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Article(id=1241102820670230901, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241102813938380911, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202312186, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1702310400000, receivedDateStr=2023-12-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773831571022, onlineDateStr=2026-03-18, pubDate=1724515200000, pubDateStr=2024-08-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773831571022, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773831571022, creator=13701087609, updateTime=1773831571022, updator=13701087609, issue=Issue{id=1241102813938380911, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='16', pageStart='2881', pageEnd='3072', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773831569418, creator=13701087609, updateTime=1773831807198, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241103811318706322, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241102813938380911, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241103811318706323, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241102813938380911, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2898, endPage=2902, ext={EN=ArticleExt(id=1241102820997386647, articleId=1241102820670230901, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Establishment and evaluation of minimumclinically important difference of the peptic ulcer scale among the system of quality of life instruments for chronic diseases based on the anchor-based and distribution-based method, columnId=1228016567443718970, journalTitle=Modern Preventive Medicine, columnName=Epidemiology and Statistical Methods Advances, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the minimum clinically important difference (MCID) of peptic ulcer scale QLICD-PU (V2.0) among the System of quality of life instruments for chronic diseases.

Methods

Using convenience sampling, the questionnaire was administered from March 2013 to August 2014 using the QLICD-PU (V2.0) scale, and the MCIDs were calculatedusing the anchor-based and distribution-based methods, respectively, and analyzed to compare the MCIDs developed by taking the mean, taking the minimum, and taking the maximum methods.

Results

The MCIDs of physical functioning (8.53), psychological functioning (8.45), social functioning (7.61), general module (7.05), specific module (8.82), and overall scale (7.53) obtained by taking the mean method; the MCIDs obtained by taking the minimum method were 5.25, 5.78, 6.16, 4.19, 7.18 and 4.09, respectively; the MCID obtained by taking the maximum method were 11.99, 12.05, 10.09, 9.48, 10.99 and 11.04, respectively.

Conclusion

In this paper, MCID was formulated by using various methods and criteria, which can be chosen by the users according to the situation. MCID can be used to assess the clinical efficacy of patients with peptic ulcers for the application of quality of life. The MCID values formulated can be validated further by clinical practice in subsequent studies.

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目的

探讨慢性病患者生命质量测量体系之消化性溃疡量表QLICD-PU(V2.0)得分的最小临床重要性差值（MCID）。

方法

采用方便抽样，于2013年3月至2014年8月使用QLICD-PU(V2.0)量表进行问卷调查，采用效标法和分布法制定MCID，分析比较取平均值法、取小值法和取大值法制定的MCID。

结果

取平均值法得到的生理功能（8.53）、心理功能（8.45）、社会功能（7.61）、共性模块（7.05）、特异模块（8.82）和量表总分（7.53）；取小值法得到的MCID分别为5.25、5.78、6.16、4.19、7.18、4.09；取大值法得到的MCID分别为11.99、12.05、10.09、9.48、10.99、11.04。

结论

本文采用多种方法和标准制定了MCID，使用者可根据情况选用。MCID可用于评估消化性溃疡患者的临床疗效，为生命质量的应用提供参考。在后续研究中，制定的MCID值可通过临床实践进一步验证。

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万崇华，E-mail：
, copyrightStatement=本刊刊出的所有文章不代表中华预防医学会和本刊编委会的观点，除非特别声明。, copyrightOwner=中华预防医学会和四川大学华西公共卫生学院, extLink=null, articleAbsUrl=null, sourceXml=wkFN7U5jItD0SnP+BRJmIw==, magXml=A1j1z42ZqyN5uYOiwnMpgw==, pdfUrl=null, pdf=3i/FNFnGf7K36kTX5B8gow==, pdfFileSize=540469, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=WgSk5XJHOoNxDhGud2Eb0Q==, mapNumber=null, authorCompany=null, fund=null, authors=

欧金清（1982—），男，硕士，副主任医师，研究方向：消化内科疾病

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欧金清（1982—），男，硕士，副主任医师，研究方向：消化内科疾病

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欧金清（1982—），男，硕士，副主任医师，研究方向：消化内科疾病

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Chinese Journal of Health Statistics, 2019, 36(3): 436-440., articleTitle=Minimum clinically important difference (MCID) development methodology based on scale scores, refAbstract=null)], funds=[Fund(id=1241102830476514232, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, awardId=71373058, language=CN, fundingSource=国家自然科学基金(71373058), fundOrder=null, country=null), Fund(id=1241102831994852287, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, awardId=72164024, language=CN, fundingSource=国家自然科学基金(72164024), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241102824176669247, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, xref=1., ext=[AuthorCompanyExt(id=1241102824185057856, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, companyId=1241102824176669247, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Digestive medicine, People’s Hospital of Songgang, Baoan, Shenzhen, Guangdong 518105, China), AuthorCompanyExt(id=1241102824193446465, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, companyId=1241102824176669247, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.深圳市宝安区松岗人民医院消化内科，广东 深圳 518105)]), AuthorCompany(id=1241102824310886992, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, xref=2., ext=[AuthorCompanyExt(id=1241102824319275601, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, companyId=1241102824310886992, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.广东医科大学生命质量与应用心理研究中心/生命质量与心理测评干预重点实验室)]), AuthorCompany(id=1241102824436716121, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, xref=3., ext=[AuthorCompanyExt(id=1241102824440910424, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, companyId=1241102824436716121, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.南方医科大学附属花都医院)])], figs=[ArticleFig(id=1241102829507629929, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=EN, label=Table 1, caption=

Calculation of MCID for each domain of QLICD-PU (V2.0) with two subjective anchor methods

, figureFileSmall=null, figureFileBig=null, tableContent=
领域主观锚A（SF-36:Q1）主观锚B（医生评价）
例数治疗前()治疗后()MCID例数治疗前()治疗后()MCID
生理功能8361.01±14.8472.16±13.4311.9910160.45±15.0569.88±14.259.78
心理功能8369.55±16.0480.91±13.8412.0510169.40±15.8577.41±16.067.97
社会功能8370.63±14.4278.35±13.8810.0910169.93±15.0576.39±14.566.47
共性模块8367.11±12.6577..37±11.819.4810166.67±13.1374.70±13.268.18
特异模块8360.47±12.1972.80±10.929.6210159.33±13.8070.32±12.9810.99
量表总分8365.01±11.4475.92±10.6811.0410164.34±12.1573.31±12.169.05
), ArticleFig(id=1241102829604098931, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=CN, label=表1, caption=

以两种主观锚法计算QLICD-PU(V2.0)各领域的MCID

, figureFileSmall=null, figureFileBig=null, tableContent=
领域主观锚A（SF-36:Q1）主观锚B（医生评价）
例数治疗前()治疗后()MCID例数治疗前()治疗后()MCID
生理功能8361.01±14.8472.16±13.4311.9910160.45±15.0569.88±14.259.78
心理功能8369.55±16.0480.91±13.8412.0510169.40±15.8577.41±16.067.97
社会功能8370.63±14.4278.35±13.8810.0910169.93±15.0576.39±14.566.47
共性模块8367.11±12.6577..37±11.819.4810166.67±13.1374.70±13.268.18
特异模块8360.47±12.1972.80±10.929.6210159.33±13.8070.32±12.9810.99
量表总分8365.01±11.4475.92±10.6811.0410164.34±12.1573.31±12.169.05
), ArticleFig(id=1241102829687985021, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=EN, label=Table 2, caption=

MCID of QLICD-PU (V2.0) calculated by using distribution-based method SEM as a mediator

, figureFileSmall=null, figureFileBig=null, tableContent=
领域例数σxrttMCID
生理功能17814.040.865.25
心理功能17816.040.875.78
社会功能17815.400.846.16
共性模块17812.630.894.19
特异模块17814.980.777.18
量表总分17811.810.884.09
), ArticleFig(id=1241102829776065414, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=CN, label=表2, caption=

QLICD-PU (V2.0)以分布法SEM为中介指标来计算的MCID结果

, figureFileSmall=null, figureFileBig=null, tableContent=
领域例数σxrttMCID
生理功能17814.040.865.25
心理功能17816.040.875.78
社会功能17815.400.846.16
共性模块17812.630.894.19
特异模块17814.980.777.18
量表总分17811.810.884.09
), ArticleFig(id=1241102829901894546, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=EN, label=Table 3, caption=

MCID of QLICD-PU (V2.0) calculated by using distribution-based method ES as a mediator

, figureFileSmall=null, figureFileBig=null, tableContent=
领域SD治疗前MCID
(ES=0.2)		MCID
(ES=0.5)		MCID
(ES=0.8)
生理功能14.162.837.0811.33
心理功能16.003.208.0012.80
社会功能15.453.097.7212.36
共性模块12.682.546.3410.15
特异模块14.972.997.4811.98
量表总分11.872.375.939.49
), ArticleFig(id=1241102830027723676, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=CN, label=表3, caption=

QLICD-PU (V2.0)以分布法ES为中介指标计算的MCID

, figureFileSmall=null, figureFileBig=null, tableContent=
领域SD治疗前MCID
(ES=0.2)		MCID
(ES=0.5)		MCID
(ES=0.8)
生理功能14.162.837.0811.33
心理功能16.003.208.0012.80
社会功能15.453.097.7212.36
共性模块12.682.546.3410.15
特异模块14.972.997.4811.98
量表总分11.872.375.939.49
), ArticleFig(id=1241102830224855973, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=EN, label=Table 4, caption=

Comparisons of MCIDs by synthesizing the two methods

, figureFileSmall=null, figureFileBig=null, tableContent=
领域取平均值法取小值法取大值法
生理功能8.535.2511.99
心理功能8.455.7812.05
社会功能7.616.1610.09
共性模块7.054.199.48
特异模块8.827.1810.99
量表总分7.534.0911.04
), ArticleFig(id=1241102830329713582, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241102820670230901, language=CN, label=表4, caption=

综合两种方法的MCID比较

, figureFileSmall=null, figureFileBig=null, tableContent=
领域取平均值法取小值法取大值法
生理功能8.535.2511.99
心理功能8.455.7812.05
社会功能7.616.1610.09
共性模块7.054.199.48
特异模块8.827.1810.99
量表总分7.534.0911.04
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基于效标法与分布法的消化性溃疡生命质量测定量表的最小临床重要性差值制定与评估
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欧金清 1 , 雷平光 1 , 刘欢婷 2 , 于磊 3 , 何均辉 1 , 余洁梅 1 , 万崇华 2
现代预防医学 | 流行病与统计方法 2024,51(16): 2898-2902
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现代预防医学 | 流行病与统计方法 2024, 51(16): 2898-2902
基于效标法与分布法的消化性溃疡生命质量测定量表的最小临床重要性差值制定与评估
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欧金清1, 雷平光1, 刘欢婷2, 于磊3, 何均辉1, 余洁梅1, 万崇华2
作者信息
  • 1.深圳市宝安区松岗人民医院消化内科，广东 深圳 518105
  • 2.广东医科大学生命质量与应用心理研究中心/生命质量与心理测评干预重点实验室
  • 3.南方医科大学附属花都医院

    • 欧金清（1982—），男，硕士，副主任医师，研究方向：消化内科疾病

通讯作者:

万崇华，E-mail：
Establishment and evaluation of minimumclinically important difference of the peptic ulcer scale among the system of quality of life instruments for chronic diseases based on the anchor-based and distribution-based method
Jin-qing OU1, Ping-guang LEI1, Huan-ting LIU2, Lei YU3, Jun-hui HE1, Jie-mei YU1, Chong-hua WAN2
Affiliations
  • Department of Digestive medicine, People’s Hospital of Songgang, Baoan, Shenzhen, Guangdong 518105, China
出版时间: 2024-08-25 doi: 10.20043/j.cnki.MPM.202312186
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摘要
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目的

探讨慢性病患者生命质量测量体系之消化性溃疡量表QLICD-PU(V2.0)得分的最小临床重要性差值（MCID）。

方法

采用方便抽样，于2013年3月至2014年8月使用QLICD-PU(V2.0)量表进行问卷调查，采用效标法和分布法制定MCID，分析比较取平均值法、取小值法和取大值法制定的MCID。

结果

取平均值法得到的生理功能（8.53）、心理功能（8.45）、社会功能（7.61）、共性模块（7.05）、特异模块（8.82）和量表总分（7.53）；取小值法得到的MCID分别为5.25、5.78、6.16、4.19、7.18、4.09；取大值法得到的MCID分别为11.99、12.05、10.09、9.48、10.99、11.04。

结论

本文采用多种方法和标准制定了MCID，使用者可根据情况选用。MCID可用于评估消化性溃疡患者的临床疗效，为生命质量的应用提供参考。在后续研究中，制定的MCID值可通过临床实践进一步验证。

消化性溃疡  /  慢性病  /  生命质量  /  最小临床重要性差值
Objective

To explore the minimum clinically important difference (MCID) of peptic ulcer scale QLICD-PU (V2.0) among the System of quality of life instruments for chronic diseases.

Methods

Using convenience sampling, the questionnaire was administered from March 2013 to August 2014 using the QLICD-PU (V2.0) scale, and the MCIDs were calculatedusing the anchor-based and distribution-based methods, respectively, and analyzed to compare the MCIDs developed by taking the mean, taking the minimum, and taking the maximum methods.

Results

The MCIDs of physical functioning (8.53), psychological functioning (8.45), social functioning (7.61), general module (7.05), specific module (8.82), and overall scale (7.53) obtained by taking the mean method; the MCIDs obtained by taking the minimum method were 5.25, 5.78, 6.16, 4.19, 7.18 and 4.09, respectively; the MCID obtained by taking the maximum method were 11.99, 12.05, 10.09, 9.48, 10.99 and 11.04, respectively.

Conclusion

In this paper, MCID was formulated by using various methods and criteria, which can be chosen by the users according to the situation. MCID can be used to assess the clinical efficacy of patients with peptic ulcers for the application of quality of life. The MCID values formulated can be validated further by clinical practice in subsequent studies.

Peptic ulcer  /  Chronic disease  /  Quality of life  /  Minimum clinically important difference
欧金清, 雷平光, 刘欢婷, 于磊, 何均辉, 余洁梅, 万崇华. 基于效标法与分布法的消化性溃疡生命质量测定量表的最小临床重要性差值制定与评估. 现代预防医学, 2024 , 51 (16) : 2898 -2902 . DOI: 10.20043/j.cnki.MPM.202312186
Jin-qing OU, Ping-guang LEI, Huan-ting LIU, Lei YU, Jun-hui HE, Jie-mei YU, Chong-hua WAN. Establishment and evaluation of minimumclinically important difference of the peptic ulcer scale among the system of quality of life instruments for chronic diseases based on the anchor-based and distribution-based method[J]. Modern Preventive Medicine, 2024 , 51 (16) : 2898 -2902 . DOI: 10.20043/j.cnki.MPM.202312186
正文
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消化性溃疡（Peptic Ulcer，PU）是一种多发性和常见性疾病，具有较长的病程，且有较高的复发率，相对而言，其完全治愈相对困难[1]。这种疾病常表现为溃疡面引发的上腹部疼痛或不适症状，不仅直接影响患者的身体健康，而且对其生命质量产生深远的影响。患者经历着不断的症状和复发，使得生活质量受到持续的影响。上腹部的疼痛和不适感可能导致患者的饮食、睡眠和日常活动的困扰，进而影响其整体的生活体验。消化性溃疡的治疗过程常常是复杂而漫长的，对患者的耐受性和生活质量提出了更高的要求。慢性病患者生命质量测量体系之消化性溃疡量表QLICD-PU(Quality of Life Instruments for Chronic Diseases-Peptic Ulcer)，包括第一版QLICD-PU(V1.0)[2]和第二版QLICD-PU(V2.0)[3-4]。随着医学研究的深入，对治疗效果和患者体验进行可靠评估的工具变得至关重要。生命质量测定量表在全面评估患者的身体健康、心理状态和社会功能方面提供了丰富的信息，但要确定其得分的最小临床重要性差值MCID（Minimum Clinically Important Difference）却是一个复杂而至关重要的问题。在慢性病患者，尤其是像消化性溃疡这样的疾病中，确定MCID对于真实反映治疗效果的临床重要性至关重要。这涉及到深入理解患者的需求和感受，以便更有效地量化治疗的实际效果。一方面，MCID的制定有助于解释生命质量量表得分变化在临床上是否具有实际的、临床上显著的意义。通过确定一个阈值，可以更准确地了解患者的生命质量是否发生了有意义的变化，而不仅仅是统计学上的变异。另一方面，MCID可以作为治疗效果的评价标准之一。在临床试验或治疗过程中，通过比较患者在治疗前后的量表得分变化是否超过MCID，可以更客观地评估治疗效果的临床重要性。判断量表得分变化是否在临床上具有重要意义时，将计算的量表得分变化与设定的MCID阈值进行比较。如果变化超过了MCID，即可认为这种变化在临床上是有意义的[5]。通过评估量表得分的MCID，不仅有助于医生在临床决策中理解患者的生命质量状况，还结合患者观点和医生理解，评估临床试验所需的样本量[6]。因此，对生命质量测定量表和MCID的研究不仅有助于更深入地理解患者的生活状态，还为改善治疗效果的评估提供了重要的参考依据。
为了确保测定量表的应用具有临床意义，许多研究采用了效标法（也称锚法）(anchor-based method)[7]和分布法(distribution-based method)[8]来确定最小临床重要性差值。目前，国内关于计算MCID以及解读其临床意义的研究较少，制定方法相对不太成熟[7]，本文在已公开发表的关于制定最小临床有意义差异相关研究的基础上，探讨慢性病患者生命质量测量体系之消化性溃疡量表QLICD-PU(V2.0)得分的最小临床重要性差值（MCID），深入分析患者的生命质量得分分布，制定一个可靠且实用的最小临床重要性差值，以促进临床实践中对消化性溃疡患者生命质量的准确理解。
1　对象与方法
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1.1　对象与资料搜集
由于住院患者中消化性溃疡患者相对较少，采用方便抽样，于2013年3月至2014年8月在广东医科大学附属医院、东莞市石龙博爱医院、东莞市大朗医院以及深圳市宝安区松岗人民医院作为调查点。医学伦理学审查批准号为PJ2013037。在调查期间，纳入了这些医院收治的消化性溃疡住院患者作为调查对象，以多中心的方式搜集测试住院患者的信息。纳入标准：（1）经临床上内镜检查为消化性溃疡患者；（2）小学学历，具有一定的读写和理解能力；（3）自愿参加量表的填写。排除标准：（1）文盲或缺乏读写能力的患者；（2）住院治疗期间意识模糊，无法清楚表达感受的患者；（3）病危、患有恶性肿瘤及不愿意合作的患者。
QLICD-PU(V2.0)量表由共性和特异模块组成，其中共性模块包括三个领域（生理功能、心理功能、社会功能）28个条目。量表共计41个条目，每个条目均为五级等级式评分。相关研究证实量表QLICD-PU(V2.0)具有较好的信度效度[9]。
入院第1天进行第一次测量（治疗前测量），出院前1天再次进行测量（治疗后测量）。测定中同时使用SF-36中文版量表。
1.2　MCID制定方法
采用效标法需要在问卷中添加一个或多个与量表相关的效标，也称为锚点。这些效标通常是具有临床意义、可测量的变量，能够反映患者病情或生活质量的改变。量表评分变化的含义通过检验量表得分与效标之间关系体现[10]。
按A, B两种锚分别计算MCID。以SF-36的条目Q1（总体来讲，您的健康状况：1．非常好2．很好3．好4．一般5．差）为主观锚A，选择治疗前后该条目的选项改变一个等级的患者。以患者治疗后其主治医生对患者治疗效果的“医生评价”条目（您认为该患者住院治疗效果为：-1．恶化 0．无效1．好转 2．治愈）为主观锚B，选择治疗后该条目的选项绝对值大于等于1的患者。
分布法是通过统计方法来确定MCID。常用的效应统计指标有效应大小（ES）、标准测量误差（SEM）和标准差（SD）等[11]。本文采用ES和SEM计算MCID，计算SEM时临界值可取1（小效应）、1.96（中等效应）和2.77（大效应）[12-13]。本文取1。
1.3　质量控制
调查前对调查员进行培训，确保按统一标准进行调查。调查员以医生身份参与，说明调查内容。由患者同意签署知情同意书并自行填写QLICD-PU(V2.0)量表。现场调查中及时检查，确保无遗漏，如有发现，立即纠正。数据采取双录入方法，确保数据准确性。
1.4　统计学方法
使用Epidata 3.1双录入数据，运用SPSS 24.0进行数据统计分析，计算各领域及总量表得分，进行正态性检验。正态分布资料采用描述，非正态分布的资料使用M(QR)描述。锚法是将患者根据锚的变化分组（如显著改善、略有改善、无变化）。然后计算每组的平均变化量，通常“略有改善”组的平均变化量定义为MCID。分布法采用ES和SEM计算MCID，ES等于治疗前后量表评分的变化均值除于初始标准差。SEM等于初始评分的标准差乘以。检验水准α=0.05。
2　结果
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2.1　效标法计算MCID
SF-36的Q1与QLICP-PU(V2.0)总量表得分的相关系数r=0.389，P<0.001；“医生评价”条目与QLICP-PU(V2.0)总量表得分的相关系数r=0.118，P>0.05。有83名患者在治疗前后，主观锚A的选择改变一个等级。QLICD-PU(V2.0)的生理功能、心理功能、社会功能以及总量表的差值绝对值符合正态分布，故取均值为MCID，共性模块与特异模块为非正态分布，取其中位数作为MCID。
有101名患者的主观锚B选项绝对值等于1。各领域差值绝对值均符合正态分布，故取各领域的均值为MCID。结果见表1。
2.2　分布法计算MCID
第一次调查180例患者，完成治疗后调查的有178例。根据治疗前后两次的调查数据，可计算两个指标作为MCID，一是通过测量标准误(SEM)来计算，结果见表2。二是通过ES来计算，分别计算ES等于0.2、0.5和0.8时的治疗前后得分差值。当ES为0.5时，通常认为具有一定的反应度，故采用ES=0.5时的变化分数为最小临床有意义差异[12]。结果见表3。
2.3　综合效标法和分布法制定MCID
以上是通过效标法和分布法计算MCID，本研究中，结合了这两种方法，采用了三种不同的计算方式：平均值法、取大法和取小法，得到综合结果(其中分布法取ES=0.5)，结果见表4。
3　讨论
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在本研究中，我们运用效标法和分布法分别制定了与QLICD-PU(V2.0)量表的最小临床重要性差异（MCID）值。MCID的制定不仅弥补了P值在结果解释方面的限制，而且对解释生命质量的得分提供了更科学和直观的依据，具有更为实际的应用价值。这样MCID值的制定不仅更全面地考虑了临床意义，而且有助于更准确地理解患者在治疗过程中的生命质量变化。这为今后的研究和临床实践提供了重要的参考基准。
在效标法研究中，发现主观锚A与QLICP-PU(V2.0)总量表得分之间存在着较为显著的相关性，相关系数为0.389，这意味着主观锚A在一定程度上能够预测或反映出参与者在QLICP-PU(V2.0)总量表上的得分情况。然而，与之相比，主观锚B与总量表得分的相关系数相对较低，仅为0.118。这表明主观锚B与总量表得分之间的关联性不如主观锚A显著，因此，在解释效标法的研究结果时，更侧重于主观锚A的数据，将其作为主要依据。以SF-36量表的总体健康状况条目为主观锚A，QLICD-PU(V2.0)的最小临床有意义差异值为：生理功能（11.99）、心理功能（12.05）、社会功能（10.09）、共性模块（9.48）、特异模块（9.62）和总量表（11.04）。以医生评价为主观锚B，QLICD-PU(V2.0)各领域和总量表的MCID分别是9.78、7.97、6.47、10.99、8.18、9.05。主观锚A的MCID除特异模块以外均比主观锚B大，主观锚A计算的MCID标准变化更大，因此其效应更大。因此效标法中除特异模块使用主观锚B计算的MCID外，其他领域建议使用主观锚A计算的MCID，即各领域得分及总量表MCID为9.62~12.05。
我们还可以探讨其它锚，尤其客观锚来制定MCID。以消化性溃疡为例，采用大便常规中的隐血试验（1 正常，2 +- ，3 + ，4 ++ ，5 +++， 6 ++++及以上）作为客观锚，选取了消化性溃疡患者，入院时和出院时的隐血试验指标，筛选出差值大于等于1的患者，共计12例。这种客观锚的选择使得MCID的制定更加多维度，从生理指标出发更全面地反映了患者在治疗过程中的实质性变化。量表各领域标准分的差值不符合正态分布，取各领域的中位数为MCID。结果为生理功能（12.50），心理功能（9.09），社会功能（3.13），共性模块（8.19），特异模块（7.69），总量表（10.12）。但是例数过少导致结果可信度较低，后期可增加样本量以提高可信度。
在分布法中，以测量标准误(SEM)作为变异标准，QLICD-PU(V2.0)的MCID如下：生理功能（5.25）、心理功能（5.78）、社会功能（6.16）、特异模块（4.19）、共性模块（7.18）和总量表（4.09）。效应大小(ES)为变异标准时，QLICD-PU(V2.0)的MCID如下：生理功能（7.08）、心理功能（8.00）、社会功能（7.72）、特异模块（7.48）、共性模块（6.34）和总量表（5.93）。ES法计算的MCID各领域得分及量表总分均高于SEM法，说明采用ES法计算MCID更为保守，可能更强调对患者的实际临床影响的谨慎评估。SEM法可能导致对治疗效果的估计相对较低，更容易产生高估治疗效果的情况。因此，这样的结果可能提示在选择MCID计算方法时，需要考虑不同方法之间的差异和偏好。两种分布法MCID均低于效标法两种主观锚计算的MCID，ES法与效标法计算的MCID更接近，与头颈癌生命质量MCID的研究结果相吻合[14]。
目前关于效标法和分布法两种方法中，哪种方法计算的MCID更能准确的反映患者的临床变化尚无定论。一般认为，如果有较好的适宜的锚，应该首选效标法；没有太适宜的锚，则可以尝试不同的分布法计算。部分研究选取平均值作为最后的结果[15]。本研究采取平均值法、取大法和取小法分别计算了MCID进行比较。综合效标法和分布法得到的QLICD-PU(V2.0)量表MCID的平均值作为最后的MCID，即生理功能（8.53）、心理功能（8.45）、社会功能（7.61）、共性模块（7.05）、特异模块（8.82）和总量表（7.53）；将综合两种结果中较小的MCID值，得到最终的MCID，各领域的MCID分别为5.25、5.78、6.16、4.19、7.18、4.09；将两种结果中较大的MCID值综合，得到最终的最小临床重要性差异值，各领域的MCID分别为11.99、12.05、10.09、9.48、10.99、11.04。
三种方法各自具有优缺点，取小值法的优势在于其较高的灵敏度，能够捕捉到大多数患者在治疗前后得分有差异的情况，但却牺牲了一定的特异度。因此，其计算出的MCID相对更为保守。相反，取大值法则具有较高的特异度，有助于排除一些较小的、可能无实际临床意义的变化，但相应地降低了灵敏度。而平均法采用了综合的策略，平衡了取小值法和取大值法的优缺点，得出的MCID值相对更为中肯。这种方法旨在综合考虑患者群体的整体特点，尽可能全面而客观地揭示治疗效果的真实差异。为了使MCID在临床应用中更方便，将MCID值取整，以平均法为例，QLICD-PU(V2.0)各领域及总量表的MCID值为：9、9、8、8、9、8。
作为探索，本文提供了多种方法和标准制定的MCID，选择哪种方法取决于研究的具体目的和对灵敏度与特异度的需求。在实际应用中，研究者可以根据研究问题的特性和数据的特点，谨慎选择合适的方法，以更准确地判断患者在生命质量方面的临床重要性差异。
鉴于本文的研究对象仅来自少量医院的住院患者，可能对样本的代表性有一定程度的限制。在之后的研究中，我们将扩大样本规模，以提高样本的代表性，以更全面地反映不同人群的情况，扩大适用范围。同时，我们将继续探索采用客观锚，如大便常规中的隐血试验等，来制定MCID。这一探索旨在引入更为客观、生理学上相关的指标，以提高MCID的科学性和实用性。通过结合客观锚的信息，期望更准确地捕捉患者在治疗过程中生命质量变化的关键点，为未来的研究和实践提供更有力的依据。
基金
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  • 国家自然科学基金(71373058)
  • 国家自然科学基金(72164024)
文献
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2024年第51卷第16期
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doi: 10.20043/j.cnki.MPM.202312186
  • 接收时间：2023-12-12
  • 首发时间：2026-03-18
  • 出版时间：2024-08-25
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  • 收稿日期：2023-12-12
基金
国家自然科学基金(71373058)
国家自然科学基金(72164024)
作者信息
    1.深圳市宝安区松岗人民医院消化内科，广东 深圳 518105
    2.广东医科大学生命质量与应用心理研究中心/生命质量与心理测评干预重点实验室
    3.南方医科大学附属花都医院

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2种不同金属材料的力学参数
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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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