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Article(id=1220689492327973718, tenantId=1146029695717560320, journalId=1220038315760373764, issueId=1220689483859677846, articleNumber=null, orderNo=null, doi=10.12102/j.issn.1009-6493.2025.19.010, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1731600000000, receivedDateStr=2024-11-15, revisedDate=1757347200000, revisedDateStr=2025-09-09, acceptedDate=null, acceptedDateStr=null, onlineDate=1768964654284, onlineDateStr=2026-01-21, pubDate=1760025600000, pubDateStr=2025-10-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1768964654284, onlineIssueDateStr=2026-01-21, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1768964654284, creator=13701087609, updateTime=1768964654284, updator=13701087609, issue=Issue{id=1220689483859677846, tenantId=1146029695717560320, journalId=1220038315760373764, year='2025', volume='39', issue='19', pageStart='3201', pageEnd='3376', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1768964652266, creator=13701087609, updateTime=1768965013333, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1220690998338961744, tenantId=1146029695717560320, journalId=1220038315760373764, issueId=1220689483859677846, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1220690998338961745, tenantId=1146029695717560320, journalId=1220038315760373764, issueId=1220689483859677846, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=3270, endPage=3276, ext={EN=ArticleExt(id=1220689492780958579, articleId=1220689492327973718, tenantId=1146029695717560320, journalId=1220038315760373764, language=EN, title=Reliability validity and measurement invariance cross cancer types test of the Treatment⁃Induced Neuropathy Assessment Scale, columnId=1220689492655129450, journalTitle=Chinese Nursing Research, columnName=Scale Study, runingTitle=null, highlight=null, articleAbstract=

Objective To test the reliability,validity and cross⁃group measurement invariance of the Treatment⁃Induced Neuropathy Assessment Scale. Methods Convenience sampling method was used to conduct a questionnaire survey on 392 patients in the inpatient and outpatient departments of tumor-related departments of 2 tertiary grade A hospitals in Tianjin and Nanchang from March to July 2024. Results The Chinese version of TNAS included 9 items and 2 subscales.The critical ratio t value of each item was 14.169⁃20.374(P<0.001).The correlation coefficient r between the score of each item and the total score of the scale was 0.690⁃0.845(P<0.001).Confirmatory factor analysis(CFA) supported the two⁃factor model,and each indicator reached the ideal fitting standard.The factor loading of each item of the scale was 0.776⁃0.900.The CR of the two subscales were 0.910 and 0.912 respectively.The AVE were 0.629 and 0.778 respectively.The absolute value of the correlation coefficient between the two subscales was 0.574.The Chinese version of TNAS showed a positive correlation with EORTC QLQ⁃CIPN 20(r=0.460,P<0.001).The Cronbach's α coefficient of the Chinese version of the TNAS was 0.910.The Cronbach's α coefficients of the two subscales were 0.912 and 0.915 respectively.The retest reliability was 0.802.The Chinese version of the TNAS had measurement invariance across groups in the equivalence test(P>0.05). Conclusions The Chinese version of the TNAS has good reliability,validity and measurement invariance across groups,and could be used to identify the severity of neuropathy in various cancer treatments.

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JIN Yanfei, E⁃mail:
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目的 对治疗引起的周围神经损伤量表（Treatment⁃Induced Neuropathy Assessment Scale，TNAS）进行信效度和跨癌症类型测量不变性检验。 方法 采用便利抽样法，于2024年3月—7月对天津市和南昌市2所三级甲等医院肿瘤相关科室住院和门诊就诊的392例病人进行问卷调查。 结果 中文版TNAS量表包括2个分量表，共9个条目。各条目临界比值t值为14.169~20.374（P<0.001），各条目得分与量表总分的相关系数为0.690~0.845（P<0.001）。验证性因子分析支持两因子模型，且各指标均达到理想的拟合标准。量表各条目的因子负荷为0.776~0.900；2个分量表的组合信度（CR）分别为0.910和0.912；平均方差变异（AVE）值分别为0.629和0.778。2个分量表间相关系数的绝对值为0.574。中文版TNAS得分与欧洲癌症研究与治疗组织生活质量化疗致周围神经病变问卷（EORTC QLQ⁃CIPN 20）得分呈正相关（r=0.460，P<0.001）。中文版TNAS总量表的Cronbach's α系数为0.910，2个分量表的Cronbach's α系数分别为0.912和0.915，重测信度为0.802。中文版TNAS量表在等值检验中具有跨群组测量不变性（P>0.05）。 结论 中文版TNAS量表具有良好的信效度和跨癌症类型测量不变性，可用于识别各种癌症治疗中神经病变的严重程度。

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金燕飞，E⁃mail：
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耿庆春，硕士研究生在读

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journalId=1220038315760373764, articleId=1220689492327973718, language=EN, label=Table 1, caption=

General information of cancer patients

, figureFileSmall=null, figureFileBig=null, tableContent=
项目分类多发性骨髓瘤（n=143）结直肠癌（n=136）乳腺癌（n=113）
年龄（岁）60.92±7.8353.14±6.7256.24±9.28
性别[例（%）]男53(37.1)75(55.1)0(0.0)
女90(62.9)61(44.9)13(100.0)
受教育程度[例（%）]小学或以下43(30.1)44(32.4)22(19.5)
初中48(33.6)50(36.8)38(33.6)
高中或中专35(24.5)33(24.3)33(29.2)
专科及以上17(11.9)9(6.6)20(17.7)
居住地[例（%）]城镇95(66.4)75(55.1)66(58.4)
农村48(33.6)61(44.9)47(41.6)
癌症分期[例（%）]Ⅰ期36(25.2)26(19.1)35(31.0)
Ⅱ期47(32.9)54(39.7)32(28.3)
Ⅲ期50(35.0)41(30.1)40(35.4)
Ⅳ期10(7.0)15(11.0)6(5.3)
), ArticleFig(id=1220838937589891341, tenantId=1146029695717560320, journalId=1220038315760373764, articleId=1220689492327973718, language=CN, label=表1, caption=

癌症病人一般资料

, figureFileSmall=null, figureFileBig=null, tableContent=
项目分类多发性骨髓瘤（n=143）结直肠癌（n=136）乳腺癌（n=113）
年龄（岁）60.92±7.8353.14±6.7256.24±9.28
性别[例（%）]男53(37.1)75(55.1)0(0.0)
女90(62.9)61(44.9)13(100.0)
受教育程度[例（%）]小学或以下43(30.1)44(32.4)22(19.5)
初中48(33.6)50(36.8)38(33.6)
高中或中专35(24.5)33(24.3)33(29.2)
专科及以上17(11.9)9(6.6)20(17.7)
居住地[例（%）]城镇95(66.4)75(55.1)66(58.4)
农村48(33.6)61(44.9)47(41.6)
癌症分期[例（%）]Ⅰ期36(25.2)26(19.1)35(31.0)
Ⅱ期47(32.9)54(39.7)32(28.3)
Ⅲ期50(35.0)41(30.1)40(35.4)
Ⅳ期10(7.0)15(11.0)6(5.3)
), ArticleFig(id=1220838937698943252, tenantId=1146029695717560320, journalId=1220038315760373764, articleId=1220689492327973718, language=EN, label=Table 2, caption=

The critical ratio of the Chinese version of TNAS items and the correlation coefficient between item scores and total scores

, figureFileSmall=null, figureFileBig=null, tableContent=
分量表条目t值条目得分与总分的相关系数
感觉条目1：手、足、臂、腿的麻木感最严重程度15.9290.739
条目2：手、足、臂、腿的针刺感最严重程度17.1900.733
条目3：手、足、臂、腿的疼痛感最严重程度16.2620.712
条目4：手、足、臂、腿的灼烧感最严重程度16.6520.730
条目5：手或足的冷刺激感最严重程度16.8970.731
条目6：睡眠不安最严重程度14.1690.690
干扰条目7：行走最困难程度20.3740.845
条目8：平衡困难或易跌倒最严重程度18.7300.828
条目9：使用手或者手指最困难程度19.8460.826
), ArticleFig(id=1220838937820578070, tenantId=1146029695717560320, journalId=1220038315760373764, articleId=1220689492327973718, language=CN, label=表2, caption=

中文版TNAS条目临界比值及条目得分与总分相关系数

, figureFileSmall=null, figureFileBig=null, tableContent=
分量表条目t值条目得分与总分的相关系数
感觉条目1：手、足、臂、腿的麻木感最严重程度15.9290.739
条目2：手、足、臂、腿的针刺感最严重程度17.1900.733
条目3：手、足、臂、腿的疼痛感最严重程度16.2620.712
条目4：手、足、臂、腿的灼烧感最严重程度16.6520.730
条目5：手或足的冷刺激感最严重程度16.8970.731
条目6：睡眠不安最严重程度14.1690.690
干扰条目7：行走最困难程度20.3740.845
条目8：平衡困难或易跌倒最严重程度18.7300.828
条目9：使用手或者手指最困难程度19.8460.826
), ArticleFig(id=1220838937929629978, tenantId=1146029695717560320, journalId=1220038315760373764, articleId=1220689492327973718, language=EN, label=Table 3, caption=

CFA path coefficient significance test

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分量表条目因子负荷P
感觉条目10.803<0.001
条目20.776<0.001
条目30.795<0.001
条目40.788<0.001
条目50.808<0.001
条目60.788<0.001
干扰条目70.900<0.001
条目80.874<0.001
条目90.869<0.001
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CFA路径系数显著性检验

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分量表条目因子负荷P
感觉条目10.803<0.001
条目20.776<0.001
条目30.795<0.001
条目40.788<0.001
条目50.808<0.001
条目60.788<0.001
干扰条目70.900<0.001
条目80.874<0.001
条目90.869<0.001
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Model fitting indicators for each equivalent model

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模型χ2值νCFITLIRMSEAΔχ2ΔνP
形态等值模型122.796840.9790.9710.066
单位等值模型140.684700.9770.9730.06417.888140.212
尺度等值模型151.788560.9790.9780.06511.104140.6778
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各等值模型的模型拟合指标

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模型χ2值νCFITLIRMSEAΔχ2ΔνP
形态等值模型122.796840.9790.9710.066
单位等值模型140.684700.9770.9730.06417.888140.212
尺度等值模型151.788560.9790.9780.06511.104140.6778
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治疗引起的周围神经损伤量表的信效度及跨癌症类型的测量不变性检验
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耿庆春 1 , 李阳 2 , 熊丽娜 3 , 金燕飞 1
护理研究 | 量表研究 2025,39(19): 3270-3276
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护理研究 | 量表研究 2025, 39(19): 3270-3276
治疗引起的周围神经损伤量表的信效度及跨癌症类型的测量不变性检验
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耿庆春1, 李阳2, 熊丽娜3, 金燕飞1
作者信息
  • 1.南京医科大学护理学院，江苏 210029
  • 2.天津市人民医院
  • 3.南昌大学第一附属医院

    • 耿庆春，硕士研究生在读

通讯作者:

金燕飞，E⁃mail：
Reliability validity and measurement invariance cross cancer types test of the Treatment⁃Induced Neuropathy Assessment Scale
Qingchun GENG1, Yang LI2, Li'na XIONG3, Yanfei JIN1
Affiliations
  • 1.School of Nursing, Nanjing Medical University, Jiangsu 210029 China
  • 2.Tianjin People's Hospital
  • 3.The First Affiliated Hospital of Nanchang University
出版时间: 2025-10-10 doi: 10.12102/j.issn.1009-6493.2025.19.010
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目的 对治疗引起的周围神经损伤量表（Treatment⁃Induced Neuropathy Assessment Scale，TNAS）进行信效度和跨癌症类型测量不变性检验。 方法 采用便利抽样法，于2024年3月—7月对天津市和南昌市2所三级甲等医院肿瘤相关科室住院和门诊就诊的392例病人进行问卷调查。 结果 中文版TNAS量表包括2个分量表，共9个条目。各条目临界比值t值为14.169~20.374（P<0.001），各条目得分与量表总分的相关系数为0.690~0.845（P<0.001）。验证性因子分析支持两因子模型，且各指标均达到理想的拟合标准。量表各条目的因子负荷为0.776~0.900；2个分量表的组合信度（CR）分别为0.910和0.912；平均方差变异（AVE）值分别为0.629和0.778。2个分量表间相关系数的绝对值为0.574。中文版TNAS得分与欧洲癌症研究与治疗组织生活质量化疗致周围神经病变问卷（EORTC QLQ⁃CIPN 20）得分呈正相关（r=0.460，P<0.001）。中文版TNAS总量表的Cronbach's α系数为0.910，2个分量表的Cronbach's α系数分别为0.912和0.915，重测信度为0.802。中文版TNAS量表在等值检验中具有跨群组测量不变性（P>0.05）。 结论 中文版TNAS量表具有良好的信效度和跨癌症类型测量不变性，可用于识别各种癌症治疗中神经病变的严重程度。

癌症  /  治疗引起的周围神经损伤  /  量表  /  信度  /  效度  /  测量不变性

Objective To test the reliability,validity and cross⁃group measurement invariance of the Treatment⁃Induced Neuropathy Assessment Scale. Methods Convenience sampling method was used to conduct a questionnaire survey on 392 patients in the inpatient and outpatient departments of tumor-related departments of 2 tertiary grade A hospitals in Tianjin and Nanchang from March to July 2024. Results The Chinese version of TNAS included 9 items and 2 subscales.The critical ratio t value of each item was 14.169⁃20.374(P<0.001).The correlation coefficient r between the score of each item and the total score of the scale was 0.690⁃0.845(P<0.001).Confirmatory factor analysis(CFA) supported the two⁃factor model,and each indicator reached the ideal fitting standard.The factor loading of each item of the scale was 0.776⁃0.900.The CR of the two subscales were 0.910 and 0.912 respectively.The AVE were 0.629 and 0.778 respectively.The absolute value of the correlation coefficient between the two subscales was 0.574.The Chinese version of TNAS showed a positive correlation with EORTC QLQ⁃CIPN 20(r=0.460,P<0.001).The Cronbach's α coefficient of the Chinese version of the TNAS was 0.910.The Cronbach's α coefficients of the two subscales were 0.912 and 0.915 respectively.The retest reliability was 0.802.The Chinese version of the TNAS had measurement invariance across groups in the equivalence test(P>0.05). Conclusions The Chinese version of the TNAS has good reliability,validity and measurement invariance across groups,and could be used to identify the severity of neuropathy in various cancer treatments.

cancer  /  treatment⁃induced peripheral neuropathy  /  scale  /  reliability  /  validity  /  measurement invariance
耿庆春, 李阳, 熊丽娜, 金燕飞. 治疗引起的周围神经损伤量表的信效度及跨癌症类型的测量不变性检验. 护理研究, 2025 , 39 (19) : 3270 -3276 . DOI: 10.12102/j.issn.1009-6493.2025.19.010
Qingchun GENG, Yang LI, Li'na XIONG, Yanfei JIN. Reliability validity and measurement invariance cross cancer types test of the Treatment⁃Induced Neuropathy Assessment Scale[J]. Chinese Nursing Research, 2025 , 39 (19) : 3270 -3276 . DOI: 10.12102/j.issn.1009-6493.2025.19.010
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治疗引起的周围神经病变（treatment⁃induced peripheral neuropathy，TIPN）是各种癌症治疗（手术、化疗及靶向疗法）所致的毒性症状，其症状包括疼痛、刺痛、麻木、对温度变化的敏感性增强以及精细运动技能受损等[1⁃2]。研究显示，与治疗引起的周围神经病变相关的症状常导致病人日常功能受损和生活质量下降，严重时甚至会扰乱病人临床治疗计划，需调整治疗药物剂量，并影响治疗结果[3⁃5]。治疗引起的周围神经病变通常具有累积性和持续性，由于手术、放疗和靶向疗法是多种癌症的标准疗法，经历治疗引起的周围神经病变的病人数量多且普遍。因此，需要一种系统评估治疗引起的周围神经病变的方法，以了解治疗引起的周围神经病变带来的日益加重的负担。目前，现有治疗引起的周围神经病变患者报告结局（patient⁃reported outcomes，PROs）的工具多限于化疗引起的周围神经病变[6⁃7]，这些工具在开发过程中缺少定性研究的证据支持、基于生活质量（QOL）范式且在后续信效度检验中其因子结构遭到质疑[8⁃10]。考虑到现有测量工具的限制，得克萨斯大学安德森癌症中心开发了治疗引起的周围神经损伤量表(Treatment⁃Induced Neuropathy Assessment Scale，TNAS)[11]，该量表严格遵循美国食品药品管理局（FDA）的患者报告结局工具开发行业指南[12]，用于评估癌症治疗中神经病变的严重程度的评估。该中心已将英文版TNAS翻译成中文和希伯来语，但目前仅对英文版TNAS进行过心理测量验证[13]。因此，本研究的目的之一是检验TNAS在我国癌症病人中的信度和效度。此外，不同癌症类型的治疗方式不同，对应的治疗引起的周围神经病变可能存在差异，即使TNAS展现出良好的信效度，也不能说明在不同癌症类型的病人中所测的潜在因素具有相同意义，由于缺少测量不变性检验，不同癌症类型病人的治疗引起的周围神经病变因素差异仍不明确。鉴于此，本研究还分析了TNAS因子结构是否在不同癌症类型中具有不变性。综上所述，鉴于TNAS严谨、科学的开发过程及其对治疗引起的周围神经病变症状和严重程度的敏锐捕捉能力，本研究旨在测量TNAS在我国癌症病人中的信度、效度和跨癌症类型稳定性，这将有助于增加非西方国家TNAS良好心理特性和稳定性的证据，也有助于推动TNAS在我国临床环境中的应用。
1 研究方法
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1.1　TNAS原量表介绍
TNAS初始版本（Ⅴ1.0和Ⅴ2.0）的症状项目由专家小组、文献综述以及病人对初始项目集的汇报生成，随后在对该工具的验证迭代修订中对病人进行了一对一定性访谈形成了TNAS Ⅴ3.0[11,13⁃14]。TNAS Ⅴ3.0包括感觉分量表和干扰分量表，共9个条目，量表采用0~10分评分法，“无症状”计0分，“症状已严重到无法想象”计10分。量表总分为所有条目的总体算术平均值，分数越高，表明受试者神经病变越严重。还可以计算2个分量表得分评估与感觉和干扰维度相关的症状。感觉分量表得分为麻木、刺痛、疼痛、热或灼热、冷感和睡眠障碍6个感觉条目的平均值；干扰分量表得分为行走困难、平衡困难和使用双手困难3个条目的平均值。TNAS条目简短，平均需要不到2 min即可完成。在研究的原始版本中，TNAS表现出了良好的心理测量特性，各分量表的Cronbach's α系数为0.822~0.960，总量表的Cronbach's α系数为0.860；重测信度为0.970；效标关联效度为0.690[11,13]。
1.2　中文版TNAS量表的获取与授权
研究开始之前，本研究团队与安德森癌症中心取得了联系并签订协议，获得了TNAS中文版以及在我国进行心理特性和测量不变性测试的授权。
1.3　中文版TNAS量表的正式调查
1.3.1　调查对象
采用便利抽样法，选取2024年3月—7月在天津市和南昌市2所三级甲等医院肿瘤相关科室住院和门诊就诊的病人为调查对象。病人纳入标准：1）确诊为多发性骨髓瘤、结直肠癌或乳腺癌的病人，这些病人分别首次接受硼替佐米、奥沙利铂或紫杉烷⁃铂类化疗治疗；2）年龄>18岁；3）能够独立完成问卷；4）自愿参与本研究。排除有认知或精神障碍以及患有严重的心脏、肝脏、肾脏和其他严重并发症者。依据因子分析样本量为量表条目的5~10倍，并考虑20%的无效问卷，3种类型的癌症病人至少分别需要108例[15]。本研究经南京医科大学伦理委员会审批（审批号：〔2024〕697号），研究对象均知情同意，自愿参与本研究。
1.3.2　资料收集方法
对纳入的研究对象，在住院部或门诊由经过系统培训的研究小组成员面对面现场发放问卷。发放问卷前向研究对象逐一介绍研究目的、意义及内容。若调查对象因视力、文化程度等原因限制填写，则由研究小组成员询问代为填写，问卷填写完立即收回，并及时检查问卷的有效性并填补漏填项目。本研究共发放问卷410份，回收有效问卷392份，有效回收率为95.6%。
1.3.3　调查工具
1.3.3.1　一般资料调查表
由课题组自行设计，内容包括病人的一般人口学资料及疾病资料，如性别、年龄、受教育程度、居住地、癌症分期等。
1.3.3.2　中文版TNAS量表
该量表包括2个分量表，共9个条目。
1.3.3.3　欧洲癌症研究与治疗组织生活质量化疗致周围神经病变问卷（EORTC QLQ⁃CIPN 20）
EORTC QLQ⁃CIPN 20量表包括感觉、运动和自主神经3个维度，共20个条目。所有条目均采用Likert 4级评分法，“完全没有”至“非常有”分别计1~4分，总分20~80分，依据欧洲癌症组织的计分方式，将问卷转化为百分制，得分越高表明周围神经病变症状越严重[6]。中文版EORTC QLQ⁃CIPN 20具有良好的内部一致性，总量表的Cronbach's α系数为0.90，分量表的Cronbach's α系数为0.70~0.87[9]。
1.4　中文版TNAS量表的信效度检验
1.4.1　项目分析
1.4.1.1　临界比值法
将中文版TNAS总分由高到低排序，将总分最高的27%设定为高分组，最低的27%设定为低分组，然后对两组各条目得分行独立样本t检验，两组得分差异有统计学意义（P<0.05）且t值>3，说明量表区分度好，条目予以保留[16]。
1.4.1.2　相关系数法
采用Pearson相关系数法计算量表各条目得分与量表总分相关系数，若相关系数<0.40或未达到显著水平（P≥0.05），则删除该条目[16]。
1.4.2　效度检验
1.4.2.1　结构效度
对于文化适应量表，需要进行验证性因子分析（confirmatory factor analysis，CFA），根据拟合度指标及研究人员专业背景知识进行模型修正，若修正模型仍不能被接受，则需重新通过探索性因子分析（exploratory factor analysis，EFA）构建新的模型并验证[17]。由于该量表已相对较为成熟，因此本研究将验证性因子分析作为确定TNAS两因子结构效度的关键步骤。采用以下拟合指数检查模型拟合[18]：卡方/自由度(χ2/ν)<3，比较拟合指数（comparative fit index，CFI）≥0.90，Tucker⁃Lewis指数（Tucker⁃Lewis index,TLI）≥0.90，近似平方根误差（root mean square error of approximation，RMSEA）≤0.05。
1.4.2.2　聚敛效度与区分效度
采用各条目的因子负荷（factor loading）、2个因子的组合信度（composite reliability，CR）以及平均方差变异（average variance extracted，AVE）检验聚敛效度与区分效度，当各条目的因子负荷≥0.50、各因子CR≥0.60以及AVE≥0.50，说明量表聚敛效度好。当各维度间相关系数绝对值<AVE的平方根，说明量表区分效度好[19]。
1.4.2.3　效标效度
以EORTC QLQ⁃CIPN 20作为标准，通过TNAS与EORTC QLQ⁃CIPN 20之间的Pearson相关性衡量中文版TNAS的效标效度。如果TNAS与EORTC QLQ⁃CIPN 20具有相关性，说明TNAS的效标效度较好[20]。
1.4.3　信度检验
1.4.3.1　内部一致性
采用Cronbach's α系数评估中文版TNAS总量表与各维度的内部一致性。总量表及各维度的Cronbach's α系数>0.70说明量表的内部一致性较好[21]。
1.4.3.2　重测信度
选取30例研究对象2周后进行重测，根据其前后2次得分计算相关系数，当组内相关系数（intraclass correlation coefficient，ICC）>0.70，说明量表的重测信度良好[22]。
1.5　中文版TNAS量表跨群组的测量不变性检验
为了确定中文版TNAS的两因子模型在不同癌症类型（多发性骨髓瘤、结直肠癌或乳腺癌症）中是否具有等效性，本研究进一步使用多组验证性因子分析检验TNAS的测量不变性[23]。按照多组等值的严格程度依次分为形态等值（configural invariance）、单位等值（metric invariance）和尺度等值(scalar invariance)等。将评估2个嵌套模型的χ2变化的显著性检验作为测量不变性的标准。如果χ2检验P>0.05，则说明单位等值模型和尺度等值模型成立，即模型所代表的量表具有跨群组不变性。
1.6　统计学方法
采用Excel软进双人核对录入所有数据，使用IBM SPSS Statistics 26.0和AMOS 27.0软件进行统计分析。符合正态分布的定量资料采用均数±标准差（$\bar{x}\pm s$）表示，定性资料采用频数、百分比（%）表示。以P<0.05为差异有统计学意义。
2 结果
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2.1　癌症病人的一般资料
共纳入392例癌症病人，其中多发性骨髓瘤病人143例、结直肠癌病人136例、乳腺癌病人113例。病人一般资料见表1。
2.2　项目分析结果
临界比值结果显示，各条目临界比值t值为14.169~20.374，且P<0.001，说明各条目的区分度较好。各条目得分与量表总分的相关系数为0.690~0.845（P<0.001），均>0.4，保留所有条目。详见表2。
2.3　效度
2.3.1　结构效度
采用验证性因子分析对两因子模型的结构效度进行验证，各拟合指数显示出充分的拟合度：χ2/ν=1.525（P<0.001），CFI=0.994，TLI=0.992，RMSEA=0.037。中文版TNAS验证性因子分析结构图见图1。
2.3.2　效标效度
结果显示，中文版TNAS与EORTC QLQ⁃CIPN 20存在正相关关系（r=0.460，P<0.001）；感觉分量表与EORTC QLQ⁃CIPN 20存在正相关关系（r=0.374，P<0.001）；干扰分量表EORTC QLQ⁃CIPN 20存在正相关关系（r=0.438，P<0.001），表明中文版TNAS效标效度好。
2.3.3　聚敛效度与区分效度
量表各条目的因子负荷为0.776~0.900，均≥0.50。2个分量表的CR值分别为0.910和0.912，均≥0.60；AVE值分别为0.629和0.778，均≥0.50，说明各条目相关性好，聚敛效度理想。2个分量表的AVE平方根为0.793，0.882；2个分量表间相关系数的绝对值为0.574，均小于AVE平方根，说明量表具有很好的区分效度。详见表3。
2.4　信度
中文版TNAS总量表的Cronbach's α系数为0.910，2个分量表的Cronbach's α系数分别为0.912和0.915，均>0.70，说明中文版TNAS具有良好的内部一致性。2周后对30例病人进行重测，量表重测信度为0.802，>0.70，说明中文版TNAS具有较好的时间稳定性。
2.5　跨群组的测量不变性检验
采用多组CFA检验中文版TNAS是否在多发性骨髓瘤病人、结直肠癌病人以及乳腺癌病人中具有跨群组的结构等值性。形态等值模型设定所有因子负荷、观察变量结局和残差均自由估计，各模型拟合指标良好，说明中文版TNAS量表在多发性骨髓瘤病人、结直肠癌病人以及乳腺癌病人群体中具有跨群组的形态一致性。其次，通过设定因子负荷在多发性骨髓瘤病人、结直肠癌病人以及乳腺癌病人3组样本中相等，检验单位等值模型，各模型拟合指标良好，说明中文版TNAS的单位等值模型成立。最后，通过设定多发性骨髓瘤病人、结直肠癌病人以及乳腺癌病人3组样本之间对应观测变量的截距相等，检验尺度等值模型，各模型拟合指标良好，说明尺度等值模型成立。以上结果表明中文版TNAS在等值检验中具有跨群组不变性，各等值模型拟合指标见表4。
3 讨论
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3.1　中文版TNAS信效度和跨癌症类型测量不变性检验的必要性
治疗引起的周围神经病变是癌症病人治疗过程中经历的一种毒性反应，不仅导致日常功能受损、生活质量下降，还会限制病人接受最佳治疗的能力，精准、可靠的评估工具对于治疗引起的周围神经病变早期检测具有重要意义。通过科学开发及迭代修改的英文版TNAS具有良好的敏感性、响应性、可靠性和有效性，然而尚未检索到其在我国进行测试与推广。本研究测试了中文版TNAS的信效度和跨群组的测量不变性，发现TNAS在我国癌症病人中信度和效度良好以及跨群组稳定性。
3.2　中文版TNAS具有良好的鉴别度和信度
本研究采用临界比值法及相关系数法对中文版TNAS进行项目分析，结果显示量表各条目具有较好的区分度，各条目得分与总分的相关系数均>0.4，所有条目予以保留并用于进一步信效度检验。信度是检验量表一致性和稳定性的必要指标[24]，通常采用Cronbach's α系数和ICC反映量表的内部一致性和稳定性。本研究结果显示，总量表及各维度的Cronbach's α系数均>0.70，重测信度>0.70，表明中文版TNAS具有较好的内部一致性和稳定性。
3.3　中文版TNAS量表具有良好的效度
效度是测量工具能够真正反映其所期望研究的概念和程度[24]，本研究通过结构效度、聚敛效度、区分效度、效标效度考察中文版TNAS的效度。结构效度是量表理论预期与调查结果间的吻合程度，当量表调查结果能够测量其理论特征，且调查结果与理论预测一致时，说明该量表具有良好的结构效度。本研究将验证性因子分析作为验证中文版TNAS结构效度的重要步骤，验证性因子分析结果显示，各拟合指数显示出充分的拟合度，中文版TNAS包含2个因子（感知与干扰），与原TNAS提出的两因子模型一致。聚敛效度是量表中相同潜在特质的项目应属于同一维度，而区分效度是同一潜在特质的各维度间应呈低相关或有显著差异，本研究中各条目的因子负荷≥0.50、2个分量表的CR值≥0.60、AVE值≥0.50以及2个分量表间相关系数绝对值<AVE值的平方根，显示中文版TNAS具有较好的聚敛效度和区分效度。效标效度是测试量表与效标量表之间的相关程度。本研究将中文版TNAS量表与EORTC QLQ⁃CIPN 20进行相关性分析，结果显示TNAS总量表及其2个分量表分别与EORTC QLQ⁃CIPN 20呈正相关，与原TNAS量表的结果一致，说明中文版TNAS具有较好的效标效度。
3.4　中文版TNAS具有良好的跨群组测量不变性
测量不变性是验证测量工具在不同情境下（如不同群体、不同场合及不同时间点）对同一心理构念或潜变量进行测量时所得的结果是否具有不变性[25]。本研究进一步采用多组CFA分析经检验中文版TNAS跨癌症类型的测量不变性，评估了TNAS的两因子结构模型在多发性骨髓瘤病人、结直肠癌病人以及乳腺癌病人中是否等效。本研究结果显示，中文版TNAS在多发性骨髓瘤病人、结直肠癌病人以及乳腺癌病人群组中有相同的结构和含义，具有跨群组不变性。临床上不同的癌症群组使用的治疗方式，尤其在化疗药物及药物的剂量选择上一般有差异，这些差异可能导致不同癌症群组的病人表现出的治疗引起的周围神经病变症状有所差异。本研究结果显示，TNAS量表在不同癌症类型群组间具有测量不变性，这为中文版TNAS在多种癌症群体的潜在效用提供了重要的信息。
3.5　中文版TNAS的应用价值
中文版TNAS是一种信息丰富、实用的患者报告结局评估工具，其几乎不会给病人带来负担，并且可用于在多个地点进行的临床试验。该量表为临床医护人员精准掌握癌症病人治疗过程中的周围神经损伤严重程度并及时实施个性化干预以减少治疗引起的周围神经病变引起的病情恶化提供了参考和指导，也为后续治疗引起的周围神经病变的研究和临床实践提供了准确、可靠的量化工具。
3.6　本研究的局限性
首先，样本仅限于我国天津市和南昌市，研究结果可能不具有普遍性；其次，本研究收集的治疗引起的周围神经病变症状是病人对24 h内症状的感知，可能会受到记忆偏差的影响。未来的研究应采用生态瞬时评估及时捕捉病人当前的症状。最后，建议在未来的验证研究中考虑纵向追踪多个时间点TNAS的敏感性与可靠性。
4 小结
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中文版TNAS具有良好的信效度及跨癌症类型的测量不变性，可用于评估临床各种癌症治疗引起的周围神经病变的严重程度。中文版TNAS为未来对治疗引起的周围神经病变的研究和临床实践提供了条件，准确测量和跟踪治疗引起的周围神经病变对于设计干预措施，以预防或减少治疗引起的周围神经病变具有重要意义。
基金
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  • 江苏高校优势学科建设工程四期项目“护理学”，编号：苏教研函〔2023〕11号
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2025年第39卷第19期
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doi: 10.12102/j.issn.1009-6493.2025.19.010
  • 接收时间：2024-11-15
  • 首发时间：2026-01-21
  • 出版时间：2025-10-10
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  • 收稿日期：2024-11-15
  • 修回日期：2025-09-09
基金
江苏高校优势学科建设工程四期项目“护理学”，编号：苏教研函〔2023〕11号
作者信息
    1.南京医科大学护理学院，江苏 210029
    2.天津市人民医院
    3.南昌大学第一附属医院

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金燕飞，E⁃mail：
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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