背景:许多人认为夜尿症是一种严重的麻烦,导致健康相关生活质量(HRQOL)下降。然而,在中国环境中,缺乏符合心理测量标准的患者报告结局指标来评估夜尿症对患者的影响.本研究旨在翻译,文化适应,并验证国际尿失禁问卷夜尿症生活质量咨询模块(ICIQ-NQOL)在香港的初级保健患者中使用,中国。此外,它试图通过采用适度的中介分析来研究将夜尿症和睡眠质量与HRQOL联系起来的机制.
方法:ICIQ-NQOL的繁体中文版本是通过迭代翻译开发的,认知汇报访谈,和小组审查。心理测量评估包括对因素结构的评估,收敛有效性,并发有效性,已知组有效性,内部一致性,重测可靠性和响应性。研究仪器包括ICIQ-NQOL,国际前列腺症状评分(IPSS)匹兹堡睡眠质量指数(PSQI)和改良的失禁影响问卷-简表(IIQ-7)。
结果:从普通门诊招募了419名初级保健患者,其中228人在过去四周内平均每晚出现两次或更多次夜尿症。验证性因子分析支持ICIQ-NQOL的双因素结构。通过IIQ-7总分与总分之间的中等相关性以及ICIQ-NQOL的两个领域得分(r范围从0.43到0.49,所有p<0.001)证实了并发有效性。ICIQ-NQOL与IPSS总症状评分也有中等相关性(r范围从0.40到0.48,所有p<0.001)。总体PSQI得分与总分以及ICIQ-NQOL的两个领域得分之间的中等相关性支持了收敛有效性(r范围从0.42到0.52,所有p<0.001)。已知组比较表明,ICIQ-NQOL可以在睡眠/能量域评分方面区分有和没有夜尿症的患者(p<0.001),打扰/关注领域得分(p<0.001),和总分(p<0.001),每个都表现出适度的科恩d效应大小。校正为重叠的项目总相关性超过0.4,Cronbach的α系数大于0.7。在2周的随访中,报告夜尿症症状没有变化的患者中,通过组内相关系数超过0.7来确认测试重测可靠性。关于响应,在夜尿症改善的患者中,基线和2周随访评估之间领域和总分差异的Cohen效应大小大于0.3.我们的调节中介分析表明,睡眠质量显着减轻了夜尿症对HRQOL的影响,与男性相比,女性的间接影响明显更强。
结论:ICIQ-NQOL是评估患有夜尿症的初级保健患者的HRQOL的可靠且有效的工具。研究结果主张在夜尿症的管理和治疗中采用针对性别的方法,以优化HRQOL。
BACKGROUND: Many individuals consider nocturia a significant nuisance, leading to a reduced health-related quality of life (HRQOL). However, there has been a lack of psychometrically sound patient-reported outcome measures to assess the impact of nocturia on patients in Chinese contexts. This study aimed to translate, culturally adapt, and validate the International Consultation on Incontinence Questionnaire Nocturia Quality of Life Module (ICIQ-NQOL) for use among primary care patients in Hong Kong, China. Additionally, it sought to investigate the mechanisms that link nocturia and sleep quality with HRQOL by employing moderated mediation analysis.
METHODS: The traditional Chinese version of the ICIQ-NQOL was developed through iterative translations, cognitive debriefing interviews, and panel reviews. The psychometric evaluation included assessments of factor structure, convergent validity, concurrent validity, known-group validity, internal consistency, test-retest reliability and responsiveness. Study instruments included the ICIQ-NQOL, International Prostate Symptom Score (IPSS), Pittsburgh Sleep Quality Index (PSQI), and a modified Incontinence Impact Questionnaire-Short Form (IIQ-7).
RESULTS: A total of 419 primary care patients were recruited from general outpatient clinics, among whom 228 experiencing an average of two or more nocturia episodes per night over the past four weeks. Confirmatory factor analysis supported the two-factor structure of the ICIQ-NQOL. Concurrent validity was confirmed by moderate correlations between the IIQ-7 total score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.43 to 0.49, all p < 0.001). The ICIQ-NQOL also had moderate correlations with the IPSS total symptom score (r ranging from 0.40 to 0.48, all p < 0.001). Convergent validity was supported by moderate correlations between the global PSQI score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.42 to 0.52, all p < 0.001). Known-group comparisons showed that the ICIQ-NQOL could differentiate between patients with and without nocturia in terms of sleep/energy domain score (p < 0.001), bother/concern domain score (p < 0.001), and total score (p < 0.001), each demonstrating a moderate Cohen\'s d effect size. Item-total correlations corrected for overlap exceeded 0.4, and Cronbach\'s alpha coefficients were greater than 0.7. Test-retest reliability was confirmed with intraclass correlation coefficients exceeding 0.7 among patients reporting no change in their nocturia symptoms at a 2-week follow-up. Regarding responsiveness, the Cohen\'s d effect sizes for differences in domain and total scores between the baseline and 2-week follow-up assessments were greater than 0.3 among patients showing improvement in nocturia. Our moderated mediation analysis indicated that sleep quality significantly moderated the impact of nocturia on HRQOL, with a notably stronger indirect effect among females compared to males.
CONCLUSIONS: The ICIQ-NQOL is a reliable and valid instrument for assessing the HRQOL in primary care patients suffering from nocturia. The findings advocate for gender-specific approaches in the management and treatment of nocturia to optimize HRQOL.