Holm-Larsen Tove, Andersson Fredrik, van der Meulen Egbert, Yankov Vladimir, Rosen Raymond C, Nørgaard Jens Peter
Pharma Evidence, Farum, Denmark; Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
Ferring International PharmaScience Center, Copenhagen, Denmark; Center for Medical Technology Assessment, Linköping University, Linköping, Sweden.
Value Health. 2014 Sep;17(6):696-706. doi: 10.1016/j.jval.2014.06.007. Epub 2014 Aug 20.
Nocturia is a chronic, fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life. Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment, but the available tools are suboptimal.
This study reports the development and validation of the Nocturia Impact Diary-an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary.
The process comprised three steps: Step 1: Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; Step 2: Content validity study; Step 3: Psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo-controlled study in patients with nocturia.
Step 1: Fourteen items and 4 domains were included in the first draft of the diary. Step 2: Twenty-three patients with nocturia participated in the cognitive debriefing study. Items were adjusted accordingly, and the content validity was high. Step 3: Fifty-six patients were randomized to desmopressin orally disintegrating tablet or placebo. The diary demonstrated high construct validity, with good sensitivity and a good fit to Rasch model, as well as high internal consistency, discriminatory ability, and acceptable sensitivity to change. Results indicated that the diary was unidimensional.
The Nocturia Impact Diary is a convenient, validated patient-reported outcome measure. It should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment.
夜尿症是一种慢性、波动的疾病，会扰乱睡眠并对生活质量产生广泛影响。有效的工具来衡量患者报告的夜尿症影响对于评估治疗价值至关重要，但现有的工具并不理想。
本研究报告了夜尿症影响日记的开发和验证，这是夜尿症生活质量问卷的一种增强形式，旨在与广泛使用的3天排尿日记一起完成。
该过程包括三个步骤：步骤1：使用夜尿症生活质量问卷和相关研究数据开发概念池；步骤2：内容效度研究；步骤3：在夜尿症患者的随机、安慰剂对照研究中对日记的结构效度、信度和敏感性进行心理测量测试。
步骤1：日记初稿包含14个项目和4个领域。步骤2：23名夜尿症患者参与了认知反馈研究。项目相应调整，内容效度高。步骤3：56名患者被随机分配接受去氨加压素口腔崩解片或安慰剂。该日记显示出高结构效度，具有良好的敏感性且与拉施模型拟合良好，同时具有高内部一致性、区分能力和可接受的变化敏感性。结果表明该日记是单维的。
夜尿症影响日记是一种方便、经过验证的患者报告结局测量工具。它应与排尿日记一起使用，以了解夜尿症及其治疗的实际后果。
