摘要
研究背景
盆腔器官脱垂(pelvic organ prolapse, POP)、尿失禁(urinary incontinence,UI)及子宫平滑肌瘤(uterine fibroids, UF)是女性生殖系统的常见的非致命性疾病。其中尿失禁从上世纪90年代起开始被认为是影响人类的五大疾病之一。上述三种疾病不仅给患者的生理、心理及性生活等方面带来诸多影响,而且还造成了社会的巨大经济支出,严重影响女性患者的健康相关生活质量(health-related quality of life, HRQL)。研究显示对于POP、UI及UF,临床客观检查结果并不完全与患者主观感受一致,仅依靠临床妇科查体与各项辅助检查并不能准确地反应患者病情的严重程度和评价治疗效果。
近几年使用问卷对患者HRQL评估日益普及,患者报告结果(patient reported outcomes, PRO)是POP、UI及UF诊断和疗效评价中非常重要的工具。国际上评价POP、UI及UF患者生活质量的问卷主要为英文问卷,非英文母语的问卷不能简单翻译后即被应用,应按照"WHO-QOL跨文化生活质量研究问卷翻译法”译制并经统计学方法验证后方可使用。本院妇产科已有前期研究,完成对盆腔器官脱垂与尿失禁性功能问卷简版(PISQ-12).盆底功能影响问卷简版(PFIQ-7)及尿失禁影响问卷简版(IIQ-7)的译制和验证。
国际上常用的改良女性自我形象评价量表(The Modified Body Self-Image Scale,MBIS)、国际尿控协会ICS推荐的尿失禁生活质量问卷(Incontinence Quality of Life Questionnaire,I-QOL)、作为妇科良性肿瘤常见病的子宫肌瘤症状及健康相关生活质量问卷(The Uterine Fibroid Symptom and Health-Related Quality of Life, UFS-HRQL)问卷在中国尚未经过验证,故影响临床的准确使用,是亟待解决的临床重要问题。
改良女性自我形象评价量表(MBIS)简体中文版研制与验证
目的
本研究引进国际上常用的改良女性自我形象评价量表(MBIS),对其进行中文版本的研制,并评价其在POP患者中应用的信度和效度。
方法
1.在北京协和医院妇产科门诊随机选取符合纳入标准的症状性POP患者。
2.以"WHO-QOL跨文化生活质量研究问卷翻译法”为标准对MBIS进行中文版本研制。
3.对研制的简体中文版MBIS进行中国人群的信度效度检验。
结果
1.52例符合纳入标准的POP患者参与改良女性自我形象评价量表MBIS的验证。
2.简体中文版MBIS量表总的Cranach's α系数为0.926,量表的内部一致性较好。
3.简体中文版MBIS两次调查结果各题目得分之间ICC值为0.554-0.963(P<0.01),重测信度良好,Wilcoxon符号秩检验显示两次调查中所有题目得分间的差异无统计学意义(P>0.05)。
4.因子分析结果显示简体中文版MBIS提取出的因子成分为1与制作者设计相符合,量表具有极高的结构效度。
5.简体中文版MBIS与中文版SF-12得分在0.01水平(双侧)上显著相关,Spearman相关系数r1为-0.390,相关程度普通。说明MBIS得分越高,患者生活质量越低。与简体中文版PISQ-12得分在0.01水平(双侧)上显著相关,Spearman相关系数r2为-0.709,相关程度高。说明MBIS得分越高,患者性功能评价越低。
尿失禁生活质量问卷(I-QOL)简体中文版研制与验证
目的
本研究引进国际尿控协会ICS推荐的尿失禁生活质量问卷(I-QOL),对其进行中文版本的研制,并评价其在UI患者中应用的信度和效度。
方法
1.在北京协和医院妇产科门诊随机选取符合纳入标准的UI患者。
2.以"WHO-QOL跨文化生活质量研究问卷翻译法”为标准对I-QOL进行中文版本研制。
3.对研制的简体中文版I-QOL进行中国人群的信度效度检验。
结果
1.148例符合纳入标准的UI患者参与尿失禁生活质量问卷I-QOL验证,其中SUI患者47人,UUI患者51人,MUI患者50人。
2.简体中文版I-QOL量表总的Cranach's a系数为0.963,量表的内部一致性较好。
3.两次调查简体中文版I-QOL量表结果各题目得分之间ICC值为0.74-0.96(P<0.01),重测信度良好,Wilcoxon符号秩检验显示两次调查中所有题目得分间的差异无统计学意义(P>0.05)。
4.因子分析结果显示简体中文版I-QOL提取出的因子成分为3与制作者设计相符合,量表具有极高的结构效度。
5.简体中文版I-QOL与中文版SF-12得分在0.01水平(双侧)上显著相关,Spearman相关系数r1为0.829,相关程度高。说明I-QOL得分越高,患者生活质量越高。I-QOL与1h尿垫结果在0.01水平(双侧)上显著相关,Spearman相关系数r2为-0.312,相关程度普通。说明1h尿垫结果越高,I-QOL得分越低,患者生活质量越差,与原量表设计相吻合。
子宫肌瘤症状及健康相关生活质量问卷(UFS-HRQL)简体中文版研制与验证目的
本研究引进子宫肌瘤症状及健康相关生活质量问卷(UFS-HRQL),对其进行中文版本的研制,并评价其在症状性UF患者中应用的信度和效度。
方法
1.在北京协和医院妇产科门诊随机选取符合纳入标准的症状性UF患者。
2.以"WHO-QOL跨文化生活质量研究问卷翻译法”为标准对UFS-HRQL进行中文版本研制。
3.对研制的简体中文版UFS-HRQL进行中国人群的信度效度检验。
结果
1.190例符合纳入标准的症状性UF患者参与简体中文版UFS-HRQL验证,其中拟HIFU治疗的患者18人,拟子宫肌瘤剔除术治疗125人；拟子宫切除术治疗47人。
2.简体中文版UFS-HRQL症状亚量表UFS8Cranach's a系数为0.912；生活质量亚量表HRQL Cranach's a系数0.976,说明量表的内部一致性较好。
3. UFS8亚量表两次调查结果各题目得分之间ICC值为0.572-0.951(P<0.01), HRQL亚量表该值为：0.628-0.931,(P<0.01),说明量表重测信度良好。Wilcoxon符号秩检验显示两次调查中所有题目得分间的差异无统计学意义(P>0.05)
4.因子分析结果显示UFS-HRQL生活质量亚量表提取出的因子成分为6,与制作者设计相符合,量表具有极高的结构效度。
5. UFS8亚量表与中文版SF-12得分在0.01水平(双侧)上显著相关,Spearman相关系数r1为-0.813,相关程度高。说明UFS8亚量表得分越高,患者生活质量越差。HRQL亚量表与中文版SF-12得分在0.01水平(双侧)上显著相关,Spearman相关系数r2为0.620,相关程度显著,说明HRQL亚量表得分越高,患者生活质量越高。
结论
研究结果表明,我们研制的MBIS、I-QOL及UFS-HRQL中文版本在中国人群中具有较高的信度和效度,可以作为评价相关疾病生活质量的专用量表。
Pelvic organ prolapse (POP), urinary incontinence (UI) and Uterine Fibroid(UF) are common non-fatal disease of the female reproductive system.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 POP, UI and UF clinical treatment and research. Many questionnaires currently used in pelvic floor and uterine fibroid 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; this lacks psychometric cross-language translation and validation. It impedes the domestic clinical use of questionnaires and needs to be resolved.
The validation of the Chinese version of the Modified Body Self-Image Scale (MBIS)
Objective
To evaluate the reliability and validity of the Chinese version of the Modified Body Self-Image Scale (MBIS) in patients with POP.
Methods
1. The Original English MBIS was translated into Chinese and linguistically validated following the Cross-cultural adaptation of health-related quality of life measures.
2. Patients recruited randomly from PUMCH clinics were scheduled for two visits with2weeks apart, and they were surveyed through the Chinese version of the MBIS,SF-12and PISQ-12.
3. Evaluate the reliability and validity of the Chinese version of the Modified Body Self-Image Scale.
Results
A total of52POPpatients who met the criteria participated the study,All the subscales of MBIS showed high levels of internal consistency(Cranach's α=0.926);moderate to excellent test-retest reliability(ICC:0.554-0.963,P<0.01)and acceptable construct validity. The MBIS and SF-12scores were negatively correlated.(r=-0.390;P<0.001). The MBIS scores and PISQ-12scores were negatively correlated.(r=-0.709; P<0.001).
The validation of the Chinese version of Incontinence Quality of Life Questionnaire (I-QOL)
Objective
To evaluate the reliability and validity of the Chinese version of the Incontinence Quality of Life Questionnaire (I-QOL) in patients with UI.
Methods
1. The Original English I-QOL was translated into Chinese and linguistically validated following the Cross-cultural adaptation of health-related quality of life measures.
2. Patients recruited randomly from PUMCH clinics were scheduled for two visits with2weeks apart,and they were surveyed through the Chinese version of the I-QOL,SF-12.All the patients have the1h pad test.
3. Evaluate the reliability and validity of the Chinese version of the I-QOL.
Results
A total of148POP patients who met the criteria participated the study,within SUI47,UUI51, MUI50.All the subscales of I-QOL showed high levels of internal consistency(Cranach's α=0.963); excellent test-retest reliability(ICC:0.74-0.96,P<0.01)and acceptable construct validity.The I-QOL and SF-12scores were positively correlated.(r=0.829;P<0.001). The I-QOLscores and1h pad results were negatively correlated.(r=-0.312; P<0.001).
The validation of the Chinese version of The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-HRQL)
Objective
To evaluate the reliability and validity of the Chinese version of the The Uterine Fibroid Symptom and Health-Related Quality of Life, UFS-HRQL in patients with UF.
Methods
1. The Original English UFS-HRQL was translated into Chinese and linguistically validated following the Cross-cultural adaptation of health-related quality of life measures.
2. Patients recruited randomly from PUMCH clinics were scheduled for two visits with2weeks apart,and they were surveyed through the Chinese version of the UFS-HRQL and SF-12
3. Evaluate the reliability and validity of the Chinese version of the UFS-HRQL.
Results
A total of190UF patients who met the criteria participated the study The Chinese UFS-HRQL had a high internal consistency (Cronbach's alpha,0.912-0.976and high test-retest reliability (ICC coefficient,0.572-0.951; P<0.001).The symptom severity scores and SF-12scores were negatively correlated.(r=-0.813;P<0.001). The HRQL scores and SF-12scores were positively correlated.(r=0.620; P<0.001).The factor analysis showed good construct validity.
Conclusion
Psychometric testing supports the reliability and validity of the Chinese version of the MBIS, I-QOL and UFS-HRQL as an diease-specific measure of HRQOL.
引文
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