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中国循证儿科杂志

中国循证儿科杂志 ›› 2022, Vol. 17 ›› Issue (1): 44-48.

• 论著 • 上一篇    下一篇

儿童保健体检系统中嵌入孤独症谱系障碍筛查路径的诊断准确性研究

龚建梅1,苏雪云2,樊珏1,王兰1,朱琼1,王洁1,徐秀3   

  1. 1 上海市长宁区妇幼保健院上海，200051；2 华东师范大学上海，200062；  3 复旦大学附属儿科医院上海，201102
  • 收稿日期:2021-12-14 修回日期:2021-12-30 出版日期:2022-02-25 发布日期:2022-02-25
  • 通讯作者: 徐秀，王洁

Diagnostic accuracy of autism spectrum disorder screening pathway embedded in children's health physical examination system

GONG Jianmei1, SU Xueyun2, FAN Jue1, WANG Lan1, ZHU Qiong1, WANG Jie1,XU Xiu3   

  1. 1 Changning Maternity and Infant Health Hospital, Shanghai 200051, China; 2 East China Normal University, Shanghai 200062, China; 3 Children's Hospital of Fudan University,  Shanghai 201102, China
  • Received:2021-12-14 Revised:2021-12-30 Online:2022-02-25 Published:2022-02-25
  • Contact: XU Xiu,email:xuxiu@fudan.edu.cn；WANG Jie,email:1062172060@qq.com

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摘要： 背景：孤独症谱系障碍（ASD）早期筛查已成为共识，利用我国儿童保健体检系统筛查是否可行，筛查工具和路径均有待成熟。 目的：探索适合儿童保健体检系统ASD的早期筛查工具和路径。 设计：诊断准确性研究。 方法：在2018年8月1日至2020年10月31日上海市长宁区妇幼保健院18~36月龄儿童的常规体检中嵌入ASD筛查临床路径，以ASD诊断观察量表第2版（ADOS2）结合《精神障碍诊断统计手册》第5版（DSM5）为金标准，以改良版婴幼儿孤独症筛查量表（MCHATR）+MCHATR/F或2次行为观察（自定义）为待测标准，先行MCHATR初筛，阳性儿童行MCHATR/F复筛，阴性儿童经过2轮行为观察复筛；复筛阳性儿童或诊断或排除ASD，复筛阴性儿童在常规体检中询问诊断ASD后即记录到儿童保健体检系统中。初筛阳性未行复筛和复筛阳性者诊断信息未记录到儿童保健体检系统，视为失访不纳入分析。 主要结局指标：初筛和复筛ASD的约登指数。 结果：初筛10 635名，男童5 579名，平均月龄（22.3±2.9）月，女童5 056名，平均月龄（22.4±2.9）月。初筛阳性252名，失访38名（失访率15.1%）；MCHATR/F复筛阳性53名，失访13名（失访率24.5%），诊断ASD 26名；MCHATR/F复筛阴性161名，经常规体检询问诊断ASD 4名；初筛阴性10 383名，其中2018亚组（2018年8月1日至2019年9月30日）经常规体检询问诊断ASD 8名，2019亚组（2019年10月1日至2020年10月31日）行为观察复筛阴性经常规体检询问诊断ASD 3名；行为观察复筛阳性（n=54）再次行为观察复筛阳性33名，失访18名（失访率54.5%），诊断ASD 13名。总体筛查诊断ASD 54名，男童41名，平均月龄（26.2±5.9）月，女童13名，平均月龄（23.8±5.3）月。MCHATR初筛约登指数0.539，特异度98.4%，敏感度55.6%。在MCHATR初筛阳性的基础上，MCHATR/F复筛约登指数0.78，特异度91.3%，敏感度86.7%；在MCHATR初筛阴性的基础上，2轮的行为观察复筛约登指数081，特异度99.96%，敏感度81.2%。MCHATR 初筛阴性的2018亚组儿童在后续的常规体检通过询问诊断ASD 8名，诊断月龄（34.8±2.7）月；MCHATR 初筛阴性的2019亚组1轮行为观察阴性经后续常规体检询问诊断ASD 3名，诊断月龄（32.7±3.8）月，第2轮行为观察阳性诊断ASD 13名，诊断月龄（24.2±4.0）月，组间差异有统计学意义（F=22.809，P＜0.001），进一步两两比较差异也有统计学意义（P＜0.001，P=0.004）。 结论：在18~36月龄儿童的常规体检中嵌入ASD筛查路径可行，且筛查效能较好，在MCHATR初筛阴性儿童中进行行为观察复筛较初筛可提早10月诊断ASD。

关键词: 孤独症谱系障碍, 改良版婴幼儿孤独症筛查量表, 筛查, 行为观察, 特异度, 敏感度, 约登指数

Abstract: Background: Early screening for autism spectrum disorder (ASD) has become a consensus, but it is unclear whether the children's health physical examination system can be used for screening, and the screening tools and paths need to be explored further. Objective: To explore the path and tools of ASD early screening suitable for children's health physical examination system. Design: Diagnostic accuracy study. Methods: From August 1, 2018 to October 31, 2020,the ASD screening clinical pathway was embedded in the child health physical examination system of Shanghai Changning Maternal and Child Health Hospital for children aged 1836 months. The gold standard was the Autism Diagnostic Observation Scale version 2 (ADOS2) combined with Diagnostic and Statistical Manual of Mental Disorders version 5(DSM5), and the modified checklist for autism in toddlers (MCHATR) + MCHATR/F or two behavioral observations (customized) were the test criteria. After primary MCHATR screening, positive children were rescreened by MCHATR/F, and negative children were rescreened by two rounds of behavior observation. Children with positive rescreening were diagnosed as ASD or not. Children with negative rescreening were inquried in routine physical examination, and after the diagnosis of ASD was confirmed, that would be recorded in the children health physical examination system. Those who were positive in the primary screening but were not rescreened and those who were positive in the rescreening but were not recorded in the children's health examination system were lost to followup and were not included in the analysis. Main outcome measures: The Youden's index of primary screening and secondary screening of ASD. Results: In the primary screening，there were 10,635 children, 5,579 boys with an average age of (22.3±2.9) months and 5,056 girls with an average age of (22.4±2.9) months. A total of 252 cases were positive and 38 cases were lost to followup (loss rate 15.1%). There were 53 cases positive in MCHATR/F rescreening, 13 cases were lost to followup (loss rate 24.5%), and 26 cases were diagnosed as ASD. A total of 161 cases were negative in MCHATR/F rescreening, and 4 cases were inquiny ASD by routine physical examination. Among 10,383 cases negative in the primary screening, there were 8 ASD in the 2018 subgroup, and 3 ASD in the 2019 subgroup by inquiry in the routine physical examination. In rescreening positive patients of the first behavior observation (n= 54),33 cases were positive, 18 cases were lost to followup (loss rate 54.5%), and 13 cases were diagnosed as ASD. There were 54 case of ASD dignosed by the overall screening, 41 boys and 13 girls with an average age of (26.2±5.9) and (23.8±5.3)months, respectively. The Youden's index of MCHATR was 0.539, the specificity was 98.4%, and the sensitivity was 55.6%. On the basis of positive MCHATR primary screening, the rescreening Youden's index of MCHATR/F was 0.78, the specificity was 91.3%, and the sensitivity was 86.7%. On the basis of negative MCHATR primary screening, the rescreening Youden's index of two rounds behavior observation was 0.81, the specificity was 99.96%, and the sensitivity was 81.2%. Eight children in the 2018 subgroup with negative results in MCHATR screening were diagnosed as ASD through inquiry in the following routine physical examination, and the age of diagnosis was (34.8±2.7) months. In 2019 subgroup of negative results in MCHATR screening, 3 cases were diagnosed as ASD during one round of behavior observation, and for negative subjects the age of diagnosis was(32.7±3.8) months. In the second round of behavior observation, 13 cases were diagnosed as ASD, and the age of diagnosis was (24.2±4.0) months. The difference between groups was statistically significant (F=22.809, P＜0.001), and there was also statistically significant difference in further pairwise comparison (P＜0.001, P=0.004). Conclusion: It is feasible for children aged 1836 months to embed ASD screening path in children's health physical examination system, and the screening efficiency is desirable. Behavior observation rescreening in children negative in the MCHATR screening can diagnose ASD 10 months earlier.

Key words: Autism spectrum disorder, Modified checklist for autism in toddlers, Screening, Behavior observation, Specificity, Sensitivity, Youden's index