School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 5/F, Academic Building, 3 Sassoon Road Pokfulam, Hong Kong SAR, China.
School of Nursing, Faculty of Health and Social Development, University of British Columbia, Kelowna, Canada.
J Patient Rep Outcomes. 2024 Aug 7;8(1):86. doi: 10.1186/s41687-024-00756-2.
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.
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).
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.
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.
许多人认为夜尿症是一种严重的困扰，导致健康相关生活质量（HRQOL）下降。然而，在中文环境下，缺乏经过心理测量验证的患者报告结局测量工具来评估夜尿症对患者的影响。本研究旨在翻译、文化适应和验证国际尿失禁咨询问卷夜尿症生活质量模块（ICIQ-NQOL），用于中国香港的初级保健患者。此外，还通过调节中介分析研究了将夜尿症与睡眠质量与 HRQOL 联系起来的机制。
通过迭代翻译、认知审阅访谈和小组审查，开发了 ICIQ-NQOL 的繁体中文版。心理测量评估包括因子结构、收敛效度、同时效度、已知组效度、内部一致性、重测信度和反应性。研究工具包括 ICIQ-NQOL、国际前列腺症状评分（IPSS）、匹兹堡睡眠质量指数（PSQI）和改良的尿失禁影响问卷-短表（IIQ-7）。
共有 419 名初级保健患者从普通门诊招募，其中 228 名患者在过去四周内平均每晚经历两次或两次以上的夜尿症发作。验证性因子分析支持 ICIQ-NQOL 的两因素结构。同时效度通过 IIQ-7 总分与 ICIQ-NQOL 的总分以及两个领域得分之间的中度相关性得到证实（r 范围为 0.43 至 0.49，均 p<0.001）。ICIQ-NQOL 还与 IPSS 总症状评分中度相关（r 范围为 0.40 至 0.48，均 p<0.001）。汇聚效度通过全球 PSQI 得分与 ICIQ-NQOL 的总分和两个领域得分之间的中度相关性得到支持（r 范围为 0.42 至 0.52，均 p<0.001）。已知组比较表明，ICIQ-NQOL 可以区分有夜尿症和无夜尿症患者在睡眠/能量域评分（p<0.001）、烦恼/关注域评分（p<0.001）和总分（p<0.001）方面的差异，每个方面的 Cohen's d 效应大小为中度。经重叠校正的项目-总分相关性超过 0.4，Cronbach's alpha 系数大于 0.7。在两周随访时报告夜尿症症状无变化的患者中，内部一致性系数（ICC）超过 0.7，证实了重测信度。关于反应性，在基线和两周随访评估之间，域和总分的差异，Cohen's d 效应大小在夜尿症改善的患者中大于 0.3。我们的调节中介分析表明，睡眠质量显著调节了夜尿症对 HRQOL 的影响，女性的间接影响明显强于男性。
ICIQ-NQOL 是一种可靠且有效的工具，可用于评估夜尿症初级保健患者的 HRQOL。研究结果主张针对夜尿症采用性别特异性的管理和治疗方法，以优化 HRQOL。
