Clinical Outcomes Solutions, Tucson, AZ, USA.
Clinical Outcomes Solutions, 1820 E River Rd, Ste 220, Tucson, AZ, 85718, USA.
Qual Life Res. 2022 Jun;31(6):1837-1848. doi: 10.1007/s11136-021-03060-4. Epub 2021 Dec 21.
Psychometric evaluation of the Nocturia Impact (NI) Diary was conducted to support its use as a trial endpoint.
As part of a randomized, controlled Phase 2 clinical trial investigating a novel drug candidate for nocturnal polyuria, adult nocturia patients completed the NI Diary and a voiding diary for three nights preceding their clinic visit at Baseline and Weeks 1, 4, 8, and 12 (end of treatment). Exit interviews were conducted to obtain patient impressions of the NI Diary.
A total of N = 302 participants were included. Confirmatory factor analysis (CFA) indicated that the 11-item measure is unidimensional with values of CFI, TLI, and RMSEA meeting relevant thresholds. Good internal consistency (Cronbach's α 0.941) and test-retest reliability (intra-class correlation coefficients 0.730-0.880). Convergent validity with two reference measures was demonstrated with strong correlations of 0.573-0.730 were shown. Significant differences (P = 0.0018, standardized effect size = 0.372) between groups defined by number of night-time voids supported known-groups validity. Exit interviews in 66 patients indicated all participants experienced improvement in at least 1 NI Diary item and that a 1-point improvement on the item response scale and 1-void reduction per night (associated with an average best cut point on ROC analysis of - 11.6) constituted meaningful improvement. Anchor and distribution-based analyses identified a meaningful change threshold of - 15 to - 18 points on the NI Diary.
The NI Diary is a reliable and valid patient-reported psychometric instrument which is fit-for-purpose to evaluate the impact of nocturia on patient quality of life in the clinical trial setting. Trial registration number and registration date NCT03201419; June 28, 2017.
对夜间多尿症影响（NI）日记进行心理计量学评估，以支持将其用作试验终点。
作为一项针对夜间多尿症新型候选药物的随机、对照 2 期临床试验的一部分，成年夜间多尿症患者在基线和第 1、4、8 和 12 周（治疗结束时）就诊前的三个晚上填写 NI 日记和排尿日记。进行退出访谈以获取患者对 NI 日记的印象。
共纳入 302 名参与者。验证性因子分析（CFA）表明，该 11 项测量具有单维性，其 CFI、TLI 和 RMSEA 值均符合相关标准。良好的内部一致性（Cronbach's α 0.941）和测试-重测信度（内类相关系数 0.730-0.880）。与两个参考测量值的收敛效度通过显示 0.573-0.730 的强相关性得到证明。根据夜间排尿次数定义的组间差异具有统计学意义（P=0.0018，标准化效应量=0.372），支持已知组间的有效性。对 66 名患者的退出访谈表明，所有参与者在至少 1 项 NI 日记项目中都有改善，并且项目反应量表上的 1 分改善和每晚减少 1 次排尿（与 ROC 分析中平均最佳切点相关，为-11.6）构成了有意义的改善。锚定和基于分布的分析确定 NI 日记的有意义变化阈值为-15 至-18 分。
NI 日记是一种可靠和有效的患者报告心理计量学工具，适用于评估夜间多尿症对临床试验中患者生活质量的影响。试验注册号和注册日期 NCT03201419；2017 年 6 月 28 日。
