女性盆底功能障碍性疾病问卷中文版本研制与中国人群验证
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摘要
背景
女性盆底功能障碍性疾病(PFD)是一组以尿失禁(UI)、粪失禁(FI)以及盆腔器官脱垂(POP)为主的疾病症候群,经常合并发生。对于此类疾病的治疗,除了解剖学上的恢复外,更重要的是要改善患者的生活质量。问卷作为一种以患者为主导的评估方式,在PFD疾病临床治疗以及研究中,应用日益广泛。国际上应用于PFD的问卷较多,多为英文问卷,非英文母语的问卷不能简单翻译后即被应用,应进行验证后方可使用，国际上常用的盆底功能障碍性疾病问卷在中国尚未经过验证,故影响临床的准确使用,是亟待解决的重要问题。
目的
本研究引进尿失禁影响问卷简版ⅡQ-7、盆底功能障碍影响问卷PFIQ-7以及盆腔器官脱垂/尿失禁性功能问卷简版PISQ-12等国际尿控委员会(ICS)推荐问卷,对其进行中文版本的研制和中国人群信度、效度验证,并对健康调查12条简表SF-12进行简体中文修正,验证其在中国人群的信度。
方法
1.严格按照心理测量学原则,对中国大陆尿失禁影响问卷简版(ⅡQ-7)、盆底功能障碍性疾病(PFIQ-7)以及盆底器官脱垂/尿失禁性功能问卷简版(PISQ-12)进行了中文版本的研制；
2.对经过香港人群效度检验的繁体版生活质量健康调查12条(SF-12)简表问卷进行了简体中文修正版的研制；
3.对研制的尿失禁影响问卷简版(ⅡQ-7)、盆底功能障碍性疾病(PFIQ-7)以及盆底器官脱垂/尿失禁性功能问卷简版(PISQ-12)进行了中国人群的信度效度检验,对简体修正版(SF-12)在盆底功能性障碍性疾病人群中进行了信度检验。
结果
74位尿失禁患者完成了IIQ-7中文版、SF-12问卷以及1h尿垫实验；134位尿失禁/盆腔器官脱垂患者完成了PFIQ-7以及SF-12问卷；86位被调查者(其中患者组45位,对照组41位)完成了PISQ-12以及SF-12问卷并对健康调查12条简表。
研究结果显示四款问卷均具有较高的内部一致性(尿失禁影响问卷简版IIQ-7、盆底功能障碍影响问卷简版PFIQ-7、盆腔器官脱垂/尿失禁性功能问卷简版PISQ-12以及健康调查12条简表SF-12的Cronbach's alpha分别为0.824、0.801、0.725和0.881),较高重测信度(IIQ-7、PFIQ-7、PISQ-12以及SF-12的组内相关性分析相关系数分别为0.749、0.862、0.745和0.845)和足够的分半信度(IIQ-7、PFIQ-7、PISQ-12以及SF-12的分半Cronbach's alpha分别为0.696/0.707,0.742/0.789,0.649/0.597和0.776/0.805),所有信度检验P值均小于0.01；PFIQ-7和IIQ-7得分与SF-12得分成负相关,P值小于0.01,IIQ-7得分与1h尿垫实验成正相关,P值小于0.01,IIQ-7得分与患者病程成正相关,P值小于0.05,PISQ-12得分与SF-12得分成正相关,P值小于0.01；因子分析显示ⅡQ-7、PFIQ-7以及PISQ-12提取因子与问卷理论结构基本相符。
结论
1.研究结果表明,我们研制的ⅡQ-7、PFIQ-7以及PISQ-12中文版本在中国人群中具有较高的信度和效度,我们研制的健康调查12条简表简体修正版(SF-12)有较好的信度,适合中国大陆科研和临床使用。当然一份优秀的问卷也应当具有良好的反应性(responsiveness),其反应性可在以后的科研或临床使用进一步验证。
2.本研究填补了国内(大陆)女性盆底功能障碍性疾病问卷中文版本研制和人群验证的空白,使中国的盆底功能障碍性疾病患者有了能真正准确反映他们疾病状态的评估问卷。
Female pelvic floor disorders (PFD) is a group of diseases, including urinary incontinence (UI), fecal incontinence (FI) and pelvic organ prolapse (POP), which often combine with each other. Treatment for such diseases, in addition to anatomic reconstruction, the more important is to improve patient's quality of life. Questionnaire as an assessment of patient-oriented approach is widely used in the PFD clinical treatment and research. Mmany questionnaires currently used in pelvic floor research were validated in population of middle class Americans in American English most of them were validated in the target languages. As the conditions of domestic clinicians, most of the clinical used questionnaires were self-translated, which lacks psychometric cross-language translation and validation. It impedes the domestic clinical use of questionnaires and needs to be resolved.
Objective
In this study, we introduced IIQ-7, PFIQ-7and another ICS recommended PISQ-12questionnaires. After developing the Chinese version of the above instruments,we aimed at validating them in the Chinese population. The Simplified Chinese version of SF-12was also developed, whose reliability was also verified in this study.
Method
1. According to the principles of psychometrics, the Chinese version of IIQ-7, PFIQ-7and PISQ-12were developed;
2. The Simplified Chinese version of SF-12which has been validated in the Hongkong Chinese population was developed from the Traditional Hongkong Chinese;
3. We validated the IIQ-7, PFIQ-7and PISQ-12in the Chinese population, and test the reliability of SF-12in the PFD patients.
Result
74patients with urinary incontinence completed the IIQ-7Chinese version and SF-12questionnaires, after that the1h pad test was made;134incontinence/pelvic organ prolapse patients completed PFIQ-7and SF-12questionnaires;86respondents (45in the patients group and41in the control group) completed the PISQ-12and the SF-12questionnaires.
All of the4questionnaires have high internal consistency (the Cronbach's alpha of IIQ-7, PFIQ-7, PISQ-12and SF-12were0.824,0.801,0.725and0.881independently), high test-retest reliability (the ICC coefficients of IIQ-7, PFIQ-7, PISQ-12and SF-12were0.749,0.862,0.745and0.845), adequate split-half reliability (the half Cronbach's alpha for IIQ-7, PFIQ-7, PISQ-12and SF-12were0.696/0.707,0.742/0.789,0.649/0.597and0.776/0.805). Of all the reliability test P <0.01; PFIQ-7and IIQ-7scores were negatively correlated with SF-12scores (P <0.01), IIQ-7scores were positively correlated with1h pad test (P<0.01), IIQ-7scores were positively correlated with the course of disease (P<0.05), PISQ-12scores and SF-12scores were positively correlated (P<0.01); factor analysis of IIQ-7, PFIQ-7and PISQ-12showed good construct validity.
Conclusion
The Chinese version of IIQ-7, PFIQ-7and PISQ-12has high reliability and validity in the Chinese population (Mainland). They are highly recommended for clinical treatment and research. Of course, a good questionnaire should also have good responsiveness, which may be verified in future researches and clinical use.
This study has filled the domestic (mainland) gap of psychometric translation and validation of PFD questionnaires. From now on, we have validated questionnaires for PFD research and clinical use.
女性盆底功能障碍性疾病(PFD)是一组以尿失禁(UI)、粪失禁(FI)以及盆腔器官脱垂(POP)为主的疾病症候群,经常合并发生。对于此类疾病的治疗,除了解剖学上的恢复外,更重要的是要改善患者的生活质量。问卷作为一种以患者为主导的评估方式,在PFD疾病临床治疗以及研究中,应用日益广泛。国际上应用于PFD的问卷较多,多为英文问卷,非英文母语的问卷不能简单翻译后即被应用,应进行验证后方可使用，国际上常用的盆底功能障碍性疾病问卷在中国尚未经过验证,故影响临床的准确使用,是亟待解决的重要问题。
目的
本研究引进尿失禁影响问卷简版ⅡQ-7、盆底功能障碍影响问卷PFIQ-7以及盆腔器官脱垂/尿失禁性功能问卷简版PISQ-12等国际尿控委员会(ICS)推荐问卷,对其进行中文版本的研制和中国人群信度、效度验证,并对健康调查12条简表SF-12进行简体中文修正,验证其在中国人群的信度。
方法
1.严格按照心理测量学原则,对中国大陆尿失禁影响问卷简版(ⅡQ-7)、盆底功能障碍性疾病(PFIQ-7)以及盆底器官脱垂/尿失禁性功能问卷简版(PISQ-12)进行了中文版本的研制；
2.对经过香港人群效度检验的繁体版生活质量健康调查12条(SF-12)简表问卷进行了简体中文修正版的研制；
3.对研制的尿失禁影响问卷简版(ⅡQ-7)、盆底功能障碍性疾病(PFIQ-7)以及盆底器官脱垂/尿失禁性功能问卷简版(PISQ-12)进行了中国人群的信度效度检验,对简体修正版(SF-12)在盆底功能性障碍性疾病人群中进行了信度检验。
结果
74位尿失禁患者完成了IIQ-7中文版、SF-12问卷以及1h尿垫实验；134位尿失禁/盆腔器官脱垂患者完成了PFIQ-7以及SF-12问卷；86位被调查者(其中患者组45位,对照组41位)完成了PISQ-12以及SF-12问卷并对健康调查12条简表。
研究结果显示四款问卷均具有较高的内部一致性(尿失禁影响问卷简版IIQ-7、盆底功能障碍影响问卷简版PFIQ-7、盆腔器官脱垂/尿失禁性功能问卷简版PISQ-12以及健康调查12条简表SF-12的Cronbach's alpha分别为0.824、0.801、0.725和0.881),较高重测信度(IIQ-7、PFIQ-7、PISQ-12以及SF-12的组内相关性分析相关系数分别为0.749、0.862、0.745和0.845)和足够的分半信度(IIQ-7、PFIQ-7、PISQ-12以及SF-12的分半Cronbach's alpha分别为0.696/0.707,0.742/0.789,0.649/0.597和0.776/0.805),所有信度检验P值均小于0.01；PFIQ-7和IIQ-7得分与SF-12得分成负相关,P值小于0.01,IIQ-7得分与1h尿垫实验成正相关,P值小于0.01,IIQ-7得分与患者病程成正相关,P值小于0.05,PISQ-12得分与SF-12得分成正相关,P值小于0.01；因子分析显示ⅡQ-7、PFIQ-7以及PISQ-12提取因子与问卷理论结构基本相符。
结论
1.研究结果表明,我们研制的ⅡQ-7、PFIQ-7以及PISQ-12中文版本在中国人群中具有较高的信度和效度,我们研制的健康调查12条简表简体修正版(SF-12)有较好的信度,适合中国大陆科研和临床使用。当然一份优秀的问卷也应当具有良好的反应性(responsiveness),其反应性可在以后的科研或临床使用进一步验证。
2.本研究填补了国内(大陆)女性盆底功能障碍性疾病问卷中文版本研制和人群验证的空白,使中国的盆底功能障碍性疾病患者有了能真正准确反映他们疾病状态的评估问卷。
Female pelvic floor disorders (PFD) is a group of diseases, including urinary incontinence (UI), fecal incontinence (FI) and pelvic organ prolapse (POP), which often combine with each other. Treatment for such diseases, in addition to anatomic reconstruction, the more important is to improve patient's quality of life. Questionnaire as an assessment of patient-oriented approach is widely used in the PFD clinical treatment and research. Mmany questionnaires currently used in pelvic floor research were validated in population of middle class Americans in American English most of them were validated in the target languages. As the conditions of domestic clinicians, most of the clinical used questionnaires were self-translated, which lacks psychometric cross-language translation and validation. It impedes the domestic clinical use of questionnaires and needs to be resolved.
Objective
In this study, we introduced IIQ-7, PFIQ-7and another ICS recommended PISQ-12questionnaires. After developing the Chinese version of the above instruments,we aimed at validating them in the Chinese population. The Simplified Chinese version of SF-12was also developed, whose reliability was also verified in this study.
Method
1. According to the principles of psychometrics, the Chinese version of IIQ-7, PFIQ-7and PISQ-12were developed;
2. The Simplified Chinese version of SF-12which has been validated in the Hongkong Chinese population was developed from the Traditional Hongkong Chinese;
3. We validated the IIQ-7, PFIQ-7and PISQ-12in the Chinese population, and test the reliability of SF-12in the PFD patients.
Result
74patients with urinary incontinence completed the IIQ-7Chinese version and SF-12questionnaires, after that the1h pad test was made;134incontinence/pelvic organ prolapse patients completed PFIQ-7and SF-12questionnaires;86respondents (45in the patients group and41in the control group) completed the PISQ-12and the SF-12questionnaires.
All of the4questionnaires have high internal consistency (the Cronbach's alpha of IIQ-7, PFIQ-7, PISQ-12and SF-12were0.824,0.801,0.725and0.881independently), high test-retest reliability (the ICC coefficients of IIQ-7, PFIQ-7, PISQ-12and SF-12were0.749,0.862,0.745and0.845), adequate split-half reliability (the half Cronbach's alpha for IIQ-7, PFIQ-7, PISQ-12and SF-12were0.696/0.707,0.742/0.789,0.649/0.597and0.776/0.805). Of all the reliability test P <0.01; PFIQ-7and IIQ-7scores were negatively correlated with SF-12scores (P <0.01), IIQ-7scores were positively correlated with1h pad test (P<0.01), IIQ-7scores were positively correlated with the course of disease (P<0.05), PISQ-12scores and SF-12scores were positively correlated (P<0.01); factor analysis of IIQ-7, PFIQ-7and PISQ-12showed good construct validity.
Conclusion
The Chinese version of IIQ-7, PFIQ-7and PISQ-12has high reliability and validity in the Chinese population (Mainland). They are highly recommended for clinical treatment and research. Of course, a good questionnaire should also have good responsiveness, which may be verified in future researches and clinical use.
This study has filled the domestic (mainland) gap of psychometric translation and validation of PFD questionnaires. From now on, we have validated questionnaires for PFD research and clinical use.
引文
[1].Bland JM, Altman DG. Statistics notes:validating scales and indexes. BMJ 2002; 324:606-607
[2].Guyatt GH, Feeny DH, Patric DL. Measuring health-related quality of life. Ann Intern Med 1993; 118:622-629
[3].Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003; 56:395-407
[4].Naughton MJ, Donvan J, Badia X, Corcos J, Gotoh M, Kelleher C, LukacsB, Shaw C. Symptom severity and QOL scales for urinary incontinence. Gastroenterology 2004; 126:S114-S123
[5].Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 2001; 185:1338-1395
[6],Barber MD. Questionnaires for women with pelvic floor disorders. Int Urogynecol J 2007; 18:461-465
[7].Omotosho TB, Rogers RG. Shortcomings/strengths of specific sexual function questionnaires currently used in urogynecol ogy:a literature review. Int Urogynecol J 2009; 20 (Suppl 1):S51-S56
[8].Rogers RG, Kammerer-Doak D, Villarreal A, Coates K, Quells C. A new instrument to measure sexual functiorr in women with urinary incontinence and pelvic organ prolapse. Am J Obstet Gynecoi 2001; 184:552-558
[9].Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J 2003; 14:164-168
[10]. Romero AA, Hardart A, Kobak W, Qualls C, Rogers R. Validation of a Spanish Version of the Pelvic Organ Prolapse Incontinence Sexual Questionnaire. Obstet Gynecol 2003; 102:1000-1005
[11]. Fatton B, Letouzey V, Lagrange E, Mares P etc. Validation of a French version of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). J Gynecol Obstet Biol Reprod (Paris) 2009 Dec; 38(8):662-667
[12]. Cetin C, Pinar S, Nazan K, Ali S, Cem C, Ates K. Validation of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) in a Turkish population. Euro J Obstet Gynecol Repro Bio 146 2009: 104-107
[13]. Avery KNL, Bosch JLHR, etc. Questionnaires to Assess Urinary and Anal Incontinence:Review and Recommendations. J Urology 2007; 177 (1):39-49
[14]. Zhu L, Lang J, Liu C, Han S, Huang J, Li X The epidemiological study of women with urinary incontinence and risk factors for stress urinary incontinence in China. Menopause 2009; 16:831-836
[15]. 李鲁,王红姝,沈毅.SF-36健康调查量表中文版的研制及其性能测试.中华预防医学杂志2002；36(2)：109-113
[16]. Cindy LKL, Eileen YYT, Barbara G Is the standard SF-12 Health Survey valid and equivalent for a Chinese population? Qual Life Res 2005; 14:539-547
[17]. Woodmanl PJ, Miskol CA, Fischer JR. The Use of Short-Form Quality of Life Questionnaires to Measure the Impact of Imipramine on Women with Urge Incontinence. Int Urogynecol J 2001; 12:312-316
[18]. Brislin R. Questionnaire wording and translation. In:Lonner W, Thorndike R (eds) Cross-cultural research methods, Wiley, New York, pp 32-58
[19]. Sperber AD. Translation and validation of study instruments for cross cultural research. Gastroenterology 2004; 126; S124-128
[20]. 张迎辉,鲁永鲜.盆底功能障碍研究中的问卷调查.中华妇产科杂志2009；44(12)：956-959
[21]. Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA, for the Continence Program for Women Research Group. Health-related quality of life measures for women with urinary incontinence:the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Quality Life Res 1994;3:291-306
[22]. Bryant FB, Yarnold PR Principal components analysis and exploratory and confirmatory factor analysis. In:GrimmLG,Yarnold Int Urogynecol J PR (eds) Reading and understanding multivariate analysis. (1995) AmericanPsychological Association Books, Washington DC, pp 99-136
[23]. Gorusch RL Factor Analysis (1983),2nd edn. Lawrence Erlbaum Associates, Hillsdale
[24]. 柯惠新等编著调查研究中的统计分析法北京广播学院出版社,1992
[2].Guyatt GH, Feeny DH, Patric DL. Measuring health-related quality of life. Ann Intern Med 1993; 118:622-629
[3].Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003; 56:395-407
[4].Naughton MJ, Donvan J, Badia X, Corcos J, Gotoh M, Kelleher C, LukacsB, Shaw C. Symptom severity and QOL scales for urinary incontinence. Gastroenterology 2004; 126:S114-S123
[5].Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 2001; 185:1338-1395
[6],Barber MD. Questionnaires for women with pelvic floor disorders. Int Urogynecol J 2007; 18:461-465
[7].Omotosho TB, Rogers RG. Shortcomings/strengths of specific sexual function questionnaires currently used in urogynecol ogy:a literature review. Int Urogynecol J 2009; 20 (Suppl 1):S51-S56
[8].Rogers RG, Kammerer-Doak D, Villarreal A, Coates K, Quells C. A new instrument to measure sexual functiorr in women with urinary incontinence and pelvic organ prolapse. Am J Obstet Gynecoi 2001; 184:552-558
[9].Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J 2003; 14:164-168
[10]. Romero AA, Hardart A, Kobak W, Qualls C, Rogers R. Validation of a Spanish Version of the Pelvic Organ Prolapse Incontinence Sexual Questionnaire. Obstet Gynecol 2003; 102:1000-1005
[11]. Fatton B, Letouzey V, Lagrange E, Mares P etc. Validation of a French version of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). J Gynecol Obstet Biol Reprod (Paris) 2009 Dec; 38(8):662-667
[12]. Cetin C, Pinar S, Nazan K, Ali S, Cem C, Ates K. Validation of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) in a Turkish population. Euro J Obstet Gynecol Repro Bio 146 2009: 104-107
[13]. Avery KNL, Bosch JLHR, etc. Questionnaires to Assess Urinary and Anal Incontinence:Review and Recommendations. J Urology 2007; 177 (1):39-49
[14]. Zhu L, Lang J, Liu C, Han S, Huang J, Li X The epidemiological study of women with urinary incontinence and risk factors for stress urinary incontinence in China. Menopause 2009; 16:831-836
[15]. 李鲁,王红姝,沈毅.SF-36健康调查量表中文版的研制及其性能测试.中华预防医学杂志2002；36(2)：109-113
[16]. Cindy LKL, Eileen YYT, Barbara G Is the standard SF-12 Health Survey valid and equivalent for a Chinese population? Qual Life Res 2005; 14:539-547
[17]. Woodmanl PJ, Miskol CA, Fischer JR. The Use of Short-Form Quality of Life Questionnaires to Measure the Impact of Imipramine on Women with Urge Incontinence. Int Urogynecol J 2001; 12:312-316
[18]. Brislin R. Questionnaire wording and translation. In:Lonner W, Thorndike R (eds) Cross-cultural research methods, Wiley, New York, pp 32-58
[19]. Sperber AD. Translation and validation of study instruments for cross cultural research. Gastroenterology 2004; 126; S124-128
[20]. 张迎辉,鲁永鲜.盆底功能障碍研究中的问卷调查.中华妇产科杂志2009；44(12)：956-959
[21]. Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA, for the Continence Program for Women Research Group. Health-related quality of life measures for women with urinary incontinence:the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Quality Life Res 1994;3:291-306
[22]. Bryant FB, Yarnold PR Principal components analysis and exploratory and confirmatory factor analysis. In:GrimmLG,Yarnold Int Urogynecol J PR (eds) Reading and understanding multivariate analysis. (1995) AmericanPsychological Association Books, Washington DC, pp 99-136
[23]. Gorusch RL Factor Analysis (1983),2nd edn. Lawrence Erlbaum Associates, Hillsdale
[24]. 柯惠新等编著调查研究中的统计分析法北京广播学院出版社,1992