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浙江大学学报(医学版)  2022, Vol. 51 Issue (5): 603-612    DOI: 10.3724/zdxbyxb-2022-0336
原著     
功能状态评估量表的汉化、改良及在极低出生体重婴儿信效度检验
杨洋1,2,王晶1,童梅玲1,*,程锐2,潘晶晶3
1. 南京医科大学附属妇产医院儿童保健科,江苏 南京 210004
2. 南京医科大学附属儿童医院新生儿科,江苏 南京 210008
3. 南京医科大学第一附属医院妇幼分院新生儿科,江苏 南京 210036
The localization and improvement of the Functional Status Scale and the reliability and validity in very low birth weight infants
YANG Yang1,2,WANG Jing1,TONG Meiling1,*,CHENG Rui2,PAN Jingjing3
1. Department of Child Health Care, Maternity Hospital Affiliated to Nanjing Medical University, Nanjing 210004, China;
2. Department of Neonatology, Children’s Hospital Affiliated to Nanjing Medical University, Nanjing 210008, China;
3. Department of Neonatology, Maternal and Child Branch, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210036, China
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摘要:

目的:汉化、改良功能状态评分量表(FSS),并以极低出生体重儿(VLBWI)为对象检测其信效度。方法:征得原量表作者同意后,按照相关指南及规范,将原量表内容进行汉化并改良。纳入2018年1月1日至2020年6月30日收治住院的VLBWI,分别于出生后7?d及纠正胎龄34周时进行改良FSS评估,对得分进行描述统计(变异系数法、临界比值法和答案分布分析法)、信度分析[内部一致性信度(克伦巴赫α系数)和评分者间信度(Spearman相关系数)]及效度分析[内容效度(相关系数法、专家评分法)、结构效度(探索性和验证性因子分析法)和已知群效度(受试者操作特征曲线下面积、Pearson相关系数)],最后分析初、复评量表初步反应度。结果:根据纳入和排除标准,先后纳入548名和523名VLBWI进行初评及复评。描述统计中,变异系数法示条目的平均值与中位数接近,最大值和最小值接近或等于两端值,变异系数均大于0.15;临界比值法示初评和复评所有条目|t|>3、P<0.01;答案分布分析法示各条目不同水平答案选择率小于80%。信度分析中,内部一致性检验示初评克伦巴赫α系数为0.803,复评系数为0.708,内部一致性较好;评分者间信度示初评Spearman相关系数0.968,复评Spearman相关系数为0.989(P<0.01)。效度分析中,相关系数法示量表条目相关系数均在0.4以上;专家评分法示初、复评条目内容效度指数均大于0.78,全体一致量表内容效度指数为0.83、平均量表内容效度指数为0.97,Kappa均大于0.74;探索性因子分析示结构效度初评Kaiser-Meyer-Olkin(KMO)值为0.846,复评KMO值为0.843,差异有统计学意义(P<0.01),提取特征值大于1的因子初评和复评各有1个,分别可解释总变异的54.221%和53.403%;验证性因子分析示结构效度初、复评各条目P<0.01,且标准载荷系数值大于0.5;受试者操作特征曲线下面积示已知群效度初评FSS对短期结局具有较好的预测区分能力;复评量表中神志、运动、感知、交流条目与格塞尔发育量表大运动及精细动作评分有较好相关性。初评总得分与复评总得分反应度良好。结论:FSS量表汉化内容可靠、信效度稳定性好,条目简单,易于推广。

关键词: 功能状态量表极低出生体重儿汉化信度效度反应度    
Abstract:

Objective: To develop a Chinese version of Functional Status Scale (FSS) and to test its reliability and validity in very low birth weight infants (VLBWIs). Methods: The FSS was translated into Chinese and the content was modified in accordance with relevant guidelines and specifications. The Chinese version of FSS was applied to evaluate VLBWIs admitted from January 2018 to June 2020 at 7th day after birth and 34 weeks of postmenstrual age, respectively. The scores were analyzed by descriptive statistics (coefficient of variation method, critical ratio method and answer distribution analysis method), and the reliability and the validity were analyzed. The internal consistency reliability was analyzed using Cronbach’s α coefficient, the inter rater reliability was analyzed using Spearman correlation coefficient. The content validity was analyzed using correlation coefficient method and expert scoring method; the structural validity was analyzed using exploratory and confirmatory factor analysis method; the known group validity was analyzed using area under the curve (AUC) value and Pearson correlation coefficient. The preliminary response of the initial and re-evaluation scales was calculated. Results: After screening by inclusion and exclusion criteria, 548 and 523 VLBWIs were included for initial evaluation and re-evaluation, respectively. Descriptive statistics showed that the mean was close to the median, the maximum and minimum values were close to or equal to the values at both ends, and the coefficient of variation was >0.15. The critical ratio method showed that the | t| value of all items in the initial evaluation and re-evaluation was >3 ( P<0.01). The answer distribution analysis method showed that the answer selection rate of different levels of each item was <80%. Internal consistency test showed that the general Cronbach’s α was 0.803 and the re-evaluation Cronbach’s α was 0.708, with a good internal consistency. According to the inter-rater reliability, the Spearman correlation coefficient was 0.968 in the initial evaluation and 0.989 in the re-evaluation (P<0.01). The correlation coefficient of the items in the scale by the correlation coefficient method was more than 0.4. The item-level content validity index (I-CVI) was greater than 0.78, universal agreement of scale of content validity index was 0.83, the average of scale of content validity index was 0.97 and the Kappa was greater than 0.74. Exploratory factor analysis showed that the initial Kaiser-Meyer-Olkin (KMO) value was 0.846, the re-evaluated KMO value was 0.843 (P<0.01). There was one factor with extracted eigenvalue>1, which could explain 54.221% and 53.403% of the total variation respectively, suggesting that there was a common factor in the initial evaluation and re-evaluation scales, which was consistent with the original scale design. Confirmatory factor analysis showed that the items in the initial and re-evaluation were significant (P<0.01), and the value of standard load coefficient was greater than 0.5. The known group validity showed that FSS had a good predictive and discriminative ability for short-term outcomes. The items of mental status, motor function, sensory and communication in the re-evaluation scale had a good correlation with gross motor and fine motor energy areas in Gesell developmental schedule. The Pearson correlation coefficient between initial evaluation and re-evaluation was 0.609 (P<0.01).Conclusion: The Chinese version FSS scale has good reliability and validity, the included items are simple and easy to be applied in clinical practice.

Key words: Functional status scale    Very low birth weight infant    Sinicization    Reliability    Validity    Responsiveness
收稿日期: 2022-06-23 出版日期: 2022-12-28
CLC:  R722.6  
基金资助: 南京市卫健委医学发展专项课题(YKK20127)
通讯作者: 童梅玲   
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引用本文:

杨洋,王晶,童梅玲,程锐,潘晶晶. 功能状态评估量表的汉化、改良及在极低出生体重婴儿信效度检验[J]. 浙江大学学报(医学版), 2022, 51(5): 603-612.

YANG Yang,WANG Jing,TONG Meiling,CHENG Rui,PAN Jingjing. The localization and improvement of the Functional Status Scale and the reliability and validity in very low birth weight infants. J Zhejiang Univ (Med Sci), 2022, 51(5): 603-612.

链接本文:

https://www.zjujournals.com/med/CN/10.3724/zdxbyxb-2022-0336        https://www.zjujournals.com/med/CN/Y2022/V51/I5/603

量表条目

正常(1分)

轻度异常(2分)

中度异常(3分)

重度异常(4分)

极重度异常(5分)

呼吸方面

出生后1周内无需呼吸支持或仅需无创通气(FiO2≤30%且PEEP≤5cmH2O)

出生后1周内无创通气(FiO2 >30%~40%和/或PEEP >5~8 cmH 2O)

出生后1周内无创通气(FiO2>40%或PEEP>8 cmH2O)或有创通气(FiO2≤40%且PEEP≤6 cmH2O)

出生后1周内有创通气(FiO2>40%或PEEP>6 cmH2O)

出生后1周内有创通气(FiO2>40%且PEEP>6 cmH2O)和/或一氧化氮吸入

喂养方面

出生后24?h内开始微量喂养且评分时间内耐受好

未能在出生后24?h内开展微量喂养a,喂养后耐受可

出生后24?h内或24?h后开始微量喂养,但评分时间内有喂养不耐受症状,暂停喂养可缓解

微量喂养后或未开始喂养,在评分时间内出现消化道异常表现b,但尚无需手术

微量喂养后或未开始喂养,在评分时间内出现明显消化道异常表现c,和/或需手术治疗

精神 / 神经方面

①意识清(意识状态与胎龄符合),有主动睁眼、肢体活动;②无惊厥

①睡眠状态(意识状态与胎龄不符),抚触、话语、音乐等轻度刺激可唤醒,唤醒后意识清,无激惹;②疑似惊厥

①睡眠状态(与胎龄不符),疼痛等刺激方可唤醒或易激惹,唤醒后意识清;②和/或惊厥1~3次/24h

①浅昏迷、 疼痛等刺激不能唤醒, 但有皱眉、肢体收缩动作,瞳孔对光反射存在;②和/或惊厥多于3次/24h

①深昏迷或强直状态;②和/或惊厥持续状态

交流 / 回应方面

可表达饥饿、烦躁,可回应轻度及以上疼痛刺激d(如足底血)造成的不适(如哭闹、呻吟、扭动等),对其采取吸吮、音乐、抚触、撤除刺激等措施可安抚

可表达饥饿、烦躁,对轻度及以上疼痛刺激d造成的不适回应表达减弱,撤除此轻度及以上疼痛刺激可缓解不适

饥饿、烦躁表达能力减弱,对中度及以上疼痛刺激d造成的不适方可回应表达,撤除此中度及以上疼痛刺激可缓解不适

对饥饿、烦躁无表达能力,对重度及以上疼痛刺激d造成的不适方可回应表达,撤除此重度及以上疼痛刺激可缓解不适

对饥饿、烦躁无表达能力,对重度及以上疼痛刺激d造成的不适不能回应表达,和(或)深昏迷、强直状态

感觉方面

①可感觉各种不同程度外在触觉刺激,有正常肢体动作,伴有正常表情(如皱眉)及发声(或哭声);②听觉正常

①对各种不同程度外在触觉刺激感知减弱,伴有肢体动作、表情(如皱眉)及发声(如哭声),程度均减弱;②和/或疑似单侧听觉异常(单侧听力筛查未过)

①对各种不同程度外在触觉刺激感知明显减弱,伴有肢体动作和/或表情和/或发声,程度均明显减弱;②和/或疑似双侧听觉异常(双侧听力筛查未过)

①对轻、中度触觉刺激无感知,对重度刺激如压眶反射、疼痛,无肢体动作,仅有轻微表情(如皱眉)和/或发声(如哭声);②和/或单侧听觉损害(复测听力筛查单侧仍未过或首次ABR单侧异常)

①感觉丧失,深昏迷和(或)强直状态;②和/或双侧听觉损害(复测听力筛查双侧仍未过或首次ABR双侧异常)

运动方面

肢体自主活动可, 下肢牵拉有收缩动作 (与纠正胎龄符合)

单侧肢体活动减弱或受限

双侧肢体活动减弱或受限

不能维持正常姿势, 全身肌力及肌张力均明显减弱(与纠正胎龄不符)

四肢均完全丧失活动能力或去大脑强直状态

表1  新生儿入院7天时改良功能状态评分量表

量表条目

正常(1分)

轻度异常(2分)

中度异常(3分)

重度异常(4分)

极重度异常(5分)

呼吸方面

无需呼吸支持

需箱式或头罩吸氧

24?h内部分时间需无创通气

24?h内均需无创通气

24?h内均需有创通气

喂养方面

母乳或配方奶,喂养方式及喂养量同其纠正胎龄、日龄相吻合,耐受好

可经口喂养,喂养量同其纠正胎龄、日龄相吻合,但奶粉为特殊配方a,耐受好

部分或完全管饲,喂养量同其纠正胎龄、日龄相吻合,无需静脉营养

需完全管饲,喂养量不能满足需要,须额外补充部分静脉营养

完全不能经口或管饲喂养,须全静脉营养

精神 / 神经方面

①意识清,具有正常睡眠-觉醒周期(与年龄符合);②无惊厥

①睡眠延长(与年龄不符),抚触、话语等轻度刺激可唤醒,唤醒后意识清, 无激惹;②疑似惊厥

①睡眠延长(与年龄不符),疼痛等中度以上刺激可唤醒或易激惹,唤醒后意识清;②和/或惊厥1~3次/24h

①浅昏迷,中度以上刺激不能唤醒,但有皱眉、肢体收缩动作,瞳孔对光反射存在;②和/或惊厥多于3次/24h

①深昏迷或强直状态;②和/或惊厥持续状态

交流 / 回应方面

可表达饥饿、烦躁等不适,可回应轻度及以上疼痛刺激b(如足底血)造成的不适(如哭闹、呻吟、扭动等),对其采取吸吮、音乐、抚触、撤除刺激等措施可安抚

可表达饥饿、烦躁等不适,对轻度及以上疼痛刺激b造成的不适回应表达减弱,撤除此轻度及以上疼痛刺激可缓解不适

饥饿、烦躁等不适表达能力减弱,对中度及以上疼痛刺激b造成的不适方可回应表达,撤除此中度及以上疼痛刺激可缓解不适

对饥饿、烦躁等不适无表达能力,对重度及以上疼痛刺激b造成的不适方可回应表 达,撤除此重度及以上疼痛刺激可缓解不适

对饥饿、烦躁等不适无表达能力,对重度及以上疼痛刺激b造成的不适不能回应表达,和/或深昏迷、强直状态

感觉方面

①可感觉各种不同程度外在触觉刺激,有正常肢体动作,伴有正常表情(如皱眉)及发声(或哭声);②听觉、视觉正常

①对各种不同程度外在触觉刺激感知减弱,伴肢体动作、表情(如皱眉)及发声(如哭声),程度均减弱;②和/或疑似听觉异常(含听筛)和/或视觉异常(非1型ROP及其他非致盲问题c)

①对各种不同程度外在触觉刺激感知明显减弱,伴有肢体动作和(或)表情和(或)发声,程度均明显减弱;②和/或单侧听觉明确损害(含ABR)和/或单侧视觉损害(1型ROP和/致盲性病变d)

①对轻、中度触觉刺激无法感知,对重度刺激如压眶反射、疼痛,无肢体动作,仅有轻微表情(如皱眉)和/或发声(如哭声);②和/或双侧听觉明确损害(含ABR)或双侧视觉损害(1型ROP和/或致盲性病变d)

①感觉丧失,深昏迷和(或)强直状态;②和/或双侧听觉明确损害 (含ABR)且双侧视觉损害(1型ROP和/或致盲性病变d)

运动方面

肢体自主活动可,下肢牵拉有收缩动作(与年龄符合)

单侧肢体活动减弱或受限

双侧肢体活动减弱或受限

不能维持正常姿势, 全身肌力及肌张力均明显减弱(与年龄不符)

四肢均完全丧失活动能力或去大脑强直状态

表2  新生儿纠正胎龄34周时改良功能状态评分量表
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15 SWEETD G, CARNIELLIV, GREISENG, et al.European consensus guidelines on the management of respiratory distress syndrome——2019 update[J]Neonatology, 2019, 115( 4): 432-450.
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16 中国医师协会新生儿科医师分会, 中国当代儿科杂志编辑委员会. 新生儿疼痛评估与镇痛管理专家共识 (2020版) [J]. 中国当代儿科杂志, 2020, 22(9): 923-930
Neonatal Pediatricians Branch of Chinese Medical Doctor Association, Editorial Committee of Chinese Journal of Contemporary Pediatrics. Expert consensus on neonatal pain assessment and analgesia management (2020 edition) [J]. Chinese Journal of Contemporary Pediatrics, 2020, 22(9): 923-930. (in Chinese)
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