as statistical methods. ResultsA total of 179 neonates were enrolled in this study with the mean gestational age of (36.2±2.1) weeks and the mean birth weight of (2 871±735) g. Based on all data, the mean difference between the absolute value of AIB minus TSB (|AIB-TSB|) and the absolute value of TcB minus TSB (|TcB-TSB|) was 0.77 mg/dl (1 mg/dl=17.1 μmol/L) with the 95%CI of (0.60-0.95) mg/dl, suggesting that the accuracy of AIB was not inferior to that of the TcB. Furthermore, AIB was not inferior to TcB in its accuracy in different subgroups based upon the time after birth (≤48 h and >48 h), gestational age (≤35 weeks and >35 weeks) and in the daytime subgroup. In the nighttime subgroup, the mean difference between∣AIB-TSB∣and∣TcB-TSB∣was 1.47 mg/dl [95%CI:(1.08-1.87) mg/dl], which indicated that the accuracy of AIB was inferior to that of the TcB. There were good correlation (r=0.788) and highly consistency between AIB and TSB based on all data [96.4%(238/247) of the samples were within the 95% limits of agreement of (-4.75 to 5.71) mg/dl]. Such results were also found in different subgroups, such as smartphone brands, detection areas, the time after birth and gestational age. The correlation and consistency between AIB and TSB in daytime subgroup (r=0.924, 98.4%) were obviously stronger than those of the nighttime subgroup (r=0.727, 87.5%). The mean difference between the absolute value of ocular value minus TSB (|ocular value-TSB|) and |AIB-TSB| was 2.13 mg/dl [95%CI:(1.68-2.58) mg/dl], implying a superior accuracy of AIB than ocular estimation. The areas under the ROC curves, the sensitivity and the specificity of AIB for the prediction of TSB >10,>15 and >20 mg/dl were 0.94, 93% and 85%;0.89, 75% and 87%;and 0.84, 50% and 88%, respectively. ConclusionsAIB is not inferior to TcB in accuracy, and is significantly superior to ocular estimation. There are good correlation and strong consistency between AIB and TSB. The accuracy of AIB, and the correlation and consistency between AIB and TSB are less likely to be affected by the time after birth, gestational age, smartphone brands and areas being examined, but are largely affected when examining during nighttime. Therefore, it is recommended to detect AIB at daytime with bright natural light.